SURGICAL PRODUCTS

APPAVISC^®

(Hydroxypropyl Methylcellulose Ophthalmic Solution USP)

Preservative Free Sterile Solution

DESCRIPTION:

APPAVISC (Hydroxypropyl Methylcellulose Opthalmic Solution USP) is sterile, a pyrogen free clear & transparent viscous solution of highly purified HPMC. The chemical name of active ingredient is Cellulose 2-hydroxypropyl methyl ether. Each mL contains: Hydroxyp ropyl Methylcellulose USP 2% w/v & Sterile isotonic base q.s.

MODE OF ACTION (Mechanism Of Action)

HPMC consists of large macromolecules that exert a protective effect on ocular tissue during surgical procedures. It limits the mechanical damage from invasive procedures by separating and lubricating tissues. The HPMC also shows to decrease the damage of corneal endothelial surgery.
It is routinely used as an adjuvant in cataract surgery, IOL, corneal transplantation and surgery of glaucoma.HPMC goes well with the lens and other corneal surfaces because of its low contact angle.

INTENDED USE

Appavisc is indicated as a surgical aid (medical device ) in anterior segment surgical procedures involving the anterior chamber of the eye, including extraction of the lens and insertion of intraocular lenses. It maintains the depth of the anterior chamber during the whole surgical procedure and permits greater operative precision without the risk o f damaging the endothelium of the cornea or other intraocular tissues.

CONTRAINDICATIONS

APPAVISC is contraindicated in patients with glaucoma and Contraindicated in patients with known history hypersensitivity to its ingredients.

WARNING

Do not use if the solution becomes dark brown or any floating particles are observed If pouch is damaged should not be reused. In-case of any serious accident in relation to the device, inform to the manufacturer and to the regulatory authority.

PRECAUTIONS

GENERAL: Overfilling of APPAVISC in anterior chamber should be avoided as it may raise lOP cause glaucoma. APPAVISC is to be removed out of eye after the surgery by irrigation or aspiration. IOP should be monitored, especially after the end of surgery. If IOP is recorded, the appropriate therapy should be employed. APPAVISC should be introduced in anterior chamber such that no air bubble should be trapped in HPMC. Vials and cannula once used should be discarded.

DRUG INTERACTIONS

Since HPMC is an inert substance and does not have any pharmacological action, no evidence suggests that the drug in intraocular millieu bind to APPAVISC solution to any significant degree. There is no evidence of drug binding established so far.

SIDE EFFECTS

APPAVISC has the risk of IOP elevation. The viscoelastic substances that are not removed from the eye after surgery is not degraded to any significant degree when in the anterior chamber. It obstructs the outflow mainly trabucular meshwork into schlemms canal. A spike of IOP is more likely to occur in early hours of surgery (maximum 4-7 hours and often returns to baseline 24 hours). Residual effect of retained Viscoelastic material in anterior chamber should be considered in the differential diagnosis of corneal edema. Severe corneal edema may occur due to thiomersal residues of reused Viscoelastic cannulas. There is a significant cell death at 30 minutes and near complete cell deaths at 2 hours if viscoelastic reused cannulas are used. Severe corneal edema may occur if the contact time of the viscoelastics with corneal endothelium by using reused cannula, following instillation, Additional events occurring includes corneal staining, keratopathy/keratitis, allergic reactions, lid edema, tearing, photophobia, corneal infiltrates, nausea and decreased vision.

DOSAGE AND ADMINISTRATION

APPAVISC (Hydroxypropyl Methylcellulose Ophthalmic Solution USP) should be carefully introduced into the anterior chamber using the sterile cannula supplied along with the pack. It may be injected into the chamber prior to or following delivery of intraocular lens (IOL). It may be used to coat an intraocular lens as well as tips of surgical instruments prior to implantation which protect the corneal endothelium from possible damage during cataract surgical procedure.

PREPARATION & ADMINISTRATION GUIDE

Appavisc should be held at room temperature for approximately 30 minutes before use. Protect from freezing and exposure to light. For intraocular use.
1. Remove the vial from its packging in a sterile environment
2. Open the vial, withdraw the solution using sterile disposable syringe
3. Open the cannula and firmly screw it into the lock fitting
4. Depress the pluger and discard the first 0.1 to 0.3 ml of fluid
5. Do not overfill the eye chamber with Appavisc.
6. At the closing of procedure, irrigate the Appavisc out of the anterior chamber with Balanced Salt Solution (BSS).

USABILITY & INFORMATION HARZARDS

Mishandling of the product for package leads to microbial contamination of the device and post-operative inflammation.
Improper removal of device from package leads to product damage and eye redness. use by unskilled personnel leads to product damage and eye redness. Inadequate irrigation & aspiration of solution leads to reversible eye infection.

HOW SUPPLIED

APPAVISC is a sterile , single use viscoelastic device supplied in a non-pyrogenic glass vial containing 3mL or 5mL with single use sterile angular cannula 23 G.

STORAGE

Store in dry Place. Store away from sunlight. Store between 15°C to 25°C.

PACKING

APPAVISC 3mL or 5mL packed in 5mL glass vial with one sterilized disposable cannula.
Waste Disposal Method: Dispose in accordance with local, state and federal regulations.

^{® Registered Trademark}

APPAVISC

APPAVISC PFS ^® / 2mL

(Hydroxypropyl Methylcellulose Ophthalmic Solution USP)

PRESERVATIVE FREE STERILE SOLUTION

DESCRIPTION:

APPAVISC PFS (Hydroxypropyl Methylcellulose Ophthalmic Solution USP) is sterile, a pyrogen free clear &transparent viscous solution of highly puriﬁed HPMC. The chemical name of active ingredient is Cellulose 2- Hydroxypropyl Methyl Ether. Each mL contains: Hydroxypropyl Methylcellulose USP 2% w/v& Sterile isotonic base q.s.

MODE OF ACTION (Mechanism of Action)

HPMC consists of large macromolecules that exert a protective effect on ocular tissue during surgical procedures. It limits the mechanical damage from invasive procedures by separating and lubricating tissues.The HPMC also shows to decrease the damage of corneal endothelial cell loss during surgery. It is routinely used as an adjuvant in cataract surgery, IOL, corneal transplantation and surgery of glaucoma. HPMC goes well with the lens and other corneal surfaces because of its low contact angle.

INTENDED USE

•APPAVISC PFS is indicated as a surgical aid (medical device) in anterior segment surgical procedures involving the anterior chamber of the eye, including extraction of the lens and insertion of intraocular lenses. It maintains the depth of the anterior chamber during the whole surgical procedure and permits greater operative precision without the risk of damaging the endothelium of the cornea or other intraocular tissues.

CONTRAINDICATIONS

APPAVISC PFS is contraindicated in patients with glaucoma and Contraindicated in patients with known history hypersensitivity to its ingredients.

WARNING

PRECAUTIONS

GENERAL Overfilling of APPAVISCPFS in anterior chamber should be avoided as it may raise IOP & cause glaucoma. APPAVISCPFS is to be removed out of eye after the surgery by irrigation or aspiration. IOP should be monitored, especially after the end of surgery. If IOP is recorded, the appropriate therapy should be employed. APPAVISC PFS should be introduced in anterior chamber such that no air bubble should be trapped in HPMC. Syringe and cannula once used should be discarded.

DRUG INTERACTIONS

Since HPMC is an inert substance and does not have any pharmacological action, no evidence suggests that the drug in intraocular milieu bind to APPAVISCPFS solution to any significant degree. There is no evidence of drug binding established so far.

PREPARATION & ADMINISTRATION GUIDE

APPAVISC PFS should be held at room temperature for approximately 30 minutes before use. Protect from freezing and exposure to light. For intraocular use:
1. Remove the syringe from its packaging in a sterile environment2.Openthe syringe, withdraw the solution using sterile disposable syringe3. Open the cannula and firmly screw it onto the lock fitting4. Depress the plunger and discard the first 0.1 to 0.3 ml of fluid5.Do not overfill the eye chamber with APPAVISC PFS.6. At the closing of procedure, irrigate the bulk of the APPAVISCPFS out of the anterior chamber with Balanced Salt Solution (BSS).SIDE EFFECTS

SIDE EFFECTS

APPAVISC PFS has the risk of IOP elevation. The viscoelastic substances that are not removed from the eye after surgery is not degraded to any significant degree when in the anterior chamber. It obstructs the outflow mainly trabucular meshwork into schlemm’s canal. A spike of IOP is more likely to occur in early hours of surgery(maximum 4-7 hours and often returns to baseline24 hours). Residual effect of retained Viscoelastic material in anterior chamber should be considered in the differential diagnosis of corneal edema.
There is a significant cell death at 30 minutes and near complete cell deaths at 2 hours if viscoelastic reused cannulas are used. Severe corneal edema may occur if the contact time of the visco elastics with corneal endothelium by using reused cannula, following instillation, Additional events occurring includes corneal staining, keratopathy/keratitis, allergic reactions, lid edema, tearing, photophobia, corneal infiltrates, nausea and decreased vision.

DOSAGE AND ADMINISTRATION

APPAVISC PFS (Hydroxypropyl Methylcellulose Ophthalmic Solution USP) should be carefully introduced into the anterior chamber using the sterile cannula supplied along with the pack. It may be injected into the chamber prior to or following delivery of intraocular lens (IOL) It may be used to coat an intraocular lens as well as tips of surgical instruments prior to implantation which protect the corneal endothelium from possible damage during cataract surgical procedure

USABILITY & INFORMATION HARZARDS

Mishandling of the product for package leads to microbial contamination of the device and post-operative inflammation. Improper removal of device from package leads to product damage and eye redness. use by unskilled personnel leads to product damage and eye redness. Inadequate irrigation &aspiration of solution leads to reversible eye infection.

HOW SUPPLIED

APPAVISC PFS is a sterile, single use viscoelastic device supplied in a non- pyrogenic Syringe containing 2mLor 3mLwith single use sterile angular cannula 23 G.

STORAGE

Store in dry Place. Store away from sunlight. Store between 15°C to25°C.

PACKING

APPAVISC PFS 2mL or 3mL packed in 3mL syringe with one sterilized disposable cannula.

‍Waste Disposal Method: Dispose in accodance with local, state and federal regulations

® Registered Trademark

APPAVISC PFS

APPAVISC HV PFS ^®

(Hydroxypropyl Methylcellulose Ophthalmic Solution USP)

PRESERVATIVE FREE STERILE SOLUTION

DESCRIPTION

APPAVISC HV PFS (Hydroxypropyl Methylcellulose Ophthalmic Solution USP) is sterile, a pyrogen free clear & transparent viscous solution of highly purified HPMC. The chemical name of active ingredient is Cellulose 2- Hydroxypropyl Methyl Ether. Each mL contains: Hydroxypropyl Methylcellulose USP 2% w/v & Sterile isotonic base q.s.

MODE OF ACTION (Mechanismof Action)

HPMC consists of large macromolecules that exert a protective effect on ocular tissue during surgical procedures. It limits the mechanical damage from invasive procedures by separating and lubricating tissues. The HPMC also shows to decrease the damage of corneal endothelial cell loss during surgery. It is routinely used as an adjuvant in cataract surgery, IOL, corneal transplantation and surgery of glaucoma. HPMC goes well with the lens and other corneal surfaces because of its low contact angle.

INTENDED USE

APPAVISC HV PFS is indicated as a surgical aid (medical device) during surgical procedures involving the anterior chamber of the eye, including extraction of the lens and insertion of intraocular lenses. It maintains the depth of the anterior chamber during the whole surgical procedure and permits greater operative precision without the risk of damaging the endothelium of the cornea or other intraocular tissues.

CONTRAINDICATIONS

APPAVISC HV PFS is contraindicated in patients with glaucoma and Contraindicated in patients with known history hypersensitivity to its ingredients.

WARNING

PRECAUTIONS

GENERAL Overﬁlling of APPAVISC HV PFS in anterior chamber should be avoided as it may raise IOP & cause glaucoma. APPAVISCHV PFS is to be removed out of eye after the surgery by irrigation or aspiration. IOP should be monitored, especially after the end of surgery. If IOP is recorded, the appropriate therapy should be employed. APPAVISCHV PFS should be introduced in anterior chamber such that no air bubble should be trapped in HPMC. Vials and cannula once used should be discarded.
‍
DRUG INTERACTIONS
Since HPMC is an inert substance and does not have any pharmacological action, no evidence suggests that the drug in intraocular milieu bind to APPAVISC HV PFS solution to any signiﬁcant degree. There is no evidence of drug binding established so far.
‍

PREPARATION & ADMINISTRATION GUIDE

APPAVISC HV PFS should be held at room temperature for approximately 30 minutes before use. Protect from freezing and exposure to light. For intraocular use
1.Remove the syringe from its packaging in a sterile environment
2. Open the syringe, withdraw the solution using sterile disposable syringe
3. Open the cannula and firmly screw it onto the lock ﬁtting
4. Depress the plunger and discard the first 0.1 to 0.3 ml of ﬂuid
5. Do not overfill the eye chamber with APPAVISCHV PFS.
6.. At the closing of procedure, irrigate the bulk of the APPAVISCHV PFS out of the anterior chamber with Balanced Salt Solution (BSS).

SIDE EFFECTS

APPAVISC HV PFS has the risk of IOP elevation. The viscoelastic substances that are not removed from the eye after surgery is not degraded to any significant degree when in the anterior chamber. It obstructs the outflow mainly trabucular meshwork into schlemm’s canal. A spike of IOP is more likely to occur in early hours of surgery(maximum 4-7 hours and often returns to baseline 24 hours). Residual effect of retained Viscoelastic material in anterior chamber should be considered in the differential diagnosis of corneal edema.
Severe corneal edema may occur due to thiomersal residues of reused Viscoelastic cannulas. There is a significant cell death at 30 minutes and near complete cell deaths at 2 hours if viscoelastic reused cannulas are used. Severe corneal edema may occur if the contact time of the viscoelastics with corneal endothelium by using reused cannula, following instillation, Additional events occurring includes corneal staining, keratopathy/keratitis, allergic reactions, lid edema, tearing, photophobia, corneal inﬁltrates, nausea and decreased vision.

DOSAGE AND ADMINISTRATION

APPAVISC HV PFS (Hydroxypropyl Methylcellulose Ophthalmic Solution USP) should be carefully introduced into the anterior chamber using the sterile cannula supplied along with the pack. It may be injected into the chamber prior to or following delivery of intraocular lens (IOL) It may be used to coat an intraocular lens as well as tips of surgical instruments prior to implantation which protect the corneal endothelium from possible damage during cataract surgical procedure.

USABILITY & INFORMATION HARZARDS

Mishandling of the product for package leads to microbial contamination of the device and post-operative inflammation. Improper removal of device from package leads to product damage and eye redness. use by unskilled personnel leads to product damage and eye redness. Inadequate irrigation &aspiration of solution leads to reversible eye infection

HOW SUPPLIED

APPAVISC HV PFS is a sterile , single use viscoelastic device supplied in a non- pyrogenic Syringe containing 2mL or 3mL with single use sterile angular cannula 23 G.

STORAGE

Store in dry Place. Store away from sunlight. Store between 15°C to25°C.

PACKING

APPAVISC HV PFS 2mL or 3mL packed in 3mL Prefilled Syringe with one sterilized disposable cannula.
Waste Disposal Method: Dispose in accordance with local, state and federal regulations.

APPAVISC HV PFS

COHEVISC 1.0

Pack : 1ml Pack

DESCRIPTION:

Cohevisc Ophthalmic Solution (Sodium Hyaluronate 1.0, 1.4 & 1.8) is a cohesive high quality viscoelastic formulation. It has high molecular weight, high pseudoplasticity, and high surface tension. Facilitates IOL implantation can be easily removed.
GENERIC NAME: Sodium hyaluronate ophthalmic Solution

COMPOSITION:

1. COHEVISC 1.0:

Each ML Contains :

Sodium Hyaluronate BP....10 mg
Sterile Isotonic Solution....q.s.

2. COHEVISC 1.4:

Each ML Contains :

Sodium Hyaluronate BP....14 mg
Sterile Isotonic Solution....q.s

3. COHEVISC 1.8:

Each ML Contains :

Sodium hyaluronate BP....18mg
Sterile Isotonic Solution...q.s.

PRODUCT FEATURES:

Easy implementation.
Protects against mechanical damage.
Better Increased protection to corneal endothelium.
Good maintenance of the anterior chamber and capsules.

PACKAGING:

Primary packing- 2.25 mL glass syringe & pouch
‍Secondary Packing - Carton box, 27G Sterile Cannula.

INDICATIONS:

Cataract extraction.
IOL implementation.
Vitrectomy.
Surgical procedure detach the retina.

VISCOSITY:

1. Cohevisc 1.0

40,000 to 1.5 lakh cps
‍

2.Cohevisc 1.4

60,000 to 2.0 lakh cps

3. Cohevisc 1.8

NLT 1,00,000 cps

‍

SHELF LIFE:

24 months from the date of manufacturing.

STORAGE:

Store between 80C-250C.

AVAILABILITY:

1. Cohevisc 1.0

1ml in Pre filled glass syringes
‍

2. Cohevisc 1.4

1ml in Pre filled glass syringes

3. Cohevisc 1.8

1ml in Pre filled glass syringes
‍

INTENDED USE:

Cohevisc, visco ophthalmic surgical device is indicated as an aid for ophthalmic surgical and anterior segment during cataract extraction and IOL implantation. Cohevisc helps to maintain a deep anterior chamber during anterior segment surgery reduce trauma to the corneal endothelium and surrounding ocular tissue. It helps to push back the vitreous face and prevent formation of a flat chamber during the surgery.

DIRECTION OF USE:

Cataract surgery and intraocular lens (IOL) implantation: Instill Cohevisc slowly in to the artificially created opening in the eye through the blunt cannula into the anterior chamber. The use of Cohevisc is most effective when the Instill is made before phacoemulsification, removal of the cataract and before insertion of the IOL. Cohevisc can also be applied to the IOL before placement. During the procedure, more Cohevisc can be infused for anterior chamber maintenance or to replace viscoelastic lost during surgery. At the end of the surgical procedure

CONTRAINDICATION:

No contraindications known when used as per instruction.

SUPPLY:

Available in 1mL Sterile pre-filled glass syringes & 27 Gauge Cannula. one syringe & 27 Gauge cannula packed with double pouch printed labelled & carton and carton packed in corrugated box.

COHEVISC 1mL

COHEVISC 1.4mL

COHEVISC 1.4

Pack : 1ml Pack

DESCRIPTION:

COMPOSITION:

1. COHEVISC 1.0:
Each ML Contains :

Sodium Hyaluronate BP....10 mg
Sterile Isotonic Solution....q.s.

2. COHEVISC 1.4:
Each ML Contains :

Sodium hyaluronate BP.....14mg
Sterile Isotonic Solution....q.s.

3. COHEVISC 1.8:
Each ML Contains :

Sodium hyaluronate BP....18mg
Sterile Isotonic Solution...q.s.

PRODUCT FEATURES:

Easy implementation.
Protects against mechanical damage.
Better Increased protection to corneal endothelium.
Good maintenance of the anterior chamber and capsules.

PACKAGING:

Primary packing- 2.25 mL glass syringe & pouch
Secondary Packing - Carton box, 27G Sterile Cannula.

INDICATIONS:

Cataract extraction.
IOL implementation.
Vitrectomy.
Surgical procedure detach the retina.

VISCOSITY:

1. Cohevisc 1.0

40,000 to 1.5 lakh cps
‍
‍

2.Cohevisc 1.4

60,000 to 2.0 lakh cps

3. Cohevisc 1.8

NLT 1,00,000 cps
‍
‍

SHELF LIFE:

24 months from the date of manufacturing.

STORAGE:

Store between 80C-250C.

AVAILABILITY:

1. Cohevisc 1.0

1ml in Pre filled glass syringes
‍

2. Cohevisc 1.4

1ml in Pre filled glass syringes

3. Cohevisc 1.8

1ml in Pre filled glass syringes
‍

INTENDED USE:

DIRECTION OF USE:

CONTRAINDICATION:

No contraindications known when used as per instruction.

SUPPLY:

Available in 1mL Sterile pre-filled glass syringes & 27 Gauge Cannula. one syringe & 27 Gauge cannula packed with double pouch printed labelled & carton and carton packed in corrugated box.

COHEVISC 1.8^®

(Sodium Hyaluronate Sterile Ophthalmic Solution)
‍

THIS LEAFLET CONTAINSIMPORTANT PRODUCT USE ANDSAFETY INFORMATION, PLEASE READ CAREFULLYAND RETAIN FOR FURTHER FUTURE REFERENCE.

DESCRIPTION

Cohevisc 1.8 ophthalmic viscosurgical device is a sterile, non-pyrogenic, high molecular weight, non-inflammatory highly purified fraction of Sodium Hyaluronate dissolved in physiological sodium chloride, phosphate buffer. Each mL of Cohevisc 1.8 contains 18 mg of Sodium Hyaluronate in a sterile isotonic base. pH is adjusted with Sodium Hydroxide / Hydrochloric acid.

CHARACTERISTICS:

Sodium Hyaluronate is a high molecular weight poly saccharide, composed of sodium glucuronate and N-acetyl glucosamine which forms a repeating disaccharide unit by linking alternativelybeta-1- 3 and beta1-4glycosidic bonds. Sodium Hyaluronate Ophthalmic solution is a transparent &viscous used as an aid in Ophthalmic Surgery.

MODE OF ACTION (Mechanism of Action)

Sodium Hyaluronate functions as a tissue lubricant and is thought to play an important role in modulating the interactions between adjacent tissues M. echanical protection for tissues (iris, retina) and cell layers (corneal endothelium, and epithelium) are provided by the high viscosity of the solution. Elasticity of the solution assists in absorbing mechanical stress and providing a protective buffer for tissues.

INTENDED USE

Cohevisc 1.8 is viscoelastic ophthalmic devices use as an aid for ophthalmic surgical procedures and anterior segment during cataract extraction and IOL implantation. Cohevisc helps to maintain deep anterior chamber during anterior segment surgery reduce trauma to the corneal endothelium and surrounding ocular tissue It helps to push back the vitreous face and prevent formation of a ﬂat chamber during the surgery.

CONTRAINDICATIONS

At present there are no known contraindications for the use of Cohevisc 1.8 ophthalmic visco surgical device.

WARNING

Do not use if the solution becomesdark brown or any floating particles are observed If pouch is damaged should not be reused.In-case of any serious accident in relation tothe device, inform to the manufacturer and to the regulatory authority.

PRECAUTIONS:

Recommended to remove Cohevisc 1.8 by irrigation and/or aspiration at the close of surgery. Do not overfill the anterior chamber. Post operative increase in intraocular pressure is reported with use of Sodium Hyaluronate. The rise in IOP should be monitored closely and appropriate drug therapy if significant intraocular pressure occurs. Do not reuse cannula. Avoid trapping air bubbles.

ADVERSE REACTION

Cohevisc 1.8 is well tolerated during ophthalmic surgical procedure in human eye. Like most of the visco elastic rise in a transient rise in intra ocular pressure is reported in some cases.

APPLICATION

Use a cannula slowly and carefully inject a sufficient quantity of Cohevisc 1.8 into the anterior Chamber. Cohevisc 1.8 may also be use to coat surgical instruments and intraocular lens prior to implantation. Additional Cohevisc 1.8 can be injected during the surgery to replace any loss of viscoelastic during surgical manipulation

HOW SUPPLIED:

Cohevisc 1.8 is a sterile, single use viscoelastic device supplied in a non-pyrogenic Glass Syringe containing 1ml with single use sterile angular cannula 27 G.

PREPARATION & ADMINISTRATION GUIDE

Cohevisc 1.8 should be held at room temperature for approximately 30 minutes before use. Protect from freezing and exposure to light. For intraocular use.1. Remove the syringe from its packaging in a sterile environment2. Remove the cap from the tip of the syringebarrel3. Open the cannula and firmly screw it onto the lock fitting4. Depress the plunger and discard the first 0.1 to 0.3 ml of fluid5. Do not overfill the eye chamber with Cohevisc 1.8.6.At the closing of procedure, irrigate the bulk of the Cohevisc1.8 out of the anterior chamber with Balanced Salt Solution (BSS)

USABILITY & INFORMATION HARZARDS

Mishandling of the product for package leads to microbial contamination of the device and post-operative inflammation. Improper removal of device from package leads to product damage and eye redness. use by unskilled personnel leads to product damage and eye redness. Inadequate irrigation & aspiration of solution leads to reversible eye infection.

STORAGE

Store at 8°C to 25°C,Protect form light. Do not Freeze.

PACKING

Cohevisc 1.8 /1mL is packed in 2.25 ml glass syringe with one sterile disposable cannula.
For Intraocular use. Not for injection. Single use only

COHEVISC 1.8mL

RHEX-ID

Pack : Each Ml Contains

DESCRIPTION:

Rhex ID (Trypan Blue sterile solution preservative free) 0.8 mg is a sterile solution of Trypan Blue solution (an acid di-azo group dye).
‍Rhex ID (Trypan Blue solution) is a selective tissue staining agent for use as a medical aid in ophthalmic surgery. Each mL of Rhex ID (Trypan Blue solution) sterile solution contains not more than 0.8 mg of Trypan Blue and 8.2 mg of Sodium Chloride in a aqueous buffered.It is a blue dye (Sodium ditolyldisazobis-8-amino-1-naphthol-3,6-disulfonate) used to stain capsules and has very low toxicity profile. It is available as a 0.1% solution.GENERIC NAME: Trypan Blue Sterile Solutions

COMPOSITION:

Each ML Contains:

● Trypan Blue ............0.8mg
● Sodium Chloride USP.......8.2mg
● Aqueous Buffered Vehicle......q.s.

PACKAGING

Primary packing - 5ml Clear Poly bottles White caps & Nozzles.
‍Secondary Packing - Labels, Cartons, Shrink Pack & Shipper box.

SHELF LIFE:

24 months from the date of manufacturing.

STORAGE:

Store between 150C-250C.

CLINICAL PHARMACOLOGY:

Rhex ID (Trypan Blue Solution) selectively stains connective tissue structures in the human eye such as the anterior lens capsule of the human crystalline lens.
‍Rhex ID (Trypan Blue Solution) is intended to be applied directly on the anterior lens capsule, staining any portion of the capsule which comes in contact with the dye. Excess dye is washed out of the anterior chamber. The dye does not penetrate the capsule, permitting visualization of the anterior capsule in contrast to the non-stained lens cortex and inner lens material.

CONTRA-INDICATIONS:

Rhex ID (Trypan Blue Solution) is contraindicated when a non-hydrated (dry state), hydrophilic acrylic intraocular lens (IOL) is planned to be inserted into the eye because the dye may be absorbed by the IOL and stain the IOL.

INDICATION:

To stain the anterior capsule during capulorrhexis and in macular hole surgery capsule for muculorrhexis (it stains the internal limiting membrane)

ADVERSE EFFECTS:

It is well tolerated though rare reports of post surgical inflammatory reactions and bullous keratopathy are reported.

WARNING & PRECAUTION:

It is harmful if used systemically as it has been used as an experimental teratogen and may cause liver damage.
General: It is recommended that after injection all excess Rhex ID be immediately removed from the eye by thorough irrigation of the anterior chamber. Carcinogenesis, mutagenesis, impairment of fertility.
Rhex ID is carcinogenic in rats. Wister/Lewis rats developed lymphomas after receiving subcutaneous injections of 1% trypan blue dosed at 50 mg/kg every other week for 52 weeks (total dose approximately 1,250,000-fold the maximum recommended human dose of 0.8 mg per injection in a 60 kg person, assuming total absorption).
Rhex ID was mutagenic in the Ames test and caused DNA strand breaks in vitro.
● Do not use the products after the expiry date.
● Do not use on children.
● For single use only
● Not for injection

DOSAGE AND ADMINISTRATION:

It is available as 1 mg single use vials. Each ml contains 0.8mg trypan blue. It can be injected in the anterior chamber ideally under air bubble and is allowed to stay for a minute to allow staining before removal.

CATARACT SURGERY:

Rhex ID is packaged in a 2.0 mL glass vial in sterile pouch. After opening the eye, an air bubble is injected into the anterior chamber of the eye in order to minimize dilution of Rhex ID by the aqueous.
Rhex ID is carefully applied onto the anterior lens capsule using a blunt cannula. Sufficient staining is achieved as soon as the dye has contacted the capsule. The anterior chamber is then irrigated with balanced salt solution to remove all excess dye. An anterior capsulotomy can then be performed.

SUPPLY:

1 ml solution (TRYPAN-BLUE SOLUTION) filled in 2 ml glass vial packed with printed labelled pouch & cartons And Such Carton Packed in a corrugated shipper box.

RHEX-ID

Supracoat

SUPRACOAT

Sodium Chondroitin Sulphate & Sodium Hyaluronate Ophthalmic Solution

DESCRIPTION:

SUPRACOAT is a sterile, non-pyrogenic, viscoelastic solution of a highly purified non- inflammatory medium molecular weight fraction of sodium chondroitin sulphate and sodium hyaluronate. SUPRACOAT solution is formulated to a viscosity of 20000 to 60000 cps (at shear rate of 2 sec.-1 25°C). Each mL of SUPRACOAT Solution contains not more than 40 mg sodium chondroitin sulphate and 17 mg sodium hyaluronate in a physiological buffer.
Sodium chondroitin sulphate and sodium hyaluronate are quite similar in regard to chemical and physical composition, as each occurs as a large, unbranched chain structure of medium to high molecular weight.

COMPOSITION:

Each ML Contains:

Sodium chondroitin sulphate USP ............40 mg
Sodium hyaluronate BP ............17 mg
Aqueous Buffered Solution .............q.s.

INDICATION:

Viscoelastic Solution is indicated for use as an ophthalmic surgical aid in the anterior segment during cataract extraction. Ophthalmic viscoelastic solutions serve to maintain a deep anterior chamber during anterior segment surgery, thereby reducing trauma to the corneal endothelium and surrounding ocular tissues. They help to push back the vitreous face and prevent formation of a flat chamber postoperatively.

PHARMACOLOGICAL ACTION:

SUPRACOAT solution maintains a deep chamber during anterior segment surgeries, enhances visualization during the surgical procedure, and protects the corneal endothelium and other ocular tissues. The viscoelasticity of the solution maintains the normal position of the vitreous face, thus preventing formation of a postoperative flat chamber. The sugar moieties of these two compounds occur as repeating disaccharide subunits consisting of glucuronic acid in B 1-3 linkage with Nacetylglucosamine for sodium chondroitin sulphate and Nacetylglucosamine for sodium hyaluronate. The subunits are then combined by B 1-4 linkage of the amino sugar residue to the glucuronic residue of the next subunit to form large polymers. The two compounds differ in that sodium chondroitin sulphate possesses a sulphate group and a double, rather than a single, negative charge (as in the case of sodium hyaluronate) per repeating disaccharide subunit. Sodium chondroitin sulphate and sodium hyaluronate are biological polymers centered in the extra-cellular matrix of animals and humans. The cornea is the ocular tissue having the greatest concentration of sodium chondroitin sulphate, while the vitreous and aqueous humor contain the greatest concentration of sodium hyaluronate. SUPRACOAT solution is completely transparent and exhibits flow properties.

CONTRA-INDICATIONS:

There are no contra-Indications recorded on using SUPRACOAT, If Used as recommended. CLINICAL APPLICATIONS: In surgery involving the anterior segment, SUPRACOAT should be carefully and slowly injected into the anterior chamber using a sterile single-use Luer lock canula (in no case a reusable cannula should be used, even if it is well cleaned, rinsed and re-sterilized since it could release particles during injection) SUPRACOAT is injected before the capsulorhexis procedure, so that its protective effect will be optimized. At this stage of the surgery, SUPRACOAT protects the endothelium of the cornea from potential damage by surgical instruments. SUPRACOAT may be injected into the anterior chamber several times during surgery to replace the product lost during the surgical procedure. At the end of the surgery, SUPRACOAT should be aspiration with sterile irrigating solution.

DOSAGE AND DIRECTIONS FOR USE:

FOR INTRAOCULAR USE ONLY
FOR SINGLE USE ONLY
NOT FOR IV/IM INJECTION

SUPRACOAT should be allowed to attain room temperature prior to use. The syringe assembly is designed only for the injection of the SUPRACOAT viscoelastic solution it contains. Use of the syringe assembly for aspiration is not advised. When left in the eye, endothelial loss can be expected to be lower. For cataract surgery and intraocular lens implantation SUPRACOAT solution should be carefully introduced (using a 27-gauge cannula) into the anterior chamber. SUPRACOAT solution may be injected into the chamber prior to or following delivery of the crystalline lens. Instillation of SUPRACOAT solution prior to lens delivery will provide additional protection to the corneal endothelium. Instillation of the solution at this point is significant in that a coating of SUPRACOAT solution may protect the corneal endothelium from possible damage arising from surgical instrumentation during the cataract extraction surgery. SUPRACOAT solution may also be used to coat an intraocular lens as well as the tips of surgical instruments prior to implantation surgery. Additional solution may be injected during anterior segment surgery to fully maintain the chamber or replace any solution lost during the surgical procedure. At the end of the surgical procedure SUPRACOAT solution may be removed from the eye by thoroughly irrigating and aspirating with a balanced salt solution. Alternatively SUPRACOAT solution may be left in the eye, when used as directed.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:

Atransient rise in intraocular pressure may be expected due to the presence of sodium hyaluronate which has been shown to effect such a rise. The intraocular pressure should be carefully monitored and appropriate therapy instituted if significant increases occur. In high risk patients tonometry should be performed on the first and second post-operative days. Precautions are limited to those normally associated with the surgical procedure being performed. Although sodium chondroitin sulphate and sodium hyaluronate are highly purified biological polymers, the physician should be aware of the potential allergic risks inherent in the use of any biological material.

WARNINGS:

Do not use if package is damaged. Do not resterilize. Resterilization on this product has not been validated. Discard remaining solution after single use. Do not freeze. Physical, chemical and microbiological parameters may not be guaranteed if SUPRACOAT is reused

PRESENTATION:

SUPRACOAT solution is a sterile, non-pyrogenic, 1 mL, viscoelastic preparation supplied in a disposable syringe with a threaded luer. Lock. A sterile 27-gauge, disposable, bent, blunt-tip cannula is provided separately.

SHELF LIFE:

24 Months

STORAGE INSTRUCTIONS:

Store between 10°C-25°C. Protect from light. The contents are sterile unless the package is opened or broken. Do Not Freeze. Keep Out of the Reach of Children.

NOTE:

For Use during surgery Do not exert more pressure on the plunger prior to removing the cannula from the eye. This is to avoid aspiration of air Bubbles into the cannula.

APPARET BLUE

Trypan Blue Sterile Solution

THIS LEAFLET CONTAINSIMPORTANT PRODUCT USE AND SAFETY INFORMATION, PLEASE READ CAREFULLY AND RETAIN FOR FURTHER FUTURE REFERENCE.

DESCRIPTION:

Apparet Blue is a tissue dye for use as a medical aid in ophthalmic surgery, enables visualization of connective tissue structures. It is a sterile non-inflammatory solution of trypan blue dissolved in sodium chloride and buffer solution.

COMPOSITION:

Each ML Contains:

Trypan Blue 1.5 mg
Aqueous Buffered Vehicle q.s.

CLINICAL PHARMACOLOGY

Mechanism of action
Apparet Blue selectively stains membranes in the human eye during posterior surgery, such as epiretinal embranes (ERM) and Internal Limiting Membranes (ILM).
‍
Nonclinical toxicology
Trypan blue is carcinogenic in rats. Wister/Lewis rats developed lymphomas after receiving subcutaneous injections of 1% trypan blue dosed at 50 mg/kg every other week for 52 weeks (total dose approximately 100,000-fold the maximum recommended human dose of 0.75 mg per injection in a 60 kg person, assuming total absorption).

INDICATIONS

- Used as an aid during vitreoretinal surgery in posterior eye segment
.- Used to stain and / or visualize epiretinal membrane and internal limiting membrane facilitating removal of the tissue and reducing the risk of retinal damage.
-Used to identify and facilitate removal of posterior hyaloid remnants in traction Diabetic Retinopathy

CONTRAINDICATIONS

Apparet Blue is contraindicated when a non-hydrated (dry state), hydrophilic acrylic intraocular lens (IOL) is planned to be insertedinto the eye. The dye may be absorbed by the IOL and stain it...

WARNINGS

- Excessive staining: Excess Apparet Blue should be removed from the eye immediately after staining.
- Priming of the syringe: make sure the plunger moves smoothly before use: first retract the plunger or twist the plunger in a clockwise motion before injecting the fluid.

PRECAUTIONS:

Pregnancy Category C
Trypan blue is teratogenic in rats, mice, rabbits, hamsters, dogs, guinea pigs, pigs, and chickens. The majority of teratogenicity studies performed involve intravenous, intraperitoneal, or subcutaneous administration in the rat. The teratogenic dose is 50 mg/kg as a single dose or 25 mg/kg/day during embryogenesis in the rat. These doses are approximately 4,000- and 2,000-fold the maximum recommended human dose of 0.75 mg per injection based on a 60 kg person, assuming that the whole dose is completely absorved. Characteristic anomalies included neural tube, cardiovascular, vertebral, tail, and eye defects. Trypan blue also caused an increase in post implantation mortality, and decreased fetal weight. In the monkey, trypan blue caused abortions with single or two daily doses of 50 mg/kg between the 20th to 25th days of pregnancy, but no apparent increase in birth defects (approximately 4,000-fold maximum recommended human dose of 0.75 mg per injection, assuming total absorption). There are no adequate and well-controlled studies in pregnant women. Trypan blue should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus

Nursing mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when trypan blue is administered to a nursing woman.

Pediatric use
The safety and effectiveness of Trypan blue have been established in pediatric patients. use of Trypan blue is supported by evidence from an adequate and well-controlled study in pediatric patients.

Geriatric use.
No overall differences in safety and effectiveness have been observed between elderly and younger patients.

ADVERSE REACTIONS

Adverse reactions reported following use of Apparet Blue include discoloration of high water content hydrogen intra ocular lenses (see Contraindications) and inadvertent staining of the posterior lens capsule and vitreous face. Staining of the posterior lens capsule or staining of the vitreous face is generally self limited, lasting up to one week.

DOSAGE & ADMINISTRATION GUIDE

Make sure the plunger moves smoothly before use. Prime the syringe prior to use by retracting the plunger before injecting the fluid. Alternatively, twist the plunger into the stopper in a clockwise motion until tight. Once tight, continue turning the plunger in a clockwise motion until the stopper rotates freely within the syringe, two or three rotations. The syringe is now primed and suitable for injection.

Before injection of Apparet Blue perform a 'fluid-air exchange', i.e. filling the entire vitreous cavity with air, to prevent aqeous dilution of Apparet Blue. Apparet Blue is carefully applied to the retinal membrane using a blunt cannula attached to the Apparet Blue , without allowing the cannula to contact or damage the retina. Sufficient staining is expected on contact with the membrane. All excess dye should be removed from the vitreous cavity before performing an air-fluid exchange, to prevent unnecessary spreading of the dye. Apparet Blue can also be injected directly in a BSS filled vitreous cavity (instead of injecting under air). Clinical use demonstrated that, after complete vitreous and posterior hyaloid removal, sufficient staining is achieved after30 seconds of application under BSS. Apparet Blue is intended to be applied directly on the areas where membranes could be present, staining any portion of the membrane which comes in contact with the dye. The dye does not penetrate the membrane.

SHELF LIFE:

24 Months

STORAGE INSTRUCTIONS:

APPARET BLUE should be stored between 15°C and 25°C.

HOW SUPPLY

Apparet Blue 1 mL supplied in a sterile 2mL glass vial.

Apparet Blue

APPASIL

Silicone Oil 1000 mm²/s (cSt) (Polydimethylsiloxane BP)

DESCRIPTION:

APPASIL(Purified Polydimethyl Siloxane) is highly purified long chain Polydimethyl Siloxane trimethyl siloxy terminated silicone oil. It is sterile, non-pyrogenic clear colorless and has a viscosity of NLT 1000 mPa·s.

PHYSICO-CHEMICAL PROPERTIES

- Viscosity (25 °C): 1,050 ± 150 mPas
- Specific weight(25 °C): 0.97 ± 0.01 g/cm³
- Refractive index (25 °C): 1.403 ± 0.003
- OH end group content: ≤ 100 ppm
- Low molecular components (oligosiloxanes) : ≤ 100 ppm

COMPOSITION

Silicone Oil 1000 mm2 cSt
(Polydimethylsiloxane BP)

INDICATIONS

For long-term tamponade in the surgical treatment of:
- Proliferative Vitreo-Retinopathy (PVR)
- Retinal Detachment caused by trauma
- Giant Retinal Tears
- Diabetic Tractional Detachment
- Cytomegalovirus (CMV) Retinitis

CONTRAINDICATIONS

As Silicone Oil can chemically interact and opacify silicone elastomers, the use of APPASIL is contraindicated in pseudophakic patients with silicone intraocular lenses (IOLs).

WARNINGS

Oil-induced pupillary block and angle closure can occur in aphakic eyes if a six o'clock iridectomy is not performed.
In rare instances, silicone oil could migrate out of the eye and form lesions in the conjunctiva or eyelid. The use of CO2 laser should be avoided in the presence of such silicone oil related skin lesions, due to potential ignition.

PRECAUTIONS:

-   Do not use a vial for more than one patient
.-   Discard unused portion
.-   Do not admix with any other substances prior to injection.
-   Do not resterilize. Resterilization on this product has not been validated
.-   Do not use if the seal is broken
.-   An underfill may result in an ineffective inferior tamponade and an overfill may result in corneal abnormalities and elevated IOP.
-   The use of APPASIL as a long term tamponade has not been studied and must be determined by the treating physician
.-    Must not be used after the expiry date printed on the label
.-   Sterility assurance may not be guaranteed if APPASIL is reused.
-    Physical, chemical and microbiological parameters may not be guaranteed if APPASIL is reused.

ADVERSE REACTIONS

- The most common adverse reactions include Cataract, Anterior chamber oil migration, Keratopathy and Glaucoma.

DIRECTIONS FOR USE

-  APPASIL should be injected in the posterior chamber only and should be filled into the iris plane.
-  Air bubbles should be absent from the APPASIL in the syringe prior to instillation.
-  Large bubbles or droplets of oil in the anterior chamber can be removed manually by syringe
- APPASIL is usually removed from the eye 3 months after initial surgery. But the period can vary between2 months and 2 years.
-   The removed silicone oil must be treated as clinical waste.

PREPARATION & ADMINISTRATION GUIDE

1. Outside the sterile field, open the pouch and transfer the sterile vial in to a sterile table. Do not shake APPASIL.
2. Hold the APPASIL vial firmly and remove the aluminium seal and stopper.
3. Within the sterile field, securely place a sterile cannula on a 10mlglass vial .4.Aseptically introduce the cannula fitted to the syringe into the vial and withdraw the APPASIL taking care not to introduce air bubbles.
5.After APPASIL has been completely transferred to the syringe remove the sterile cannula from the syringe and dispose of it properly. Securely place a new sterile cannula onto the syringe.
6.The APPASIL is now ready to be used. The syringe may be stored temporarily with the cannula pointed upward to allow any air bubbles to come to the tip for easy removal
.7. At the conclusion of the procedure properly discard the syringe and any remaining APPASIL
.8. All components for single use only

SURGICAL TECHNIQUES

There are 3 surgical techniques to inject silicone oils into the eye:
(I) fluid-silicone exchange,
(ii) air-silicone exchange,
(iii)perfluorocarbon liquid-silicone exchange.

We do not perform a fluid-silicone exchange because, due to the low surface tension, we believe that the risk is too high that silicone oil enters the subretinal space through retinal breaks. The choice of air, rather than perfluorocarbon liquid-silicone exchange, depends on two main reasons: the eventual presence of a retinotomy or an anterior break. If the break is in the midperiphery or at the posterior pole, we usually perform first a fluid-air exchange with internal drainage of subretinal fluid and then, once the retina is flattened under air, an air-silicone exchange. If a relaxing retinotomy has been applied or the retinal break is anterior, we prefer to perform a direct exchange between PFCL and silicone oil in order to avoid the slippage of the posterior edge of the tear. In this case, we connect the syringe to the infusion line and an extrusion needle is placed into the vitreous cavity. In this way, while the surgeon injects the silicone oil pushing the foot-pedal, either passive or active aspiration may be used to remove the PFCL. In case of 23- or 25-gaugevitrectomy systems, we set the machine with an aspiration rate from 0 to 30 mmHg and an infusion pressure rate from 0 to 28 Psi. It is important to not exceed 30 Psi to avoid the disconnection of the infusion line from the eye.

Regarding the management of the anterior segment, particular attention has to be drawn to aphakic patients. In these patients, an inferior peripheral iridectomy (IPI) is mandatory to avoid pupillary block secondary to the silicone oil filling. The IPI allows aqueous humor to pass under the silicone oil bubble and to enter into the anterior chamber without causing a pupillary block.

SHELF LIFE:

24 Months

STORAGE

Store between 2°C to 30°C.

HOW SUPPLIED

APPASIL is supplied in a sterile 10ml glass vial with paper pouch. It has been terminally sterilized by dry heat sterilization at 160°C.

HANDLING OF SPILLAGES

If APPASIL is spill on the floor, it will make the surface dangerously slippery. It must be cleaned up immediately with copious soap and water.

Appasil

APPASIL PLUS BP

SiliconeOil 5000 mm²/s (cSt) (Polydimethylsiloxane BP)

DESCRIPTION:

APPASIL PLUS is a sterile, highly purified long chain Polydimethyl Siloxane of the formula (CH3)3SiO- [(CH3)2SiO]n-Si(CH3)3.It is a clear colorless liquid at room temperature with a viscosity of NLT 5000mPa·s.

PHYSICO-CHEMICAL PROPERTIES

- Viscosity (25 °C): 5,000 ± 250 mPas
- Speciﬁc weight (25 °C): 0.97 ± 0.01 g/cm³
- Refractive index (25 °C): 1.403 ± 0.003
- OH end group content: ≤ 100 ppm
- Low molecular components (oligosiloxanes): ≤ 100 ppm

COMPOSITION

Silicone Oil 5000 mm2 cSt (Polydimethylsiloxane BP)

INDICATIONS

CONTRAINDICATIONS

As Silicone Oil can chemically interact and opacify silicone elastomers, the use of APPASIL PLUS is contraindicated in pseudophakic patients with silicone intraocular lenses (IOLs).

WARNINGS

PRECAUTIONS:

-   APPASIL PLUS is supplied in a sterile vial intended for single use only and      contains no preservative.
.-    Do not resterilize.
.-   Discard unused portions of APPASIL PLUS.
-   Do not mix oil with any other substances prior to injection.
.-   Product should be discarded following expiration date.
.-   An underfill may result in an ineffective inferior tamponade and an overfill may      result in corneal abnormalities and elevated IOP.
-   The use of APPASIL PLUS as a long term tamponade has not been studied     and must be determined by the treating physician. APPASIL PLUS should be      removed when, in the judgement of the physician, the retinal attachment         would not be compromised.
.-  The scleral incisions should be completely sealed to minimize the potential for postoperative extravasation of the oil into the sub-conjunctival space and eyelids.

ADVERSE REACTIONS

- The most common adverse reactions include Cataract, Anterior chamber oil migration, Keratopathy and Glaucoma.

DIRECTIONS FOR USE

-  APPASIL PLUSshould be injected in the posterior chamber only and should be filled into the iris plane.
-  Air bubbles should be absent from the APPASIL in the syringe prior to instillation.
-  Large bubbles or droplets of oil in the anterior chamber can be removed manually by syringe
- APPASIL PLUS is usually removed from the eye 3 months after initial surgery. But the period can vary between 2 months and 2 years.
-   The removed silicone oil must be treated as clinical waste.

PREPARATION & ADMINISTRATION GUIDE

1. Outside the sterile field, open the pouch and transfer the sterile vial in to a sterile table. Do not shake APPASIL PLUS.
2. Hold the APPASIL PLUS vial firmly and remove the aluminium seal and stopper.
3. Within the sterile field, securely place a sterile cannula on a 10mlglass vial .4.Aseptically introduce the cannula fitted to the syringe into the vial and withdraw the APPASIL PLUS taking care not to introduce air bubbles.
5.After APPASIL PLUS has been completely transferred to the syringe remove the sterile cannula from the syringe and dispose of it properly. Securely place a new sterile cannula onto the syringe.
6.The APPASIL PLUS is now ready to be used. The syringe may be stored temporarily with the cannula pointed upward to allow any air bubbles to come to the tip for easy removal
.7. At the conclusion of the procedure properly discard the syringe and any remaining APPASIL PLUS.
.8. All components for single use only

SURGICAL TECHNIQUES

SHELF LIFE:

24 Months

STORAGE

Store between 2°C to 30°C.

HOW SUPPLIED

APPASIL PLUS is supplied in a sterile 10ml glass vial with paper pouch. It has been terminally sterilized by dry heat sterilization at 160°C.

HANDLING OF SPILLAGES

If APPASIL PLUS is spill on the floor, it will make the surface dangerously slippery. It must be cleaned up immediately with copious soap and water.

Appasil Plus

APPAVISC PFS 2.4 3mL

(Hydroxypropyl Methyl Cellulose Ophthalmic Solution USP)PRESERVATIVE FREE STERILE SOLUTION

DESCRIPTION:

APPAVISC PFS 2.4 (Hydroxypropyl Methyl Cellulose Ophthalmic Solution USP) is sterile, apyrogen free clear & transparent viscous solution of highly purified HPMC. The chemical name of active ingredient is Cellulose 2-hydroxypropylmethyl ether. Each mL contains: Hydroxypropyl Methylcellulose USP 2.4%w/v & Sterile isotonic base q.s. Appavisc PFS 2.4 solution is formulated to a viscosity of NLT 7000 cps.

CLINICAL PHARMACOLOGY:

Mode of Action (Mechanism of Action)
‍HPMC consists of large macromolecules that exert a protective effect on ocular tissue during surgical procedures. It limits the mechanical damage from invasive procedures by separating and lubricating tissues .The HPMC also shows to decrease corneal endothelial cell loss during surgery. It is routinely used as an adjuvantin cataract surgery, IOL, corneal transplantation and surgery of glaucoma, etc. HPMC goes well with the lens and other corneal surfaces because of its low contact angle.

INDICATIONS

Appavisc PFS 2.4 is indicated as a surgical aid (medical device) during surgical procedures involving the anterior chamber of the eye, including extraction of the lens and insertion of intraocular lenses. It maintains the depth of the anterior chamber during the whole surgical procedure and permits greater operative precision without the risk of damaging the endothelium of the cornea or other intraocular tissues.

CONTRAINDICATIONS

APPAVISC PFS 2.4 is contraindicated in patients with glaucoma.

WARNINGS

Do not use if the solution becomes dark brown or any floating particles are observed. Should not be reused.

PRECAUTIONS:

GENERAL
‍Overfilling of APPAVISC PFS 2.4 in anterior chamber should be avoided as it may raise IOP & cause glaucoma. APPAVISC PFS 2.4 is to be removed out of eye after the surgery by irrigation or aspiration. IOP should be monitored, especially after the end of surgery. If IOP is recorded, the appropriate therapy should be employed. APPAVISCPFS 2.4 should be introduced in anterior chamber such that no air bubble should be trapped in HPMC. Syringes and cannula once used should be discarded.

DRUG INTERACTIONS

Since HPMC is an inert substance and does not have pharmacological action, no evidence suggests that the drug inintra ocular milieu bind to APPAVISC PFS 2.4 solution to any significant degree. There is no evidence of drug binding established so far.

SIDE EFFECTS

APPAVISCPFS 2.4 has the risk of IOP elevation. The viscoelastic substances that are not removed from the eye after surgery is not degraded to any significant degree when in the anterior chamber. It obstructs the outflow mainly trabucular meshwork into schlemm's canal. A spike of IOP is more likely to occur in early hours of surgery (maximum 4-7 hours and often returns to baseline 24 hours). Residual effect of retained Viscoelastic material in anterior chamber should be considered in the differential diagnosis of corneal edema. Severe corneal edema may occur due to thiomersal residues of reused Viscoelastic cannulas. There is a significant cell death at 30 minutes and near complete cell deaths at 2 hours if viscoelastic reused cannulas are used. Severe corneal edema may occur if the contact time of the visco elastics with corneal endothelium by using reused cannula, following instillation, Additional events occurring includes corneal staining, keratopathy/keratitis, allergic reactions, lid edema, tearing, photophobia, corneal infiltrates, nausea and decrease dvision.

PREPARATION & ADMINISTRATION GUIDE

Appavisc PFS 2.4 should be held at room temperature for approximately 30 minutes before use. Protect from freezing and exposure to light. For intraocular use.
1. Remove the syringe from its packaging in a sterile environment
2. Remove the cap from the tip of the syringe barrel
3. Open the cannula and firmly screw it onto the lock fitting
4. Depress the plunger and discard the first 0.1 to 0.3 ml of fluid
5. Do not overfill the eye chamber with Appavisc PFS 2.4.
6. At the closing of procedure, irrigate the bulk of the Appavisc PFS 2.4 out of the anterior chamber with Balanced Salt Solution(BSS).

DOSAGE AND ADMINISTRATION:

APPAVISC PFS 2.4 (Hydroxypropyl Methyl Cellulose Ophthalmic Solution USP) should be carefully introduced into the anterior chamber using the sterile cannula. It may be applied into the chamber prior to or following delivery of intraocular lens (IOL). It may be used to coat an intraocular lens as well as tips of surgical instruments prior to implantation which protect the corneal endothelium from possible damage during cataract surgical procedure

SHELF LIFE:

24 Months

STORAGE

Store in a dry Place. Store away from sunlight. Store between 15°C to 25°C.

HOW SUPPLIED

APPAVISC PFS 2.4 is a sterile , single use viscoelastic device supplied in a non-pyrogenic Syringe containing 2mL or 3mL with single use sterile angular cannula 23 G.

Appavisc PFS 2.4/3mL

APPAVISC PFS ^®

(Hydroxypropyl Methylcellulose Ophthalmic Solution USP)PRESERVATIVE FREE STERILE SOLUTION

DESCRIPTION:

APPAVISC PFS 2.4 (Hydroxypropyl Methyl Cellulose Ophthalmic Solution USP) is sterile, a pyrogen free clear & transparent viscous solution of highly purified HPMC. The chemical name of active ingredient is Cellulose 2-Hydroxypropyl Methyl Ether. Each mL contains: Hydroxypropyl Methylcellulose USP 2.4%w/v & Sterile isotonic base q.s. Appavisc PFS 2.4 solution is formulated to a viscosity of NLT 7000 cps.

CLINICAL PHARMACOLOGY:

Mode of Action (Mechanism of Action)
‍HPMC consists of large macromolecules that exert a protective effect on ocular tissue during surgical procedures. It limits the mechanical damage from invasive procedures by separating and lubricating tissues .The HPMC also shows to decrease corneal endothelial cell loss during surgery. It is routinely used as an adjuvantin cataract surgery, IOL, corneal transplantation and surgery of glaucoma, etc. HPMC goes well with the lens and other corneal surfaces because of its low contact angle.

INTENDED USE

APPAVISC PFS is indicated as a surgical aid (medical device) in anterior segment surgical procedures involving the anterior chamber of the eye, including extraction of the lens and insertion of intraocular lenses. It maintains the depth of the anterior chamber during the whole surgical procedure and permits greater operative precision without the risk of damaging the endothelium of the cornea or other intraocular tissues.

CONTRAINDICATIONS

APPAVISC PFS is contraindicated in patients with glaucoma and Contraindicated in patients with known history hypersensitivity to its ingredients.

WARNINGS

Do not use if the solution becomes dark brown or any ﬂoating particles are observed If pouch is damaged should not be reused. In-case of any serious accident in relation to the device, inform to the manufacturer and to the regulatory authority.

PRECAUTIONS:

GENERAL
‍Overﬁlling of APPAVISCPFS in anterior chamber should be avoided as it may raise IOP & cause glaucoma. APPAVISCPFS is to be removed out of eye after the surgery by irrigation or aspiration. IOP should be monitored, especially after the end of surgery. If IOP is recorded, the appropriate therapy should be employed. APPAVISC PFS should be introduced in anterior chamber such that no air bubble should be trapped in HPMC. Syringe and cannula once used should be discarded.

DRUG INTERACTIONS

Since HPMC is an inert substance and does not have any pharmacological action, no evidence suggests that the drug in intraocular milieu bind to APPAVISCPFS solution to any signiﬁcant degree. There is no evidence of drug binding established so far.

PREPARATION & ADMINISTRATION GUIDE

APPAVISC PFS should be held at room temperature for approximately 30 minutes before use. Protect from freezing and exposure to light. For intraocular use
1. Remove the syringe from its packaging in a sterile environment
2.Openthe syringe, withdraw the solution using sterile disposable syringe
3. Open the cannula and ﬁrmly screw it onto the lock ﬁtting
4. Depress the plunger and discard the ﬁrst 0.1 to 0.3 ml of ﬂuid
5.Do not overﬁll the eye chamber with APPAVISC PFS.6. At the closing of procedure, irrigate the bulk of the APPAVISCPFS out of the anterior chamber with Balanced Salt Solution (BSS).

SIDE EFFECTS

APPAVISC PFS has the risk of IOP elevation. The viscoelastic substances that are not removed from the eye after surgery is not degraded to any signiﬁcant degree when in the anterior chamber. It obstructs the outﬂow mainly trabucular meshwork into schlemm’s canal. A spike of IOP is more likely to occur in early hours of surgery(maximum 4-7 hours and often returns to baseline24 hours). Residual effect of retained Viscoelastic material in anterior chamber should be considered in the differential diagnosis of corneal edema.
There is a signiﬁcant cell death at 30 minutes and near complete cell deaths at 2 hours if viscoelastic reused cannulas are used. Severe corneal edema may occur if the contact time of the visco elastics with corneal endothelium by using reused cannula, following instillation, Additional events occurring includes corneal staining, keratopathy/keratitis, allergic reactions, lid edema, tearing, photophobia, corneal inﬁltrates, nausea and decreased vision.

DOSAGE AND ADMINISTRATION:

APPAVISC PFS (Hydroxypropyl Methyl Cellulose Ophthalmic Solution USP) should be carefully introduced into the anterior chamber using the sterile cannula. It may be applied into the chamber prior to or following delivery of intraocular lens (IOL). It may be used to coat an intraocular lens as well as tips of surgical instruments prior to implantation which protect the corneal endothelium from possible damage during cataract surgical procedure

USABILITY & INFORMATION HARZARDS

Mishandling of the product for package leads to microbial contamination of the device and post-operative inﬂammation. Improper removal of device from package leads to product damage and eye redness. use by unskilled personnel leads to product damage and eye redness. Inadequate irrigation &aspiration of solution leads to reversible eye infection.

PACKING

APPAVISC PFS 2mL or 3mL packed in 3mL syringe with one sterilized disposable cannula.
‍Waste Disposal Method: Dispose in accodance with local, state and federal regulations.

STORAGE

Store in a dry Place. Store away from sunlight. Store between 15°C to 25°C.

HOW SUPPLIED

APPAVISC PFS is a sterile , single use viscoelastic device supplied in a non-pyrogenic Syringe containing 2mL or 3mL with single use sterile angular cannula 23 G.

® Registered Trademark

Appavisc PFS 3mL

CLEARSOL

(BALANCED SALT SOLUTION)

DESCRIPTION:

Clearsol Balanced Salt Solution is a sterile ophthalmic irrigating solution, Each mL contains: Sodium Chloride 6.4mg, Potassium Chloride0.75mg, Calcium Chloride 0.48mg, Magnesium Chloride 0.3mg, Sodium Acetate 3.9, Sodium Citrate 1.7mg, Water for Injections q.s. Sodium Hydroxide and/or Hydrochloric Acid (to adjust pH).The pH is approximately 7.0. The osmolality is approximately 300 mOsm/ Kg.

CLINICAL PHARMACOLOGY:

Mode of Action (Mechanism of Action)
‍Balanced Salt Solution is an isotonic solution for use in irrigating tissues of the eyes.

INDICATIONS AND USAGE

For use as an extraocular and intraocular irrigating solution during ocular surgical procedure involving perfusion of the eye with an expected maximum duration of less than 60minutes.

WARNINGS

-Not for Injection or Intravenous Infusion.
-Do not use unless product is clear, seal isintact, vacuum is present and container is undamaged.
-Do not use if product is discolored or contains a precipitate.
-SINGLE patient use only. The contents of this bag should not be used in more than one patient.
-The use of additives with this solution may cause corneal decompensation.
-This solution contains no preservative, unused contents should be discarded.

PRECAUTIONS:

Open under aseptic conditions only.
Studies suggest that intraocular irrigating solutions which are iso- osmotic with normal aqueous fluids should be used with caution in diabetic patients undergoing vitrectomy since intra operative lens changes have been observed.
There have been reports of corneal clouding or edema following ocular surgery in which Balanced Salt Solution (Sterile Irrigating Solution) was used as an irrigating solution.

ADVERSE REACTIONS

Irrigation or any other trauma may result in corneal swelling or bullous
keratopathy. Post-operative inflammatory reactions as well as incidents of corneal edema and corneal decompensation have been reported.

Clearsol Bag 100mL/250mL /500 mL –Directions for use
(A) Opening Protective Packaging
1. Tear straight down to create a suitable opening
.2. Remove solution container and squeeze firmly to check for leaks.

(B) Administration

Follow directions of the particular administration set to be used. Clean and disinfect the rubber stopper by using a sterile alcohol wipe. Insert the spike aseptically into the bag through the target area of the rubber stopper.
Allow the fluid to flow and remove air from the tubing before irrigation begins.

(C) Attaching and Removing Administration Set

1. Suspend container from eyelet support, and remove administration port protector
.2. Grasp administration port at the tubing joint(without pinching), and insert set. spike by simultaneously PUSHING and TWISTING the spike in a single motion, until spike is seated.

STORAGE

Store below 30°C and protected from light

HOW SUPPLIED

Clearsol Balanced Salt Solution ( Sterile Irrigating Solution) is supplied in over wrap non PVC Infusion Bag with injection port & Spike port .
‍

Clearsol

LIDOVISC GEL /2mL

(Lidocaine Hydrochloride Ophthalmic Sterile Gel 3.5% w/v)

THIS LEAFLETCONTAINS IMPORTANT PRODUCTUSE AND SAFETY INFORMATION,PLEASE READ CAREFULLY AND RETAIN FOR FURTHER FUTURE REFERENCE

DESCRIPTION:

Lidovisc Gel ( Lidocaine Hydrochloride Ophthalmic Gel 3.5% w/v) is a sterile, viscous, preservative-free, single patient use ophthalmic gel preparation for ocular anesthesia. Lidocaine hydrochloride is designated chemically as a c e t a m i d e , 2 - ( d i e t h y l a m i n o ) - N - ( 2 , 6 - dimethylphenyl) monohydrochloride with a molecular formula of C14H22N2OHCl and molecular weight of 270.8. The structural formula of the active ingredient is: Lidovisc Gel contains 35mg of Lidocaine Hydrochloride per mL as the active ingredient. Lidovisc Gel also contains Hypromellose2910, Sodium Chloride. Di-Sodium Hydrogen Phosphate, Sodium Di-Hydrogen Phosphate and Water for Injection q.s.The pH may be adjusted to 5.5 to 7.5 with Hydrochloric Acid and/or Sodium Hydroxide.

CLINICAL PHARMACOLOGY:

Mode of Action (Mechanism of Action)
‍Lidovisc Gel is a local anesthetic agent that stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, therebyeffecting local anesthetic action. Anesthesia generally occurs between 20 seconds to 1 minute and persistsfor5 to 30 minutes.
Pharmacokinetics
‍Lidocaine Gel may be absorbed following topical administration to mucous membranes. Its rate and extent of absorption depend upon various factors such as concentration, the specific site of application, viscosity of the agent, and duration of exposure. The plasma binding of Lidocaine is dependent on drug concentration, and the fraction bound decreases with increasing concentration. At concentrations of 1 to 4 mcg of free base per mL, 60 to 80 percent of Lidocaine is protein bound. Binding is also dependent on the plasma concentration of the alpha-1-acid glycoprotein. Lidocaine is metabolized rapidly by the liver, and metabolites and unchanged drug are excreted by the kidneys. Biotransformation includes oxidative N-dealkylation, ring Hydroxylation, cleavage of the amide linkage, and conjugation. N-dealkylation, a major pathway of biotransformation, yields the metabolites monoethyl glycinexylidide and glycinexylidide. The pharmacologic/toxicologic actions of these metabolites are similar to, but less potent than, those of Lidocaine. Approximately 90% of Lidocaine administered is excreted in the form of various metabolites, and less than 10% is excreted unchanged. The primary metabolite in urine is a conjugate of 4-hydroxy-2, 6-dimethylaniline.Studies of Lidocaine metabolism following intravenous bolus injections have shown that the elimination half-life of this agent is typically 1.5 to 2 hours. Because of the rate at which Lidocaine is metabolized, any condition that affects liver function may alter Lidocaine kinetics. The half-life may be prolonged twofold or more in patients with liverdysfunction. Renal dysfunction does not affect Lidocaine kinetics but may increase the accumulation of metabolites.

INDICATION

Lidovisc Gel is indicated for ocular surface anesthesia during ophthalmologic procedures It also used in surgical anaesthesia and pupil dilation of eye during surgical procedure.

CONTRAINDICATIONS

At present there are no known contraindications for the use of Lidovisc Gel ophthalmic viscoelastic. Care should be taken with patients hypersensitive to any component in the materials.

WARNING & PRECAUTIONS

-Not for Injection
-Corneal Opacification. Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss.

PRECAUTIONS:

ADVERSE REACTION

Most common adverse reactions are conjunctival hyperemia, corneal epithelial changes, headache, and burning upon instillation.

OVERDOSAGE

Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss.

STORAGE

Store below 30°C,Protect from light. Do not allow to Freeze.

HOW SUPPLIED

Lidovisc Gel 2mL is packed in glass syringe with one sterile disposable angular cannula. For Intra-ocular use. Single use only.

LIDOVISC GEL

SUPRACOAT PLUS

Sodium Chondroitin Sulphate & Sodium Hyaluronate Ophthalmic Solution

DESCRIPTION:

SUPRACOAT PLUS is a sterile, non-pyrogenic, viscoelastic solution of a highly purified non-inflammatory medium molecular weight fraction of Sodium Chondroitin Sulphate and Sodium Hyaluronate. SUPRACOAT PLUS solution is formulated to a viscosity of 20000 cps (at shear rate of 2 sec.-1 25°C). Each mL of SUPRACOAT PLUS Solution contains not more than 40 mg Sodium Chondroitin Sulphate and 30 mg Sodium Hyaluronate in a physiological buffer. Sodium Chondroitin Sulphate and Sodium Hyaluronate are quite similar in regard to chemical and physical composition, as each occurs as a large, unbranched chain structure of medium to high molecular weight.

COMPOSITION:

Each ML Contains:

Sodium chondroitin sulphate USP ............40 mg
Sodium hyaluronate BP ............30 mg
Aqueous Buffered Solution .............q.s.

INDICATIONS:

PHARMACOLOGICAL ACTION:

SUPRACOAT PLUS solution maintains a deep chamber during anterior segment surgeries, enhances visualization during the surgical procedure, and protects the corneal endothelium and other ocular tissues. The viscoelasticity of the solution maintains the normal position of the vitreous face, thus preventing formation of a postoperative flat chamber. The sugar moieties of these two compounds occur as repeating disaccharide subunits consisting of glucuronic acid in B 1-3 linkage with Nacetylglucosamine for sodium chondroitin sulphate and Nacetylglucosamine for sodium hyaluronate. The subunits are then combined by B 1-4 linkage of the amino sugar residue to the glucuronic residue of the next subunit to form large polymers. The two compounds differ in that sodium chondroitin sulphate possesses a sulphate group and a double, rather than a single, negative charge (as in the case of sodium hyaluronate) per repeating disaccharide subunit. Sodium chondroitin sulphate and sodium hyaluronate are biological polymers centered in the extra-cellular matrix of animals and humans. The cornea is the ocular tissue having the greatest concentration of sodium chondroitin sulphate, while the vitreous and aqueous humor contain the greatest concentration of sodium hyaluronate. SUPRACOAT PLUS solution is completely transparent and exhibits flow properties.

CONTRA-INDICATIONS:

There are no contra-Indications recorded on using SUPRACOAT PLUS, If Used as recommended.

CLINICAL APPLICATIONS:

In surgery involving the anterior segment, SUPRACOAT PLUS should be carefully and slowly injected into the anterior chamber using a sterile single-use Luer lock canula (in no case a reusable cannula should be used, even if it is well cleaned, rinsed and re-sterilized since it could release particles during injection) SUPRACOAT PLUS is
injected before the capsulorhexis procedure, so that its protective effect will be optimized. At this stage of the surgery, SUPRACOAT PLUS protects the endothelium of the cornea from potential damage by surgical instruments. SUPRACOAT PLUS may be injected into the anterior chamber several times during surgery to replace the product lost during the surgical procedure. At the end of the surgery, SUPRACOATPLUS should be aspiration with sterile irrigating solution.

DOSAGE AND DIRECTIONS FOR USE:

FOR INTRAOCULAR USE ONLY
FOR SINGLE USE ONLY
NOT FOR IV/IM INJECTION

SUPRACOAT PLUS should be allowed to attain room temperature prior to use. The syringe assembly is designed only for the injection of the SUPRACOAT PLUS viscoelastic solution it contains. Use of the syringe assembly for aspiration is not advised. When left in the eye, endothelial loss can be expected to be lower. For cataract surgery and intraocular lens implantation SUPRACOAT solution should be carefully introduced (using a 27-gauge cannula) into the anterior chamber. SUPRACOAT PLUS solution may be injected into the chamber prior to or following delivery of the crystalline lens. Instillation of SUPRACOAT solution prior to lens delivery will provide additional protection to the corneal endothelium. Instillation of the solution at this point is significant in that a coating of SUPRACOAT PLUS solution may protect the corneal endothelium from possible damage arising from surgical instrumentation during the cataract extraction surgery. SUPRACOAT PLUS solution may also be used to coat an intraocular lens as well as the tips of surgical instruments prior to implantation surgery. Additional solution may be injected during anterior segment surgery to fully maintain the chamber or replace any solution lost during the surgical procedure. At the end of the surgical procedure SUPRACOAT PLUS solution may be removed from the eye by thoroughly irrigating and aspirating with a balanced salt solution. Alternatively SUPRACOAT PLUS solution may be left in the eye, when used as directed.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:

WARNINGS:

HOW SUPPLIED:

SUPRACOAT PLUS is a sterile , single use viscoelastic device supplied in a non-pyrogenic Syringe containing 1mL with single use sterile angular cannula 27 G.

SHELF LIFE:

24 Months

STORAGE INSTRUCTIONS:

Store between 10°C-25°C. Protect from light. The contents are sterile unless the package is opened or broken. Do Not Freeze. Keep Out of the Reach of Children.

NOTE:

For Use during surgery Do not exert more pressure on the plunger prior to removing the cannula from the eye. This is to avoid aspiration of air Bubbles into the cannula.

SUPRACOAT PLUS

TRYPAN BLUE

(TRYPAN BLUE STERILE SOLUTION)

DESCRIPTION:

Trypan Blue Solution (Preservative free) 0.6 mg is a sterile solution(an acid di-azo group dye). Trypan Blue Solution is a selective tissue staining agent for use as a medical aid in ophthalmic surgery. Each mL of Trypan Blue Solution contains not more than 0.6 mg of Trypan Blue and 8.2 mg of Sodium Chloride in a aqueous buffered. The drug substance Trypan Blue Solution has the chemical name 3.3’.-[(3.3’-dimethy 1-4,4’ biphenylylene) bis (azo)] bis (5-amino-4hydroxy-2,7-naphthalanedisulfonic acid) tetra sodium salt, a molecular eright of 960.8, a molecular formula of C34H24N6Na4O14S4, and has the following chemical structure weight.

COMPOSITION:

Each ML Contains:

Trypan Blue...... 0.6 mg
Sodium Chloride USP..... 8.2 mg
Aqueous Buffered Vehicle .............q.s.

INTENDED USE:

Trypan Blue Solution is indicated for use as an aid in ophthalmic surgery by staining the anterior capsule of the lens.

DOSAGE AND ADMINISTRATION:

CATARACT SURGERY:
‍Trypan Blue Solution is packaged in a 2.0 mL glass vial in sterile pouch. After opening the eye, an air bubble is injected in to the anterior chamber of the eye in order to minimize dilution of Trypan Blue Solution by the aqueous.

Trypan Blue Solution is carefully applied onto the anterior lens capsule using a blunt cannula. Sufficient staining is achieved as soon as the dye has contacted the capsule. The anterior chamber is then irrigated with balanced salt solution to remove all excess dye. An anterior capsulotomy can then be performed.

MODE OF ACTION(Mechanism of Action):
Trypan Blue Solution selectively stains connective tissue structures in the human eye such as the anterior lens capsule of the human crystalline lens. Trypan Blue Solution is intended to be applied directly on the anterior lens capsule, staining any portion of the capsule which comes in contact with the dye. Excess dye is washed out of the anterior chamber. The dye does not penetrate the capsule, permitting visualization of the anterior capsule in contrast to the the non-stained lens cortex and inner lens material.

CONTRA-INDICATIONS:

Trypan Blue Solution is contraindicated when a non-hydrated (dry state), hydrophilic acrylic intraocular intracular lens (IOL) is planned to be inserted into the eye because the dye may be absorbed by the and stain the IOL.

PRECAUTIONS:

General: It is recommended that after injection all excess Trypan Blue Solution be immediately removed from the eye by thorough irrigation of the anterior chamber. Carcinogenesis, mutagenesis, impairment of fertility. Trypan Blue Solution is carcinogenic in rats. Wister/Lewis rats developed Iymphom as after receiving subcutaneous injections of 1% trypan blue dosed at 50 mg/kg every other week for 52 weeks (total dose approximately1,250,000-fold the maximum recommended human dose of 0.6 mg per injection in a 60kg person, assuming total absorption)Trypan Blue Solution was mutagenic in the Ames test and causes DNA strand breaks in vitro.

WARNINGS ON DURG:

USFDA pregnancy category: C (Usage of Trypan Blue Solution during pregnancy) Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well- controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. The usage may lead to foetal birth defects.
Excreted into huma milk: Unknown The effects in the nursing infant are unknown if the nursing mother undergo use of Trypan Blue Solution

HOW SUPPLIED:

Trypan Blue Solution is preservative free, sterile solution, non – pyrogenic, 1 ml preparation supplied in a glass vial packed in a sterilized pouch.

PREGNANCY:

Teratogenic Eﬀects
Pregnancy Category C
Trypan Blue Solution is teratogenic in rats, mice, rabbits, hamsters, dogs, guinea pigs, pigs, and chickens. The majority of teratogenicity studies performed involve intravenous, intraperitoneal, or subcutaneous administration in the rat. The teratogenic dose is 50 mg/kg as a single dose or 25 mg/kg/day during embryogenesisin the rat. These doses are approximately 50,000- and 25,000-fold the maximum recommended human dose of 0.8 mg per injection based in a 60 kg person, assuming that the whole dose is completely absorbed. Characteristic anomalies included neural tube, cardiovascular, vertebral, tail, and eye defects. Trypan Blue Solution also caused an increase in post-implantation mortality, and decreased fetal weight. In the monkey, Trypan Blue Solution caused abortions with single or two daily doses of 50 mg/kg between 20th to 25th days of pregnancy, but no apparent increase in birth defects (approximately50,000-fold maximum recommended human dose of 0.6 mg per injection, assuming total absorption). There are no adequate and well- controlled studies in pregnant women. Trypan Blue Solution should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus.

NURSING MOTHERS:

Trypan Blue Solution is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Trypan Blue Solution is administered to a nursing woman. Pediatric use. The safety and effectiveness of Trypan Blue Solution have been established in Pediatric patients.NH2 OH OH NH2 Use of Trypan Blue is supported by evidence from an adequate and well-controlled study in pediatric patients.

SIDE EFFECTS:

Adverse reactions reported following use of Trypan Blue Solution include discoloration of high water content hydrogen intraocular lenses (see contraindications) and in advertent staining of the posterior lens capsule and vitereous face. Staining of the posterior lens capsule or staining of the vitreous face is generally self limited, lasting up to one week.

TECHNIQUE:

To use Trypan Blue Solution the ﬁrst step is to inject air into the anterior chamber using a 26 gauge needle in the area where the second site is made. This prevents water like dilution of the dye. Then Trypan Blue Solution is withdrawn from the vial into a syringe which is then injected into the anterior chamber between the air bubble and the lens capsule. Use the bevel down of the needle and see to it the injection is made in a drop format so that the whole capsule gets stained. If some stain is left unstained, inject a drop in that area till it gets stained. It is kept like that for a minute for attaining of the anterior capsule to occur. Next the viscoelastic is injected into the anterior chamber, this will distend the eye so that when you make a clear corneal incision, the eye will be trense and one can create a good valve. Now use a straight rod to stabilize the eye with the left hand and with the right hand make a clear corneal incision or scleral incision. Inject viscoelastic inside the eye to remove the air bubble and the Trypan Blue Solutio.n. Now Trypan Blue Solution is started with a needle or with a forceps. One will see the contrast between the capsule, which has been stained and the cortex which is not stained. The Trypan Blue Solution is continued and ﬁnally completed.W hen the Trypan Blue Solution is complete, we can see the stained anterior capsule lying in the anterior chamber.

WARNINGS:

Do not use if package is damaged. Do not resterilized, Resterilization on this product has not been validated. Discard remaining solution after single use. Physical, chemical and microbiological parameters may not be guaranteed if Trypan Blue Solution is reused. Avoid excess fill to frontal eye chamber allergic reaction may occur in hypersensitive patients. For Intraocular use only. Preservative free. Not for injection. Keep out of the reach of children.

USABILITY & INFORMATION HARZARDS

Mishandling of the product for package leads to microbial contamination of the device and post-operative inflammation. Improper removal of device from package leads to product damage and eye redness. use by unskilled personnel leads to product damage and eye redness. Inadequate irrigation &aspiration of solution leads to reversible eye infection.

SHELF LIFE:

24 Months

STORAGE INSTRUCTIONS:

Store in dry place. Store away from sunlight. Store between 15°C to 25°C.
‍Waste Disposal Method: Dispose in accordance with local, state and federal regulations.

SURGICAL PRODUCTS

APPAVISC®

(Hydroxypropyl Methylcellulose Ophthalmic Solution USP)

Preservative Free Sterile Solution

DESCRIPTION:

MODE OF ACTION (Mechanism Of Action)

INTENDED USE

CONTRAINDICATIONS

WARNING

PRECAUTIONS

DRUG INTERACTIONS

SIDE EFFECTS

DOSAGE AND ADMINISTRATION

PREPARATION & ADMINISTRATION GUIDE

USABILITY & INFORMATION HARZARDS

HOW SUPPLIED

STORAGE

PACKING

APPAVISC

APPAVISC PFS ® / 2mL

(Hydroxypropyl Methylcellulose Ophthalmic Solution USP)

PRESERVATIVE FREE STERILE SOLUTION

DESCRIPTION:

MODE OF ACTION (Mechanism of Action)

INTENDED USE

CONTRAINDICATIONS

WARNING

PRECAUTIONS

DRUG INTERACTIONS

PREPARATION & ADMINISTRATION GUIDE

SIDE EFFECTS

DOSAGE AND ADMINISTRATION

USABILITY & INFORMATION HARZARDS

HOW SUPPLIED

STORAGE

PACKING

APPAVISC PFS

APPAVISC HV PFS ®

(Hydroxypropyl Methylcellulose Ophthalmic Solution USP)

PRESERVATIVE FREE STERILE SOLUTION

DESCRIPTION

MODE OF ACTION (Mechanismof Action)

INTENDED USE

CONTRAINDICATIONS

WARNING

PRECAUTIONS

PREPARATION & ADMINISTRATION GUIDE

SIDE EFFECTS

DOSAGE AND ADMINISTRATION

USABILITY & INFORMATION HARZARDS

HOW SUPPLIED

STORAGE

PACKING

APPAVISC HV PFS

COHEVISC 1.0

Pack : 1ml Pack

DESCRIPTION:

COMPOSITION:

1. COHEVISC 1.0:

Each ML Contains :

2. COHEVISC 1.4:

Each ML Contains :

3. COHEVISC 1.8:

Each ML Contains :

PRODUCT FEATURES:

PACKAGING:

INDICATIONS:

VISCOSITY:

SHELF LIFE:

STORAGE:

AVAILABILITY:

INTENDED USE:

DIRECTION OF USE:

CONTRAINDICATION:

SUPPLY:

COHEVISC 1mL

COHEVISC 1.4mL

COHEVISC 1.4

Pack : 1ml Pack

DESCRIPTION:

APPAVISC^®

APPAVISC PFS ^® / 2mL

APPAVISC HV PFS ^®

1. COHEVISC 1.0:
Each ML Contains :

2. COHEVISC 1.4:
Each ML Contains :

3. COHEVISC 1.8:
Each ML Contains :

COHEVISC 1.8^®

(Sodium Hyaluronate Sterile Ophthalmic Solution)
‍

FOR INTRAOCULAR USE ONLY
FOR SINGLE USE ONLY
NOT FOR IV/IM INJECTION