CORNEAL CROSS-LINKING

K-LINK H 3mL
K-LINK PLUS 3mL
K-LINK 2mL
K-LINK H 2mL

K-Link H

Riboflavin-5-Phosphate 0.1%W/V

DESCRIPTION

K-Link H (Riboflavin-5-Phosphate 0.1%w/v) is intended for topical ophthalmic administration as part of corneal collagen cross-linking with the KXL System. K-LinK H (Riboflavin-5-Phosphate 0.1% w/v) is yellow sterile buffered solution containing 1.0 mg/mL Riboflavin-5-Phosphate. The pH of the solution is approximately 7.1 and the osmolality is 155-175 mOsm/kg. Each 1 mL solution contains Riboflavin-5-Phosphate Sodium IP equivalent to Riboflavin 1.0 mg. The chemical formula for Riboflavin-5-Phosphate Sodium (Vitamin B2)is C17H20N4NaO9P with a molecular mass of 478.33 g/mol.

COMPOSITION

Each ML Contains:

Riboflavin -5- Phosphate Sodium IP
● Equivalent to Riboflavin ...........1.0 mg
● Sterile Hypotonic Solution............q.s.

Clinical Pharmacology

Mechanism Of Action

Riboflavin-5-Phosphate Sodium (Vitamin B2) is the precursor of two coenzymes, flavin adenine dinucleotide and flavin mononucleotide, which catalyze oxidation/reduction reactions involved in a number of metabolic pathways. Under the conditions used for corneal collagen cross-linking, Riboflavin-5-Phosphate functions as a photoenhancer and generates singlet oxygen which is responsible for the crosslinking.

NONCLINICAL TOXICOLOGY

Clinical toxicology study done with animals. Animal Study: Skin sensitization test done in guinea pigs, ocular irriadation and Intracutenous reactivity test done with New Zealand rabbits. Based on the study K-Link H is safe as per the animal study data. As per ISO-10993 part V (Biological evaluation of Medical Devises. Cytotoxic study done in line with balb/C3T3 Cultures. Based on this study K-Link H is non Cytotoxic.

Indications & Uses

Indicated for use in mild to moderate progressive Keratoconus, post LASIK Ectasia, pellucid marginal degeneration, bullous keratopathy, infectious keratitis, progressive hyperopia post radial keratectomy, scleral cross linking for glaucoma and pathological myopia.

● For use in cornea with thickness less than 400 μ.
● Epithelium debridement necessary (Epithelium-off)

Dosage & Administration

Instill 1 drops of K-Link H using the appropriate dispenser. During treatment with UV-A radiation instill the solution every 5 Seconds until corneal thickness has reached 400μ. If solution becomes dark brown or floating particles are found, it should be discarded. Supplied in a single use prefilled Syringe with Sterile dispenser. Once the yellow flare is observed, perform ultrasound pachymetery. If corneal thickness is less than 400μ, instill 2 drops of K Link H every 5 to 10 Seconds until the corneal thickness increases to at least 400μ. Irradiation should not be performed unless this 400μ threshold is met and the yellow flare is seen. For Ophthalmic use. Not for Injection. For single use only. K Link H is for use with the KXL System only.

Warnings & Precautions

● Single use only. Not for Injection. The product must be kept away from direct light.
● Right up to the moment the product is to be utilized, it must be store between 2°C to 25°C .
● Kept within its dispenser, the solution is maintained sterile.
● Do not touch the eye surface or other objects with the cannula needle in order to avoid the risk of    contamination to the solution.
● Do not utilize the product after more than one hour from first use.
● Do not utilize the dispenser for more than one patient.
● Do not utilize the product after the date indicated on the package.
● The product is strictly indicated for external ophthalmic parasurgical use and is therefore utilize exclusively     by registered Ophthalmologists.
 Do not use if the package is damaged.

Contraindications

None.

Side Effects

No systemic or eye structure related side-effects have been reported.

Adverse Reactions

The most common ocular adverse reactions in any CXL-treated eye were corneal opacity (haze), punctate keratitis, corneal striae, corneal epithelium defect, eye pain, reduced visual acuity, and blurred vision.

Storage

Store between 2°C to 25°C . Store away from sunlight. Store in a dry place.

Supplied

K-Link H 3 mL sterile single use pre-filled syringe. One sterile single use dispenser.

Aod address

K-Link H

K-Link Plus

Riboflavin Sterile Solution

DESCRIPTION:

K-Link Plus (Riboflavin Sterile Solution) is intended for ophthalmic administration as part of corneal collagen cross-linking with the KXL System.K-Link (Riboflavin Sterile Solution) is pale yellow to yellow sterile buffered solution containing 1.0 mg/mL Riboflavin-5-Phosphate. The pH of the solution is approximately 7.0 and the osmolality is 285-400 mOsm/kg. Each 1 mL solution contains Riboflavin-5- Phosphate Sodium equivalent to Riboflavin IP 1.0 mg.

COMPOSITION:

Each ML Contains:

Riboflavin-5-Phosphate Sodium IP
• equivalent to Riboflavin...........1.0 mg
• Sterile Isotonic Solution ............q.s.

Clinical Pharmacology:

Mechanism Of Action:

Riboflavin-5-Phosphate Sodium (Vitamin B2) is the precursor of two coenzymes, flavin adenine dinucleotide and flavin mononucleotide, which catalyze oxidation/reduction reactions involved in a number of metabolic pathways.
Under the conditions used for corneal collagen cross-linking, Riboflavin-5-Phosphate functions as a photoenhancer and generates singlet oxygen which is responsible for the cross-linking.
K-Link Plus is an ophthalmic solution containing Riboflavin 0.1% instilled in the eye during irradiation of UV-A light as part of the parasurgical procedure of corneal collagen cross-linking. The principal objective of K-Link Plus is to provide a barrier against UVA penetration beneath the corneal stroma, and thus protect the delicate internal structures of the eye (corneal endothelium, lens and retina) from damage that may be caused by radiation. K-Link Plus solution is in fact capable of reducing up to 95% of the UV energy that reaches the deep strata of the cornea.

Indications & Uses:

In association with ophthalmic UV-A radiation, the solution is administered during conservative procedures for keratoconus and other corneal estasia pathologies.In particular the treatment is indicated in the following conditions:
• For all ectasic conditions of the cornea, whether genetic or iatrogenic.
• For progressive keratoconus (clinically and instrumentally documented) and fordiseases linked to wear of the cornea.
The treatment (UV-A + Riboflavin) helps to slow down the progression of keratoconus.The treatment can prevent the necessity of corneal transplant. The treatment does not exclude the possible need of keratoplasty in the future.

Dosage & Administration:

Using topical anesthesia, debride the epithelium to a diameter of approximately 9 mm using standard aseptic technique. Post epithelial debridement, instill 1 drop of K-Link Plus topically on the eye every 2 minutes for 20 minutes. At the end of the 20 minute soaking period, examine the eye under the slit lamp for the presence of a yellow flare in the anterior chamber. If the yellow flare is not detected, instill 1 drop of K-Link Plus every 2 minutes for an additional 2 & 3 drops and recheck for the presence of a yellow flare. this process scan be repeated as necessary. Irradiate the eye for 20 continuous minutes at 3mW/cm² at a wavelength of 365 nm centered over the cornea, using the KXL System as per the instructions in the KXL manual. During Irradiation, continue topical instillation of K-Link Plus onto the eye every 2 minutes for the 20 minutes irradiation period.

Warnings & Precautions:

• Single use only. Not for Injection. The product must be kept away from direct light.
• Right up to the moment the product is to be utilized, it must be store between 15°C to 25°C .
• Kept within its dispenser, the solution is maintained sterile.
• Do not touch the eye surface or other objects with the cannula needle in order to avoid the risk of contamination to the solution.
• Do not utilize the product after more than one hour from first use.• Do not utilize the dispenser for more than one patient.
• Do not utilize the product after the date indicated on the package.
• The product is strictly indicated for external ophthalmic parasurgical use and is therefore utilize exclusively by registered Ophthalmologists.
Do not use if the package is damaged.

Contraindications:

There are no known contraindications associated with the ophthalmic solution. Use must be avoided in cases of hypersensitivity reactions to the components of the product or to other chemically-related substances.

Side Effects:

No systemic or eye structure related side-effects have been reported.

Adverse Reactions:

The most common ocular adverse reactions in any KXL-treated eye were corneal opacity (haze), punctate keratitis, corneal striae, corneal epithelium defect, eye pain, reduced visual acuity, and blurred vision.

Storage:

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

Supplied:

K-Link Plus 3 mL sterile single use pre-filled syringe.

IFUAod address

K-Link Plus


K-LINK
‍‍

(Riboflavin and Dextran Sterile Solution)

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

DESCRIPTION:

K-Link (Riboflavin& Dextran Sterile Solution) is intended for ophthalmic administration as part of corneal collagen cross-linking with the KXL System. K-Link (Riboflavin & Dextran Sterile Solution) is pale yellow to yellow sterile buffered solution containing 1.0 mg/mL Riboflavin-5-Phosphate & Dextran 500 200mg. The pH of the solution is approximately 7.0 and the osmolality is 285-350 mOsm/kg. Each 1 mL solution contains Riboflavin- 5-Phosphate Sodium equivalent to Riboflavin IP 1.0 mg & Dextran500 200mg.Please refer to the KXL System Operator’s Manual for a specific device description and instructions.

COMPOSITION:

Each mL contains
Riboflavin -5- Phosphate Sodium
Equivalent to Riboflavin    IP 1.0 mg
Dextran 500                        200 mg
Sterile Isotonic Solutions            q.s.

CLINICAL PHARMACOLOGY

 Mechanism of Action
Riboflavin-5-Phosphate Sodium (Vitamin B2) is the precursor of two coenzymes, flavin adenine dinucleotide and flavin mononucleotide, which catalyze oxidation/reduction reactions involved in a number of metabolic pathways. Under the conditions used for corneal collagen cross-linking, Riboflavin-5-Phosphatefunctions as a photo enhancer and generates singlet oxygen which is responsible for the cross-linking. K-Link is an ophthalmic solution containing Riboflavin 0.1% instilled in the eye during irradiation of UV-A light as part of the parsurgical procedure of corneal collagen cross-linking. The principal objective of K-Link is to provide a barrier against UV-A penetration beneath the corneal stroma, and thus protect the delicate internal structures of the eye (corneal endothelium, lens and retina) from damage that may be caused by radiation. K-Link solution is infact capable of reducing up to 95% of the UV energy that reaches the deep strata of the cornea.

NONCLINICAL TOXICOLOGY

Clinical toxicology study done with animals. 
Animal Study: skin sensitization test done in guinea pigs, ocular irriadation and Intracutenous reactivity test done with New Zealand rabbits.
Based on the study K-Link is safe asper the animal study data.
As per ISO-10993 part V (Biological evaluation of Medical Devices.
Cytotoxic study done in line with balb/C3T3 Cultures.
Based on this study K-Link is non Cytotoxic.

Indications & Uses

In association with ophthalmic UV-A radiation, the solution is administered during conservative procedures for keratoconus and other corneal estasia pathologies. In particular the treatment is indicated in the following conditions
:- For all ectasic conditions of the cornea, whether genetic or iatrogenic
-For progressive keratoconus (clinically and instrumentally documented) and for diseases linked to wear of the cornea.
The treatment (UV-A + Riboflavin) helps to slow down the progression of keratoconus
The treatment can prevent the necessity of corneal transplant.
The treatment does not exclude the possible need of keratoplasty in the future

Dosage & Administration

Using topical anesthesia, debride the epithelium to a diameter of approximately 9 mm using standard aseptic technique. Post epithelial debridement, instill 1 drop of K-Link topically on the eye every 2 minutes for 30 minutes. At the end of the 30 minute soaking period, examine the eye under the slit lamp for the presence of a yellow flare in the anterior chamber. If the yellow flare is not detected, instill1 drop of K-Link every 2 minutes for an additional 2 & 3 drops and recheck for the presence of a yellow flare. this processs can be repeated as necessary. Irradiate the eye for 30 continuous minutes at 3mW/cm² at a wavelength of 365 nm centered over the cornea, using the KXL System as per the instructions in the KXL manual. During Irradiation, continue topical instillation of K-Link onto the eye every 2 minutes for the 30 minutes irradiation period.

Warnings & Precautions

-  Single use only. Not for Injection. The product must be kept away from direct light
.-Right up to the moment the product is to be utilized, it must be store between2°C to 8°C .
-Kept within its dispenser, the solution is maintained sterile.
-  Do not touch the eye surface or other objects with the cannula needle in order to avoid the risk of contamination to the solution.
- Do not utilize the product after more than one hour from first use.
- Do not utilize the dispenser for more than one patient.
-  Do not utilize the product after the date indicated on the package.
- The product is strictly indicated for external ophthalmic parasurgical use and is therefore utilize exclusively by registered Ophthalmologists.
- Do not use if the package is damaged.

Contraindications                            

There are no known contraindications associated with the ophthalmic solution. Use must be avoided in cases of hypersensitivity reactions to the components of the product or to other chemically-related substances.

Side Effects:

No systemic or eye structure related side-effects have been reported.

Adverse Reactions

The most common ocular adverse reactions in any CXL-treated eye were corneal opacity(haze), punctate keratitis, corneal striae, corneal epithelium defect, eye pain, reduced visual acuity, and blurred vision.

Storage

Store between2°C to 8°C . Storeaway from sunlight. Store in dry place.

Shelf Life

18 Months

How Supplied

K-Link is supplied in 2 or 3 mL sterile single use pre-filled syringe with sterile dispenser or single use sterile cannula.
‍

Aod address

K-Link 2mL


K-LINK H/ 2mL
‍‍

(Riboflavin and Dextran Sterile Solution)

DESCRIPTION:

K-Link H (Riboflavin-5-Phosphate 0.1%w/v) is intended for topical ophthalmic administration as part of corneal collagen cross-linking with the KXL System. K-LinK H (Riboflavin-5-Phosphate 0.1% w/v) is yellow sterile buffered solution containing 1.0 mg/mL Riboflavin-5-Phosphate. The pH of the solution is approximately7.1 and the osmolality is 155-175 mOsm/kg. Each1 mL solution contains Riboflavin-5-Phosphate Sodium IP equivalent to Riboflavin 1.0 mg. The chemical formula for Riboflavin-5-Phosphate Sodium (Vitamin B2) is C17H20N4NaO9P with a molecular mass of 478.33g/mol.

Please refer to the KXL System Operator’s Manual for a specific device description and instructions.

COMPOSITION:

Each mL contains
Riboflavin -5- Phosphate Sodium IP
Equivalent to Riboflavin     1.0 mg
‍Sterile tonic Solutions            q.s.

CLINICAL PHARMACOLOGY

 Mechanism of Action
Riboflavin-5-Phosphate Sodium (Vitamin B2) is the precursor of two coenzymes, flavin adenine dinucleotide and flavin mononucleotide, which catalyze oxidation/reduction reactions involved in a number of metabolic pathways.
Under the conditions used for corneal collagen cross-linking, Riboflavin-5-Phosphate functions as a photo enhancer and generates singlet oxygen which is responsible for the cross-linking.

NONCLINICAL TOXICOLOGY

Clinical    toxicology    study    done    with    animals. Animal Study: Skin sensitization test done in guinea pigs, ocular irriadation and Intracutenous reactivity test done with New Zealand rabbits.
Based on the study K-Link H is safe as per the animal study data. As per ISO-10993 part V (Biological evaluation of Medical Devises.
Cytotoxic study done in line with balb/C3T3 Cultures.
Based on this study K-Link H is non Cytotoxic.

Indications & Uses

 -Indicated for use in mild to moderate progressive Keratoconus, post LASIK Ectasia, pellucid marginal degeneration, bullous keratopathy, infectious keratitis, progressive hyperopia post radial keratectomy, scleral cross linking for glaucoma and pathological myopia.
- For use in cornea with thickness less than 400 µ.
- Epithelium debridement necessary (Epithelium-off)

Dosage & Administration

Instill 1 drops of K-Link H using the appropriate dispenser. During treatment with UV-A
radiation instill the solution every 5 Seconds until corneal thickness has reached 400µ. If solution becomes dark brown or floating particles are found, it should be discarded. Supplied in a single use prefilled Syringe with Sterile dispenser. Once the yellow flare is observed, perform ultrasound pachymetery. If corneal thickness is less than 400μ, instill 2 drops of K Link H every 5 to 10 Seconds until the corneal thickness increases to at least400μ. Irradiation should not be performed unless this 400μ threshold is met and the yellow flare is seen. For Ophthalmic use. Not for Injection. For   single   use    only. K Link H is for use with the KXL System only.

Warnings & Precautions

-  Single use only. Not for Injection. The product must be kept away from direct light
.-Right up to the moment the product is to be utilized, it must be store between 2°C to 25°C .
-Kept within its dispenser, the solution is maintained sterile.
-  Do not touch the eye surface or other objects with the cannula needle in order to avoid the risk of contamination to the solution.
- Do not utilize the product after more than one hour from first use.
- Do not utilize the dispenser for more than one patient.
-  Do not utilize the product after the date indicated on the package.
- The product is strictly indicated for external ophthalmic parasurgical use and is therefore utilize exclusively by registered Ophthalmologists.
- Do not use if the package is damaged.

Contraindications                            

None

Side Effects:

No systemic or eye structure related side-effects have been reported.

Adverse Reactions

The most common ocular adverse reactions in any CXL-treated eye were corneal opacity(haze), punctate keratitis, corneal striae, corneal epithelium defect, eye pain, reduced visual acuity, and blurred vision.

Storage

Store between 2°C to 25°C . Store away from sunlight. Store in dry place.

Shelf Life

18 Months

How Supplied

K-Link H is supplied in 2 or 3 mL sterile single use pre-filled syringe with sterile dispenser or single use sterile cannula.
‍

IFUAod address

K-Link H 2mL

APPASAMY ASSOCIATES (P) LTD,No.20, SBI Officer's colony,
1st Street, Arumbakkam, Chennai - 600 106, Tamil Nadu, India.
Call: +91 6382758855 /  +91 9381216555
E-mail : info@appasamy.com

©2024 Appasamy Associates Private Limited