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.
Riboflavin -5- Phosphate Sodium IP
• Equivalent to Riboflavin ...........1.0 mg
• Sterile Hypotonic Solution............q.s.
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.
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.
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)
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.
• 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.
None.
No systemic or eye structure related side-effects have been reported.
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.
Store between 2°C to 25°C . Store away from sunlight. Store in a dry place.
K-Link H 3 mL sterile single use pre-filled syringe. One sterile single use dispenser.
