K-Link Plus

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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.