AUROLAB
RIBOLINK
RIBOFLAVIN
OPHTHALMIC
SOLUTION

Description

Ribolink is an ophthalmic solution containing Riboflavin 0.1%. It is instilled in the eye during irradiation of UV-A light as part of the para surgical procedure of corneal collagen cross-linking. Ribolink is used as a photo sensitizer to increase the structural integrity of cornea. It is formulated to facilitate corneal penetration and binding to collagen fibers.

Formulation for keratoconus corneal ectasia
ISO 13485 certified facility
Sterilized using validated processes
Sterile & Single doseSteam sterilized

Chemical Composition:

Riboflavin sodium phosphate IP eqt. to Riboflavin 0.1% w/v Dextran 500 20% w/v Purified water qs.

Characteristics:

Ribolink is a sterile and single dose formula for corneal cross linking procedures
It does not contain preservative agents
Ribolink is yellow colored isotonic solution remains stable under heat and becomes fluorescent under UV light
When exposed to light the photolysis reaction causes the detachment of ribitole root and subsequent loss of vitamin activity
Produced in world-class clean room monitored processes in compliance with WHО GMP
Steam sterilized

Indications And Clinical Use

In association with ophthalmic UV-A radiation, the solution is administered during conservative para surgical procedures for keratoconus and other corneal extasia pathologies. The administration of Riboflavin in association with UV-A light retards the progression of Keratoconus. This treatment can prevent the necessity of corneal transplant
The Riboflavin in the solution penetrated into the corneal stroma layer and it will generate oxygen free radicals in presence of UV-radiation which causes cross linking process
It is also used for pellucid marginal degeneration, bullous keratopathy combined with corneal ulcer, corneal ulceration, advanced corneal edema and infectious keratitis with corneal melts

Dosage And Administration

5-10 minutes prior to irradiation, instil or 2 drops of the solution, During treatment with UV-A light having the intensity of 3.0mW/cm² or 5.4J/cm² at 365 nm with 50 mm to 100 mm distance, instil the solution every 5 minutes, for a total of 30 minutes

Contraindications

Riboflavin ophthalmic solution has no contraindications. Use must be avoided in cases of hypersensitivity reactions to the components of the product or to other chemically related substances

Adverse Reactions

No systemic side effects regarding the ocular surface have been reported

Warnings and Precautions

The product must be kept away from direct light. Do not use if package is opened or damaged
The product must not be utilized after more than two hours from first use
The product must not be utilized after the date indicated on the package
The product should be stored at a temperature below 30°C
The product is strictly indicated for external ophthalmic para surgical use, therefore utilized exclusively by registered ophthalmologists
Do not resterilize. Resterilization on this product has not been validated
Sterility assurance may not be guaranteed if Ribolink is reused
Physical, chemical and microbiological parameters may not be guaranteed if Ribolink is reused
If the solution becomes dark brown or floating particles are found it should be discarded

Storage: