AUROLAB
RIBOLINK
RIBOFLAVIN
OPHTHALMIC
SOLUTION

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

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:

• Store below 30°C. Protect from light. Care should be taken to minimize exposure of the syringe to light once removed from its protective packaging

How Supplied:

• Riboflavin ophthalmic solution - 2 ml is supplied in sterile pre filled syringe with pouch pack and sterile cannula.