RICROLIN^® – Ophthalmic solution for parasurgical use

RICROLIN^® 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 RICROLIN^® 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. RICROLIN solution is in fact capable of reducing up to 95% of the UV energy that reaches the deep strata of the cornea.

INDICATIONS
In association with ophthalmic UV-A radiation, the solution is administered during conservative parasurgical procedures for keratoconus and other corneal extasia pathologies The administration of RICROLIN® in association with UV-A light retards the progression of Keratoconus. This treatment can prevent the necessity of corneal transplant.

DOSAGE AND ADMINISTRATION
5-10 minutes prior to irradiation, instil 1 or 2 drops of the solution using the appropriate dispenser provided During treatment with UV-A light instil the solution every 5 minutes, for a total of 30 minutes

CONTRAINDICATIONS
RICROLIN^® 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.

SIDE EFFECTS
No systemic side effects regarding the ocular surface have been reported.

WARNINGS
– The product must be kept away from direct light
– Right up to the moment the product is to be utilised, it must be stored under refrigeration at a temperature between  +4 and +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
– The product must not be utilised after more than one hour from first use
– The dispenser must not be utilised for more than one patient
– The product must not be utilised after the date indicated on the package
– The product must not be kept at a temperature higher than 25°C
– The product is strictly indicated for external ophthalmic parasurgical use and is therefore utilised exclusively by registered Ophthalomologists
– The product must not be utilised if packaging is damaged

PACKAGE
1 sterile single-use dispenser filled with 1ml solution
1 sterile single-use cannula needle

RICROLIN^® TE- ophthalmic solution for cllagen cross-linking

RICROLIN^®TE hypotonic ophthalmic solution containing Riboflavin (0.1%) and enhancers helping the Riboflavin pass through the intact corneal epithelium. The solution is used in the eye in conjunction with the administration of UV-A light, enabling cross-linking without the need to remove the corneal epithelium. The principal objective of RICROLIN^®TE 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. RICROLIN^®TE solution is in fact capable of reducing up to 95% of the UV energy that reaches the deep strata of the cornea.
The transepithelial penetration of the Riboflavin, aided by the addition of enhancers and without the need to remove the corneal epithelium, facilitates cross-linking and cuts the time of the operation while reducing post-operative discomfort for the patient.

INDICATIONS
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 AND ADMINISTRATION
Instill 1 or 2 drops of RICROLIN^®TE approximately every 2 minutes in the 30 minutes prior to the start of irradiation. During the application of UV-A, instill 1 or 2 drops of the product every 2-3 minutes throughout the operation (30 minutes in total).

CONTRAINDICATION
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 otherchemically-related substances

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

PRECAUTIONS
The product must be kept away from direct light.
Right up to the moment the product is to be utilised, it must be stored under refrigeration at a temperature between +4 and +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 utilise the product after more than one hour from first use.
Do not utilise the dispenser for more than one patient.
Do not utilise the product after the date indicated on the package.
Do not keep the product in temperature over 25°C.
The product is strictly indicated for external ophthalmic parasurgical use and is therefore utilised exclusively by registered Ophthalomologists.
Do not use if the package is damaged.

PACKAGE
1 monodose sterile dispenser filled with 1 ml solution
1 sterile single-use cannula needle