Each ml contains 1 mg Sodium hyaluronate.
Excipients/Inactive Ingredients: Citric acid anhydrous, sodium citrate dihydrate, sorbitol, water for injections.
ATC Code: S01XA20.
Pharmacology: Pharmacodynamics: The usual management of dry eye is with artificial tears. Alleviation of symptoms and an increase in tear film stability has been shown after topical application of sodium hyaluronate solution. Sodium hyaluronate might play a role in maintaining a healthy corneal epithelium.
Pharmacokinetics: High molecular weight molecules such as sodium hyaluronate are not expected to pass through the conjunctiva and the corneal epithelium.
Toxicology: Preclinical safety data: No maternal toxicity, fetal toxicity, or teratogenic effects on the fetuses of treated dams (rats or rabbits) has been observed after subcutaneous sodium hyaluronate administration at doses up to 50 mg/kg/day. Sodium hyaluronate has shown no mutagenic or clastogenic potential in bacterial assays and cytogenetic assays conducted both in vitro and in vivo.
Sodium hyaluronate 0.1 % is used for the relief of dry eye and as a contact lens lubricant. Used for the treatment of keratoconjuctivitis sicca and eye drops for patient wearing hard and soft contact lenses. It is also used in patients who underwent different types of surgical interventions such as, LASIK, cataract surgery or others.
Posology for the treatment of keratoconjuctivitis sicca and patient wearing contact lenses: Regimens of ophthalmic hyaluronan 0.1% solution 1 to 2 drops, 3-4 times daily.
Posology in patients who underwent surgical interventions: At least 3, maximum 10 drops per day into the treated eye.
Mode of administration: Only use HYLO-COMOD if the sealing of the folding carton was intact before the first use.
Step 1: Remove cap before use.
Step 2: Before the first application please turn the HYLO-COMOD bottle with its tip down and press onto the bottom of the bottle until the first drop appears at the nozzle. Now the bottle is ready for further use. Hold the bottle upside down with the thumb on the shoulder of the bottle and the other fingers on the bottom of the bottle.
Step 3: Support the hand holding the COMOD-bottle as shown with the other hand.
Step 4: Lean head back slightly, gently pull down the lower eyelid and apply a strong and quick pressure on the middle of bottom of the bottle.
This activates the mechanism for the release of one drop. Because of the special COMOD valve system, size and speed of each drop are the same independently on how much pressure is applied. Slowly close eyes to allow the fluid to spread evenly on the eye surface.
Step 5: Replace cap immediately after use. Take care that the dropper tip is dry.
When applying the fluid, avoid any contact between the tip of the bottle and eye or skin. The COMOD-bottle releases 10 ml of solution which is the equivalent of approximately 300 drops. For technical reasons a small amount remains in the bottle at the end of exhaustion. Only one person should be treated with one particular bottle of HYLO-COMOD.
Given the nature of product and the route of administration, no problems of overdosage are expected as the excess fluid will flow from the eye.
Hypersensitivity to hyaluronate or any component of the formulation (listed in Description).
Not to be used if hypersensitivity occurs.
Each bottle of HYLO-COMOD should be used by one patient only in order to reduce risk of cross-infection.
Effects on ability to drive and use machines: The eye drops may cause blurred vision for a short time after application even at normal dosages and with proper use. This can subsequently impair reaction time while driving or operating machinery.
Use in Pregnancy: Pregnancy risk category C. Give to a pregnant patient only if clearly needed.
Use in Lactation: It is not known if sodium hyaluronate is excreted in breast milk. Exercise caution when administering the drug to a nursing woman.
Most of the adverse events were symptoms which are very closely related to the symptoms of Keratoconjunctivitis sicca which was the main inclusion criterium for this study, such as burning, hyperemia, pain of the eye or edema of the eye lids. There was no correlation to the medical treatment.
Metabolism/transport Effects: None known.
Avoid concomitant use: There are no known interactions where it is recommended to avoid concomitant use.
Increased effect/toxicity: There are no known significant interactions involving an increase in effect.
Decreased effect: There are no known significant interactions involving a decrease in effect.
Incompatibilities: Do not use concomitantly with disinfectants containing quaternary ammonium salts because hyaluronic acid can precipitate in their presence.
Store below 30 °C.
Shelf-Life: Shelf-life of product: 3 years.
Shelf-life after first opening of the bottle: 6 months.
S01XA20 - artificial tears and other indifferent preparations ; Belongs to the class of other ophthalmologicals.
Eye drops (bottle) 0.1% (clear, colourless, odourless and homogenous eye drops) x 10 ml x 1's.