Hylo-Gel

Hylo-Gel

sodium hyaluronate

Manufacturer:

URSAPHARM

Distributor:

BJC Healthcare
Full Prescribing Info
Contents
Sodium hyaluronate.
Description
Each ml contains 2 mg Sodium hyaluronate.
Excipients/Inactive Ingredients: Anhydrous Citric acid, Sodium citrate dihydrate, Sorbitol and Water for injections.
Action
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.
Indications/Uses
HYLO-GEL is used as a lubricant for the postoperative care of penetrating keratoplasty. The use of HYLO-GEL after perforating keratoplasty (PKP) led to an increase in visual acuity.
Lubrication of the surface of the eye while wearing all types of contact lenses to increase the comfort of wearing contact lenses. 0.2% HA eye drops improves signs and symptoms of dry eye disease in patients with moderate to severe dry eye disease related to keratitis or keratoconjunctivitis.
Dosage/Direction for Use
Posology for postoperative care of penetrating keratoplasty: one drop into operated eye 5-10 times daily.
Posology for lubrication of the surface of the eye while wearing contact lenses: 3-4 drops per day.
Posology for moderate to severe dry eye disease related to keratitis or keratoconjunctivitis: One drop three times a day.
Mode of administration: Only use HYLO-GEL if the sealing of the folding carton was intact before the first use.
Step 1: Remove cap before use. For this purpose, hold the cap just over the bottle. With the other hand, pull away the bottle from the cap with a rotary movement. Before the first application please turn the HYLO-GEL 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.
Step 2: 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 with other hand.
Step 4: Lean the 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. Due to the special COMOD valve system, size and speed of each drop are the same no matter how much pressure is applied. Slowly close the 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 please avoid any contact between the tip of the bottle and the eye or the 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.
HYLO-GEL is suitable for long term treatment.
One bottle HYLO-GEL should be used only by the same person.
Overdosage
Given the nature of product and route of administration, no problems of overdosage are expected as the excess fluid will flow from the eye.
Contraindications
Hypersensitivity to hyaluronate or any component of the formulation (listed in Description).
Special Precautions
Each bottle of HYLO-GEL 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 & Lactation
Pregnancy: Pregnancy risk category C. Give to a pregnant patient only if clearly needed.
Lactation: It is not known if sodium hyaluronate is excreted in breast milk. Exercise caution when administering the drug to a nursing woman.
Adverse Reactions
Burning, foreign body sensation, itching, tearing, feeling of eye pressure, hardly any formation of mucus, slightly impaired vision during treatment.
HYLO-GEL should not be used in case of a hypersensitivity or allergy to one of the ingredients.
Drug Interactions
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.
Caution For Usage
Incompatibilities: Do not use concomitantly with disinfectants containing quaternary ammonium salts because hyaluronic acid can precipitate in their presence.
Storage
Store below 30°C.
Shelf-life of product: 3 years.
Shelf-life after first opening of the bottle: 6 months.
ATC Classification
S01XA20 - artificial tears and other indifferent preparations ; Belongs to the class of other ophthalmologicals.
Presentation/Packing
Eye drops 0.2% (clear, colourless, odourless and homogenous) x 10 mL x 1's.
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