HYLO GEL

Sodium hyaluronate.

HYLO GEL is a sterile, phosphate- and preservative-free solution for ocular use.
1 ml HYLO GEL contains 2 mg sodium hyaluronate, citric acid anhydrous, sodium citrate, sorbitol and water for injections.

HYLO GEL is indicated for the treatment of dry eye disease.
HYLO GEL contains the sodium salt of hyaluronic acid, a natural substance found in many organs of the human body including the eye. Its unique property is that it forms a regular, stable, and long lasting, lubricating, and moisturising film on the eye surface that is not easily rinsed off. This so-called bioadhesive property ensures that the cornea and conjunctiva are protected and together with the physiologic tears the eye lid moves easily over the surface of the eye. HYLO GEL contains a higher amount of sodium hyaluronate which makes it more viscous and in so doing the eye is provided with an intensive, soothing and long-lasting moisturising film. Persistent or more severe symptoms are relieved, and the eye is protected against further irritation.
Due to surgical interventions on the eye or after eye injuries the physiologic tear secretion may be reduced. A continuous moisturising of the surface of the eye is necessary for the regeneration of the eye's tissues. By applying HYLO GEL, increased moisture and lubrication is supplied to cornea and conjunctiva so that the physiologic wound healing process is optimal.
Being preservative-free, HYLO GEL is usually very well tolerated. Additionally, HYLO GEL is free of phosphates so that possible complications due to the formation of insoluble deposits in the cornea are avoided.

HYLO GEL is an eye drop for the intensive, therapeutic lubrication of the ocular surface in more severe and persistent dry eye sensation including treatment after surgical interventions on the eye.

Generally, instill one drop of HYLO GEL three times a day into each eye. If necessary, it can also be used more frequently. If HYLO GEL is used more frequently (e.g. more than 10 times per day) or when the patient's complaints persist, consult the eye doctor or pharmacist.

Do not use HYLO GEL if the patient is hypersensitive to any of the ingredients.

If the patient uses any other eye drops there should be at least 30 minutes between the applications, and HYLO GEL should always be used last. Eye ointments should, however, always be administered after using HYLO GEL.
If the patient does not feel better or feel worse after several days of use talk to the doctor or pharmacist.
As HYLO GEL is preservative-free it is well tolerated even when used over a longer period of time. In very rare cases adverse reactions like hypersensitivity, burning or excessive tearing, pain, foreign body sensation or other temporary local irritations have been reported which stop when the use of HYLO GEL is discontinued.
Note that temporary blurred vision is possible after application of HYLO GEL due to the viscosity of the eye drops solution. In very rare cases this may cause temporary headache in sensitive patients.
HYLO GEL relieves the symptoms in case of more severe or persistent dry eye sensation. HYLO GEL may be used while wearing contact lenses, in consultation with the eye specialist. However, in these cases, there may be some smearing on the contact lenses that will disappear after blinking a few times.
After inserting contact lenses, waiting for about 30 minutes before applying the eye drops is recommended. In this way, the patient can avoid intolerance reactions which may occur due to interactions between lens care products and HYLO GEL.
Based on available evidence HYLO GEL can be used in children, pregnant and breast-feeding women.
In case a serious incident has occurred during the use of this medical device or as a result of its use, report it to the distributor.

Based on available evidence HYLO GEL can be used in pregnant and breast-feeding women.

Do not store above 25 °C.
HYLO GEL can be used for 6 months after first opening.
Dispose this medical device via household waste according to the national legislation. This measure will help to protect the environment.

How should HYLO GEL be applied: Do not use HYLO GEL if any part of the protective seal on the folding carton is broken or damaged before using for the first time.
Step 1: Remove the cap before use.
To do this, hold the cap above the bottle. With your other hand, pull away the bottle from the cap with a rotary movement. Before the first application turn the HYLO GEL bottle with its tip down and press the bottom of the bottle repeatedly until the first drop appears at the nozzle. Now the bottle is ready for further use.
Step 2: Hold the bottle upside down and place your thumb on the shoulder of the bottle and the other fingers on the base of the bottle.
Step 3: Support the hand holding the COMOD-bottle with your other hand.
Step 4: When applying the eye drops, avoid any contact between the tip of the bottle and your eye and skin. With your head leaning back slightly, gently pull down your lower eyelid. Press the base of the bottle vigorously and quickly. This activates the mechanism to release one drop. Because of the special COMOD valve system, the size and speed of each drop remain constant regardless of the pressure applied to the base of the bottle. Slowly close your eyes to allow the fluid to spread evenly on the eye surface.
Step 5: Replace the cap immediately and carefully after use. Ensure that the dropper tip is dry.
Contact the manufacturer in case of any question about correct use of this medical device.
A bottle containing 10 ml of solution corresponds to approximately 300 drops.
For technical reasons a small amount always remains in the bottle.
HYLO GEL is suitable for long term treatment and can be used by adults and children without limitation of age.
Each bottle HYLO GEL should be used only by the same person.

Ophthalmic Lubricants

S01KA01 - hyaluronic acid ; Belongs to the class of viscoelastic substances used as ophthalmologic surgical aids.

B