APPLICATION AND ADMINISTRATION:

Instill one drop at a time to eye 2-3 times daily or as directed by the Physician.

CONTRAINDICATIONS:

Known hypersensitivity to active component.

SPECIAL WARNINGS AND PRECAUTIONS:

Do not allow the tip to make contact with the eyes. Do not use while wearing soft contact lenses

DRUG INTERACTIONS:

There are no known drug interactions. In cases of co-administration with other eye medication should always be applied last, after an interval of at least 5 minutes.

PREGNANCY AND LACTATION:

Reproductive studies have not demonstrated any risk, but no controlled studies in pregnant women are available. Sodium Hyaluronate has a purely physical effect on the eyes without being absorbed and hence can be used during pregnancy and lactation.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:

Patients who experience blurred vision after application of the eye drops should not drive or use machinery until their vision has cleared.

UNDESIRABLE EFFECTS:

Blepharis, Eyelid dermatitis, Itching, Irritation, Conjunctivitis, Conjunctival infection, Corneal lesion such as keratitis superficial diffuse.

OVERDOSE:

There are no known reports of overdosing.

PHARMACODYNAMICS:

Sodium Hyaluronic acid contains a highly purified specific fraction of sodium salt of hyaluronic acid produced by bacterial fermentation and is therefore free from animal proteins. Hyaluronic acid is a natural polymer, which is present throughout the human body and also in the structures of human eyes. Its main physical characteristic is viscoelasticity. This means that Sodium Hyaluronic acid has a high viscosity between blinks and a low viscosity during blinking, ensuring efficient coating of the surface of the eye. Hyaluronic acid also possesses mucoadhesive properties and the ability to entrap water, thus resembling tear mucus glycoprotein. This together with the coating properties of hyaluronic acid results in an increased pre-corneal residence time and tear film break-up time and therefore a longer lubrication of corneal surface. The protective coating of the eye surface offered by Sodium Hyaluronic acid helps prevent dryness and irritation.

The core mechanisms of dry eye are driven by tear hyperosmolarity and tear film instability. The hypotonic solution counteracts the hyperosmolarity of altered tear fluid thus limiting corneal damage.

PHARMACOKINETICS:

Due to its high molecular weight, Sodium Hyaluronate is not expected to pass through the conjunctiva and the corneal epithelium. Following Intraocular administration of Sodium Hyaluronate, the half-life (t1/2) for elimination from the aqueous humour was around 10.5 hrs after administration.

STORAGE:

Store in a cool & dry place at a temperature not exceed 25°C. Do not freeze. Use the solution within one month after opening the container. NOT FOR INJECTION. FOR EXTERNAL USE ONLY. Keep out of reach of children.

PRESENTATION:

HyloSoft Sterile Eye Gel is available in 10 ml container & packed in a carton along with a package insert.