TREHASOFT | Sodium Hyaluronate Ophthalmic Solution 0.18% w/v
For the use of an Ophthalmologist or a Hospital or a Laboratory only.
Composition:
Sodium Hyaluronate BP 0.18% w/v
Stabilized Oxychlorocomplex 0.005% w/v
Sterile Aqueous Buffer Vehicle q.s.
Other Ingredients: TREHALOSE USP 3% W/V, Sodium Chloride IP, Potassium Chloride IP, Sodium Dihydrogen Phosphate Dihydrate IP, Borax BP Carbomer NF
Description:
Trehasoft® contains Sodium Hyaluronate, a natural polymer which is also present in the structures of the human eye. The particular physical characteristics of Sodium Hyaluronate confer to this formulation its viscoelastic and water retaining properties.
Sodium Hyaluronate provides a stable coating on the surface of the eye, which is slowly eliminated by blinking. Therefore, TrehaSoft® combines long lasting relief with maximum comfort. It is well tolerated due to its unique composition.
Mechanism of Action:
Sodium Hyaluronate Eye Drops have unique physical properties that make them ideal for use in the treatment of sensations of ocular dryness. The most important property of Sodium Hyaluronate solutions is their viscoelasticity. This property allows such solutions, when instilled into the eye, to behave differently during and between blinks. During blinks, shear stress causes the molecules of Sodium Hyaluronate in solution to align with one another. As a result the solution becomes elastic and relatively non viscous and spreads easily over the surface of the cornea. Between blinks, the molecules of Sodium Hyaluronate form a tangled meshwork and the solution becomes less elastic and more viscous. Consequently the precorneal tear film is stabilized and the residence time of the solution on the surface of the eye is maximized.
Sodium Hyaluronate is highly effective in relieving symptoms associated with sensations of dryness. It can aid the healing of superficial keratitis, increase tear film break up time and is also very comfortable for the eye.
Indications:
For the treatment of sensation of dryness and other minor complaints of no pathological significance, as well as burning and ocular fatigue induced, for example by dust, smoke, dry heat, air conditioning, extended computer screen use or contact lens wear.
Contra-indications:
Hypersensitivity to any component of the formulation.
Warning & Precautions:
FOR EXTERNAL USE ONLY. NOT FOR INJECTION.
If discomfort persists or increases, the use of this drug should be discontinued and the patients should consult the doctor immediately.
Use the solution within one month after opening the container. If the solution becomes cloudy or dark brown, it should be discarded.
Keep the medicine out of reach of children.
Drug Interactions:
Sodium Hyaluronate Eye Drops should not be used at the same time as any other drug or product applied to the eyes since it may modify their effects.
Side Effects:
Adverse effects reported include eye sting, burn or itch (irritation), foreign body sensation, scratched area, excessive watering (tearing) of the eye, unusual eye secretions, redness of the eye, reduced sharpness of vision (poor visual acuity), blurred vision, rainbows or halos around objects, sensitivity to light (photo phobia).
Dosage & Administration:
Dosage should be individualized and the appropriate strength should be selected based on the severity of the condition and patient response. Place one or two drops of Trehasoft® into the conjunctival sac of the eye as often as needed. After blinking the solution will disperse and from a transparent and long lasting coating on the surface of eye. Patients wearing contact lenses should be advised to remove them before administering TrehaSoft in their eyes. The lenses can be reinserted after 15 minutes.
Do not touch the tip of the container and do not touch the surface of eye with the tip of container.
Storage: Store in a dry, well-ventilated place at a temperature not exceeding 30°C.
Presentation:
Trehasoft is available in 10 ml in plastic bottle.
