For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory
COMPOSITION: Sodium Hyaluronate BP 0.1% w/v, Stabilized Oxychloro Complex (As preservative) 0.05 mg, Purified Water IP q.s.
EXCIPIENTS: Carboxymethylcellulose Sodium IP, Erythritol NF, Boric Acid IP, Calcium Chloride IP, Magnesium Chloride IP, Potassium Chloride IP, Borax BP, Glycerin IP, Sodium Citrate IP
Molecular formula: (C14H20NNa011)n
Hyaluronic acid, a glycosaminoglycans, is a highly viscous and elastic biopolymer occurring in many connective tissues throughout the body, including both the aqueous and the vitreous humor. Hyaluronic acid is a high molecular weight unbranched polyaccharide formed by a linear chain.
It comprises repeating dissacharide units of glucuronic acid and N-acetyl-D-glucosamine.
All strengths mentioned in this document might not be available in the market.
PHARMACEUTICAL FORM: Ophthalmic solution.
CLINICAL PARTICULARS
Therapeutic Indications:
0.1% sodium hyaluronate, ophthalmic solution are used for treatment of dry eyes and burning sensations due to environmental conditions.
Dosage and Method of Administration:
Posology
Normally one drop of HYLOSOFT is applied three times a day into each eye. If necessary it can also be used more frequently and as often as required. However a more frequent application (i.e. more than 10 times per day) of HYLOSOFT should be done under an ophthalmologists’ control.
HYLOSOFT can be used while wearing contact lenses. Wearing soft or hard contact lenses can be more comfortable by using HYLOSOFT as it does not form crusts or residues.
HYLOSOFT is suitable for long-term treatment.
Method of administration
For ocular use
Use in Elderly: Dosage recommendations and indications for use in elderly have not been established.
Use in Patients with Renal Impairment: Not applicable
Use in Patients with Hepatic Impairment: Not applicable
Use in Children: Dosage recommendations and indications for use in children have not been established.
Contraindications:
Hypersensitivity to any of the ingredients. In the event of persisting eye irritation discontinue use and consult your doctor.
Do not touch the nozzle and do not allow the nozzle tip to touch the eye during use.
HYLOSOFT should not be used at the same time as other ophthalmic drugs. If any other eye drops have to be used there should be an adequate gap before applying HYLOSOFT. Eye ointments should, however always be administered after the application of HYLOSOFT.
Interaction with Other Medicinal Products and Other Forms of Interaction :
As HYLOSOFT reaches its target directly by topical application and has primarily a physical effect (wetting of the surface) and no systemic effect, no drug interactions other than the physical interaction of topically applied eye drops are known.
HYLOSOFT can be applied during pregnancy and lactation as there is no pharmacological effect.
Effects on Ability to Drive and Use Machines:
HYLOSOFT ophthalmic solution 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.
Undesirable Effects:
Because it is preservative-free, HYLOSOFT is well tolerated even when used over a long period of time. Safety data does not provide any evidence that would represent an unacceptable hazard to its use in humans. In rare cases hypersensitive reactions like burning, itching, tearing has been reported which recedes immediately on discontinuation of HYLOSOFT.
Overdose:
Overdosage is unlikely to occur with this topical preparation.
PHARMACOLOGICAL PROPERTIES:
Pharmacodynamic Properties
0.1% sodium hyaluronate, ophthalmic solution reach their target directly by topical application and have primarily a physical effect (wetting of the surface). The substance does not become systemically available and are not metabolised in the human body. It is washed out of the eye after a while.
Preclinical Safety Data:
There is no data known about any toxic effect of sodium hyaluronate.
Because sodium hyaluronate is a naturally physiologic substance occurring in the eye but also in other parts of the body, the substance is very well tolerated in general.
Incompatibilities: None Known
PRESENTATION: 10 ml available in 10ml Vial.
STORAGE INSTRUCTIONS: Store in a cool & dry place. Protect from light.
For external use only.
KEEP OUT OF REACH OF CHILDREN.
