VISMED MULTI SmPC

 

Instructions for Use 

VISMED® MULTI

Sodium hyaluronate from fermentation 0.18 %. Transparent solution of natural, highly purified sodium hyaluronate. Devoid of animal proteins. 

Sterile, free from preservatives.

Available on the NHS (FP10)

COMPOSITION:

1 ml solution with neutral pH contains sodium hyaluronate 1.8 mg, sodium chloride, potassium chloride, disodium phosphate, sodium citrate, magnesium chloride, calcium chloride and purified water. The solution is hypotonic.

INDICATIONS

Symptoms and signs of dry eye and/or ocular surface damage without restriction in regard to severity, due to diseases such as superficial keratitis, Sjögren syndrome or primary dry eye syndrome. For lubrication of the eyes in case of sensation of dryness, burning and ocular fatigue and other minor complaints of no pathological significance induced, for example, by dust, smoke, dry heat, air conditioning, wind, cold, extended computer screen use or contact lens wear.

CONTRA-INDICATIONS

Individual hypersensitivity to any constituent of the product.

PRECAUTIONS

Do not touch the tip of the opened container and do not touch the surface of the eye with the tip of the opened container. Put the protective cap back on after using VISMED® MULTI. VISMED® MULTI can be used up to 6 months after first use. Any solution not used within 6 months after opening must be discarded. Otherwise the sterility is no longer guaranteed and this may be associated with a risk of infection. Do not use VISMED® MULTI if the container is damaged. If discomfort persists while using VISMED® MULTI consult a physician.

INTERACTIONS

Do not use VISMED® MULTI at the same time as any drug or other product applied to the eye since it may modify their effects. Wait for at least 15 minutes until instillation of other eye products.

UNDESIRABLE EFFECTS

On very rare occasions, transient disorders such as local irritation, foreign body sensation, pain, redness or burning sensation of the eye, or short-term blurred vision may occur. 

REPORTING OF SIDE EFFECTS

Any serious incident that has occurred in relation to the device should be reported to the manufacturer TRB Chemedica AG and the local competent authority of the user. 

DOSAGE AND ADMINISTRATION

Tear off the tamper-evident seal before the first administration. Remove the protective cap. Tilt the head backwards and position the tip of the container above the eye to be treated. Move the lower eyelid down with the forefinger of one hand. Press the container and one drop of VISMED® MULTI will be released (see illustrations).

If not otherwise recommended, instill 1 or 2 drops of VISMED® MULTI onto the eye as often as needed. After blinking, the solution will disperse and form a transparent and long lasting coating on the surface of the eye.

VISMED® MULTI may also be used while wearing contact lenses (rigid or soft).


1 Remove the tamper-evident seal. 

2 Remove the protective cap

3 Instill one or two drops onto the eye. 

4 Put the protective cap back on after administration.


CHARACTERISTICS AND MODE OF ACTION

VISMED® MULTI 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 VISMED® MULTI its viscoelastic and water retaining properties. VISMED® MULTI provides a stable coating on the surface of the eye which is only slowly eliminated by blinking. Therefore VISMED® MULTI combines long lasting relief with maximum comfort. VISMED® MULTI is well tolerated due to its unique composition.

STORAGE AND DISPOSAL

Store below 30°C in a dry place, protected from light! Do not freeze! Do not use VISMED® MULTI after the expiry date indicated on the container and the folding box. Keep out of reach of children!
Empty as well as unused bottles of VISMED® MULTI can be disposed of with household waste.

PRESENTATION

10 ml solution in a multidose container.

Last revision date: 2022-04.

Manufactured by:

TRB CHEMEDICA AG
Otto-Lilienthal-Ring 26
85622 Feldkirchen/Munich, Germany

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