VIRGAN Eye gel Ref.[8187] Active ingredients: Ganciclovir

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: LABORATOIRES THEA, 12 RUE LOUIS-BLERIOT, Z.I. DU BREZET, 63017 CLERMONT, FERRAND CEDEX 2, FRANCE

Therapeutic indications

Treatment of acute herpetic keratitis (dendritic and geographic ulcers).

Posology and method of administration

Posology

Instil one drop of gel in the inferior conjunctival sac of the eye to be treated, 5 times a day until complete corneal re-epithelialisation. Then 3 instillations a day for 7 days after healing. The treatment does not usually exceed 21 days.

Use in the elderly

The dosage in the elderly is the same as in adults (see above). There is no need to adjust the dosage in the elderly as in clinical trials patients up to the age of 85 years have been treated and no specific health concerns were observed.

Use in children

Use of the medicinal product in children under 18 years is not recommended since no specific studies have been conducted.

Method of administration

Ocular instillation.

Overdose

There is practically no risk of adverse events due to accidental oral ingestion since a tube of 5g contains 7.5mg ganciclovir compared to the daily adult i.v. dose of 500-1000mg.

In the unlikely event of overdose, dialysis and hydration may be of benefit in reducing drug plasma levels.

Toxic manifestations seen in animals given very high single intravenous doses of ganciclovir (500mg/kg) included emesis, hypersalivation, anorexia, bloody diarrhoea, inactivity, cytopenia, abnormal liver function tests and BUN, testicular atrophy and death.

Shelf life

In the unopened container: 3 years.

In the opened container: 4 weeks.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

5g tube (polyethylene-aluminium) with dropper nozzle (polyethylene) and screw cap (polyethylene).

Special precautions for disposal and other handling

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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