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

This medicinal product is not indicated in the treatment of cytomegalovirus (CMV) retina infections.

Efficacy in other viral types of keratoconjunctivitis has not been demonstrated.

No specific clinical studies were performed in immunodepressed subjects.

This medicine contains 0.375 mg benzalkonium chloride in each tube of 5 g.

Benzalkonium chloride may also cause eye irritation, especially in dry eyes or disorders of the cornea. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. Remove contact lenses prior to application and wait at least 15 min before reinsertion.

If more than one topical ophthalmic drug is being used, the drugs should be administered at least fifteen minutes apart. VIRGAN should be instilled last.

Although the quantities of ganciclovir passing into the general circulation after ophthalmic use are small, the risk of drug interactions cannot be ruled out. Interactions with ganciclovir administered systemically have been observed:

Binding of ganciclovir to plasma proteins is only about 1-2% and drug interactions involving binding site displacement are not anticipated.

It is possible that drugs which inhibit replication of rapidly dividing cell populations such as bone marrow, spermatogonia and germinal layers of skin and gastrointestinal mucosa might have combined additive toxic effects when used concomitantly with, before or after ganciclovir. Because of the possibility of additive toxicity with co-administration of drugs such as dapsone, pentamidine, flucystosine, vincristine, vinblastine, adriamycin, amphotericin B, trimethoprim/sulpha combinations or other nucleoside analogues, combination with ganciclovir therapy should be used only if the potential benefits outweigh the risks.

Since both zidovudine and ganciclovir can result in neutropenia, it is recommended that these two drugs should not be given concomitantly during induction treatment with ganciclovir. Maintenance ganciclovir treatment plus zidovudine at the recommended dose resulted in severe neutropenia in most patients studied to date.

Generalised seizures have been reported in patients taking ganciclovir and imipenem-cilastatin concomitantly.

It is also possible that probenecid, as well as other drugs which inhibit renal tubular secretion or resorption, may reduce renal clearance of ganciclovir and could increase the plasma half-life of ganciclovir.

There is insufficient experience regarding administration during pregnancy or lactation for evaluating the safety of VIRGAN during these periods.

Teratogenicity and effect on fertility have been observed in animal studies with orally or intravenous administered ganciclovir. Furthermore ganciclovir had shown potential genotoxicity with low safety margin (see section 5.3).

Consequently, administration during pregnancy or lactation is therefore not recommended, except in the absence of an alternative treatment. For women of childbearing age, contraceptives measures should be used.

Due to the genotoxic effect in animal studies, men taking VIRGAN are advised to use local contraceptive measure (as condom) during treatment and for up to three months thereafter.

Patients should refrain from driving a vehicle or operating machines on the occurrence of any visual disturbance or other visual symptomatology.

The following adverse reactions were reported during four clinical trials with VIRGAN 0.15% w/w eye gel (three phase IIB trials and one Phase III trial).

Adverse events are categorised by frequency as follows: very common (≥ 1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000), not known (cannot be estimated from the available data).

Eye disorders

Very common: Transient burning or stinging sensations, eye irritation, blurred vision.

Common: Superficial punctate keratitis, conjunctival hyperaemia.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Not applicable.