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SPC, UK: Zovirax Eye Ointment (2013)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
GlaxoSmithKline UK
Διεύθυνση :
Stockley Park West, Uxbridge, Middlesex, UB11 1BT, UK
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Name of the medicinal product

Zovirax Eye Ointment.

Qualitative and quantitative composition

Aciclovir 3.0% W/W For the full list of excipients, see section 6.1.

Pharmaceutical form

Ophthalmic ointment.

Therapeutic indications

Treatment of herpes simplex keratitis.

Posology and method of administration

Topical administration to the eye. Adults: 1cm ribbon of ointment should be placed inside the lower conjunctival sac five times a day at approximately four hourly intervals, omitting the night time application. ...

Contraindications

Zovirax eye ointment is contra-indicated in patients with a known hypersensitivity to aciclovir or valaciclovir, or any of the excipients listed in section 6.1.

Special warnings and precautions for use

Patients should be informed that transient mild stinging immediately following application may occur. Patients should avoid wearing contact lenses when using Zovirax Eye Ointment.

Interaction with other medicinal products and other forms of interaction

No clinically significant interactions have been identified.

Fertility, pregnancy and breast-feeding

Pregnancy A post-marketing aciclovir pregnancy registry has documented pregnancy outcomes in women exposed to any formulation of Zovirax. The registry findings have not shown an increase in the number ...

Effects on ability to drive and use machines

Eye ointments can affect visual ability and therefore caution is advised when driving or using machines.

Undesirable effects

Adverse reactions are listed below by MedDRA body system organ class and by frequency. The frequency categories used are: Very common ≥ 1/10, Common ≥ 1/100 and < 1/10, Uncommon ≥ 1/1,000 and <1/100, ...

Overdose

No untoward effects would be expected if the entire contents of the tube containing 135 mg of aciclovir were ingested orally. However, the accidental, repeated overdose of oral aciclovir, over several ...

Pharmacodynamic properties

Aciclovir is an antiviral agent which is highly active in vitro against herpes simplex (HSV) types I and II, but its toxicity to mammalian cells is low. Aciclovir is phosphorylated to the active compound ...

Pharmacokinetic properties

Aciclovir is rapidly absorbed from the ophthalmic ointment through the corneal epithelium and superficial ocular tissues, achieving antiviral concentrations in the aqueous humor. It has not been possible ...

Preclinical safety data

The results of a wide range of mutagenicity tests in vitro and in vivo indicate that aciclovir does not pose a genetic risk to man. Aciclovir was not found to be carcinogenic in long-term studies in the ...

List of excipients

White petrolatum USP

Incompatibilities

None known.

Shelf life

Shelf life: 5 years.

Special precautions for storage

Store below 25°C.

Nature and contents of container

Laminate ophthalmic ointment tubes closed with high-density polyethylene screw caps or tamper evident screw caps. Pack size: 4.5G

Special precautions for disposal and other handling

No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Administrative data.

Marketing authorization holder

The Wellcome Foundation Ltd 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom Trading as: GlaxoSmithKline UK Stockley Park West Uxbridge Middlesex UB11 1BT

Marketing authorization number(s)

PL 00003/0150

Date of first authorization / renewal of the authorization

16 October 1996

Date of revision of the text

13th December 2013