Zovirax Eye Ointment (2013)
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