ZOVIRAX Cream (2017)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Zovirax Cream.
Qualitative and quantitative composition
Aciclovir BP 5.0% w/w. For the full list of excipients, see section 6.1.
Pharmaceutical form
Topical Cream.
Therapeutic indications
Zovirax Cream is indicated for the treatment of Herpes Simplex virus infections of the skin including initial and recurrent genital herpes and herpes labialis. Route of administration Topical. Do not use ...
Posology and method of administration
Adults and Children Zovirax Cream should be applied five times daily at approximately four hourly intervals, omitting the night time application. Zovirax Cream should be applied to the lesions or impending ...
Contraindications
Zovirax Cream is contraindicated in patients known to be hypersensitive to aciclovir, valaciclovir, propylene glycol or any of the excipients of Zovirax Cream listed in section 6.1.
Special warnings and precautions for use
Zovirax Cream is not recommended for application to mucous membranes such as in the mouth, eye or vagina, as it may be irritant. Particular care should be taken to avoid accidental introduction into the ...
Interaction with other medicinal products and other forms of interaction
No clinically significant interactions have been identified.
Fertility, pregnancy and lactation
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
Not applicable.
Undesirable effects
The following convention has been used for the classification of undesirable effects in terms of frequency: very common ≥1/10, common ≥1/100 and <1/10, uncommon ≥1/1000 and <1/100, rare ≥1/10,000 and <1/1000, ...
Overdose
No untoward effects would be expected if the entire contents of a 10 gram tube of Zovirax Cream containing 500 mg of aciclovir were ingested orally. However the accidental, repeated overdose of oral aciclovir, ...
Pharmacodynamic properties
Aciclovir is an antiviral agent which is highly active in vitro against herpes simplex virus (HSV) types I and II and varicella zoster virus. Toxicity to mammalian host cells is low. Aciclovir is phosphorylated ...
Pharmacokinetic properties
Pharmacology studies have shown only minimal systemic absorption of aciclovir following repeated topical administration of Zovirax Cream.
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
Poloxamer 407 Cetostearyl alcohol Sodium lauryl sulfate White soft paraffin Liquid paraffin Propylene glycol Purified water Arlacel 165 (containing glycerol monostearate and polyoxyethylene stearate) ...
Incompatibilities
None known.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Store below 25°C. Do not refrigerate.
Nature and contents of container
Collapsible aluminium tubes with plastic screw caps. Pack size: 2g or 10g tubes.
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.
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 00003/0180
Date of first authorization / renewal of the authorization
Date of first authorisation: 11 August 1983 Date of latest renewal: 07 January 2011
Date of revision of the text
01 December 2017
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