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SPC, UK: Zovirax I.V. (2015)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
GlaxoSmithKline UK
Διεύθυνση :
Stockley Park West, Uxbridge, Middlesex, UB11 1BT, UK
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Δωρεάν εγγραφή

Name of the medicinal product

Zovirax I.V. 250 mg. Zovirax I.V. 500 mg.

Qualitative and quantitative composition

250 mg aciclovir or 500 mg aciclovir in each vial. Excipients with known effect: Sodium hydroxide For the full list of excipients, see section 6.1.

Pharmaceutical form

Intravenous injection.

Therapeutic indications

Zovirax I.V. is indicated for the treatment of Herpes simplex infections in immunocompromised patients and severe initial genital herpes in the non-immunocompromised. Zovirax I.V. is indicated for the ...

Posology and method of administration

Route of administration: Slow intravenous infusion over 1 hour. A course of treatment with Zovirax I.V. usually lasts 5 days, but this may be adjusted according to the patients condition and response to ...

Contraindications

Hypersensitivity to aciclovir or valaciclovir, or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Adequate hydration should be maintained in patients given i.v. or high oral doses of aciclovir. Intravenous doses should be given by infusion over one hour to avoid precipitation of aciclovir in the kidney; ...

Interaction with other medicinal products and other forms of interaction

Aciclovir is eliminated primarily unchanged in the urine via active renal tubular secretion. Any drugs administered concurrently that compete with this mechanism may increase aciclovir plasma concentrations. ...

Fertility, pregnancy and breast-feeding

Fertility There is no information on the effect of aciclovir on human female fertility. In a study of 20 male patients with normal sperm count, oral aciclovir administered at doses of up to 1g per day ...

Effects on ability to drive and use machines

Aciclovir i.v. for infusion is generally used in an in-patient hospital population and information on ability to drive and operate machinery is not usually relevant. There have been no studies to investigate ...

Undesirable effects

The frequency categories associated with the adverse events below are estimates. For most events, suitable data for estimating incidence were not available. In addition, adverse events may vary in their ...

Overdose

Overdosage of intravenenous aciclovir has resulted in elevations of serum creatinine, blood urea nitrogen and subsequent renal failure. Neurological effects including confusion, hallucinations, agitation, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Direct acting antivirals, Nucleosides and nucleotides excl. reverse transcriptase inhibitors ATC code: J05AB01 Aciclovir is a synthetic purine nucleoside analogue with in vitro ...

Pharmacokinetic properties

In adults, the terminal plasma half-life of aciclovir after administration of Zovirax I.V. is about 2.9 hours. Most of the drug is excreted unchanged by the kidney. Renal clearance of aciclovir is substantially ...

Preclinical safety data

Mutagenicity The results of a wide range of mutagenicity tests in vitro and in vivo indicate that aciclovir is unlikely to pose a genetic risk to man. Carcinogenicity Aciclovir was not found to be carcinogenic ...

List of excipients

Sodium hydroxide (used to adjust pH)

Incompatibilities

None known

Shelf life

Shelf life: 60 months.

Special precautions for storage

Store below 25°C.

Nature and contents of container

Type I glass vials closed with butyl or bromobutyl rubber stoppers secured by aluminium collars. 17 ml-nominal capacity of vial containing 250 mg aciclovir. 25 ml-nominal capacity of vial containing 500 ...

Special precautions for disposal and other handling

Reconstitution Zovirax I.V. should be reconstituted using the following volumes of either Water for Injections BP or Sodium Chloride Intravenous Injection BP (0.9% w/v) to provide a solution containing ...

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 00003/0159

Date of first authorization / renewal of the authorization

Date of first authorisation: 6 April 1982 Date of last renewal: 9 June 1997

Date of revision of the text

19 March 2015