ZOVIRAX Dispersible film-coated tablets (2018)
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Περιεχόμενα
Name of the medicinal product
Zovirax Tablets 200 mg.
Qualitative and quantitative composition
Aciclovir BP 200 mg. For the full list of excipients, see section 6.1.
Pharmaceutical form
Dispersible film-coated tablet.
Therapeutic indications
Zovirax Tablets are indicated for the treatment of herpes simplex virus infections of the skin and mucous membranes including initial and recurrent genital herpes (excluding neonatal HSV and severe HSV ...
Posology and method of administration
Zovirax tablets may be dispersed in a minimum of 50 ml of water or swallowed whole with a little water. Ensure that patients on high doses of aciclovir are adequately hydrated. Dosage in adults Treatment ...
Contraindications
Hypersensitivity to aciclovir or valaciclovir, or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Use in patients with renal impairment and in elderly patients Aciclovir is eliminated by renal clearance, therefore the dose must be adjusted in patients with renal impairment (see 4.2 Posology and Method ...
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 lactation
Pregnancy The use of aciclovir should be considered only when the potential benefits outweigh the possibility of unknown risks. A post-marketing aciclovir pregnancy registry has documented pregnancy outcomes ...
Effects on ability to drive and use machines
There have been no studies to investigate the effect of aciclovir on driving performance or the ability to operate machinery. A detrimental effect on such activities cannot be predicted from the pharmacology ...
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
Symptoms and signs Aciclovir is only partly absorbed in the gastrointestinal tract. Patients have ingested overdoses of up to 20g aciclovir on a single occasion, usually without toxic effects. Accidental, ...
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
Aciclovir is only partially absorbed from the gut. Mean steady state peak plasma concentrations (C<sub>ssmax</sub>) following doses of 200 mg administered four-hourly were 3.1 microMol (0.7 micrograms/ml) ...
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
Core: Microcrystalline cellulose Aluminium magnesium silicate Sodium starch glycollate Povidone K30 Magnesium stearate Purified water Industrial methylated spirit Or Ethanol Or Absolute alcohol Film coat ...
Incompatibilities
None known.
Shelf life
Shelf life: 36 months.
Special precautions for storage
Do not store above 30°C. Store in the original package.
Nature and contents of container
PVC/PVdC/Aluminium/Paper child resistant foil blister packs. Pack size: 25 tablets.
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 Limited, 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 00003/0344
Date of first authorization / renewal of the authorization
Date of first authorisation: 14 November 1994 Date of latest renewal: 07 January 2011
Date of revision of the text
24 January 2018
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