Κλαύδιος Γαληνός
Δωρεάν εγγραφή Αποκτήσετε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του galinos.gr για έναν μήνα
Γαληνός Office Χρησιμοποιήστε δωρεάν το νέο cloud πρόγραμμα διαχείρισης κάθε σύγχρονου ιατρείου
Έλεγχος συγχορήγησης Ελέγξτε την αγωγή σας για αντενδείξεις και αλληλεπιδράσεις μεταξύ των φαρμάκων
Πρόγραμμα συνδρομητών Μάθετε περισσότερα για τα οφέλη και τις επιπλέον παροχές των συνδρομητικών προγραμμάτων
Γαληνός Mobile Κατεβάστε τη δωρεάν εφαρμογή και απολαύστε τις υπηρεσίες του galinos.gr σε κινητό ή tablet
Γνωρίζατε οτι... Μοιραζόμαστε μαζί σας γεγονότα της πορείας του galinos.gr από το 2011 μέχρι σήμερα
 

SPC, UK: Zovirax 200mg Tablets (2011)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
GlaxoSmithKline UK
Διεύθυνση :
Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

Name of the medicinal product

Zovirax Tablets 200 mg.

Qualitative and quantitative composition

Aciclovir BP 200 mg.

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

Zovirax tablets are contra-indicated in patients known to be hypersensitive to aciclovir or valaciclovir, or to any of the excipients.

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

No clinically significant interactions have been identified. Aciclovir is eliminated primarily unchanged in the urine via active renal tubular secretion. Any drugs administered concurrently that compete ...

Pregnancy and lactation

A post-marketing aciclovir pregnancy registry has documented pregnancy outcomes in women exposed to any formulation of Zovirax. The birth defects described amongst Zovirax exposed subjects have not shown ...

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

Aciclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against human herpes viruses, including herpes simplex virus (HSV) types I and II and varicella zoster ...

Pharmacokinetic properties

Aciclovir is only partially absorbed from the gut. Mean steady state peak plasma concentrations (Cssmax) following doses of 200 mg administered four-hourly were 3.1 microMol (0.7 micrograms/ml) and equivalent ...

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

36 months.

Special precautions for storage

Store below 30°C. Keep dry. Protect from light.

Nature and contents of container

Amber glass bottles with polyethylene snap fitting caps. PVC/PVDC/Aluminium foil blister packs. Pack size: 25 tablets.

Special precautions for disposal and other handling

No special instructions.

Marketing authorization holder

The Wellcome Foundation Limited Glaxo Wellcome House Berkeley Avenue Greenford Middlesex UB6 0NN 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

13 September 2001

Date of revision of the text

September 2011