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 Cream (2017)

Αναφορές

Βιβλιογραφική αναφορά

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

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

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:

File
application/pdf - 87,2 KB