FENISTIL COLD SORE Cream (2016)
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
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
Fenistil Cold Sore Cream.
Qualitative and quantitative composition
Each gram of the cream contains: 10 mg penciclovir. Excipients with known effect: cetostearyl alcohol, propylene glycol. For a full list of excipients, see section 6.1.
Pharmaceutical form
Cream. Smooth white cream of homogeneous appearance.
Therapeutic indications
Fenistil Cold Sore Cream is indicated for the treatment of herpes simplex virus infections of the lips and face (herpes labialis) in adults (including older people) and children over 12 years of age. ...
Posology and method of administration
Adults (including older people) and children over 12 years of age Fenistil Cold Sore Cream should be applied at approximately two hourly intervals during waking hours, (approximately 8 times a day). Treatment ...
Contraindications
Hypersensitivity to penciclovir, famciclovir or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
The cream should only be used on cold sores on the lips and around the mouth. It is not recommended for application to mucous membranes (e.g. in the eyes, mouth, or nose or on the genitals). Particular ...
Interaction with other medicinal products and other forms of interaction
Clinical trial experience has not identified any interactions resulting from concomitant administration of topical or systemic drugs with Fenistil Cold Sore Cream.
Pregnancy and lactation
Pregnancy There is unlikely to be any cause for concern regarding adverse effects when the cream is used in pregnant women as systemic absorption of penciclovir following topical administration of Fenistil ...
Effects on ability to drive and use machines
Fenistil Cold Sore Cream has no influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile Fenistil Cold Sore Cream has been well-tolerated in human studies. Clinical trial experience has shown that there was no difference between Fenistil Cold Sore Cream and placebo ...
Overdose
No untoward effects would be expected even if the entire contents of a container of Fenistil Cold Sore Cream were ingested orally; penciclovir is poorly absorbed following oral administration. However, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Topical antiviral agent ATC code: D06BB06 Mechanism of action Penciclovir has demonstrated in vivo and in vitro activity against herpes simplex viruses (types 1 and 2) and varicella ...
Pharmacokinetic properties
General characteristics Following application of Fenistil Cold Sore Cream in a human volunteer study at a daily dose of 180mg penciclovir (approximately 67 times the proposed daily clinical dose), to occluded ...
Preclinical safety data
General toxicology Topical application of 5% Fenistil Cold Sore Cream for 4 weeks to rats and rabbits was well tolerated. There was no evidence of contact sensitisation in guinea pigs. A full programme ...
List of excipients
White soft paraffin Liquid paraffin Cetostearyl alcohol Propylene glycol Cetomacrogol 1000 Purified water
Incompatibilities
Not applicable.
Shelf life
2g aluminium tubes 3 years.
Special precautions for storage
Store at temperatures not exceeding 30°C. Do not freeze.
Nature and contents of container
2g aluminium tube.
Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Omega Pharma Ltd., 1st Floor, 32 Vauxhall Bridge Road, LONDON, SW1V 2SA, United Kingdom
Marketing authorization number(s)
PL 02855/0306
Date of first authorization / renewal of the authorization
23/08/2006
Date of revision of the text
22/02/2016
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
