VECTAVIR Cream (2021)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Vectavir Cold Sore Cream.
2. Qualitative and quantitative composition
Each gram of the cream contains 10 mg penciclovir. <u>Excipients with known effect:</u> cetostearyl alcohol, propyleneglycol. For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Cream. Smooth white cream of homogeneous appearance.
4.1. Therapeutic indications
Vectavir Cold Sore Cream is indicated for the treatment of cold sores (herpes labialis) in adults (including older people) and children over 12 years of age.
4.2. Posology and method of administration
Posology Adults (including older people) and children over 12 years of age Vectavir Cold Sore Cream should be applied at approximately two hourly intervals during waking hours. Paediatric population Children ...
4.3. Contraindications
Hypersensitivity to penciclovir, famciclovir or to any of theexcipients listed in section 6.1.
4.4. 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 ...
4.5. 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 Vectavir Cold Sore Cream.
4.6. 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 Vectavir ...
4.7. Effects on ability to drive and use machines
Vectavir Cold Sore Cream has no influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile Vectavir Cold Sore Cream has been well-tolerated in human studies. Clinical trial experience has shown that there was no difference between Vectavir Cold Sore Cream and placebo ...
4.9. Overdose
No untoward effects would be expected even if the entire contents of a container of Vectavir Cold Sore Cream were ingested orally; penciclovir is poorly absorbed following oral administration. However, ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Topical antiviral agent <b>ATC code:</b> D06BB06 Mechanism of action Penciclovir has demonstrated <em>in vivo</em> and <em>in vitro</em> activity against herpes simplex ...
5.2. Pharmacokinetic properties
Following application of Vectavir 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 and abraded skin ...
5.3. Preclinical safety data
General toxicology Topical application of 5% Vectavir 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 ...
6.1. List of excipients
White soft paraffin Liquid paraffin Cetostearyl alcohol (see section 4.4 Special warnings and precautions for use) Propylene glycol (see section 4.4 Special warnings and precautions for use) Cetomacrogol ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2g and 5g aluminium tubes 3 years. 2g plastic airless pump dispenser 2 years.
6.4. Special precautions for storage
Store at temperatures not exceeding 30°C. Do not freeze.
6.5. Nature and contents of container
2g and 5g aluminium tube. May be supplied with 20 single-use Low Density Polyethylene(LDPE) applicators. 2g plastic airless pump dispenser. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Chefaro Ireland DAC, The Sharp Building, Hogan Place, Dublin 2, Ireland
8. Marketing authorization number(s)
PA1186/020/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 28 February 2001 Date of last renewal: 27 February 2006
10. Date of revision of the text
June 2021
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