Vantage Antiseptic 0.5%W/W Cream
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cetrimide Cream BP Bells Antiseptic Cream Wilko Antiseptic 0.5% w/w Cream Galpharm Medical Antiseptic Cream Asda Antiseptic First Aid Cream Numark Antiseptic Cream Vantage Antiseptic 0.5%w/w Cream
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Cetrimide BP 0.5% w/w
3. PHARMACEUTICAL FORM
Cream
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
For application to minor burns, minor wounds, cuts, grazes, minor abrasions and minor scalds to prevent infection.
4.2 Posology and method of administration
For topical application to the affected areas, there is no difference in use for children, adults or the elderly.
4.3
Contra-Indications
Avoid contact with eyes, brain, meninges and middle ear. Do not use in body cavities or as an enema.
4.4 Special warnings and Special precautions for use
None stated
4.5 Interactions with other Medicinal Products and other Forms of interaction
None stated
4.6 Pregnancy and lactation
None stated
4.7 Effects on ability to drive and use machines
None stated
4.8 Undesirable effects
Some patients may become hypersensitive to cetrimide on repeated application.
4.9 Overdose
Overdose may cause nausea and vomiting. The product has depolarising muscle relaxant properties and toxic symptoms including dyspnoea and cyanosis (due to paralysis of the respiratory muscles and possibly leading to asphyxia), depression of the central nervous system, hypotension and coma may also occur. Treatment of poisoning is symptomatic.
5.
PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Cetrimide is a quaternary ammonium disinfectant with properties and uses typical of cationic surfactants. These surfactants dissociate in aqueous solution into a relatively large and complex cation, which is responsible for the surface activity, and a smaller inactive anion. In addition to the emulsifying and detergent properties, Cetrimide has bactericidal activity against gram positive and some gram negative organisms.
5.2 Pharmacokinetic properties
Plasma concentrations for topical applications are extremely low, therefore clinically not significant.
5.3 Preclinical safety data
None stated
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Cetostearyl Alcohol BP Liquid Paraffin BP
Nipastat*
Purified Water BP
* Nipastat is a mixture of Methyl, Ethyl, Propyl, iso-Butyl and n-Butyl Hydroxybenzoates.
6.2. Incompatibilities
None stated
6.3. Shelf life
2 years
6.4. Special precautions for storage
Store below 25 °C.
6.5. Nature and contents of container
15g, 30g and 50g aluminium tubes.
6.6. Instruction for Use, Handling and Disposal
None stated.
7 MARKETING AUTHORISATION HOLDER
Ecolab Ltd,
Lotherton Way,
Garforth,
Leeds,
LS25 2JY
8. MARKETING AUTHORISATION NUMBER
PL 04509/0007
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
1st March 2003
10 DATE OF REVISION OF THE TEXT
06/03/2011