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CETAVLEX CREAM

Active substance(s): CETRIMIDE / CETRIMIDE / CETRIMIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
CETAVLEX CREAM.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Cetrimide 0.5% w/w

3.

PHARMACEUTICAL FORM
White Cream.

4.

CLINICAL PARTICULARS

4.1.

Therapeutic Indications
Cetavlex is an antiseptic cream for skin disorders such as minor wounds,
minor burns and abrasions and napkin rash.

4.2.

Posology and Method of Administration
Apply liberally to the affected area. In some cases it may be necessary to
cover the wound or bum with a clean dressing.

4.3.

Contra-indications
Cetavlex is contra-indicated for patients who have previously shown a
hypersensitivity reaction to cetrimide preparations.

4.4

Special warnings and precautions for use

If no improvement or there is aggravation, use should be discontinued and a
physician consulted.
For topical application only. Keep out of the eyes and ears.

4.5

Interaction with other medicinal products and other forms of interaction
See section 6.2.

4.6.

Pregnancy and Lactation
No special precautions are necessary.

4.7.

Effects on Ability to Drive and Use Machines
It is unlikely that Cetavlex cream would effect the ability to drive or operate
machinery.

4.8.

Undesirable Effects
Side effects include allergic reactions and local irritation.

4.9

Overdose
The toxicity of Cetavlex arises from the cetrimide content. It seems unlikely
that systemic toxicity will occur from accidental ingestion of the cream.
However, in the event of large quantities being swallowed, carry out gastric
lavage with milk, raw egg, gelatin or mild soap. Do not induce vomiting.
Central paralysis cannot be countered by curare antagonists or CNS stimulants
but sympathomimetic drugs have been given.
Mechanically assisted ventilation with oxygen may be necessary. Persistent
convulsions may be controlled with cautious doses of diazepam or a shortacting barbiturate. Do not give alcohol in any form.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic Properties
Studies with cetrimide have shown it to be active against a wide range of
vegetative bacteria, both Gram positive and Gram negative, including Staph.
aureus the commonest cause of infection in wounds and burns. Certain Gram
negative bacteria, particularly strains of Pseudomonas and Proteus remain the
least susceptible of the pathogenic bacteria to cetrimide, requiring a higher
concentration than other species to produce an effective kill. There are no
general pharmacological studies available on topically administered cetrimide
preparations.

5.2.

Pharmacokinetic Properties
Cetrimide is strongly cationic in nature, binding strongly to skin and other
tissue, and thus absorption is negligible.

5.3.

Preclinical Safety Data
Cetrimide is a drug on which extensive clinical experience has been obtained.
All relevant information for the prescriber is provided elsewhere in the
Summary of Product Characteristics.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of Excipients
Industrial Methylated Spirits
Cetostearyl Alcohol
Liquid Paraffin
Methyl Parahydroxybenzoate(E218)
Propyl Parahydroxybenzoate (E216)
Purified water

6.2.

Incompatibilities
Cetrimide is incompatible with soap and other anionic agents.

6.3.

Shelf Life
4 years.

6.4.

Special Precautions for Storage
Store below 30 C.

6.5.

Nature and Contents of Container
Internally lacquered aluminium tubes (50g).

6.6.

Instructions for Use/Handling
Use undiluted.

7.

MARKETING AUTHORISATION HOLDER
Centrapharm Ltd
Finch House
28 30 Wolverhampton Street
Dudley
West Midlands
DY1 1DB
United Kingdom

8.

MARKETING AUTHORISATION NUMBERS
PL 19876/0011

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF
AUTHORISATION
30 April 2004

10

DATE OF REVISION OF THE TEXT
16/04/2010

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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