BRASIVOL MEDIUM 52 %w/w Cutaneous Paste
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-04-2024
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Active ingredient:
ALUMINIUM OXIDE
Available from:
Stiefel Laboratories (U.K.) Ltd.
INN (International Name):
ALUMINIUM OXIDE
Dosage:
52 %w/w
Pharmaceutical form:
Cutaneous Paste
Authorization status:
Withdrawn
Authorization date:
2009-05-08
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Brasivol No. 2 Medium
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Aluminium oxide 52.0% w/w.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Cutaneous Paste
A greyish-blue moderately gritty cutaneous paste with a slight perfume.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Brasivol is indicated in the treatment of acne vulgaris. Brasivol No. 2 Medium effectively cleanses and removes
debris from blocked pores and removes excess sebum from the skin, thus maintaining patency of the pore duct
openings.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Two grades of Brasivol are available: Brasivol No. 1 Fine and Brasivol No. 2 Medium.
Treatment should normally commence with Brasivol No. 1 Fine. The abrasive cleansing paste should be applied to
wetted skin and rubbed gently but firmly over the affected area with a circular motion for 15-20 seconds, then rinsed
off thoroughly with water. This routine may be repeated two or three times daily, replacing ordinary soap and water.
In more severe conditions, after the use of Brasivol No. 1 Fine for several weeks, the skin may require the slightly
more abrasive action of Brasivol No. 2 Medium.
4.3 CONTRAINDICATIONS
Brasivol is contra-indicated in the presence of superficial venules and telangiectasia (actinic sequelae).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Care should be taken to avoid using Brasivol No. 2 Medium close to the eyes or mouth. Male patients using an
electric razor should shave before applying Brasivol No. 2 Medium.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
None.
IRISH MEDICINES BOARD
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_Date Printed 07/12/2006
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