国: イギリス
言語: 英語
ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cetrimide; Benzalkonium chloride; Chlorobutanol; Aldioxa
Norma Chemicals Ltd
D08AJ01
Cetrimide; Benzalkonium chloride; Chlorobutanol; Aldioxa
4microgram/1gram ; 1microgram/1gram ; 1microgram/1gram ; 3.75microgram/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 13100500
SAVOY ANTISEPTIC FIRST AID CREAM ACTIVE INGREDIENTS: Benzalkonium Chloride BP 0.1%, Cetrimide BP 0.4%, Chlorbutol BP 0.1% and Aluminium Dihydroxy Allantoinate 0.375%. _It also contains the following non-active _ _ingredients: _Cetyl Alcohol, Polychol 15, Wool Alcohols, Chlorhexidine Solution, Nonoxinol '9' and Purified water. HOW IT WORKS. Benzalkonium Chloride, Cetrimide and Chlorbutol are antiseptic agents; in addition Chlorbutol also has a mild anaesthetic action. Aluminium Dihydroxy Allantoinate is a derivative of Allantoin and believed to accelerate wound healing. WHAT IT IS FOR. The cream is intended for the treatment of cuts, scratches, abrasions and small wounds. It may also be used as a treatment for napkin rash. WHEN IT SHOULD NOT BE USED. Do not use if you know you suffer from sensitivity to any of the ingredients. SPECIAL WARNINGS. For external use only. Keep away from the eyes, nose and mouth. The cream contains a derivative of lanolin which may cause local skin reactions e.g. contact dermatitis. IF YOU ARE PREGNANT OR TRYING TO BECOME PREGNANT. The cream is considered safe for use during pregnancy, however it is wise to be cautious before using any medicines at this time. HOW TO USE SAVOY ANTISEPTIC FIRST AID CREAM . The Cream is for use by Adults, The Elderly and Children. Make sure the area to be treated is free from soap before application as it can reduce the cream's effectiveness. Apply sparingly to the affected area two or three times daily. OVERDOSE. Overdose is unlikely in a product of this nature when used as directed. If someone accidentally swallows this cream, tell your doctor immediately. SIDE EFFECTS. In a few individuals the skin may become sensitised to one or more of the ingredients, resulting in irritation at the site of application. If this happens discontinue use and seek medical advice. If symptoms persist or worsen, or you suffer any side effects discontinue use and consult a doctor or a pharmacist. STORAGE. Store between 4°C and 25°C. Do not use after the expiry date marked 完全なドキュメントを読む
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cetanorm Cream Vantage Pharmacy Antiseptic Cream Savoy First Aid Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100g of cream contains the following active ingredients: Benzalkonium Chloride 0.10 G Cetrimide 0.40 G Chlorbutanol 0.10 G Aldioxa 0.375 G 3 PHARMACEUTICAL FORM Cream, for topical application. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS External treatment of cuts, scratches, abrasions, small wounds, and napkin rash. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Apply sparingly two or three times per day ensuring the area is first free from soap. No distinction is made between adults, children and the elderly. 4.3. CONTRA-INDICATIONS Known sensitivity to any of the ingredients. 4.4. SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Ensure the skin is washed free from soap before application. 4.5. INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Incompatible with soap and other anionic detergents. 4.6. PREGNANCY AND LACTATION The product is considered safe for use during pregnancy when used as directed, but medicaments should only be used at in pregnancy when anticipated benefits exceed the risks. 4.7. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None 4.8. UNDESIRABLE EFFECTS Local irritation may occur. 4.9 OVERDOSE Overdose is unlikely when used as directed. If someone accidentally swallows this cream medical advice should be sought immediately. 5. PHARMACOLOGICAL PROPERTIES 5.1. PHARMACODYNAMIC PROPERTIES Allantoin and its derivatives stimulate tissue and accelerate wound healing. They appear to have a keratin dispersing activity. The quaternary ammonium compounds have detergent, and gram positive and gram negative bactericidal activity. Chlorbutol has antibacterial and antifungal activity. It also has a mild local anaesthetic action. 5.2. PHARMACOKINETIC PROPERTIES When used as directed systemic absorption is negligible. 5.3. PRE-CLINICAL SAFETY DATA None stated. 6. PHARMACEUTICAL PARTICULARS 6.1. LIST 完全なドキュメントを読む