Land: Malta
Sprache: Englisch
Quelle: Medicines Authority
TROLAMINE
JOHNSON & JOHNSON Sante Beaute France 43 Rue camille Desmoulins, 92130 Issy-Les-Moulineaux, France
D02AX
TROLAMINE 0.67 % (W/W)
CUTANEOUS EMULSION
TROLAMINE 0.67 % (W/W)
OTC
EMOLLIENTS AND PROTECTIVES
Authorised
2007-03-02
PACKAGE LEAFLET : INFORMATION FOR THE PATIENT NAME OF THE MEDICINAL PRODUCT BIAFINE, EMULSION FOR CUTANEOUS APPLICATION TROLAMINE INSET PLEASE READ ALL THE INFORMATION IN THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINAL PRODUCT BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. • Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. • You must talk to a doctor if you do not feel better or if you feel worse. WHAT IS IN THIS LEAFLET? 1. What is BIAFINE, emulsion for cutaneous application and what it is used for? 2. What you need to know before using BIAFINE, emulsion for cutaneous application? 3. How to use BIAFINE, emulsion for cutaneous application? 4. Possible side effects 5. How to store BIAFINE, emulsion for cutaneous application? 6. Contents of the pack and other information. 1. WHAT IS BIAFINE, EMULSION FOR CUTANEOUS APPLICATION AND WHAT IT IS USED FOR? Pharmacotherapeutic class: SKIN PROTECTIVE (D. DERMATOLOGICALS). • Erythema secondary to radiation therapy treatments. • First- or second-degree burns and any other uninfected skin wounds. 2. WHAT YOU NEED TO KNOW BEFORE USING BIAFINE, EMULSION FOR CUTANEOUS APPLICATION? NEVER USE BIAFINE, EMULSION FOR CUTANEOUS APPLICATION • if you are allergic to trolamine or to any of the other ingredients of this medicine (listed in section 6). • if you have a haemorrhagic wound (with bleeding). • if you have an infected lesion. IF YOU HAVE ANY QUESTIONS, OR IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK THE ADVICE OF A DOCTOR OR PHARMACIST. WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR OR PHARMACIST BEFORE USING BIAFINE EMULSION FOR CUTANEOUS APPLICATION. In case of burns with formation of blisters or extensive burns, or in case of a deep or Lesen Sie das vollständige Dokument
Page 1 of 4 1. NAME OF THE MEDICINAL PRODUCT BIAFINE, emulsion for cutaneous application 2. QUALITATIVE AND QUANTITATIVE COMPOSITION TROLAMINE ..............................................................................................................0.670 g Per 100 g of emulsion for cutaneous application. Excipients with known effect: Propylene glycol, Potassium sorbate, Sodium methyl parahydroxybenzoate (E219), Sodium propyl parahydroxybenzoate (E 217); Yerbatone fragrance. For the complete list of excipients, see 6.1. 3. PHARMACEUTICAL FORM Emulsion for cutaneous application. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Secondary erythema due to radiotherapy treatments. - First and second degree burns and all other non-infected cutaneous wounds. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION - Secondary erythema due to radiotherapy treatments: 2 to 3 applications a day , at regular intervals, allowing the emulsion to penetrate by gently massaging. - Second-degree burns and other cutaneous wounds: after cleaning the wound, apply a thick layer of emulsion widely overlapping the surface of the lesion and repeat applications to maintain an excess of emulsion on the lesion. If necessary, cover with a moistened compress and finish the dressing. Do not use a dry absorbent dressing. - First-degree burns: Apply a thick layer until emulsion is no longer absorbed. Allow to penetrate by gently massaging. Repeat 2 to 4 times a day. 4.3 CONTRAINDICATIONS - Hypersensitivity to trolamine or to any of the excipients listed in section 6.1. - Hemorrhagic wounds - Infected wounds. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE SPECIAL WARNINGS : In case of superficial burn or non-infected cutaneous wound, management depends on the extent of the lesion, its location, the patient's age and history, the associated lesions and the etiology. SPECIAL PRECAUTIONS FOR USE : This medication does not provide sun protection. This drug must not be used as a beauty care product on healthy skin. Page 2 of 4 Keep away from eyes This product Lesen Sie das vollständige Dokument