In this manual :
1. WHAT IS BIAFINE, emulsion for cutaneous application AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE USING BIAFINE, emulsion for cutaneous application
3. HOW DO I USE BIAFINE, emulsion for cutaneous application?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE BIAFINE, emulsion for cutaneous application?
6. ADDITIONAL INFORMATION
1. WHAT IS BIAFINE, emulsion for cutaneous application AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
CUTANE PROTECTOR (D. Dermatology).
- Erythema secondary to radiotherapy treatments.
- First and second degree burns and all other non-infected skin wounds.
2. WHAT YOU SHOULD KNOW BEFORE USING BIAFINE, emulsion for cutaneous application
List of information needed before taking the medicine
Not applicable.
Never use BIAFINE, emulsion for cutaneous application in the following cases:
- Known allergy to any component of the preparation.
- Bleeding wound (with bleeding).
- Infected lesion.
IN CASE OF DOUBT, IT IS ESSENTIAL TO SEEK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.
Precautions for use; special warnings
Be careful with BIAFINE, emulsion for cutaneous application
Special warnings
In case of blistering or extensive burns, or in case of deep or extensive wounds, medical advice should be sought before applying any medication to the lesion.
IN CASE OF DOUBT, IT IS ESSENTIAL TO SEEK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.
Precautions for use
This medicine is not a sunscreen.
This medicine must not be used as a skin care cream on healthy skin.
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other medicines
Taking or using other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy - Lactation
Ask your doctor or pharmacist for advice before taking any medicine.
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
Not applicable.
3. HOW TO USE BIAFINE, emulsion for cutaneous application
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
- Erythema secondary to radiotherapy treatments: follow your doctor's recommendations. In general, 2 to 3 applications daily, spaced evenly, massaging in gently.
- Second degree burns and other skin wounds: consultation with your doctor is necessary (see Warnings). After cleaning the wound, apply a thick layer of the product over the surface of the lesion and repeat the application 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: in the event of extensive burns, consultation with your doctor is essential (see Warnings). Apply a thick layer until the skin does not accept it. Massage gently into the skin. Repeat 2 to 4 times a day.
Method and route of administration
Dermal route.
Symptoms and instructions in case of overdose
Not applicable.
Instructions in case of missed dose(s)
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, BIAFINE, emulsion for cutaneous application is likely to have undesirable effects, although not everyone is subject to them.
- Moderate, transient (15 to 30 minutes) pain (tingling) may occur after application.
- Rare contact allergy.
- Very rare cases of contact eczema requiring immediate discontinuation of treatment.
If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO STORE BIAFINE, emulsion for cutaneous application
Keep out of the reach and sight of children.
Do not use BIAFINE, emulsion for cutaneous application after the expiry date stated on the box.
Do not store below 0°C.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of the medicine in the sewer or in the household waste. Ask your pharmacist what to do with unused medicines. This will help protect the environment.
Not applicable.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does BIAFINE, emulsion for cutaneous application, contain?
The active substance is:
Trolamine ........................................................................................................................................ 0.670 g
Per 100 g of emulsion for skin application.
Other components are:
Ethylene glycol stearate, stearic acid, cetyl palmitate, solid paraffin, liquid paraffin, perhydrosqualene, propylene glycol, avocado oil, sodium trolamine alginate, potassium sorbate, sodium methyl parahydroxybenzoate (E 219), sodium propyl parahydroxybenzoate (E 217), yerbatone flavour, purified water.
Pharmaceutical form and content
What is BIAFINE, emulsion for cutaneous application and what does it contain?
This medicinal product is in the form of an emulsion for cutaneous application.
Tube of 46.5 g, 93 g, 139.5 g or 186 g and pressurised bottle of 50 ml and 150 ml.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
JOHNSON & JOHNSON SANTE BEAUTE FRANCE
1, rue Camille Desmoulins
92130 ISSY LES MOULINEAUX
Operator
JOHNSON & JOHNSON SANTE BEAUTE FRANCE
1, rue Camille Desmoulins
92130 ISSY LES MOULINEAUX
Manufacturer
LABORATOIRE MEDIX S.A.
18 RUE SAINT-MATHIEU
78550 HOUDAN
or
JANSSEN CILAG S.A
DOMAINE DE MAIGREMONT
27100 VAL DE REUIL
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the package leaflet
The last date on which this package insert was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information reserved for health professionals
Not applicable.
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