BIAFINE, emulsion for cutaneous application

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TROLAMINE

Available from:

JOHNSON & JOHNSON Sante Beaute France 43 Rue camille Desmoulins, 92130 Issy-Les-Moulineaux, France

ATC code:

D02AX

INN (International Name):

TROLAMINE 0.67 % (W/W)

Pharmaceutical form:

CUTANEOUS EMULSION

Composition:

TROLAMINE 0.67 % (W/W)

Prescription type:

OTC

Therapeutic area:

EMOLLIENTS AND PROTECTIVES

Authorization status:

Authorised

Authorization date:

2007-03-02

Patient Information leaflet

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

Summary of Product characteristics

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