1. WHAT IS TROLAMINE BIOGARAN 0.67%, emulsion for cutaneous application AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
CUTANE PROTECTOR (D. Dermatology).
Therapeutic indications
- - Erythema secondary to radiotherapy treatments.
- - First and second degree burns and all other non-infected skin wounds.
2. WHAT YOU SHOULD KNOW BEFORE USING TROLAMINE BIOGARAN 0.67%, emulsion for cutaneous application
List of information needed before taking the medicine
Not applicable.
Contraindications
Never use TROLAMINE BIOGARAN 0.67%, emulsion for cutaneous application in the following cases:
- - Known allergy to any of the components of the preparation.
- - Bleeding wound (with bleeding).
- - Infected lesion.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Precautions for use; special warnings
Take care with TROLAMINE BIOGARAN 0.67%, 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 medications
If you are taking or have recently taken any other medication, including medication 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 and breastfeeding
Ask your doctor or pharmacist for advice before taking any medication.
Sportsmen
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 TROLAMINE BIOGARAN 0.67%, emulsion for cutaneous application
Instructions for proper use
Not applicable.
Dosage, Method and/or route 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, regularly spaced, by making penetrate by a light massage.
- - Second degree burns and other skin wounds: consultation with your doctor is necessary (see Be careful with TROLAMINE BIOGARAN 0.67%, emulsion for cutaneous application). After cleansing the wound, apply a thick layer well above 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: in case of extensive burns, consultation with your doctor is essential (see Take care with TROLAMINE BIOGARAN 0.67%, emulsion for cutaneous application). Apply in a thick layer until the skin does not accept it. Gently massage into skin. Repeat 2 to 4 times daily.
Method of administration
Apply to the skin.
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, TROLAMINE BIOGARAN 0.67%, 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 inform your doctor or pharmacist.
5. HOW TO USE TROLAMINE BIOGARAN 0.67%, emulsion for cutaneous application
Keep out of the reach and sight of children.
Expiry date
Do not use TROLAMINE BIOGARAN 0.67%, emulsion for cutaneous application after the expiry date stated on the box.
Conditions of storage
No special storage conditions.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of the medicine in the sewer or in your household waste. Ask your pharmacist what to do with unused medicines. This will help protect the environment.
Not applicable.
6. ADDITIONAL INFORMATION
Complete list of active ingredients and excipients
What does TROLAMINE BIOGARAN 0.67%, emulsion for dermal application, contain?
The active substance is:
Trolamine ........................................................................................................................................ 0.670 g
Per 100 g of emulsion for dermal application.
The other components are:
Ethylene glycol stearate, stearic acid, cetyl palmitate, solid paraffin, light liquid paraffin, perhydorsqualene, avocado oil, propylene glycol, sodium trolamine alginate, potassium sorbate, sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217), Campania flavour, purified water.
Pharmaceutical form and content
What is TROLAMINE BIOGARAN 0.67%, 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.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
Societe ALEPT
42, avenue la Bruyere
38100 Grenoble
Operator
LABORATOIRES BIOGARAN
15 BOULEVARD CHARLES DE GAULLE
92707 COLOMBES CEDEX
Français
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