BIAFINE Emulsion for cutaneous application Ref.[51155] Active ingredients: Trolamine

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.

Keep away from eyes.

This product contains 38 mg propylene glycol per dose of 1.65 g and may cause skin irritations. Do not use this medicine in babies less than 4 weeks old with open wounds or large areas of injured or damaged skin (such as burns).

This medicine contains potassium sorbate and may cause local skin reactions (eg. contact dermatitis)

This medicine contains sodium methyl parahydroxybenzoate (E 219) and Sodium propyl parahydroxybenzoate (E217) and may cause allergic reactions (possibly delayed). This medicine contains fragrance (Yerbatone aroma) with the following substances: 3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, benzyl benzoate, citral, citronellol, d-limonene, eugenol, geraniol, hexyl cinnamaldehyde, hydroxycitronellal, isoeugenol and linalool. These substances may cause allergic reactions.

No interaction studies have been performed.

Pregnancy

There are no adequate and well-controlled studies in pregnant women. However, it is considered unlikely that the use of trolamine as recommended will present a significant risk to the pregnant woman and foetus.

Breast-feeding

There are no adequate and well-controlled studies in breastfeeding women. However, it is considered unlikely that the use of trolamine as recommended will present a significant risk to the breastfeeding woman and breastfeeding infant.

It is not known if trolamine or its metabolites are excreted in human milk.

BIAFINE emulsion for cutaneous application has no effect on the ability to drive and use of machinery.

Adverse drug reactions are classified by frequency using the following convention: Uncommon (>1/1,000 and <1/100), rare (>1/10,000 and <1/1,000), very rare (<1/10,000).

General Disorders and Application site Conditions

Uncommon: mild and transient tingling pain, after application

Rare: contact allergy

Very rare: contact eczema requiring treatment withdrawal

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the French National Agency for Medicine and Health Products Safety (Agence nationale de sécurité du médicament et des produits de santé or ANSM) and the French network of Regional Pharmacovigilance Centers (réseau des Centres Régionaux de Pharmacovigilance).

Website: www.signalement-sante.gouv.fr and the Malta Medicines Authority.
(http://www.medicinesauthority.gov.mt/reportingadversereactions)

Not applicable.