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

Source: Medicines Authority (MT)  Revision Year: 2023  Publisher: JOHNSON & JOHNSON Santรฉ Beautรฉ France, 1, RUE CAMILLE DESMOULINS, 92130 ISSY-LES-MOULINEAUX, FRANCE

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.

4.9. Overdose

No symptoms of overdosage have been identified from the analysis of post marketing data and scientific literature for the topical use of this product.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Do not freeze.

6.5. Nature and contents of container

Aluminium tube containing, 93g internally coated by an epoxyphenolic coating and closed by a high-density polyethylene cap.

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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