Biafine Emulsion for Burns 186g

For Whom: Teenagers, Adults, Children
Pregnancy & Breastfeeding: Safe to use
Form: Emulsion

Product Overview

Biafine Emulsion is a topical treatment specifically designed to soothe and promote the healing of skin affected by first and second-degree burns, erythema caused by radiotherapy, and other non-infected skin injuries. This emulsion offers fast relief for redness, irritation, and discomfort, making it a versatile addition to any first-aid kit.

Key Benefits

• Effective for Radiotherapy-Induced Redness: Helps reduce skin irritation secondary to radiotherapy treatments.
• Burns & Skin Wounds: Ideal for treating first and second-degree burns, as well as minor skin injuries.
• Non-Sensitizing Formula: Safe for teenagers, adults, and children over 4 weeks old, including pregnant and breastfeeding individuals.

Ingredients

• Active Ingredient: Trolamine (0.670 g per 100 g)
• Other Ingredients: Ethylene glycol stearate, stearic acid, cetyl palmitate, solid and liquid paraffin, perhydrosqualene, propylene glycol, avocado oil, sodium alginate, potassium sorbate, sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217), yerbatone flavor, purified water.

Usage Instructions

• For Radiotherapy-Induced Erythema: Apply a light layer 2-3 times daily or as directed by your healthcare provider.
• For 2nd-Degree Burns & Skin Wounds: Clean the affected area thoroughly, then apply a generous layer. Cover with a moistened compress rather than a dry dressing, and reapply as needed to maintain a surplus of emulsion over the wound.
• For 1st-Degree Burns: Apply a thick layer until the skin no longer absorbs the emulsion. Massage lightly and reapply 2-4 times a day as needed.

Contraindications

• Infants: Do not use on babies under 4 weeks old or on large, open wounds without consulting a healthcare provider.
• Allergic Reactions: Avoid use if you have known allergies to any ingredients.
• Severe Burns or Blisters: Seek medical advice for deep or extensive burns, or if blistering occurs.

Note: Biafine Emulsion is not a sunscreen and should not be used as a regular moisturizer.

Additional Information

If you are using other medications, consult your doctor or pharmacist before using Biafine Emulsion, especially if you are pregnant or breastfeeding.

Packaging: 186g tube, ideal for home or travel first-aid kits.

Please read the following full disclosure before taking or using this product.

PRODUCT SUMMARY

ANSM - Updated on: 04/24/2023

1. NAME OF THE MEDICATION

BIAFINE, Emulsion for Topical Application

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Trolamine ................................................................................. 0.670 g

Notable excipients: propylene glycol, potassium sorbate, sodium methyl parahydroxybenzoate (E 219), sodium propyl parahydroxybenzoate (E 217), Yerbatone fragrance.

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Topical emulsion.

4. CLINICAL DATA

4.1 Therapeutic Indications

• Erythema secondary to radiotherapy treatments.
• First- and second-degree burns and other non-infected skin wounds.

4.2 Dosage and Administration

• Radiotherapy-induced Erythema: Apply 2 to 3 times daily, spaced out evenly, with a gentle massage.
• Second-Degree Burns and Other Wounds: After cleaning the wound, apply a thick layer that extends beyond the wound edges and reapply to maintain an excess of emulsion on the wound. If necessary, cover with a moistened compress but avoid a dry absorbent dressing.
• First-Degree Burns: Apply a thick layer until the skin can absorb no more. Gently massage in. Repeat 2 to 4 times daily.

4.3 Contraindications

• Hypersensitivity to the active substance or any of the excipients in section 6.1.
• Bleeding wounds.
• Infected lesions.

4.4 Special Warnings and Precautions for Use

Special Warnings

For second-degree burns or non-infected skin wounds, treatment should consider the wound size, location, patient age and history, associated injuries, and the wound cause.

Precautions for Use

• This medication is not a sunscreen.
• Do not use as a skincare cream on healthy skin.
• Avoid applying near the eyes.
• Contains 38 mg of propylene glycol per 1.65 g dose, which may cause skin irritation.
• Not suitable for babies under 4 weeks old with open wounds or large areas of damaged skin (e.g., burns).
• Contains potassium sorbate, which may cause local skin reactions (e.g., eczema).
• Contains sodium methyl parahydroxybenzoate (E 219) and sodium propyl parahydroxybenzoate (E 217), which may cause allergic reactions (possibly delayed).
• Contains Yerbatone fragrance with allergenic 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 cinnamal, hydroxycitronellal, isoeugenol, and linalool), which may cause allergic reactions.

4.5 Drug Interactions

No interaction studies have been conducted.

4.6 Fertility, Pregnancy, and Lactation

• Pregnancy: No data available in pregnant women, but no effects are expected on the woman or fetus.
• Breastfeeding: No data available in breastfeeding women, but no effects are expected on the woman or the nursing infant. The passage of trolamine or its metabolites in breast milk is unknown.

4.7 Effects on Ability to Drive and Use Machines

Not applicable.

4.8 Undesirable Effects

Adverse reactions are classified by frequency: uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), and very rare (<1/10000).

• General Disorders and Site Conditions:
  • Uncommon: mild and transient stinging after application.
  • Rare: contact allergy.
  • Very rare: contact eczema requiring immediate discontinuation.

Reporting Suspected Adverse Reactions
It is important to report suspected adverse reactions post-authorization for continuous monitoring of the benefit-risk balance. Healthcare professionals report suspected adverse reactions via the national reporting system: ANSM and Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr.

4.9 Overdose

No cases of overdose have been reported.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic Properties

Therapeutic category: Skin Protectant, ATC code: D03AX12 (Dermatology).

Mechanism of Action
Trolamine, combined with fatty acids like stearic acid, acts as an emulsifier. When applied to the skin, it forms a protective, hydrating barrier, attracting macrophages to the wound site, promoting dermal healing, and granulation tissue formation.

5.2 Pharmacokinetics

Effects are limited to the skin’s superficial layers, aiding hydration without systemic effects.

5.3 Preclinical Safety Data

In vitro mutagenicity and chromosomal aberration tests with trolamine were negative. Rodent carcinogenicity studies showed equivocal results. Trolamine was embryotoxic in chick reproduction studies; no human data is available.

6. PHARMACEUTICAL DATA

6.1 List of Excipients

Ethylene glycol stearate, stearic acid, cetyl palmitate, solid paraffin, liquid paraffin, perhydrosqualene, propylene glycol, avocado oil, trolamine and sodium alginate, potassium sorbate, sodium methyl parahydroxybenzoate (E 219), sodium propyl parahydroxybenzoate (E 217), Yerbatone fragrance, purified water.

Yerbatone Fragrance Composition: Deterpenated orange essential oil, galbanum essential oil, deterpenated petitgrain essential oil, lemongrass essential oil, celestolide, para-tert-butylcyclohexyl acetate, hexyl cinnamal, citral, limonene, phenylethyl alcohol, traséolide, hercolyn, phenylethyl acetate, methylionone, dipropylene glycol, isopropyl myristate, methyl dihydrojasmonate.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years.

6.4 Special Storage Precautions

Do not freeze.

6.5 Packaging and Container

Aluminum tube (46.5 g, 93 g, 139.5 g, and 186 g) with epoxy-phenolic coating and high-density polyethylene cap. Pressurized aluminum bottle (50 ml and 150 ml) with a polypropylene pump.

Not all presentations may be marketed.

6.6 Disposal and Handling Precautions

Dispose of any unused medicine or waste per current regulations.

7. MARKETING AUTHORIZATION HOLDER

JOHNSON & JOHNSON SANTE BEAUTE FRANCE
43 RUE CAMILLE DESMOULINS
92130 ISSY-LES-MOULINEAUX

8. MARKETING AUTHORIZATION NUMBER(S)

• 34009 357 994 0 1: 46.5 g in varnished aluminum tube
• 34009 319 228 2 7: 93 g in varnished aluminum tube
• 34009 357 995 7 9: 139.5 g in varnished aluminum tube
• 34009 328 570 1 2: 186 g in varnished aluminum tube
• 34009 376 327 6 8: 50 ml in pressurized aluminum bottle
• 34009 376 327 6 8: 150 ml in pressurized aluminum bottle

9. DATE OF FIRST AUTHORIZATION/RENEWAL

[To be completed by the holder]

10. TEXT REVISION DATE

[To be completed by the holder]

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR PREPARING RADIOPHARMACEUTICALS

Not applicable.

PRESCRIPTION AND DISPENSING REQUIREMENTS

Medication not subject to medical prescription.