Dermaraef (Ointment) Instructions for Use

Marketing Authorization Holder

Belmedpreparaty RUP (Republic of Belarus)

ATC Code

D11AX (Other drugs used in dermatology)

Active Substance

Bien (Grouping name)

Dosage Form

Dermaraef

Ointment for external use 5%: tubes 15, 25, or 30 g

Dosage Form, Packaging, and Composition

Ointment for external use of light yellow color with a weak specific odor.

Excipients: geranium oil (fraction 1) 0.1 g, sunflower oil 10 g, emulsifying wax 10 g, glycerol 5 g, glyceryl monostearate 1 g, methylparaben 0.15 g, propylparaben 0.05 g, purified water up to 100 g.

15 g – aluminum tubes (1) – cardboard packs.
25 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

A drug with anti-inflammatory and tissue regeneration-improving action for external use

Pharmacotherapeutic Group

Herbal dermatoprotective agent

Pharmacological Action

Bien is a mixture of ethyl esters of polyunsaturated fatty acids, obtained from the lipids of the mycelial fungus Entomophthora virulenta, family Entomophthoraceae, class Zygomycetes, strain “E.INMI”, stabilized with alpha-tocopheryl acetate (vitamin E). Bien consists of 90-95% higher fatty acids.

Bien contains: ethyl esters of alpha-linolenic acid (omega-3); linoleic acid (omega-6); gamma-linolenic acid (omega-6); arachidonic acid (omega-6); eicosadienoic acid (omega-6); eicosatrienoic acid (omega-6); palmitic acid (omega-7); palmitoleic acid (omega-9); oleic acid (omega-9), as well as ethyl esters of stearic acid and myristic acid.

The unsaturated fatty acids included in Bien, including essential ones (linoleic, alpha-linolenic, and arachidonic) are important components of biomembranes and sources of eicosanoids – universal bioregulators of the functional activity of cells and tissues.

Bien is characterized by a balanced ratio of polyunsaturated fatty acids of the omega-6 and omega-3 series, has a cytoprotective effect, and enhances reparative processes.

Essential polyunsaturated fatty acids (PUFAs) and their derivatives – eicosanoids – have a modulating effect on the processes of hyperreactivity development and the formation of allergic inflammation, and proliferative processes.

The arachidonic acid metabolite prostaglandin PGE₂ in low concentrations inhibits leukocyte migration and the release of inflammatory mediators from mast cells.

Eicosanoids that exert a dose-dependent anti-inflammatory effect also include PGE₁, PGF_2a, PGD₂.

The ointment has an anti-inflammatory effect and stimulates reparative processes in the skin (reduces hyperemia and swelling, reduces the feeling of skin burning, promotes epithelialization of the wound defect).

Pharmacokinetics

It is practically not absorbed through the skin and does not enter the systemic circulation. It is absorbed in insignificant amounts through damaged skin.

Indications

• As part of complex therapy, for the symptomatic treatment of skin manifestations of dermatitis (atopic, allergic, contact), eczema (true, seborrheic).

ICD codes

Dosage Regimen

Apply the ointment externally only.

Use a thin layer of the ointment.

Apply to the damaged or inflamed skin area.

Apply 1 to 2 times per day.

The standard treatment course is 10 to 15 days.

Extend the treatment course only on the recommendation of a physician.

Avoid contact with eyes and mucous membranes.

Wash hands thoroughly before and after application.

Do not apply to open, weeping wounds or actively infected skin lesions.

Discontinue use and consult a physician if allergic reactions or severe irritation occur.

Do not use occlusive dressings unless directed by a doctor.

Do not exceed the recommended frequency or duration of application.

Adverse Reactions

Allergic reactions (urticaria, itching), burning at the application site. If side effects occur, the use of the ointment should be discontinued.

Contraindications

• Bacterial, viral, and fungal skin diseases (including herpes simplex, chickenpox, skin tuberculosis, actinomycosis);
• Eczema in the acute stage with weeping phenomena;
• Syphilitic skin lesions;
• Pregnancy;
• Lactation period;
• Children under 18 years of age;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

The safety of the drug during pregnancy and lactation has not been studied. The use of the drug is contraindicated during pregnancy and lactation.

Pediatric Use

Contraindicated in children under 18 years of age.

Special Precautions

Effect on the ability to drive vehicles and mechanisms

The drug does not affect the ability to drive vehicles and other potentially dangerous mechanisms.

Overdose

Cases of overdose with the use of the drug have not been described.

Drug Interactions

Cases of interaction with other drugs are unknown.

Storage Conditions

Store the drug in a dry, light-protected place at a temperature not exceeding 8°C (46.4°F). Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

Do not use after the expiration date printed on the packaging.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.