Ravederm^® (Ointment) Instructions for Use

Marketing Authorization Holder

Russian Medicine, LLC (Russia)

Manufactured By

Biopin Pharma, LLC (Russia)

ATC Code

D03 (Drugs for the treatment of wounds and ulcers)

Dosage Form

Ravederm®

Ointment for external use 0.1%: tubes or jars 30 g or 40 g

Dosage Form, Packaging, and Composition

Ointment for external use of light yellow color with a faint smell of beeswax.

Excipients: olive oil – 80 g, yellow beeswax – 19.68 g, methylparahydroxybenzoate (nipagin) – 0.2 g, propylparahydroxybenzoate (nipasol) – 0.02 g.

30 g – aluminum tubes (1) – cardboard packs.
40 g – aluminum tubes (1) – cardboard packs.
30 g – polymer jars (1) – cardboard packs.
40 g – polymer jars (1) – cardboard packs.

Clinical-Pharmacological Group

A drug improving trophism and tissue regeneration, for external use

Pharmacotherapeutic Group

Topical anti-inflammatory agent

Pharmacological Action

Ravederm^® is a means for the local treatment of burn wounds.

It has wound-healing, anti-burn, moderate analgesic, antibacterial, and antifungal effects.

The use of Ravederm^® ointment prevents the formation of coagulation necrosis.

The gradual rejection of necrotized tissues occurs against a background of moderate inflammation that does not extend beyond the burn area.

The dressing change is painless, without destruction of epithelial islets and granulation tissue.

It prevents the formation of post-burn keloid scars and dermatogenic contractures.

The best results are achieved when using the ointment within the first 24 hours from the moment of receiving the burn.

Pharmacokinetics

Lead does not accumulate in the body in dangerous amounts when Ravederm^® ointment is used at the recommended dosage.

The percentage of lead resorption does not exceed 0.5-1%.

Indications

• Complex treatment of II, III a degree burns, including those of the hands and joint areas (prevention of dermatogenic contractures);
• At the stage of preparing a burn wound for skin grafting;
• After performing necrectomy.

ICD codes

Dosage Regimen

Externally.

The ointment is applied to a sterile napkin in a layer of about 2 mm and applied to the affected area.

The layer of ointment should exceed the wound size in circumference by at least 5 mm.

The dressing is changed once a day or as the dressing becomes saturated with wound contents.

The daily dose of Ravederm^® depends on the size of the burn surface, but should not exceed 10g.

The course of treatment is until the complete healing of the wound surface, but not more than 30 days.

Adverse Reactions

Burning and itching at the application site may sometimes be noted, which resolve on their own within a few hours.

Allergic reactions.

Contraindications

• Individual intolerance to the components of the ointment, acute and chronic lead intoxication;
• Childhood;
• Not recommended for use in III b degree burns and an area of more than 10% of the body surface.

Use in Pregnancy and Lactation

Do not use during pregnancy and lactation.

Pediatric Use

Contraindicated in children.

Overdose

No cases of Ravederm^® overdose have been reported.

Drug Interactions

Not described.

Storage Conditions

Store at a temperature of 12 to 15°C (59°F).

Keep out of reach of children.

Shelf Life

Shelf life – 3 years.

Dispensing Status

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.