Ebermin (Ointment) Instructions for Use

Marketing Authorization Holder

Alkana Medical, LLC (Russia)

Manufactured By

Center For Genetic Engineering And Biotechnology (Cuba)

ATC Code

D03AX (Other drugs that promote normal scarring)

Dosage Form

Ebermin

Ointment for external use: bottle 30 g or 200 g

Dosage Form, Packaging, and Composition

Ointment for external use in the form of a homogeneous white mass, with a soft cream consistency and a faint characteristic odor.

Excipients: stearic acid – 18 g, potassium carbonate – 500 mg, methylparahydroxybenzoate – 180 mg, propylparahydroxybenzoate – 20 mg, glycerol – 5 g, purified water – q.s.

30 g – high-density polyethylene bottles (1) – cardboard boxes.
200 g – high-density polyethylene bottles (1) – cardboard boxes.

Clinical-Pharmacological Group

A drug improving trophism and tissue regeneration, for external use

Pharmacotherapeutic Group

Tissue regeneration stimulant

Pharmacological Action

Recombinant human epidermal growth factor (rhEGF) is a highly purified peptide. It is produced by a strain of the yeast Saccharomyces Cerevisiae, into whose genome the gene for human Epidermal Growth Factor has been introduced using genetic engineering methods. rhEGF, obtained using recombinant DNA technology, is identical in its mechanism of action to the endogenous epidermal growth factor produced in the body.

Ebermin, containing rhEGF and Silver sulfadiazine as active substances, has a complex wound-healing and bactericidal effect. rhEGF stimulates the migration and proliferation of fibroblasts, keratinocytes, endothelial and other cells actively involved in wound healing, promoting epithelialization, scarring and restoration of tissue elasticity.

Silver sulfadiazine has a broad spectrum of antimicrobial action; it is active against gram-positive and gram-negative bacteria, fungi of the genus Candida and dermatophytes.

The hydrophilic base of the ointment provides a moderate dehydrating effect, reduces pain, creates and maintains the necessary therapeutic concentrations of the active substances at the site of the lesion. Ebermin has a cosmetic effect, ensures scar aesthetics by normalizing the orientation and maturation of collagen fibers, preventing pathological scarring.

Pharmacokinetics

When the drug is applied to intact skin and a burn wound surface, no reabsorption of rhEGF from the site of application into the systemic circulation is observed.

Indications

The drug is used in adults and children over 1 year of age for the treatment of

• Superficial and deep skin burns of varying degrees;
• Trophic ulcers (including those associated with chronic venous insufficiency, obliterating endarteritis, diabetes mellitus, erysipelas);
• Bedsores;
• Long-term non-healing wounds (including stump wounds, wounds during autodermoplasty in areas of lysis and between engrafted autologous skin grafts, as well as residual wounds at donor sites);
• Skin integrity impairments due to injuries, surgical and cosmetic interventions;
• Frostbite;
• Ulcers developing during the administration of cytostatics;
• Treatment and prevention of radiation dermatitis (including during superficial radiotherapy).

ICD codes

Dosage Regimen

Ebermin can be used at all stages of the wound process.

Standard surgical treatment of the wound is preliminarily performed using antiseptic solutions in case of infection. After drying, a layer of ointment about 1-2 mm thick is applied to the wound surface. With the closed method of treatment, sterile gauze pads or occlusive film dressings (moist wound healing) are placed on top. In some cases, for example, with superficial shallow (I-II degree) and partially deep (III degree) burns, the use of the ointment with atraumatic mesh wound dressings is possible.

With the moist healing method, as well as with pronounced exudation, it is recommended to apply the ointment once a day. With moderate or scanty exudation, the ointment can be applied once every 2 days. If the dressing sticks to the wound and to prevent unwanted drying of the wound surface, it is recommended to moisten the pad applied over the ointment with a sterile 0.9% sodium chloride solution or antiseptic solutions. With the open (non-occlusive) method of treatment, the ointment is applied 1-3 times a day.

Wound cleansing before repeated applications of the ointment is carried out using a sterile 0.9% sodium chloride solution or antiseptic solutions. The procedure is performed carefully, avoiding injury to the forming granulation tissue and growing epithelium when removing the remnants of the ointment.

Treatment is continued until the wound epithelializes or is ready for plastic closure with a skin graft.

For the prevention of radiation dermatitis, a 1 mm layer of ointment is applied to the irradiated area of the skin, without removing it from the application site for 6-8 hours after irradiation. The use of the ointment is continued daily throughout the entire course of radiotherapy and is not interrupted in case of a forced missed irradiation procedure.

Adverse Reactions

The drug is well tolerated. In rare cases, the development of

• Allergic reactions characteristic of sulfonamide drugs and drugs containing silver;
• A sensation of burning, pain, tightness and discomfort in the area of ointment application (usually resolve on their own within 5-10 minutes after applying the dressing).

Contraindications

• Children under 1 year of age;
• Hypersensitivity to sulfonamides, silver and other components of the drug.

The drug should not be used on areas with active tumor lesions and to stimulate scarring in areas of surgical tumor excisions.

With caution in congenital deficiency of glucose-6-phosphate dehydrogenase, hepatic and renal insufficiency.

Use in Pregnancy and Lactation

Ebermin has not been sufficiently studied regarding its effects on the fetus or breastfed infants, therefore its use is not recommended during pregnancy and lactation. In the event that a pregnant or breastfeeding woman has a lesion that can be treated with Ebermin, the physician should determine the risk-benefit ratio and make a decision on its use.

Use in Hepatic Impairment

Use with caution in hepatic insufficiency.

Use in Renal Impairment

Use with caution in renal insufficiency.

Pediatric Use

Contraindicated in children under 1 year of age.

Special Precautions

Use with caution in congenital deficiency of glucose-6-phosphate dehydrogenase, hepatic and renal insufficiency.

With the open (non-occlusive) method of treatment, direct sunlight on the area of ointment application should be avoided.

Overdose

No cases of overdose have been reported.

Drug Interactions

No incompatibilities or interactions with other drugs have been reported.

Storage Conditions

Store at a temperature from 15°C (59°F) to 25°C (77°F) in a place protected from light and out of the reach of children.

Shelf Life

The shelf life is 2 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.