Composition, form of production and packaging
Ointment for external use in the form of a homogeneous mass of white, with a soft consistency of the cream and a weak characteristic odor.
epidermal growth factor human recombinant 1 mg
sulfadiazine silver 1 g
Excipients: stearic acid - 18 g, potassium carbonate - 500 mg, methyl parahydroxybenzoate - 180 mg, propyl parahydroxybenzoate - 20 mg, glycerol - 5 g, purified water - qs
30 g - high density polyethylene bottles (1) - cardboard boxes.
200 g - high density polyethylene bottles (1) - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
Epidermal growth factor human recombinant (rchEhFR) is a highly purified peptide. It is produced by the strain of yeast Saccharomyces Cerevisiae, into the genome of which the gene of human epidermal growth factor was introduced into the genome by genetic engineering methods. The rchEhFR, obtained on the basis of recombinant DNA technology, is identical in its mechanism of action to the endogenous epidermal growth factor produced in the body.
Ebermin, containing as active substances rchEhFR and silver sulfadiazine, has a complex wound healing and bactericidal action, rchEhF stimulates the migration and proliferation of fibroblasts, keratinocytes, endothelial and other cells actively involved in wound healing, promoting epithelization, scarring and restoration of tissue elasticity.
Sulfadiazine silver has a broad spectrum of antimicrobial action; it is active against Gram-positive and Gram-negative bacteria, Candida fungi 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 in the lesion site. Ebermin has a cosmetic effect, provides aesthetics of the rumen due to the normalization of the orientation and maturation of collagen fibers, preventing pathological scarring.
When applying the drug to intact skin and burn wound surface reabsorption rCHEF from the place of application in the systemic circulation is not observed.
The drug is used in adults and children over 1 year for treatment:
- superficial and deep skin burns of various degrees;
- trophic ulcers (including chronic venous insufficiency, obliterating endarteritis, diabetes, erysipelas);
- long-term non-healing wounds (including wounds of the stump, wounds during autodermoplasty on the lysis sites and between the surviving autologous skin, as well as residual wounds on the donor sites);
- violations of the integrity of the skin in injuries, surgical and cosmetological interventions;
- ulcers developing with the introduction of cytostatics;
- treatment and prevention of radiation (radiation) dermatitis (including in the conduct of surface radiotherapy).
Ebermin can be used at all stages of the wound process.
Preliminary, the standard surgical treatment of the wound is carried out using antiseptic solutions in case of infection. After drying on the wound surface, a layer of ointment is applied about 1-2 mm. When the treatment method is closed, sterile gauze napkins or occlusive film coatings (healing in a moist environment) are placed on top. In a number of cases, for example, with superficial shallow (grade I-II) and partially deep (grade III) burns, it is possible to use an ointment with atraumatic reticular wound covers.
With a moist method of healing, as well as pronounced exudation, it is recommended to apply the ointment once a day. With moderate or poor exudation, the application of the ointment can be performed once every 2 days. In case of adhesion of the bandage to the wound and to prevent unwanted drying of the wound surface, it is recommended to moisten the napkin applied over the ointment with a sterile 0.9% solution of sodium chloride or solutions of antiseptics. With an open (non-detached) method of treatment, the ointment is applied 1-3 times a day.
Toilet wounds before repeated applications of the ointment are carried out using a sterile 0.9% solution of sodium chloride or solutions of antiseptics. The procedure is carried out neatly, avoiding traumatization of the resulting granulation tissue and growing epithelium when removing residual ointments.
Treatment continues until the epithelization of the wound or its readiness for plastic closure with a skin flap.
To prevent radiation dermatitis, an ointment with a layer of 1 mm is applied to the irradiated area of вЂ‹вЂ‹the skin without removing it from the application site within 6-8 hours after irradiation. The use of the ointment is continued daily throughout the course of radiotherapy and does not interrupt any of the irradiation procedures in the event of a forced miss.
The drug is well tolerated. In rare cases, development is possible:
- allergic reactions, characteristic of sulfonamide drugs and preparations containing silver;
- the appearance of a burning sensation, pain, constriction and discomfort in the area of вЂ‹вЂ‹application of the ointment (usually pass on their own 5-10 minutes after the dressing is applied).
- Children's age up to 1 year;
- hypersensitivity to sulfonamides, silver and other components of the drug.
The drug should not be used on areas with active tumor lesions and for stimulation of scarring in the areas of surgical excision of tumors.
With caution: with congenital deficiency of glucose-6-phosphate dehydrogenase, deficiency of liver and kidney function.
PREGNANCY AND LACTATION
Ebermin has not been sufficiently studied with respect to exposure to fetuses or infants, so its use is not recommended in pregnancy and during lactation. In the event that a pregnant woman or a breast-feeding woman has a lesion that can be treated with Ebermin, the doctor must determine the risk-benefit ratio and decide on its use.
APPLICATION FOR FUNCTIONS OF THE LIVER
Use with caution when failure of kidney function.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Use with caution when insufficiency of liver function.
APPLICATION FOR CHILDREN
Contraindicated for children under 1 year.
Use with caution in congenital deficiency of glucose-6-phosphate dehydrogenase, insufficiency of liver and kidney function.
With an open (non-detached) method of treatment, direct sunlight exposure to the ointment area should be avoided.
There have been no cases of overdose.
Incompatibilities or interactions with other drugs have not been noted.
TERMS OF RELEASE FROM PHARMACY
TERMS AND CONDITIONS OF STORAGE
Store at temperatures between 15 В° and 25 В° C in a place protected from light and out of reach of children. Shelf life - 2 years.