Active substanceEpidermal growth factorEpidermal growth factor
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  • Eberprot-P®
    lyophilizate for injections 
    Eber Biotech SA     Cuba
  • Dosage form: & nbsplyophilizate for solution for injection
    Composition:

    1 bottle contains:

    active substance: growth factor epidermal human recombinant 0.075 mg;

    Excipients: sucrose 15,000 mg, dextran-40 5,000 mg, sodium dihydrogen phosphate dihydrate 1.061 mg, sodium hydrogen phosphate 0.454 mg.

    Description:

    Lyophilizate: lyophilized white mass.

    Reconstituted solution: transparent, colorless, homogeneous liquid without suspended particles.

    Pharmacotherapeutic group:regeneration of tissue stimulant
    ATX: & nbsp

    D.03.A.X   Other drugs that promote normal scarring

    Pharmacodynamics:

    The growth factor epidermal human recombinant (EGFR) is a highly purified peptide consisting of 53 amino acids with a molecular weight of 6054 daltons and an isoelectric point of 4.6.

    EFRCP is produced by yeast strain Saccharomyces Cerevisiae, in the genome of which genetic engineering methods introduced the gene EFRchr. EFRchp, obtained on the basis of recombinant DNA technology, by the mechanism of action is identical to the endogenous growth factor epidermal, produced in the body. EFRCHR stimulates the proliferation of fibroblasts, keratinocytes,endothelial and other cells involved in wound healing, promoting epithelization, scarring and restoration of tissue elasticity.
    Pharmacokinetics:

    EFRchp in plasma is not detected, but is determined in platelets (approximately 500 mmol / 1012 platelets).

    In most patients, the time to reach the maximum level of the drug in the blood plasma (TmOh) after injection into the affected area was from 5 to 15 minutes. The mean value of the area under the pharmacokinetic curve (AUC) after the first administration of the drug at a dose of 75 μg and 27 days after the administration is 198 and 243 pg * h / ml, respectively, and the average maximum concentration of the drug in the blood (CmOh) was 1040 pg / ml. Half-life (tl/2) and average retention time (MRT) of the drug in the body were close to 1 hour. The total ground clearance takes about 2 hours.

    Indications:

    As part of the complex treatment of diabetic foot syndrome with deep non-healing for more than 4 weeks and more neuropathic or neuroischemic wounds more than 1 sq. Cm in area, reaching the tendons, ligaments, joints or bones.

    Contraindications:

    - Hypersensitivity to the components of the drug;

    - diabetic coma or diabetic ketoacidosis;

    - chronic heart failure III-IV class on NYHA;

    - the presence during the last 3 months of episodes of acute cardiovascular pathology (severe acute cardiovascular conditions) such as acute myocardial infarction, severe angina, acute stroke or transient ischemic attack, and / or thromboembolic events (deep vein thrombosis, pulmonary embolism );

    - severe atrioventricular block (grade III), atrial fibrillation with uncontrolled rhythm;

    - malignant neoplasms;

    - pregnancy, the period of breastfeeding;

    - children's age till 18 years;

    - renal failure (glomerular filtration rate

    <30 ml / min);

    - The presence of wound necrosis (before the drug is needed

    surgical treatment of the wound);

    - presence of an infectious process, including osteomyelitis (the drug is used after its full resolution);

    - presence of signs of critical limb ischemia (magnitude ankle-brachial index (LPI) ≥0.6, but <1.3 and / or the value of the thumb-brachial index ≥0.5, and / or TCDO2 <30 mm Hg. (it is possible to use the drug only after revascularization).

    Carefully:

    Eberproth-P® should be used with caution in patients with valvular heart disease (eg calcification of aortic valves), severe stenosis of the carotid arteries (<70% NACET), severe uncontrolled arterial hypertension (see Contraindications).

    Pregnancy and lactation:

    The use of Eberprote-P® during pregnancy is contraindicated (due to the lack of safety data).

    When prescribing the drug during breastfeeding, breastfeeding should be discontinued.

    Dosing and Administration:

    For use only in conditions of a specialized treatment and prophylactic institution, taking into account the inpatient and outpatient stages.

    Before administering Eberprot-P®, personnel working with it should be properly washed and put on sterile gloves. The drug Eberprot-P® is applied at the rate of one vial per patient. The wound surface should be cleaned with sterile physiological solution and dry sterile gauze wipes. The area of ​​the lesion focus should be measured (in cm2).

    The Eberprot-P® vials contain a lyophilized white powder.Before use, five milliliters of water for injections are added to the vial, after which it is gently stirred for a few seconds. The solution prepared in this way should be clear and colorless, without visible particles. The resulting solution should be used immediately after preparation. If any solid particles are noted in the solution or if the appearance of the solution is different from that described above, the reconstituted product should not be used; it must be properly disposed of.

    The contents of each vial with Eberprote-P® are reconstituted by adding 5 ml of solution for injection; using the resulting solution, up to ten injections containing 0.5 ml of the solution can be carried out. The syringe must be equipped with a needle 26Gx1/2"or with a needle 24Gx11/2", for small or deep injections, respectively.

    For the treatment of ulcers larger than 10 cm2 should make ten injections of 0.5 ml. Injections should be done in soft tissues with a uniform distribution of the injection site, first of all, by cutting the edges of the wound, and then the bed of the wound (see the figure below). The depth of needle insertion during injection should be about 0.5 cm.

    For the treatment of wounds with an area of ​​less than 10 cm2 per cm2 of the area of ​​the lesion focus, use only one injection in a volume of 0.5 ml of Eberprot-P. For example, to treat a 4 cm wound2 Only four injections of 1.25 ml of the drug should be performed.

    To reduce the risk of infection, each injection should be done with a new sterile needle.

    After the injections are completed, the ulcer should be covered with gauze moistened with saline, or a moist bandage applied to create a moist and clean environment.

    Splitting is carried out 3 times a week. Injections of Eberproth-P® should be continued until the formation of granulation tissue covering the entire surface of the wound, or up to 8 weeks (maximum duration of treatment).

    The wound surface should be covered with a neutral atraumatic bandage.

    If after three weeks of treatment with Eberprot-P® the granulation tissue in the wound does not begin to form, the presence of a local infection or osteomyelitis should be excluded.

    Side effects:

    The incidence of adverse events (in view of the number of all patients treated with Eberprot-P® in clinical trials,including in the Russian Federation): 1.2% of patients had a headache, 24.3% had a thymor, 24.0% had pain at the injection site, 17.8% had a burning sensation at the injection site, 11.3% - chills, 2.8% - body temperature increase, 4.4% - infection at the injection site.

    Pain or burning at the injection site was observed at a similar frequency in patients who received EberProt-P and placebo. These undesirable phenomena are most likely related to the procedure of injection.

    Approximately 10-30% of patients in all studies observed chills and tremors. These phenomena were often observed shortly after injection and were transient. They were never heavy and did not lead to interruption of treatment. In most cases, their association with treatment was considered to be definite or probable.

    Moderate severity or severe infection of the wound at the site of administration was recorded in 15-18% of patients, both in the Eberprot-P® group and in the placebo group, therefore, these adverse events were not probably associated with drug use, but could be associated with the procedure of injection. All other undesirable phenomena were observed with a low occurrence rate in the Eberprot-P® group and in the placebo group, so their association with the treatment is unlikely.

    Overdose:

    There is no information about an overdose of Eberprot-P®.

    Interaction:

    During the course of treatment with Eberprot-P®, local use of other drugs is not recommended.

    Special instructions:

    Eberprot-P® is used as part of complex therapy (antibacterial therapy, surgical treatment of the wound) of the diabetic foot syndrome.

    Before the introduction of the drug, surgical treatment of the wound is carried out with observance of all conditions of aseptic and antiseptic.

    Before the beginning of Eberprot-P® treatment it is necessary to exclude the malignant etiology of the ulcer.

    The contents of the EberPort-P® vial are used for only one patient. Care should be taken to avoid damage and bacterial contamination of the vials.

    It is highly recommended to use a new sterile needle for each injection to avoid any potential entry of pathogens into the lesion.

    Unused timely preparation or its residues should be appropriately disposed of.

    It is necessary to change the needle for each injection.

    Effect on the ability to drive transp. cf. and fur:

    Data on the adverse effect of Eberprot-P® on the ability to drive a vehicle or work with mechanisms is not.

    Form release / dosage:Lyophilizate for solution for injection, 0.075 mg.
    Packaging:

    By 0.075 mg of the growth factor of the epidermal human recombinant into flasks of light neutral borosilicate glass of hydrolytic class with caps flip-top and a cork made of silicone bromobutyl rubber.

    For 1 or 6 bottles, along with instructions for medical use, put in a cardboard box.

    Storage conditions:

    At a temperature of 2 to 8 ° C. Do not freeze.

    Keep out of the reach of children.

    Shelf life:

    2 years.

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

    Terms of leave from pharmacies:On prescription
    Registration number:LP-002375
    Date of registration:17.02.2014
    The owner of the registration certificate:Eber Biotech SAEber Biotech SA Cuba
    Manufacturer: & nbsp
    Representation: & nbspBBC FARMA BV BBC FARMA BV Netherlands
    Information update date: & nbsp12.09.2015
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