Composition, form of production and packaging
Lyophilizate for the preparation of solution for injection as a lyophilized white mass; The reconstituted solution is a clear, colorless, homogeneous liquid without suspended particles.
1 f.
epidermal growth factor human recombinant 0.075 mg
Excipients: sucrose 15 mg, dextran 40 5 mg, sodium dihydrogen phosphate dihydrate 1.061 mg, sodium hydrogen phosphate 0.454 mg.
0.075 mg - glass bottles (1) - packs of cardboard.
0.075 mg - bottles of glass (6) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
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.
EFRchp is produced by the strain of yeast Saccharomyces cerevisiae, the genome of which was introduced by the genetic engineering methods by the EFRCR gene.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 T max after injection into the affected area was 5 to 15 minutes. The average area under the pharmacokinetic curve (AUC) after the first administration of the drug at a dose of 75 Ојg and 27 days after administration is 198 and 243 pg h / ml, respectively, and the mean C max is 1040 pg / ml. T 1/2 and the 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 complex therapy of diabetic foot syndrome with deep non-healing for more than 4 weeks and more neuropathic or neuroischemic wounds of more than 1 cm 2 , reaching the tendons, ligaments, joints or bones.
DOSING MODE
For use only in conditions of a specialized treatment and prophylactic institution, taking into account the inpatient and outpatient stages.
Before the introduction of the drug Eberprot-P, personnel working with it should properly wash their hands 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 cm 2 ).
The Eberprot-P vials contain a lyophilized powder of white color. 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 found in the solution or if the appearance of the solution is different from that described, the reconstituted product should not be used; it must be properly disposed of.
The contents of each bottle with Eberprot-P are reconstituted by adding 5 ml of the injection solution; using the resulting solution, up to ten injections containing 0.5 ml of the solution can be carried out. The syringe should be equipped with a 26Gx 1/2 needle or 24Gx1 1/2 "needle for small or deep injections, respectively.
To treat ulcers larger than 10 cm 2 , ten injections of 0.5 ml should be done. 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. 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 cm 2 for each cm 2 of the lesion area, only one injection should be used in a volume of 0.5 ml of Eberprot-P.For example, to treat a 4 cm2 wound, 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 Eberprot-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 EberPort-P the granulation tissue in the wound does not begin to form, the presence of local infection or osteomyelitis should be excluded.
SIDE EFFECT
The frequency of side effects (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 headache, 24.3% had tremor, 24.0% -been at the injection site, 17.8% had a burning sensation at the injection site, 11.3% had chills, 2.8% had a fever, and 4.4% had an 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 related to drug use, but could be related to the procedure of injection. All other adverse events were observed with a low incidence in the Eberprot-P group and in the placebo group, so their association with the treatment is unlikely.
CONTRAINDICATIONS
hypersensitivity to the components of the drug;
- diabetic coma or diabetic ketoacidosis;
- chronic heart failure III-IV class in 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 thromboembolism arteries);
- 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 introduction of the drug, surgical treatment of the wound is necessary);
- the presence of an infectious process, including osteomyelitis (the drug is used after its full resolution);
- the presence of signs of critical ischemia of the extremity (the size of the ankle-brachial index (LPI) is 0.6, but is 1.3 and / or the value of the thumb-brachial index is 0.5, and / or TcP0 2 <30 mmHg. ) (it is possible to use the drug only after revascularization.)
Carefully
Eberprot-P should be used with caution in patients with heart valve disease (eg, calcification of aortic valves), severe stenosis of the carotid arteries (<70% NACET), severe uncontrolled arterial hypertension.
PREGNANCY AND LACTATION
The use of Eberprot-P during pregnancy is contraindicated (due to the lack of data on safety of use).
When prescribing the drug during breastfeeding, breastfeeding should be discontinued.
APPLICATION FOR FUNCTIONS OF THE LIVER
The drug is contraindicated in patients with renal insufficiency (glomerular filtration rate <30 ml / min.)
APPLICATION FOR CHILDREN
The drug is contraindicated for children under 18 years.
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 start of Eberprot-P treatment, it is necessary to exclude the malignant etiology of the ulcer.
The contents of the Eberprot-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.
Impact on ability to drive a vehicle and work with mechanisms
Data on the negative effect of the drug Eberprot-P on the ability to drive a vehicle or work with mechanisms there.
OVERDOSE
There is no information about an overdose of Eberprot-P.
DRUG INTERACTION
During the course of treatment with Eberprot-P, local use of other drugs is not recommended.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
Store at a temperature of 2 to 8 В° C. Do not freeze. Keep out of the reach of children. Shelf life - 2 years.
