Expiration date: 10/2027
Dosage form
Lyophilizate: a lyophilized mass in the form of a tablet, whole, partially or completely crumbled, white, white with a yellowish tinge or a yellowish tinge of color.
Reconstituted solution: a clear, colorless or slightly yellowish solution.
Composition
1 bottle contains:
active substance:
vascular polypeptides of cattle - 5.0 mg.
auxiliary substance: glycine - 20.0 mg.
Pharmacotherapeutic group
angioprotective agent
Pharmacodynamics
Slavinorm® is a complex of polypeptides isolated from the vessels of cattle.
Slavinorm® is a peptide regulator that triggers a cascade of metabolic reactions leading to a decrease in lipid peroxidation, as a result of which it normalizes the function of the vascular wall endothelium; prevents the development of atherosclerosis by improving the coefficient of atherogenicity (increasing the content of high-density lipoproteins and reducing atherogenic cholesterol fractions), as well as lowering the level of triglycerides in the blood. Prevents the development of hypercoagulation by influencing the processes of blood clotting and fibrinolysis, as a result of which it restores microcirculation in organs and tissues in various diseases and pathological conditions caused by atherosclerotic vascular damage.
According to the results of randomized, double-blind, placebo-controlled clinical trials, the course use of Slavinorm® as part of complex therapy significantly increases the ankle-brachial index (MPI), which is an objective indicator of improved blood circulation (reducing the degree of ischemia) in the lower extremities in obliterating diseases, and also leads to a significant reduction in symptoms of intermittent claudication.: increased pain-free walking distance and maximum walking distance compared with placebo in patients with chronic obliterating diseases of the arteries of the lower extremities.
The effect of Slavinorm® persists for at least 7-10 days after the last administration of the drug; the continuation of the therapeutic effect in the longer term after the course of treatment has not been studied in clinical studies.
The effect of Slavinorm® on long-term disease outcomes (frequency of amputations, cardiovascular complications, and mortality in patients with chronic obliterating diseases of the arteries of the lower extremities) has not been studied in clinical studies.
Pharmacokinetics
The composition of the drug Slavinorm® does not allow for a pharmacokinetic analysis of individual components. In tissues, peptides are rapidly cleaved by cellular proteases to amino acids, as a result, the determined amounts of peptides and their metabolites do not correlate with the therapeutic effect of the drug.
Indications
Slavinorm® is used to increase the pain-free walking distance in adult patients with chronic obliterating arterial diseases of the lower extremities of stage I-II according to the Fontaine classification.
Contraindications
Individual hypersensitivity to the drug or its components.
Pregnancy and lactation.
Children under 18 years of age (no medical experience).
Use during pregnancy and lactation
There are no data on the safety of using Slavinorm® during pregnancy and lactation, and therefore it is not recommended to use the drug during these periods.
Method of administration and dosage
The drug is administered intramuscularly.
The contents of the vial are dissolved in 1-2 ml of 0.9% sodium chloride solution before injection, directing the needle to the wall of the vial to avoid foaming.
The drug is administered intramuscularly in 1 vial (5 mg) 1 time a day, 2 times a week, the course of treatment is 10 injections. If the injection is missed, it is not recommended to administer a double dose, the next dose of the drug is administered at the usual time of the next scheduled day.
Slavinorm® is administered intramuscularly into the upper outer quadrant of the gluteus maximus muscle, alternating administration of the drug into the left and right gluteal muscles.
Side effects
In the framework of the conducted clinical trials, Slavinorm® has demonstrated a favorable safety profile. The reported adverse reactions associated with the administration of Slavinorm® were mild in severity and did not require any corrective measures.
Adverse reactions observed during clinical trials of the drug are divided into systemic organ classes, indicating the frequency of their development in accordance with the classification of the World Health Organization (WHO): very common (1/10); common (1/1/100, <1/10), infrequent (1/1/1000, <1/100), rare (1/10000, <1/1000) and very rarely (<1/10000), the frequency is unknown (according to available data, it is not possible to determine the frequency of occurrence):
MedDRA classification of Undesirable effects Frequency
General disorders and reactions at the injection site Pain and discomfort at the injection site are very common
General weakness Frequency unknown
Nervous system disorders Headache
Often
Hyperesthesia, numbness in the lower extremities is common
Disorders of the gastrointestinal tract
Nausea
The frequency is unknown
Disorders of the musculoskeletal and connective tissue Cramps in the calf muscles Frequency unknown
Skin and subcutaneous tissue disorders Skin itching Frequency unknown
Erythema at the injection site Frequency unknown
Laboratory and instrumental data Leukocytosis is common
Increased ALT Activity Is often
Overdose
Overdose cases are unknown.
Drug interaction
Drug interactions of Slavinorm® have not been studied.
Clinical studies have established the absence of drug interactions with antiplatelet drugs (acetylsalicylic acid, clopidogrel) and lipid-lowering drugs from the group of statins (atorvastatin, lovastatin, rosuvastatin, simvastatin).
Special instructions
Storage of a vial with a dissolved medicinal product and delayed administration of the reconstituted solution is unacceptable.
No special precautions are required when disposing of unused medicines.
With parenteral administration of drugs containing animal protein, allergic / anaphylactic reactions may develop. If allergic reactions occur during the use of Slavinorm®, the administration of the drug should be discontinued and standard measures aimed at treating the allergic reaction should be carried out. No allergic reactions to the drug were detected during clinical trials.
The use of Slavinorm® in chronic obliterating arterial diseases of the lower extremities (HOZANK) of stage III-IV according to the Fontaine classification has not been studied in clinical studies.
There is no experience of repeated course use of Slavinorm®.
Influence on the ability to drive vehicles, mechanisms
The drug does not affect the ability to drive vehicles or engage in other potentially dangerous activities that require increased concentration of attention and psychomotor reactions.
Storage temperature
from 2℃ to 25℃
