Slavinorm^® (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Peptidpro, LLC (Russia)

Manufactured By

Samson-Med LLC (Russia)

Contact Information

PEPTIDPRO LLC (Russia)

ATC Code

C05 (Angioprotective agents)

Active Substance

Cattle vessels polypeptides (Grouping name)

Dosage Form

Slavinorm®

Lyophilizate for preparation of solution for intramuscular injection 5 mg: fl. 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of solution for intramuscular injection in the form of a tablet, whole, partially or completely crumbled, white, white with a yellowish tint or yellowish in color; reconstituted solution: a transparent, colorless or slightly yellowish solution.

Excipients: glycine – 20 mg.

Glass vials (5) – contour cell packs (2) – cardboard packs.

Clinical-Pharmacological Group

Angioprotector

Pharmacotherapeutic Group

Angioprotectors

Pharmacological Action

The drug Slavinorm^® is a complex of polypeptides isolated from cattle vessels.

The drug Slavinorm^® is a peptide regulator, it initiates a cascade of metabolic reactions leading to a decrease in lipid peroxidation, thereby normalizing the function of the vascular wall endothelium; it prevents the development of atherosclerosis by improving the atherogenicity coefficient (increasing the content of high-density lipoproteins and reducing atherogenic cholesterol fractions), as well as reducing the level of triglycerides in the blood.

It prevents the development of hypercoagulation by influencing blood coagulation and fibrinolysis processes, as a result of which it restores microcirculation in organs and tissues in various diseases and pathological conditions caused by atherosclerotic vascular lesions.

According to the results of randomized double-blind placebo-controlled clinical trials, course use of the drug Slavinorm^® as part of complex therapy significantly increases the ankle-brachial index (ABI), which is an objective indicator of improved circulation (reduced degree of ischemia) in the lower extremities in obliterating diseases, and also leads to a significant reduction in the symptoms of intermittent claudication: an increase in the pain-free walking distance and the maximum distance walked compared to placebo in patients with chronic obliterating diseases of the arteries of the lower extremities.

The effects of the drug Slavinorm^® persist for at least 7-10 days after the last administration of the drug; the continuation of the therapeutic effect at more remote times after course treatment was not studied in clinical trials.

The effect of the drug 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) was not studied in clinical trials.

Pharmacokinetics

The composition of the drug Slavinorm^® does not allow for pharmacokinetic analysis of individual components. In tissues, peptides are rapidly cleaved by cellular proteases into amino acids, as a result, the detectable amounts of peptides and their metabolites do not correlate with the therapeutic effect of the drug.

Indications

• To increase the pain-free walking distance in adult patients with chronic obliterating diseases of the lower extremities of stages I-II according to the Fontaine classification.

ICD codes

Dosage Regimen

Administered intramuscularly, for adults 1 vial (5 mg) once a day 2 times a week. The course of treatment is 10 injections.

If an injection is missed, it is not recommended to administer a double dose; the next dose of the drug should be administered at the usual time of the next scheduled day.

The contents of the vial should be dissolved in 1-2 ml of 0.9% sodium chloride solution before injection, directing the needle towards the wall of the vial to avoid foaming.

The drug Slavinorm^® is administered intramuscularly into the upper outer quadrant of the gluteus maximus muscle; it is necessary to alternate the administration of the drug into the left and right gluteal muscles.

Special patient groups

Patients with hepatic insufficiency

There are no data on the need for dose adjustment and dosing regimen in patients with hepatic insufficiency.

Patients with renal insufficiency

There are no data on the need for dose adjustment and dosing regimen in patients with renal insufficiency.

Children

The safety and efficacy of use in children under 18 years of age have not been established. Data are not available.

Adverse Reactions

Within the framework of the conducted clinical trials, the drug Slavinorm^® demonstrated a favorable safety profile. The registered adverse reactions (AR) associated with the administration of the drug Slavinorm^® were of mild severity and did not require any corrective measures. The ARs observed during the clinical trials of the drug are distributed by system-organ classes with an indication of the frequency of their development in accordance with the WHO classification: very common (≥1/10); common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000) and very rare (<1/10000), frequency unknown (cannot be estimated from the available data).

Contraindications

• Individual hypersensitivity to the drug or its components;
• Pregnancy;
• Breastfeeding period;
• Childhood and adolescence under 18 years of age (no medical use experience).

Use in Pregnancy and Lactation

Data on the safety of the drug Slavinorm^® during pregnancy and breastfeeding are not available, therefore, the use of the drug during these periods is not recommended.

Use in Hepatic Impairment

There are no data on the need for dose adjustment and dosing regimen in patients with hepatic insufficiency.

Use in Renal Impairment

There are no data on the need for dose adjustment and dosing regimen in patients with renal insufficiency.

Pediatric Use

The use of the drug is contraindicated in childhood and adolescence under 18 years of age (no medical use experience).

Special Precautions

Storage of the vial with the dissolved drug and delayed administration of the reconstituted solution is not allowed. Special precautions for the destruction of unused medicinal products are not required.

With parenteral administration of medicinal products containing protein of animal origin, the development of allergic/anaphylactic reactions is possible. If allergic reactions occur during the use of the drug Slavinorm^®, the administration of the drug should be discontinued and standard measures aimed at treating the allergic reaction should be carried out. During clinical trials, no allergic reactions to the drug were identified.

The use of the drug Slavinorm^® in chronic obliterating diseases of the arteries of the lower extremities (COAD) of stages III-IV according to the Fontaine classification has not been studied in clinical trials.

There is no experience with repeated course use of the drug Slavinorm^®.

Effect on the ability to drive vehicles and mechanisms

The drug does not affect the ability to drive vehicles or engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Cases of overdose are unknown.

Drug Interactions

Drug interactions of the drug Slavinorm^® have not been studied. During clinical trials, the absence of drug interaction with antiplatelet drugs (acetylsalicylic acid, clopidogrel) and lipid-lowering agents from the statin group (atorvastatin, lovastatin, rosuvastatin, simvastatin) was established.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date stated on the packaging.

Dispensing Status

The drug is dispensed 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.