BLASTOMUNIL

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BLASTOMUNYL (BLASTOMUNYL)

Composition:

Active substance: 1 vial contains 0.6 mg of blastolen, calculated as peptides;

Excipient: dextran 70.

Pharmaceutical form. Powder for solution for injection.

Main physicochemical properties: amorphous white powder or porous mass, readily soluble in water for injections and in 0.9% sodium chloride solution for injections.

Pharmacotherapeutic group.
Immunostimulants. ATC code L03AX.

Pharmacological Properties

Pharmacodynamics

Blastomunil is an immunomodulator that stimulates cellular and humoral immunity and cytokine activity. The drug increases the number of leukocytes in peripheral blood when their levels are reduced, primarily neutrophils, T- and B-lymphocytes. It enhances phagocytosis, reduces levels of immune complexes, normalizes serum concentrations of immunoglobulins M and G, and acts as an inducer of interferon, interleukin-1, and interleukin-2, which play a central role in regulating T-cell immune responses and differentiation and activation of B- and NK-cells. It improves endocrine function of the thymus gland. The drug improves tissue microcirculation, stimulates regenerative processes, exerts antibacterial and antiviral effects, exhibits mild antitumor and antimetastatic activity, and reduces adverse reactions during radiation therapy. The drug does not produce local irritant, embryotoxic, mutagenic, or teratogenic effects.

Pharmacokinetics

Pharmacokinetic studies of the drug have not been conducted.

Clinical characteristics.

Indications.

Diseases accompanied by secondary immunodeficiency and leukopenia, namely – in oncological patients and leukemia patients undergoing chemotherapy and radiation therapy, with the aim of enhancing the antitumor efficacy of cytostatics and reducing their toxic effects; in acute and chronic radiation injuries, especially under conditions of prolonged exposure to low-intensity radiation in small doses; in comprehensive anti-inflammatory and antiviral therapy of acute and chronic diseases of the bronchi and lungs; in surgical treatment of oncological and other diseases of the abdominal cavity and thorax, genital organs, and mammary gland, for prevention of postoperative complications and acceleration of patient recovery. Trophic ulcers, chronic diffuse streptoderma, rheumatoid joint lesions, leukopenias of various origins, to enhance treatment efficacy in debilitated patients and elderly individuals.

Contraindications.

Acute heart failure, increased individual sensitivity to the components of the drug.

Interaction with other medicinal products and other types of interactions.

When used concomitantly with other immunomodulators of tissue origin, immune response and antitumor effect are enhanced.

Special precautions.

Use with caution in patients prone to allergic reactions.

Use during pregnancy or breastfeeding.

There is no experience with the use of the drug during pregnancy or breastfeeding; therefore, the drug is not recommended for use during these periods.

Ability to affect reaction rate while driving or operating machinery.

Studies on the effect on reaction speed while driving or operating machinery have not been conducted.

Administration and Dosage

Administer subcutaneously or intramuscularly. Before use, add 2 mL of 0.9% sodium chloride injection solution or water for injections to the vial, and shake the vial until the drug is completely dissolved.

The daily dose for adults is 0.6 mg. The interval between injections is 5–7 days. The treatment course consists of 3–5 injections. If necessary, repeated courses may be administered after 3–6 and 12 months.

Children

There is no experience with the use of the drug in children; therefore, Blastomunil should not be prescribed to patients in this age group.

Overdose

Has not been observed.

Adverse reactions.

Hypersensitivity reactions may occur during administration of the drug. In some patients, a slight increase in body temperature may be observed, lasting for several hours; local reactions, joint pain (especially in patients with rheumatism), and general malaise that resolves spontaneously may occasionally occur.

Shelf life.

4 years.

Storage conditions.

Store in the original packaging protected from light at a temperature not exceeding 25 °C.

Packaging.

0.6 mg of active substance in glass vials, pack of 5 in a cardboard package.

Prescription status.

Prescription only.

Manufacturer.

LLC NVK "Interpharmbiotec".

Manufacturer's address and location of its business activity.

150 Zabolotnoho Street, Kyiv, 03143, Ukraine.

Marketing Authorization Holder.

LLC "Pharmaceutical Company "Enzifarm".

Address of the Marketing Authorization Holder.

3 Khlibozavodska Street, Ladizhin, Vinnytsia region, 24321, Ukraine.