Instruction for use: Polydanum

Dosage form: Solution for injection

Active substance: Natrii nucleospermas

ATX

L03A Immunostimulants

Pharmacological group:

Stimulators of hematopoiesis

The nosological classification (ICD-10)

D70 Agranulocytosis: Agranulocytosis is hereditary; Aleicia; Aleykocytosis; Agranulocytic angina; Angina agranulocytic; Primary cytopenia

D72.8.0 * Leukopenia: Autoimmune neutropenia; Congenital neutropenia; Granulocytopenia; Idiopathic and drug-induced leukopenia; Idiopathic neutropenia; Leukopenia aplastic; Leukopenia radiation; Leukopenia with radiation therapy; Radiation leukopenia; Hereditary neutropenia; Neutropenia in patients with AIDS; Periodic neutropenia; Radiation leukopenia; Persistent neutropenia; Febrile neutropenia; Two-stage cytopenia; Radiation cytopenia; Neutropenia is cyclic

Composition and release form

1 bottle with 5 ml solution for injection contains sodium nucleosupermate 75 mg; In a cardboard bundle 1 and 5 bottles.

Characteristic

A highly purified standardized mixture of sodium salts of polychlorohydrates of DNA and RNA derivatives derived from milk from sturgeon.

Pharmachologic effect

Mode of action - Leukopoietic, hematopoietic.

It is a stimulant of hematopoiesis of indirect action. Has the ability to stimulate hemopoiesis, causes an increase in the production of endogenous colony-stimulating factors, acting through a microenvironment that induces hematopoiesis. Promotes increased platelet count. Reduces the degree of immunosuppression after PCT and RT, increasing the content of CD4 +, increases their share in the ratio of immunoregulatory subpopulations (CD4 + / CD8 +), while maintaining high proliferative activity of T lymphocytes. Significantly reduces the level of superoxide dismutase and malonic dialdehyde, showing moderate antioxidant activity.

Pharmacokinetics

Rapidly absorbed into the systemic bloodstream from the injection site. Cmax in plasma after IM is achieved after 60 minutes. The concentration of the drug in the bone marrow is maintained for 72 hours. At the same time, the colony-stimulating effect significantly exceeding the baseline level is clearly maintained. Thus, the repeated injection of the drug is not advisable before 72 hours. The bone marrow, lymph nodes, spleen, thymus, and kidneys have the greatest tropism. Penetrates through GEB. T1 / 2 - 69-72 h. It is excreted unchanged in the form of metabolites, mainly with urine and partly with feces.

Clinical Pharmacology

Reduces hematotoxicity caused by high doses of cytostatics, restores leukocyte / neutrophil levels in peripheral blood. Prevents the development of leuko-, neutropenia and related infectious complications (bacterial, fungal, viral).

Indication of the drug Polydanum

Leukopenia arising from radiation and cytostatic therapy (treatment and prevention).

Contradiction

Hypersensitivity, pregnancy, lactation, children up to 3 years.

Side effects

Short-term increase in body temperature (up to 38 ° C), hyperemia and soreness at the injection site, which do not require special medication.

Dosing and Administration

SC or IM (slowly - for 1.5-2 minutes), pre-warming the bottle in his hand to body temperature. To reduce pain, it is allowed to inject in / m with the addition of 0.5 ml of lidocaine.

The recommended single dose for adults and children over 3 years old is from 42 mg / m2 / day, but not less than 66 mg / day (regardless of body surface area and patient's age); The maximum single dose is 150 mg.

Prevention of leuko / neutropenia: the optimal scheme is from 66 to 150 mg once 24 hours before the start of chemotherapy. It is possible to administer from 66 to 150 mg once every 24 hours after the end of the course of chemotherapy.

Treatment of leuko / neutropenia: a single dose (from 66 to 150 mg) of 1-5 injections with an interval of 3-7 days.

Storage conditions of the drug Polydanum

In dry, the dark place at a temperature of 4-8 ° C.

Keep out of the reach of children.

Shelf life of the drug Polydanum

3 years.

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