Instruction for use: Nucleospermate sodium

Dosage form: Solution for intramuscular and subcutaneous administration; Substance-powder

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

T66 Unspecified radiation effects: Radiation disease; Diarrhea radiation; Gastrointestinal syndrome with irradiation; Radiation sickness; Radiation disorders of mucous membranes; Irradiation chronic; Osteoradionecrosis; Acute radiation sickness; Acute and chronic radiation injuries; Acute radiation syndrome with radiation therapy; Subacute and chronic radiation sickness; Radiation Neuropathy; Radiation edema; Radiation damage to the nervous system; Radiation immunodeficiency; Radiation syndrome; Radio-epileleitis; Radiation acute syndrome; State after irradiation; Cytopenia due to previous radiation or chemotherapy; Cytopenia radiation; Cytopenia due to radiation therapy; Cytopenia due to chemotherapy

Z51.0 Radiotherapy course: Supplement to external radiation therapy; Local X-Ray Irradiation; Radiation therapy; Brain edema associated with radiation therapy; Lesion in radiation therapy; Radiotherapy

Z51.1 Chemotherapy for neoplasm: Cystitis hemorrhagic, caused by cytostatics; Urotoxicity of cytostatics

Composition and release form

Solution for intramuscular and subcutaneous administration 1 ml

Sodium nucleosumate 15 mg

Sodium Chloride 1 mg

Water for injection - enough

In ampoules of 5 ml (complete with a knife ampoule); In the box there are 5 ampoules.

Description of dosage form

Colorless, clear or slightly opalescent solution.

Characteristic

Nucleospermate sodium is a highly purified standardized mixture of nucleic acids derived from milk from sturgeon. Stimulator of hemopoiesis.

Pharmachologic effect

Mode of action - Immunomodulating, hematopoietic.

Pharmacodynamics

Accelerates granulocytopoiesis in the stage of promyelocytes and myelocytes, increases the neutrophil maturation index. Significantly activates the processes of proliferation, migration and differentiation of erythrocytes, platelets and lymphocytes, acting at all levels of hematopoiesis. It has an immunomodulatory effect on the cellular and humoral levels: activates and increases the content of killer cells of CD4 +, stimulates antibody formation. Activates antiviral, antifungal and antimicrobial immunity.

The use of the drug provides a much more smooth course of the wound process in the postoperative period in patients receiving complex and combined treatment for cancer diseases - the incidence of local purulent and system-wide complications decreases, and general intoxication.

The drug does not have a carcinogenic and mutagenic effect.

Pharmacokinetics

With SC and IM introduction of the recommended dose of sodium nucleospermate quickly enters the blood. Its concentration in the blood rises in a direct linear relationship. Tmax at once SC and IM introduction - 0.5 h, T1 / 2 - about 60 h. After 24 h, a rapid decrease in the concentration of the drug in the blood, associated with its distribution in organs and tissues. Redistribution of the drug between the plasma and the shaped elements of the blood occurs in parallel with its metabolism and excretion.

Gradual removal of the drug from the blood occurs in the time interval from 2 to 8 days from the time of administration. With repeated administration of the drug every 24 hours for 5 days there is a process of its accumulation in the blood and bone marrow from only the first four doses. In other proliferating tissues, the total concentration of sodium nucleosupermate increases after the fifth dose administered. 8 days after the 5th administration of the drug, its concentration is significantly reduced in all organs and tissues, but it exceeds the concentration achieved with a single administration and is sufficient for the therapeutic effect of the drug.

The main transport pathway of sodium Nucleospermate for all routes of administration is the endolymphatic pathway. The bone marrow, lymph nodes, spleen, thymus, and kidneys have the greatest tropism. The drug passes the BBB. Output, incl. In the form of metabolites, mainly with urine and partly with feces. T1 / 2 for SC and IM introduction is 63 to 69 hours.

With the IM introduction during the first 24 hours, about 50% of the drug is excreted in the urine, 12.5% in feces; At SC introduction - 37 and 3% accordingly.

Indication of the drug Nucleospermate sodium

Prevention and treatment of inflammatory and wound complications in the complex and combined treatment of cancer patients;

Prevention and treatment of leuko-and neutropenia in the conduct of cytostatic chemotherapy and radiation therapy in adults and children older than 3 years.

Contradiction

Hypersensitivity to any of the components of the drug;

Acute diseases of the liver, kidneys, pancreas, gastrointestinal tract;

Severe heart failure;

Impaired cerebral circulation;

pregnancy;

Lactation period;

Children's age (up to 3 years).

With caution - any myeloid precancerous disease.

Side effects

A short-term increase in body temperature to 38 ° C, hyperemia and tenderness at the injection site, which do not require special medication.

Interaction

It can be used simultaneously with cytostatics and lidocaine; Enhances the effect of anticoagulants.

Dosing and Administration

IM, SC. Before administration, preheat the vial or ampoule to body temperature. It is recommended a slow injection - 5 ml in 1.5-2 minutes.

Prevention of neutropenia. Adults - in a dose of 5 ml once a day for 3-5 days; Children older than 3 years - in a dose of 5 ml 1 time per day for 1-2 days, the first introduction of the drug - 24 hours before the start of the course of chemotherapy.

Treatment of neutropenia. Adults - in a dose of 5-10 ml once a day for 5-10 days; Children older than 3 years - in a dose of 5 ml 1 time per day for 1-4 days.

The maximum single dose for adults is 150 mg (10 ml of a solution of 15 mg / ml), for children - 75 mg (5 ml of a solution of 15 mg / ml)

To reduce pain at the injection site, it is permissible to take a joint intravenous injection with 0.5 ml of a 0.5 or 2% solution of lidocaine.

Special instructions

Solutions for injection do not contain preservatives, so after opening the vial / ampoule for injection solutions should be used immediately.

Storage conditions of the drug Nucleospermate sodium

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

Keep out of the reach of children.

Shelf life of the drug Nucleospermate sodium

3 years.

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