Zarsio solution for infection. and inf. 48 mln units / 0.5мл syringe No. 5 ***

Solution for injections and Zarsio's infusions is shown for reduction of duration and weight of a neutropenia at the patients receiving intensive myelosuppressive chemotherapy cytotoxic medicines concerning malignant new growths (except for a myelosis and MDS) and reduction of duration of a neutropenia at patients who receive receiving high-dose chemotherapy cytotoxic medicines with the subsequent autologous or allogenic bone marrow transplantation.

Structure

Active ingredient: filgrasty (recombinant human granulotsitarny colony stimulating factor);

Previously filled the syringe (syringe dose) contains 48 mln units (480 mkg) of a filgrastim in 0.5 ml;

Excipients: glutaminic acid, sorbite (E 420), polysorbate 80, water for injections.

Contraindication

• Hypersensitivity to a filgrastim, colony stimulating factors, Escherichia coli or to any excipients.
• Heavy hereditary neutropenia (Kostman's syndrome) with cytogenetic violations and an autoimmune neutropenia.
• End-stage of the chronic kidney disease (CKD).
• Myelosis and miyelodisplastichesky syndrome.

Route of administration

in medical institutions where there is a necessary diagnostic equipment. Doctors have to have experience of use of the medicines containing a granulotsitarny colony stimulating factor (G-KSF) and treatments of patients with hematologic diseases.

Procedure of mobilization and an aferez in interaction with doctors who have the corresponding experience and a possibility of necessary monitoring of progenitors of a hematopoiesis.

Drug to dissolve 5% of solution of glucose in 20 ml and to apply in the form of short infusion within 30 minutes of long hypodermic or intravenous infusion within 24 hours.

Pregnant

it is not recommended by

Feature of application

At application in children's practice by the patient with THN and oncological diseases the profile of safety Zarsio® did not differ in

from those at adults. Safety and efficiency of use of medicine by the newborn are not established.

Recommendation about dosing for patients of children's age same, as for the adults receiving myelosuppressive cytotoxic chemotherapy.

Drivers

Researches were not conducted by

.

Overdose

Symptoms of overdose of Zarsio® are unknown to

. In 1-2 days after the treatment termination the quantity of the circulating neutrophils usually decreases by 50%, and in 1-7 days returns to norm.

Side effects

Most frequent by-effects against the background of therapy using a filgrastim is bone and muscles pain from low to moderate severity (it is observed at 10% of patients). Bone and muscles pain, as a rule, is eliminated at intake of standard anesthetics.

At mobilization of PSKK at healthy donors frequent side reaction was skeletal and muscular pain.

Interaction

Safety and efficiency of administration of the medicine Zarsio® on the same day, as myelosuppressive cytotoxic khimiopreparat, are not established. Because of sensitivity of myeloid cells which quickly share, in myelosuppressive cytotoxic chemotherapy it is not recommended to appoint Zarsio® in the range of the 24th hour to or after administration of these medicines.

to Store

at a temperature of 2 ° - 8 °C in original packing. Not to freeze.

to Store

out of children's reach.

solution is stable

After cultivation within 24 hours at a temperature of 2 ° - 8 °C. From the microbiological point of view solution should be used immediately.