Epirubicin Medak (epirubicin) solution for injections 2 mg/ml. vial 25 ml.

Description

Epirubicin Medak 25 ml. Storage
active substance: epirubicin hydrochloride;

1 ml of solution for injection contains 2 mg of epirubicin hydrochloride;

Excipients: sodium chloride, concentrated hydrochloric acid, water for injections.

Epirubicin Medak 25 ml. Dosage form
Solution for injection.

Main physical and chemical properties: transparent red solution, free from visible mechanical inclusions.

Pharmacotherapeutic group
Antineoplastic agents. ATX code L01D B03.

Pharmacological properties

Pharmacodynamics.

Epirubicin is an antibiotic of the anthracycline group with cytotoxic activity. The mechanism of action of epirubicin is related to its ability to bind to DNA. Cell culture studies have shown rapid cell penetration, localization in the nucleus, inhibition of nucleic acid synthesis and mitosis. Epirubicin has been shown to be active against a wide range of experimental tumors, including leukemia L1210 and P388, sarcomas SAI 80 (solid and ascites), melanoma B16, breast cancer, Lewis lung cancer, and colon cancer 38. Epirubicin activity has also been demonstrated. humans transplanted into non-thymus nude mice (melanoma, breast, lung, prostate, and ovarian cancer).

Indication
Epirubicin is used to treat a number of neoplastic conditions, including:

breast cancer;
ovarian cancer;
stomach cancer;
lung cancer;
malignant lymphoma;
soft tissue sarcomas;
liver cancer;
pancreatic cancer;
rectal cancer;
cervical ‑ facial cancer;
leukemia.
It has been shown that epirubicin when administered intravesically is effective for the treatment of:

papillary transitional cell carcinoma of the bladder;
in situ carcinomas of the bladder;
intravesical prevention of recurrence of superficial carcinoma of the bladder after transurethral resection.

Epirubicin Medak 25 ml. Contraindication
Hypersensitivity to epirubicin or to any of the excipients, to other anthracyclines and anthracenediones;
breastfeeding period.
Intravenous administration of epirubicin is contraindicated in the following diseases:

persistent myelosuppression due to previous chemotherapy or radiation therapy;
active depression of bone marrow function due to previous courses of treatment with other anticancer drugs or radiotherapy;
severe liver dysfunction;
cardiac diseases, including in the anamnesis (in particular myocardial insufficiency of the IV degree, acute myocardial infarction or myocardial infarction in the anamnesis which caused myocardial insufficiency of the III or IV degree, acute inflammatory heart diseases, arrhythmias with serious hemodynamic disturbances);
cardiomyopathy;
unstable angina;
obtaining previously the maximum cumulative dose of other anthracyclines (eg, doxorubicin or daunorubicin);
acute systemic (generalized) infections.

Contraindications for intravesical use:

urinary tract infections;
invasive tumors that penetrate the bladder wall;
catheterization problems (urethral obstruction caused by significant intravesical neoplasms);
inflammation of the bladder;
hematuria.