Gemcitabin Medak powder for infusions 200 mg. vial №1

Description

Gemcitabin Medak Storage
active substance: gemcitabine (as gemcitabine hydrochloride);

1 ml of reconstituted solution for infusion contains 38 mg of gemcitabine (as gemcitabine hydrochloride);

Excipients: mannitol (E 421), sodium acetate trihydrate, hydrochloric acid, sodium hydroxide.

Gemcitabin Medak Dosage form
Powder for solution for infusion.

Main physical and chemical properties: white or almost white powder.

Gemcitabin Medak Pharmacotherapeutic group
Antitumor drugs. Structural analogues of pyrimidine. ATX code L01B C05.

Pharmacological properties

Pharmacodynamics.

Cytotoxic activity in cell cultures.

Gemcitabine has significant cytotoxic effects on various types of human cancer cells and cultured mouse cancer cells. Gemcitabine has cell-phase specificity, mainly destroying cells that undergo a phase of DNA synthesis (S-phase), and under certain conditions blocks the passage of cells across the G1 / S phase boundary. The cytotoxic effect of gemcitabine in vitro depends on the concentration and time.

Indication
Bile duct cancer.

Gemcitabine is indicated for the treatment of patients with bile duct cancer.

Bladder cancer. Gemcitabine medac in combination with cisplatin is indicated for the treatment of patients with locally recurrent or metastatic bladder cancer.

Breast cancer. Gemcitabine medac in combination with paclitaxel is indicated for the treatment of patients with inoperable, locally recurrent or metastatic breast cancer after prior adjuvant / neoadjuvant chemotherapy. Anthracycline should be prescribed before chemotherapy if there are no contraindications.

Non-small cell lung cancer. Gemcitabine medac in combination with cisplatin is indicated as a first-line drug for the treatment of patients with locally progressive or metastatic non-small cell lung cancer. Gemcitabine medac as monotherapy is indicated for the treatment of elderly patients and patients with second functional status.

Ovarian cancer. Gemcitabine medac in combination with carboplatin is indicated for the treatment of patients with locally progressive or metastatic epithelial ovarian carcinoma. Gemcitabine medac is indicated for the treatment of patients with recurrent ovarian epithelial carcinoma after a remission period of at least 6 months after previous first-line platinum therapy.

Pancreatic cancer. Gemcitabine medac is indicated for the treatment of patients with locally progressive or metastatic adenocarcinomas of the pancreas.

Contraindication
Hypersensitivity to the active substance or to any of the excipients.

Breastfeeding period.