Država: Indonezija
Jezik: indonezijski
Izvor: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
VINORELBINE TARTRATE
MENARINI INDRIA LABORATORIES - Indonesia
VINORELBINE TARTRATE
13.85 MG
INJEKSI
DUS, 1 VIAL @ 1 ML
FAREVA PAU 1 - France
2021-04-22
1 PRESENT – CURRENT INDONESIAN LEAFLET Instruction for use! Read carefully! NAVELBINE® VINORELBINE TARTRATE 10 mg/1 ml & 50 mg/5 ml Injectable solution in vial COMPOSITION INGREDIENTS FORMULATION 10 mg/1 ml 50 mg/5 ml _Active ingredient _ vinorelbine tartrate (mg) equivalent to vinorelbine (INN) base (mg) 13.85 10.00 69.25 50.00 _Other ingredient _ Water for injection (ml) qs 1.00 5.00 PHARMACOTHERAPEUTIC GROUP Cytostatic - Antineoplastic drug MECHANISM OF ACTION Navelbine is a cytostatic antineoplastic of the vinca alkaloid group. The molecular target of its activity is tubulin/microtubule dynamic equilibrium. Navelbine inhibits the polymerization of tubulin. lt acts preferentially on mitotic microtubules and affects axonal microtubules only at high concentration. The effects on tubulin spiralization are Iower than with vincristine. Navelbine blocks mitosis in phase G2+M and induces cell death at interphase or at the following mitosis. INDICATION • Treatment of non small cell lung cancer. • Treatment of advanced breast cancer in combination with standard chemotherapy. CONTRAINDICATIONS Pregnancy, lactation, known hypersensitivity to vinorelbine or other vinca alkaloids, or to any of the constituents, neutrophil count <1500/mm 3 or severe infection current or recent (within 2 weeks), platelet count < 100000/mm 3 in combination with yellow fever vaccine. SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE • Navelbine injection should be administered under the supervision of a physician experienced in the use of chemotherapy. The product is for intravenous (IV) use only. Intrathecal administration of other vinca alkaloids has resulted in death. • Severe granulocytopenia resulting in increased susceptibility to infection may occur. Granulocyte counts should be ≥ 1500 cells/mm3. Prior to the administration of Navelbine, the dosage should be adjusted according to complete blood counts with differentials obtained on the day of treatment. • Navelbine must only be administered by the intravenous route. • It Pročitajte cijeli dokument