País: Armenia
Idioma: inglés
Fuente: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
vinorelbine (vinorelbine tartrate)
Accord Healthcare Limited
L01CA04
vinorelbine (vinorelbine tartrate)
10mg/ml
concentrate for solution for infusion
(1) glass vial 1ml
Prescription
Registered
2017-08-16
PACKAGE LEAFLET: INFORMATION FOR THE USER VINORELBINE 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION Vinorelbine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. See section 4. WHAT IS IN THIS LEAFLET: 1. What Vinorelbine solution is and what it is used for 2. What you need to know before you use Vinorelbine solution 3. How to use Vinorelbine solution 4. Possible side effects 5. How to store Vinorelbine solution 6. Contents of the pack and other information 1. WHAT VINORELBINE SOLUTION IS AND WHAT IT IS USED FOR Vinorelbine solution is a concentrate for solution for infusion. The active substance vinorelbine belongs to a group of cytostatic agents. These agents interfere with the growth of malignant cells. Vinorelbine solution is indicated in adults for the treatment of cancers, specifically non-small cell lung cancer and breast cancer. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE VINORELBINE SOLUTION DO NOT USE VINORELBINE SOLUTION: - if you are allergic to vinorelbine or any medicine in the family of medicines called vinca alkaloids; - if you are allergic to any of the other ingredients of Vinorelbine solution (listed in section 6); - if you are pregnant or think you may be pregnant; - if you are breast-feeding; - if you have a low white blood cell (neutrophil) count or a current or recent (in the past 2 weeks) serious infection; - if you have a low platelet count; - _if you are planning to get (or have recently had) _ _a yellow fever vaccine_ - This medicine is strictly for intravenous use only and should not be injected into the spine WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before usin Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vinorelbine 10 mg/ml concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution contains 10 mg vinorelbine (as vinorelbine tartrate) Each 1-ml vial contains a total of 10 mg vinorelbine (as tartrate) Each 5-ml vial contains a total of 50 mg vinorelbine (as tartrate) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion A clear, colourless to pale yellow solution, free from visible particles. pH in the range of approximately 3.0 to 4.0 and osmolality in the range of approximately 30 to 40 mOsm/Kg. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vinorelbine is indicated in adults in the treatment of: - As a single agent in patients with metastatic breast cancer (stage 4) in which chemotherapy with anthracycline and taxane has failed or is inadequate. - Non-small cell lung cancer (stage 3 or 4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Vinorelbine must be administered under the supervision of a doctor experienced in the use of chemotherapy. POSOLOGY _Non-small cell lung cancer_. In monotherapy the usual dose given is 25-30 mg/m² once weekly. In combination chemotherapy the usual dose (25-30 mg/m²) is usually maintained, while the frequency of administration is reduced e.g. day 1 and 5 every 3 weeks or day 1 and 8 every 3 weeks according to treatment protocol. _Metastatic breast cancer _ The usual dose given is 25-30 mg/m² once weekly.” Maximum tolerated dose per administration: 35.4 mg/m² of body surface area. Maximum total dose per administration: 60 mg. _ELDERLY_: Clinical experience has not detected any significant differences among elderly patients with regard to the response rate, although greater sensitivity in some of these patients cannot be excluded. Age does not modify the pharmacokinetics of vinorelbine (see section 5.2) _DOSE ADJUSTMENT_: Vinorelbine metabolism and clearance are mostly hepatic: only 18.5% is excreted unchanged in the u Leer el documento completo