국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
Vinorelbine tartrate
PIERRE FABRE Ltd
L01CA; L01CA04
Vinorelbine tartrate
30 Base Milligrams
Capsule, soft
Product subject to prescription which may not be renewed (A)
Vinca alkaloids and analogues; vinorelbine
Marketed
2006-04-13
PACKAGE LEAFLET: INFORMATION FOR THE USER NAVELBINE 20MG SOFT CAPSULE NAVELBINE 30MG SOFT CAPSULE NAVELBINE 80MG SOFT CAPSULE Vinorelbine (as tartrate) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their their signs of illness are the same as yours. - If you get any of the side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Navelbine soft capsule is and what it is used for 2. Before you take Navelbine soft capsule 3. How to take Navelbine soft capsule 4. Possible side effects 5 How to store Navelbine soft capsule 6. Contents of the pack and other information. 1. WHAT NAVELBINE SOFT CAPSULE IS AND WHAT IT IS USED FOR Navelbine contains the active substance Vinorelbine (as tartrate), and belongs to a family of medicines used to treat cancer called the vinca-alkaloid family. Navelbine is used to treat some types of lung cancer and some types of breast cancer in patients over 18 years old. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NAVELBINE SOFT CAPSULE DO NOT TAKE NAVELBINE SOFT CAPSULE If you are allergic to Vinorelbine, or to any of the related family of cancer drugs called the vinca alkaloids, or any of the other ingredients of this medicine, (listed in section 6) If you are breast feeding. If you have had an operation on your stomach or small bowel, or if you have gut disorder which affects how you absorb food. These may affect how your body absorbs Navelbine. If you have a low white blood cell count (neutrophils, leucocytes) or a severe infection current or recent within two weeks. If you have a low blood platelet cell count (thrombocytopenia). If you plan to have a yellow fever 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT NAVELBINE 30 mg soft capsule 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each soft capsule contains 30 mg vinorelbine (as tartrate). Excipients: Each 30mg capsule contains: Ethanol anhydrous 7.50 mg Sorbitol 15.96 mg For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Soft capsule Pink soft capsule printed N30 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of non small cell lung cancer in adult patients. Treatment of advanced breast cancer stage 3 and 4. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology IN ADULT PATIENTS AS A SINGLE AGENT, the recommended regimen is: FIRST THREE ADMINISTRATIONS 60mg/m² of body surface area, administered once weekly SUBSEQUENT ADMINISTRATIONS Beyond the third administration, it is recommended to increase the dose of Navelbine to 80mg/m² once weekly except in those patients for whom the neutrophil count dropped once below 500/mm 3 or more than once between 500 and 1000/mm 3 during the first three administrations at 60mg/m². Neutrophil count during the first 3 administrations of 60 mg/m 2 /week Neutrophils > 1000 Neutrophils 500 and < 1000 (1 episode) Neutrophils 500 and < 1000 (2 episodes) Neutrophils < 500 Recommended dose starting with the 4 th administration 80 80 60 60 H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _0_ _8_ _/_ _0_ _2_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _8_ _8_ _9_ _9_ _5_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ 전체 문서 읽기