البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
VINORELBINE AS TARTRATE
PADAGIS ISRAEL AGENCIES LTD, ISRAEL
L01CA04
CAPSULES
VINORELBINE AS TARTRATE 20 MG
PER OS
Required
PIERRE FABRE MEDICAMENT, FRANCE
VINORELBINE
VINORELBINE
For the treatment of non small cell lung cancer. For the treatment of advanced breast cancer.
2014-05-31
PATIENT PACKAGE INSERT ACCORDING TO PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986 The medicine is marketed with a doctor’s prescription only Navelbine ® 20 mg Soft Capsule Navelbine ® 30 mg Soft Capsule The active ingredient and its quantity: Each soft capsule contains: Vinorelbine )as tartrate( 20 mg The active ingredient and its quantity: Each soft capsule contains: Vinorelbine )as tartrate( 30 mg For a list of inactive and allergenic ingredients in the preparation, please see section 6 “Further Information” and section 2 “Important information about some of the ingredients of the medicine”. Read the entire leaflet carefully before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer the doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Navelbine is intended for the treatment of non-small cell lung cancer, treatment of advanced breast cancer. Therapeutic group: Navelbine belongs to the group of medicines for the treatment of cancer extracted from the vinca plant )vinca alkaloids(. 2. BEFORE USING THE MEDICINE Do not use the medicine if: • You are sensitive )allergic( to the active substance vinorelbine, or to any other substance from the family of cancer medicines called vinca alkaloids. • You are sensitive )allergic( to any of the additional ingredients contained in Navelbine (for more information, please see section 6 “Further information” and section 2 “Important information about some of the ingredients of the medicine”(. • You are pregnant or think that you are pregnant. • You are breastfeeding. • You suffer from a serious liver disease. • You have had gastric or small intestine surgery or if you suffer from intestinal problems that affect the absorption of food. This may affect how Navelbine is absorbed in your body. • Your white blood اقرأ الوثيقة كاملة
PRESCRIBING INFORMATION 1 NAME OF THE MEDICINAL PRODUCT NAVELBINE ® 20 mg NAVELBINE ® 30 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION NAVELBINE 20 mg: Each soft capsule contains 20mg Vinorelbine (as tartrate) NAVELBINE 30 mg: Each soft capsule contains 30mg Vinorelbine (as tartrate ) For a full list of excipients, see section 6.1 Excipients with known effect: Each dose of 20 mg soft capsule contains ethanol, sorbitol . - ethanol (alcohol) 5 mg - sorbitol 5.36 mg each dose of 30 mg soft capsule contains ethanol, sorbitol . - ethanol (alcohol) 7.5 mg - sorbitol 8.11 mg 3. PHARMACEUTICAL FORM Soft capsule. NAVELBINE 20 mg: light brown soft capsule containing light yellow to orange-yellow solution printed N20 in red. NAVELBINE 30 mg: pink soft capsule containing light yellow to orange-yellow solution printed N30 in red. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of non small cell lung cancer. For the treatment of advanced breast cancer . 4.2 POSOLOGY AND METHOD OF ADMINISTRATION IN ADULT PATIENTS NAVELBINE SOFT CAPSULE IS INDICATED AS A SINGLE AGENT FIRST THREE ADMINISTRATIONS 60mg/m² of body surface area, administered once weekly . EVEN FOR PATIENTS WITH BSA 2 M 2 THE TOTAL DOSE SHOULD NEVER EXCEED 120 MG PER WEEK AT 60 MG / M 2 AND 160 MG PER WEEK AT 80 MG/M 2 . 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 DOSE MODIFICATION For any administration planned to be given at 80mg/m², if the neutrophil count is below 500/mm 3 or more than once between 500 and 1000 / اقرأ الوثيقة كاملة