País: Malta
Língua: inglês
Origem: Medicines Authority
medac Gesellschaft Fur klinische Spezialpräparate mbH Theaterstr. 6 22880 Wedel, Germany
L01CA04
VINORELBINE 80 mg
SOFT CAPSULE
VINORELBINE 80 mg
POM
ANTINEOPLASTIC AGENTS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2022-03-08
palmultiple (MT-English) Vinorelbine medac 20 mg/30 mg/80 mg Soft Capsules National version: 03/2023 PACKAGE LEAFLET: INFORMATION FOR THE USER VINORELBINE MEDAC 20 MG SOFT CAPSULES VINORELBINE MEDAC 30 MG SOFT CAPSULES VINORELBINE MEDAC 80 MG SOFT CAPSULES Vinorelbine ditartras 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 any further questions, ask your doctor or pharmacist. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Vinorelbine medac is and what it is used for 2. What you need to know before you take Vinorelbine medac 3. How to take Vinorelbine medac 4. Possible side effects 5. How to store Vinorelbine medac 6. Content of the pack and other information 1. WHAT VINORELBINE MEDAC IS AND WHAT IT IS USED FOR Vinorelbine medac contains the active substance Vinorelbine and belongs to a family of medicines called the vinca alkaloid, family used to treat cancer. Vinorelbine medac 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 VINORELBINE MEDAC DO NOT TAKE VINORELBINE MEDAC: - If you are allergic to vinorelbine, or to any of the related family of cancer drugs called the vinca alkaloids, or any 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 intestinal disorders. - If you have a low white blood cell and/or platelet count, or a severe infection current or recent (within 2 weeks). - If you plan to have a yellow fever vaccine or have just had one. - If you require long-term oxyge Leia o documento completo
spcmultiple (MT-English) Vinorelbine medac 20 mg/30 mg/80 mg Soft Capsules National version: 03/2023 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Vinorelbine medac 20 mg Soft Capsules Vinorelbine medac 30 mg Soft Capsules Vinorelbine medac 80 mg Soft Capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each soft capsule contains vinorelbine tartrate equivalent to 20 mg vinorelbine Each soft capsule contains vinorelbine tartrate equivalent to 30 mg vinorelbine Each soft capsule contains vinorelbine tartrate equivalent to 80 mg vinorelbine Excipients with the known effect : Each soft capsule containing 20 mg vinorelbine contains 10.54 mg sorbitol. Each soft capsule containing 30 mg vinorelbine contains 15.96 mg sorbitol. Each soft capsule containing 80 mg vinorelbine contains 29.35 mg sorbitol. Each soft capsule containing 20 mg vinorelbine contains 5 mg ethanol. Each soft capsule containing 30 mg vinorelbine contains 7.5 mg ethanol. Each soft capsule containing 80 mg vinorelbine contains 20 mg ethanol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsules Soft 20 mg soft capsule: An oval-shaped light brown soft capsule with a size of 9.0 mm x 7.0 mm with black “20” printed on the surface 30 mg soft capsule: An oblong-shaped pink soft with a size of 15.0 mm x 6.0 mm capsule with black “30” printed on the surface 80 mg soft capsules: An oblong-shaped pale yellow soft capsule with a size of 20.0 mm x 8.0 mm with black “80” printed on the surface. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Non-small cell lung cancer Advanced Breast Cancer _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION IN ADULT PATIENTS - AS A SINGLE AGENT: the recommended regimen is: FIRST THREE ADMINISTRATIONS 60 mg/m² of body surface area, ADMINISTERED ONCE WEEKLY. SUBSEQUENT ADMINISTRATIONS Beyond the third administration, it is recommended to increase the dose of Vinorelbine medac to 80 mg/m² once weekly except in those patients for whom the neutrophil count dropped once belo Leia o documento completo