País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Vinorelbine tartrate
Accord Healthcare Ireland Ltd.
L01CA04
Vinorelbine tartrate
Capsule, soft
vinorelbine
Not marketed
2023-02-17
1 PACKAGE LEAFLET: INFORMATION FOR THE USER VINORELBINE ACCORD 20 MG SOFT CAPSULES VINORELBINE ACCORD 30 MG SOFT CAPSULES 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 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Vinorelbine Accord is and what it is used for 2. What you need to know before you take Vinorelbine Accord 3. How to take Vinorelbine Accord 4. Possible side effects 5. How to store Vinorelbine Accord 6. Contents of the pack and other information 1. WHAT VINORELBINE ACCORD IS AND WHAT IT IS USED FOR Vinorelbine Accord contains the active substance vinorelbine and belongs to a family of medicines called the vinca-alkaloid family, used to treat cancer. Vinorelbine Accord 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 ACCORD _ _ DO NOT TAKE VINORELBINE ACCORD - If you are allergic to vinorelbine, 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 where a part of your stomach or small bowel has been removed, or if you have gut disorder which affects how you absorb food. These may affect how your body absorbs Vinorelbine Accord. - 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 vaccinat Leer el documento completo
Health Products Regulatory Authority 18 May 2023 CRN00DJ8P Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vinorelbine Accord 20 mg soft capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each soft capsule contains vinorelbine tartrate equivalent to 20 mg vinorelbine. Excipients with known effect Each soft capsule contains 8.03 mg of sorbitol (as sorbitol liquid partially dehydrated) and 2.89 mg ethanol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Soft capsule Light brown, opaque, oval shaped (9.3 mm x 6.7 mm) soft gelatin capsule, free from surface defect, imprinted "JJ1" in black, containing a clear colourless liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vinorelbine Accord is indicated in adult patients for treatment of: - advanced non-small-cell lung cancer as monotherapy or in combination with other chemotherapy. - as adjuvant treatment of non-small-cell lung cancer in combination with platinum-based chemotherapy. - advanced breast cancer as monotherapy or in combination with other agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The use of soft capsules should be considered in cases where intravenous administration of vinorelbine is not possible (see section 4.4). Posology 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_ After the third administration, it is recommended to increase the dose of vinorelbine to 80 mg/m 2 once weekly except in those patients for whom the neutrophil count dropped once <500/mm 3 or more than once between 500 and 1,000/mm 3 during the first three administrations at 60 mg/m 2 . Neutrophil count during the first 3 administrations of 60 mg/m 2 /week Neutrophils>1,000 Neutrophils ≥500 and <1,000 (1 episode) Neutrophils ≥500 and <1,000 (2 episodes) Neutrophils <500 Recommended dose starting with the 4 th administration 80 80 60 60 _Dose modification_ Health Products Regulatory Auth Leer el documento completo