Țară: Malta
Limbă: engleză
Sursă: Medicines Authority
PharmSol Europe Limited The Victoria Centre Unit 2, Lower Ground Floor, Valletta Road, Mosta MST 9012 , Malta
L01CA04
VINORELBINE 20 mg
SOFT CAPSULE
VINORELBINE 20 mg
POM
ANTINEOPLASTIC AGENTS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2022-03-08
PACKAGE LEAFLET: INFORMATION FOR THE USER VINORELBINE PHARMSOL 20 MG SOFT CAPSULES VINORELBINE PHARMSOL 30 MG SOFT CAPSULES VINORELBINE PHARMSOL 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 PharmSol is and what it is used for 2. What you need to know before you take Vinorelbine PharmSol 3. How to take Vinorelbine PharmSol 4. Possible side effects 5. How to store Vinorelbine PharmSol 6. Content of the pack and other information 1. WHAT VINORELBINE PHARMSOL IS AND WHAT IT IS USED FOR Vinorelbine PharmSol contains the active substance Vinorelbine and belongs to a family of medicines called the vinca alkaloid, family used to treat cancer. Vinorelbine PharmSol 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 PHARMSOL DO NOT TAKE VINORELBINE PHARMSOL : - 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 oxygen therapy WARNING AND PRECAUTIONS Talk to your doctor or pharmacist b Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Vinorelbine PharmSol 20 mg Soft Capsules Vinorelbine PharmSol 30 mg Soft Capsules Vinorelbine PharmSol 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 a 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 9.0mm x 7.0mm with black “20” printed on the surface 30 mg soft capsule: An oblong-shaped pink soft with a size of 15.0mm x 6.0mm capsule with black “30” printed on the surface 80 mg soft capsules: An oblong-shaped pale yellow soft capsule with a size of 20.0mm x 8.0mm 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 PharmSol to 80 mg/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 60 mg/ Citiți documentul complet