Země: Malta
Jazyk: angličtina
Zdroj: Medicines Authority
VINORELBINE TARTRATE
Lotus Support Services S.R.L. 47 Theodor Pallady Blvd. 2nd Office, Entrance B, 1st Floor 3rd District Bucharest, Romania
L01CA04
VINORELBINE TARTRATE 80 mg
SOFT CAPSULE
VINORELBINE TARTRATE 80 mg
POM
ANTINEOPLASTIC AGENTS
Licence number in the source country: NOT APPLICAPABLE
Withdrawn
2021-03-22
1 PACKAGE LEAFLET Page 2 of 7 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Vinorelbine Lotus 20 mg soft capsule Vinorelbine Lotus 30 mg soft capsule Vinorelbine Lotus 80 mg 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 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 Lotus is and what it is used for 2. What you need to know before you take Vinorelbine Lotus 3. How to take Vinorelbine Lotus 4. Possible side effects 5. How to store Vinorelbine Lotus 6. Contents of the pack and other information 1. WHAT VINORELBINE LOTUS IS AND WHAT IT IS USED FOR Vinorelbine Lotus contains the active substance vinorelbine (as tartrate), and belongs to a family of medicines used to treat cancer called the vinca-alkaloid family. Vinorelbine is used to treat specific types of lung cancer and specific types of breast cancer in patients older than 18 years of age. Your doctor may prescribe this medicine for any other disease or dose other than this leaflet. Always follow your doctor’s or pharmacist’s instructions 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VINORELBINE LOTUS DO NOT TAKE VINORELBINE LOTUS: - 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 on your stomach or small bowel, or if you have gut disorder - If you have a low white blood cell and/or blood platelets count or a severe infection current or recent within Přečtěte si celý dokument
1 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 13 1. NAME OF THE MEDICINAL PRODUCT Vinorelbine Lotus 20 mg soft capsule Vinorelbine Lotus 30 mg soft capsule Vinorelbine Lotus 80 mg soft capsule 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each soft capsule contains vinorelbine tartrate 27.70 mg equivalent to 20 mg vinorelbine. Each soft capsule contains vinorelbine tartrate 41.55 mg equivalent to 30 mg vinorelbine. Each soft capsule contains vinorelbine tartrate 110.80 mg equivalent to 80 mg vinorelbine. Excipient with known effect Each soft capsule containing 20 mg vinorelbine contains 38.44 mg sorbitol. Each soft capsule containing 30 mg vinorelbine contains 59.85 mg sorbitol. Each soft capsule containing 80 mg vinorelbine contains 99.91 mg sorbitol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Soft capsule Vinorelbine Lotus 20 mg soft capsule: An oval-shaped light brown soft capsule with a size of 11x7 mm filled with a transparent, colour less to slightly yellow liquid. Vinorelbine Lotus 30 mg soft capsule: An oblong-shaped pink soft capsule with a size of 18x6 mm filled with a transparent, colourless to slightly yellow liquid. Vinorelbine Lotus 80 mg soft capsule: An oblong-shaped pale yellow soft capsule with a size of 21x8 mm filled with a transparent, colourless to slightly yellow liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adult patients with non-small cell lung cancer. Adult patients with advanced breast cancer, when other therapies are not an option. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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/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 1,000/mm 3 during the first three administrations at 60 mg/m Přečtěte si celý dokument