Země: Malajsie
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
VINORELBINE TARTRATE
Orient Europharma (M) Sdn Bhd
VINORELBINE TARTRATE
1Capsule Capsules
FAREVA PAU 1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ ______________________________________________________________________________ 1 NAVELBINE SOFT CAPSULE Vinorelbine Tartrate (20mg, 30mg) ________________________________________________________________________________________________________ WHAT IS IN THIS LEAFLET 1. What _Navelbine Soft Capsule_ is used for 2. How _Navelbine Soft Capsule_ works 3. Before you use _Navelbine _ _Soft Capsule _ 4. How to use _Navelbine Soft _ _Capsule_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Navelbine Soft Capsule_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _NAVELBINE SOFT CAPSULE_ IS USED FOR Navelbine is used to treat non-small cell lung cancer and advanced breast cancer. HOW _NAVELBINE SOFT CAPSULE _WORKS Navelbine belongs to a family of medicines called the vinca alkaloid Navelbine is an antimitotic agent, causing cell death by blocking cell division BEFORE YOU USE _NAVELBINE SOFT _ _CAPSULE _ _-When you must not use it: _ - If you are allergic (hypersensitive) to vinorelbine (active ingredient), or any of the related group of cancer drugs called the vinca-alkaloids - If you are allergic to any other ingredients of Navelbine (refer to section ‘Ingredients’ in this leaflet) - If you have had an operation on your stomach or small bowel, or if you have intestinal disorders, or if you present disorder affecting absorption - If you have a low white blood cell count (leukocytes and/or neutrophils) or a severe infection currently or recently (within 2 weeks) - If you have a low platelet count - If you require long-term oxygen therapy - If you are breast feeding - If you plan to have a yellow fever vaccine or have just had one _-Before you start to use it: _ Please inform your doctor if: - You have a history of heart attack or severe chest pain - Your ability to carry out activities of daily living is strongly reduced - You have received radiotherapy treatment involving the liver - You have symptom Přečtěte si celý dokument
PACKAGE INSERT 1- NAME OF THE MEDICINAL PRODUCT NAVELBINE ® 20 mg soft capsule NAVELBINE ® 30 mg soft capsule 2- QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE INGREDIENT FORMULATION 20 mg 30 mg Vinorelbine tartrate (mg) 27.70 41.55 Equivalent to vinorelbine (INN) base (mg) 20 30 Each dose of 20 mg soft capsule contains: ethanol (alcohol) 5 mg, sorbitol (E420) 5,36 mg. Each dose of 30 mg soft capsule contains: ethanol (alcohol) 7,5 mg, sorbitol (E420) 8,11 mg. For excipients, refer to section 6.1. 3- PHARMACEUTICAL FORM SOFT CAPSULE 20 mg soft capsule: light brown soft capsule printed N20 30 mg soft capsule: pink soft capsule printed N30 4- CLINICAL PARTICULARS 4.1- Therapeutic indications For treatment of Non-small cell lung cancer / Advanced Breast Cancer 4.2- Posology and method of administration Navelbine ® soft capsules must be given strictly by the oral route. Navelbine ® soft capsules should be swallowed with water without chewing or sucking the capsule. It is recommended to take the capsule with some food. As a single agent: The recommended regimen is: First three administrations 60 mg/m 2 of body surface area, administered once weekly. Subsequent administrations Beyond the third administration, it is recommended to increase the dose of Navelbine ® soft capsules 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 2 . Neutrophil count during the first 3 administrations of 60 mg/m² /week Neutro- phils > 1000 Neutrophils ≥ 500 and < 1000 (1 episode) Neutrophils ≥ 500 and < 1000 (2 episodes) Neutro- phils < 500 Recommended dose Starting with the 4 th administration 80 80 60 60 Dose modification For any administration planned to be given at 80 mg/m 2 , if the neutrophil count is below 500/mm 3 , the administration should be delayed until recovery and the dose reduced from 80 to 60 mg/m 2 per week during the 3 following administrations. Neutrophil coun Přečtěte si celý dokument