Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Vinorelbine tartrate
Pierre Fabre Ltd
L01CA04
Vinorelbine tartrate
80mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010400; GTIN: 3573994000600
UK Navelbine 20mg, 30mg, 80mg soft capsule: PL 00603/0029; PL 00603/0030; PL 00603/0032 Date last approved: Dec 2016 PL 00603/0029 - 0072; PL 00603/0030 – 0073; PL 00603/0032 - 0075 PACKAGE LEAFLET: INFORMATION FOR THE USER NAVELBINE 20MG SOFT CAPSULE NAVELBINE 30MG SOFT CAPSULE NAVELBINE 80MG SOFT CAPSULE Vinorelbine as tartrate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have further questions, ask your doctor or your pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET : 1. What Navelbine soft capsule is and what it is used for 2. Before you take Navelbine soft capsule 3. How to take Navelbine soft capsule 4. Possible side effects 5 Storing Navelbine soft capsule 6. Further information. 1. WHAT NAVELBINE SOFT CAPSULE IS AND WHAT IT IS USED FOR Navelbine belongs to a family of medicines used to treat cancer called the vinca-alkaloid family. Navelbine is used to treat: o Non-small cell lung cancer o Advanced breast cancer that has not responded to other medicines. It is NOT recommended for use by children under 18 years old. 2. BEFORE YOU TAKE NAVELBINE SOFT CAPSULE DO NOT TAKE NAVELBINE SOFT CAPSULE • If you are allergic (hypersensitive) to the active ingredient, vinorelbine, or any of the related family of cancer drugs called the vinca alkaloids. • If you are allergic to any of the other ingredients in Navelbine capsules (refer to section 6 of this leaflet). • If you are pregnant or think that you might be pregnant. • If you are breast feeding. • If you have a severe liver disease. • If you have had an operation on your stomach or small bowel, or if you have gut disorder which affects how you absorb food. These may affect how your body absorbs Nav Read the complete document
OBJECT 1 NAVELBINE 80MG SOFT CAPSULE Summary of Product Characteristics Updated 20-Apr-2017 | Pierre Fabre Limited 1. Name of the medicinal product NAVELBINE ® 80 mg soft capsule 2. Qualitative and quantitative composition Each soft capsule contains 80mg vinorelbine as tartrate For a full list of excipients, see section 6.1 3. Pharmaceutical form Soft capsule. Pale yellow soft capsule printed N80. 4. Clinical particulars 4.1 Therapeutic indications As a single agent or in combination for: • The first line treatment of stage 3 or 4 non small cell lung cancer. • The treatment of advanced breast cancer stage 3 and 4 relapsing after or refractory to an anthracycline containing regimen. 4.2 Posology and method of administration IN ADULT PATIENTS AS A SINGLE AGENT, the recommended regimen is: FIRST THREE ADMINISTRATIONS 60mg/m² of body surface area, administered once weekly SUBSEQUENT ADMINISTRATIONS Beyond the third administration, it is recommended to increase the dose of Navelbine to 80mg/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 60mg/m². Neutrophil count during the first 3 administrations of 60 mg/m 2 /week Neutrophils > 1000 Neutrophils ≥ 500 and < 1000 Neutrophils ≥ 500 and < 1000 Neutrophils < 500 (1 episode) (2 episodes) Recommended dose starting with the 4 th administration 80 80 60 60 DOSE MODIFICATION For any administration planned to be given at 80mg/m², if the neutrophil count is below 500/mm 3 or more than once between 500 and 1000 / mm 3 the administration should be delayed until recovery and the dose reduced from 80 to 60mg/m 2 per week during the 3 following administrations. If the neutrophil count is below 1500 /mm 3 and/or the platelet count below 100000/mm 3 , then the treatment should be delayed until recovery. Neutrophil count beyond the 4 th administration of 80 mg/m 2 /week Neutrophils > 1000 Neutrophils ≥ 500 and < 1000 (1 episode) Neutroph Read the complete document