البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)
Vinorelbine tartrate
Pierre Fabre Ltd
L01CA04
Vinorelbine tartrate
10mg/1ml
Solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010400; GTIN: 3573991467345
PACKAGE LEAFLET: INFORMATION FOR THE USER NAVELBINE 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION Vinorelbine (as tartrate) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor or your pharmacist. • 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 is and what it is used for 2. Before you use Navelbine 3. How to use Navelbine 4. Possible side effects 5. How to store Navelbine 6. Further information 1. WHAT NAVELBINE 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 some types of lung and breast cancer in patients over 18 years of age: 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 USE NAVELBINE DO NOT USE NAVELBINE • If you are allergic (hypersensitive) to the active substance (vinorelbine), or to any of the related family of cancer drugs called the vinca alkaloids, • If you are allergic to any of the other ingredients of Navelbine (refer to section 6 in this leaflet), • If you are pregnant or think that you might be pregnant, • If you are breast feeding, • If you have a low white blood cell (neutrophils, leucocyte) count or a severe infection current or recent (within 2 weeks), • If you have a low platelet count (thrombocytopenia), • If you plan to receive a yellow fever vaccination or have just received one. TAKE SPECIAL CARE WITH NAVELBINE Please inform your doctor if: • you have a history of heart attack or severe chest pain, • you have problems with your liver or you have received radiotherapy where the treatment field included the liver, • you have signs or symptoms of infection (such as fever, chills, joi اقرأ الوثيقة كاملة
OBJECT 1 NAVELBINE 10 MG / ML CONCENTRATE FOR SOLUTION FOR INFUSION Summary of Product Characteristics Updated 04-Jul-2017 | Pierre Fabre Limited 1. Name of the medicinal product NAVELBINE ® 10 mg/ml concentrate for solution for infusion 2. Qualitative and quantitative composition Vinorelbine 10 mg/ml as vinorelbine tartrate Each 1ml vial contains 10 mg Vinorelbine as vinorelbine tartrate Each 4ml vial contains 40 mg Vinorelbine as vinorelbine tartrate Each 5ml vial contains 50 mg Vinorelbine as vinorelbine tartrate For a full list of excipients, see section 6.1 3. Pharmaceutical form Concentrate for solution for infusion. Navelbine is a clear colourless to pale yellow solution with a pH range from 3.3 to 3.8. 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. - 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 Strictly intravenous administration after appropriate dilution Intra-thecal administration of Navelbine may be fatal. Navelbine must only be administered by the intravenous route as an infusion over 6 – 10 minutes. Instructions for use and handling: see section 6.6. ADMINISTRATION - It is recommended to infuse Navelbine over 6 to 10 minutes after dilution in a 50 ml infusion bag with sodium chloride 9 mg/ml (0.9%) solution for injection or in 5% glucose solution for injection. - Administration should always be followed with at least 250 ml of a normal saline infusion to flush the vein. - The infusion time of 6 to 10 minutes must be followed as the risk of venous irritation is increased if the infusion exposure time is increased. - It is vital to ensure that the cannula is accurately placed in the vein before starting to infuse Navelbine. If the drug extravasates into the surrounding tissue during the administration considerable local irritation may occur. In this case, the administra اقرأ الوثيقة كاملة