Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Vinorelbine
Pierre Fabre Medicament
L01CA; L01CA04
Vinorelbine
10 milligram(s)/millilitre
Concentrate for solution for infusion
Vinca alkaloids and analogues; vinorelbine
Not marketed
1996-06-26
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 ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have further question, ask your doctor or your pharmacist. • If you get any of the side effects, talk to your doctor or pharmacist. This includes and possible side effect not listed in this leaflet; see section 4. WHAT IS IN THIS LEAFLET 1. What Navelbine is and what it is used for 2. What you need to know before you are given Navelbine 3. How Navelbine is given 4. Possible side effects 5. How to store Navelbine 6. Contents of the pack and other information 1. WHAT NAVELBINE IS AND WHAT IT IS USED FOR Navelbine contains the active substance Vinorelbine (as tartrate) and belongs to a family of medicines called the vinca-alkaloid family, used to treat cancer. Navelbine 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 ARE GIVEN NAVELBINE DO NOT USE NAVELBINE • If you are allergic to Vinorelbine, or 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 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. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before you are given Navelbine 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, joint pain, cough), • you plan to have a vacci Olvassa el a teljes dokumentumot
Health Products Regulatory Authority 08 January 2024 CRN00DLJQ Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 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 the 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 of 3.3 – 3.8 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vinorelbine is indicated in adult patients for treatment of: advanced non-small-cell lung cancer as monotherapy or in combination with other chemotherapy as adjuvant treatment of non-small-cell lung cancer in combination with platinum-based chemotherapy advanced breast cancer as monotherapy or in combination with other agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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. - 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. - Administration should always be followed with at least 250 ml of a normal saline infusion to flush the vein to avoid the risk of venous irritation. - 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 Olvassa el a teljes dokumentumot