Țară: Regatul Unit
Limbă: engleză
Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)
Vindesine sulfate
Genus Pharmaceuticals Ltd
L01CA03
Vindesine sulfate
5mg
Powder for solution for injection
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010400; GTIN: 5030451002716
# PACKAGE LEAFLET: INFORMATION FOR THE USER ELDISINE * (Vindesine Sulphate) 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 any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. 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 Eldisine is and what it is used for 2. What you need to know before you use Eldisine 3. How to use Eldisine 4. Possible side-effects 5. How to store Eldisine 6. Contents of the pack and other information 1. WHAT ELDISINE IS AND WHAT IT IS USED FOR Eldisine contains vindesine sulphate. Eldisine is a cytotoxic medicine. Cytotoxic medicines kill cells which are dividing, including cancer cells. It is used to treat patients who have a cancer such as leukaemia, malignant melanoma (a type of skin cancer) or breast cancer. If your doctor gives you this medicine for anything else, ask him or her if you have any questions. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ELDISINE DO NOT USE ELDISINE IF YOU: • are ALLERGIC to vindesine sulphate or any of the other ingredients in Eldisine (see section 6 – Contents of the pack and other information) • suffer from any disease affecting the nerves or muscles (such as Charcot-Marie-Tooth syndrome) • have a bacterial infection. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Eldisine if you: • are having radiotherapy in the liver area • suffer from constipation • have liver trouble OTHER MEDICINES AND ELDISINE Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. • phenytoin for treating epilepsy • mitomycin PREGNANCY, BREAST-FEEDING AND FERTILITY Do not use Eldisine if you are pregnant or breast-feeding. If you Citiți documentul complet
OBJECT 1 ELDISINE POWDER FOR SOLUTION FOR INJECTION 5MG Summary of Product Characteristics Updated 26-Nov-2014 | Genus Pharmaceuticals 1. Name of the medicinal product Eldisine Powder for Solution for Injection 5.0 mg 2. Qualitative and quantitative composition Eldisine Powder 5mg contains 5mg vindesine sulphate per 5ml when reconstituted. For a full list of excipients, see section 6.1 3. Pharmaceutical form Powder for Solution for Injection A clear glass vial containing a lyophilised plug of white crystalline powder. 4. Clinical particulars 4.1 Therapeutic indications Eldisine is an anti-neoplastic drug for intravenous use which can be used alone or in combination with other oncolytic drugs. Information available at present suggests that Eldisine as a single agent may be useful for the treatment of: • acute lymphoblastic leukaemia of childhood resistant to other drugs; • blastic crises of chronic myeloid leukaemia; • malignant melanoma unresponsive to other forms of therapy; • advanced carcinoma of the breast, unresponsive to appropriate endocrine surgery and/or hormonal therapy. 4.2 Posology and method of administration This preparation is for intravenous use only. It should be administered only by individuals experienced in vindesine administration. FOR INTRAVENOUS USE ONLY - FATAL IF GIVEN BY OTHER ROUTES See special warnings in section 4.4 for the treatment of patients given intrathecal vindesine sulphate Extreme care must be used in calculating and administering the dose of vindesine, since overdosage may have a very serious or fatal outcome. It is recommended that the drug be administered intravenously in a single rapid bolus injection at weekly intervals. The size of the dose is determined by body surface area. In adults and the elderly, the recommended starting dose is 3mg/m 2 , and children may be started at 4mg/m 2 . Thereafter, granulocyte counts should be made prior to each subsequent dose to determine the patient's sensitivity to the drug. Provided there is no granulocytopenia or other toxic Citiți documentul complet