Country: Malta
Language: English
Source: Medicines Authority
VINCRISTINE SULFATE
Hospira UK Limited
L01CA02
VINCRISTINE SULFATE
SOLUTION FOR INJECTION
VINCRISTINE SULFATE 1 mg
POM
ANTINEOPLASTIC AGENTS
Authorised
2007-05-07
PACKAGE LEAFLET: INFORMATION FOR THE USER VINCRISTINE SULPHATE 1 MG/ML INJECTION (1 mg/1 ml and 2 mg/2 ml vials) 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 any further questions, ask your doctor. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. IN THIS LEAFLET: 1. What Vincristine Sulphate Injection is and what it is used for 2. Before you use Vincristine Sulphate Injection 3. How to use Vincristine Sulphate Injection 4. Possible side effects 5. How to store Vincristine Sulphate Injection 6. Further information 1. WHAT VINCRISTINE SULPHATE INJECTION IS AND WHAT IT IS USED FOR Vincristine sulphate is an anti-cancer medicine. Treatment with an anti-cancer medicine is sometimes called cancer chemotherapy. Vincristine Sulphate Injection is used in the treatment of cancers of the blood (eg. leukaemia or lymphomas), breast, head and neck or lung. It may be used to treat multiple myeloma (a cancer of plasma cells) and it may also be used in the treatment of some cancers in children. It may be used in a blood disorder known as idiopathic thrombocytopenic purpura (ITP) after other treatments have not been successful. Vincristine Sulphate Injection may be given alone or in combination with other anti- cancer medicines. 2. BEFORE YOU USE VINCRISTINE SULPHATE INJECTION VINCRISTINE SULPHATE INJECTION MUST NEVER BE INJECTED INTRATHECALLY (INTO THE SPINE). DO NOT USE VINCRISTINE SULPHATE INJECTION if you have shown signs of hypersensitivity (severe allergy) to vincristine or mannitol in the past if you have Charcot-Marie-Tooth syndrome (disease which causes weakness in the leg muscles) if you have an infection that is not being treated Tell your doctor if any of the above applies to you before this medicine is used. TAKE SPECIAL CARE WITH VINCRISTINE SULPHATE INJECTION to make sure that this medicine is only given to you through a v Read the complete document
Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Vincristine Sulphate 1 mg/ml Injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml contains 1.0 mg of vincristine sulphate Each 1 ml presentation contains 1 mg of vincristine sulphate Each 2 ml presentation contains 2 mg of vincristine sulphate For excipients, see 6.1 3. PHARMACEUTICAL FORM Solution for injection A sterile, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vincristine sulphate is used either alone or in conjunction with other oncolytic drugs for the treatment of: 1. Leukaemias, including acute lymphocytic leukaemia, chronic lymphocytic leukaemia, acute myelogenous leukaemia and blastic crisis of chronic myelogenous leukaemia. 2. Malignant lymphomas, including Hodgkin's disease and non-Hodgkin's lymphomas. 3. Multiple myeloma. 4. Solid tumours, including breast carcinoma, small cell bronchogenic carcinoma, head and neck carcinoma and soft tissue sarcomas. 5. Paediatric solid tumours, including Ewing's sarcoma, embryonal rhabdomyosarcoma, neuroblastoma, Wilms' tumour, retinoblastoma and medulloblastoma. 6. Idiopathic thrombocytopenic purpura. Patients with true ITP refractory to splenectomy and short-term treatment with adrenocortical steroids may respond to vincristine but the medicinal product is not recommended as primary treatment of this disorder. Recommended weekly doses of vincristine given for 3 to 4 weeks have produced permanent remissions in some patients. If patients fail to respond after 3 to 6 doses, it is unlikely that there will be any beneficial results with additional doses. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION This preparation is for intravenous use only. It should only be administered by individuals experienced in vincristine administration. Page 2 of 10 FOR INTRAVENOUS USE ONLY FATAL IF GIVEN BY ANY OTHER ROUTE See Section 4.4 Special warnings and precautions for use for the treatment of patients given intrathecal vincristine sulphate. Vincristine sulphate is a Read the complete document