Country: Malta
Language: English
Source: Medicines Authority
VINCRISTINE SULFATE
Pfizer Hellas S.A. 243 Messoghion Ave., Neo Psychiko 15451, Athens, Greece
L01CA02
VINCRISTINE SULFATE 1 mg/ml
SOLUTION FOR INFUSION OR INJECTION
VINCRISTINE SULFATE 1 mg/ml
POM
ANTINEOPLASTIC AGENTS
Authorised
2007-05-07
Page 1 of 9 2021-0073475 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VINCRISTINE SULFATE 1 MG/ML SOLUTION FOR INJECTION OR INFUSION vincristine sulfate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, pharmacist or nurse. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Vincristine Sulfate is and what it is used for 2. What you need to know before you use Vincristine Sulfate 3. How to use Vincristine Sulfate 4. Possible side effects 5. How to store Vincristine Sulfate 6. Contents of the pack and other information 1. WHAT VINCRISTINE SULFATE IS AND WHAT IT IS USED FOR Vincristine Sulfate is an anti-cancer medicine in the form of a solution for injection or infusion. Treatment with an anti-cancer medicine is sometimes called cancer chemotherapy. Vincristine Sulfate is mainly used in the treatment of cancers of the blood (leukaemia). It may also be given in combination with other anti-cancer medicines to treat other types of cancer, for example cancers of the breast, brain or lung and some cancers in children. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE VINCRISTINE SULFATE VINCRISTINE SULFATE MUST NEVER BE INJECTED INTO THE SPINE (INTRATHECALLY). DO NOT USE VINCRISTINE SULFATE if you are allergic to Vincristine Sulfate or any of the other ingredients of this medicine (listed in section 6) if you have Charcot-Marie-Tooth syndrome (weakness in the leg muscles) if you have an infection that is not being treated for treatment of diseases that are not cancers, except for using to reduce your immune response WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using Vincristine Sulfate TO MAKE SURE THAT THIS MEDICINE IS ONLY GIVEN TO YOU THROUGH A VEIN EITHER BY INTR Read the complete document
Page 1 of 15 2022-0078751 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Vincristine Sulfate 1 mg/ml Solution for Injection or Infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml contains 1 mg of vincristine sulfate. Each 2 ml contains 2 mg of vincristine sulfate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection/infusion A sterile colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vincristine Sulfate is used primarily as a component of various chemotherapeutic regimens for the treatment of acute leukaemias. It has also been used in conjunction with other oncolytic drugs in the treatment of Hodgkin's Disease, all forms of lymphoma, Wilm's tumour, sarcomas and tumours of the breast, brain and lung. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The following dosage regimens have been used: Acute Leukaemia ADULTS: The suggested dose is 1.4 - 1.5 mg/m 2 given on a weekly basis to a maximum weekly total dose of 2 mg. The dosage must always be adjusted individually because of the narrow range between therapeutic and toxic levels, and individual variations in response. CHILDREN: The suggested dose is 1.4 – 2.0 mg/m 2 given on a weekly basis beginning with the lowest dose in the range with a maximum weekly dose of 2 mg. For children weighing 10 kg or less, the starting dose should be 0.05 mg/kg, administered once a week. Page 2 of 15 2022-0078751 Once the remission has occurred, dosage may often be reduced for maintenance therapy. Other Tumours 25 micrograms/kg body weight weekly until a response is observed and 5-10 micrograms/kg body weight thereafter for maintenance. Use in the elderly As for use in adults. Use in hepatic impairment A 50% reduction in the dose of vincristine sulfate is recommended for patients having a direct serum bilirubin value above 3 mg/100 ml (51 micromol/l) (see section 4.4). Method of administration Precautions to be taken before handling or administering the medicinal product. This prepa Read the complete document