País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
VINBLASTINE SULFATE
Pfizer Healthcare Ireland
L01CA; L01CA01
VINBLASTINE SULFATE
1 milligram(s)/millilitre
Solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Vinca alkaloids and analogues; vinblastine
Marketed
1990-10-15
Page 1 of 7 2021-0073400 PACKAGE LEAFLET: INFORMATION FOR THE USER VINBLASTINE SULFATE 1 MG/ML SOLUTION FOR INJECTION OR INFUSION vinblastine 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 Vinblastine Sulfate is and what it is used for 2. What you need to know before you use Vinblastine Sulfate 3. How to use Vinblastine Sulfate 4. Possible side effects 5. How to store Vinblastine Sulfate 6. Contents of the pack and other information 1. WHAT VINBLASTINE SULFATE IS AND WHAT IT IS USED FOR Vinblastine Sulfate is a vinca alkaloid which is an anti-cancer medicine. Treatment with an anti- cancer medicine is sometimes called cancer chemotherapy. Vinblastine Sulfate is sometimes used in the treatment of cancers of the lymph nodes, spleen, bone marrow, testicles, ovaries, skin and breast. It may be given alone or in combination with other anti- cancer medicines. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE VINBLASTINE SULFATE VINBLASTINE SULFATE MUST NEVER BE INJECTED INTRAMUSCULARLY, SUBCUTANEOUSLY OR INTRATHECALLY (INTO THE SPINE). VINBLASTINE SULFATE IS FOR INTRAVENOUS USE ONLY. DO NOT USE VINBLASTINE SULFATE • if you are allergic to vinblastine sulfate or any of the other ingredients of this medicine (listed in section 6). • if your blood tests show that you do not have enough white blood cells to fight infection (unless this is a result of your condition) • if you have a bacterial infection which is not under control WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using vinblastine sulfate • if you are an elderly patient in poor health or with skin sores • if you have liver disease, inclu Llegiu el document complet
Health Products Regulatory Authority 13 October 2023 CRN00DT17 Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vinblastine Sulfate 1mg/ml Solution for Injection or Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml contains 1.0 mg vinblastine sulfate Each 10 ml vial contains 10 mg of vinblastine sulfate Excipient(s) with known effect: Vinblastine Sulfate 1 mg/ml solution for injection or infusion contains 35.42 mg sodium in each 10 ml vial. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection/infusion. A clear, colourless, sterile solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vinblastine Sulfate is used either alone or in combination with other neoplastic agents, in the treatment of Hodgkin's Disease (Stages III and IV); lymphocytic lymphoma (nodular and diffuse, poorly and well differentiated); histiocytic lymphoma; advanced stages of mycosis fungoides; advanced carcinoma of the testis; Kaposi's sarcoma and Letterer-Siwe disease (histocytosis X). Vinblastine Sulfate may be used in the treatment of choriocarcinoma resistant to other chemotherapeutic agents; carcinoma of the breast, unresponsive to appropriate endocrine surgery and hormonal therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION FOR INTRAVENOUS USE ONLY. FATAL IF GIVEN BY OTHER ROUTES (see section 4.4) IN CASE OF MISTAKEN ADMINISTRATION BY THE INTRATHECAL ROUTE, SEE SECTION 4.4. Posology Vinblastine Sulfate is given intravenously at weekly intervals according to the needs of the patient. Therapy is initiated by a single intravenous dose in accordance with the following dosage table, and white blood cell counts should be made to determine the sensitivity of the patient to vinblastine. Dosage should not be increased after that dose which reduces the white cell count to approximately 3000 cells/mm 3 . Adults mg/m 2 bsa Children mg/m 2 bsa First Dose 3.7 2.5 Second Dose 5.5 3.75 Third Dose 7.4 5.0 Fourth Dose 9.25 6.25 Fifth Dose 11.1 7.5 Dosage increase may Llegiu el document complet