País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
VINBLASTINE SULFATE
Hospira UK Limited
L01CA01
VINBLASTINE SULFATE
1 Mg/Ml
Solution for Inj/Inf
Product subject to prescription which may not be renewed (A)
Vinca alkaloids and analogues
Authorised
1990-10-15
0004120-MC03 Black: COMPONENT SPECIFICATION Item number: 0004120-MC03 Request number: PAR-2016-0004120 Country: Ireland I have checked this artwork against the registered text including spelling, layout, size, colours, registration numbers and scientific equations, the name and address and trademarks. Also for any possible changes to related items. This artwork is in conformance with the Marketing Authorisation and can now proceed to the printing stage. Previous Item Number: Signed: Date: VERSION 1 Technician: COD Date: 09/Jun/16 VERSION 2 Technician: BC Date: 08/Sep/16 VERSION 3 Technician: BR Date: 13/Sep/16 VERSION 4 Technician: CS Date: 17/Oct/16 VERSION 5 Technician: XX Date: dd/mmm/yy VERSION 6 Technician: XX Date: dd/mmm/yy VERSION 7 Technician: XX Date: dd/mmm/yy VERSION 8 Technician: XX Date: dd/mmm/yy VERSION 9 Technician: XX Date: dd/mmm/yy VERSION 10 Technician: XX Date: dd/mmm/yy OI template: Amalia version: Mulgrave version: SVI007 1 n/a Dimensions: Container(s): Supplier: Stock: Folded dimensions: Printed both sides: Perforated: 118 x 570 mm (20 panels) vial EU Packing Centre 40 gsm 28.5 x 118 mm Yes No Pharma code: Pharma code length: Supplier Code: n/a n/a n/a COLOURS REQUESTER 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. • 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 Vinblastine Sulfate is and what it is used for 2. 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 an a Llegiu el document complet
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 of Vinblastine Sulfate. Each 10ml vial contains 10 mg of Vinblastine Sulfate. Excipient(s) with known effect: Each 10ml vial contains approximately 35mg (1.5mmol) sodium 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 IN CASE OF MISTAKEN ADMINISTRATION BY THE INTRATHECAL ROUTE, SEE SECTION 4.4. It is recommended to infuse Vinblastine Sulfate over 5 to 10 minutes after dilution in Sodium Chloride 0.9% to a final volume of 50 ml to 100 ml with a final concentration between 0.04 and 0.4mg/ml. Alternatively, Vinblastine Sulfate may be injected directly into a vein over about one minute. Syringes containing this product should be overlabelled with the warning label provided: 'FOR INTRAVENOUS USE ONLY. FATAL IF GIVEN BY OTHER ROUTES'. DOSAGE 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. FOR INTRAVENOUS USE ONLY. FA Llegiu el document complet