Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Actavis Group PTC ehf
25 Mg/Ml
Solution for Inj/Inf
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
Methotrexate 25 mg/ml Solution for Injection or Infusion PIL - UK / EIRE item no: AAAE0054 print proof no: 6 origination date: 03-07-12 originated by: BW revision date: 15.03.13 revised by: DR dimensions: 130x600 pharmacode: colours/plates: approved for print/date Non Printing Colours 1. Black 2. 3. 4. 5. 6. 1. 2. 3. date sent: 03-07-12 supplier: Sindan technically app. date: 03-07-12 min pt size: 9pt TECHNICAL APPROVAL ! 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 or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their sign of illness are the same as yours. • If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. • The full name of this medicine is Methotrexate 25mg/ml Solution for Injection or Infusion but within the leaflet it will be referred to as Methotrexate Solution. IN THIS LEAFLET: 1 WHAT METHOTREXATE SOLUTION IS AND WHAT IT IS USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU USE 3 HOW TO USE 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT METHOTREXATE SOLUTION IS AND WHAT IT IS USED FOR Methotrexate Solution is a substance with the following properties: • it interferes with the growth of tumour cells in the body that reproduce quickly (anti-tumour agent) • it reduces undesired reactions of the body’s own defence mechanism (immunosuppressant) • it has anti-inflammatory effects. Methotrexate Solution is used to treat cancer, such as: • lymphatic leukaemia (disease of the blood or bone marrow with increased number of white blood cells) • breast cancer • bone cancer (osteosarcoma) • head and neck canc Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Methotrexate 25mg/ml Solution for Injection or Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution for injection or infusion contains 25 mg methotrexate. 2 ml vial contains 50 mg methotrexate. 10 ml vial contains 250 mg methotrexate. 20 ml vial contains 500 mg methotrexate. 40 ml vial contains 1,000 mg methotrexate. Excipient with known effect: The medicinal product contains 4.425 mg/ml sodium (0.192 mmol/ml sodium). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection or infusion Clear, yellow solution, with pH approximately 8.5 (8.0-9.0) 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Methotrexate is used alone or in combination with other anticancer agents in the treatment of: - Acute lymphocytic leukaemias - Intermediate or high degree Non-Hodgkin's lymphomas in adults - Non-Hodgkin's lymphomas in paediatric patients - Metastatic or recurrent head and neck cancer - Adjuvant treatment of breast cancer after tumour resection or mastectomy - Advanced breast cancer - Choriocarcinoma and other trophoblastic tumors (in monotherapy in patients at low risk or in combination therapy in patients at high risk) - Adjuvant and neoadjuvant therapy of osteosarcoma 4.2 POSOLOGY AND METHOD OF ADMINISTRATION WARNINGS The DOSE MUST BE ADJUSTED CAREFULLY depending on the body surface area if methotrexate is used for the treatment of TUMOUR DISEASES. Fatal cases of intoxication have been reported after administration of INCORRECT CALCULATED doses. Methotrexate can be given intramuscularly, intravenously, intraarterially and intrathecally. The dose is usually calculated per m 2 body surface area (BSA). Methotrexate 25 mg/ml solution for injection or infusion should only be applied by ph Lire le document complet