Krajina: Malta
Jazyk: angličtina
Zdroj: Malta Medicines Authority
METHOTREXATE
Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland
L01BA01
METHOTREXATE 100 mg/ml
CONCENTRATE FOR SOLUTION FOR INFUSION
METHOTREXATE 100 mg/ml
POM
ANTINEOPLASTIC AGENTS
Withdrawn
2014-07-15
1 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ METHOTREXATE 100 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION Methotrexate 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 or nurse. - 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, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. _ _ WHAT IS IN THIS LEAFLET : 1. What Methotrexate 100 mg/ml is and what it is used for 2. What you need to know before you use Methotrexate 100 mg/ml 3. How to use Methotrexate 100 mg/ml 4. Possible side effects 5. How to store Methotrexate 100 mg/ml 6. Contents of the pack and other information 1. WHAT METHOTREXATE 100 MG/ML IS AND WHAT IT IS USED FOR Methotrexate 100 mg/ml contains the active substance methotrexate. Methotrexate is a cytostatic that inhibits cell growth. Methotrexate has its greatest effect on cells which increase frequently like cancer cells, bone marrow cells and skin cells. Methotrexate 100 mg/ml is used in the treatment of the following types of cancer: - acute lymphocytic leukaemia, - non-Hodgkin’s lymphomas, - osteogenic sarcoma, - adjuvant and in advance disease of breast cancer, - metastatic or recurrent head and neck cancer, - choriocarcinoma and similar trophoblastic diseases, - advanced cancer of urinary bladder. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE METHOTREXATE 100 MG/ML _ _ DO NOT USE Methotrexate 100 mg/ml - If you are allergic (hypersensitive) to methotrexate or any of the other ingredients of this medicine (listed in section 6). - If you have severe liver or kidney disease . - If you have increased alcohol consumption. - If you have disorders of the blood-forming system. - If you have severe or existin Prečítajte si celý dokument
Page 1 of 19 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Methotrexate 100 mg/ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITIONS Each ml contains 100 mg methotrexate. 5 ml of solution contains 500 mg methotrexate. 10 ml of solution contains 1000 mg methotrexate. 50 ml of solution contains 5000 mg methotrexate. Excipients with known effect: 10.60 mg/ml (0.461 mmol/ml) sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion Clear, yellow solution with pH 7.0 to 9.0. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acute lymphocytic leukaemia, Non-Hodgkin’s lymphomas, osteogenic sarcoma, adjuvant and in advance disease of breast cancer, metastatic or recurrent head and neck cancer, choriocarcinoma and similar trophoblastic diseases, advanced cancer of urinary bladder. 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. Health care professionals and patients should be fully informed about toxic effects. Methotrexate Accord 100mg/ml is hypertonic and must not be administered intrathecally. Method of administration: Treatment should be initiated by or occur in consultation with a doctor with significant experience in cytostatic treatment. Methotrexate can be administered intramuscularly, intravenously or intra-arterial. Methotrexate Accord 100mg/ml is hypertonic and must not be administered intrathecally. The dosage is generally calculated per m 2 body surface area or body weight. Doses of over 100 mg methotrexate always require subsequent administration of folinic acid (See calcium folinate rescue). Page 2 of 19 The application and dosage recommendation for the administration of methotrexate for different indications varies considerably. Some common dosages which have Prečítajte si celý dokument