البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)
Methotrexate sodium
Pfizer Ltd
L01BA01
Methotrexate sodium
25mg/1ml
Solution for injection
Intramuscular; Intraarterial; Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010300; GTIN: 5015997441151
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER METHOTREXATE 25 MG/ML INJECTION 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 or pharmacist. 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 Methotrexate Injection is and what it is used for 2. Before you are given Methotrexate Injection 3. How you are given Methotrexate Injection 4. Possible side effects 5. How to store Methotrexate Injection 6. Further information 1. WHAT METHOTREXATE INJECTION IS AND WHAT IT IS USED FOR Methotrexate Injection is an anti-metabolite medicine (medicine which affects how the body’s cells grow) and immunosuppressant (medicine which reduces the activity of the immune system). Methotrexate is used in large doses (on its own or in combination with other medicines) to treat certain types of cancer such as breast cancer. In smaller doses it can be used to treat severe psoriasis (a skin disease with thickened patches of inflamed red skin, often covered by silvery scales), when it has not responded to other treatments. 2. BEFORE YOU ARE GIVEN METHOTREXATE INJECTION YOU WILL NOT BE GIVEN METHOTREXATE INJECTION IF YOU ARE ALLERGIC (HYPERSENSITIVE) TO METHOTREXATE OR ANY OF THE OTHER INGREDIENTS OF METHOTREXATE INJECTION have significant kidney or liver problems have been told you have (or think you have) a blood disorder such as low levels of white blood cells, red blood cells (anaemia) or platelets have any infection your immune system is not working as well as it should Tell your doctor if any of the above applies to you before this medicine is used. TAKE SPECIAL CARE WITH METHOTREXATE INJECTION IF YOU have a stomach ulcer or ulcerative colitis (inflammation and ulceration of the gut) have an infection have mild kidney problems have a medical condition which اقرأ الوثيقة كاملة
OBJECT 1 METHOTREXATE 25 MG/ML INJECTION Summary of Product Characteristics Updated 10-May-2018 | Hospira UK Ltd 1. Name of the medicinal product Methotrexate 25 mg/ml Injection 2. Qualitative and quantitative composition Each ml of solution contains 25 mg methotrexate (sodium salt formed _in situ_) Each vial of 2 ml of solution contains 50 mg methotrexate (sodium salt formed _in situ_) Each vial of 10 ml of solution contains 250 mg methotrexate (sodium salt formed _in situ_) Each vial of 20 ml of solution contains 500 mg methotrexate (sodium salt formed _in situ_) Each vial of 40 ml of solution contains 1 g methotrexate (sodium salt formed _in situ_) For excipients, see 6.1. 3. Pharmaceutical form Solution for Injection Vials containing a clear yellow solution 4. Clinical particulars 4.1 Therapeutic indications Methotrexate is indicated in the treatment of neoplastic disease, such as trophoblastic neoplasms and leukaemia, and the symptomatic treatment of severe recalcitrant disabling psoriasis which is not adequately responsive to other forms of therapy. 4.2 Posology and method of administration ADULTS AND CHILDREN ANTINEOPLASTIC CHEMOTHERAPY Methotrexate is active orally and parenterally. Methotrexate Injection may be given by the intramuscular, intravenous, intraarterial or intrathecal routes. NOTE: ONLY THE 50 MG/2 ML PRESENTATION SHOULD BE USED FOR THE INTRATHECAL ROUTE OF ADMINISTRATION TO PREVENT ACCIDENTAL OVERDOSE. Dosage is related to the patient's body weight or surface area. Methotrexate has been used with beneficial effect in a wide variety of neoplastic diseases, alone and in combination with other cytotoxic agents. CHORIOCARCINOMA AND SIMILAR TROPHOBLASTIC DISEASES Methotrexate is administered orally or intramuscularly in doses of 15-30 mg daily for a 5 day course. Such courses may be repeated 3-5 times as required, with rest periods of one or more weeks interposed between courses until any manifesting toxic symptoms subside. The effectiveness of therapy can be evaluated by 24 hours quantitative an اقرأ الوثيقة كاملة