Țară: Regatul Unit
Limbă: engleză
Sursă: myHealthbox
Methotrexate
hameln pharmaceuticals ltd
L01BA01
Methotrexate
25 mg/ml
Solution for injection in pre-filled syringe
subcutaneous or intramuscular route
0.3 ml, 0.4 ml, 0.6 ml, 0.8 ml, 1.0 ml pre-filled syringe, in a pack of 1.
POM - Prescription Only Medicine
hameln rds a.s
Antineoplastic and immunomodulating agents, antimetabolites, folic acid analogues
Active rheumatoid arthritis in adult patients where treatment with disease modifying antirheumatic drugs (DMARD) is indicated; Polyarthritic forms of severe, active juvenile idiopathic arthritis (JIA), when the response to non-steroidal anti-inflammatory drugs (NSAIDs) has been inadequate; Severe forms of psoriasis vulgaris, particularly of the plaque type, which cannot be sufficiently treated with conventional therapy such as phototherapy, PUVA, and retinoids, and severe psoriatic arthritis
Authorised
2015-07-20
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- PACKAGE LEAFLET: INFORMATION FOR THE USER METHOTREXATE 25 MG/ML SOLUTION FOR INJECTION, PRE-FILLED SYRINGE Methotrexate HAMELN 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 signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effect not listed in this leaflet, METHOTREXATE 25 MG/ML SOLUTION FOR INJECTION, PRE-FILLED SYRINGE THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR HEALTHCARE PROFESSIONALS ONLY: PREPARATION GUIDE FOR: HAMELN IN THIS LEAFLET: 1. What Methotrexate is and what it is used for 2. What you need to know before you use Methotrexate 3. How to use Methotrexate 4. Possible side effects 5. How to store Methotrexate 6. Contents of the pack and other information 1. WHAT METHOTREXATE IS AND WHAT IT IS USED FOR Methotrexate is a drug with the following properties: - it interferes with the growth of certain cells in the body that reproduce quickly (anti-tumour agent), - it reduces undesired reactions of the body’s own defence mechanism (immunosuppressant), and - it has anti-inflammatory effects. Methotrexate is used for the treatment of: - active rheumatoid arthritis (RA) in adult patients where treatment with disease modifying antirheumatic drugs (DMARDs) is indicated. - polyarthritic forms (when five or more joints are involved) of severe, active juvenile idiopathic arthritis (JIA) when the response to so-called Citiți documentul complet
Methotrexate 25 mg/ml solution for injection, prefilled syringe Summary of Product Characteristics Updated 05Aug2015 | hameln pharmaceuticals ltd 1. Name of the medicinal product Methotrexate 25 mg/ml solution for injection, prefilled syringe 2. Qualitative and quantitative composition 1 ml solution for injection contains 25 mg methotrexate. 1 prefilled syringe of 0.3 ml solution for injection contains 7.5 mg methotrexate. 1 prefilled syringe of 0.4 ml solution for injection contains 10 mg methotrexate. 1 prefilled syringe of 0.6 ml solution for injection contains 15 mg methotrexate. 1 prefilled syringe of 0.8 ml solution for injection contains 20 mg methotrexate. 1 prefilled syringe of 1.0 ml solution for injection contains 25 mg methotrexate. The medicinal product contains maximum 5.21 mg per ml sodium (see section 4.4). For a full list of excipients, see section 6.1 3. Pharmaceutical form Solution for injection in prefilled syringe The medicinal product is a clear, yellowish solution for injection with a pH of 7.0 – 9.0. 4. Clinical particulars 4.1 Therapeutic indications Active rheumatoid arthritis in adult patients where treatment with disease modifying antirheumatic drugs (DMARD) is indicated. Polyarthritic forms of severe, active juvenile idiopathic arthritis (JIA), when the response to nonsteroidal anti inflammatory drugs (NSAIDs) has been inadequate. Severe forms of psoriasis vulgaris, particularly of the plaque type, which cannot be sufficiently treated with conventional therapy such as phototherapy, PUVA, and retinoids, and severe psoriatic arthritis. 4.2 Posology and method of administration Important warning with reference to methotrexate dosage Methotrexate for the therapy of rheumatic or skin diseases must only be used once weekly. In Citiți documentul complet