País: Israel
Idioma: anglès
Font: Ministry of Health
METHOTREXATE
TZAMAL BIO-PHARMA LTD
L01BA01
SOLUTION FOR INJECTION
METHOTREXATE 50 MG/ML
S.C
Required
MEDAC GESELLSCHAFT FUR KLINISCHE SPEZIALPRAPARATE MBH, GERMANY
METHOTREXATE
METHOTREXATE
Psoriasis in adult patients :because of the high risk attending its use, Methotrexate is indicated only in the symptomatic control of severe recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, and only when the diagnosis has been established, as by biopsy and/or after dermatological consultation. Rheumatoid Arthritis: Methotrexate can be used in the treatment of selected adults with severe rheumatoid arthritis, only when the diagnosis has been well estabished according to rheumatological standards, with inadequate response to other forms of antirheumatic therapy, including full dose NSAIDs and usually a trial of at least one or more disease-modifying antirheumatic drugs.Juvenile Idiopathic Arthritis:Treatment of Polyarthritic forms of severe, active juvenile idiopathic arthritis in patients 3 years of age and above when the response to non-steroidal anti-inflammatory drugs (NSAIDs) has been inadequateCrohn’s Disease: Mild to moderate Crohn's disease either alone or in combination with corticosteroids in adult patients refractory or intolerant to thiopurines.
2016-01-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor's prescription only METOJECT 50 MG/ML S.C. SOLUTION FOR INJECTION PRE-FILLED SYRINGE Active ingredient and concentration: methotrexate 50 mg/ml For information about inactive ingredients and allergens in this medicine see section 2 under ‘Important information about some of this medicine’s ingredients’, and section 6 ‘Additional information'. READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, contact your doctor or pharmacist. This medicine has been prescribed for your illness. Do not pass it on to others. It may harm them, even if you think that their illness is the same as yours. For the treatment of rheumatoid arthritis, psoriasis and Crohn's disease – the medicine is intended for use in adults only. For the treatment of juvenile idiopathic arthritis (JIA) - the medicine is intended for children over 3 years of age. Metoject S.C. is given once a week, by injection under the skin. Do not use this medicine daily. Daily use can cause side effects and serious complications which could lead to death. Choose a weekday with your doctor. To help you remember on which day you are given Metoject, you are advised to keep a diary. 1. WHAT IS THE MEDICINE USED FOR? • In cases of severe rheumatoid arthritis in adult patients that was properly diagnosed according to rheumatological standards and when the patients did not respond to other forms of antirheumatic therapy, including non-steroidal anti-inflammatory drugs (NSAIDs) and usually a trial of at least one or more disease-modifying antirheumatic drugs (DMARDs). • Active and severe juvenile idiopathic arthritis in patients over 3 years of age that involves several joints, and when treatment with non-steroidal anti-inflammatory drugs (NSAIDs) is not sufficient. • For the symptomatic control of severe recalcit Llegiu el document complet
METOJECT 50 MG/ML S.C. PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT Metoject 50 mg/ml S.C. solution for injection, pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution contains 50 mg methotrexate. 1 pre-filled syringe of 0.15 ml contains 7.5 mg methotrexate. 1 pre-filled syringe of 0.20 ml contains 10 mg methotrexate. 1 pre-filled syringe of 0.25 ml contains 12.5 mg methotrexate. 1 pre-filled syringe of 0.30 ml contains 15 mg methotrexate. 1 pre-filled syringe of 0.35 ml contains 17.5 mg methotrexate. 1 pre-filled syringe of 0.40 ml contains 20 mg methotrexate. 1 pre-filled syringe of 0.45 ml contains 22.5 mg methotrexate. 1 pre-filled syringe of 0.50 ml contains 25 mg methotrexate. 1 pre-filled syringe of 0.55 ml contains 27.5 mg methotrexate. 1 pre-filled syringe of 0.60 ml contains 30 mg methotrexate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection, pre-filled syringe. Clear, yellow-brown solution. IMPORTANT WARNING ABOUT THE DOSAGE OF METOJECT (METHOTREXATE) In the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis and Crohn’s disease, Metoject (methotrexate) MUST ONLY BE USED ONCE A WEEK . Dosage errors in the use of Metoject (methotrexate) can result in serious adverse reactions, including death. Please read 'Posology and method of administration' section very carefully. _ _ 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rheumatoid Arthritis: Methotrexate can be used in the treatment of selected adults with severe rheumatoid arthritis, only when the diagnosis has been well established according to rheumatological standards, with inadequate response to other forms of antirheumatic therapy, including full dose NSAIDs and usually a trial of at least one or more disease-modifying antirheumatic drugs. Juvenile Idiopathic Arthritis: − Treatment of Polyarthritic forms of severe, active juvenile idiopathic arthritis in patients 3 years of age and above when the response to non-steroidal anti-infla Llegiu el document complet