Χώρα: Αρμενία
Γλώσσα: Αγγλικά
Πηγή: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
methotrexate (methotrexate disodium)
Medac GmbH
methotrexate (methotrexate disodium)
10mg/ml
solution for injection
Prescription
SPC (common) Metoject 10 mg/ml solution for injection, pre-filled syringe; date of revision: 2014-03-31 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Metoject 10 mg/ml solution for injection, pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution contains 10 mg methotrexate (as methotrexate disodium). 1 pre-filled syringe of 0.75 ml contains 7.5 mg methotrexate 1 pre-filled syringe of 1 ml contains 10 mg methotrexate 1 pre-filled syringe of 1.5 ml contains 15 mg methotrexate 1 pre-filled syringe of 2 ml contains 20 mg methotrexate 1 pre-filled syringe of 2.5 ml contains 25 mg methotrexate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection in pre-filled syringe. Clear, yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Metoject is indicated for the treatment of: Severe, active rheumatoid arthritis in adult patients Polyarthritic forms of severe, active juvenile idiopathic arthritis when the response to non- steroidal anti-inflammatory drugs (NSAIDs) has been inadequate Severe and generalised psoriasis vulgaris, especially plaque-type, and psoriatic arthritis in adult patients which are unresponsive to conventional therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Metoject should only be prescribed by physicians, who are familiar with the various characteristics of the medicinal product and its mode of action. Metoject is injected ONCE WEEKLY . The patient is to be explicitly informed about the fact of administration once weekly. It is advisable to determine a fixed, appropriate weekday as day of injection. Methotrexate elimination is reduced in patients with a third distribution space (ascites, pleural effusions). Such patients require especially careful monitoring for toxicity, and require dose reduction or, in some cases, discontinuation of methotrexate administration (see sections 5.2 and 4.4). Dosage in adult patients with rheumatoid arthritis: The recommended initial dose is 7.5 mg of m Διαβάστε το πλήρες έγγραφο