Riik: Suurbritannia
keel: inglise
Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Methotrexate
medac UK
L04AX03
Methotrexate
50mg/1ml
Solution for injection
Subcutaneous
No Controlled Drug Status
Caution - AMP level prescribing advised
BNF: 10010300; GTIN: 4037353001213
OBJECT 1 METOJECT PEN SOLUTION FOR INJECTION IN PRE-FILLED PEN Summary of Product Characteristics Updated 03-Jul-2017 | medac GmbH 1. Name of the medicinal product Metoject PEN 7.5 mg solution for injection in pre-filled pen Metoject PEN 10 mg solution for injection in pre-filled pen Metoject PEN 12.5 mg solution for injection in pre-filled pen Metoject PEN 15 mg solution for injection in pre-filled pen Metoject PEN 17.5 mg solution for injection in pre-filled pen Metoject PEN 20 mg solution for injection in pre-filled pen Metoject PEN 22.5 mg solution for injection in pre-filled pen Metoject PEN 25 mg solution for injection in pre-filled pen Metoject PEN 27.5 mg solution for injection in pre-filled pen Metoject PEN 30 mg solution for injection in pre-filled pen 2. Qualitative and quantitative composition 1 pre-filled pen with 0.15 ml solution contains 7.5 mg methotrexate. 1 pre-filled pen with 0.20 ml solution contains 10 mg methotrexate. 1 pre-filled pen with 0.25 ml solution contains 12.5 mg methotrexate. 1 pre-filled pen with 0.30 ml solution contains 15 mg methotrexate. 1 pre-filled pen with 0.35 ml solution contains 17.5 mg methotrexate. 1 pre-filled pen with 0.40 ml solution contains 20 mg methotrexate. 1 pre-filled pen with 0.45 ml solution contains 22.5 mg methotrexate. 1 pre-filled pen with 0.50 ml solution contains 25 mg methotrexate. 1 pre-filled pen with 0.55 ml solution contains 27.5 mg methotrexate. 1 pre-filled pen with 0.60 ml solution contains 30 mg methotrexate Excipients with known effect: sodium chloride and sodium hydroxide. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for injection in pre-filled pen. Clear, yellow-brown solution. 4. Clinical particulars 4.1 Therapeutic indications Metoject PEN is indicated for the treatment of • active rheumatoid arthritis in adult patients, • polyarthritic forms of severe, active juvenile idiopathic arthritis, when the response to nonsteroidal anti- inflammatory drugs (NSAIDs) has been inadequate, • severe recalci Lugege kogu dokumenti