Metoject PEN 12.5mg/0.25ml solution for injection pre-filled pens

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Methotrexate

Available from:

medac UK

ATC code:

L04AX03

INN (International Name):

Methotrexate

Dosage:

50mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

Caution - AMP level prescribing advised

Product summary:

BNF: 10010300; GTIN: 4037353001213

Summary of Product characteristics

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