Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: medac, Gesellschaft für klinische Spezialpräparate mbH, Theaterstr. 6, 22880 Wedel, Germany, Tel.: +49 4103 8006-0, Fax: +49 4103 8006-100
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.
| Pharmaceutical Form |
|---|
|
Solution for injection in pre-filled pen. Clear, yellow-brown solution. |
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.
| Active Ingredient | Description | |
|---|---|---|
| Methotrexate |
Methotrexate (4-amino-10-methylfolic acid) is a folic acid antagonist which inhibits the reduction of folic acid and increase of tissue cells. Methotrexate enters the cell through an active transport mechanism of reduced folates. As a result of polyglutamation of methotrexate caused by the folylpolyglutamylate enzyme, the duration of the cytotoxic effect of the drug substance in the cell increases. |
| List of Excipients |
|---|
|
Sodium chloride |
Pre-filled pens containing a colourless pre-filled syringe (glass) with plunger stopper (chlorobutyl rubber) and embedded injection needle. The syringe is externally equipped with the device for self-administration (pen).
Pack sizes:
Pre-filled pens containing 0.15 ml (7.5 mg) solution are available in packs of 1, 2, 4, 5, 6, 10, 11, 12, 14, 15, and 24 pre-filled pens.
Pre-filled pens containing 0.2 ml (10 mg) solution are available in packs of 1, 2, 4, 5, 6, 10, 11, 12, 14, 15, and 24 pre-filled pens.
Pre-filled pens containing 0.25 ml (12.5 mg) solution are available in packs of 1, 2, 4, 5, 6, 10, 11, 12, 14, 15, and 24 pre-filled pens.
Pre-filled pens containing 0.3 ml (15 mg) solution are available in packs of 1, 2, 4, 5, 6, 10, 11, 12, 14, 15, and 24 pre-filled pens.
Pre-filled pens containing 0.35 ml (17.5 mg) solution are available in packs of 1, 2, 4, 5, 6, 10, 11, 12, 14, 15, and 24 pre-filled pens.
Pre-filled pens containing 0.4 ml (20 mg) solution are available in packs of 1, 2, 4, 5, 6, 10, 11, 12, 14, 15, and 24 pre-filled pens.
Pre-filled pens containing 0.45 ml (22.5 mg) solution are available in packs of 1, 2, 4, 5, 6, 10, 11, 12, 14, 15, and 24 pre-filled pens.
Pre-filled pens containing 0.5 ml (25 mg) solution are available in packs of 1, 2, 4, 5, 6, 10, 11, 12, 14, 15, and 24 pre-filled pens.
Pre-filled pens containing 0.55 ml (27.5 mg) solution are available in packs of 1, 2, 4, 5, 6, 10, 11, 12, 14, 15, and 24 pre-filled pens.
Pre-filled pens containing 0.6 ml (30 mg) solution are available in packs of 1, 2, 4, 5, 6, 10, 11, 12, 14, 15, and 24 pre-filled pens.
Alcohol pads are included in the package.
Not all pack sizes may be marketed.
medac, Gesellschaft für klinische Spezialpräparate mbH, Theaterstr. 6, 22880 Wedel, Germany, Tel.: +49 4103 8006-0, Fax: +49 4103 8006-100
PL 11587/0076-0085
Date of first authorisation: 23 August 2013
| Drug | Countries | |
|---|---|---|
| METOJECT | Austria, Canada, Ecuador, Estonia, Spain, Finland, France, Ireland, Israel, Japan, Netherlands, United Kingdom |
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