METOJECT PEN Solution for injection in pre-filled pen Ref.[6980] Active ingredients: Methotrexate

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

Product name and form

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.

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.

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
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

medac, Gesellschaft für klinische Spezialpräparate mbH, Theaterstr. 6, 22880 Wedel, Germany, Tel.: +49 4103 8006-0, Fax: +49 4103 8006-100

Marketing authorization dates and numbers

PL 11587/0076-0085

Date of first authorisation: 23 August 2013

Drugs

Drug Countries
METOJECT Austria, Canada, Ecuador, Estonia, Spain, Finland, France, Ireland, Israel, Japan, Netherlands, United Kingdom

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