Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
Methofill 7.5 mg solution for injection in pre-filled injector.
| Pharmaceutical Form |
|---|
|
Solution for injection in pre-filled injector. Clear, yellow to brown solution. pH: Between 7.0 to 9.0 |
1 pre-filled injector with 0.15 ml solution contains 7.5 mg methotrexate.
Excipient with known effect: Each pre-filled injector contains <1 mmol sodium.
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 injector containing a colourless pre-filled glass syringe (type I) with plunger stopper (chlorobutyl rubber) and embedded injection needle. The syringe is externally equipped with the device for self-administration (pre-filled injector).
Pack sizes: For 0.15 mL: pack of 1, multipacks of 4 (4 packs of 1) or 8 (8 packs of 1) pre-filled injectors in a carton.
Not all pack sizes may be marketed.
Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
PL 20075/0493
04/04/2017
| Drug | Countries | |
|---|---|---|
| METHOFILL | Austria, Germany, Spain, Croatia, Ireland, Poland, United Kingdom |
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