Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Therakind (Europe) Limited, Paramount Court, Corrig Road, Sandyford Business Park, Dublin 18, D18 R9C7, ฮreland
Jylamvo 2 mg/ml oral solution.
| Pharmaceutical Form |
|---|
|
Oral solution. Clear yellow solution. |
One ml of solution contains 2 mg methotrexate.
Excipients with known effect: One ml of solution contains 2 mg methyl hydroxybenzoate (as the sodium salt), and 0.2 mg ethyl hydroxybenzoate.
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 |
|---|
|
Macrogol 400 |
75 ml amber type III glass bottle with tamper evident child-resistant closure (polypropylene with expanded polyethylene liner) containing 60 ml of oral solution.
Each pack contains one bottle, an LDPE bottle adaptor and a 10 ml white polypropylene dosing syringe (with major graduations at every 1 ml and minor graduations at every 0.25 ml).
Therakind (Europe) Limited, Paramount Court, Corrig Road, Sandyford Business Park, Dublin 18, D18 R9C7, ฮreland
EU/1/17/1172/001
Date of first authorisation: 29 March 2017
| Drug | Countries | |
|---|---|---|
| JYLAMVO | Austria, Estonia, Finland, Croatia, Ireland, Lithuania, Poland, Romania, United Kingdom |
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