Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: medac, Gesellschaft für klinische, Spezialpräparate mbH, Theaterstr. 6, 22880, Wedel, Germany
Levofolinic acid 50 mg/ml solution for injection/infusion.
| Pharmaceutical Form |
|---|
|
Solution for injection/infusion. Slightly yellow, clear solution. |
Each ml of solution contains 54.65 mg disodium levofolinate equivalent to 50 mg levofolinic acid.
Each 1 ml vial contains 54.65 mg disodium levofolinate equivalent to 50 mg levofolinic acid.
Each 4 ml vial contains 218.6 mg disodium levofolinate equivalent to 200 mg levofolinic acid.
Each 9 ml vial contains 491.85 mg disodium levofolinate equivalent to 450 mg levofolinic acid.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Levoleucovorin |
Levoleucovorin is the pharmacologically active isomer of 5-formyltetrahydrofolic acid. Administration of levoleucovorin can “rescue” normal cells and thereby prevent toxicity of folic acid antagonists such as methotrexate which act by inhibiting dihydrofolate reductase. |
| List of Excipients |
|---|
|
Sodium hydroxide (for pH-adjustment) |
Colourless glass vials type I with bromobutyl rubber stoppers and aluminium flip-off caps.
Pack sizes: Vials with 1 ml, 4 ml, or 9 ml solution for injection/infusion in packs of 1 or 5 vials. Not all pack sizes may be marketed.
medac, Gesellschaft für klinische, Spezialpräparate mbH, Theaterstr. 6, 22880, Wedel, Germany
PL 11587/0042
Date of first authorisation: 19/03/2008
Date of latest renewal: 06/03/2013
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