Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: medac, Gesellschaft für klinische, Spezialpräparate mbH, Theaterstr. 6, 22880 Wedel, Germany
Sodiofolin 50 mg/ml, solution for injection/infusion.
| Pharmaceutical Form |
|---|
|
Solution for injection/infusion. Slightly yellow, clear solution. |
Sodiofolin contains 54.65 mg/ml disodium folinate equivalent to 50 mg/ml folinic acid.
2 ml of solution contains 109.3 mg disodium folinate equivalent to 100 mg folinic acid.
4 ml of solution contains 218.6 mg disodium folinate equivalent to 200 mg folinic acid.
6 ml of solution contains 327.9 mg disodium folinate equivalent to 300 mg folinic acid.
8 ml of solution contains 437.2 mg disodium folinate equivalent to 400 mg folinic acid.
10 ml of solution contains 546.5 mg disodium folinate equivalent to 500 mg folinic acid.
18 ml of solution contains 983.7 mg disodium folinate equivalent to 900 mg folinic acid.
Excipient(s) with known effect: Sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Sodium folinate |
Sodium folinate is a reduced derivative of folic acid. Sodium folinate is mainly used for colorectal cancer treatment in association with 5-fluorouracil and Oxaliplatin (FOLFOX regimen) or with 5-fluorouracil and Irinotecan (FOLFIRI regimen). Additionally, it is administered as salvage therapy to reduce toxic effects following high doses of methotrexate in the treatment of some neoplastic diseases, rheumatoid arthritis or severe psoriasis. Sodium folinate is also given to treat anemia caused by folate deficiency. |
| List of Excipients |
|---|
|
Sodium hydroxide |
Colourless glass vials type 1 of 5, 10 or 20 ml.
Closure: bromobutyl rubber stopper with aluminium flip-off cap as seal.
Vials with 2 ml, 4 ml, 6 ml, 8 ml, 10 ml or 18 ml solution for injection/infusion.
Packs containing 1 vial or 5 vials. Not all pack sizes may be marketed.
medac, Gesellschaft für klinische, Spezialpräparate mbH, Theaterstr. 6, 22880 Wedel, Germany
PL: 11587/0005
Date of first authorisation: 2 August 2000
Date of latest renewal: 30 May 2006
| Drug | Countries | |
|---|---|---|
| SODIOFOLIN | United Kingdom |
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