Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Isovorin Solution for Injection 10 mg/ml.
| Pharmaceutical Form |
|---|
|
Solution for injection. Isovorin Solution is a clear yellow solution. |
Calcium levofolinate equivalent to 1.00% w/v (10 mg/ml) of levoleucovorin (levofolinic acid).
Vials contain 25 mg, 50 mg or 175 mg of levofolinic acid (as calcium levofolinate) in 2.5 ml, 5 ml or 17.5 ml of solution respectively.
Excipients with known effect:
Isovorin 25 mg/2.5 ml solution for injection contains 7.6 mg of sodium in each 2.5 ml of solution.
Isovorin 50 mg/5 ml solution for injection contains 15.2 mg of sodium in each 5 ml of solution.
Isovorin 175 mg/17.5 ml solution for injection contains 53.03 mg of sodium in each 17.5 ml of solution.
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 chloride |
Type I amber glass vials each containing the equivalent of 25 mg, 50 mg or 175 mg of calcium levofolinate in 2.5 ml, 5 ml or 17.5 ml of solution respectively. Isovorin Solution for Injection is packed in boxes of 1 vial.
Not all pack sizes may be marketed.
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
PL 00057/1282
17 Aug 2011
| Drug | Countries | |
|---|---|---|
| ISOVORIN | Spain, Japan, United Kingdom |
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