Vorisan

Vorisan

calcium folinate

Manufacturer:

Sanbe

Marketer:

Sanbe
Full Prescribing Info
Contents
Folinic acid.
Description
Each mL contains: Calcium Folinate equivalent to Folinic Acid 10 mg.
Action
Pharmacology: Folinic Acid is the formyl derivative of tetrahydrofolic acid which is a metabolite and active form of folic acid. Onset of action is 10-20 minutes after i.m. administration, which last for 3-6 hours.
Peak Plasma concentration will be achieved after 1.5-2 hours: 80-90% is eliminated through the kidney.
Indications/Uses
VORISAN is indicated in: Neutralising the immediate toxic effects of folic acid antagonist, e.g. methotrexate.
Parenteral treatment of megaloblastic anaemias, if the oral therapy is impossible.
Dosage/Direction for Use
VORISAN may be parenterally by i.m. injection, i.v. injection or i.v. infusion. When required for intravenous infusion, it may be diluted in 1 liter of 5% w/v glucose in water for injections or normal saline. Such solutions are stable for 24 hours when stored between 2°- 8°C to avoid microbial contamination hazards, infusion should be commenced as soon as practicable after preparation.
Example of calculation: To prepare 20 mg Folinic Acid from 50 mg/5 mL Folinic Acid: Draw 2 mL from 5 mL containing 50 mg Folinic Acid (the result is 20 mg/2 mL).
Overdosage
Treatment of overdosage of folic acid antagonists: In cases of overdosage of folic acid antagonists Folinic Acid 10 mg/m2 may be administered i.v. or i.m. every 6 hours until the serum concentration Methotrexate under 10-8 M. In general, where overdosage is susceptible, the dose of Folinic Acid should be equal to or higher than the offending dose of the folic acid antagonists administered, and should be given as soon as possible; preferably within the first hour, after which it is much less effective.
Treatment of megaloblastic anaemia: For treatment of megaloblastic anaemia, the dose should not exceed 1 mg daily given intramuscularly or orally.
Contraindications
Folinic Acid is contraindicated in the treatment of pernicious anaemia or other megaloblastic anaemias where vitamin B12 is deficient.
Haematologic remission, may occur but the neurologic manifestation could be persistent and progressive.
Warnings
Methotrexate serum concentration should be monitored to determine the optimal dose and duration of therapy.
Excretion of Methotrexate may be prolonged due to renal insufficiency, adequate hydration.
During pregnancy or breast feeding, the administration of Folinic Acid must be carefully evaluated.
Overdosage of Folinic Acid could reduce the efficacy of folic acid antagonist.
Adverse Reactions
Occasional allergic reactions have been reported: pyrexia has occurred after parenteral administration.
Drug Interactions
Concomitant administration of Folinic Acid with Fluorouracil may increase the toxicity of Fluorouracil.
Storage
Store between 2-8°C, away from light. Do not freeze.
After diluted, store below 30°C for 24 hours, away from light.
MIMS Class
Antidotes & Detoxifying Agents / Vitamins & Minerals (Pre & Post Natal) / Antianemics
ATC Classification
V03AF03 - calcium folinate ; Belongs to the class of detoxifying agents used in antineoplastic treatment.
Presentation/Packing
Form
Vorisan inj 10 mg/mL
Packing/Price
5 mL x 1's (Rp82,000/boks)
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