Sodiofolin (disodium folinate) solution for injections or infusions 400 mg. 50 mg/ml. 8 ml. №1 vial

Description

Sodiofolin (disodium folinate) solution for injections or infusions 400 mg. 50 mg/ml. 8 ml. №1 vial

Composition

active substance: disodium folinate;

1 ml of solution contains 54.65 mg of disodium folinate, which is equivalent to 50 mg of folinic acid;

Excipients: sodium hydroxide, hydrochloric acid, water for injections.

Dosage form

Solution for injection or infusion.

Main physical and chemical properties: clear solution from light yellow to yellow.

Pharmacotherapeutic group

Drugs used to eliminate the toxic effects of antitumor therapy.
ATX code V03A F06.

Pharmacological properties

This drug belongs to a group of drugs that are used to eliminate intoxication after anti-tumor measures.
The main component is folic acid, the active form is a derivative of tetrahydrofolic acid. This substance takes an active part in the metabolic processes of the body, participating in the synthesis of purines, the synthesis of pyrimidine nucleotides, and the metabolic processes of various amino acids.
Fluorouracil is able to inhibit DNA synthesis by binding to thymidylate synthase. As a result, a ternary complex is formed, the components of which are thymidylate synthetase, 5-fluorodeoxa-uridine monophosphate, and 5,10-methylenetetrahydrofolate.
This causes a long-term blocking of thymidylate synthetase, followed by an increase in inhibition of DNA biosynthesis. As a result, cytotoxicity is enhanced, compared to monotherapy with fluorouracil.

Indications

This drug Sodiofolin solution for injections is recommended to be used to reduce and prevent possible intoxication caused by folic acid antagonists, in particular methotrexate, in cases where cytotoxic therapy is carried out, as well as in case of overdose with folic acid antagonists in both adults and children.
High serum methotrexate levels are possible during treatment with low methotrexate drugs such as hydrothorax, ascites for renal failure, and / or insufficient fluid intake during treatment with methotrexate drugs.

Contraindications

Not applicable if the patient has hypersensitivity (allergy) to one of the components that make up the drug.
Use is contraindicated in:

• severe diarrhea, colitis;
• a symptom of gastrointestinal intoxication, until the symptoms are eliminated;
• pernicious anemia, other types of anemia caused by vitamin B12 deficiency.

It is not used in pediatrics.

Application during pregnancy and lactation

The use of this drug in pregnant women or in women during the period when breastfeeding is carried out is contraindicated.

Method of application and dosage

The combined use of disodium folinate and 5-fluorouracil should be performed by a physician experienced in the treatment of colorectal cancer.

The drug should not be used intrathecally.

Sodiofolin solution for injections is administered intravenously undiluted as an injection or after dilution by infusion. The solution for infusion should be prepared under aseptic conditions. The product is diluted with sodium chloride 9 mg / ml (0.9%) solution for injection. Sodiofolin is compatible with fluorouracil.

Only a clear solution without visible particles is suitable for use.

The contents of the vial are for single injection only. Any unused product should be disposed of in accordance with local requirements.

After mixing with fluorouracil or after dilution with 0.9% sodium chloride solution, the chemical and physical stability of the solution was maintained for 72 hours at a temperature of 20-25 ° C. From a microbiological point of view, the solution should be used immediately. If the solution has not been used immediately, medical personnel are responsible for the duration and conditions of storage, which should not exceed 24 hours at room temperature.

2 – 8 ° C, unless dilution was performed under controlled and validated aseptic conditions.

Overdose

An overdose of the drug can weaken the effect of methotrexate, which should be taken into account when calculating the dosage of the drug.

Side effects

The use of this drug can cause side effects in the form of:

• allergic reactions – headache, weakness, dizziness, nausea, urticaria, weakness, loss of appetite;
• gastrointestinal disorders;
• disodium folinate increases the toxicity of fluorouracil.

If you have any unusual side effects as a result of taking this drug, you should consult your doctor about possible changes in the treatment regimen.