Moliksan - instructions for use, doses, side effects, contraindications

Active substanceInosine glycyl-cysteinyl-glutamate disodiumInosine glycyl-cysteinyl-glutamate disodium

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solution w / m in / in

Dosage form: & nbspsolution for intravenous and intramuscular administration

Composition:

1 ml of solution contains active substance: inosine glycyl-cysteinyl-glutamate disodium 10 mg or 30 mg and Excipients: sodium, acetate trihydrate-13.6 mg, acetic acid diluted to pH 6.0, water for injection - up to 1 ml.

Description:Transparent colorless or slightly colored liquid, odorless or with a faint smell of acetic acid.

Pharmacotherapeutic group:Immunomodulating agent

ATX: & nbsp

L.03.A.X Other immunostimulants

Pharmacodynamics:

Molyxane® is an organic salt comprising inosine (purine component) and glycyl-cysteinyl-glutamate disodium (peptide component) in a ratio of 1: 1. Moliksan® regulates thiol-disulfide exchange of hepatocytes, induces the expression of enzymes of the first and second phases of detoxification of xenobiotics, suppresses the replication of DNA and RNA of viruses that cause hepatitis B and C, stimulates the production of interferons α and γ macrophages of the liver, interleukin-2 T-lymphocytes.

Cytoprotective and immunomodulating activity of the peptide and purine component of the Molixan® preparation lead to inhibition of cytolysis of hepatocytes, resolution of the inflammatory process in toxic and viral lesions of liver cells.The peptide and purine components of the Molixan® medication indirectly affect the metabolism, proliferation, differentiation and apoptosis of liver cells, contributing to the restoration of the normal structure of the hepatic tissue. The drug has immunomodulatory, antiviral and hepatoprotective effects.

Pharmacokinetics:

The pharmacokinetics of the Molixan® preparation with an intravenous dose of 1 mg / kg is described by a two-part model with the following indices for the peptide component of the organic salt of the preparation Molixan®, the maximum concentration of the peptide component in the blood plasma is 170-180 μg / ml; the peptide component elimination constant is 0.085 min^-1; bioavailability of the peptide component 90%; total clearance of peptide component 20 ml / kg / min; the average retention time of the peptide component is 6-8 min; the half-life of the peptide component is 15-20 min. The components of the organic salt of the preparation Moliksan®, peptide and purine components, are metabolized in the organs and tissues of the organism to amino acids and derivatives of purine bases, are excreted through the kidneys.

Indications:Acute and chronic viral hepatitis B, C.

Contraindications:Individual intolerance, the period of pregnancy and breastfeeding, children's age.

Dosing and Administration:

Solution for intravenous and intramuscular injection.

Recommended treatment regimens.

In acute viral hepatitis B Molixan® is administered intravenously or intramuscularly once 10 mg per day, every other day, throughout the course of symptomatic and detoxification therapy.

In severe forms of acute viral hepatitis B, Molixan® is administered intravenously or intramuscularly once daily, 20 mg daily, throughout the course of symptomatic and detoxification therapy.

In complex antiviral therapy for chronic viral hepatitis B, Molixan® is administered intravenously or intramuscularly once daily, 30 mg per day, three times a week, every other day throughout the course of specific antiviral therapy.

In monotherapy of chronic viral hepatitis B, resistant to the means of specific antiviral therapy or when it is impossible to conduct it. for medical reasons, Molixan® is administered intravenously or intramuscularly once 30 mg per day, three times a week, every other day, a course of treatment of 24 weeks.

In complex antiviral therapy for chronic viral hepatitis C, Molixan® is administered intravenously or intramuscularly once daily, 60 mg per day, three times a week, every other day throughout the course of specific antiviral therapy.

In monotherapy of chronic viral hepatitis C, resistant to the means of specific antiviral therapy or when it is impossible to perform it for medical reasons, Molixan® is administered intravenously or intramuscularly once 60 mg per day, three times a week, every other day, a course of treatment of 24 weeks.

Side effects:

Local allergic reactions are possible: local hyperemia, burning, swelling (at the injection site). Individual patients may experience a slight increase in body temperature (up to 37.1 ° - 37.5 ° C), soreness at the injection site (in this case, the drug is administered together with 1-2 ml of 0.25% procaine solution).

Overdose:No cases of drug overdose have been reported.

Interaction:Not found.

Special instructions:

Treatment with the drug should be carried out with regular medical supervision.

As the carrier solution for intravenous administration, isotonic sodium chloride solution or 5% glucose solution is used.As a solvent for intravenous use 0.9% solution of sodium chloride or 5% solution of dextrose.

Effect on the ability to drive transp. cf. and fur:There was no negative impact on the ability to manage vehicles and mechanisms.

Form release / dosage:

Solution for intravenous and intramuscular injection 10 and 30 mg / ml.

Packaging:

1 or 2 ml into neutral glass ampoules.

For 5 or 10 ampoules (containing 1 ml or 2 ml) in a contoured cell pack of a polyvinyl chloride film and foil of aluminum printed varnished or paper with a single-layer polyvinylidene chloride coating.

For 5 or 10 ampoules (containing 1 ml or 2 ml) in a contiguous cell pack of a polyvinyl chloride film without foil or coating.

On 1,2,5 or 10 (containing 5 or 10 ampoules) contour packs together with a knife ampoule or scarifier together with instructions for use in a pack of cardboard.

When packing ampoules with incisions, rings and break points, scarifiers or ampoule knives do not.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after expiry date. .

Terms of leave from pharmacies:On prescription

Registration number:P N001355 / 02

Date of registration:14.07.2011 / 07.02.2018

Expiration Date:Unlimited

The owner of the registration certificate:PHARMA VAM, CJSC PHARMA VAM, CJSC Russia