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Instructions

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Instruction for use: Molixan

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Dosage form: Solution for intravenous and intramuscular injection

Active substance: Inosini dinatrii glicyl-cysteinyl-glutamas

ATX

L03AX Other immunostimulants

Pharmacological groups

Hepatoprotectors

Other immunomodulators

Antiviral drugs (excluding HIV)

The nosological classification (ICD-10)

B16 Acute hepatitis B: Viral hepatitis B; Hepatitis B; Acute hepatitis; Vaccination against hepatitis B; Subacute hepatitis; Acute viral hepatitis B; Acute lingering hepatitis B

B17.1 Acute hepatitis C: Viral active hepatitis C; Viral hepatitis C; Hepatitis C

B18 Chronic viral hepatitis

B18.0 Chronic viral hepatitis B with delta-agent: Chronic viral hepatitis B; Chronic active hepatitis B; Chronic viral hepatitis B; Chronic hepatitis B HBeAg-positive

B18.1 Chronic viral hepatitis B without delta-agent: Chronic viral hepatitis B; Chronic active hepatitis B; Chronic viral hepatitis B; Chronic hepatitis B; Chronic hepatitis B HBeAg-negative

B18.2 Chronic viral hepatitis C: Hepatitis C; Recurrence of chronic hepatitis C; Chronic active hepatitis C; Chronic viral hepatitis C; Chronic hepatitis C without cirrhosis; Chronic hepatitis C with compensated cirrhosis; Chronic hepatitis C

Compositionand release form

1 ml of 1% or 3% solution for injection contains moxane 10 or 30 mg respectively; In ampoules of 1 and 2 ml with a ring or break point; In a blister 5 or 10 ampoules, in a cardboard bundle 1 blister.

Pharmachologic effect

Mode of action - antiviral, immunomodulating, hepatoprotective.

Regulates thiol-disulphide exchange of hepatocytes and immunocompetent cells, production of macrophages of liver cytokines, incl. Interleukin-2, interferon (alpha and gamma), inhibits cytolysis of functionally active hepatocytes, and induces apoptosis of virus-infected liver cells.

Pharmacodynamics

It penetrates into target cells and triggers biochemical reactions to regulate metabolism, proliferation, differentiation and apoptosis of cells.

Pharmacokinetics

With iv dose of 1 mg / kg, pharmacokinetic parameters (for bis- (gamma-L-glutamyl) -L-cysteinyl-bis-glycine) are: bioavailability 90%, Cmax 170-180 μg / ml, total Cl - 20 ml / kg / min, average retention time - 6-8 min, T1 / 2 - 15-20 min. Metabolized in tissues to amino acids and derivatives of purine bases, is excreted through the kidneys.

Indications of the Molixan

Viral hepatitis B, C (acute, chronic); Mixed-hepatitis.

Contraindications

Increased individual sensitivity, pregnancy, breastfeeding.

Application in pregnancy and breastfeeding

Clinical studies of the drug during pregnancy and during lactation were not conducted.

Side effects

Rarely, an increase in body temperature (up to 37.1-37.5 ° C), a slight soreness at the injection site.

Dosing and Administration

IV, IM with prolonged and severe forms of acute viral hepatitis B - 10-30 mg / day daily, single, the duration of the course is 24 days (in combination with symptomatic and detoxification therapy). In chronic viral hepatitis B - 10-30 mg / day once, daily for 3 months or more (possibly a combination with antiviral chemotherapy). With chronic viral hepatitis C - 30-60 mg / day in 1-2 injections, treatment course - 3-6 months (in combination with antiviral chemotherapy).

Special instructions

To reduce pain at the injection site, it is possible to co-administer 1-2 ml of 0.25% solution of novocaine.

Storage conditions of the drug Molixan

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

Keep out of the reach of children.

The shelf life of the drug Molixan

3 years.

Do not use beyond the expiration date printed on the package.

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Ferinject injection 50mg/ml 2ml 5 vials