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INSTRUCTION ON MEDICAL APPLICATION

MOLIXAN®

1% and 3% SOLUTION OF MOLIXAN FOR INJECTIONS

Trade patented drug name: Molixan®.

Chemical name: organic salt of bis-glycine-L-cysteinyl-bis-(g -L-glutamate)•9-b -D-ribofuranozilhypoxanthine.

Drug form: 1% and 3% solution for injections.

Formulation: 1 ml of the solution comprises 10 or 30 mg of the organic salt of bis-glycine-L-cysteinyl-bis-(g -L-glutamate) and 9-b -D-ribofuranozilhypoxanthine.

DESCRIPTIONS

Transparent colorless or slightly greenish odorless liquid.

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group:

Hepatoprotective agent with immunomodulating and antiviral activity.

Pharmacodynamics:

Molixan® possesses unique biological and pharmacological effects due to the following:

  • Regulation of thiol-disulfide metabolism in hepatocytes and immune cells.
  • Regulation of endogenous production of cytokines by liver macrophages including IFN a and g determining the drug immunorehabilitating and antiviral activity.
  • Pronounced differentiated impact on the normal and virus-transformed cells.
  • Inhibition of ATP-ase/helicase activity of NS3 HCV.

Being the analogue of key cell metabolites the active principles of the composite therapeutics, Molixan®, have high bioavailability, therefore, being introduced into biological media they instantly translocate into target cells inducing cascade mechanism of biochemical reactions regulating cell metabolism, proliferation, differentiation and apoptosis forming a wide range of immunomodulating and hepatoprotective effects. The differentiated action on unimpaired hepatocytes and resident macrophages (stimulation of metabolism, proliferation, and differentiation) and virus-infected cells (induction of apoptosis mechanism including due to expression of FasAg-CD95+ and Ras-signaling and p53-dependent apoptotic pathways in the virus-infected hepatocytes) is the basis for the mechanisms inhibiting the HBV and HCV replicative activity.

The antiviral Molixan® efficacy on HVC is determined by its capacity to inhibit the NS3 HCV ATP-ase/helicase activity hindering chronization and facilitating the viral elimination.

Molixan® corrects the Th1/Th2 cytokine production ratio with the T-cell group with prevailing activation of Th1-cells due to endogenous production stimulation of IL-2 and IL-12 providing stable cell-mediated immune response including functional activity of resident liver macrophages (Kupffer's cells).

Thus, Molixan® possesses antiviral, immunomodulating and hepatoprotective (inhibition of post-hepatitis fibrogenesis) effects that determines its medical indications.

Pharmacokinetics:

The Molixan® substance is an organic salt where counter-ions are endogenous substances (oxidized glutathione and inosine). The natural origin of the drug determinates its metabolic particularities by cell enzyme systems. According to preclinical studies the Molixan® pharmacokinetics after intravenous dosing of 10 mg/kg is described using double-part model with the following indices (as per oxidized glutathione): maximal plasma concentration - 170-180 m g/ml; elimination constant - 0.085 min-1; bioavailability - 450-500 min.m g/ml; total clearance - 20 ml/kg/min; average retention rate - 6-8 min. Being a natural product having peptide and purine constituents Molixan® is metabolized in organs and tissues to amino acids and derivatives of purine bases and it is eliminated via kidneys.

MOLIXAN® ADMINISTRATION TO THE PATIENTS WITH VIRAL HEPATITIS B AND C ENSURES THE FOLLOWING:

  • Antiviral immunity stimulation and the HBV and HCV replicative activity inhibition due to induction of apoptosis in the virus-infected cells
  • Cytolytic syndrome cessation and reduction of pathologic morphological signs in liver
  • Normalization of serological and biochemical indices
  • Serum HBsAg persistency cessation
  • Prevailing activation of the T-cell immunity along with regulable stimulation of the resident macrophage functions
  • Regulation of serum levels of anti-inflammatory cytokines
  • Inhibition of liver fibrogenesis

INDICATIONS

Therapy

  • Acute and chronic viral hepatitis B, C and mixed forms
  • Drug-induced hepatitis (including cases after tuberculous and cancer chemotherapy)
  • Alcohol-induced liver disease
  • Toxic hepatitis
  • Fat liver degeneration of various origin

Prevention

  • Liver cirrhosis and hepatocellular carcinoma

CONTRAINDICATIONS

The drug introduction is contraindicated only in cases of individual intolerance.

ADVERSE EFFECTS

Adverse effects were not noted. However, individual drug intolerance is possible. In that case the drug should be canceled and consulting with an attending physician is necessary.

DRUG FORM

1% and 3% solution for injections in 1-ml and 2-ml ampoules. Packages - 5 or 10 ampoules

STORAGE CONDITIONS

The drug should be stored in a shadowed place at not higher than +250C.

The drug shall not be used after expiration date.

The drug should be stored in a place inaccessible for children.

 SHELF LIFE

2 years.

MANUFACTURE DETAILS

Pharma BAM Spb, Ltd.

Pskovskaya str., 17.

Saint-Petersburg, Russia.

Licensed by BAM-R&D Laboratories, Ltd.

Patent of the Russian Federation No. 2001103535/14.

For more references:

Dr. Giorgio Castello

Via A. Cecchi, 19/9

16129 – Genova (Italy)

Tel: +39.010.58.94.95

Mobil phone: +39.335.628.34.24

e-mail: castello@tiopoietine.info

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