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:
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:
INDICATIONS
Therapy
Prevention
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
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.
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:
Mobil
phone:
e-mail:
castello@tiopoietine.info