Download министерство здравоохранения российской федерации

Medication Guide
for FERROVIR drug
Drug trade name: Ferrovir.
Chemical name: Complex of natrium deoxyribonucleat and ferrum
Pharmaceutical dosage form: solution for intramuscular introduction.
Composition:
Active ingredient: 1 ml of the solution contains 0.015 g of natrium deoxyribonucleat
and 0.000048 g of oxide ferrum chloride (FeCl2)
Auxiliary ingredient: water for injection.
Description: Pellucid yellow liquid without any inclusions.
Pharmacotherapeutic Group: immunomodulating and antiviral drug.
BTCh Code: JO5ACh.
Pharmacological characteristics:
Pharmacodynamics
Ferrovir is a biologically active substance derived from milt of sturgeon or salmon
(refined and standardized complex salt of natrium deoxyribonucleat and ferrum).The
drug has antiviral and immunomodulating effect, it activates antiviral, antimycotic and
antimicrobial immunity. It make antiviral effect against various RNA- and DNAcontaining viruses. The drug clinical use has proved its high efficacy, high tolerance
level, no toxicity (IC50>4000mkg/ml) and no unwanted side-effects. Monotherapy of
AIDS/HIV-infection, in fourteen-day used of Ferrovir demonstrated the increases
CD4+lymphocytes concentration in the blood. The concentration continues increasing
within 1-1.5 months after the termination of the course of treatment. Reported is lower
of viral load which is evidenced by HIV RNA concentration decrease, if compared to
the initial level. For recurrent herpetic infection, ten-day course of treatment leads to
decrease in severity of recurrence and to reduction of its continuance, and quick and
prolonged remission occurs. Ferrovir application for the complex treatment of chronic
C-hepatitis patients contributes to the improvement of the treatment tolerance (reduction
of vertigo and nausea, etc.) and decreasing of the replicative activity for all HCV-virus
genotypes, as well as to the process conversion into latent phase with complete recovery
of hepatocytes and interruption of the viral replication. The drug demonstrates a high
activity rate in both: a primary infection, and an opportunistic virus disease. The drug
chemotherapeutic index exceeds 20 that are typical for high-active drugs.
Pharmacokinetics
When the recommended dose is introduced intramuscularly, the drug is absorbed fast
and distributed within organs and tissues via endolymphatic transportation way. This
drug is high-tropic to hematopoietic system organs, and it actively participates in cell
metabolism process regulation, and specific interact with the cell structures. During
daily course application it can be cumulated in organs and tissues. Maximum
concentration at single introduction is reached in 30 minutes, and then the drug
concentration in blood decreases which happens due to the drug distribution within
organs and tissues. At multiple-dose introduction every 24 hours during 4 days,
maximum drug accumulation can be observed in spleen, lymph nodes and bone marrow.
The drug concentration in all organs and tissues does not increase with every further
introduction after the 5th injection; on the contrary, gradual concentration decrease is
observed.
Metabolism and excretion
The drug is excreted from organism (as metabolites) mainly with urine and partially
with faeces. Average time of drug persistence within organs and tissues is 72 hrs. Semi
excretion time is 36 hrs.
Indications for application
Ferrovir is used for combined therapeutic treatment of HIV- and AIDS-patients, HIVpatients with C-hepatitis, HIV-patients with recurrent herpetic infection, as well as for
the treatment of tick-borne encephalitis patients, C-hepatitis patients and herpetic
patients.
Contraindications
Individual intolerance.
Pregnancy and lactation period, childhood.
Dosage and mode of administration
For the treatment of HIV-infection or AIDS, the drug is prescribed to adults
intramuscularly: 5 ml (15 mg/ml) of the solution for intramuscular introduction (75 mg
on a dry basis) twice a day (150 mg) during 14 days. If necessary, the 2 nd therapeutic
course can be prescribed 1-1.5 months after the 1st one.
For herpes treatment: 5 ml (15 mg/ml) of the solution for intramuscular introduction,
twice a day during 10 days.
For C-hepatitis treatment, 5 ml (15 mg/ml) of Ferrovir solution for intramuscular
introduction is introduced intramuscularly twice a day during 14 days. In the following
14 days, the same daily dose of the drug is introduced every second day.
For tick-borne encephalitis treatment, 5 ml (15 mg/ml) solution of Ferrovir for
intramuscular introduction is introduced twice a day during 5-10 days.
When used 2 ml solutions for intramuscular introduction, it is necessary to re-calculate
the dosage in order to get the total course dose of 750-2,100 mg.
Side-effects
Possible short-time fever (body temperature can increase up to 38°С), hyperemia and
painfulness at the injection site.
Overdose
A negative consequence of overdosing was not reported.
Interaction with other drugs
Lightly potentiates anticoagulant activity.
In complex therapy, reduces toxicity and negative effect of the drugs prescribed
(headache, nausea, etc.).
Special instructions
In order to make the injection less painful, Ferrovir is slowly introduced intramuscularly
within 1-2 minutes.
The solution for injection should be entirely used immediately upon the bottle opening;
keeping open bottles is not allowed.
Intravenous introduction of the drug is not allowed!
Product form
15 mg/ml solution for intramuscular introduction in neutral or dark glass bottles of 2 ml
and 5 ml.
Original carton box package contains either 5 bottles 5 ml each, or 10 bottles 2 ml each
on a blister tray, inside with Medication Guide.
Keeping conditions
Keep in a shadowed place at a temperature range from +4°С to +20ºС. Save away from
children.
Period of validity
5 years. Do not use after the expiration of validity period which is indicated on the
package.
Pharmacy purchasing terms
Available on prescription only.
Producer / Claim considering company
Pharmaceutical manufacturing plant « Immunolex», Russia.
33 Mironovskaya Str., Moscow, 105318
Tel.: 369-35-05, 367-90-72, 367-90-88, 234-46-99.
IDKELS Director, Professor
/ V.V. Cheltsov /
General Director of
CJSC «FP «Technomedservice»
/ V.Yu. Kaplin /