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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.

Auxiliary ingredient: water for injection.

Description: Clear yellow liquid without any inclusions.

Pharmacotherapeutic Group: immunomodulating and antiviral drug.

ATCh Code: JO5ACh.

Pharmacological characteristics:

Pharmacodynamics

Ferrovir as a biologically active substance is an extract from sturgeon or salmon milt (refined and standardized complex salt of natrium deoxyribonucleat and ferrum). The drug has antiviral and immunomodulating effect, it activates antiviral, antimycotic and antimicrobial immunities. It has antiviral effect against various RNA- and DNA-containing viruses. The drug clinical use has proved its high activity, high tolerance level, no toxicity (IC50>4000mkg/ml) and no unwanted side-effects. Within the frames of AIDS/HIV-infection therapy, fourteen-day Ferrovir course increases CD4+lymphocytes concentration in blood. This concentration continues increasing within 1-1.5 months after the termination of the course of treatment. At the same time, body viral load drops, 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 recurrence seriousness 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 (vertigo and nausea reduction, etc.) and to replicative activity decrease for all HCV-virus genotypes, as well as to the process conversion into latent phase with complete recovery of liver cells and without viral replication. The drug demonstrates a high activity rate if both prior and opportunistic disease viruses are represented. The drug chemotherapeutic index exceeds 20, which is 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 in respect to hematopoietic system organs, and it actively participates in cell metabolism process by embedding into 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 one; 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 residence within organs and tissues is 72 hrs. Semiexcretion time is 36 hrs.

Indications for application

Ferrovir is used for combined therapeutic treatment of HIV- and AIDS-patients, HIV-patients 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 2nd 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) of Ferrovir solution for intramuscular introduction is introduced twice a day during 5-10 days.

When 2 ml solution for intramuscular introduction is used, it is necessary to re-calculate the dosage in order to get the total course dose of 750-2,100 mg.

Side-effects

Simple continued fever (body temperature can increase up to 38°С), hyperaemia and moderate painfulness at the injection site.

Overdose

No negative consequences of overdosing have been evidenced.

Interaction with other drugs

Gently 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, alongside with Medication Guide.

Keeping conditions

Keep in a shadowed place at a temperature range from +4°С to +20ºС.Keep 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.