Anaferon

Anaferon
Anaferon belongs to the group of immunomodulators and antiviral agents. The drug exerts dual action, that is, early antiviral action mediated through the induction of IFN-α and complementary antiviral аnd full-scale immunomodulatory effects that are realized via IFN-γ production. Anaferon treatment results in the increased functional cell pool involved in the immune response, increased functional activity of phagocytes and natural killer cells, and production of protective antibodies. Thus, acting through the interferon system, Anaferon exerts its influence on all aspects of antiinfectious response, i.e. nonspecific defense mechanisms and cellular and humoral immune responses. Anaferon inhibits viral replication at the stage of translation, imperative and universal for all viruses. Exactly this action provides for its broad-spectrum antiviral activity. As these effects are realized without direct action on virions and their genomes, viral resistance to Anaferon would never develop. Experimental and clinical studies confirmed efficacy of Anaferon against various viruses, including variants of influenza virus (A(H1N1), A(H3N2), B, and avian influenza), parainfluenza virus, adenoviruses, rhynoviruses, respiratory-syncitial virus, type 1 and 2 herpes simplex viruses (labial herpes, genital herpes), other herpes viruses (varicella, infectious mononucleosis), enteroviruses, tick-borne encephalitis virus, rotavirus, coronavirus, and calicivirus. Anaferon is used for the treatment and prevention of acute respiratory viral infections (including influenza virus infection); in the complex therapy of infections caused by herpes viruses (labial herpes, genital herpes, infectious mononucleosis); in the therapy and prophylaxis of chronic herpes virus infection recurrences, including relapses of labial and genital herpes infections. Anaferon is effective in the complex therapy and prophylaxis of other acute and chronic viral infections caused by tick-borne encephalitis virus, enterovirus infections, and enteric infections caused by other viruses (rotaviruses, coronaviruses, caliciviruses). In addition, the drug is used in the complex therapy of bacterial infections and secondary immunodeficiencies of various origin, including the prevention and treatment of complications of viral and bacterial infections. Anaferon is presented in the form of orodispersible tablets and administered at a dose of 1 tablet per intake (tablets are to be held in the mouth until their complete dissolution; not to administer with food). In the majority of viral infections (ARVI, influenza, enteric infections, neuroinfections, varicella, infectious mononucleosis), Anaferon therapy should be started as early as possible, preferably immediately after the occurrence of early signs and symptoms of acute viral infection. Therapy is conducted according to the following regimen: the drug is to be taken every 30 minutes during the first 2 hours, then three doses administered with equal time intervals during the first day. At the second day and thereafter, the drug (1 tablet) is administered three times daily up to complete recovery. During epidemic seasons, Anaferon is administered once daily for 20-40 days to prevent ARVI and influenza. If necessary, the preventive treatment is extended up to 3 months. In acute forms of genital herpes infection, Anaferon is administered with equal time intervals according to manufacturer’s recommendations for at least 3 weeks. For the prevention of chronic herpes virus infection relapses, Anaferon is administered at a dose of 1 tablet daily for up to 6 months. In therapy or prevention of immunodeficiencies and in the complex therapy of bacterial infections, Anaferon is administered at 1 tablet daily for up to 3 months. If necessary, Anaferon may be used in combination with other antiviral, antibacterial, and symptomatic therapies.

Instructions
for use


Trade name: Anaferon

Pharmaceutical form: orodispersible tablets

Composition: Each orodispersible tablet contains:

Active ingredient: Affinity purified antibodies to human gamma interferon – 0.003 g*

Excipients: lactose, microcrystalline cellulose, magnesium stearate.

* – Water-ethanol mixture of the active substance dilutions with concentration not more than 10-15 ng/g used for saturation of lactose.

Description:

White to off-white, round, flat, scored on one side and beveled tablets, marked «MATERIA MEDICA» on one side and «ANAFERON» on the other.

Pharmacotherapeutic group

Immunomodulators. Antivirals.

ATC codes: L03, J05AX

Pharmacological properties

Pharmacodynamics: The medicine exerts immunomodulatory and antiviral effects upon prophylactic and therapeutic administration. Effectiveness is established experimentally and clinically towards influenza viruses (including bird flu), parainfluenza viruses, herpes simplex virus of type 1 and 2 (labial herpes, genital herpes), other herpes virus diseases (varicella, infectious mononucleosis), enterovirus, tick-borne encephalitis virus, rotavirus, coronavirus, calicivirus, adenovirus, respiratory syncytial virus. The drug reduces the concentration of virus in the affected tissues, influences on the system of endogenous interferons and related cytokines, induces the production of endogenous ''early" interferons (IFN a/β) and gamma interferon (IFNγ).

The drug stimulates humoral and cell-mediated immune responses. Anaferon increases antibody production (including secretory IgA), activates the functions of T-effectors and T-helpers (Th) and normalizes their ratio. The drug increases the functional reserves of Th and other cells involved in the immune response. The drug induces combined Th1 and Th2-type immune response through enhancing the production of Thl (IFNγ, IL-2) and Th2 (IL-4, 10) cytokines, normalizes (modulates) the Thl/Th2 activity balance. The drug increases the functional activity of phagocytes and natural killer cells (NK cells). The drug also possesses antimutagenic properties.

Pharmacokinetics: The sensitivity of contemporary physicochemical methods (gas-liquid chromatography, high performance liquid chromatography and mass spectrometry) does not allow to assess the content of ultralow doses of antibodies in biological fluids, organs and tissues, that makes technically impossible to investigate the pharmacokinetic properties of Anaferon.

Therapeutic indications

Prophylaxis and treatment of acute viral respiratory infections (including influenza).

Complex therapy of infections caused by herpes viruses (infectious mononucleosis, varicella, labial herpes, genital herpes).

Complex therapy and prophylaxis of relapses of chronic herpes virus infection including labial and genital herpes.

Complex therapy and prophylaxis of other acute and chronic viral infections caused by tick-borne encephalitis virus, enterovirus, rotavirus, coronavirus, calicivirus.

Used in a complex therapy of bacterial infections.

Complex therapy of secondary immunodeficiencies of various etiology including prophylaxis and treatment of complications of virus and bacterial infections.

Contraindications

Individual hypersensitivity to components of the medicine.

Posology and method of administration

Oral route.

One tablet per intake (the tablet should be held in the mouth until it is completely dissolved, not during the meal).

URI’s, influenza, intestinal infections, herpes virus infections, neuroinfections.

Treatment should begin as early as possible - beginning from the first onset of symptoms of an acute viral infection according to the following regimen: 1 tablet is taken every 30 minutes during the first 2 hours, then 3 more tablets of Anaferon should be administered in equal time intervals during the first day of treatment. Beginning from the second day of treatment 1 tablet is administered 3 times a day until full recovery.

If no improvement occurs by the third day of treatment of acute respiratory virus infections and influenza, a doctor should be consulted.

Throughout the epidemic season for prophylaxis purposes the drug is administered 1 tablet daily for 1-3 months.

Genital herpes. In cases of acute manifestations of genital herpes the drug is taken in equal time intervals according to the following regimen: 1-3 days - 1 tablet is taken 8 times/day, furthermore 1 tablet is taken 4 times/day for not less than 3 weeks.

For the prophylaxis of relapses of chronic herpes virus infections – 1 tablet is taken daily. The recommended duration of the prophylactic course should be defined individually and may reach 6 months.

When administering the drug for treatment and prophylaxis of immunodeficiencies, in the complex therapy of bacterial infections – 1 tablet is administered daily.

If necessary Anaferon can be co-administered with other antiviral and symptomatic drugs.

Children are persons under 18 years should administer Anaferon for children.

Undesirable effects

No side effects have been reported for the drug used in accordance with the specified indications in the recommended doses.

Individual hypersensitivity to components of the medicine is possible.

Inform doctors of any unwanted effects related to drug use.

Overdose

No cases of overdose have been reported.

Dyspepsia caused by excipients is possible in accidental overdose.

Effects on ability to drive and use machines

Anaferon has no influence on the ability to drive and use machines.

Interaction with other medicinal products and other forms of interaction

Cases of incompatibility with other medicines have not been reported. If necessary the drug can be co-administered with other antiviral, antibacterial and symptomatic drugs.

Special warnings and precautions for use

Medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, the lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Use in Pregnancy and lactation

There were no special clinical studies of Anaferon on woman in period of pregnancy or lactation.

Animal studies do not indicate direct of indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition of postnatal development.

Caution should be exercised when prescribing to pregnant women.

Nature and contents of container

20 orodispersible tablets in PVC/Aluminum blister. 1 blister is inserted into a cardboard box with leaflet.

Storage conditions

Store in dry light-protected place at temperature below 300C.

Store in the original package.

Keep out of reach of children.

Dispensing rules

Over the counter.

Shelf life

3 years since the manufacturing date. Do not use after the expiry date indicated on the package.

Specification: Manufacturer’s standard (In house).

Manufacturer:

ООО «NPF «MATERIA MEDICA HOLDING»

9, 3rd Samotyochny per., Moscow, Russia, 127473

Tel/fax: +7 (495) 684-43-33