Kipferon^® (Suppositories) Instructions for Use

Marketing Authorization Holder

Binnopharm JSC (Russia)

Manufactured By

Binnopharm JSC (Russia)

Or

Altpharm LLC (Russia)

Packaging and Quality Control Release

BINNOPHARM JSC (Russia)

Contact Information

ALIUM JSC (Russia)

ATC Code

L03AX (Other immunostimulants)

Active Substances

Interferon alfa-2b (USAN)

Human normal immunoglobulin [IgG+IgA+IgM] (Grouping name)

Dosage Form

Kipferon®

Vaginal and rectal suppositories 200 mg+500000 IU: 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Vaginal and rectal suppositories white, white with a yellowish tint or light beige in color, cylindrical in shape with a pointed end, homogeneous on the longitudinal section; the presence of an air rod or a funnel-shaped depression on the section is allowed; heterogeneity of coloring in the form of marbling is allowed; with a characteristic odor.

* human normal immunoglobulin, containing IgG, IgA, IgM.

Excipients: special purpose fat “SolPro” confectionery for chocolate products and candies – 838 mg, hard petroleum paraffin P-2 – 85 mg, emulsifier “Solid” (T-2) – 85 mg, sodium hydrogen phosphate dodecahydrate – 0.055 mg, sodium dihydrogen phosphate dihydrate – 0.018 mg, sodium chloride – 0.11 mg, purified water – 12 mg.

5 pcs. – contour cell packs (1) – cardboard packs.
5 pcs. – contour cell packs (2) – cardboard packs.

Clinical-Pharmacological Group

Immunomodulator. A combination of immunoglobulin with interferon

Pharmacotherapeutic Group

MIBP-cytokine

Pharmacological Action

Kipferon^® is a complex dosage form containing human recombinant interferon-α2 and a complex immunoglobulin preparation (CIP). It has immunomodulatory, antiviral, antichlamydial action.

Interferon-α2 is an activator of innate and acquired immunity, has pronounced antiviral activity, enhances protection against viral, chlamydial, mycoplasmal and bacterial infections, exerts an immunomodulatory effect in the development of immunological reactions, promotes the growth and preservation of normal intestinal and vaginal flora. The biological activity of interferon-α2 is realized through interaction with the receptor apparatus of immunocompetent and other cells, leading to increased expression of HLA I and HLA II molecules on the surface of all cell types and regulation of cell cooperation, increased activity of natural killers, as well as conferring resistance to intact cells against their cytolytic action, proliferation of CD8 T-cells. Increases the production of gamma-interferon by natural killers.

Complex immunoglobulin preparation contains specific and nonspecific immunoglobulins of classes G, M, A. The combination of antiviral, antichlamydial, antibacterial and antitoxic antibodies belonging to different immunoglobulin classes ensures agglutination, neutralization and precipitation of etiotropic pathogenic agents. At the application site, it stabilizes interferon from mucosal secretions, normalizes local immunity due to the supply of IgA and IgM with the suppositories (replacement effect), and increases the activity of locally produced cytokines.

Indications

The drug is used in the complex therapy of diseases accompanied by secondary immunodeficiency states

• Acute respiratory diseases, inflammatory diseases of the oropharynx of bacterial and viral etiology in children and adults;
• Acute viral (rotavirus) and bacterial (salmonellosis, dysentery, coliform infection) intestinal infections, including those with manifestations of intestinal dysbiosis of varying severity in children;
• Urogenital chlamydia in women (including in pregnant women in the II-III trimesters of pregnancy), including those with manifestations of vaginal dysbiosis, vulvovaginitis, cervicitis, cervical erosion.

ICD codes

Dosage Regimen

The drug is used rectally and vaginally.

Kipferon^® is used in combination with generally accepted means of pathogenetic therapy of infectious diseases, as well as antibiotics according to indications. The method and regimen of dosing, as well as use in complex treatment, is determined by the doctor depending on the diagnosis, acuity and severity of the disease.

Acute respiratory diseases, inflammatory diseases of the oropharynx of bacterial and viral etiology suppositories are administered rectally (preferably after defecation) to children under 1 year of age – 1 supp./day, to children under 12 years of age – 1 supp. 2 times/day, to adults and children over 12 years of age – 1 supp. 3 times/day. The appointment of the drug Kipferon^® is most effective and appropriate in the acute period of the disease (preferably within the first 3 days). The duration of the treatment course is determined by the etiology, form of severity of the disease, the presence of concomitant complications, pathological conditions and is 5-7 days.

Acute viral (rotavirus) and bacterial (salmonellosis, dysentery, coliform infection) intestinal infections, including those with manifestations of intestinal dysbiosis of varying severity in children suppositories are administered rectally (preferably after defecation) to children under 1 year of age – 1 supp./day, to children under 12 years of age – 1 supp. 2 times/day, to adults and children over 12 years of age – 1 supp. 3 times/day. The appointment of the drug is most effective and appropriate in the acute period of the disease (preferably within the first 3 days). The duration of the treatment course is determined by the etiology, form of severity of the disease, the presence of concomitant complications, pathological conditions and is 5-7 days.

Urogenital chlamydia in women (including in pregnant women in the II-III trimesters of pregnancy), including those with manifestations of vaginal dysbiosis, vulvovaginitis, cervicitis, cervical erosion suppositories are administered deep intravaginally (until contact with the posterior vaginal fornix and cervix). Prescribe 1-2 supp., depending on the severity of the disease, 2 times/day. The course of treatment averages 10 days; in the presence of cervical erosion, the use of the drug is continued until its epithelialization. According to indications, the course of treatment can be repeated after 1 month. Treatment should be started in the first days after the end of menstruation. Before administration, it is recommended to remove mucus from the mucous membranes of the vagina and cervix.

Adverse Reactions

Not registered.

Contraindications

• Individual intolerance to individual components;
• I trimester of pregnancy;
• Lactation period.

Use in Pregnancy and Lactation

The use of the drug is contraindicated in the I trimester of pregnancy and during lactation.

Pediatric Use

Use is possible according to the dosing regimen.

Special Precautions

Influence on the ability to drive vehicles and mechanisms

When used in recommended doses, the drug does not affect behavior or functional indicators of the body, and also does not affect the ability to drive vehicles and mechanisms.

Overdose

Cases of drug overdose are unknown.

Drug Interactions

No negative effect on other drugs has been noted.

Storage Conditions

The drug should be stored out of the reach of children at a temperature from 2°C (35.6°F) to 8°C (46.4°F).

Shelf Life

Shelf life – 1 year 6 months. Do not use after the expiration date printed on the package.

Dispensing Status

The drug is dispensed without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.