Instructions for use Alfarekin rectal suppositories 1000000 IU strip 1 g No. 10
Composition
active ingredient: recombinant human interferon alpha-2b;
1 suppository contains 250 thousand IU or 500 thousand IU, or 1 million IU or 3 million IU of recombinant human interferon alpha-2b;
excipients: dextran; disodium edetate; emulsifier T2; citric acid monohydrate; sodium hydroxide; polysorbate; solid fat.
Dosage form
Rectal suppositories.
Main physicochemical properties: a cylindrical suppository with a pointed end, from white to light yellow in color, of uniform consistency, color heterogeneity in the form of marbling and the presence of a funnel-shaped depression on the cut is allowed.
Pharmacotherapeutic group
Immunostimulants. Interferon alpha-2b.
ATX code L03A B05.
Pharmacological properties/Immunological and biological properties
Immunological properties.
Alfarekin® is a dosage form of recombinant human interferon alpha-2b, synthesized by Escherichia coli cells based on a gene encoding a product identical to human interferon alpha-2b, using phage-dependent genetic engineering biotechnology.
Alfarekin®, like natural leukocyte interferon, has a wide spectrum of biological activity.
Pharmacodynamics
Of paramount importance is the pronounced antiviral and immunostimulating effect, as well as the activation of antitumor protection. Interferons (IFNs) regulate the relationship between the links of cellular and humoral immunity. Under the influence of IFNs, the differentiation and activity of natural killer cells and T-lymphocytes increases, which determines the active course of cellular immunity reactions. IFNs regulate the production of inflammatory mediators, affect the migration of inflammatory cells into the pathological focus, stimulate phagocytosis and other bactericidal reactions, normalizing the dynamics of the inflammatory process. The antiallergic effect is determined by the influence of interferons on the expression of molecules of the major histocompatibility complex and the cytokine spectrum.
IFNs directly affect the main stages of replication of intracellular pathogens, stop their reproduction, and ensure effective lysis of infectious agents. IFNs are characterized by high antiviral and antichlamydial activity.
The use of the drug Alfarekin® as part of the complex treatment of chronic infectious and inflammatory diseases makes it possible to increase the effectiveness of antibacterial and other drugs used for treatment, as well as reduce their systemic toxic effects and shorten the duration of treatment.
Pharmacokinetics
Not studied.
Indication
Alfarekin® suppositories are used in children and adults as monotherapy and as part of complex treatment for various viral and viral-bacterial infections. The drug is indicated for use in infectious-inflammatory diseases of the respiratory and urogenital tracts, cervical dysplasia, meningitis, sepsis, childhood viral infectious diseases (measles, rubella, chickenpox, mumps), for the purpose of rehabilitation of children who often suffer from respiratory infections.
Contraindication
Hypersensitivity to interferon alfa-2b or to any of the other components of the drug.
Interaction with other medicinal products and other types of interactions
Alfarekin® is compatible with antibiotics and hormones used in the treatment of viral, viral-bacterial, and autoimmune diseases.
Since interferon alfa alters cellular metabolism, there is a potential for modification of the action of other drugs. Interferon alfa may alter oxidative metabolic processes, which should be considered when co-administering drugs that are metabolized by this pathway (cimetidine, phenytoin, warfarin, theophylline, aminophylline, diazepam, propranolol).
The drug should be used with caution simultaneously with opioid drugs, analgesics, hypnotics and sedatives (potentially causing a myelosuppressive effect).
Application features
Alpharequin® should be used under the supervision of a physician. Patients should be informed about the benefits of this therapy and possible adverse reactions.
If the side effect does not subside or worsens, the dose of the drug is reduced to 50% or treatment is discontinued.
During treatment with the drug, alcohol consumption should be avoided.
The drug should be prescribed with caution in patients with a history of diseases such as diabetes mellitus with episodes of ketoacidosis and chronic obstructive pulmonary disease, with blood clotting disorders, and with severe myelosuppression.
Use during pregnancy or breastfeeding
There are no data on the use of the drug during pregnancy and breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
Sometimes, depending on the dose, regimen and individual sensitivity to interferon alpha, treatment may be accompanied by drowsiness, weakness, fatigue and lead to a decrease in the speed of psychomotor reactions. In such cases, you should refrain from driving vehicles and working with other mechanisms.
The drug is used rectally.
When treating diseases that have a long course, the course of treatment with Alfarekin® is set individually, taking into account the clinical picture and dynamics of the disease.
In the complex therapy of infectious and inflammatory diseases (ARI, influenza, pneumonia, sepsis, meningitis, etc.) for children aged 3 months to 1 year, Alfarekin® is used at a dose of 250 thousand IU 2 times a day for 5 days. If necessary, treatment courses can be repeated with an interval of 5 days.
In the complex therapy of viral-bacterial infections, children aged 1-7 years are prescribed the drug Alfarekin® 250 thousand IU 2 times a day for 10 days, children aged 7 years and older and adults - 500 thousand IU 2 times a day for 10 days. In the future, maintenance treatment with interferon can be prescribed for 1-12 months according to an individual regimen.
Treatment of influenza and acute respiratory viral infections in children aged 1-7 years is carried out with the drug Alfarekin® at a dose of 250 thousand IU 2 times a day for 5 days, in children aged 7 and over - 500 thousand IU 2 times a day for 5 days. In severe cases of acute respiratory viral infections and influenza, the single dose is doubled.
For the treatment of mumps, measles, rubella, and chickenpox, children aged 1-7 years are prescribed Alfarekin® at a dose of 250,000 IU twice daily for 5 days. Children over 7 years of age are prescribed the drug at a dose of 500,000 IU twice daily for 5 days.
For the treatment of rotavirus infection, Alfarekin® is prescribed to children aged 3 months to 1 year at a dose of 250 thousand IU once a day, to children aged 1 to 3 years - 500 thousand IU once a day, to children aged 3 to 7 years - 500 thousand IU twice a day. The duration of treatment is 5 days.
In the complex treatment of chronic infectious and inflammatory diseases of the urogenital tract in adults, Alfarekin® is used at a dose of 1 million IU once a day for 10 days. Treatment is carried out for both sexual partners.
In the complex treatment of cervical dysplasia, Alfarekin® is used at 3 million IU daily for 10 days. The combination of antibacterial (according to the identified pathogens) and antiviral treatment with Alfarekin® should precede the instrumental destruction of the damaged dysplastic epithelium. If diathermo- or cryodestruction of the cervix is necessary, treatment with Alfarekin® is also carried out during the rehabilitation period in the same dose.
Rehabilitation therapy for children aged 1-7 years, who often suffer from recurrent viral-bacterial infections of the respiratory tract, ENT organs, and recurrent herpes type 1, is carried out with Alfarekin® suppositories according to the following scheme:
250 thousand IU 2 times a day for 10 days, then
250 thousand IU 2 times a day 3 times a week for 2 weeks, then
250 thousand IU 2 times a day 2 times a week for 2 weeks, then
250 thousand IU once a night 2 times a week for 2 weeks, then
250 thousand IU once a night, once a week for 2 weeks.
Children aged 7-14 years are treated according to the same regimen, using a therapeutic dose of 500 thousand IU.
The total duration of the course is 2 months.
Children.
Alfarekin® in suppositories is used in pediatric practice (see the section “Method of administration and dosage”).
Overdose
No cases of acute overdose of the drug were observed.
Adverse reactions
No side effects are observed during basic courses of treatment with Alfarekin® suppositories at recommended doses.
Rectal administration of the drug is not accompanied by severe side effects, which are usually observed with parenteral administration of interferon drugs. In some cases, in the first days of treatment, flu-like symptoms may occur, which subsequently decrease and disappear. To prevent them, paracetamol preparations can be used in doses appropriate to the patient's age.
Long-term use of high doses of interferon can cause changes in blood composition (leukopenia, thrombocytopenia, anemia), increased levels of ALT, AST, alkaline phosphatase, sleep disturbances, and fluctuations in blood pressure. These effects are dose-dependent and are eliminated by reducing the dose.
Expiration date
1.5 years.
Storage conditions
Store in original packaging at a temperature of 2 to 8 ° C. Keep out of the reach of children.
Packaging
5 rectal suppositories with an activity of 250 thousand IU, 500 thousand IU, 1 million IU or 3 million IU in a strip.
2 strips in a cardboard box.
Vacation category
According to the recipe.
Producer
LLC "Research and Production Company "Interpharmbiotech", Ukraine.
Location of the manufacturer and its business address
Ukraine, 03680, Kyiv, Zabolotnogo St., 150.
Applicant: LLC "VALARTIN PHARMA"
Applicant's location
Ukraine, 08130, Kyiv region, Kyiv-Svyatoshynskyi district, Chayky village, Hrushevskoho str., 60.
