Instructions for use Alfarekin rectal suppositories 3000000 IU strip 1 g No. 10
Composition
active ingredient: recombinant human interferon alpha-2b;
1 suppository contains recombinant human interferon alpha-2b 250 thousand IU or 500 thousand IU, or 1 million IU, or 3 million IU;
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 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 other components of the drug; the presence of thyroid dysfunction in the patient; the presence of severe visceral disorders in patients with Kaposi's sarcoma; severe cardiovascular diseases; psoriasis; severe liver and/or kidney dysfunction; epilepsy and other CNS diseases (including functional); chronic hepatitis against the background of progressive or decompensated liver cirrhosis; chronic hepatitis in patients receiving or recently receiving immunosuppressant therapy (except for a short course of corticosteroid therapy); autoimmune hepatitis or other autoimmune diseases in history. Suppression of myeloid hematopoiesis.
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.
When used simultaneously with drugs that are metabolized by oxidation (including xanthine derivatives - aminophylline and theophylline), the possibility of the effect of Alfarekin® on oxidative metabolic processes should be taken into account. The concentration of theophylline in the blood serum should be monitored and, if necessary, the dosage regimen should be adjusted.
When using the drug in combination with chemotherapeutic drugs (cytarabine, doxorubicin, teniposide, cyclophosphamide), the risk of developing life-threatening toxic effects (their severity and duration) increases.
The drug should be used with caution simultaneously with opioid drugs, analgesics, hypnotics and sedatives (potentially causing a myelosuppressive effect).
When used simultaneously with zidovudine, the risk of neutropenia increases.
Application features
Treatment with Alfarekin® should be carried out under the supervision of a physician.
During treatment with the drug, alcohol consumption should be avoided.
All patients are recommended to undergo a comprehensive peripheral blood test before starting and regularly during treatment, with mandatory qualitative and quantitative blood tests, as well as a biochemical blood test, including determination of electrolytes, calcium, liver enzymes, and creatinine.
It is recommended that serum albumin levels and prothrombin time be carefully monitored in all patients receiving the drug.
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 (including pulmonary artery thrombophlebitis), and with severe myelosuppression.
During treatment with the drug, it is necessary to ensure adequate hydration of the body; in case of fever, other causes of its occurrence should be excluded.
It is recommended to use the drug against the background of antihistamine and antipyretic therapy.
The development of severe and moderate side effects requires dose adjustment, and in some cases, discontinuation of treatment with the drug.
Discontinue use of the drug in the event of: prolonged blood clotting time (in patients with chronic hepatitis), manifestations of pulmonary syndrome and radiological detection of infiltrate or impaired lung function, appearance or increase in visual impairment, thyroid dysfunction (deviation from the normal level of TSH), decreased serum albumin levels and decreased prothrombin time.
If an immediate-type hypersensitivity reaction develops (urticaria, angioedema, bronchospasm, anaphylaxis), the drug should be immediately discontinued and appropriate measures taken.
The drug is not allowed to be used after the expiration date. The drug is not subject to repeated quality control and extension of the expiration date after its expiration.
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.
Method of administration and doses
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
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.
Side effects
During basic courses of treatment with Alfarekin® suppositories in recommended doses, side effects are not observed. Rectal administration of the drug is not accompanied by pronounced 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.
General disorders. When administering Alfarekin®, flu-like symptoms are possible: chills, fever, fatigue, lethargy, as well as headache, muscle and joint pain, sweating; rarely - vomiting, dizziness, hot flashes. Hypersensitivity reactions to the drug are possible.
Hematopoietic system disorders. With prolonged use, leukopenia, thrombocytopenia, anemia, and nosebleeds are possible.
Gastrointestinal and hepatic disorders. Increased ALT and AST levels, increased LF levels, loss of appetite. Liver dysfunction.
Endocrine disorders. Thyroid dysfunction.
Central and peripheral nervous system disorders. With prolonged use, dizziness, sleep disturbances, confusion, anxiety and depression, increased excitability, drowsiness, ataxia, paresthesias are possible.
Cardiovascular system disorders: Hypertension or hypotension may occur; rarely, tachycardia.
Skin and subcutaneous tissue disorders: Allergic reactions, including rash (including herpetic), itching, flushing, urticaria, anaphylactic shock.
Respiratory system disorders: cough.
Other: changes at the injection site, visual disturbances, renal dysfunction, electrolyte imbalance.
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.
Address
Ukraine, 08135, Kyiv region, Kyiv-Svyatoshynskyi district, Chaykyi village, Hrushevskoho str., 60.
Applicant
LLC "VALARTIN PHARMA"
Location of the applicant.
Ukraine, 08135, Kyiv region, Kyiv-Svyatoshyn district, Chayky village, Hrushevskoho str., 60.
