IFN-EU lipint lyophilizate for prig.suspenzii inside 500000me fl 5 pcs

Description

Composition
Active substance:
1 vial contains: 250 thousand IU, 500 IU or 1 thousand million IU of interferon alfa-2b recombinant human ;…
Excipients:
Sodium chloride – 8.01 mg sodium phosphate dodecahydrate – 4.52 mg sodium dihydrogen phosphate dihydrate – 0.56 mg, lipoids C100 (phospholipids [mixture with a percentage of phosphatidylcholine of at least 94%]) – 41.18 mg Cholesterol – 4.53 mg, alpha-tocopherol acetate – 0.56 mg lactose monohydrate – 91.34 mg.
Description:
Powder or porous mass of white or yellowish color. It allowed peeling, completely or partially, from the surface of the glass vial to form tabletopodobnoy form. Hygroscopic.
Product form:
Lyophilisate for suspension for oral administration.
250 thousand. IU or 500 thousand. IU or 1 million IU active substance in glass vials. The vials were hermetically capped with rubber stoppers and crimped aluminum caps.
1 bottle together with instructions for use in a cardboard package.
3, 5 or 6 vials in a blister made of PVC film; 1 or 2 cell package together with instructions for use in a cardboard package.
Contraindications
– Increased sensitivity to interferon or any other components of the formulation; – severe forms of allergic diseases; – lactase deficiency, lactose intolerance, glucose-galactose malabsorption; – Pregnancy and lactation.
Carefully
Hepatic and / or renal insufficiency, severe myelosuppression, thyroid disease.
Application of pregnancy and during breastfeeding
The drug is contraindicated during pregnancy and lactation.
Dosage
500 thousand. IU
Indications
Combined therapy of patients with acute hepatitis B, chronic hepatitis B in the active and inactive forms of replication, as well as chronic hepatitis B complicated by glomerulonephritis.
Treatment of patients with atopic diseases, allergic rhinoconjunctivitis, asthma during specific immunotherapy.
Prevention and treatment of influenza and acute respiratory viral infections in adults and children.
Combined therapy of urogenital chlamydial infection in adults.
Combined therapy of febrile and meningeal form of tick-borne encephalitis in adults.
Emergency prevention TBE in combination with protivokleschevye immunoglobulin.
Interaction with other drugs
Interferon alpha-2b is able to reduce the activity of cytochrome P450 isoenzymes and therefore interfere with the metabolism of cimetidine, phenytoin dipyridamole, theophylline, diazepam, propranolol, warfarin, some cytostatics. May potentiate neurotoxic, myelotoxic or cardiotoxic action of drugs prescribed previously or simultaneously therewith. Avoid concomitant administration with drugs that depress the central nervous system, immunosuppressive drugs (including oral and parenteral forms of corticosteroids).
Drinking alcohol during treatment is not recommended.
Overdose
Cases of overdose were observed. May increase dose-related side effects. Treatment is symptomatic.
pharmachologic effect
Pharmacological group:
MIP-cytokines.
Pharmacological properties:
It has immunomodulatory and antiviral effect.
Interferon alfa-2b, recombinant human being in the active substance preparation is synthesized bacterial cells of the strain Escherichia coli SG-20050 / pIF16, a genetic unit which is integrated gene of human alpha-2b interferon. It is a protein comprising 165 amino acids and is identical in characteristics and properties of human leukocyte interferon alpha-2b.
The antiviral effect of interferon alpha-2b is shown a reproduction period of the virus by incorporating the active in cell metabolic processes. Interferon alfa-2b, by interacting with specific receptors on cell surfaces triggers a number of intracellular changes that include the synthesis of specific cytokines and enzymes (2-5 adenilatsintetazy and protein), the action which inhibits the formation of the viral protein and viral RNA in the cell.
Immunomodulatory effect of interferon alpha-2b shown in enhancing macrophage phagocytic activity, enhancing a specific cytotoxic action of lymphocytes to target cells, changing the qualitative and quantitative composition of secreted cytokines; change the functional activity of immune cells; changes in production and secretion of intracellular proteins.
IFN-EU Lipint® developed by the specialists of “Vector-Medica” to meet the needs of doctors and patients in an easy to use safe and effective interferon for the treatment of viral diseases such as influenza, tick-borne encephalitis, hepatitis B, hepatitis C and many other adults and children.
By itself, interferon rapidly destroyed under the influence of aggressive environment of the stomach or blood enzymes, so the customary formulations of interferon produced in the form of injections or suppositories. This limits their performance and requires the use of high doses, thus increasing the side effects.
IFN-EU Lipint® – new liposomal formulation of interferon. This means that the interferon molecules are placed inside the smallest biochastits called liposomes. Such bio-interferon protects from destruction in a hostile environment of the stomach, allows for longer circulate in the blood and maintain its activity longer.
Due to the liposome, interferon retains all its therapeutic properties and rarely causes side effects. Prolonged circulation in the blood liposomal interferon provide the same therapeutic effect, but using a lower dose than interferon in suppositories or as an injection.
IFN-EU Lipint® available in vials doses for adults and children from 3 years. Convenient form of drinking and neutral taste of the drug is especially valued in pediatrics. Patients with severe pain in the throat or developed gag reflex also prefer interferon in the vials, IFN-EU Lipint®.
Conditions of supply of pharmacies
On prescription.
side effects
In applying the drug IFN-EU-Lipint in clinical studies adverse drug reactions were observed. Given that the active substance is a recombinant interferon alpha-2b, when using the drug IFN-EU-Lipint possible side effects typical of this group of drugs: chills, fever, asthenia symptoms (apathy, fatigue, lethargy), headache, myalgias, arthralgias . These side effects partly cropped indomethacin / paracetamol. May develop allergic reactions.
From the digestive system: nausea, dry mouth, indigestion, loss of appetite.
From the nervous system: long-term use may be irritability, anxiety, insomnia, apathy, depression.
From endocrine system: possible changes in the thyroid gland.
From laboratory indicators: long-term use may be leukopenia, lymphopenia, thrombocytopenia.
special instructions
In diseases of the thyroid gland the administration of the drug should be under the supervision of an endocrinologist. When the therapy symptoms thyroid dysfunction, it is recommended to control the concentration of thyroid stimulating hormone (TSH).
Effect on the ability to drive mechanisms and
The period of application of the drug to patients experiencing fatigue, drowsiness or disorientation, should refrain from activities potentially hazardous activities that require high concentration and psychomotor speed reactions.
In the production of the drug IFN-EU Lipint® not used human leukocyte interferon, which means that the drug is safe and is not a source of HIV infection, hepatitis and other diseases transmitted through blood.
Storage conditions
Store in a dark place at a temperature of not higher than 8 ° C.
Keep out of the reach of children.
Dosing and Administration
It is administered orally.
Immediately prior to use the contents of the vial was added 1.2 ml of chilled distilled or boiled water. With shaking for 1-5 minutes, a homogeneous suspension has formed.
The prevention and treatment of influenza and acute respiratory viral infections take the drug 30 minutes before a meal – for prevention: adults and children over 15 years – 500 thousand IU once a day, 2 times a week for 1 month while lifting morbidity. children from 3 to 15 years -. 250 thousand IU once a day, 2 times a week for 1 month at the time of rise of morbidity. – With flu and SARS treatment: adults and children over 15 years – 500 thousand IU daily 2 times a day for 3 days. children from 3 to 15 years -. 250 thousand IU daily 2 times a day for 3 days.
In treatment of tick-borne encephalitis drug taking 30 minutes before meals: – when feverish form: 500 thousand IU 2 times a day (morning and night) for 7 days. – with meningeal form: 500 thousand IU 2 times a day (morning and evening) for 10 days.
When the emergency prevention of tick-borne encephalitis, drug taking for 30 minutes before a meal to 500 thousand. IU 2 times a day (morning and evening) for 5 days. Protivokleschevoy immunoglobulin is administered intramuscularly once no later than 4 days after the tick bite at a dose of 0.1 ml / kg.
In acute hepatitis B drug taking for 30 minutes before a meal, as follows: – adults and children of school age – at 1 million IU 2 times a day for 10 days; – pre-school children (3 to 7 years.) – 500 thousand IU 1 time per day for 10 days, or after the monitoring of biochemical blood tests, a longer period – up to full clinical recovery.
In chronic hepatitis B in the active and inactive replicative forms as well as in chronic hepatitis B, associated with glomerulonephritis take medication for 30 minutes before a meal, as follows: – adults and children of school age – at 1 million IU twice daily for 10 days, and then for 1 month – every other day, once a day (at night); – pre-school children (3 to 7 years.) – 500 thousand IU twice a day for 10 days and then – 500 thousand IU for 1 month every other day, once a day (at night)..
In carrying out immunotherapy take medication in the morning, after 30 minutes of a meal, as follows: – in allergic rhinoconjunctivitis adults – 500 thousand IU daily for 10 days (a course dose of 5 million IU). – with atopic asthma adults – 500 thousand IU once daily for 10 days and then 500 thousand IU every other day for 20 days… The total duration of treatment of 30 days.
When the complex treatment of urogenital infections in adults taking the drug for 30 minutes before a meal to 500 thousand. IU daily 2 times a day for 10 days.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist