Active substanceInterferon alfa-2Interferon alfa-2
Similar drugsTo uncover
  • Intel®-P
    lyophilizate for injections 
  • Infagel
    gel locally externally 
    VECTOR-MEDICA, CJSC     Russia
  • Dosage form: & nbsp
    lyophilizate for solution for injection
    Composition:

    The drug is a globular, monomeric, recombinant protein consisting of 165 amino acids synthesized by the strain Pseudomonas putida VG-84 (pVG3), in the genetic apparatus of which the human leukocyte interferon alpha-2 gene is built.

    One ampoule of the drug contains 0.5 million ME, 1.0 million ME, 3.0 million ME or 5.0 million ME interferon alpha-2, excipients: albumin, infusion solution 10% (in dry albumin) - 5 mg, sodium chloride - 3.2 mg, sodium hydrogen phosphate - 2.6 mg, sodium dihydrogen phosphate - 0.3 mg.

    Description:The porous mass or powder is white. Hygroscopic.
    Pharmacotherapeutic group:Interferon alfa
    ATX: & nbsp

    L.03.A.B.01   Interferon alfa

    Pharmacodynamics:Intel®-P has antiviral, antitumor, immunomodulating activity. When parenteral administration is disintegrated, partially excreted unchanged, mainly through the kidneys: The drug, like all interferons, can lead to the appearance of specific antibodies, which leads to a decrease in its therapeutic effect.
    Indications:

    Integral-P is used in complex therapy in adults:

    - with acute viral hepatitis B - moderate and severe forms at the beginning of the icteric period before the 5th day of jaundice (at a later date, the administration of the drug is less effective, Inter-P is not effective in developing hepatic coma and the cholestatic course of the disease);

    - with acute prolonged hepatitis B, chronic active hepatitis B and D without signs of cirrhosis and with the initial stage of cirrhosis;

    - with chronic active hepatitis C, accompanied by the definition of antibodies to hepatitis C virus, high viral load according to polymerase chain reaction, increased activity of alanine aminotransferase (ALAT) without signs of hepatic decompensation (Child-Pugh class A). For the treatment of chronic viral hepatitis C, monotherapy or combination therapy with ribavirin is recommended in the absence of contraindications. Duration of treatment and optimal doses of drugs are determined by the attending physician depending on the tolerability of the therapy and its results;

    - in viral (influenza, adenovirus, enterovirus, herpetic, parotitic), viral-bacterial and mycoplasma meningoencephalitis. The use of Interal®-P is most effective in the first 4 days of the disease;

    - with stromal keratitis and keratoyridocyclitis;

    - with stage IV kidney cancer, hairy cell leukemia, malignant skin lymphomas (mushroom mycosis, primary reticulosis), Kaposi's sarcoma, basal cell and squamous cell carcinomas, keratoacanthoma, chronic myelogenous leukemia, histocytosis-X, subleukemic myelosis, essential thrombocytopenia;

    - with multiple sclerosis.

    Integral-P is used in complex therapy in children:

    - with acute lymphoblastic leukemia in the remission period after the end of inductive chemotherapy (for 4-5 months of remission);

    - with respiratory papillomatosis of the larynx, starting from the next day after removal by papillomas;

    - with chronic active hepatitis C in children, starting with three years, in monotherapy and in combination therapy with antiviral drugs.

    Contraindications:Severe forms of allergic diseases; pregnancy.
    Dosing and Administration:

    Integral®-P is used intramuscularly, in the focus or under the lesion, subconjunctivally. Immediately before use, the contents of the ampoule are dissolved in water for injection (1 ml for intramuscular administration and introduction into the focus, 5 ml for subconjunctival administration). The dissolution time is not more than 3 min.The drug solution should be transparent, without foreign inclusions. The diluted drug is not subject to storage.

    Intramuscular injection. For acute hepatitis B, Intral®-P is administered 1 million IU 2 times a day for 5-6 days, then the dose is reduced to 1 million IU per day and injected for another 5 days. If necessary (after the control biochemical blood tests) the treatment course can be continued 1 million ME 2 times a week for 2 weeks. The exchange rate is 15-21 million ME.

    In acute prolonged and chronic active hepatitis B, with the exception of delta infection and without signs of hepatic cirrhosis, Intel®-P is administered 1 million ME 2 times a week for 1-2 months. If there is no effect, prolong the treatment to 3-6 months or after the end of the 1-2-month treatment, carry out 2-3 similar courses at intervals of 1-6 months.

    In chronic active hepatitis D without signs of liver cirrhosis, the drug is administered 500,000 to 1 million IU per day 2 times a week for 1 month. Repeated course of treatment after 1-6 months.

    With chronic active hepatitis B and D with signs of cirrhosis of the liver for 250-500 thousand ME per day 2 times a week for 1 month. When there are signs of decompensation, similar repeated courses are conducted with an interval of at least 2 months.

    In chronic hepatitis C, intrauterine-P monotherapy is recommended subcutaneously at 3 million IU once a day every other day for 24 weeks or combined therapy with ribavirin. In case of recurrence of the disease after the course of monotherapy with interferon, the repeated course should be performed in combination with ribavirin for at least 6 months. In patients who do not have RNA of hepatitis C virus (HCV RNA) by the end of the first 6 months of therapy in serum, the treatment is continued for another 6 months. In chronic hepatitis C in children, monotherapy (excluding treatment of patients with the lb genotype of the virus) is recommended for 3 million IU /m2 body surface area, but not more than 3 million ME, 3 times a week or combined therapy with antiviral drugs for 12 months. If there is no early virologic response with monotherapy (after 3 months), it is necessary to switch to combination therapy. With the cancer of the kidney, Intral®-P is used for 3 million ME daily for 10 days. Repeated courses of treatment (3-9 or more) are carried out at intervals of 3 weeks. The total amount of the drug is from 120 million ME to 300 million ME or more. With hairy cell leukemia, Intra® is administered daily for 3-6 million IU for 2 months.After normalization of the hemogram, the daily dose of Interal®-P is reduced to 1-2 million IU. Then support maintenance is prescribed for 3 million ME 2 times a week for 6-7 weeks. The total amount of the drug is 420-600 million ME or more.

    In acute lymphoblastic leukemia in children in remission after the end of inductive chemotherapy (for 4-5 months of remission), 1 million ME once a week for 6 months, then 1 every 2 weeks for 24 months. Simultaneously, supportive chemotherapy is performed. In chronic myelogenous leukemia, 3 million ME daily or 6 million ME every other day. Term of treatment from 10 weeks to 6 months. With histo-cytosis-X, 3 million IU daily for 1 month. Repeated courses with 1-2-month intervals for 1 -3 years. With subleukemic myelosis and essential thrombocytopenia to correct hyperthrombocytosis by 1 million ME daily or 1 day for 20 days. With malignant lymphomas and Kaposi's sarcoma, InterA® is administered 3 million IU per day daily for 10 days in combination with cytostatics (prospidin, cyclophosphamide) and glucocorticosteroids. In the tumor stage of fungal mycosis and reticulosarcomatosis, it is advisable to alternate intramuscular injection of Interal®-P to 3 million ME and intraluminal injection of 2 million ME for 10 days.In patients with erythrodermic stage of fungal mycosis, when the temperature rises above 39 ° C and in case of aggravation of the process, the drug administration should be discontinued. In case of insufficient therapeutic effect, after 10-14 days a second course of treatment is prescribed. After achieving a clinical effect, a maintenance therapy of 3 million IU is prescribed once a week for 6-7 weeks. With respiratory papillomatosis of the larynx, the drug is administered for 100-150 thousand IU per 1 kg of body weight daily for 45-50 days, then in the same dosage 3 times a week for 1 month. The second and third courses are conducted at intervals of 2-6 months. With multiple sclerosis, Intral®-P is prescribed for 1 million ME: for a pyramidal syndrome 3 times a day, for cerebellar syndrome 1-2 times a day for 10 days, followed by 1 million IU once a week for 5-6 months. The total amount of the drug is 50-60 million ME. In persons with a high pyrogenic reaction (39 ° C and above), the simultaneous use of indomethacin is recommended for the administration of Interal®-P.

    Perifocal administration. With basal cell and squamous cell carcinoma, Intral®-P keratoacanthoma is injected under the lesion site of 1 million ME once daily for 10 days.In the case of pronounced local inflammatory reactions, the injection under the lesion is carried out after 1-2 days. At the end of the course, if necessary, conduct a cryodestruction.

    Subconjunctival administration. In stromal keratitis and keratoiridocyclitis, sub-conjunctival injections of Interal®-P are administered at a dose of 60,000 IU in a volume of 0.5 ml daily or every other day, depending on the severity of the process. Injections are performed under local anesthesia with a 0.5% solution of dicain. The course of treatment for 15 to 25 injections.

    Side effects:

    With the parenteral administration of the drug, Intel®-P, chills, fever, fatigue, skin rashes and itching, as well as leuko- and thrombocytopenia, in the case of the latter, a blood test 2-3 times a week is necessary. When the lesion is cut off, a local inflammatory reaction occurs. These side effects are usually not an obstacle to the continued use of InterAral®-P.

    With pronounced local and general adverse reactions, the introduction of Interal®-P should be discontinued.

    Interaction:Not found.
    Form release / dosage:Liofilizate for solution for injection for 0.5 million ME, 1.0 million ME, 3.0 million ME, 5.0 million ME.
    Packaging:Liofilizate for solution for injection for 0.5 million ME, 1.0 million ME, 3.0 million ME, 5.0 million ME in glass ampoules, 5 ampoules in a cassette contour pack. Each package in a cardboard box with instructions for use.
    Storage conditions:

    List B. At a temperature of 2 to 10 ° C, in accordance with SP 3.3.2.1248-03.

    Keep out of the reach of children.

    Shelf life:
    2 years. Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:P N000697 / 01
    Date of registration:18.08.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:GosNII OCHB FMBA, FSUE GosNII OCHB FMBA, FSUE Russia
    Manufacturer: & nbsp
    Information update date: & nbsp30.10.2017
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