Active substanceAmino dihydrophthalazinedione sodiumAmino dihydrophthalazinedione sodium
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  • Galavit®
    suppositories rect. 
    SELVIM, LLC     Russia
  • Galavit®
    powder w / m 
    SELVIM, LLC     Russia
  • Galavit®
    pills n / az. 
    SELVIM, LLC     Russia
  • Dosage form: & nbspPowder for solution for intramuscular injection
    Composition:

    Pharmaceutical substance: aminodihydrophthalazinedione sodium (Galavit®) - 50 mg, 100 mg.

    Pharmacotherapeutic group:Immunomodulating and anti-inflammatory agent
    ATX: & nbsp

    L.03   Immunostimulators

    Pharmacodynamics:

    The mechanism of action of the drug is associated with its ability to affect the functionally metabolic activity of phagocytic cells (monocytes / macrophages, neutrophils, natural killers). In addition, Galavit normalizes antibody formation, indirectly stimulates the production of endogenous interferons (IFN-α, IFN-γ).

    In inflammatory diseases, the drug reversibly for 6-8 hours inhibits excessive synthesis of hyperactivated macrophages tumor necrosis factor-α, interleukin-1, interleukin-6 and other pro-inflammatory cytokines, active forms of oxygen, the level of which determines the degree of inflammatory reactions, their cyclicity, and the severity intoxication and oxidant stress level. Normalization of the functional state of macrophages leads to the restoration of the antigen presenting and regulating function of macrophages, to a decrease in the level of autoaggression.Stimulates bactericidal activity of neutrophilic granulocytes, enhancing phagocytosis and increasing unspecific resistance of the organism to infectious diseases.

    Pharmacokinetics:It is excreted from the body, mainly through the kidneys. After intramuscular injection, the elimination half-life is 30-40 minutes. The main pharmacological effects are observed within 72 hours.
    Indications:

    As an immunomodulatory and anti-inflammatory drug in the complex therapy of immunodeficient conditions in adults and adolescents from the age of 12:

    - Stomach ulcer and duodenal ulcer;

    - viral hepatitis;

    - chronic recurrent diseases caused by the herpes virus;

    - diseases caused by the human papillomavirus;

    - Infectious-inflammatory urogenital diseases (urethritis of chlamydial and trichomonas etiology, chlamydial prostatitis, acute and chronic salpingo-oophoritis, endometritis);

    - Pyoinflammatory diseases of the pelvic organs;

    - postoperative rehabilitation of patients with uterine myoma;

    - Complications of the postoperative period in women of reproductive age;

    - postoperative purulent-septic complications and their prophylaxis (including in cancer patients);

    - chronic recurrent furunculosis, erysipelas.

    - asthenic conditions, neurotic and somatoform disorders, decrease in physical working capacity (including athletes); mental, behavioral and post-abstinence disorders in alcohol and drug dependence;

    - inflammatory diseases of the mucous membrane of the oral cavity and throat, periodontal disease.

    In adults and adolescents with 12 years in monotherapy:

    - acute and chronic infectious and inflammatory diseases of the gastrointestinal tract, accompanied by intoxication and / or diarrhea;

    - chronic urogenital infections, including during immunorehabilitation activities during the inter-recessive period with the aim of maintaining clinical remission.

    As an immunomodulating and anti-inflammatory drug in the complex therapy of immunodeficiency states in children older than 6 years:

    - purulent surgical diseases (burn injury, relapsing furunculosis, chronic osteomyelitis, gangrenous omentitom with appendicitis, peritonitis, purulent pleuritis);

    - frequent recurrent airway disease and ENT bacterial and viral etiology (frequent SARS, bronchitis, pneumonia, chronic tonsillitis,chronic otitis media, chronic adenoiditis).

    Contraindications:

    Individual intolerance; pregnancy and lactation; Children under 6 years of age (no clinical experience of use).

    Pregnancy and lactation:

    The drug is not prescribed to pregnant women, women during breastfeeding, children under 6 years.

    Dosing and Administration:

    Intramuscularly. Before the introduction, the drug is diluted in 2 ml of water for injection or 0.9% solution of sodium chloride. Methods of application, dose and duration of use are chosen by the doctor depending on the diagnosis, severity of the disease, age of the patient.

    - With peptic ulcer of stomach and duodenum in acute period: 2 days of 200 mg once a day, then 100 mg with an interval of 72 hours. The course of 15-25 injections. In the chronic period: 5 days of 100 mg once a day, then 100 mg after 72 hours. Course of 20 injections.

    - In viral hepatitis, the initial dose is 200 mg once, then 100 mg 2 times a day until the symptoms of intoxication and inflammation stop. The subsequent continuation of the course of 100 mg with an interval of 72 hours. The course of 20 -25 injections.

    - For chronic recurrent diseases caused by the herpes virus: 100 mg daily 5 injections, then 100 mg every other day 15 injections.

    - In diseases caused by papilloma virus 5 days on 100 mg 1 time per day, followed by 100 mg every other day injections 15. Course - 20 injections.

    - When urogenital diseases - chlamydial urethritis and trichomonas etiology chlamydial prostatitis 1 day 100 mg twice, then 100 mg every other day. The course of 10-15 injections (depending on the severity of the pathological process).

    - When oophoritis, endometritis in the acute period 2 days 200 mg 1 time per day, followed by 100 mg every 72 hours, the duration of the application depends on the severity of the disease. A total of 20 injections. In the chronic period - 5 days to 100 mg once a day, then to 100 mg every 72 hours. Course of 20 injections.

    - In acute and chronic purulent diseases of the pelvic organs: in an acute period - 1 day 200 mg once, 3 days for 100 mg daily, then 100 mg every other day 5 injections. A course of 10 injections. In the chronic period - 5 days to 100 mg once a day, then 100 mg every 72 hours. Course - 20 injections.

    - For post-operative rehabilitation of patients with uterine fibroids and postoperative complications in women of reproductive age: 5 days of 100 mg 1 time per day, followed by 100 mg every other day. Course - 15 injections.

    - For the prevention and treatment of postoperative infectious complications in pre- and postoperative period (including cancer patients), 100 mg once a day, 5 injections before surgery, 5 after surgery, 100 mg every other day, and 5 injections of 100 mg every 72 hours. In severe cases, the initial dose of 200 mg once or twice a day for 100 mg. Course - 20 injections.

    - In chronic recurrent furunculosis, erysipelas - 5 days of 100 mg once a day, then 100 mg every other day. Course of 20 injections.

    - With asthenic conditions, neurotic and somatoform disorders, with mental, behavioral and post-abstinence disorders, in patients with alcohol and drug dependence: 5 days, 100 mg daily, then 100 mg after 72 hours. The course of 15-20 injections. To increase physical performance: 100 mg every other day - 5 injections, then 100 mg after 72 hours, course up to 20 injections.

    - With inflammatory diseases of the mucous membrane of the oral cavity and throat, periodontal diseases: the initial dose of 100 mg daily 5 injections, then 100 mg with an interval of 72 hours. A course of 15 injections.

    In adults and adolescents with 12 years in monotherapy:

    - acute and chronic infectious and inflammatory diseases of the gastrointestinal tract, accompanied by intoxication and / or diarrhea: 200 mg once, then 100 mg 2 times a day until symptoms of intoxication stop.Perhaps the subsequent continuation of the course of 100 mg with an interval of 72 hours. Course of 20-25 injections.

    - chronic urogenital infections, including during immunorehabilitation activities in the inter-recessive period with the aim of maintaining clinical remission: 100 mg every other day by a course of 10 injections.

    In children older than 6 years:

    - For purulent surgical diseases (burn lesions, recurrent furunculosis, chronic osteomyelitis, gangrenous appendicitis with omentitis, peritonitis, purulent pleurisy): for children from 6 to 11 years, one injection 50 mg daily - 5 days, then one injection 50 mg every other day during 10-15 days. Course 10-15 injections; children aged 12-18 years - treatment is carried out according to the same scheme in the form of intramuscular injections of 100 mg. In dressings, external application of galavite in the form of dressings with sterile wipes moistened with 1% solution of galavite in water for injection (in bandages with a talker or water-soluble ointment dressings) is desirable.

    - With frequent recurrent diseases of the respiratory tract and ENT organs of bacterial and viral etiology (frequent acute respiratory viral infection, bronchitis, pneumonia, chronic tonsillitis, chronic otitis, chronic adenoiditis): children from 6 to 11 years, one injection of 50 mg daily for 5 days, then 50 mg once a day every other day for 10-15 days.The course of 10-15 injections. Children aged 12-18 years - treatment by the same scheme in the form of intramuscular injections of 100 mg.

    Side effects:

    In rare cases, allergic reactions are possible.

    Overdose:Cases of overdose are not marked.
    Interaction:

    With simultaneous use, it is possible to reduce the dose of antibiotics. Cases of incompatibility with other drugs have not been noted.

    Special instructions:

    Precautions for use

    There are no special measures.

    Effect on the ability to drive transp. cf. and fur:

    There is no information.

    Form release / dosage:Powder for the preparation of solution for intramuscular injection 50 mg, 100 mg.
    Packaging:Vials, packs cardboard.
    Storage conditions:

    At temperatures from + 15 ° С to + 25 ° С in the dark place.

    Keep out of the reach of children.

    Shelf life:4 years. Do not use after the expiration date indicated on the cardboard pack.
    Terms of leave from pharmacies:On prescription
    Registration number:P N000088 / 02
    Date of registration:02.06.2010 / 07.10.2013
    Expiration Date:Unlimited
    The owner of the registration certificate:SELVIM, LLC SELVIM, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp12.03.2017
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