Composition, form of production and packaging
Powder for the preparation of solution for the / m introduction 1 fl.
aminodihydrophthalazinedione sodium 50 mg
- "- 100 mg
Vials (3) - packs of cardboard.
Vials (5) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
PHARMACHOLOGIC EFFECT
The mechanism of action is related to the ability to influence the functional metabolic activity of phagocytic cells (monocytes / macrophages, neutrophils, natural killers). In addition, Galavit В® normalizes antibody formation, indirectly stimulates the production of endogenous interferons (IFN-О±, IFN-ОІ).
In inflammatory diseases reversibly (for 6-8 hours) inhibits excessive synthesis of hypercoagulant macrophages by tumor necrosis factor-, interleukin-1, interleukin-6 and other pro-inflammatory cytokines, active forms of oxygen, whose level determines the degree of inflammatory reactions, their cyclicity, and also the severity of intoxication and the level of oxidative stress. 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 by the kidneys. After the / m introduction, T 1/2 is 30-40 minutes.
The main pharmacological effects are observed for 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 and inflammatory diseases of the urogenital tract (urethritis of chlamydial and trichomonas etiology, chlamydial prostatitis, acute and chronic salpingoophoritis, endometritis);
- Pyoinflammatory diseases of the pelvic organs;
- postoperative rehabilitation of patients with uterine myoma;
- Complications of the postoperative period in patients of reproductive age;
- postoperative purulent-septic complications and their prevention (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.
As a monotherapy in adults and adolescents from the age of 12:
- acute and chronic infectious-inflammatory diseases of the gastrointestinal tract, accompanied by intoxication and / or diarrhea;
- chronic urogenital infections, incl. when carrying out immunorehabilitation activities during the inter-recurrence period with the aim of maintaining clinical remission.
As an immunomodulatory and anti-inflammatory drug in the complex therapy of immunodeficient conditions in children over 6 years of age:
- Purulent surgical diseases (including burn injuries, recurrent furunculosis, chronic osteomyelitis, gangrenous appendicitis with omentitis, peritonitis, purulent pleurisy);
- frequent recurrent diseases of the respiratory tract and ENT organs of bacterial and viral etiology (including frequent ARI, bronchitis, pneumonia, chronic tonsillitis, chronic otitis media, chronic adenoiditis).
DOSING MODE
Intramuscularly. Before the introduction of the drug, dilute in 2 ml of water for injection or in a 0.9% solution of sodium chloride.
The methods of administration, dosages and duration are chosen by the physician depending on the diagnosis, the severity of the disease, and the age of the patient.
With peptic ulcer of the stomach and duodenum in the acute period - 2 days for 200 mg 1 time / 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 1 time / day, then - 100 mg every 72 hours. Course - 20 injections.
In viral hepatitis, the initial dose is 200 mg once, then 100 mg twice a day until the symptoms of intoxication and inflammation stop. The subsequent continuation of the course of therapy in a dose of 100 mg with an interval of 72 hours. Course - 20-25 injections.
In chronic relapsing diseases caused by the herpes virus, 100 mg daily 5 injections, then 100 mg every other day 15 injections.
For diseases caused by the human papillomavirus, appoint 100 mg once a day for 5 days, then 100 mg every other day for 15 injections. Course - 20 injections.
With urogenital infections (chlamydial and trichomonadal urethritis, chlamydial prostatitis), the drug is prescribed 100 mg 2 times / day on day 1, then 100 mg every other day. Course - 10-15 injections, depending on the severity of the pathological process.
With salpingo-oophoritis, endometritis in the acute period - for 2 days 200 mg 1 time / day, then - 100 mg with an interval of 72 hours, the duration of use depends on the severity of the disease. Course - 20 injections. In the chronic period - for 5 days to 100 mg 1 time / day, then - to 100 mg every 72 hours. Course - 20 injections.
In acute and chronic purulent diseases of the pelvic organs in the acute period , 200 mg once is prescribed on the first day, then 3 days at 100 mg daily, then 100 mg every other day 5 injections. Course - 10 injections. In the chronic period - for 5 days to 100 mg 1 time / day, then - to 100 mg every 72 hours. Course - 20 injections.
For postoperative rehabilitation of patients with uterine myoma and with postoperative complications, women of reproductive age are prescribed 100 mg once a day for 5 days, then 100 mg every other day. Course - 15 injections.
For the prevention and treatment of complications in the pre-operative and postoperative period (including in cancer patients) , 100 mg 1 time / day are prescribed.Before the operation, 5 injections, after the operation, 5 injections of 100 mg every other day and 5 injections of 100 mg every 72 hours. In severe cases, the initial dose of 200 mg 1 time / day or 100 mg 2 times / day. Course - 20 injections.
With chronic recurrent furunculosis, erysipelas are prescribed 100 mg of the drug 1 time / day for 5 days, then - 100 mg every other day. Course - 20 injections.
With asthenic conditions, neurotic and somatoform disorders, with mental, behavioral and post-abstinence disorders, patients with alcohol and drug dependence are prescribed for 5 days 100 mg once a day, then 100 mg after 72 hours. The course is 15- 20 injections.
To increase physical performance , 100 mg every other day 5 injections, then 100 mg every 72 hours. Course - up to 20 injections.
With inflammatory diseases of the oral and pharyngeal mucosa, periodontal diseases, the initial dose of 100 mg daily 5 injections, then - 100 mg with an interval of 72 hours. Course - 15 injections.
Adults and adolescents with 12 years (as a monotherapy)
In acute and chronic infectious and inflammatory diseases of the digestive tract, accompanied by intoxication and / or diarrhea , 200 mg once, then 100 mg 2 times / day until the symptoms of intoxication are stopped. Perhaps the subsequent continuation of the course of 100 mg with an interval of 72 hours. Course - 20-25 injections.
With chronic urogenital infections, incl. when immunorehabilitation measures are performed during the inter-recurrence period , 100 mg every other day are prescribed to maintain clinical remission . Course - 10 injections.
Children over the age of 6 years
When purulent surgical diseases (burn lesions, recurrent furunculosis, chronic osteomyelitis, gangrenous appendicitis with omentitis, peritonitis, purulent pleurisy), the drug is prescribed for children aged 6 to 11 years - 1 injection 50 mg 1 time / day for 5 days, then 1 injection of 50 mg every other day for 10-15 days. The rate is 10-15 injections. Children and adolescents aged 12 to 18 years are treated according to the same scheme in the form of intramuscular injections of 100 mg.
In dressings, external application of Galavit in the form of dressings with sterile napkins moistened with 1% Galavit solution 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 ARVI, bronchitis, pneumonia, chronic tonsillitis, chronic otitis, chronic adenoiditis) children aged 6 to 11 years are prescribed 1 injection of 50 mg daily for 5 days , then - 50 mg 1 time / day every other day for 10-15 days. The rate is 10-15 injections. Children and adolescents aged 12 to 18 years are treated according to the same scheme in the form of intramuscular injections of 100 mg.
SIDE EFFECT
Rarely: allergic reactions are possible.
CONTRAINDICATIONS
- Pregnancy;
- lactation period;
- Children under 6 years of age (there is no clinical experience with the drug);
- Individual intolerance.
PREGNANCY AND LACTATION
The drug is not prescribed for pregnancy and lactation.
APPLICATION FOR CHILDREN
The drug is not prescribed for children under the age of 6 years.
SPECIAL INSTRUCTIONS
With simultaneous use with antibiotics, it is possible to reduce the exchange rates of the latter.
Impact on the ability to drive vehicles and manage mechanisms
No information.
OVERDOSE
Cases of overdose are not marked.
DRUG INTERACTION
Cases of incompatibility with other drugs have not been noted.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children, protected from light at a temperature of 15 В° to 25 В° C. Shelf life - 4 years.
