Galavit 50 mg 5 pcs. injection solution for intramuscular administration Selvim 1/5

pharmachologic effect

Immunomodulatory and anti-inflammatory agent.

Composition and release form Galavit 50 mg 5 pcs. injection solution for intramuscular administration Selvim 1/5

Pharmaceutical substance: sodium aminodihydrophthalazindione (Galavit®) - 50 or 100 mg.

Description of the dosage form

Crystalline powder - white or white with a yellowish tint.

Suppositories - from white to white with a yellowish tint, torpedo-shaped without visible inclusions on a longitudinal section.

Directions for use and doses

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

For gastric and duodenal ulcers in the acute period: 2 days, 200 mg once a day, then 100 mg at intervals of 72 hours. A course of 15-25 injections. In the chronic period: 5 days, 100 mg once a day, then 100 mg every 72 hours. Course of 20 injections.
For viral hepatitis: the initial dose is 200 mg once, then 100 mg 2 times a day until the symptoms of intoxication and inflammation subside. Subsequent continuation of the course of 100 mg at intervals of 72 hours. Course 20 - 25 injections.
For chronic recurrent diseases caused by the herpes virus: 100 mg daily for 5 injections, then 100 mg every other day for 15 injections.
For diseases caused by the papilloma virus: 5 days, 100 mg once a day, then 100 mg every other day, 15 injections. Course of 20 injections.
For urogenital diseases - urethritis of chlamydial and trichomonas etiology, chlamydial prostatitis: 1 day 100 mg twice, then 100 mg every other day. A course of 10-15 injections (depending on the severity of the pathological process).
For salpingoophoritis, endometritis in the acute period: 2 days, 200 mg once a day, then 100 mg at intervals of 72 hours, duration of use depends on the severity of the disease. There are a total of 20 injections per course. In the chronic period: 5 days, 100 mg once a day, then 100 mg every 72 hours. Course of 20 injections.
For acute and chronic purulent diseases of the pelvic organs: in the acute period - 1 day 200 mg once, 3 days 100 mg daily, then 100 mg every other day 5 injections. Course of 10 injections. In the chronic period – 5 days, 100 mg once a day, then 100 mg every 72 hours. Course of 20 injections.
For postoperative rehabilitation of patients with uterine fibroids and complications of the postoperative period in women of reproductive age: 5 days, 100 mg once a day, then 100 mg every other day. Course of 15 injections.
For the prevention and treatment of postoperative infectious complications in the pre- and postoperative period (including in cancer patients): prescribed 100 mg once a day, 5 injections before surgery, 5 after surgery, 100 mg every other day, and 5 injections of 100 mg. with an interval of 72 hours. For severe disease, the initial dose is 200 mg once or 100 mg 2 times a day. Course of 20 injections.
For chronic recurrent furunculosis, erysipelas: 5 days, 100 mg once a day, then 100 mg every other day. Course of 20 injections.
For asthenic conditions, neurotic and somatoform disorders, for mental, behavioral and post-abstinence disorders, in patients with alcohol and drug addiction: 5 days, 100 mg daily, then 100 mg every 72 hours. A course of 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.
For inflammatory diseases of the mucous membrane of the mouth and throat, periodontal diseases: initial dose of 100 mg daily for 5 injections, then 100 mg at intervals of 72 hours. Course of 15 injections.

In adults and adolescents over 12 years of age 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 the symptoms of intoxication subside. It is possible to subsequently continue the course of 100 mg at intervals of 72 hours. A course of 20-25 injections.
chronic urogenital infections, including when carrying out immunorehabilitation measures during the inter-relapse period in order to maintain clinical remission: 100 mg every other day in a course of 10 injections.

In children over 6 years of age:

For purulent surgical diseases (burn lesions, recurrent furunculosis, chronic osteomyelitis, gangrenous appendicitis with omentitis, peritonitis, purulent pleurisy): children from 6 to 11 years old, one injection of 50 mg daily for 5 days, then one injection of 50 mg every other day within 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. When dressings, it is desirable to apply Galavit externally in the form of dressings with sterile napkins moistened with a 1% solution of Galavit in water for injection (in dressings with mash or water-soluble ointment dressings).
For 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 from 6 to 11 years old, one injection of 50 mg daily for 5 days, then 50 mg once a day every other day for 10 – 15 days. A course of 10-15 injections. Children aged 12-18 years – treatment according to the same regimen in the form of intramuscular injections of 100 mg.

Pharmacodynamics

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

In inflammatory diseases, the drug reversibly inhibits for 6-8 hours the excessive synthesis of tumor necrosis factor-α, interleukin-1, interleukin-6 and other pro-inflammatory cytokines, reactive oxygen species by hyperactivated macrophages, the level of which determines the degree of inflammatory reactions, their cyclicity, as well as severity intoxication and level of oxidative stress. Normalization of the functional state of macrophages leads to the restoration of the antigen-presenting and regulatory functions of macrophages and a decrease in the level of autoaggression. Stimulates the bactericidal activity of neutrophil granulocytes, enhancing phagocytosis and increasing the body's nonspecific resistance to infectious diseases.

Pharmacokinetics

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

Indications for use Galavit 50 mg 5 pcs. injection solution for intramuscular administration Selvim 1/5

As an immunomodulatory and anti-inflammatory agent in the complex therapy of immunodeficiency conditions in adults and adolescents from 12 years of age:

peptic ulcer of the stomach and duodenum;
viral hepatitis;
chronic recurrent diseases caused by the herpes virus;
diseases caused by the human papillomavirus;
infectious and inflammatory urogenital diseases (urethritis of chlamydial and trichomonas etiology, chlamydial prostatitis, acute and chronic salpingoophoritis, endometritis);
purulent-inflammatory diseases of the pelvic organs;
postoperative rehabilitation of patients with uterine fibroids;
complications of the postoperative period in women of reproductive age;
postoperative purulent-septic complications and their prevention (including in cancer patients);
chronic recurrent furunculosis, erysipelas.
asthenic conditions, neurotic and somatoform disorders, decreased physical performance (including in athletes); mental, behavioral and post-withdrawal disorders in alcohol and drug addiction;
inflammatory diseases of the mucous membrane of the mouth and throat, periodontal diseases.

In adults and adolescents over 12 years of age in monotherapy:

acute and chronic infectious and inflammatory diseases of the gastrointestinal tract, accompanied by intoxication and/or diarrhea;
chronic urogenital infections, including when carrying out immunorehabilitation measures during the inter-relapse period in order to maintain clinical remission.

As an immunomodulatory and anti-inflammatory agent in the complex therapy of immunodeficiency conditions in children over 6 years of age:

purulent surgical diseases (burn lesions, 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 (frequent ARVI, 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).

Application Galavit 50 mg 5 pcs. injection solution for intramuscular administration of Selvim 1/5 during pregnancy and lactation

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

special instructions

There are no special measures.

Overdose

No cases of overdose have been reported.

Side effects Galavit 50 mg 5 pcs. injection solution for intramuscular administration Selvim 1/5

In rare cases, allergic reactions are possible.

Drug interactions

With simultaneous use, it is possible to reduce the course doses of antibiotics. There are no cases of incompatibility with other drugs.

General information

Registration number P N000088/02
Trade name: Galavit®

INN or group name: Sodium aminodihydrophthalazindione.

Dosage form: powder for the preparation of a solution for intramuscular administration.

Compound:

Active ingredient: sodium aminodihydrophthalazindione - 50 mg and 100 mg.

Pharmacotherapeutic group:

Immunomodulatory and anti-inflammatory agent.

ATX code: L03, G02.

Pharmacological properties

Pharmacodynamics

The mechanism of action of the drug is associated with its ability to regulate the functional and metabolic activity of innate and adaptive immune cells (monocytes, macrophages, neutrophils, natural killer cells, etc.). The drug Galavit normalizes the phagocytic activity of monocytes/macrophages, the bactericidal activity of neutrophils and the cytotoxic activity of NK cells.

At the same time, by restoring the reduced activity of innate and adaptive immune cells, the drug increases the body’s resistance to infectious diseases.

In addition, the drug Galavit normalizes antibody formation, indirectly stimulates the production of endogenous interferons (IFN-α, IFN-γ), and increases the functional activity (affinity) of antibodies.

Galavit reduces the production of reactive oxygen species by hyperactivated macrophages, thereby reducing the level of oxidative stress and protecting tissues and organs from the destructive effects of radicals.

Normalization of excessively increased functional activity of phagocytic cells leads to the restoration of their antigen-presenting and regulatory functions, and a decrease in the level of autoaggression.

The drug has no allergenic, mutagenic, embryotoxic, teratogenic or carcinogenic effects.

Pharmacokinetics

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