Detailed description of the study
In the modern world, more and more patients with chronic infectious diseases are registered every day. For treatment, drugs have been developed that affect not only the pathogen itself (virus, bacteria, fungi), but also the human body to activate the immune system, such drugs include immunomodulators.
Immunomodulators are substances that can increase the activity of the immune system to fight pathogenic organisms (bacteria, viruses, fungi). These drugs are prescribed to correct the functioning of the immune system in complex treatment. Galavit is a synthetic drug that belongs to the immunomodulators and also has an anti-inflammatory effect, the active ingredient of which is aminophthalhydrazite. The mechanism of action of this drug is due to its ability to interact with blood cells (phagocytes, monocytes, neutrophils, macrophages, natural killer cells) to combat pathogenic organisms. Side effects when taking it are rare. This drug is used in children over 12 years of age and adults in the form of tablets or suppositories (suppositories). It is used in complex therapy of many diseases and conditions, including:
- acute respiratory infections;
- diseases of the ENT organs (tonsillitis, otitis media, etc.);
- inflammation of the mouth and gums;
- diseases caused by the herpes virus;
- infectious and non-infectious diseases of the genitourinary system and pelvic organs
- pathology of the gastrointestinal tract;
- asthenia, increased fatigue
- postoperative complications and their prevention.
Galavit indirectly affects the stimulation of interferons (alpha and gamma), promoting the activation of the human immune system. Interferons are a family of protein molecules that belong to cytokines; they actively participate in the immune system to fight pathogenic microorganisms. They regulate intercellular interactions, cell growth and reproduction, and participate in the coordination of innate and acquired immunity.
There are several types of interferons:
- Interferon alpha - produced by leukocytes, participates in the fight against pathogenic microorganisms.
- Interferon beta - produced in fibroblasts, its function is similar to interferon alpha.
- Interferon gamma is synthesized by immune blood cells: T-lymphocytes and so-called killer T-cells. Its function is to have an immunomodulatory and antitumor effect on the cells of the body.
In order to understand how effective treatment with Galavit will be in a patient, especially if the drug is prescribed for a long time, it is necessary to assess sensitivity to it, that is, the body’s ability to produce interferons in response to taking the drug.
The more interferons released, the stronger the immune system's response to this drug and the more effective the treatment.
General information
Trade name Galavit®
Registration number LSR-008746/09
INN or group name Aminodihydrophthalazindione sodium
Chemical name 5-amino-1,2,3,4-tetrahydrophthalazine-1,4-dione sodium salt
Dosage form Sublingual tablets
Release form
Sublingual tablets, 25 mg. 10 or 20 sublingual tablets in blister packs made of polyvinyl chloride film and aluminum foil. 1, 2, 3 or 4 contour packages along with instructions for use in a cardboard box. 10, 20, 30, 40 or 50 contour packs with an equal number of instructions for use in a group pack
Compound
Active ingredient - sodium aminodihydrophthalazindione (Galavit®) 0.025 g, excipients - sorbitol 0.315 g, starch 0.14 g, lactose 0.1 g, calcium stearate 0.005 g, talc 0.015 g and racementol (menthol) 0.0001 g. Description The tablets are white with a yellowish tint, biconvex, without a score, with a menthol odor.
Pharmacotherapeutic group
Immunomodulatory and anti-inflammatory agent.
ATX code L03
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.). 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 of bacterial, viral and fungal etiology, promotes faster elimination of the pathogen from the body, and reduces the frequency, severity and duration of infections.
In addition, Galavit normalizes antibody formation, increases the functional activity (affinity) of antibodies, and indirectly regulates the production of endogenous interferons (IFN-α, IFN-γ) by producer cells. 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 by hyperactivated macrophages, the level of which determines the degree of inflammatory reactions, their cyclicity, as well as the severity of intoxication of the body.
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 is well tolerated and has no allergenic, mutagenic, embryotoxic, teratogenic or carcinogenic effects. Pharmacokinetics Excreted from the body mainly through the kidneys. When administered sublingually, the half-life is 30 minutes. The main pharmacological effects are observed within 72 hours.
Russia, 123290, Moscow, dead end Magistralny 1st, 5A, room. 91 Tel/fax 8-800-707-71-81 E-mail: [email protected] ; https://www.galavit.ru Address of production site 308013, Belgorod, st. Rabochaya, 14 Send claims to the address 123290, Moscow, dead end Magistralny 1st, 5A, room. 91. Tel. 8-800-707-71-81
Indications for use
In adults and adolescents over 12 years of age (including those with secondary immune deficiency) as an immunomodulatory and anti-inflammatory agent in complex therapy:
- acute respiratory infections, diseases of the respiratory tract and ENT organs (including often recurrent ones) of bacterial and viral etiology (ARVI, influenza, bronchitis, pneumonia, tonsillitis, otitis, adenoiditis) and their prevention;
- inflammatory diseases of the mucous membrane of the mouth and throat, periodontal diseases;
- chronic recurrent diseases caused by the herpes virus;
- decreased physical performance (including among athletes)
Directions for use and doses
Sublingually, 1 tablet up to 4 times a day or 2 tablets up to 2 times a day.
- For acute respiratory infections, flu, bronchitis, pneumonia, tonsillitis, otitis, adenoiditis for treatment: 1 tablet 4 times a day. Course 5 days.
- In case of chronic and frequent relapsing course, continue 1 tablet 4 times a day every other day for a course of up to 15 days.
- For prevention: 1 tablet 2 times a day. Course 5-10 days.
- For inflammatory diseases of the mucous membrane of the mouth and throat, periodontal diseases: 1 tablet 4 times a day for 5 days. Then 1 tablet 4 times a day after 3 days for a course of up to 3 weeks.
- For chronic recurrent diseases caused by the herpes virus: 1 tablet 4 times a day for 10 days. Then 1 tablet 4 times a day every other day for 10 days.
- To increase physical performance: 1 tablet 4 times every other day for 10 days, then 1 tablet 4 times a day after 3 days for a course of up to 3 weeks.
Treatment with Galavit can be started at any stage of the disease. Use the drug according to the indications, the method of administration and in the doses indicated in the instructions. If after these courses of treatment there is no improvement, or the symptoms worsen, or new symptoms appear, you should consult your doctor.
Precautionary measures
Contraindications
Individual intolerance, intolerance to galactose, fructose, lactase deficiency or glucose-galactose malabsorption, pregnancy and breastfeeding, children under 12 years of age.
Use during pregnancy and breastfeeding
The drug is contraindicated for pregnant women and women during breastfeeding.
Side effects
In rare cases, allergic reactions are possible. If you experience the side effects listed in the instructions or they get worse, or you notice any other side effects not listed in the instructions, tell your doctor.
Overdose
No cases of overdose have been reported.
Interaction with other drugs
With simultaneous use, it is possible to reduce the course doses of antibiotics. Galavit allows you to increase the effectiveness of antibiotic therapy and reduce its damage
The drug contains sorbitol; patients with rare hereditary pathologies associated with fructose and sorbitol intolerance should not take the drug.
Impact on the ability to drive vehicles and machinery
The drug does not affect the ability to drive vehicles or operate machinery.
Shelf life, storage conditions
Storage conditions: Store at a temperature not exceeding 25 ° C, in a place protected from light. Keep out of the reach of children.
Shelf life: 3 years. Do not use after the expiration date indicated on the carton.
Conditions for dispensing from pharmacies Dispensed without a prescription.
What else is prescribed with this study?
Immune status (screening) (Phagocytic activity of leukocytes, cellular immunity, total immunoglobulin IgE, immunoglobulins IgA, IgM, IgG)
27.960. Ven. blood 3 days
7,640 ₽ Add to cart
Immune status expanded
17.61. Ven. blood 14 days
22 310 ₽ Add to cart
Cellular immunity (T-lymphocytes, T-helpers, T-cytotoxic cells, Immunoregulatory index, B-lymphocytes, NK-T cells, NK cells, Leukocyte formula)
17.50. Ven. blood 3 days
5 200 ₽ Add to cart
Galavit
The dosage regimen and duration of therapy are set individually depending on the nature, severity and duration of the disease. The drug should be used rectally. The suppository is released from the contour packaging and then inserted into the rectum. It is recommended to empty the intestines first.
For acute intestinal infections accompanied by diarrhea, the initial dose is 2 supp. once. Then - 1 sup. 2 until symptoms of intoxication are relieved. It is possible to continue the course of 1 supp. with an interval of 72 hours. The course is 20-25 sup.
For gastric and duodenal ulcers in the acute period, the drug is prescribed 2 supp. 1 time/for 2 days, then 1 sup. with an interval of 72 hours. The course is 15-25 supp. In the chronic period, the drug is prescribed for 5 days, 1 supp. 1 time/, then - 1 sup. after 72 hours. The course is 20 supp.
For viral hepatitis, the initial dose is 2 supp. 1 time/, then 1 sup. 2 until symptoms of intoxication and inflammation are relieved. It is possible to continue the course of 1 supp. with an interval of 72 hours. The course is 20-25 sup.
For chronic recurrent herpes infection, 1 supp. for 5 days, then - 1 sup. every other day for 15 days.
For diseases caused by HPV, the drug is prescribed for 5 days, 1 supp. 1 time/, then - 1 sup. in one day. The course is 20 sup.
For urogenital infections (chlamydial and trichomonas urethritis, chlamydial prostatitis), the drug is prescribed 1 supp. 2 for 1 day, then 1 sup. in one day. The course is 10-15 sup. depending on the severity of the pathological process.
For salpingo-oophoritis, endometritis in the acute period, 2 supp. are prescribed for 2 days. 1 time/, then - 1 sup. with an interval of 72 hours. In the chronic period, the drug is prescribed for 5 days, 1 supp. 1 time/, then - 1 sup. every 72 hours. The course is 20 soups.
For PID in the acute period, the drug is prescribed on day 1, 2 supp. once, then for 3 days 1 sup. 1 time/, then - 1 sup. every other day for 5 days. The course is 10 supp. In the chronic period, the drug is prescribed for 5 days, 1 supp. 1 time/, then - 1 sup. every 72 hours. The course is 20 supp.
For postoperative rehabilitation of patients with uterine fibroids and for complications of the postoperative period in patients of reproductive age, the drug is prescribed for 5 days, 1 supp. 1 time/, then - 1 sup. in one day. The course is 15 supp.
For the prevention and treatment of surgical complications in the preoperative and postoperative period (including in cancer patients), the drug is prescribed before surgery - for 5 days, 1 supp. 1 time/, after surgery - 1 sup. every other day (5 supp.) and 5 supp. with an interval of 72 hours. In severe cases of the disease, the initial dose of the drug is 2 supp. once or 1 sup. 2 Course – 20 supp.
References
- Sologub T.V., Osinovets O.Yu. Use of the immunomodulatory drug Galavit in the complex therapy of influenza // Clinician. 2012. No. 2.
- Ermishina V.I., Kazeko N.I., Oskolkov S.A. Results of using the immunomodulatory drug “Galavit” for complicated chronic pyelonephritis and urolithiasis // Tyumen Medical Journal. 2015. No. 3.
- Silin DS, Lyubomska OV, Ershov FI, Frolov VM, Kutsyna GA. Synthetic and natural immunomodulators acting as interferon inducers. Curr Pharm Des. 2009;15(11):1238-47. doi: 10.2174/138161209787846847. PMID: 19355963.
- da Silva EG, Gionfriddo JR, Hudachek SF, Gustafson DL, Olea-Popelka FJ, Scofield VL, Powell CC, Hill AE. Evaluation of the ocular penetration of topical alpha-luminol (Galavit®/GVT®). Vet Ophthalmol. 2011 May;14(3):180-5. doi: 10.1111/j.1463-5224.2010.00862.x. PMID: 21521442.
Galavit® (Galavit)
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, 100 mg 1 time per day for 5 days, then 100 mg every other day for 15 injections. Course - 20 injections.
- For urogenital diseases - urethritis of chlamydial and trichomonas etiology, chlamydial prostatitis - 100 mg twice a day for 1 day, 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, 200 mg 1 time per day for 2 days, 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 - 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 - 15 injections.
— For the prevention and treatment of postoperative infectious complications in the pre- and postoperative period (including in cancer patients), 100 mg is prescribed 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 - 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 are relieved. 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 for 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 - 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.
GALAVIT powder for the preparation of solution for intramuscular administration 100 mg bottles No. 5
The dosage regimen and duration of therapy are set individually depending on the nature, severity and duration of the disease. To prepare a solution for intramuscular injection, the drug in the form of a powder for preparing a solution for injection is diluted in 2 ml of water for injection or in 0.9% sodium chloride solution. Adults For acute intestinal infections accompanied by diarrhea, the initial single dose is 200 mg once. Then the drug is administered at a dose of 100 mg 2 times a day until the symptoms of intoxication are relieved. It is possible to subsequently continue the course of 100 mg at intervals of 72 hours. The course is 20-25 injections. For peptic ulcer of the stomach and duodenum in the acute period - 2 days, 200 mg 1 time / day, then - 100 mg with an interval of 72 hours. A course of 15-25 injections. In the chronic period - for 5 days, 100 mg 1 time / day, then - 100 mg every 72 hours. Course - 20 injections. For viral hepatitis of various etiologies in the acute period of the disease, the initial dose is 200 mg once, then 100 mg 2 times a day until the symptoms of intoxication and inflammation are relieved. Subsequent continuation of the course of therapy at a dose of 100 mg with an interval of 72 hours. The course is 20-25 injections. For chronic recurrent herpes infection, the drug is prescribed 100 mg daily for 5 injections, then 100 mg every other day for 15 injections. For diseases caused by HPV, the drug is prescribed for 5 days at 100 mg 1 time / day, then 100 mg every other day. The course is 20 injections. For urogenital infections (chlamydial and trichomonas urethritis, chlamydial prostatitis), the drug is prescribed at 100 mg 2 times a day for 1 day, then switched to administering the drug at 100 mg every other day. The course is 10-15 injections, depending on the severity of the pathological process. For salpingoophoritis and endometritis in the acute period, the drug is prescribed for 2 days at 200 mg 1 time / day, then 100 mg at intervals of 72 hours. The course is 20 injections. In the chronic period, the drug is prescribed for 5 days, 100 mg 1 time/day, then 100 mg every 72 hours. The course is 20 injections. For acute and chronic PID in the acute period, the drug is prescribed for 1 day, 200 mg 1 time/day, then for 3 days, 100 mg daily, then 100 mg every other day, 5 injections. Course - 20 injections. In the chronic period, the drug is prescribed for 5 days, 100 mg 1 time/day, then 100 mg every 72 hours. The course is 20 injections. For postoperative rehabilitation of patients with uterine fibroids and complications of the postoperative period in patients of reproductive age, the drug is prescribed for 5 days, 100 mg 1 time / day, then 100 mg every other day. The course consists of 15 injections. For the prevention and treatment of surgical complications in the preoperative and postoperative period (including in cancer patients), the drug is prescribed at a dose of 100 mg 1 time/day. Before surgery, 5 injections, after surgery, 100 mg every other day and 5 injections with an interval of 72 hours. For severe disease, the initial dose is 200 mg 1 time / day or 100 mg 2 times / day. Course - 20 injections. For chronic recurrent furunculosis and erysipelas, 100 mg of the drug is prescribed once a day for 5 days, then 100 mg every other day. Course - 20 injections. For asthenic conditions, neurotic and somatoform disorders, for mental, behavioral and post-withdrawal disorders, alcohol and drug addiction, the drug is prescribed for 5 days, 100 mg 1 time / day, then 100 mg every 72 hours. The course is 15-20 injections . To increase physical performance, the drug is prescribed 100 mg every other day for 5 injections, then 100 mg every 72 hours. The course is up to 20 injections. For inflammatory diseases of the mucous membrane of the oral cavity and pharynx, periodontal diseases, the initial dose is 100 mg daily for 5 injections, then 100 mg at intervals of 72 hours. The course is 15 injections. Children over 6 years of age For purulent surgical diseases (including burn lesions, recurrent furunculosis, chronic osteomyelitis, gangrenous appendicitis with omentitis, peritonitis, purulent pleurisy) the drug is prescribed to children aged 6 to 11 years - 1 injection of 50 mg 1 time/day for 5 days, then 1 injection of 50 mg every other day for 10-15 days. The course is 10-15 injections. Children aged 12 to 18 years are treated according to the same regimen 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 acute respiratory viral infections, bronchitis, pneumonia, chronic tonsillitis, chronic otitis, chronic adenoiditis) for children aged 6 to 11 years, the drug is prescribed 1 injection of 50 mg 1 time / day for 5 days, then 50 mg 1 time/day every other day for 10-15 days. The course is 10-15 injections. Children aged 12 to 18 years are treated according to the same regimen in the form of intramuscular injections of 100 mg.
