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Composition:


active substance: 1 ml of the drug contains specific bacteriophages in a concentration of at least 1×105 phage particles to the following types of microorganisms: Shigella flexneri, Shigella sonnei, Salmonella enterica, Escherichia coli, Proteus vulgaris, Proteus mirabilis, Enterococcus faecalis, Staphylococcus aureus, Pseudomonas aeruginosa;


excipients: sodium chloride; magnesium chloride hexahydrate; sodium hydroxide; diluted hydrochloric acid; water for injection.


Dosage form. Solution.


Basic physical and chemical properties: clear liquid, yellowish tint is allowed.


Pharmacotherapeutic group. Antibacterial agents. Other antibacterial agents.


ATX code J01X X.


Immunobiological and biological properties. The drug has the ability to specifically Lyse such bacteria as Shigella flexneri, Shigella sonnei, Salmonella enterica, Escherichia coli, Proteus vulgaris, Proteus mirabilis, Enterococcus faecalis, Staphylococcus aureus, Pseudomonas aeruginosa. Bacteriophages specifically infect bacterial cells, multiply inside the bacterial cell, and destroy it by lysis. The antibacterial effect of the drug is due to the specific lysis of pathogenic bacteria, while the drug does not violate the state of normal microflora. Under the action of the bacteriophage, phagocytosis is activated, neutrophil activity and their metabolic activity increase, which prevents the appearance of a relapse of the infectious disease and the chronization of the inflammatory process. The number of white blood cells and neutrophils decreases, and the level of lymphocytes increases mainly due to T-lymphocytes. Bacteriophages quickly enter the blood and lymph and are excreted by the kidneys in the urine.


Clinical characteristics.


Indications.


Treatment and Prevention of diseases such as:


- shigellosis;


- salmonellosis;


- dysbiosis;


- enterocolitis, colitis of an infectious nature, mixed etiology.


Contraindications.


Hypersensitivity to the components of the drug.


Special security measures.


An important condition for effective phage therapy is the preliminary determination of the phage sensitivity of the causative agent of the disease. The use of the drug begins as early as possible. The drug is not used if it becomes cloudy.


Interactions with other drugs and other types of interactions.


It can be used in combination with other antibacterial agents, as well as as monotherapy – if the patient is intolerant to antibiotic therapy, if the strains of the causative agent of the disease are resistant to antibiotics.


Application features.


Use during pregnancy or lactation.


Safety and efficacy have not been established, so the use is contraindicated.


Ability to influence the reaction rate when driving vehicles or other mechanisms.


The use of the drug does not affect the reaction rate when driving vehicles or working with other mechanisms


Dosage and administration.


The drug is intended for internal (oral) use.


For therapeutic purposes, the bacteriophage is taken orally 4 times a day 1 hour before meals. The duration of treatment is 7-10 days. 

When dosing the drug, follow the recommendations of the instructions for medical use. The required amount of the drug is taken from the bottle using a sterile syringe. When using small doses of the drug, it is possible to use a dropper cap based on the fact that one milliliter of the drug contains 20 drops of a bacteriophage solution.


Rectal administration of the bacteriophage is possible, 1 time a day, in the form of enemas after emptying the intestines instead of 1 oral dose.

Children.


The drug is intended for use in children aged from 2 months.


Overdose.


Cases of overdose of the drug are not described.


Adverse reactions.


No cases of adverse reactions have been described.


Expiration date.


3 years.


Storage conditions.


Store at a temperature of 2 to 8 °C in the original packaging. After the first opening of the bottle, it can be stored for no more than 10 days at a temperature of 2 to 8 °C. Transportation is allowed at a temperature of no more than 25 °C for no more than 30 days, in the future the drug is stored at a temperature of 2 to 8 °C.


Tags: Bacteriophage