Klebsiella bacteriophage polyvalent purified Solution, 4 pcs, 20 ml, for oral administration


Indications for use

Therapy and prevention of diseases caused by Klebsiella ozaenae, pneumoniae and rhinoscleromatis as part of multicomponent treatment:

  • lesions of the digestive tract ( gastroenterocolitis, pancreatitis, cholecystitis, intestinal dysbiosis );
  • ozena, scleroma;
  • diseases of young children and newborns of an inflammatory nature ( intestinal dysbiosis, gastroenterocolitis, pemphigus, omphalitis, septicemia, pyoderma, septicopyemia );
  • surgical diseases (purulent skin diseases, wound suppuration, peritonitis , burns , pleurisy , osteomyelitis, mastitis, abscess );
  • urogenital infections ( pyelonephritis, cystitis, urethritis, vulvitis, colpitis, endometritis, bartholinitis, salpingoophoritis );
  • diseases of the ear, nose, throat, pharynx, oral cavity, bronchi, larynx, lungs, pleura of a purulent-inflammatory nature (sore throat , otitis, laryngitis, pharyngitis, periodontitis, stomatitis, frontal sinusitis, sinusitis, pneumonia, bronchitis, pleurisy );
  • conjunctivitis of post-traumatic origin, corneal ulcer, keratoconjunctivitis , iridocyclitis ;
  • prevention of hospital infections associated with Klebsiella .

Klebsiella bacteriophage polyvalent purified liquid

Trade name: Bacteriophage Klebsiellae polivalental purified fluid International name: Bacteriophage Klebsiellae

Release form: solution for local use and oral administration (bottles) 10, 20 ml

Ingredients: Klebsiella bacteriophage

Pharmacological group: MIBP-bacteriophage

Pharmacological group according to ATK: V03A (Other therapeutic products)

Description: The drug contains bacteriophages that are active against 89 - 93% of clinical strains of bacteria Klebsiella pneumoniae, ozena, scleroma. In terms of the spectrum of antibacterial activity, the drug is superior to antibiotics of the streptomycin, aminoglycoside, tetracycline and macrolide genera, and is active against antibiotic-resistant strains. The drug is purified from proteins and bacterial antigens, the degree of purification is 98.4 - 99.7%. The drug is harmless, non-reactogenic, in therapeutic doses and doses exceeding the therapeutic dose by 3500 times. The drug does not cause allergic or other adverse reactions, has no contraindications for use, unlike antibiotics, when administered orally it does not disturb the intestinal biocenosis and therefore can be used in newborns and children of the first year of life.

Indications: Klebsiella polyvalent bacteriophage is intended for the treatment of ozena, scleroma, as well as other purulent-septic and enteral diseases caused by the bacteria Klebsiella pneumonia, ozena and rhinoscleroma. 1. Diseases of the ear, throat, nose, respiratory tract and lungs - ozena, scleroma, inflammation of the sinuses, middle ear, tonsillitis, pharyngitis, laryngitis, bronchitis, pneumonia, pleurisy. 2. Surgical infections - wound suppuration, burns, abscesses, phlegmon, mastitis, osteomyelitis, peritonitis. 3. Urogenital infectious pathology - urethritis, cystitis, pyelonephritis, colpitis, endometritis, salpingo-oophoritis. 4. Enteral infections - gastroenterocolitis, cholecystitis, intestinal dysbiosis. 5. Generalized septic diseases. 6. Purulent-septic diseases of newborns - omphalitis, pemphigus, gastroenterocolitis, sepsis.

Dosage regimen: In the treatment of ozena and scleroma, the drug is used for irrigation of the nasal cavity, nasopharynx, and administration into the sinuses. In the treatment of diseases of the respiratory tract and lungs, the drug is used in the form of aerosols, and the oral route of administration is also used. In the treatment of other diseases, the drug is used locally in the form of irrigations, lotions, and also for administration into cavities - wounds, abscesses, abdominal, pleural, bladder, uterus, sinuses, middle ear. In addition, the drug is used orally and in the form of high enemas in the treatment of gastroenterocolitis, cholecystitis, pyelonephritis, cystitis, urethritis, mastitis, and generalized septic diseases. The therapeutic dose of the drug is 0.3 - 3.0 ml per 1 kg of body weight. The drug is used 1 - 3 times a day for 7 - 20 days; in the treatment of ozena and scleroma, treatment courses are 30 - 40 days. Repeated courses are possible.

Contraindications: Hypersensitivity.

Side effects: Not described.

Pharmacodynamics: The antibacterial effect provided by the drug is due to the specific lysis of pathogenic bacteria in the inflammation site under the influence of bacteriophages. Regardless of the method of administration of the drug, bacteriophages penetrate the blood and lymph, enter the site of inflammation and are excreted by the kidneys, providing a sanitizing effect on the urinary tract. In addition, the drug has a stimulating effect on the patient’s immune system and is effective in the treatment of purulent-septic diseases accompanied by immunosuppressive conditions, which is generally typical for diseases caused by opportunistic microflora, and in particular for chronic and acute klebsiosis - ozena and scleroma.

Shelf life: 1 year.

Drug registration number: 91/175/14

Instructions for use Bacteriophage Klebsiella polyvalent (Method and dosage)

The instructions allow the use of Klebsiella polyvalent bacteriophage internally, in the form of irrigations, applications, enemas, introduction into the nasal cavity, wound, uterus, vagina, sinuses, as well as for drainage of abscesses , bladder, abdominal and pleural cavities, renal pelvis. The drug is taken orally one hour before meals, on an empty stomach.

Recommended dosages for patients over 8 years of age are up to 30 ml of solution when administered orally and up to 50 ml when administered as enemas. Treatment of localized diseases of a purulent-inflammatory nature should be carried out by a combination of local therapy and oral administration of the drug.

When treating ozena or scleroma , the product is used to sanitize the nasal cavity and mucous membranes of the respiratory tract, for administration into the sinuses, and also in the form of inhalations for damage to the larynx, pharynx, and trachea. The dose for treating the mucous membranes of the respiratory tract is 10-20 ml. After sanitizing the mucous membranes, turundas soaked in the product are introduced into the nasal passages one by one and left for one hour. This procedure is repeated up to three times a day for 5-6 weeks. Since ozena and scleroma are chronic diseases, in order to prevent exacerbations, it is recommended to carry out such courses of treatment once a year.

In the treatment of laryngitis, pharyngitis, and sore throats, the drug is used in 15-20 ml doses to sanitize the oropharyngeal cavity three times a day for 9-10 days.

When treating bronchitis and pneumonia , the drug is taken orally up to 20 ml three times a day and is used in the form of inhalations and aerosols. The duration of such therapy is up to 3 weeks.

When treating otitis media, the drug is used to wash and sanitize the ear cavity, 4-5 ml three times a day. The course of therapy lasts 1-2 weeks.

When treating inflammatory diseases of the sinuses, the nose and nasopharynx are washed with 7-10 ml of the drug solution and sinuses are sanitized with 3 ml. This procedure is carried out once a day for 9-10 days. The drug is also administered into the nasal cavity in the form of turundas impregnated with bacteriophage, into each nasal passage in turn and left for 1 hour. This procedure is performed three times a day for two weeks.

When treating chronic periodontitis and stomatitis , rinse the mouth with 15-20 ml of the drug up to 4 times a day, and inject turundas with the drug into the periodontal pockets for 10 minutes. The duration of such treatment usually does not exceed ten days.

For keratoconjunctivitis and conjunctivitis , the product is instilled 3 drops up to five times a day for a week; for purulent iridocyclitis, instill 7 drops up to 8 times a day along with oral administration in standard doses for 10 days; for a purulent ulcer of the cornea, instill 5 drops per day for ten days.

For abscesses , after the cavity has been emptied, the drug is injected into it daily for 10 days.

For pleurisy and peritonitis, the cavity is drained with 20-70 ml of the drug through drainage tubes once a day for two weeks.

For osteomyelitis, the drug is injected into the wound using turundas and drainages, 10-30 ml daily. Treatment is continued for up to three weeks.

When treating suppurative wounds, the agent is used for irrigation, application and is used in the form of bandages; 5-50 ml is injected into the drainage at least once a day for 11-15 days.

In the treatment of gynecological diseases of a purulent-inflammatory nature ( endometritis, suppuration of wounds, vulvitis, colpitis, bartholinitis, salpingo-oophoritis ), the product is used for applications, irrigation, injected into the uterine cavity, wounds, vagina, 10-20 ml once a day for 9-10 days.

For pyelonephritis, cystitis, urethritis, the drug is taken orally in a therapeutic dose up to three times a day on an empty stomach for 2-3 weeks. If the cavity of the renal pelvis or bladder is drained, then the drug is administered through drains 20-40 ml into the bladder or 5-6 ml into the renal pelvis up to three times a day. Therapy is continued for 1-2 weeks.

For pancreatitis, gastoenterocolitis, cholecystitis, and intestinal dysbiosis, Klebsiella bacteriophage is consumed orally in age-specific dosages up to three times a day on an empty stomach for 1-2 weeks. For indomitable vomiting, 20-40 ml of the product is used in the form of high enemas three times a day.

To prevent hospital-acquired surgical infections, the polyvalent Klebsiella bacteriophage is used to treat freshly infected and postoperative wounds, 5-50 ml once daily for a week.

Use of the drug Klebsiella Bacteriophage for infants and children under one year of age

For gastoenterocolitis, sepsis and pneumonia in newborns, the drug is used orally, 3-4 ml 3 times a day, half an hour before feeding. For indomitable vomiting, Bacteriophage is used in 5-8 ml in the form of high enemas once a day. The duration of treatment is 1-2 weeks.

In order to prevent the occurrence of hospital infections in newborns, the drug is used according to epidemic indications orally, 3-5 ml three times a day, half an hour before feeding, throughout the entire stay in the hospital.

When treating pyoderma, omphalitis, and infected wounds, 5-10 ml of solution is used for applications up to 3 times a day for 1-2 weeks.

Klebsiella bacteriophage polyvalent 20ml 4 pcs. oral solution

pharmachologic effect

MIBP is a bacteriophage.

Composition and release form Klebsiella bacteriophage polyvalent 20ml 4 pcs. oral solution

Solution - 1 ml:

  • Active ingredient: Sterile purified filtrate of phagolysates of bacteria Klebsiella pneumoniae, Klebsiella ozaenae, Klebsiella rhinoscleromatis (with Appelman activity - at least 10-4) - up to 1 ml;
  • Excipient: 8-hydroxyquinoline sulfate monohydrate (preservative) in terms of 8-hydroxyquinoline sulfate - 0.0001 g/ml (calculated content).

In bottles of 20 ml.

4 bottles with instructions for use in a cardboard pack.

4 bottles each in a blister pack made of polyvinyl chloride film.

1 blister pack with instructions for use in a cardboard pack.

Description of the dosage form

It is a transparent yellow liquid of varying degrees of intensity, a greenish tint is allowed.

Directions for use and doses

The drug is used for oral administration (through the horn), in the form of enemas, applications, irrigations, introduction into wound cavities, vagina, uterus, nose, sinuses, as well as into drained cavities: abscesses, abdominal, pleural, bladder, renal pelvis.

The drug is taken orally on an empty stomach 0.5-1 hour before meals.

Recommended dosage of the drug

  • Age 0-6 months. — 5 ml orally or 10 ml rectally;
  • Age 6-12 months. — 10 ml orally or 20 ml rectally;
  • Age from 1 year to 3 years - 15 ml orally or 20-30 ml rectally;
  • Ages from 3 to 8 years - 20 ml orally or 30-40 ml rectally;
  • Ages 8 years and older - 20-30 ml orally or 40-50 ml rectally.

Treatment of purulent-inflammatory diseases with localized lesions should be carried out simultaneously both locally and by taking the drug orally.

If the cavity of a purulent lesion is treated with chemical antiseptics, before using the bacteriophage, it must be washed with a sterile 0.9% sodium chloride solution.

In the treatment of ozena and scleroma, the drug is used to rinse the nasal cavity and mucous membrane of the upper respiratory tract, for administration into the cavities of the sinuses (according to clinical indications), as well as in cases of damage to the pharynx, larynx, trachea in the form of inhalations (without heating and the use of ultrasound). The dose of the drug for treating the mucous membranes of the nose and upper respiratory tract is 10-20 ml. After washing the mucous membranes into the nasal cavity, turundas moistened with the drug are introduced into each nasal passage in turn and left for 1 hour. The procedure is repeated 2-3 times a day for 20-40 days. Since ozena and scleroma are chronic diseases, in order to prevent exacerbations, it is recommended to carry out 20-40 day courses of treatment according to the above scheme once a year.

When treating tonsillitis, pharyngitis, laryngitis, the drug is used to rinse the mouth and throat 3 times a day, 10-20 ml, the course of treatment is 7-10 days.

When treating bronchitis and pneumonia, the drug is taken orally 3 times a day, 10-20 ml, and is also used in the form of aerosols and inhalations (without heating or using ultrasound), the course of treatment is 15-20 days.

In the treatment of otitis media, the drug is used for washing and introducing 2-5 ml into the middle ear cavity 1-3 times a day. The course of treatment is 7-15 days.

When treating inflammation of the sinuses, the drug is used to rinse the nasal cavity, nasopharynx and sinuses in a dose of 5-10 ml and inject 2-3 ml into the sinuses. The procedure is repeated once daily for 7-10 days. In addition, the drug is administered into the nasal cavity in the form of turundas moistened with bacteriophage, in turn into each nasal passage and left for 0.5-1 hour. The procedure is repeated 3 times a day, the course of treatment is 7-15 days.

In the treatment of stomatitis and chronic periodontitis, the drug is used in the form of mouth rinses 3-4 times a day in a dose of 10-20 ml, as well as by introducing turundas impregnated with Klebsiella bacteriophage into the periodontal pockets for 5-10 minutes, the course of treatment is 7-10 days .

For conjunctivitis and keratoconjunctivitis, the drug is used 2-3 drops 4-5 times a day, the course of treatment is 5-7 days; for a purulent corneal ulcer - 4-5 drops per day for 7-10 days; for purulent iridocyclitis - 6-8 drops every 3 hours in combination with oral administration in therapeutic dosages for 7-10 days.

For abscesses, after opening and removing the purulent contents, the drug is administered in an amount less than the volume of removed pus once daily, the course of treatment is 7-10 days.

For peritonitis and pleurisy, the drug is administered into the drained cavities - abdominal and pleural through drainage tubes - 20-70 ml once daily, the course of treatment is 10-15 days.

For osteomyelitis, the drug is administered into the wound cavity through turundas and drainages in the amount of 10-30 ml once daily, the course of treatment is 15-20 days.

When treating suppurative wounds, the drug is used in the form of irrigation, applications, dressings, injection into drainage in a dose of 5-50 ml, depending on the lesion, at least once a day, the course of treatment is 10-15 days.

In the treatment of purulent-inflammatory gynecological diseases (suppuration of wounds, endometritis, vulvitis, bartholinitis, colpitis, salpingo-oophoritis), the drug is used for irrigation, applications, administered into wound cavities, vagina, uterus, 5-20 ml once a day for 7-10 days.

For cystitis, pyelonephritis, urethritis, the drug is taken orally in a therapeutic dose 3 times a day 1 hour before meals for 10-20 days. If the cavity of the bladder or renal pelvis is drained, the drug is administered through a cystostomy or nephrostomy 1-3 times a day, 20-50 ml into the bladder and 5-7 ml into the renal pelvis, the course of treatment is 7-15 days.

For gastroenterocolitis, pancreatitis, cholecystitis, as well as intestinal dysbacteriosis, the bacteriophage is taken orally in age-specific dosages 3 times a day 1 hour before meals for 7-15 days (according to clinical indications). For indomitable vomiting, the drug is used in the form of high enemas 2-3 times a day, 20-40 ml. In case of intestinal dysbiosis, the drug can be used with normal flora preparations.

To prevent hospital-acquired surgical infections, the drug is used to treat postoperative and newly infected wounds in a dose of 5-50 ml, depending on the lesion, once daily for 5-7 days.

Use of the drug in children under 1 year of age (including premature infants)

For gastroenterocolitis, pneumonia and sepsis of newborns, the drug is used by mouth 2-3 times a day, 3-5 ml, 30 minutes before feeding.

In cases of indomitable vomiting, the drug is used in the form of high enemas (through a gas outlet tube or catheter) once daily in a dose of 5-10 ml. A combination of rectal (in the form of high enemas) and oral administration of the drug is possible. The course of treatment is 7-15 days (according to clinical indications). In case of recurrent course of the disease, repeated courses of treatment are possible.

In order to prevent the occurrence of nosocomial infection in newborns, the bacteriophage is used according to epidemic indications orally 3-5 ml 3 times a day 30 minutes before feeding during the entire period of hospital stay.

In the treatment of omphalitis, pyoderma, and infected wounds, the bacteriophage is used in the form of applications of 5-10 ml 2-3 times a day (a gauze pad is moistened with the bacteriophage and applied to the umbilical wound or affected area of ​​skin) for 7-15 days.

The use of the drug does not exclude the use of other antibacterial and anti-inflammatory drugs.

Pharmacodynamics

The drug causes specific lysis of the bacteria Klebsiella pneumoniae, Klebsiella ozaenae, Klebsiella rhinoscleromatis.

Indications for use Klebsiella bacteriophage polyvalent 20ml 4 pcs. oral solution

Treatment and prevention of diseases caused by bacteria Klebsiella pneumoniae, Klebsiella ozaenae, Klebsiella rhinoscleromatis as part of complex therapy:

  • ozena, scleroma;
  • diseases of the gastrointestinal tract (gastroenterocolitis, cholecystitis, pancreatitis, intestinal dysbiosis);
  • inflammatory diseases of newborns and young children (gastroenterocolitis, intestinal dysbiosis, omphalitis, pemphigus, pyoderma, septicemia and septicopyemia of various localizations);
  • surgical infections (wound suppuration, purulent skin lesions, burns, peritonitis, pleurisy, mastitis, osteomyelitis, abscess);
  • urogenital infections (cystitis, pyelonephritis, urethritis, endometritis, vulvitis, bartholinitis, colpitis, salpingoophoritis);
  • purulent-inflammatory diseases of the ear, throat, nose, sinuses, oral cavity, pharynx, larynx, bronchi, lungs and pleura (otitis, sore throat, pharyngitis, laryngitis, stomatitis, periodontitis, sinusitis, frontal sinusitis, bronchitis, pneumonia, pleurisy);
  • post-traumatic conjunctivitis, keratoconjunctivitis, purulent corneal ulcer and iridocyclitis;
  • prevention of nosocomial infections caused by Klebsiella.

Contraindications

Hypersensitivity to the components of the drug.

Application Klebsiella bacteriophage polyvalent 20ml 4 pcs. solution for oral administration during pregnancy and lactation

The use of this drug during pregnancy and breastfeeding is possible in the presence of infections caused by phage-sensitive strains of Klebsiella (on the recommendation of a doctor).

special instructions

An important condition for effective phage therapy is the preliminary determination of the sensitivity of the pathogen to the bacteriophage.

Before use, the vial with the bacteriophage must be shaken and inspected. The preparation must be transparent and free of sediment.

Attention! If cloudy, do not use the drug!

Due to the content of a nutrient medium in the drug, in which bacteria from the environment can develop, causing cloudiness of the drug, the following rules must be observed when opening the bottle:

  • wash your hands thoroughly;
  • treat the cap with an alcohol-containing solution;
  • remove the cap without opening the stopper;
  • do not place the cork with the inner surface on a table or other objects;
  • do not leave the bottle open;
  • Store an opened bottle only in the refrigerator.

When using small doses (2-8 drops), the drug must be taken with a sterile syringe in a volume of 0.5-1 ml.

The drug from an opened bottle, subject to storage conditions, the above rules and the absence of turbidity, can be used throughout the shelf life.

Impact on the ability to drive vehicles and operate machinery

The use of the drug does not affect the ability to drive vehicles and machinery.

Overdose

Not installed.

Side effects Klebsiella bacteriophage polyvalent 20ml 4 pcs. oral solution

Not installed.

Drug interactions

The drug can be used in combination with other drugs, including antibiotics.

special instructions

Before use, the bottle with the drug must be shaken and its transparency and the presence of sediment assessed. If turbidity or sediment is detected, the drug should not be used!

Due to the presence in the drug of a favorable climate for the development of microorganisms from the environment that cause turbidity of the solution, opening the bottle should be done according to the rules indicated below:

  • hands must be washed thoroughly;
  • Before removing, the cap must be treated with an alcohol solution;
  • the cap should be removed without removing the stopper;
  • the drug should be removed from an opened container only by piercing the stopper with a sterile syringe;
  • if during opening the cap was accidentally uncorked along with the cap, then it should not be placed with the inner surface on the table, and the bottle should not be left open (after taking the product, it must be closed with the cork);
  • The opened bottle should be stored in the refrigerator.

If these rules are followed and there is no turbidity, the product from the opened bottle can be used throughout the entire shelf life.

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