Bacteriophage pseudomonas aeruginosa (Pseudomonas) - instructions for use, doses, side effects, contraindications

Similar drugsTo uncover

Dosage form: & nbsp

solution for oral, local and external use

Composition:

Active substance:

Sterile filtrate of bacterial phagolysates Pseudomonas aeruginosa up to 1 ml.

Excipients:

Preservant-8-hydroxyquinoline sulfate - 0.0001 g / ml (calculated content);

or 8-hydroxyquinoline sulfate monohydrate 0.0001 g / ml (in terms of 8-hydroxyquinoline sulfate, the calculated content).

Description:

The drug is a clear liquid of yellow color of varying intensity.

Pharmacotherapeutic group:MIBP bacteriophage

ATX: & nbsp

Other different drugs

Pharmacodynamics:The drug causes a specific bacterial lysis P. aeruginosa.

Indications:

Treatment and prevention of diseases caused by Pseudomonas aeruginosa (Pseudomonas aeruginosa) in adults and children.

- Diseases of the ear, throat, nose, respiratory tract and lungs (inflammation of the sinuses of the nose, middle ear, sore throat, pharyngitis, laryngitis, tracheitis, bronchitis, pneumonia, pleurisy);

- surgical infections (suppuration of wounds, burns, abscess, phlegmon, furuncles, carbuncles, hydroadenitis, panaritium, paraproctitis, mastitis, bursitis, osteomyelitis);

- urogenital infections (urethritis, cystitis, pyelonephritis, colpitis, endometritis, salpingoophoritis);

- Enteral infections (gastroenterocolitis, cholecystitis), dysbiosis intestines;

- generalized septic diseases;

- purulent-inflammatory diseases of newborns (omphalitis, pyoderma, conjunctivitis, gastroenterocolitis, sepsis, etc.);

- other diseases caused by Pseudomonas aeruginosa.

In severe manifestations of Pseudomonas aeruginosa, the drug is prescribed as part of complex therapy.

With the preventive purpose, the drug is used for the treatment of postoperative and freshly infected wounds, as well as for the prevention of nosocomial infections due to epidemic indications.

Contraindications:

Individual intolerance, hypersensitivity to the components of the drug.

Pregnancy and lactation:

It is advisable to use the drug in the presence of infections caused by phagosensitive strains of Pseudomonas aeruginosa (according to the doctor's recommendation).

Dosing and Administration:

The drug is used for oral administration (through the mouth), rectal administration, applications, irrigation, insertion into the wound cavity, vagina, uterus, nose, sinuses and drained cavities. Before use, the vial with the bacteriophage should be shaken and scanned. The drug should be clear and free of sediment.

Recommended dosage of the drug.

Age	Dose for 1 admission (ml)
Age	orally	rectally
0-6 months.	5	5-10
6-12 months.	10	10-20
from 1 year to 3 years	15	20-30
from 3 to 8 years	15-20	30-40
from 8 years and older	20-30	40-50

Treatment of purulent-inflammatory diseases with localized lesions should be carried out simultaneously both topically and by taking the drug 2-3 times a day for 1 hour before meals from the first day of the disease for 7-20 days (according to clinical indications).

In the event that chemical antiseptics were used before the bacteriophage was used to treat wounds, the wound should be thoroughly washed with sterile sodium chloride solution of 0.9%.

Depending on the nature of the source of infection, the bacteriophage is used:

In the form of irrigation, lotion and tamponization in a volume of up to 200 ml, depending on the size of the affected area. In the abscess after removal of purulent contents with puncture, the drug is administered in an amount less than the volume of the removed pus. When osteomyelitis after appropriate surgical treatment, a bacteriophage 10-20 ml is poured into the wound.
When injected into the cavity (pleural, articular and other limited cavities) to 100 ml, then leave capillary drainage, through which the bacteriophage is injected for several days.
With cystitis, pyelonephritis, urethritis, the drug is taken orally. In case the cavity of the bladder or renal pelvis is drained, the bacteriophage is injected through the cystostomy or nephrostomy 1-2 times a day for 20-50 ml in the bladder and 5-7 ml in the renal pelvis.
4When purulent-inflammatory gynecological diseases, the drug is injected into the cavity of the vagina, the uterus in a dose of 5-10 ml daily once.
With purulent-inflammatory diseases of the ear, throat, nose, the drug is administered in a dose of 2-10 ml 1-3 times a day. Bacteriophage is used to rinse, rinse, instill, inject wetted turund (leaving them for 1 hour).
With enteral infections, intestinal dysbiosis, the drug is taken orally 3 times a day for 1 hour before meals. A combination of a double oral administration with a single rectal administration of a single age-related dose of a bacteriophage in the form of an enema after bowel evacuation is possible.

Use of bacteriophage in children (up to 6 months).

In sepsis, enterocolitis of newborns, including premature infants, the bacteriophage is used in the form of high enemas (through the gas outlet tube or catheter) 2-3 times a day in a dose of 5-10 ml.In the absence of vomiting and regurgitation, the use of the drug through the mouth is possible. In this case, it is mixed with breast milk. Perhaps a combination of rectal (in the form of high enemas) and oral (through the mouth) application of the drug. The course of treatment is 5-15 days. With a recurring course of the disease, repeated courses of treatment are possible. In order to prevent sepsis and enterocolitis with intrauterine infection or the danger of nosocomial infection in newborns, the bacteriophage is used as an enema 2 times a day for 5-7 days.

In the treatment of omphalitis, pyoderma, infected wounds, the drug is applied daily in applications twice a day (the gauze cloth is moistened with a bacteriophage and applied to the umbilical wound or to the affected area of the skin).

Side effects:

None.

Overdose:

Symptoms of overdose, measures to provide assistance in case of an overdose are not available.

Interaction:

The use of the drug is possible in combination with other drugs, including antibiotics.

Special instructions:

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

The preparation is not suitable for use in vials with broken integrity or marking, with expired shelf life, with opacity.

Due to the content of the nutrient medium in which the bacteria can develop from the environment, causing the drug to cloud, it is necessary to observe the following rules when opening the vial:

- Wash hands thoroughly;

- treat the cap with an alcohol-containing solution;

- remove the cap without opening the plug;

- do not place the inner surface of the cork on a table or other objects;

- do not leave the vial open;

- Store the vial only in the refrigerator.

Opening the vial and extracting the required volume of the drug can be performed with a sterile syringe by puncturing the plug. The preparation from the opened bottle under observance of storage conditions, the above rules and absence of turbidity, can be used during the whole shelf life.

Effect on the ability to drive transp. cf. and fur:

Not installed.

Form release / dosage:

Solution for oral, local and external use.

Packaging:Solution for oral, local and external use in vials of 20 ml or 100 ml.4 or 8 bottles of 20 ml or 1 bottle of 100 ml in a pack of cardboard with instructions for use.

Storage conditions:

Storage in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C in a place inaccessible to children.

Transportation in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C, transportation at a temperature of 9 to 25 ° C is allowed for not more than 1 month.

Shelf life:

Shelf life 2 years. The drug with expired shelf life is not subject to application.

Terms of leave from pharmacies:Without recipe

Registration number:P N001976 / 01

Date of registration:01.03.2012 / 28.05.2013

Expiration Date:Unlimited

The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia

Manufacturer: & nbsp

MICROGEN FGUP NGO Russia

Information update date: & nbsp14.01.17

Illustrated instructions

Instructions

Bacteriophage pseudomonas aeruginosa (Pseudomonas aeruginosa) (Bacteriophage Pseudomonas aeroginosa fluid)