Staphylophage Solution for Oral and Local Use 100 ml

Treatment and prevention of purulent-inflammatory and enteral diseases caused by Staphylococcus bacteria in adults and children.

• ear, throat, nose, respiratory tract, and lung diseases (inflammation of the sinuses, middle ear, angina, pharyngitis, laryngitis, tracheitis, bronchitis, pneumonia, pleurisy);

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

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

• enteral infections (gastroenterocolitis, cholecystitis), intestinal dysbiosis;

• generalized septic diseases;

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

• other diseases caused by staphylococci.
In cases of severe manifestations of staphylococcal infection, the drug is prescribed as part of combination therapy.
For preventive purposes, the drug is used for the treatment of postoperative and freshly infected wounds, as well as for the prevention of nosocomial infections based on epidemiological indications.
An important condition for effective phage therapy is the preliminary determination of the pathogen's sensitivity to the bacteriophage and the early use of the drug.

Method of application and doses

The drug is used for oral administration, rectal administration, applications, irrigations, and introduction into the cavities of wounds, vagina, uterus, nose, nasal sinuses, and drained cavities. Before use, the bottle with the bacteriophage must be shaken and inspected. The drug should be transparent and free of sediment.
Recommended dosages of the drug.
Age Dose per single administration (ml)
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 both locally and by taking the drug orally 2-3 times a day on an empty stomach 1 hour before meals from the first day of the disease for 7-20 days (according to clinical indications).
If chemical antiseptics were used before applying the bacteriophage for wound treatment, the wound should be thoroughly washed with a sterile 0.9% sodium chloride solution.
Depending on the nature of the infection focus, the bacteriophage is used:
1. In the form of irrigation, compresses, and tamponing in an amount of up to 200 ml depending on the size of the affected area. In the case of an abscess, after removing the purulent contents by puncture, the drug is introduced in a smaller amount than the volume of the removed pus. In osteomyelitis, after appropriate surgical treatment, the bacteriophage is injected into the wound at 10-20 ml.
2. When introduced into cavities (pleural, joint, and other limited cavities) up to 100 ml, after which a capillary drain is left through which the bacteriophage is introduced over several days.
3. In cases of cystitis, pyelonephritis, urethritis, the drug is taken orally. If the cavity of the bladder or renal pelvis is drained, the bacteriophage is introduced through a cystostomy or nephrostomy 1-2 times a day at 20-50 ml into the bladder and 5-7 ml into the renal pelvis.
4. In cases of purulent-inflammatory gynecological diseases, the drug is introduced into the cavity of the vagina or uterus at a dose of 5-10 ml daily once, in cases of colpitis - 10 ml by irrigation or tamponing 2 times a day. Tampons are placed for 2 hours.
5. In cases of purulent-inflammatory diseases of the ear, throat, nose, the drug is introduced at a dose of 2-10 ml 1-3 times a day. The bacteriophage is used for rinsing, washing, instilling, and introducing moistened turundas (leaving them for 1 hour).
6. In cases of enteral infections, intestinal dysbiosis, the drug is taken orally 3 times a day 1 hour before meals. It is possible to combine a double oral intake with a single rectal administration of a single age dose of the bacteriophage in the form of an enema after emptying the intestines.
Use of the bacteriophage in children (up to 6 months).
In cases of sepsis, enterocolitis in newborns, including premature infants, the bacteriophage is used in the form of high enemas (through a gas outlet tube or catheter) 2-3 times a day at a dose of 5-10 ml. If there is no vomiting or regurgitation, the drug can be administered orally. In this case, it is mixed with breast milk. It is possible to combine rectal (in the form of high enemas) and oral (by mouth) administration of the drug. The course of treatment is 5-15 days. In cases of recurrent disease, repeated courses of treatment may be conducted. To prevent sepsis and enterocolitis in cases of intrauterine infection or the risk of nosocomial infection in newborns, the bacteriophage is used in the form of enemas 2 times a day for 5-7 days.
In the treatment of omphalitis, pyoderma, infected wounds, the drug is used in the form of applications twice daily (a gauze napkin is moistened with the bacteriophage and applied to the umbilical wound or the affected area of the skin).
If there is no improvement after treatment or symptoms worsen, or new symptoms appear, it is necessary to consult a doctor. Use the drug only according to the indications, method of application, and doses specified in the instructions.

Section: Composition

In 1 ml of the preparation contains:
Active ingredient.
Sterile purified filtrate of phagolysates of bacteria of the genus Staphylococcus (with activity according to Appelman - not less than 10-5) - up to 1 ml.
Excipients:
preservative - 8-hydroxyquinoline sulfate - 0.0001 g/ml (calculated content); or 8-hydroxyquinoline sulfate monohydrate calculated as 8-hydroxyquinoline sulfate - 0.0001 g/ml (calculated content).

Description of the dosage form

Transparent liquid of yellow color of varying intensity, a greenish tint is possible.

Contraindications

Individual intolerance or sensitivity to any of the components of the drug. Use during pregnancy and breastfeeding. The use of the drug is advisable in the presence of infections caused by phage-sensitive strains of staphylococci (as recommended by a doctor).

Before use, the bottle with the liquid bacteriophage must be shaken. Do not use the preparation if it is cloudy! Due to the presence of a nutrient medium in the preparation, in which bacteria from the environment can develop, causing cloudiness of the preparation, the following rules must be followed when opening the bottle:

• wash hands thoroughly;

• treat the cap with an alcohol-containing solution;

• remove the cap without opening the stopper;

• do not place the stopper with the inner surface on the table or other objects;

• do not leave the bottle open;

• store the opened bottle only in the refrigerator. The bottle can be opened and the required volume of the preparation can be extracted using a sterile syringe by puncturing the stopper. The preparation from the opened bottle, provided that the storage conditions, the above rules, and the absence of cloudiness are observed, can be used throughout its shelf life.
Effect on the ability to drive vehicles and operate machinery. The preparation does not affect the ability to perform potentially dangerous activities that require increased attention and quick psychomotor reactions (including driving vehicles, working with moving machinery).

Side effects

Possible allergic reactions. If you experience side effects listed in the instructions, or if they worsen, or if you notice any other side effects not mentioned in the instructions, inform your doctor.

Overdose

Cases of overdose have not been reported to date.

Interaction

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

Pharmacodynamics

The drug causes specific lysis of bacteria of the genus Staphylococcus.

Storage conditions. At a temperature of 2 to 8 °C in a protected from light place.