Staphylophage 4 pcs. vial solution for oral and external use 20 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 (sinusitis, otitis media, tonsillitis, pharyngitis, laryngitis, tracheitis, bronchitis, pneumonia, pleuritis);

• Surgical infections (wound suppuration, burns, abscess, phlegmon, furuncles, carbuncles, hidradenitis, paronychia, paraproctitis, mastitis, bursitis, osteomyelitis);

• Urogenital infections (urethritis, cystitis, pyelonephritis, colpitis, endometritis, salpingooophoritis);

• 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 prior determination of the pathogen's sensitivity to the bacteriophage and the early use of the drug.

The preparation is used for oral administration, rectal administration, applications, irrigations, and instillation into wound cavities, vagina, uterus, nose, nasal sinuses, and drained cavities. Before use, the bottle containing the staphylophage must be shaken and inspected. The preparation should be clear and free of sediment.

Recommended dosages of the preparation:
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 conducted both locally and by taking the preparation 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 prior to the application of staphylophage for wound treatment, the wound must be thoroughly rinsed with sterile 0.9% sodium chloride solution.
Depending on the nature of the infection focus, staphylophage is used:
1. In the form of irrigation, compresses, and tamponade in a volume of up to 200 ml depending on the size of the affected area. In the case of an abscess, after removing the purulent contents via puncture, the preparation is introduced in a volume less than that of the removed pus. In osteomyelitis, after appropriate surgical treatment, staphylophage is injected into the wound at 10-20 ml.
2. When administered into cavities (pleural, joint, and other limited cavities) up to 100 ml, after which a capillary drain is left through which staphylophage is introduced over several days.
3. In cases of cystitis, pyelonephritis, urethritis, the preparation is taken orally. If the bladder or renal pelvis is drained, staphylophage 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 preparation is introduced into the vagina and uterus at a dose of 5-10 ml daily once, and in cases of colpitis - 10 ml by irrigation or tamponade 2 times a day. Tampons are placed for 2 hours.
5. In cases of purulent-inflammatory diseases of the ear, throat, and nose, the preparation is administered at a dose of 2-10 ml 1-3 times a day. Staphylophage is used for gargling, washing, instilling, and introducing moistened turundas (leaving them for 1 hour).
6. In cases of enteral infections, intestinal dysbiosis, the preparation is taken orally 3 times a day 1 hour before meals. A combination of twice daily oral administration with a single rectal administration of the age-specific dose of staphylophage in the form of an enema after bowel evacuation is possible.

Use of staphylophage in children (up to 6 months).
In cases of sepsis, enterocolitis in newborns, including premature infants, staphylophage is used in the form of high enemas (via 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 preparation may be administered orally. In this case, it is mixed with breast milk. A combination of rectal (in the form of high enemas) and oral (by mouth) administration of the preparation is possible. The course of treatment is 5-15 days. In cases of recurrent disease, repeated treatment courses may be conducted. For the prevention of sepsis and enterocolitis in cases of intrauterine infection or risk of nosocomial infection in newborns, staphylophage is administered in the form of enemas 2 times a day for 5-7 days.
In the treatment of omphalitis, pyoderma, infected wounds, the preparation is used in the form of applications twice daily (a gauze pad is soaked with staphylophage and applied to the umbilical wound or affected skin area).
If no improvement occurs after treatment, or if symptoms worsen, or new symptoms appear, it is necessary to consult a doctor. Use the preparation only according to the indications, method of application, and dosages specified in the instructions.

In 1 ml of the preparation contains:
Active ingredient.
Sterile purified filtrate of phagolysates of Staphylococcus bacteria (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).

A transparent liquid of yellow color with varying intensity, a greenish tint is possible.

Individual intolerance or sensitivity to any of the components of the medication.

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).

Special instructions.
Before use, the bottle containing the liquid staphylophage must be shaken. Do not use the product if it is cloudy!
Due to the presence of a nutrient medium in the product, which can allow bacteria from the environment to grow, causing cloudiness of the product, the following rules must be observed when opening the bottle:

• thoroughly wash hands;

• 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 product can be extracted using a sterile syringe by puncturing the stopper. The product from the opened bottle, provided that the storage conditions, the above rules, and the absence of cloudiness are maintained, can be used throughout its shelf life.

Effect on the ability to drive vehicles and operate machinery.
The product 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).

Allergic reactions are possible. 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.

No cases of overdose have been reported to date.

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

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

Transportation conditions. At a temperature of 2 to 8 °C; transportation at a temperature of 9 to 25 °C is allowed for no more than 1 month.