Phagestaph Annotation

PHAGESTAPH (Bacteriophagum Staphylococcicum Liquidum)

Trade name: PHAGESTAPH

International nonproprietary name: Bacteriophagum Staphylococcicum Liquidum

Description: Transparent liquid of yellow color of various intensity with specific taste.

Composition: Active ingredient Preparation represents sterile filtrate of phage lysate of Staphylococcus aureus.

Quantitative Composition: 1 ml of the preparation contains Staphylococcus aureus bacteriophage in a number of not less than 10⁶.

Pharmaceutical form: Sterile liquid in 20 ml vials, for oral administration, local and external use.

Pharmacotherapeutic group: Specific antibacterial product.

ATC Code: J01XX

Pharmacological activity: Bacteriophage is a specific bacterial virus, which is adsorbed on the homological bacterial cell membrane, penetrates into the cell, multiplies, and causes its lyses. The composition of Phagestaph is selective, only virulent phages of bacteria: – Staphylococcus aureus, which provides high activity and efficiency of the preparation. Despite the mode of introduction, bacteriophage products enter the blood and lymph and enter into the nidus of infection. The main part of the medicinal product excreted by the kidney and the rest by the gastrointestinal tract.

Therapeutic Indications: Preparation is used for the treatment and prophylaxis of bacterial purulent–inflammatory infections, caused by Staphylococcus aureus in all age and high-risk groups:

• Bacterial infections of the upper and lower respiratory tract, inflammation of the sinuses, otitis media, tonsillitis, pharyngitis, laryngitis, tracheitis, bronchitis, pneumonia, pleuritis.
• Surgery: purulent wound, burns, abscess, phlegmon, furuncles, carbuncles, hidradenitis, panaritium, paraproctitis, mastitis, bursitis, osteomyelitis;
• Urology – urogenital infections: urethritis, cystitis, pyelonephritis, colpitis, endometritis, salpingo-ophoritis;
• Gastroenterology: enterocolitis, cholecystitis, Irritable bowel syndrome (IBS) (dysbiosis);
• Sepsis
• Infections of infants (omphalitis, pyoderma, sepsis)
• Other diseases caused by Staphylococcus aureus

For prophylactic purpose bacteriophage products used for:

• Treatment of post-surgical and newly infected wounds, as in the household, and in hospitals;
• For the prevention of purulent complications of surgical procedures and operations;
• For the prevention of bacterial complications of acute respiratory-viral diseases;
• For prevention of bacterial contamination and infections in hospitals.

Contraindications: Hypersensitivity to any components of the preparation.

Special warnings: No special precautions in the use of the preparation are shown. It is recommended that the content of the vial be removed with a sterile syringe.

Do not use after the expiration date printed on the package

Turbid preparation should not be used!

Interaction with other medicinal products: No interactions of preparation with other medicinal products are known. Preparation can be used together (in combination) with any groups of medicinal products, including antibacterial drugs (antibiotics).

Pregnancy and lactation: Preparation can be used during pregnancy and lactation.

Effects on the ability to drive and use machines: There are no indications that preparation may impair the ability to drive or to operate machines.

To be kept out of the reach of children

Dosage, method, and route of administration: One of the most important conditions of phage therapy is to determine the phage sensitivity of microorganisms that causes disease. Treatment efficacy of bacteriophage products depends on the use of this product at the initial stages of disease and administration as soon as possible directly to the site of infection.

Phagestaph can be used for internal use (per oral, per rectum), locally (in the form of rinses, irrigation, Wash), for introduction into the cavity (wound, abscess, peritoneal, pleural cavity, abscess, nose, sinuses, otitis media, bladder, uterus, vagina).

Phagestaph is administered for the treatment of inflammatory diseases locally and per oral at the same time. The duration of treatment is 5 -10 days.

Dosage is determined individually depending on the size of the damaged site. Preparation is administered into the cavity after the pus is removed. The quantity of the preparation should be less than the volume of removed pus.

The next day's medicinal product is administered into the cavity through drainage. The procedure takes place once a day during 3-5 days.

• For the treatment of cystitis, pyelonephritis, urethritis medicinal product is taken internally, if the cavity of the bladder or renal pelvis drained, the bacteriophage is administrated twice a day for 20-30 ml into the bladder and 5-10 ml in a nephritic cavity;
• When purulent-inflammatory gynecological diseases, the medicinal product is administered into the cavity of the vagina, uterus, 5-10 ml once daily.
• For the treatment of purulent-inflammatory diseases of the ear, nose, and throat medicine is administered

At a dose of 2-10 ml 1-3 times a day. Bacteriophage used for rinsing, washing, or insert of turundas at the site of disease for 1 hour. For the treatment of purulent tonsillitis compound can be used for rinsing and per oral at the same time;

• For the treatment of stomatitis and chronic generalized periodontitis, Phagestaph can be used as a mouth rinse 3-4 times daily at a dose of 10-20 ml, and also in the form of soaked turundas in periodontal pockets for 5-10 minutes.
• For the treatment of intestinal forms of the disease, diseases of internal organs, IBS (dysbiosis), PHAGESTAPH is used via mouth and enema. Preparation is administered 1 hour prior meals are taken enema is prescribed 1-3 times a day in the evening, before bedtime after intestines emptying.

The recommended dosage of the preparation:

Prophylaxis: The dose of the medicinal product for prophylactic use is determined by the condition of patients.

Note: In the case of the use of chemical aseptic products for the treatment of wounds or cavity, before using Staphylococcus bacteriophage appropriate sites must be cleaned by 0,9% physiology liquid.

Overdose: No data, observed.

Side effects: PHAGESTAPH preparation is nontoxic. No adverse events are observed.

Release form, the package is produced Staphylococcus bacteriophage liquid to 20 ml in vials of medical glass. In the cardboard box are 4 vials of the drug along with instructions for use.

Special precautions for storage and transportation: Stored at 2°С – 25°С, in the original package, at dry and protected from light place.

Shelf life and stability: The product in its intact package and stored in compliance with the prescribed conditions have a validity of 2 years from the date of production.

The medicinal product is issued without a prescription.