Instruction for use of medicinal product
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 phagelysate of Staphylococcus aureus.
Quantitative Composition: 1 ml of a preparation contains Staphylococcus aureus bacteriophage in number of not less than 106.
Pharmaceutical form: Sterile liquid in 20 ml bottles, for oral administration, local and external use.
Pharmacotherapeutical category: Specific antibacterial product.
ATC Code: J01XX
Pharmacological actions: Bacteriophage is specific bacterial viruses, 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 medicinal product excreted by kidney and the rest by 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:
- Surgery: purulent wound, burns, abscess, phlegmon, furuncles, carbuncles, hidradenitis, panaritium, paraproctitis, mastitis, bursitis, osteomyelitis;
- Urology – urogenital infections: urethritis, cystitis, pyelonephritis, colpitis, endometritis, salpingo-oophoritis;
- Gastroenterology: enterocolitis, cholecystitis, Irritable bowel syndrome (IBS) (dysbiosis);
- Bacterial infections of the upper and lower respiratory tract,inflammation of the sinuses, otitis media, tonsillitis, pharyngitis, laryngitis, tracheitis, bronchitis, pneumonia, pleuritis.
In 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 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. After opening vial the preparation permitted to use 24 hours under appropriate storage conditions.
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.
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
Dose, method and time of administration: One of the most important conditions of phagetherapy is to determine phagesensitivity of microorganisms which 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 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 treatment of inflammatory diseases locally and per oral at the same time. Duration of treatment is 5 -10 days.
Dosage is determined individually depending on the size of 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.
Next days medicinal product is administered into the cavity through drainage. Procedure takes place once a day during 3-5 days.
- For treatment of cystitis, pyelonephritis, urethritis medicinal product is taken internal, if the cavity of the bladder or renal pelvis drained, bacteriophage is administyered 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 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 treatment of stomatitis and chronic generalized periodontitis compound can be used as a mouth rinse 3-4 times daily at a dose of 10-20 ml, and also in periodontal pockets of turundus soaked by piobacteriophage for 5-10 minutes.
- For 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 once a day at the evening, before bedtime after intestines emptying
Recommended doseage of the preparation:
| Age |
Per oral administration |
Per rectum (enema) |
| up to 6 month |
5 ml X 1 a day |
10 ml X 1 a day |
| 6 to 12 month |
5 ml X 2 a day |
10 ml X 1 a day |
| 1 to 3 year |
5 ml X 3 a day |
20 ml X 1 a day |
| 3 to 8 year |
10 ml X 2-3 a day |
30 ml X 1 a day |
| More than 8 year |
20 ml X 2-3 a day |
40 ml X 1 a day |
Prophylaxis: Preparation is used for the treatment of post surgical and newly infected wounds, abdominal and chest cavity, and for the prevention of street accidents and industrial injuries in order to prevent postoperative infectious complications in a quantity of 40 ml. Dose of the medicinal product for the prophylactic use is determined by the condition of patients.
Note: In the case of use of chemical aseptic products for 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
in vials of medical glas. In the cardboard box are 4 bottles 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 has a validity of 2 years from the date of production.
Do not use after the expiration date printed on the package
Turbid preparation should not be used!
Medicinal product is issued without a prescription.
Manufacturer: JSC Biochimpharm
