Phagyo (4 x 20 ml)

PHAGYO

(Pyo Bacteriophagum Liquidum)

Trade name: Phagyo

International nonproprietary name:Pyo Bacteriophagum Liquidum

Description: Various intensity, yellow, transparent, specific taste liquid

Qualitative and Quantitative Composition:

Active ingredient

Mixture of sterile filtrates of bacterial phagelysates: Streptococcus, Staphylococcus, E.Coli, Pseudomonas aeruginosa, Proteus.

Quantitative composition: PHAGYO is presented as a liquid and 1 ml product contains: Bacteriophagum Streptococcus;

Bacteriophagum Staphylococcus; Bacteriophagum E.Coli; Bacteriophagum Pseudomonas aeruginosa; Bacteriophagum Proteus;

Each quantity not less than – 10⁵;

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

Pharmacotherapeutic 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 PHAGYO is selective, only virulent phages of bacteria: Streptococcus, Staphylococcus, E.Coli, Pseudomonas aeruginosa, Proteus which ensures a high activity and effectiveness of the bacteriophage products.

Antibacterial efficacy of bacteriophage products is based on specific lysis ability of pathogenic bacteria in nidus of infection under exposure of bacteriophages. Despite the mode of introduction, bacteriophage products enter the blood and lymph and enter into the nidus of infection and the main part of medicinal product excreted by kidney and the rest by gastrointestinal tract. In addition the medicinal product stimulates activity of patient immune system and is efficient in treatment of diarrheal diseases of immunocompromised patients.

Bacteriophage is bacterial virus which enters bacterial cell, multiplies in cell, causing cell rupture and yielding new mature bacteriophage particles ready to infect new bacterial cells. Bacteriophages are strictly specific towards homological bacteria and therefore don’t suppress human normal flora and are absolutely safe for human cells.

Therapeutic Indications:  PHAGYO used for treatment and prophylaxis of bacterial purulent–inflammatory infections, caused by the following microorganisms – Streptococcus, Staphylococcus, E.Coli, Pseudomonas aeruginosa, Proteus and their combinations.

Medicinal product is used in patients in all ages and high risk groups for treatment of following diseases:

• Bacterial infections of the upper and lower respiratory tract (Inflammation of the sinuses, otitis media, tonsillitis, pharyngitis, laryngitis, tracheitis, bronchitis, pneumonia, pleuritis);
• In surgery (purulent wound, burns, abscess, phlegmon, furuncles, carbuncles, hidradenitis, panaritium, paraproctitis, mastitis, bursitis, osteomyelitis);
• In Urology (urogenital infections: urethritis, cystitis, pyelonephritis, colpitis, endometritis, salpingo-oophoritis);
• Gastroenterology (enterocolitis, cholecystitis, Irritable bowel syndrome (IBS) (dysbiosis);
• Generalized septic infections;
• Purulent–inflammatory neonatal infections (omphalitis, pyoderma, conjunctivitis, sepsis);
• Other diseases, caused by: Streptococcus, Staphylococcus, E.Coli, Pseudomonas aeruginosa, Proteus.

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 precautionary measures are indicated for preparation use. Shake the vial before usage. Content must be transparent and without sediment. Do not administer turbid preparation! After usage, the vial with liquid should be stored in a refrigerator. Do not freeze the product! The preparation can be swallowed during oral cavity treatment.

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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.

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.

Depending on the site of infection PHAGYO 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).

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

Quantity of medicinal product depends on the size of damaged site. PHAGYO is administered in infected cavity after emptying from abscess and drainage. The quantity of medicinal product must be rather lower that the abscess taken from the cavity. 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, PHAGYO administered twice a day for 20-30 ml into the bladder and 5-10 ml in the renal pelvis;
• When purulent-inflammatory gynecological diseases, the medicinal product is administered into the cavity of the vagina, uterus, 5-10 ml once daily.
• For treatment, 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 soaked turundy by PHAGYO is administered into the periodontal pockets, for 5-10 minutes;
• For treatment of intestinal forms of the disease, diseases of internal organs, IBS (dysbiosis), PHAGYO administered through the mouth and enema. The medicinal product is given for per oral 1 hour before meals, in the form of enemas take once a day, evening, before bedtime.

Treatment is recommended to be done in accordance to the scheme given bellow:

Dose of the medicinal product for the prophylactic use is determined by the condition of patients.

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

Overdose: No data, observed.

Side effects: Preparation is nontoxic. No adverse events are observed.

Form of production, packaging: No 4 medical glass bottles per 20 ml sterile liquid together with insert are packed in cardboard box.

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

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.

Medicinal product is issued without a prescription (Group III).

Manufacturer:

JSC Biochimpharm