Phagyo Spray Annotation


 PHAGYO SPRAY

PHAGYO® Spray (Pyo Bacteriophagum)

International non-patented name: Pyo Bacteriophagum spray.

Description: Various intensity yellow, a transparent solution with specific taste.

Composition:

Active ingredients:

Phagolysates sterile filtration mixture of bacterias: Streptococcus, Staphylococcus, E.Coli, Pseudomonas aeruginosa, Proteus.

Quantitative composition: 1 ml of the product contains Specific phages:

Bacteriophagum Streptococcus,

Bacteriophagum Staphylococcus,

Bacteriophagum E.Coli,

Bacteriophagum Pseudomonas aeruginosa,

Bacteriophagum Proteus,

in not less than 10each.

Pharmaceutical form: Spray, 20ml sterile solution for local and external use.

Pharmacotherapeutic group: Specific antibacterial medication.

ATC code: J01XX.

Pharmacological action: Bacteriophage is a specific virus of bacteria that is adsorbed on the membrane of the cell of homological bacteria, destroying its integrity penetrates into the cell, propagates itself, and causes its lysis.

Phagyo spray contains only selected virulent phages of bacteria (Streptococcus, Staphylococcus, E.Coli, Pseudomonas aeruginosa, Proteus) conditioning high activity and effectiveness of the preparation.

Despite the way of administration preparations of Bacteriophage are rapidly penetrated in blood and lymph and thus easily reach the disease. It is secreted mainly in the kidneys and in the gastrointestinal tract.

Therapeutical indications: Phagyo spray is used for treatment and prophylaxis of the purulent diseases caused by bacteria Streptococcus, Staphylococcus, E.Coli, Pseudomonas aeruginosa, Proteus in patients of all age and high-risk groups.

The medication is used for:

The treatment of pharyngitis, laryngitis, and tonsillitis, for treatment and prevention of inflammation of oral cavity such as glossitis, gingivitis, stomatitis. For the treatment of purulent wounds, burns, abscesses, phlegmon, furuncles, carbuncles.

For the treatment of inflammation diseases in infants (omphalitis, pyoderma).

In other diseases caused by the bacteria: Streptococcus, Staphylococcus, E.Coli, Pseudomonas aeruginosa, Proteus.

The medication is used for the prevention of the following diseases: After different manipulations in the oral cavity, surgical interventions (periodontal procedures, tooth extraction, etc.).

For the processing of fresh wounds in stationery as well as household conditions; For prevention of inflammation complications in surgical manipulations and intervention. For prevention of inflammation in severe respiratory-viral infectious diseases.

Contraindications: Increased sensitivity to any components of the vial content of the product.

Special precautions:

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!

After opening the vial (first spray) the preparation can be stored for 20 days at 2°C-8°C.

The preparation can be swallowed during oral cavity treatment.

Interaction with other pharmaceutical products: The incompatibility of the preparation with other pharmaceutical products is not ascertained. The preparation is possible to be used in complex treatment with other pharmaceutical products, including antibacterial preparations (antibiotics).

Pregnancy and lactation: The product is allowed to be used in pregnancy and lactation.

Driving and machinery operations: Using the preparation doesn’t influence on the ability of driving and machinery operations.

Keep out of reach of children.

Phagyo spray should be prescribed by a physician.

When the product is used orally (oral cavity and pharynx) it might be administered 30 minutes prior to a meal or after for more therapeutic effect.

In children below 6 years old – 5 sprays in 2-3 hours intervals for 4-5 times per day.

From 6 to 12 years old children – 8 sprays in 2-4 hours intervals, for 4-5 times per day.

In adults and elderly patients – 8-10 sprays in 2-4 hours intervals for 4-5 times per day.

The treatment should be prolonged for 5-10 days.

In the case of external administration, the dosage (quantity of sprays) of the product should be determined by the physician considering the size of the affected area.

Overdosage: There is no any information about overdosage of the preparation of Bacteriophage.

Adverse reactions: The preparation is nontoxic. There is no data evidence about any side effects or harmful influence on the human body after administration of the product.

Form and package of the product:

20ml glass vial containing solution is closed by impermeable mechanical sprayer with a transparent cap. One 10ml vial is represented in a cardboard package with an instruction leaflet.

Keeping and transportation terms: Keep in a dry place away from light at 2°C – 25°C temperature.

Transportation of the product is allowed to be accomplished by any closed transport providing a stable temperature regime for the whole transportation period.

Expiration date: The product is valid for 2 years since the date of manufacture in case if storage terms are completely protected.

The product shouldn’t be used after the date of expiration.

Release from drug stores: Released without prescription