FERSISI Bacteriophage

Name of the pharmaceutical product : Fersisi Bacteriophage

Georgian pharmaceutical product registration number: R-019967

Composition:

Fersisi bacteriophage is a sterile filtrate of phage lysates active to:

  • Staphylococcus (S. aureus,S.epidermidis) titter no less than 105 ml-1,
  • Streptococcus (S.pyogenes, S. sanguis, S.salivarius, S. agalactiae) titter no less than 104 ml-1.

Inactive ingredients: Bacteriological growth medium, standard sodium saline. Chinazolin as a conservator.

Description:

Preparation is transparent liquid, with yellow to light brown colour.

Pharmaco-therapeutical group: Specific antibacterial solution.

Pharmacological actions:

Fersisi Bacteriophage leads to a specific lysis of bacteria belonging to Staphylococci and Streptococci.

Prescription:

To be used with curative and prophylaxis aim in pyo-inflammatory and enteric infections caused by the above mentioned microorganisms.

Indications:

Otolaryngological diseases:  inflammation of the middle ear, tonsillitis, laryngitis, rhinitis, tracheitis, bronchitis, pneumonia, pleurisy.

Skin infections: furunculosis, carbunculosis, abscess, deep infiltration and abscessing sycosis. Surgical diseases: Abscess, wound infections, mastitis, osteomyelitis, phlegmon. Inflammation of oral cavity: stomatitis, gingivitis, etc. Eye diseases: bacterial conjunctivitis. Secondary infections with thermal burns. Urogenetal and gynecologic infections: urethritis, cystitis, pyelonephritis, endometritis. Enteric infections:  gastroenterocolitis, cholecystitis, staphylococcal toxic infection, dysbacterioses. Pyo-inflammatory disease in children (including newborns). Prevention of postoperative periods and hospital infection.

Usage and dosage:

Used as a processing site lesions topically (as tampon), and for the introduction into the cavity (bladder, pleural and peritoneal cavity, nasal cavity, deep wounds, abscesses, uterus and vagina). The drug is also recommended for use due to enemas, to enter through a tube and drainage.

When applied topically term treatment does not exceed 3 -8 days, 3 times a day. Amount of preparation due to the size of the affected area, 50 – 200 ml. Phage therapy can start only after cleaning the wound or cavity of pus. In cystitis, pyelitis phage can be introduced by catheter. In cholecystitis, phage is given through the tube 30 ml, once in 2 days. In case of conjunctivitis phage dropped in the eye 4 – 6 times a day, 2 -3 drops. In newborns with pyoderma phage used with napkins, two times a day. Treatment lasts from 5 to 7 days. Before the use of phage per os is recommended reception 2-3% solution of baking soda.

Special Warnings:                           

Before use, the ampoule/vial should be well shaken. The contents should be transparent liquid without sediment. The preparation should not be used in case of ampoules/vials damage or if the liquid inside is non-transparent! Do not store and use the drug after destroying the integrity of the ampoule/vial!!!

Overdosing:

During the usage of Fersisi bacteriophage, overdosing symptoms have not been revealed.

Contradictions:

Usage of Fersisi bacteriophage does not have contradictions.

Side effects:

No side effects have been revealed during usage of Fersisi bacteriophage.

Usage together with other preparations:

Preparation can be used in parallel or supplemental to other medications. Drinking alcohol during treatment with bacteriophages is not recommended.

Specific categories of patients:

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

Usage in elderly people:

Preparation is used in elderly people.

Effect on drivers and people working with potentially harmful machines:

Usage of bacteriophages does not affect driving skills or skills of other equipment usage.

Packaging:

Fersisi bacteriophage is produced in 10 ml vials (5 vials per pack).

Storage conditions and shelf life:

Store at +2C0 – +8C0 in dry place, protected from direct light.

Shelf life 18 month.

 Preparation developed by G. Eliava Institute of Bacteriophages, Microbiology and Virology.