SES Bacteriophage

Name of the pharmaceutical product: SES Bacteriophage

Georgian pharmaceutical product registration number: R-019968

Composition:

SES 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,
  • Different types of E.coli titter no less than 105 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:

SES Bacteriophage leads to a specific lysis of bacteria belonging to Staphylococci, Streptococci   and Enteropathogenic E.coli of different serovars.

Prescription:

SES bacteriophage can be used in therapeutic and prophylactic purposes in pyo-inflammatory and enteric infections caused by the above-mentioned microorganisms.

Indications:

Otolaryngological diseases: Otitus, tonsillitis, laryngitis, rhinitis, tracheitis, bronchitis, pneumonia, pleurisy. Skin infections: furunculosis, carbunculosis, 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 for treatment of lesions locally (as tampon), and for injecting into the cavity (bladder, pleural and peritoneal cavity, nasal cavity, deep wounds, abscesses, uterus and vagina). The prepartion is also recommended for using by enemas, and injecting through a tube and drainage. When applied locally, the treatment term does not exceed 3 -8 days, 3 times a day. The amount of the preparation to be applied is defined according to the size of the affected area, it varies from 50 to 200 ml. Phage therapy can start only after cleaning the wound or cavity of pus. In case of cystitis and pyelitis the phage can be applied by catheter. In case of cholecystitis 30 ml of phage is applied through the tube, once in 2 days. In case of conjunctivitis the phage is dropped in the eye 4 – 6 times a day, 2 – 3 drops. In newborns with pyoderma the phage is used with napkins, 2 times a day. Treatment lasts from 5 to 7 days. Before taking the phage per os taking 2-3% solution of baking soda is recommended.

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 SES bacteriophage, overdosing symptoms have not been revealed.

Contradictions:

Usage of SES bacteriophage does not have contradictions.

Side effects:

No side effects have been revealed during usage of SES 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:

SES 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.

 The preparation is developed by G. Eliava Institute of Bacteriophages, Microbiology and Virology.