Intesti Bacteriophage Annotation


INTESTI BACTERIOPHAGE
INTESTI BACTERIOPHAGE
Name of the pharmaceutical product (patentable): Intesti Bacteriophage  

Composition:  

Intesti bacteriophage is a combined preparation. Intesti bacteriophage is a mix of sterile filtrates of phage lysates active to:            

  • Shigella (flexneri Serotypes 1,2,3,4; sonnei; newcastle titter no less than 10s ml)
  • Salmonella (paratyphi A and paratyphi B; Typhimurium; enteritidis; choleraesuis; oranienburg) titter no less than 10s ml-1.
  • Different types of E.coli, titter no less than 10s ml-1 (Escherichia coli)
  • Proteus (vulgaris, mirabilis); titter no less than 10s ml-1
  • Staphylococcus (S. aureus) titter no less than 10s ml-1
  • Pseudomonas Aeruginosa; titter no less than 10s ml-1
  • Enterococcus faecalis titter no less than 10s ml-1

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

Description: Preparation is a transparent liquid, with yellow to light brown color.

Pharmacological specifications:

Pharmaco-therapeutically group

Specific antibacterial solution

Pharmacological actions:

Intesti bacteriophage leads to specific lysis of the following bacteria: Shigella flexneri (Serotypes 1.2.3.4, Shigella Sonnei, Shigella newcastle, Salmonella paratyphi A and B, Salmonella Typhimurium; Salmonella enteritidis; Salmonella oranienburg; Escherichia coli; Proteus (Vulgaris, Mirabilis); Staphylococcus aureus; Pseudomonas aeruginosa; Enterococcus faecalis.

Description: Intesti bacteriophage is used in the treatment and prophylaxis of intestinal infectious diseases caused by enlisted microorganisms.

Indications: Dysentery; Salmonellosis; Dyspepsia; Infective colitis; Enterocolitis; Dysbacteriosis.

Usage and Dosage: Intesti bacteriophage for treatment purposes is used per as with first signs of disease with 5-6 days. Intesti bacteriophage should be used in the following doses:

Age Amount of admissions Period of admissions
Children up to 3 years of age 5ml per admission 3 times a day 30 minutes before a meal
Children from age of 3 years and adults  10 ml per admission 3 times a day 30 minutes before a meal

During the application of Intesti bacteriophage in adults and children from age of 3, drinking of 2-3% baking soda solution (one glass, 150-250ml) is recommended.

In Parallel to per as admission of Intesti bacteriophage it is recommended to use Intesti bacteriophage per rectum, once a day in the amount of 10 ml for children and 20 ml for adults. (per rectum usage is recommended in the evening with enema after emptying stomach). 

For prophylaxis use Intesti bacteriophage is recommended:

  • In organized groups to prevent the spread of infections. During seasonal infections, Intesti bacteriophage can be applied once a day in amounts of 10-20ml. The application can be made with an interval of 5 days for 1 month.
  • During the rise period of intestinal infections, all patients in the clinics are recommended to go through phage treatment despite diagnoses. Phage application is recommended 2 times with an interval of 5 days. Amount per admission should be 10-20 ml.

Special Warnings: Before use, the ampule/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 is non-transparent!

Do not store and use the drug after destroying the integrity of the ampoule/vial!!

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.

Overdosing: During the usage of Intesti bacteriophage, overdosing symptoms have not been revealed.

Contradictions: Usage of Intesti bacteriophage does not have contradictions

Side Effects: No side effects have been revealed during usage of Intesti bacteriophage.

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 driver skills or skills of other equipment used.

Packaging: Intesti bacteriophage is produced in 10 ml vials (5 vials per pack)

Storage conditions and shelf life: Store at +2 c - +8C in a dry place, protected from direct light.

Shelf life: 18 month

Preparation developed by G. Eliava institute of bacteriophage, Microbiology and Virology.