Name of the pharmaceutical product (Patentable): 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;

Description: PPreparation 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 vial should be well shaken. The contents should be transparent liquid without sediment. The preparation should not be used in case of vials damage or if the liquid inside is non-transparent! Do not store and use the drug after destroying the integrity of the 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: The 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 +2C – +8C in dry place, protected from direct light. Shelf life 18 month.
Preparation developed by G. Eliava Institute of Bacteriophages, Microbiology and Virology.
Manufactured by:
“Bacteriophage biopreparations” LTD
3, Gotua str. Tbilisi, Georgia
info@phage.ge
+(995) 32 2370702

Name of the pharmaceutical product (Patentable): Intesti Bacteriophage
Georgian pharmaceutical product registration number: R-022601





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

• Shigella (Shigella flexneri serotype 1,2, 3, 4 and Shigella sonnei) titter no less than 10⁵ ml^-1;
• Salmonella (S. patarype A, S. paratype B, S. typhimurium, S. enteritidis, S. cholera suis, S. oranienburg) titter no less than 10⁵ ml^-1;
• Different types of E. coli titter no less than 10⁵ ml^-1;
• Proteus (mirabilis and vulgaris) titter no less than 10⁵ ml^-1;
• Staphylococcus (S. aureus) titter no less than 10⁵ ml^-1;
• Pseudomonas aeruginosa titter no less than 10⁵ ml^-1;
• Enterococcus titter no less than 10⁵ ml^-1;

Description: Preparation is transparent liquid, with yellow to light brown colour.
Pharmaco-therapeutical group: Specific antibacterial solution.
Pharmacological actions: Intesti bacteriophage leads to specific lysis of following bacteria: Shigella flexneri (Serotypes 1,2,3,4; Shigella sonnei; Shigella newcastle; Salmonella paratyphi A and Salmonella paratyphi B; Salmonella typhimurium; Salmonella enteritidis; Salmonella choleraesuis; Salmonella oranienburg; Escherichia coli; Proteus (vulgaris, mirabilis); Staphylococcus aureus; Pseudomonas aeruginosa; Enterococcus faecalis.
Prescription: Intesti bacteriophage is used in the treatment and prophylaxis 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 os with first signs of disease within 5-6 days. Intesti bacteriophage should be used in following doses: Children up to 3 years of age / 5 ml per admission / 4 times a day 30 minutes before meal; Children from age of 3 and adaults / 10 ml per admission / 4 times a day 30 minutes before meal; During Per os application of Intesti bacteriophage in adults and children from age of 3, drinking of 2-3% baking soda solution (one glass, 150-250 ml) is recommended. In parallel to per os admission of Intest ibacteriophage 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 empting stomach) For prophylaxis use Intesti bacteriophage is recommended: – In organized groups to prevent spread of infections. During seasonal infections, Intestibacteriophage can be applied once a day in amount of 10-20 ml. Application can be made with the interval of 5 days during 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 the interval of 5 days. Amount per admission should be 10-20 ml.
Special Warnings: Before use, the vial should be well shaken. The contents should be transparent liquid without sediment. The preparation should not be used in case of vials damage or if the liquid inside is non-transparent! Do not store and use the drug after destroying the integrity of the vial!
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.
Usage together with other preparations: The 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: Intesti bacteriophage is produced in 10 ml vials (5 vials per pack)
Storage conditions and shelf life: Store at +2C – +8C in dry place, protected from direct light. Shelf life 18 month.
Preparation developed by G. Eliava Institute of Bacteriophages, Microbiology and Virology.
Manufactured by:
“Bacteriophage biopreparations” LTD
3, Gotua str. Tbilisi, Georgia
info@phage.ge
+(995) 32 2370702

Name of the pharmaceutical product (Patentable): Pyo bacteriophage
Georgian pharmaceutical product registration number: R-022600





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

• Staphylococcus titter no less than 10⁵ ml^-1;
• Streptococcus titter no less than 10⁴ ml^-1;
• Different types of E. coli titter no less than 10⁵ ml^-1;
• Pseudomonas aeruginosa titter no less than 10⁵ ml^-1;
• Proteus (mirabilis and vulgaris) 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: Pyo bacteriophage leads to a specific lysis of bacteria belonging to: Staphylococcus (S. aureus), Streptococcus (S.pyogenes, S. sanguis, S.salivarius, S. agalactiae), E.coli (Different types), Pseudomonas Aeruginosa, Proteus (Mirabilis and Vulgaris) spices.
Prescription: Pyo bacteriophage is used in the treatment and prophylaxis of purulent inflammatory and enteric infectious diseases caused by above enlisted microorganisms.
Indications:

• Otorhinolaryngeal and respiratory bacterial infections including: rhinitis, otitis, paranasal sinusitis, pyogenic tonsillitis, pharyngitis, laryngitis, tracheitis, bronchitis, pneumonia, pleuritic;
• Dermatological bacterial infections including: pyoderma, abscesses, furunculi and carbuncles, hydradentitis;
• Surgical site bacterial infections including: infectious wounds, mastitis, flegms;
• Oral bacterial infections including: stomatitis, gingivitis, periodontitis and other;
• Ocular bacterial infections including: conjunctivitis, blepharitis;
• Burn wounds with secondary bacterial infections
• Urogenital and gynecological infections: Urethritis, cystitis, pyelonephritis, colpitis, endometritis;
• Gastrointestinal bacterial infections including: gastroenterocolitis, dysbacteriosis (bacterial overgrowth syndrome), paraproctitis;
• Omphalitis of newborn, purulent septic infections in children (including newborn);
• Infectious diseases lead by Staphylococcus (S. aureus), Streptococcus (S. pyogenes, S. sanguis, S. salivarius, S. agalactiae), E. coli (Different types), Pseudomonas Aeruginosa, Proteus (Mirabilis and Vulgaris) bacteria;
• Prophylactic purposes against post-operational complications and hospital infections;

Usage and dosage: Optimal results are achieved when Pyo bacteriophage is used at the onset of infection and when introduced directly to the infection site. Pyo bacteriophage is used as a disinfecting agent by phage soaked bandages applied directly into a cavity (wound, including abscess, abdominal, pleural, nasal, urinary bladder, uterine, vaginal) The preparation may be used orally per os, and/or by urinary catheter or rectally per rectum via enema.
– Local application of Pyo bacteriophage is performed daily during 3-5 day period, three times a day. Amount of the preparation is determined by the size of the affected area. If various chemical antiseptics were used to treat the wound before phage application, it should be cleaned by sterile saline solution and 2-3% soda solution should be applied.
– For treatment of abscesses, pleuritis, arthritis, and peritonitis, 50-200ml of Pyo bacteriophage may be instilled directly into the cavity, every other day. (Exact amount of applied phage is determined based on the size of cavity) Before instillation of bacteriophages, pus from cavities should be extracted.
– For cystitis and pyelonephritis Pyo bacteriophage may be administered via urinary catheter or per os; – During cholecystitis, Pyobacteriophage can be applied through intubation with amount of 30 ml every other day. – In case of stomach surgery or peritonitis, 100ml phage is applied in cavity, daily during 3-4 days. In case of application through catheter 30ml phage is applied daily during 3-4 days.
– For treatment of deep forms of pyoderma. Intradermal injection may be used (0.1-0.5 ml per injection) up to maximum of 10 injections during 24 hours. – For conjunctivitis, Pyo bacteriophage is instilled via pipette, 2 drops in each eye, 4-6 times daily during 3-5 days.
– In cases of neonatal omphalitis and pyoderma, application is by Phage soaked bandage twice daily for 5-7 days. During Per os application of Pyobacteriophage in adults and children from age of 3, drinking of 2-3% baking soda solution (one glass, 150-250 ml) is recommended.
Special Warnings: Before use, the vial should be well shaken. The contents should be transparent liquid without sediment. The preparation should not be used in case of vials damage or if the liquid inside is non-transparent! Do not store and use the drug after destroying the integrity of the vial!
Overdosing: During the usage of Pyo bacteriophage, overdosing symptoms have not been revealed.
Contradictions: Usage of Pyo bacteriophage does not have contradictions.
Side effects: No side effects have been revealed during usage of Pyo bacteriophage.
Usage together with other preparations: The 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: Pyo bacteriophage is produced in 10 ml vials (5 vials per pack)
Storage conditions and shelf life: Store at +2C – +8C in dry place, protected from direct light. Shelf life 18 month.
Preparation developed by G. Eliava Institute of Bacteriophages, Microbiology and Virology.
Manufactured by:
“Bacteriophage biopreparations” LTD
3, Gotua str. Tbilisi, Georgia
info@phage.ge
+(995) 32 2370702

Name of the pharmaceutical product (Patentable): 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 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 vial should be well shaken. The contents should be transparent liquid without sediment. The preparation should not be used in case of vials damage or if the liquid inside is non-transparent! Do not store and use the drug after destroying the integrity of the 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: The 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 +2C – +8C in dry place, protected from direct light. Shelf life 18 month.
Preparation developed by G. Eliava Institute of Bacteriophages, Microbiology and Virology.
Manufactured by:
“Bacteriophage biopreparations” LTD
3, Gotua str. Tbilisi, Georgia
info@phage.ge
+(995) 32 2370702

Name of the pharmaceutical product (Patentable): Staphylococcal bacteriophage
Georgian pharmaceutical product registration number: R-022876





Composition: Staphylococcal bacteriophage is a filtrate of the purified phage lysate active against Staphylococcus aureus strains with titer no less than 10⁷ ml^-1;
Inactive ingredients: Bacteriological growth medium, standard sodium saline. Chinazolin as a conservator.
Description: Preparation is transparent, colorless liquid.
Pharmaco-therapeutical group: Specific antibacterial solution.
Pharmacological actions: Staphylococcal bacteriophage leads to a specific lysis of bacteria belonging to the Staphylococcus aureus spices.
Prescription: Staphylococcal bacteriophage is used in the treatment and prophylaxis of infections caused by Staphylococcal bacteria.
Indications: Preparation is directed to use for treatment of infections caused by staphylococci such as:

• Upper airways, nose, throat, lung, ear (pharingitis, tonsillitis, thracheitis, bronchitis, plevritis, pneumonia, inflammation of middle ear) infectious diseases;
• Surgical infections (infectious wound, infected burn, abscess, phlegmona, furuncle, carbuncle, paraproctitis, mastitis, bursitis, osteomyelitis, panaricium);
• Urogenital infections (urethritis, cystitis, pyelonephritis, colpitis, endometritis);
• Enteric infections (gastroenteric colitis, cholecystitis);
• Purulent-septic infections in newborn (omphalitis, pyodermia, conjunctivitis, gastroenteric colitis and others)
• Other Staphylococcal infections

Usage and dosage: Staphylococcal bacteriophage is used for prophylaxis and treatment of post-operational and infected wounds, as well as hospital staphylococcal infections, confirmed as an epidemiological indicator. Preparation can be used through different applications, including: per os, treatment of wounds by drainage and application, per rectum, through applications directly inside the ear, throat, nose, urinary tract cavities.
Recommended doses of Staphylococcal bacteriophage are as follows:
Infants 0-6 months / per os5ml / 5-10ml;
Kids 6-12 months / per os 10ml / per rectum 10-20ml;
Kids 1-3 years / per os 15ml / per rectum 20-30ml;
Children 3-8 years / per os 15-20ml / per rectum 30-40ml;
Children older than 8 years, adults / per os 20-30მლ / per rectum 40-50მლ;
During Per os application of Staphylococcal bacteriophage in adults and children from age of 3, drinking of 2-3% baking soda solution (one glass, 150-250 ml) is recommended.
In case of infectious abscess, phage is introduced by injection in abscess cavity after evacuation of pus; the volume of used phage should be less than evacuated pus. In case of open abscess, tampon with phage might be used in cavity. -In case of lung abscess, phage is used by trans-thoracal puncture and by catheter in tracheobronchial system. In case of emphysema, the preparation could be used by puncture and drainage. One dose includes 10- 20ml of phage during phage application by catheter of tracheobroncheal system, in case of emphysema – the single dose is from 10 ml to 50 ml.
Special Warnings: Before use, the vial should be well shaken. The contents should be transparent liquid without sediment. The preparation should not be used in case of vials damage or if the liquid inside is non-transparent! Do not store and use the drug after destroying the integrity of the vial!
Overdosing: During the usage of Staphylococcal bacteriophage, overdosing symptoms have not been revealed.
Contradictions: Usage of Staphylococcal bacteriophage does not have contradictions.
Side effects: No side effects have been revealed during usage of Staphylococcal bacteriophage.
Usage together with other preparations: The 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: Staphylococcal bacteriophage is produced in 10 ml vials (5 vials per pack)
Storage conditions and shelf life: Store at +2C – +8C in dry place, protected from direct light. Shelf life 24 month.
Preparation developed by G. Eliava Institute of Bacteriophages, Microbiology and Virology.
Manufactured by:
“Bacteriophage biopreparations” LTD
3, Gotua str. Tbilisi, Georgia
info@phage.ge
+(995) 32 2370702