Septaphage Annotation
SEPTAPHAGE (Bacteriophagum Intestinalis Liquidum) 20 ml sterile solution for internal use.
SEPTAPHAGE (Bacteriophagum Intestinalis) 0.13 g tablet for oral use.
Trade name: Septaphage®
International proprietary name: Bacteriophagum Intestinalis DescriptionSterile solution: Various intensity yellow, a transparent solution with specific taste.
Tablet: White, grayish tablets.
Composition:
Active ingredient: 1ml of fluidy product contains phagolysates sterile filtration mixture of bacteria: Shigella Flexneri
1,2,3,4,6 serogroup; Shigella Sonnei; Salmonella: paratyphi A, B, Typhimurium, Choleraesuis, Oranienburg, Enteritidis; Enteropathogenic E.coli – etiologically important serogroups of enteral diseases; Proteus: Proteus (Vulgaris, mirabilis); Staphylococcus; Pseudomonas; Enterococcus.
1 tablet contains sterile filtration concentration of liophylically dried phagolysates of bacterias:
Shigella Flexneri 1,2,3,4,6 serogroup; Shigella Sonnei; Salmonella: paratyphi A, B, Typhimurium, Choleraesuis, Oranienburg, Enteritidis; Enteropathogenic E.coli – etiologically important serogroups of enteral diseases; Proteus: Proteus (Vulgaris, mirabilis); Staphylococcus; Pseudomonas; Enterococcus.
Quantitative composition:
1 ml of fluid product and 1 tablet contain specific phages:
Shigella: Flexneri 1,2,3,4,6 serogroup B; Sonnie.
Salmonella: paratyphi A, B, Typhimurium, Choleraesuis, Oranienburg, Enteritidis
E.coli: etiologically important serogroups of enteral diseases;
Proteus (Vulgaris, mirabilis)
Staphylococcus Pseudomonas Enterococcus
in not less than 105 each.
Pharmaceutical form: 20 ml sterile solution for internal use: for oral and for rectal use (Per os/ Per rectum).
0.13g tablet for oral use.
Pharmacotherapeutic group: Specific antibacterial preparation.
ATC code: J01XX
Pharmacological activity: 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.
Septaphage® contains only selected virulent phages of bacteria (Shigella, Salmonella, E. coli, Proteus,
Staphylococcus, Pseudomonas, Enterococcus) conditioning high activity and the 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. Therapeutic indications: Septaphage® is used for treatment and prophylaxis of the diseases caused by bacteria (Shigella, Salmonella, E.coli, Proteus, Staphylococcus, Pseudomonas, Enterococcus) or diseases caused by unity of them such as shigellosis, typhoid, paratyphoid, dysbacteriosis
enterocolitis, infectious colitis, dyspepsia; foodborne infections and other bacterial diarrheas; Also discomfort of the gastrointestinal tract, in patients of all age and high-risk groups;
Contra-indication: Increased sensitivity to any components of the vial content of the product.
Special precautions: There are no special precaution measurements when using the preparation. The sterile syringe should be used for taking out the content from the vial of sterile solution form of the preparation (in the case when using less than 20ml of the solution). In case if the integrity of the vial is destroyed the content of the vial should be used within 24 hours after opening when storing conditions are completely protected.
It’s not allowed to take preparation when the content is grown turbid.
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 operation: Using the preparation doesn’t influence the ability to drive and machinery operations.
Keep in a safe place unreachable for children.
Dosage, rule, and way of administration: One of the important premises of phage therapy effectiveness is the definition of the sensitivity of microorganism to phage (to phages included in the preparation) defiant the disease. The preparation is more effective while using in the early stage of the disease.
Septaphage® is prescribed by the physician for using per os/per rectum.
Septaphage® is indicated per os in the first day of the disease when revealing first symptoms, prior to 1 hour before meal 2-3 times per day during 5-10 days. While treatment using the preparation per os for achieving more effectiveness of the course the fluid form of Septaphage is indicated also per rectum to be administered by micro enema once per day at night before sleep after gastric action.
Recommended dosage scheme for sterile solution for the treatment of intestine infections :
| Age | Per os | Frequency of Administration |
| up to 6 months | 5 ml X 1 a day | 5 ml X 1 a day |
| 6 to 1 year | 5 ml X 2 a day | 10 ml X 1 a day |
| 1 to 3 years | 5 ml X 3 a day | 20 ml X 1 a day |
| 3 to 8 years | 10 ml X 2-3 a day | 30 ml X 1 a day |
| More than 8 years | 20 ml X 2-3 a day | 40 ml X 1 a day |
Recommended dosage scheme for tablet form for the treatment of intestine infections :
| Age | Per os | Frequency of Administration |
| 3 to 8 years | 1 tablet | 3 times per day |
| More than 8 years | 2 tablet | 2-3 times per day |
Prophylaxis of intestinal infections: For avoiding intestinal infections the preparation is indicated 3 times per week according to the recommended scheme:
| Age | Sterile solution for per os | Tablets for per os |
| up to 6 months | 5 ml X 1 a day | |
| 6 to 1 year | 5 ml X 1 a day | |
| 1 to 3 years | 10 ml X 1 a day | |
| 3 to 8 years | 20 ml X 1 a day | 20 ml X 1 a day |
| More than 8 years | 20 ml X 1 a day | 2-3 tablets X 1 a day |
Overdosage: There is no information about the overdosage of the preparation.
Adverse reactions: The preparation is nontoxic. There are no data evident about any side effects or harmful influence on the human body after administration of the product.
Sterile solution: The product is produced in vials of 20 ml medical glass. The package contains 20 ml 4 vials of the preparation together with an instruction leaflet for use.
Tablet: The package contains tablet N30 of the product placed in a polyethylene bottle and an instruction leaflet for use.
Storage and transportation terms:Sterile solution: Keep in a dry place, away from light at a temperature of 2°С – 25°С.
Tablet: Keep in a dry place away from light in a closed bottle at not more than 25°С temperature.
Shelf life: The product is valid for 2 years since the date of manufacture if proper storage conditions are protected. The product shouldn’t be used after the date of expiration.
The III pharmaceutical product group (released without a prescription).