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Septaphage (tablets)

$49.95

Septaphage® contains only selected virulent phages of bacterias (Shigella, Salmonella, E. coli, Proteus,

Staphylococcus, Pseudomonas,  Enterococcus)  conditioning  high  activity  and  effectiveness  of  the

preparation.

Despite of the way of administration preparations of Bacteriophage are rapidly penetrated in blood and lymph and thus easily reach to the disease. It is secreted mainly in kidneys and in gastrointestinal tract. Therapeutic indications: Septaphage® is used for treatment and prophylaxis of the diseases caused by bacterias (Shigella, Salmonella, E.coli, Proteus, Staphylococcus, Pseudomonas, Enterococcus) or unity

of   several   bacterias,   such   as:   Shigella,   Salmonella,   paratyphi,   Typhimurium,   dysbacteriosis,

enterocolitis, infectious colitis, dyspepsia in patients of all age and high risk groups.

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Annotation

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Side effects

No side effects observed

Turbid preparation

Do not use

2°С - 25°С

Stored at

Pregnancy, lactation

preparation can be used during

Annotation

Trade name

Septaphage®

International non patented name Bacteriophagum Intestinalis Description

Sterile solution

Various intensity yellow, transparent solution with specific taste.

Tablet

White, grayish tablets.

Composition:

Active ingredient

1ml of fluidy product contains phagolysates sterile filtration mixture of bacterias: Shigella: Flexneri

1,2,3,4,6 serogroup B; Sonnei –  serogroup D; 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 serogroupB; Sonnei – serogroup D; 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 fluidy product and 1 tablet contain specific phages:

Shigella: Flexneri 1,2,3,4,6 serogroup B; Sonnei –  serogroup D

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 one.

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

Pharmacologic activity: Bacteriophage is  a  specific  virus  of  bacteria  which  is  adsorbed  on  the membrane of cell of homological bacteria , destroying its integrity penetrates into cell, propagates itself and causes its lysis.

Septaphage® contains only selected virulent phages of bacterias (Shigella, Salmonella, E. coli, Proteus,

Staphylococcus, Pseudomonas,  Enterococcus)  conditioning  high  activity  and  effectiveness  of  the

preparation.

 

Despite of the way of administration preparations of Bacteriophage are rapidly penetrated in blood and lymph and thus easily reach to the disease. It is secreted mainly in kidneys and in gastrointestinal tract. Therapeutic indications: Septaphage® is used for treatment and prophylaxis of the diseases caused by bacterias (Shigella, Salmonella, E.coli, Proteus, Staphylococcus, Pseudomonas, Enterococcus) or unity

of   several   bacterias,   such   as:   Shigella,   Salmonella,   paratyphi,   Typhimurium,   dysbacteriosis,

enterocolitis, infectious colitis, dyspepsia 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 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:  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 of the preparation doesn’t influence on ability of driving nad machinery operations.

Keep in a place unreachable for children.

Dosage, rule and way of administration: One of the important premises of phagotherapy effectiveness

is the definition of sensitivity of microorganism to phage (to phages included in the preparation) defiant the disease. The preparation is more effective while using in early stage of the disease.

Septaphage® is prescribed by 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 Phagesti is indicated also per rectum to be administered by micro clism once per day at night before sleep after gastric action.

 

Recommended dosage scheme for sterile solution for treatment of intestine infections :

 

AAge Per os Per rectum
From 0 to 6 months 5 ml – 1 time per day 5 ml – once per day
From 6 to 12 months 5 ml – 2 times per day 10 ml – once per day
From 1 to 3 years 5 ml – 3 times per day 20 ml – once per day
From 3 to 8 years 10 ml – 2-3 times per day 30 ml – once per day
Above 8 years 20 ml – 2-3 times per day 40 ml – once per day

 

Recommended dosage scheme for tablet form for treatment of intestine infections :

 

Age Per os Frequency of administration
8 years old children and above 2 tablets 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
till 6 months 5 ml – once per day
from 6 to 12 months 5 ml – once per day
from 1 to 3 years 10 ml – once per day
from 3 to 8 years 20 ml – once per day
above 8 years 20 ml – once per day 2-3 tablets once per day

 

Over dosage: There are no any information about overdosage of the preparation.

Adverse reactions: The preparation is nontoxic. There are no data evident about any side effects or harm influence on human body after administration of the product.

Form and package 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 instruciton leaflet for use.

Tablet

The package contains tablet N30 of the product placed in polyethylene vial and instruction leaflet for

use.

Storage and transportation terms

Sterile solution

Keep in a dry place, away from light at a temperature 2°С – 25°С.

Tablet

Keep in a dry place away from light in a closed vial at not more than 25°С temperature.

Shelf life

The product is valid during 2 years since the date of manufacture if proper storage conditions are

protected. The product shouldn’t be used after the date of expiration.

Release from drug stores

The III pharmaceutical product group (released without prescription).

Manufacturer: JSC “Biochimpharm”