Bifidumbacterin (Tablets, Capsules, Lyophilisate, Powder, Suppositories) Instructions for Use
ATC Code
A07FA (Antidiarrheal microorganisms)
Active Substance
Bifidobacterium bifidum (Grouping name)
Clinical-Pharmacological Group
Drug regulating the balance of intestinal microflora (probiotic)
Pharmacotherapeutic Group
Eubiotic
Pharmacological Action
Live bifidobacteria possess high antagonistic activity against a wide range of pathogenic and opportunistic intestinal microorganisms (including staphylococci, Proteus, enteropathogenic Escherichia coli, Shigella, some yeast-like fungi).
They restore the balance of intestinal and vaginal microflora, normalize the digestive and protective functions of the intestine, activate metabolic processes, and increase the body’s nonspecific resistance.
Indications
For oral administration: prevention and treatment of gastrointestinal dysbiosis of various etiologies (including in gastric and duodenal ulcers, pancreatitis, cholecystitis, hepatitis, allergic diseases, when prescribing antimicrobial drugs, hormones, and NSAIDs); acute intestinal infections (shigellosis, salmonellosis, staphylococcal enterocolitis, rotavirus infection), food toxicoinfection, malabsorption syndrome, chronic constipation or diarrhea against the background of long-term antibacterial therapy; correction of microbiocenosis before and after operations on the intestine, liver, pancreas; prevention of hospital-acquired infections and dysbiosis in patients frequently suffering from acute respiratory viral infections.
For topical, intravaginal and rectal use: dysbiosis of the urogenital tract, acute and chronic inflammatory diseases of the urogenital tract (including urogenital infections transmitted sexually – gonorrhea, urogenital chlamydia, genital herpes); bacterial vaginosis (gardnerellosis); nonspecific colpitis (including hormone-dependent colpitis – senile); chronic colitis of various etiologies, intestinal dysfunction after a previous acute intestinal infection; preparation for planned gynecological operations (to prevent postoperative infectious complications); prenatal preparation of pregnant women at risk for inflammatory diseases (for the prevention and treatment of vaginal dysbiosis).
ICD codes
| ICD-10 code | Indication |
| A02 | Other salmonella infections |
| A03 | Shigellosis |
| A04.8 | Other specified bacterial intestinal infections |
| A05.0 | Staphylococcal food poisoning |
| A08.0 | Rotaviral enteritis |
| A09.0 | Other and unspecified gastroenteritis and colitis of infectious origin (infectious diarrhea NOS) |
| A54 | Gonococcal infection |
| A56.0 | Chlamydial infections of lower genitourinary tract |
| A56.1 | Chlamydial infections of pelvic organs and other genitourinary organs |
| A60 | Anogenital herpesviral infection [herpes simplex] |
| K25 | Gastric ulcer |
| K26 | Duodenal ulcer |
| K52.9 | Noninfective gastroenteritis and colitis, unspecified |
| K59.0 | Constipation |
| K59.1 | Functional diarrhea |
| K59.8 | Other specified functional intestinal disorders |
| K63.8 | Other specified diseases of intestine |
| K73 | Chronic hepatitis, not elsewhere classified |
| K86.1 | Other chronic pancreatitis |
| K90 | Intestinal malabsorption |
| N34 | Urethritis and urethral syndrome |
| N76 | Other inflammatory diseases of vagina and vulva |
| N77.1 | Vaginitis, vulvitis and vulvovaginitis in infectious and parasitic diseases classified elsewhere |
| N89.8 | Other noninflammatory disorders of vagina |
| N95.2 | Postmenopausal atrophic vaginitis |
| Y40 | Systemically acting antibiotics |
| Y42.8 | Other and unspecified hormones and their synthetic substitutes |
| Y45 | Analgesics, antipyretics and anti-inflammatory drugs |
| Z29.8 | Other specified prophylactic measures |
| Z51.4 | Preparatory procedures for subsequent treatment or examination, not elsewhere classified |
| Z54.0 | Convalescence following surgery |
| ICD-11 code | Indication |
| 1A02 | Intestinal infections due to Shigella |
| 1A09.Z | Salmonella infection, unspecified |
| 1A0Z | Bacterial intestinal infections, unspecified |
| 1A10 | Staphylococcal food poisoning |
| 1A22 | Gastroenteritis due to Rotavirus |
| 1A40.Z | Infectious gastroenteritis or colitis, unspecified |
| 1A7Z | Gonococcal infection, unspecified |
| 1A81.0 | Chlamydial infection of lower genitourinary tract |
| 1A81.1 | Chlamydial infection of internal reproductive organs |
| 1A94.Z | Anogenital herpes simplex virus infection without further specification |
| 1F23.10 | Candidiasis of vulva and vagina |
| 1F65 | Enterobiasis |
| 1H0Z | Unspecified infection |
| DA60.Z | Gastric ulcer, unspecified |
| DA63.Z | Duodenal ulcer, unspecified |
| DA90.0 | Syndromic diarrhea |
| DA92.1 | Pneumatosis intestinalis of the small intestine |
| DA96.0Z | Intestinal malabsorption, unspecified |
| DA98.Z | Polyps of small intestine, unspecified |
| DB31.1 | Pneumatosis of the colon |
| DB32.1 | Slow-transit constipation |
| DB32.3 | Acquired hypoganglionosis of the colon |
| DB32.Z | Colonic motility disorders, unspecified |
| DB36.Z | Certain infections of the colon, unspecified |
| DB97.2 | Chronic hepatitis, not elsewhere classified |
| DC32.0 | Calcific pancreatitis |
| DC32.1 | Paraduodenal pancreatitis |
| DC32.2 | Hereditary chronic pancreatitis |
| DC32.4 | Chronic idiopathic pancreatitis |
| DC32.5 | Tropical pancreatitis |
| DC32.Z | Chronic pancreatitis, unspecified |
| DC33 | Autoimmune pancreatitis |
| DD90.2 | Functional heartburn |
| DD91.1 | Functional constipation |
| DD91.2 | Functional diarrhea |
| DD91.Y | Other specified irritable bowel syndrome or functional bowel disorders |
| DD93.Y | Other specified functional gastrointestinal disorders in infants, toddlers and school-age children |
| DD9Z | Functional gastrointestinal disorders, unspecified |
| DE2Z | Diseases of the digestive system, unspecified |
| GA00 | Vulvitis |
| GA02.Z | Unspecified vaginitis |
| GA0Z | Inflammatory diseases of female genital tract, unspecified |
| GA30.2 | Postmenopausal atrophic vaginitis |
| GC02.Z | Urethritis and urethral syndrome, unspecified |
| GC42.1 | Painful intercourse |
| MF3A | Vaginal discharge |
| PL00 | Drugs, medicaments or biological substances causing injury or harm in therapeutic use |
| QB7Y | Other specified convalescence |
| QB9A | Preparatory procedures for subsequent treatment |
| QC05.Z | Prophylactic measures, unspecified |
| 1A0Y | Other specified bacterial intestinal infections |
| XN9W5 | Enterobacter species |
| 1A94.0 | Genital or urogenital tract infection caused by Herpes simplex virus |
| GA41 | Ulcerative or erosive diseases of vulva |
| GA1Z | Unspecified noninflammatory disorders of female genital tract |
| XA1LK7 | Vagina |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
For oral administration of tablets, capsules, and powder: take orally with meals.
For acute intestinal infections and food toxicoinfections: administer for 5-7 days.
For chronic gastrointestinal diseases and dysbiosis: administer for 10-15 days, with possible extension up to 1-2 months.
For prevention of dysbiosis during antibiotic therapy: administer for 10-14 days.
For preoperative preparation and postoperative correction: administer for 3-5 days before surgery and for 10-15 days after.
For intravaginal use of suppositories: administer 1-2 suppositories twice daily for 5-10 days.
For prenatal preparation: administer intravaginally for 5-8 days before delivery.
For rectal use of suppositories: administer 1-2 suppositories three times daily.
Combine rectal administration with oral intake for chronic intestinal diseases.
For local application of powder: apply to affected mucous membranes and skin areas.
Dissolve powder and lyophilisate in cold or lukewarm water (not exceeding 40°C).
Do not store the prepared solution; use immediately after reconstitution.
Adverse Reactions
Possible: allergic reactions, nausea.
Contraindications
Individual intolerance.
Special Precautions
Simultaneous use of oral forms with antibiotics is not recommended, as well as dissolving the drug in hot water (above 40°C) and storing it in dissolved form.
The use of suppositories can be combined with the simultaneous administration of antibacterial, antiviral, and immunostimulating drugs.
Drug Interactions
The effect of drugs containing Bifidobacterium bifidum is enhanced by vitamins (especially B vitamins), and reduced by antibiotics.
Storage Conditions
Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Over-the-Counter
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Powder for oral and topical administration 500 million CFU/1 sachet: sachet 10 or 30 pcs.
Marketing Authorization Holder
Avan-Bio, LLC (Russia)
Manufactured By
Probiofarm, LLC (Russia)
Or
Avan-Bio, LLC (Russia)
Dosage Form
 |
Bifidumbacterin | Powder for oral and topical administration 500 million CFU/1 sachet: sachet 10 or 30 pcs. |
Dosage Form, Packaging, and Composition
Powder for oral and topical administration from white to light beige with inclusions of yellow or beige color, with a faint fermented milk odor.
| 1 sachet (5 doses) | |
| Bifidobacteria B. bifidum No.1 | Not less than 500 million (5×108) CFU* |
* CFU – colony-forming unit.
Excipients : lactose monohydrate – up to 0.5 g.
5 doses – sachets made of multilayer metal-polymer material (10) – cardboard packs.
5 doses – sachets made of multilayer metal-polymer material (30) – cardboard packs.
Vaginal and rectal suppositories 10 million CFU: 10 pcs.
Marketing Authorization Holder
LANAFARM, LLC (Russia)
Dosage Form
|
Bifidumbacterin | Vaginal and rectal suppositories 10 million CFU: 10 pcs. |
Dosage Form, Packaging, and Composition
Vaginal and rectal suppositories from yellowish-gray to light beige, conical or cylindrical in shape, with a specific smell of fat; color heterogeneity in the form of beige inclusions or marbling, darkening of light brown color at the conical end of the suppository is allowed.
| 1 supp. | |
| Bifidobacterium bifidum* | Not less than 107 CFU |
* in the form of microbial mass of live bifidobacteria of the strain Bifidobacterium bifidum No.1, lyophilized in a culture medium with the addition of a protective (sucrose-gelatin) drying medium and lactose (lactose monohydrate), molded into a suppository.
Excipients : sucrose – 0.065-0.07%, gelatin – 0.012-0.013%, lactose (lactose monohydrate) – 0.96-0.98%, confectionery fat or solid fat – 75-80%, solid petroleum paraffin – 5-10%, emulsifier T-2 – 5-10%.
5 pcs. – contour cell packs (2) – cardboard packs.
Lyophilizate for preparation of oral and topical suspension 10 million CFU/1 dose: fl. 3 doses 10 or 14 pcs., 5 doses 10, 12 or 14 pcs., 10 doses 10 or 14 pcs.
Marketing Authorization Holder
Microgen NPO, JSC (Russia)
Dosage Form
|
Bifidumbacterin | Lyophilizate for preparation of oral and topical suspension 10 million CFU/1 dose: fl. 3 doses 10 or 14 pcs., 5 doses 10, 12 or 14 pcs., 10 doses 10 or 14 pcs. |
Dosage Form, Packaging, and Composition
| Lyophilizate for preparation of solution for oral and topical administration | 1 dose |
| Bifidobacterium bifidum | 10 million CFU |
3 doses – bottles (10) – cardboard packs.
5 doses – bottles (10) – cardboard packs.
5 doses – bottles (12) – cardboard packs.
5 doses – bottles (14) – cardboard packs.
5 doses – bottles (10) – packs.
10 doses – bottles (10) – cardboard packs.
Vaginal and rectal suppositories: 10 pcs.
Marketing Authorization Holder
Microgen NPO, JSC (Russia)
Dosage Form
|
Bifidumbacterin | Vaginal and rectal suppositories: 10 pcs. |
Dosage Form, Packaging, and Composition
Vaginal and rectal suppositories yellowish-gray or light yellow with a brownish tint, torpedo-shaped or cylindrical in shape, with a diameter from 8 mm to 12 mm; color heterogeneity in the form of inclusions or “marbling” is allowed.
| 1 supp. | |
| Live bifidobacteria* | Not less than 107 |
* in the form of microbial mass of live antagonistically active strains of bifidobacteria (Bifidobacterium bifidum No.1 and B. bifidum No.791), lyophilized in a culture medium with the addition of a drying medium (sucrose-gelatin-milk) and molded into a suppository.
Excipients : confectionery fat – 75-80%, solid petroleum paraffin P-2 – 5-10%, emulsifier T-2 – 5-10%; components of the drying medium (food gelatin – 0.5-1.5%, sucrose (sugar) – 5-7%, cow’s milk, calculated as dry matter – 1-2.5%).
5 pcs. – contour cell packs (2) – cardboard packs.
Tablets 10 million CFU (1 dose): 20, 30 or 60 pcs.
Marketing Authorization Holder
Firma Vitafarma, JSC (Russia)
Dosage Form
|
Bifidumbacterin | Tablets 10 million CFU (1 dose): 20, 30 or 60 pcs. |
Dosage Form, Packaging, and Composition
| Tablets | 1 tab. |
| Bifidobacterium longum | 10 million CFU |
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
Tablets 50 million CFU (5 doses): 20, 30 or 60 pcs.
Marketing Authorization Holder
Firma Vitafarma, JSC (Russia)
Dosage Form
|
Bifidumbacterin | Tablets 50 million CFU (5 doses): 20, 30 or 60 pcs. |
Dosage Form, Packaging, and Composition
| Tablets | 1 tab. |
| Bifidobacterium longum | 50 million CFU |
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
Lyophilizate for preparation of solution for oral and topical administration 5 doses: fl. 10 pcs.
Marketing Authorization Holder
Firma Vitafarma, JSC (Russia)
Dosage Form
|
Bifidumbacterin | Lyophilizate for preparation of solution for oral and topical administration 5 doses: fl. 10 pcs. |
Dosage Form, Packaging, and Composition
| Lyophilizate for preparation of solution for oral and topical administration | 1 fl. |
| Bifidobacterium bifidum | 5 doses |
5 doses – bottles (10) – carton packs.
Suppositories for vaginal and rectal administration 10 million CFU (1 dose): 10 pcs.
Marketing Authorization Holder
Firma Vitafarma, JSC (Russia)
Dosage Form
|
Bifidumbacterin | Suppositories for vaginal and rectal administration 10 million CFU (1 dose): 10 pcs. |
Dosage Form, Packaging, and Composition
| Suppositories for vaginal or rectal administration | 1 supp. |
| Bifidobacterium bifidum (Bifidobacterium bifidum) | Not less than 10 million CFU |
1 pc. – waxed paper (10) – carton packs.
5 pcs. – contour cell packs (2) – carton packs.
10 pcs. – contour cell packs (1) – carton packs.
Lyophilizate for preparation of solution for oral and topical administration 5 doses: fl. 10 pcs.
Marketing Authorization Holder
Ecopolis, CJS (Russia)
Dosage Form
|
Bifidumbacterin | Lyophilizate for preparation of solution for oral and topical administration 5 doses: fl. 10 pcs. |
Dosage Form, Packaging, and Composition
| Lyophilizate for preparation of solution for oral and topical administration | 1 fl. |
| Bifidobacterium bifidum | 5 doses |
5 doses – bottles (10) – carton packs.
Lyophilizate for preparation of solution for oral and topical administration 10 doses: fl. 10 pcs.
Marketing Authorization Holder
Ecopolis, CJS (Russia)
Dosage Form
|
Bifidumbacterin | Lyophilizate for preparation of solution for oral and topical administration 10 doses: fl. 10 pcs. |
Dosage Form, Packaging, and Composition
| Lyophilizate for preparation of solution for oral and topical administration | 1 fl. |
| Bifidobacterium bifidum | 10 doses |
10 doses – bottles (10) – carton packs.
1 pc. – bottles (10) – carton packs.
Capsules 50 million CFU (5 doses): 10, 20, 30, 30, 40 or 50 pcs.
Marketing Authorization Holder
Ecopolis, CJS (Russia)
Dosage Form
|
Bifidumbacterin | Capsules 50 million CFU (5 doses): 10, 20, 30, 30, 40 or 50 pcs. |
Dosage Form, Packaging, and Composition
| Capsules | 1 caps. |
| Bifidobacterium longum | 50 million CFU |
10 pcs. – polymer jars (1) – carton packs.
20 pcs. – polymer jars (1) – carton packs.
30 pcs. – polymer jars (1) – carton packs.
40 pcs. – polymer jars (1) – carton packs.
50 pcs. – polymer jars (1) – carton packs.
Lyophilizate for preparation of solution for oral and topical administration 10 million CFU/1 dose: fl. 5 doses 10 pcs.
Marketing Authorization Holder
Biomed named after I.I.Mechnikov, PJSC (Russia)
Dosage Form
|
Bifidumbacterin siccum | Lyophilizate for preparation of solution for oral and topical administration 10 million CFU/1 dose: fl. 5 doses 10 pcs. |
Dosage Form, Packaging, and Composition
| Lyophilizate for preparation of solution for oral and topical administration | 1 dose |
| Bifidobacterium bifidum | 10 million CFU |
5 doses – bottles (10) – carton packs.
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