Instructions for Enterogermina Forte oral suspension 4 billion vial 5 ml No. 10
Composition
active ingredient: spores of the multi-resistant strain of Bacillus clausii;
1 vial of 5 ml contains 4 × 109 spores of the multi-resistant strain Bacillus clausii;
excipient: purified water.
Dosage form
Oral suspension.
Main physicochemical properties: whitish opalescent liquid.
Pharmacotherapeutic group
Antidiarrheal microbial drugs.
ATX code A07F A.
Pharmacological properties
Pharmacodynamics.
The drug Enterogermina® Forte is a suspension of Bacillus clausii spores, which are normally present in the intestines and do not exhibit pathogenic activity.
In addition, due to the ability of Bacillus clausii to synthesize various vitamins, especially group B, the drug helps to correct vitamin deficiency caused by the use of antibiotics or chemotherapeutic drugs. Due to the metabolic activity of Bacillus clausii, the use of the drug allows you to achieve a non-specific antigenic and antitoxic effect.
Due to their high resistance to chemical and physical agents, Bacillus clausii spores pass intact through the gastric juice barrier into the intestinal tract, where they transform into metabolically active vegetative cells.
Pharmacokinetics.
No data.
Indication
Treatment and prevention of intestinal dysbacteriosis and associated endogenous dysvitaminosis.
Adjunctive therapy aimed at restoring normal intestinal microflora that is disrupted during treatment with antibiotics or chemotherapeutic drugs.
Acute and chronic gastrointestinal diseases in infants associated with intoxication or intestinal dysbacteriosis and vitamin deficiency,
Contraindication
Hypersensitivity to the active substance or to any of the excipients of the drug.
Special safety precautions
Vials containing Enterogermina® Forte may contain visible particles resulting from the aggregation of Bacillus clausii spores and do not indicate that the drug has undergone any changes.
The bottle should be shaken before use.
The drug has a high degree of heterologous resistance to antibiotics, which allows it to be used both for the prevention of changes in the intestinal microflora caused by the selective action of antibiotics (especially broad-spectrum antibiotics), and for the restoration of an already disturbed balance of the intestinal microflora.
The drug does not interact with the following antibiotics: penicillin when used not in combination with beta-lactamase inhibitors, cephalosporins (partial resistance in most cases), tetracyclines, macrolides, aminoglycosides (except gentamicin and amikacin), chloramphenicol, thiamphenicol, lincomycin, clindamycin, isoniazid, cycloserine, novobiocin, rifampicin, nalidixic acid and pipemidic acid (intermediate resistance), metronidazole.
If the drug is prescribed simultaneously with antibiotics, it should be used between two doses of the antibiotic.
This medicine is for oral use only. It should not be administered by injection or any other route. Incorrect use of this medicine has resulted in severe anaphylactic reactions such as anaphylactic shock.
Interaction with other medicinal products and other types of interactions
No interaction studies have been conducted.
Use during pregnancy or breastfeeding
There are no contraindications to the use of the drug during pregnancy or breastfeeding.
Fertility
There is no data on the effect of the drug Enterogermina® Forte on human fertility.
Ability to influence reaction speed when driving vehicles or other mechanisms
Enterogermina® Forte does not affect the ability to drive vehicles and work with other mechanisms.
Method of administration and doses
The contents of the vial are taken undiluted or diluted in water or other beverages (e.g. milk, tea or orange juice). This medicinal product is for oral use only. Do not administer parenterally or by any other route.
The dose for adults is 5 ml (1 bottle) per day.
Children. The drug can be used in children from 28 days of age. The drug is used in infants and children at a dose of 5 ml (1 bottle) per day.
The duration of treatment is determined by the doctor depending on the patient's condition and the course of the disease:
treatment and prevention of intestinal dysbacteriosis and associated endogenous dysvitaminosis – 5–7 days;
adjuvant therapy aimed at restoring normal intestinal microflora that is disrupted during treatment with antibiotics or chemotherapeutic drugs – during antibiotic therapy (on average 5–10 days);
acute and chronic gastrointestinal diseases in infants associated with intoxication or intestinal dysbacteriosis and vitamin deficiency: acute - 5–7 days, chronic - up to 30 days.
Overdose
No cases of overdose have been reported.
Side effects
Skin and subcutaneous tissue disorders
Infectious and parasitic diseases
Frequency unknown: bacteremia (in immunocompromised patients).
Reporting of suspected adverse reactions
It is very important to report suspected adverse reactions that have occurred since the registration of the drug, as this allows for continuous monitoring of the benefit/risk balance of the use of this medicine. Healthcare professionals are encouraged to report any suspected adverse reactions through the national pharmacovigilance system.
Expiration date
2 years.
Storage conditions
Store out of the reach of children at a temperature below 30 ºС.
To avoid contamination of the suspension, do not open the vial in advance.
Packaging
No. 10; No. 20 (10 × 2): 5 ml in a vial; 10 vials, interconnected by a polyethylene jumper, in a cassette; 1 or 2 cassettes in a cardboard box.
Vacation category
Without a prescription.
Producer
Opel Healthcare Italy S.r.l.
Location of the manufacturer and its business address.
Viale Europa, 11 – 21040 Origgio (VA), Italy.
Applicant
Opela Healthcare Ukraine LLC, Ukraine.
The applicant's location and address of place of business.
Ukraine, 01033, Kyiv, Zhylyanska St., 48-50A.
