bacillus clausii




Opella Healthcare
Full Prescribing Info
Bacillus clausii.
Each 5 mL Suspension contains: Spores of Polyantibiotic-resistant Bacillus clausii 2 billion.
Excipient: sterile distilled water qs.
Pharmacology: Pharmacodynamics: Bacillus clausii (Erceflora) is a preparation composed of a suspension of Bacillus clausii spores. These spores are part of the normal intestinal flora and have no pathogenic potential. Administered via the oral route, Bacillus clausii spores overcome the gastric acid barrier due to their high resistance to both chemical and physical agents, and reach the intestinal tract intact where they are transformed into metabolically active vegetative cells.
Thoroughly the activity of Bacillus clausii, administration of Bacillus clausii contributes to the restoration of intestinal bacterial flora that has been upset by imbalances of various origins. In addition, as Bacillus clausii is able to produce various vitamins, particularly those in the B group, Bacillus clausii helps correct dysvitaminosis caused by antibiotics and chemotherapy in general. Bacillus clausii makes it possible to obtain antitoxic and non-specific antigenic activity, which is closely related to the metabolic action of the Bacillus clausii spores. In addition, the high level of artificially-induced heterologous resistance to antibiotics makes it possible to create therapeutic conditions that prevent the deterioration of intestinal bacterial flora caused by the selective activity of antibiotics, particularly broad-spectrums antibiotics, and to restore intestinal bacterial flora.
Due to this resistance to antibiotics, Bacillus clausii can be used between 2 successive administration of antibiotics. The antibiotic resistance applies to: penicillin, cephalosporin, tetracycline, macrolides, aminoglycosides, novobiocin, chloramphenicol, thiamphenicol, lincomycin, isoniazid, cycloserine, rifampicin, nalidixic acid and pipemidic acid.
Acute diarrhea with duration of 14 days or less due to infections, drugs or poisons.
Chronic or persistent diarrhea with duration of more than 14 days.
Treatment and prophylaxis of intestinal flora imbalance and resulting endogenous dysvitaminosis.
Adjunctive treatment to help restore intestinal bacterial flora that has been altered by antibiotic or chemotherapy treatments.
Treatment of acute and chronic gastrointestinal disorders in breast-feeding infants caused by intoxication or intestinal flora imbalance with dysvitaminosis.
Dosage/Direction for Use
Administration at regular intervals (3-4 hours), diluting the content of the bottle in sweetened water, milk, tea or orange juice.
Or as prescribed by the physician. (See table.)

Click on icon to see table/diagram/image

This medicinal product is for ORAL USE ONLY. DO NOT INJECT or administer in any other way (see Precautions).
Up to the present time no clinical manifestations of overdose have been reported.
Ascertained hypersensitivity towards the components of the product.
The possible presence of corpuscles visible in the bottles of Bacillus clausii (Erceflora) is due to aggregates of Bacillus clausii spores and does not, therefore, indicate that the product has undergone any changes. Shake the bottle before use.
Special Precautions
This medicine is for oral use only. Do not inject or administer in any other way. Severe anaphylactic reactions, such as anaphylactic shock, have occurred with incorrect route of administration.
Precautions for use: During treatment with antibiotics, the medicinal product should be used during the interval between 2 administrations of antibiotics.
Effects on ability to drive and use machines: The drug does not interfere with the ability to drive or use machinery.
Use In Pregnancy & Lactation
This medicinal product may be used during pregnancy and breast-feeding.
Adverse Reactions
Skin and subcutaneous tissue disorders: During postmarketing experience, hypersensitivity reactions, including rash, urticaria and angioedema have been reported.
Drug Interactions
There are no known interactions subsequent to the concomitant use of other drugs.
Caution For Usage
Incompatibilities: There is no known incompatibility.
Instructions for use: Shake the bottle before use.
Store at temperatures not exceeding 30°C.
Shelf life: Stability in unopened container: 2 years.
After opening the vial, the preparation should be administered immediately to avoid contaminating the suspension.
MIMS Class
ATC Classification
A07FA01 - lactic acid producing organisms ; Belongs to the class of antidiarrheal microorganisms. Used in the treatment of diarrhea.
Oral susp 2 billion/5 mL x 5 mL x 10's.
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