bacillus clausii




Full Prescribing Info
Spores of poly-antibiotic resistant Bacillus clausii.
Excipients: Purified water.
Pharmacotherapeutic Group: Anti-diarrhoeal microorganisms. ATC Code: A07FA49.
Pharmacology: Pharmacodynamics: ENTEROGERMINA is a preparation consisting of a suspension of spores of Bacillus clausii, a normal inhabitant of the intestine, with no pathogenic powers. Administered orally, Bacillus clausii spores, thanks to their high resistance to both chemical and physical agents, cross the barrier of the acid gastric juices reaching, unharmed, the intestinal tract where they are transformed into metabolically active vegetative cells. The administration of ENTEROGERMINA contributes to the recovery of the intestinal microbial flora altered during the course of dysmicrobisms of diverse origin, thanks to the action of the Bacillus clausii. Furthermore, since the Bacillus clausii is capable of producing various vitamins, in particular group B vitamins, ENTEROGERMINA contributes to correcting the dysvitaminosis caused by antibiotics and chemotherapeutic agents in general. ENTEROGERMINA makes it possible to obtain an aspecific antigenic and anti toxic action, closely connected with the metabolic action of the clausii. In addition, the high degree of heterologous resistance to the antibiotics, induced artificially, provides for the creation of the therapeutic basis for preventing the alteration of the intestinal microbial flora, following the selective action of antibiotics, especially the broad spectrum antibiotics, or to re-establish its balance. Because of this antibiotic-resistance, ENTEROGERMINA can be administered in the interval between two doses of antibiotic. The antibiotic-resistance refers to: Penicillins, cephalosporins, tetracyclines, macrolides, aminoglycosides, novobiocin, chloramphenicol, thiamphenicol, lincomycin, isoniazid, cycloserine, rifampicin, nalidixic acid and pipemidic acid.
Pharmacokinetics: Absorption and Elimination: Enterogermina is not absorbed from the gastrointestinal tract. In animals, low numbers of B. clausii cells were found in mesenteric ganglia after administration of large doses of Enterogermina but no cells were found in the blood or spleen.
No intrinsic factor (age, sex, race, genetic polymorphism, renal or hepatic impairment) is likely to influence the fate of Enterogermina in the organism.
Treatment and prophylaxis of intestinal dysmicrobism and subsequent endogenous dysvitaminosis. Therapy for aiding the recovery of the intestinal microbial flora, altered during the course of treatment with antibiotics or chemotherapeutic agents. Acute and chronic gastrointestinal disorders in breastfed infants, attributable to intoxication or intestinal dysmicrobism and dysvitaminosis.
Dosage/Direction for Use
Adults: 2-3 minibottles per day; children: 1-2 minibottles per day; breastfed infants: 1-2 minibottles per day.
Administration: At regular intervals (3-4 hours), taking the contents of the minibottles as it is or diluting it in water or other drink (eg, milk, tea, orange juice).
This medicine is for ORAL use only. DO NOT inject or administer in any other way.
Up to the present time no clinical manifestations of overdose have been reported.
Hypersensitivity to the active ingredient or any of the excipients.
Special Precautions
Do not inject, incorrect use has caused severe anaphylactic reactions such as anaphylactic shock.
Special Warnings: The possible presence of corpuscles visible in the mini bottles of ENTEROGERMINA is due to aggregates of Bacillus clausii spores and does not, therefore, indicate that the product has undergone any changes. Shake the minibottle before use.
Precautions For Use: During antibiotic therapy, the product should be administered in the interval between one dose of antibiotic and the next.
Effects on Ability to Drive and Use Machines: The drug does not interfere with the ability to drive or use machines.
Use In Pregnancy & Lactation
There are no contraindications regarding the use of the product during pregnancy and while breastfeeding.
Adverse Reactions
In post-marketing experience, cases of hypersensitivity reactions including rash, hives and angioedema have been reported.
Drug Interactions
There are no known medicinal interactions subsequent to the concomitant administration of other drugs.
Store at a temperature no higher than 30°C.
ATC Classification
A07FA01 - lactic acid producing organisms ; Belongs to the class of antidiarrheal microorganisms. Used in the treatment of diarrhea.
Oral susp (whitish, opalescent, liqd) 2 billion/5 mL x 20's.
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