Enterogermina 2 billion/5ml oral suspension 10 vials 5ml

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

Treatment and prophylaxis of intestinal dysmicrobism and consequent endogenous vitamin deficiency. Therapy assists the restoration of the intestinal microbial flora, altered during antibiotic or chemotherapy treatments. Acute and chronic gastrointestinal disorders in infants, attributable to intoxications or intestinal dysmicrobisms and vitamin deficiency.

CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1.

WARNINGS AND PRECAUTIONS FOR USE

Special warnings Bacteremia/sepsis Post-marketing cases of bacteremia, septicemia and sepsis have been reported in immunocompromised or seriously ill patients and in preterm infants. In the case of some critically ill patients, the outcome was fatal. ENTEROGERMINA should be avoided in these patient groups (see section 4.8). This medicine is for oral use only. Do not inject or administer by other routes. Incorrect use of the medicine has caused serious anaphylactic reactions such as anaphylactic shock. Precautions for use During antibiotic therapy it is advisable to administer the preparation in the interval between one antibiotic administration and the next. The possible presence of visible corpuscles in the vials of ENTEROGERMINA is due to aggregates of spores of Bacillus clausii; it is therefore not an indication of an altered product. Shake the vial before use.

INTERACTIONS

No interaction studies have been performed.

SIDE EFFECTS

The following side effects have been observed during treatment with this medicinal product, classified according to the MedDRA classification by organ class and according to the following frequency classes: Very common (≥1/10); common (≥1/100,<1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000,<1/1,000); very rare <1/10,000); not known (frequency cannot be estimated from the available data).

Classification by systems and organs | Municipality | Uncommon | Rare | Very rare | Not known

Infections and infestations | Not known: Bacteremia, septicemia and sepsis (in immunocompromised or critically ill patients) (see section 4.4)

Skin and subcutaneous tissue disorders | Not known: hypersensitivity reactions, including skin rash, urticaria and angioedema

Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.