Enterogermina 2 Billion/5 Ml 20 Vials

Treatment and prophylaxis of intestinal dysmicrobism and consequent endogenous dysvitaminosis. Adjuvant therapy for the restoration of the intestinal microbial flora, altered during antibiotic or chemotherapy treatments. Acute and chronic gastro-enteric disorders of infants, attributable to poisoning or intestinal dismicrobism and dysvitaminosis.

Therapeutic indications

Treatment and prophylaxis of intestinal dysmicrobism and consequent endogenous dysvitaminosis. Adjuvant therapy for the restoration of the intestinal microbial flora, altered during antibiotic or chemotherapy treatments. Acute and chronic gastro-enteric disorders of infants, attributable to poisoning or intestinal dismicrobism and dysvitaminosis.

Dosage and method of use

Adults: 2-3 vials per day or 2-3 capsules per day. Children: 1-2 vials per day or 1-2 capsules per day. Infants: 1-2 vials per day. Vials: administration at regular intervals. Take the contents of the vial as it is or by diluting it in water or other beverages (e.g. milk, tea, orange soda). Capsules: swallow with a sip of water or other beverage. Especially in younger children, in case of difficulty swallowing the hard capsules, it is advisable to use the oral suspension. This medicinal product is for oral use only. Do not inject or otherwise administer (see section 4.4).

Contraindications

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

Side effects

Skin and subcutaneous tissue disorders: Frequency not known: Hypersensitivity reactions, including rash, urticaria and angioedema. Infections and infestations Frequency not known: bacteraemia (in immunocompromised patients). Reporting of suspected adverse reactions. Reporting suspected adverse reactions after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Special warnings

Special warnings The possible presence of visible corpuscles in the vials of ENTEROGERMINA is due to aggregates of Bacillus clausii spores; it is therefore not an indication of an altered product. Shake the vial before use. This medicine is for oral use only. Do not inject or administer by other routes. Incorrect use of the medicine has resulted in severe anaphylactic reactions such as anaphylactic shock. Precautions for use In the course of antibiotic therapy it is advisable to administer the preparation in the interval between one and the other administration of antibiotic.

Pregnancy and breastfeeding

There are no preclusions to the use of the preparation during pregnancy or while breastfeeding.

Expiration and conservation

Store below 30°C.

Interactions with other drugs

No interaction studies have been performed.

Overdose

No cases of overdose have been reported.

Active principles

One vial contains: Active ingredient : Polyantibiotic resistant Bacillus clausii spores (SIN, O/C, T, N/R strains) 2 billion One hard capsule contains: Active ingredient : Polyantibiotic resistant Bacillus clausii spores (SIN, O/C strains , T, N/R) 2 billion For the full list of excipients, see section 6.1

Excipients

Vials: Purified water. Capsules: Heavy kaolin, Microcrystalline cellulose, Magnesium stearate, Gelatin, Titanium dioxide (E171), Purified water.