ENTEROGERMINA * OS 10FL 2MLD / 5ML

ENTEROGERMINA * OS 10FL 2MLD / 5ML

Therapeutic indications

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

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 in water or other drinks (eg milk, tea, orange juice). Capsules: swallow with a drink of water or other drink. Especially in younger children, in case of difficulty in swallowing the hard capsules, the oral suspension should be used. This medicine is for oral use only. Do not inject or administer in any other way (see section 4.4).

Contraindications

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

Side effects

The following side effects have been observed during treatment with this medicine, classified according to the MedDRA organ class and the following frequency classes: Very common (≥1 / 10); common (≥1 / 100,

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

Special warnings

Special warningsBacteraemia / sepsis Post-marketing cases of bacteraemia, septicemia and sepsis have been reported in immunocompromised or severely ill patients and in preterm infants. In the case of some critically ill patients, the outcome was fatal. ENTEROGERMINE should be avoided in these patient groups (see section 4.8). This medicine is for oral use only. Do not inject or administer by any other route. Incorrect use of the medicine has resulted in severe anaphylactic reactions such as anaphylactic shock.Precautions for useDuring antibiotic therapy it is recommended to administer the preparation in the interval between one antibiotic and the other. The possible presence of visible corpuscles in the vials of ENTEROGERMINA is due to aggregates of spores ofBacillus clausii; therefore it does not indicate an altered product. Shake the vial before use.

Pregnancy and breastfeeding

PregnancyThere are no data on the use of Enterogermina in pregnant women; therefore no conclusions can be drawn on the safety of the use of Enterogermina during pregnancy. Enterogermina should only be used during pregnancy if the potential benefits to the mother outweigh the potential risks, including those to the fetus.Feeding timeThere are no data on the use of Enterogermina during lactation regarding the composition of breast milk and the effects on the child. No conclusions can be drawn about the safety of using Enterogermina during lactation. Enterogermina should only be used during breastfeeding if the potential benefits to the mother outweigh the potential risks, including those to the breastfed infant.FertilityThere are no data on the effect of Enterogermina on human fertility.

Expiration and retention

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 principleSpores ofBacillus clausiiresistant polyantibiotic (SIN, O / C, T, N / R strains): 2 billionOne hard capsule contains: Active principleSpores ofBacillus clausiiresistant polyantibiotic (SIN, O / C, T, N / R strains): 2 billion For a full list of excipients, see section 6.1

Excipients

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