ENTEROGERMINA * OS 10FL 4MLD 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
Posology Adults: 1 vial per day. Infants and children: 1 vial per day. Method of administration Take the contents of the vial as it is or by diluting in water or other drinks (eg milk, tea, orange juice). 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,
| System and organ classification | Common | Uncommon | Rare | Very rare | Not known |
| Infections and infestations | | | | | Bacteremia, septicemia and sepsis (in immunocompromised or severely ill patients) (see section 4.4) |
| Skin and subcutaneous tissue disorders | | | | | hypersensitivity reactions, including rash, hives and angioedema |
Reporting of suspected adverse reactions.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 administration. 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 the active substance: polyantibiotic resistant Bacillus clausii spores (SIN, O / C, T, N / R strains) 4 billion. For the full list of excipients, see section 6.1
Excipients
Vials: Purified water.
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