ENTEROGERMINA * OS 10BS 6MLD 2G
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.
Dosage and method of use
DosageAdults: 1 sachet per day to be dissolved in water.Pediatric population:Enterogermina 6 billion is indicated in adult patients only.Method of administration1 sachet per day to be dissolved in water. This medicine is for oral use only.
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.Information on excipientsThis medicinal product contains less than 1 mmol sodium (23 mg) per sachet, ie essentially “sodium-free”.
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 sachet contains: Active principle: Spores ofBacillus clausiipolyantibiotic resistant (SIN, O / C, T, N / R strains) 6 billion. For the full list of excipients, see section 6.1.
Excipients
Heavy kaolin, microcrystalline cellulose, mannitol, sodium saccharin, citrus flavor, anhydrous colloidal silica.
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