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
Dosage Adults: 1 sachet per day to be dissolved in water. Pediatric population: Enterogermina 6 billion is indicated in adult patients only. Method of administration 1 sachet per day to dissolve 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 (in immunocompromised patients) |
| 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 system
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Special warnings
During antibiotic therapy it is recommended to administer the preparation in the interval between one antibiotic and the other. 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.
Pregnancy and breastfeeding
Pregnancy There are no data on the use of Enterogermina in pregnant women; therefore it is not possible to draw any conclusions 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 time There 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. Fertility No data are available 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 of Bacillus clausii resistant polyantibiotic (SIN, O / C, T, N / R strains) 6 billion For a 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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