ENTEROGERMINA * OS 20FL 2MLD / 5ML
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 it 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).
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
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.
| 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 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 The possible presence of visible corpuscles in the vials of ENTEROGERMINA is due to aggregates of Bacillus clausii spores; therefore it is not an indication of altered product. Shake the vial before use. 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 use During antibiotic therapy it is recommended to administer the preparation in the interval between one antibiotic and the other.
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.
No cases of overdose have been reported.
One vial contains: Active principle: Spores of Bacillus clausii resistant polyantibiotic (SIN, O / C, T, N / R strains) 2 billion One hard capsule contains: Active principle: Spores of Bacillus clausii resistant polyantibiotic (strains SIN, O / C, T, N / R) 2 billion For a full list of excipients, see section 6.1
Vials: Purified water. Capsules: Heavy Kaolin, Microcrystalline Cellulose, Magnesium stearate, Gelatin, Titanium dioxide (E171), Purified water.