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ENTEROGERMINA * OS 10FL 2MLD / 5ML

  • SANOFI Srl
  • 013046038
Final Price €10.90
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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,

System classification and organs 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 system https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

Special warnings. Bacteraemia / 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 use: During 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 of Bacillus clausii; therefore it does not indicate an altered product. Shake the vial before use.

Pregnancy and breastfeeding

Pregnancy: There are no data on the use of Enterogermina in pregnant women; therefore no conclusions can be drawn on the safety of using 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 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 (SIN, O / C, T, N / R strains) 2 billion. For the full list of excipients, see section 6.1.

Excipients

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

SANOFI Srl
013046038
12 Items