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ENTEROGERMINA * OS 20FL 4MLD 5ML

SANOFI SpA
013046089
10 Items
Enterogermina 4 billion 20 bottles thanks to the action of bacillus clausii spores is indicated in case of:



  • Aerophagia.

  • Antibiotic therapy.

  • Alteration of bacterial flora.




























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SANOFI SpA
013046089
10 Items

ENTEROGERMINA * OS 20FL 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 it 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 (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

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.

Overdose

No cases of overdose have been reported.

Active principles

One vial contains: Active principle: Spores of Bacillus clausii resistant polyantibiotic (strains SIN, O / C, T, N / R) 4 billion For a full list of excipients, see section 6.1

Excipients

Vials: Purified water.

SANOFI SpA
013046089
10 Items

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