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ENTEROGERMINA * OS 20FL 4MLD 5ML

  • OPELLA HEALTHCARE ITALY Srl
  • 013046089
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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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 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, 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. The possible presence of visible corpuscles in the vials of ENTEROGERMINA is due to aggregates of spores ofBacillus clausii; therefore it does not indicate an altered product. Shake the vial before use.

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 vial contains the active substance: polyantibiotic resistant Bacillus clausii spores (SIN, O / C, T, N / R strains) 4 billion. For the full list of excipients, see section 6.1

Excipients

Vials: Purified water.

013046089
5 Items

Data sheet

Packaging
4 billion / 5 ml oral suspension 20 vials
Product Type
HUMAN DRUG
ATC code
A07FA
ATC description
Antidiarrheal microorganisms
Therapeutic Group
Antidiarrheal microorganisms
Active principle
spores of Bacillus clausii
Class
C.
Pharmaceutical form
Suspension
Type of Administration
oral
Container
vial / bottle / vial in box
Quantity
20 bottle
Capacity
4 billion
Quantity of the Active Ingredient
4MLD
Recipe required
OTC - self-medication medicine