ENTEROGERMINA OS 10FL 2ML/5ML

ENTEROGERMINA 2 MILLIONS

active ingredients

A bottle contains: Active ingredient Brides of Bacillus clausii resistant polyantibiotic (SIN, O/C, T, N/R blocks): 2 billion A rigid capsule contains: Active ingredient Brides of Bacillus clausii resistant polyantibiotic (SIN, O/C, T, N/R blocks): 2 billion For the full list of excipients, see paragraph 6.1

Excellent

Flaconcini: purified water. Capsules: Microcrystalline cellulose, Magnesium stearate, Gelatine, Titanium dioxide (E171), Purified water.

Therapeutic indications

Treatment and prophylaxis of intestinal dysmicrobism and consequent endogenous dysvitaminosis. Therapy helps restore the intestinal microbial flora, altered during antibiotic or chemotherapy treatments. Acute and chronic gastro-enteric turrets of infants, attributable to intoxication or intestinal dysmicrobism and disvitaminosis.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1.

Population

Adults: 2-3 bottles per day or 2-3 capsules per day. Children: 1-2 bottles per day or 1-2 capsules per day. Milking: 1-2 bottles per day. Flaconcini: administration at regular intervals. Take the content of the bottle as such or diluting in water or other drinks (e.g. milk, tea, orange juice). Capsules: swallow with a sip of water or other drinks. Especially in small children, in case of difficulty swallowing rigid capsules, it is appropriate to use oral suspension. This medicine is for exclusive oral use. Do not inject or administer in any other way (see paragraph 4.4).

Conservation

Store at a temperature below 30°C.

Warnings

Special warnings Batteriemia/sepsi After placing on the market, cases of bacterimia, sepsis and sepsis were reported in immunocompromised or severely ill patients and in pretermined infants. In the case of some patients in critical condition, the outcome was fatal. ENTEROGERMINA should be avoided in these groups of patients (see paragraph 4.8). This medicine is only for oral use. Do not inject or administer in other ways. An incorrect use of the medicinal product has caused severe anaphylactic reactions such as anaphylactic shock. Precautions for use In the course of antibiotic therapy it is recommended to administer the preparation in the interval between one and the other administration of antibiotic. Possible presence of corpuscles visible in the bottles ENTEROGERMINA is due to aggregates of spore of Bacillus clausii; is therefore not an index of altered product. Shake the bottle before use.

Interactions

No interaction studies have been carried out.

Effects

During treatment with this medicine, the following side effects were observed, classified according to the MedDRA classification by organ class and according to the following frequency classes: Very common (≥1/10); common (≥1/100, Classification for systems and organs Town Not common Rare Very rare Notable Infections and infestations         Bacteriemia, septicemia and sepsis (in immunocompromised or severely ill patients) (see paragraph 4.4) Pathologies of skin and subcutaneous tissue         hypersensitivity reactions, including rash, hives and angioedema Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

No overdose cases have been reported.

Pregnancy

Data relating to the use of Enterogermina in pregnant women are not available; therefore it is not possible to draw conclusions on the safety of the use of Enterogermina during pregnancy. Enterogermina should only be used during pregnancy if potential benefits for the mother exceed potential risks, including those for the fetus.

Food

Data relating to the use of Enterogermina during breast milk composition and effects on the child are not available. It is not possible to draw conclusions on the safety of the use of Enterogermina during lactation. Enterogermina should only be used during breastfeeding if the potential benefits for the mother exceed potential risks, including those for breast-feededed baby.

Fertility

Data on the effect of Enterogermina on human fertility are not available.

Source: Farmadati