Enterogermina 4 Billion/5 Ml 20 Vials

Enterogermina 4 Billion/5 Ml 20 Vials lactic ferments with probiotic action for the treatment and prophylaxis of intestinal dysbiosis. Helps restore intestinal balance thanks to the spores of Bacillus clausii polyantibiotic resistant.

Enterogermina 4 Billion/5 Ml 20 Vials is indicated for:

• Prevention and treatment of alterations in the normal balance of intestinal bacterial flora (intestinal dysbiosis) and vitamin deficiencies in the body resulting from an imbalance in intestinal bacterial flora (endogenous dysvitaminosis).

• Adjuvant therapy for the restoration of the intestinal microbial flora , altered during antibiotic or chemotherapy treatments.

• Treatment of acute and chronic gastrointestinal diseases of infants caused by intoxication or alterations in the normal balance of intestinal bacterial flora (intestinal dysmicrobism) or vitamin deficiencies in the body (dysvitaminosis).

ACTIVE INGREDIENTS

Active ingredients contained in Enterogermina 4 Billion/5 Ml 20 Vials - What is the active ingredient in Enterogermina 4 Billion/5 Ml 20 Vials?

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

EXCIPIENTS

Composition of Enterogermina 4 Billion/5 Ml 20 Vials - What does Enterogermina 4 Billion/5 Ml 20 Vials contain?

Vials: purified water.

DIRECTIONS

Therapeutic indications Enterogermina 4 Billion/5 Ml 20 Vials - Why is Enterogermina 4 Billion/5 Ml 20 Vials used? What is it used for?

Treatment and prophylaxis of intestinal dysmicrobism and consequent endogenous dysvitaminosis. Adjuvant therapy for the restoration of intestinal microbial flora, altered during antibiotic or chemotherapy treatments. Acute and chronic gastro-intestinal disorders in infants, attributable to intoxications or intestinal dysmicrobism and dysvitaminosis.

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Enterogermina 4 Billion/5 Ml 20 Vials - When should Enterogermina 4 Billion/5 Ml 20 Vials not be used?

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

DOSAGE

Quantity and method of taking Enterogermina 4 Billion/5 Ml 20 Vials - How is Enterogermina 4 Billion/5 Ml 20 Vials taken?

Dosage. Adults: 1 vial per day. Infants and children: 1 vial per day. Method of administration: take the contents of the vial as is or diluted in water or other drinks (e.g. milk, tea, orange juice). This medicine is for oral use only. Do not inject or administer in any other way (see section 4.4).

CONSERVATION

Storage Enterogermina 4 Billion/5 Ml 20 Vials - How is Enterogermina 4 Billion/5 Ml 20 Vials stored?

Store below 30 degrees C.

WARNINGS

Warnings Enterogermina 4 Billion/5 Ml 20 Vials - It is important to know that about Enterogermina 4 Billion/5 Ml 20 Vials:

Special warnings. Bacteremia/sepsis: Cases of bacteremia, septicaemia and sepsis have been reported in immunocompromised or critically ill patients and in preterm infants since the introduction into the market. In some critically ill patients, the outcome was fatal. Enterogermina should be avoided in these groups of patients (see section 4.8). This medicinal product is for oral use only. Do not inject or administer by other routes. Incorrect use of the medicinal product has caused serious anaphylactic reactions such as anaphylactic shock. Precautions for use: during antibiotic therapy, it is advisable to administer the preparation in the interval between one and the other antibiotic administration. Any visible corpuscles in the vials of Enterogermina are due to aggregates of Bacillus clausii spores; therefore, they do not indicate an altered product. Shake the vial before use.

INTERACTIONS

Interactions Enterogermina 4 Billion/5 Ml 20 Vials - Which medicines or foods can modify the effect of Enterogermina 4 Billion/5 Ml 20 Vials?'

No interaction studies have been performed.

SIDE EFFECTS

Like all medicines, Enterogermina 4 Billion/5 Ml 20 Vials can cause side effects - What are the side effects of Enterogermina 4 Billion/5 Ml 20 Vials?

The following undesirable effects have been observed during treatment with this medicinal product, classified according to the MedDRA organ class and frequency categories: very common (>=1/10); common (>=1/100, <1/10); uncommon (>=1/1,000, <1/100); rare (>=1/10,000, <1/1,000); very rare <1/10,000); not known (frequency cannot be estimated from the available data). Infections and infestations. Not known: bacteraemia, septicaemia and sepsis (in immunocompromised or severely ill patients) (see section 4.4). Skin and subcutaneous tissue disorders. Not known: hypersensitivity reactions, including rash, urticaria and angioedema. Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Enterogermina 4 Billion/5 Ml 20 Vials.

Pregnancy: There are no data available on the use of Enterogermina in pregnant women; therefore, it is not possible to draw conclusions on the safety of using Enterogermina during pregnancy. Enterogermina should be used during pregnancy only if the potential benefits for the mother outweigh the potential risks, including those for the fetus. Breastfeeding: There are no data available on the use of Enterogermina during breastfeeding regarding the composition of breast milk and the effects on the child. It is not possible to draw conclusions on the safety of using Enterogermina during breastfeeding. Enterogermina should be used during breastfeeding only if the potential benefits for the mother outweigh the potential risks, including those for the breastfed child. Fertility: There are no data available on the effect of Enterogermina on human fertility.