BIOFLOR Powder for oral suspension (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

BIOFLOR 100 mg, powder for oral suspension.

2. Qualitative and quantitative composition

Saccharomyces boulardii CNCM I-745: 100.00 mg (lyophilized cells of Saccharomyces boulardii CNCM I-745) Excipient with known effect: lactose, fructose, sorbitol (contained in tutti frutti aroma). ...

3. Pharmaceutical form

Powder for oral suspension in sachets.

4.1. Therapeutic indications

Saccharomyces boulardii CNCM I-745 is indicated for the prevention and treatment of diarrhea of different etiologies in adults and children, such as: Treatment of acute infectious diarrhea of adults and ...

4.2. Posology and method of administration

2- 4 sachets daily. Pour the contents of the sachet in a little water or sweetened beverage, mix, and drink. The powder can also be mixed with food or poured into a babys feeding-bottle. Due to a risk ...

4.3. Contraindications

Hypersensitivity to the active ingredient or to any of the excipients listed in section 6.1. Patient with central venous catheter (see section 4.4). Critically ill patients or immunocompromised patients ...

4.4. Special warnings and precautions for use

Special warnings If symptoms persist for more than 2 days of treatment at usual posology, the therapeutic approach will be reevaluated. The treatment does not replace rehydration when this is necessary. ...

4.5. Interaction with other medicinal products and other forms of interaction

Because of its fungal nature, BIOFLOR 100 mg must not be administered with systemic or oral antifungal drugs. No other interaction is expected.

4.6. Fertility, pregnancy and lactation

Fertility No data available. Pregnancy Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). BIOFLOR is not recommended during pregnancy. Lactation Saccharomyces boulardii ...

4.7. Effects on ability to drive and use machines

BIOFLOR has no influence on the ability to drive or use machines.

4.8. Undesirable effects

Adverse reactions encountered most often are as follows: 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, including isolated cases), ...

4.9. Overdose

No case has been reported.

5.1. Pharmacodynamic properties

ANTI-DIARRHOEA Replacement flora Pharmacotherapeutic group: A, digestive system and metabolism ATC code: A07FA02 Saccharomyces boulardii CNCM I-745 is an intestinal flora replacement which ...

5.2. Pharmacokinetic properties

Analysis of the fecal elimination kinetics of living S. boulardii CNCM I-745 cells during repeated dosing with 1 g/day of Saccharomyces boulardii CNCM I-745 in healthy adult volunteers showed that steady ...

5.3. Preclinical safety data

LD50 is much higher than the maximal administered dose of 3,000 mg/kg repeated dose toxicity has been tested for 6 months in rats and 6 weeks in rabbits without any damage for animals. An Ames test has ...

6.1. List of excipients

Lactose, fructose, colloidal anhydrous silica, tutti frutti aroma (containing sorbitol)

6.2. Incompatibilities

None.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

No special condition for storage.

6.5. Nature and contents of container

Cardboard boxes containing sachets made of paper-aluminium-polyethylene laminate. Box of 20 sachets.

6.6. Special precautions for disposal and other handling

BIOCODEX, 7 avenue Gallieni, 94250 Gentilly, France

8. Marketing authorization number(s)

20432

9. Date of first authorization / renewal of the authorization

17/11/2008

10. Date of revision of the text

03/03/2021

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