Bioflor

Bioflor

Manufacturer:

Biocodex

Distributor:

DKSH
Full Prescribing Info
Contents
Lyophilized Saccharomyces boulardii CNCM I-745.
Description
Sachet: Lyophilized Saccharomyces boulardii CNCM I-745 (corresponding to 250mg of yeast) 282.5 mg per sachet.
Capsule: Lyophilized Saccharomyces boulardii CNCM I-745 (corresponding to 250mg of yeast) 282.5 mg per capsule.
Action
Pharmacology: Pharmacodynamics: Mechanism of Action: Antidiarrheic of biological origin.
Saccharomyces boulardii CNCM I-745 resists to gastric and intestinal juices, to antibacterial antibiotics and to sulphonamides.
It acts in intestine in a living state.
In animals, the pharmacological studies show up: in vivo and in vitro microbial antagonism against bacteria and Candida albicans; an action on immunological mechanisms in experimental infections.
It synthesizes vitamins B: vitamin B1, vitamin B2, pantothenic acid, vitamin B6, nicotinic acid.
These vitamins may be utilized by animal body.
It produces a significant increase of dissaccharidases in the brush border in humans and animals.
Indications/Uses
Treatment of Acute Diarrhoea and Infectious Diarrhoea.
Treatment and prevention of digestive complications of antibiotic therapy: diarrhoea, colitis, candidiasis.
Prevention of diarrhoea during continuous enteral feeding in adults.
Treatment of recurrent Clostridium difficile disease.
Dosage/Direction for Use
Dosage: Oral route: 1 or 2 sachets or capsules, given once or twice daily.
Direction of Use: Oral route.
This drug can be taken at any time but, in order to obtain a very rapid effect, it is best to avoid periods when digestion is taking place. However, it can be taken at the same time as a dose of the antibiotic, whenever the latter is given. BIOFLOR 250 should not be mixed with a liquid which is too hot or which contains alcohol.
DOSAGE FORM CAPSULES: either swallow the capsule with a mouthful of fluid.
DOSAGE FORM SACHETS: pour content of the sachet into some water or sugar and water, mix and swallow. The dosage form sachet is more adapted when BIOFLOR 250 has to be used for infants or with continuous enteral feeding.
For infants: pour content of the sachet over the food or feed: the mixture must not be too hot.
For continuous enteral feeding: add the drug to the nutrient solution at the time of preparation. After mixing should be used immediately.
BIOFLOR 250mg must not be used for immunocompromised or hospitalised patients (due to serious illness or altered/weakened immune system).
Side Effects
The different clinical trials and post marketing surveillance data have not allowed to show up side effects regularly attribuable to BIOFLOR. However during the clinical trials some episgastric disturbances or abdominal meteorisms were reported. They did not require that treatment be discontinued.
Very rare side effects is penetration of yeast into blood (fungaemia).
Constipation can occur (frequency not known.)
Drug Interactions
On account of its fungal nature, Saccharomyces boulardii CNCM I-745 is sensitive to antifungal antibiotics and to some quinoleine derivatives.
Storage
Store at below 25°C and keep away from damp.
MIMS Class
ATC Classification
A07FA02 - saccharomyces boulardii ; Belongs to the class of antidiarrheal microorganisms. Used in the treatment of diarrhea.
Presentation/Packing
Cap 282.5 mg (250 mg yeast) x 10's, 20's. Powd for oral susp (sachet) 282.5 mg (250 mg yeast) x 10's, 20's.
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