Maa: Malesia
Kieli: englanti
Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SACCHAROMYCES BOULARDII
SERVIER MALAYSIA SDN BHD
SACCHAROMYCES BOULARDII
765mg mg
Biocodex
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ BIOFLOR ® CAPSULES/SACHETS _Saccharomyces boulardii_ (250mg) 1 WHAT IS IN THIS LEAFLET 1. What _BIOFLOR_ _®_ is used for 2. How _BIOFLOR_ _®_ works 3. Before you use _BIOFLOR_ _® _ 4. While you are using it 5. Side effects 6. Storage and Disposal of _BIOFLOR_ _®_ 7. Product Description 8. Manufacturer and Product Registration Holder 9. Date of revision WHAT _BIOFLOR_ _®_ IS USED FOR _BIOFLOR_ _®_ is indicated for acute diarrhoea in infants, children and adults; prevention of antibiotic- associated diarrhoea in children and adults; prevention of recurrence of _Clostridium _ _difficile_ in adults and prevention of diarrhoea during continuous enteral tube feeding in adults. Ask your doctor or pharmacist if you are not sure why you need to take _BIOFLOR_ _®_ . HOW _BIOFLOR_ _® _ WORKS _Saccharomyces _ _boulardii_ is an intestinal replacement flora (live probiotic yeast) which acts as antidiarrhoeal micoorganisms in the digestive tract. _Saccharomyces _ _boulardii_ protects the digestive tract against pathogens, improves digestion and restore normal flora. BEFORE YOU USE _BIOFLOR_ _® _ _- When you must not use it_ Do not use if you • Have hypersensitivity to any ingredient of _BIOFLOR_ _®_ • Have fructose or lactose intolerance • Have congenital galactosemia, glucose and galactose malabsorption syndrome or lactose deficit • Are immunocompromised (altered/ weakened immune system) or have central venous catheter _ _ _Pregnancy and lactation _ Do not take _BIOFLOR_ _®_ if you are pregnant, trying to get pregnant or think you may be pregnant. Do not take _BIOFLOR_ _®_ if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. _BIOFLOR_ _®_ contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. _BIOFLOR_ _® _ sachet contains fructose: This medicine contains 471.90 mg fructose in each sachet. In case o Lue koko asiakirja
1. IDENTIFICATION OF MEDICINAL PRODUCT NAME: BIOFLOR ® 250 mg, powder for oral suspension QUALITATIVE AND QUANTITATIVE COMPOSITION _Saccharomyces boulardii_ CNCM I-745....250 mg (lyophilized yeast cells) Each sachet is required to present a minimum _Saccharomyces boulardii_ CNCM I-745 of 2.5 x 10 9 CFU _Excipients: _ lactose, fructose, colloidal anhydrous silica, tutti-frutti flavour . PRODUCT DESCRIPTION Paper/aluminium/polyethylene composite sachet containing a very light-brown powder with an odor of fruit. Appearance after reconstitution: liquid suspension with a milky appearance. PHARMACEUTICAL FORM Sachet: box of 10 sachets. PHARMACOTHERAPEUTIC CLASSIFICATION ANTI-DIARRHOEA, Replacement flora (A: digestive system and metabolism). 2. PHARMACODYNAMICS _Saccharomyces boulardii_ (Sb) CNCM I-745 is an intestinal replacement flora which acts as antidiarrhoeal microorganisms in the digestive tract. Pharmacodynamics of _Saccharomyces boulardii_ CNCM I-745, live probiotic yeast, have been established on various models by in vitro and in vivo, animal, and human studies which demonstrated it acts at 3 levels: LUMINAL ACTION: Sb may interfere with pathogen toxins, preserve cellular physiology, interfere with pathogens attachment (anti-toxinic effect against _C. difficile_ , cholera, _E. coli_ through preservation of tight junctions, adhesion of the bacteria to Sb enabling to stop the bacterial invasion), interact with normal microbiota or assist in re-establishing short chain fatty acid levels. TROPHIC ACTION: Sb reduces mucositis, restores fluid transport pathways, stimulates protein and energy production or act through a trophic effect by releasing spermine and spermidine or other brush border enzymes that aid in the maturation of enterocytes. Immune response: Sb increases the IgA levels in the intestine. MUCOSAL ACTION – ANTI-INFLAMMATORY EFFECT: Sb may interfere with NF- B mediated signal transduction pathways which stimulate pro-inflammatory cytokine production. In lyophilized form, _S. boulardii_ CNCM I-745 Lue koko asiakirja