Granuls pour suspension buvable de 2g /100ml. 12 comprims doss 200mg.

	NORMIX Antibiotique intestinal Le Normix contient de la Rifaximine, un nouvel antibiotique avec un spectre bactricide large et une absorption intestinale ngligeable aprs ladministration orale. Cest un driv semi-synthtique de rifamycine SV, et comme les autres membres du groupe antibiotique de la rifamycine, il lie de manire irrversible la sous-unit bta de la polymrase RNA dpendant de lADN de lenzyme bactrien et par consquence inhibe la synthse de RNA bactrien et de la protine. Le Normix a une activit bactricide sur de nombreuses de bactries intestinales Gram-ngatives et Gram-positives, arobies et anarobies, telles que : Escherichia coli, Enterobacter spp, Yersinia spp ; Pseudomonas spp ; Helicobacter pylori, Bacteroides spp ; Fusobacterium spp ; Streptococcus spp ; Staphylococcus SPP. Clostridium SPP Peptococcus spp ; Peptostreptococcus spp ; etc. Certains de ces bactries sont souvent les responsables dinfections aprs les oprations chirurgicales gastro-intestinales et/ou sont les producteurs dammoniaque. Labsorption gastro-intestinale du Normix administr par voie orale est virtuellement nulle (moins de 1%) par consquence, lantibiotique agit localement dans le tractus gastro intestinal o atteint des concentrations leves qui sont 10 fois plus hautes des MIC pour les entrobactries testes (les niveaux fcaux de 4000-8000 ug /g sont atteints aprs 3 jours de thrapie avec des doses journalires de 800mg) Ceci permet au Normix de raliser une action bactricide relle qui limine les espces pathogniques susceptibles qui sy trouvent et de diminuer la charge bactrienne du tractus gastro-intestinal, notamment au niveau du colon. Par consquent, le risque dinfections systmiques pendant les oprations gastro-intestinales diminue ainsi que la production bactrienne dammoniaque qui, dans le cas de graves maladies du foie avec une activit de dtoxication endommage est implique dans la pathognie et la symptomatologie de lencphalopathie hpatique (systmique portale) Labsorption gastro-intestinale quasiment nulle du produit limine le risque deffets systmiques indsirables ou de manifestations systmiques pouvant tre attribus aux interactions pharmacologiques ; INDICATIONS - Prophylaxie pr et postopratoire des complications infectieuses dans les interventions chirurgicales du tractus gastro-intestinal - Traitement adjuvant des hyperammonimies - Infections intestinales aigues et chroniques soutenues par des bactries Gram-positives et Gram-ngatives, syndrome diarrhique ; - Diarrhe provoque par un quilibre altr de la flore microbienne (diarrhe estivale diarrhe du voyageur, entrocolite) POSOLOGIE Prophylaxie pr et postopratoire Posologie recommande : - Adultes et jeunes de plus de 12 ans : 400mg (2 comprims ou 10-20ml de suspension orale) toutes les 8 heures : - Enfants de 6 12 ans : 200 mg-400mg (1-2 comprims ou 10-20 ml de suspension orale) toutes les 12 heures - Enfants de 2 6 ans : 100-200 mg (5-10ml de suspension orale) toutes les 12 heures la dure de la prophylaxie est de 3-5 jours avant lopration et peut tre continue pendant 3-5 jours aprs lopration Traitement adjuvant des hyperammonimies Posologie recommande : - Adultes et jeunes de plus de 12 ans : 400 mg (2 comprims ou 20ml de suspension orales) toutes les 8 heures : - Enfants de 6 12 ans : 200mg (1 comprim ou 10ml de suspension orale) toutes les 8 heures - Enfants de 2 6 ans : 100-200 mg (5-10 ml de suspension orale) toutes les 8 heures ; La dure du traitement ne doit pas dpasser 7-15 jours et doit tre dtermine par la rponse clinique du patient Dans les cas o des cycles de traitement seraient requis, chaque cycle de traitement devra Infections intestinales bactriennes, syndrome diarrhique provoqus par un quilibre altr de la flore microbienne - Posologie recommande - Adultes et jeunes de plus de 12 ans : 400mg (2comprims ou 20 ml de suspension orale) toutes le 8-12 heures - Enfants de 6 12 ans : 200mg (1 comprim ou 10 ml de suspension orales) toutes les 6-8 heures - Enfants de 2 6 ans : 100mg (5 ml de suspension orale) toutes les 6 heures La dure du traitement est de 3 jours Si la diarrhe persiste aprs 3 jours de traitement, consultez votre mdecin Les doses dans la prophylaxie chirurgicale et dans le traitement de lhperammonimie peuvent tre modifies en quantit et frquence, selon lavis du mdecin traitant CONTRE INDICATION Hypersensibilit la rifaximine ou autres rifamycines MISE EN GARDE ET PRECAUTIONS DEMPLOI Cinq ml de suspension orale contiennent 1,44g de saccharose, qui devra tre pris en considration lors du traitement chez les patients diabtiques Pendant le traitement prolong avec des doses leves, ou en cas de lsions de la muqueuse intestinale, une petite quantit du produit (en tout cas infrieure 1% ) pourrait tre absorbe et pourrait porter une couleur rougetre des urines pendant leur limination : ceci ne dpend que de lingrdient actif qui, comme la plupart des antibiotiques de la mme famille (rifamycines) est de couleur rouge-orange. Au cas o des micro-organismes non susceptibles lantibiotique se dvelopperaient, le traitement devra tre interrompu et une thrapie approprie devra tre effectue. En cas de grossesse et la toute premire enfance, le produit ne devra tre administr que si strictement ncessaire et sous le contrle direct du mdecin EFFETS INDESIRABLES Les nombreuses tudes cliniques menes ont dmontr que le Normix est bien tolr Dans certains cas, la nause a t observe, se reproduisant en association avec le premier traitement. Des ractions de la peau du type urticaire, probablement lexpression de lintolrance individuelle non prvisible au traitement, se produisent rarement. PRESENTATION - 200mg comprims revtus : bote contenant un blister pour 12 comprims - Granuls pour suspension orale de 2g/100 ml : boite contenant un flacon en verre fonc de 60 ml fermeture tanche rempli moiti avec des granuls pour suspension. Une me surette gradue en plastique transparente pour 5, 10 ou 15 ml est contenue dans la bote. Prparation de la suspension Les granuls pour la suspension orale sont contenus dans un flacon fermeture tanche Ouvrez le flacon, ajoutez de leau jusqu la marque et agitez bien. Rajoutez de leau jusqu ce que le niveau de la suspension natteigne pas de nouveau la marque La concentration de rifaximine dans la suspension reconstitue est de 100mg pour 5 ml La suspension prpare comme dcrit ci-dessus est stable pendant 7 jours temprature ambiante Agitez bien avant toute administration Tenir hors de la porte des enfants

	Rifaximin-α, an original compound fruit of Alfa Wassermann research, is used for the treatment of gastrointestinal inflammatory and infectious diseases. Rifaximin-α selectively exerts its pharmacological action exclusively in the intestinal lumen, with negligible systemic absorption, due to the unique chemical-physical and pharmacokinetic characteristics provided by the polymorph alpha form. Rifaximin-α is marketed all over the world under different trademarks (Normix®, Xifaxan®, Spiraxin®, Lormyx®, Flonorm® and others) either directly by Alfa Wassermann’s own subsidiaries or through licensees such as Salix Pharmaceuticals, Inc. in the US. Rifaximin-α in the treatment of Irritable Bowel Syndrome (IBS). The Dark Side of IBS In a Consensus Conference in 2009 an important association of American gastroenterologists, the American College of Gastroenterology, systematically reviewed the therapeutic solutions proposed for IBS, solutions which were later confirmed by the World Gastroenterological Organisation (WGO). Following this Evidence-Based Medicine evaluation Rifaximin-α was included as one of the available therapies, with a high grade positive evaluation (I-B). The other therapeutic options available in Europe received a less positive evaluation. During the United European Gastroenterology Week (UEGW) held in London last November, attended by more than 14,000 specialists, a prominent position was given to the symposium on IBS entitled "The Dark Side of IBS". Renowned international speakers such as Prof. Stanghellini of the Medical Clinic of Bologna University, Prof. Spiller of Digestive Diseases of Nottingham University and Prof. Chey of Michigan University gave presentations on the incidence of this common complaint, which affects 15% of the adult population, especially women; difficulties in making a correct diagnosis; the causes of IBS which are still not clear and finally the negative influence symptoms such as abdominal pain, bloating and alterations of bowel movements have on the quality of life of these patients. A central role was attributed to alteration and/or excessive increase in intestinal bacterial flora and how locally acting intestinal antibiotics may resolve the debilitating symptoms of this syndrome. During the symposium reference was made to two recent clinical studies, TARGET 1 and TARGET 2, with Rifaximin-α performed in the USA and Canada by AW's licensee Salix as part of our long-term collaboration. Both studies aimed at evaluating the efficacy and safety of Rifaximin-α in the treatment of patients with IBS with diarrhoea (IBS-D), using a double-blind placebo-controlled design and involving over 1,000 patients altogether. A statistically significant improvement in symptoms of IBS was observed at the end of two weeks’ of treatment with Rifaximin-α as well as one month after the end of treatment. These results confirm the positive results obtained in the initial Phase II study. Rifaximin-α, an original compound of Alfa Wassermann, is marketed all over the world under different trademarks (Normix®, Xifaxan®, Spiraxin®, Lormyx®, Flonorm® and others) either directly by Alfa Wassermann’s own subsidiaries or through licensees such as Salix Pharmaceuticals Inc. in the US. The FDA Advisory Committee recommends approval of Rifaximin-α in Hepatic Encephalopathy (HE) On February 23, 2010 the Gastrointestinal Drug Advisory Committee of the FDA recommended the approval of Rifaximin-α in patients with Hepatic Encephalopathy. Final decision will be issued by the FDA on March 24. The Advisory Committee recommendation is based on data from one of the largest international studies ever performed in HE, carried out by AW's licensee Salix Pharmaceuticals, Inc. as part of our long-term collaboration. This double-blind study in 299 patients with recent episodes of HE demonstrated that Rifaximin-α 1100 mg/day for 6 months prevented further episodes (risk reduction of 58%), delayed reappearance of HE to a highly significant extent and at the same time reduced hospitalizations. Furthermore, during the six months of treatment Rifaximin-α demonstrated a safety and tolerability profile comparable to that of placebo. Follow-up of these patients, with the extension of treatment for up to 24 months, highlighted how the incidence of episodes of HE continued to be dramatically reduced by Rifaximin-α therapy. These results confirm enduring preventive action, reducing the number of days of hospitalization and favourably influencing the pharmacoeconomic evaluation of direct and indirect social costs. These efficacy and safety data confirm previous results obtained by Alfa Wassermann during clinical trials in Italy and other European countries as well as decades of Rifaximin-α use in Europe. Hepatic encephalopathy (HE) is a recurrent alteration of consciousness and neuromuscular function due to severe hepatic impairment. In patients with severe chronic hepatic damage, such as that seen in liver cirrhosis due to hepatitis or alcohol abuse, the liver is no longer able to remove toxic substances produced in the intestine. These substances accumulate in the blood, cross the blood-brain barrier and produce alterations in cerebral function which gradually become more and more serious. Ammonium and other nitrogenous compounds derived from intestinal bacteria represent the principal neurotoxin. One of the therapeutic approaches used in the management of HE is to reduce ammonium production by intestinal bacteria via the administration of locally acting intestinal antibiotics. HE is a severe, chronic and disabling disease, which affects 20% of cirrhotic patients and represents about 50% of terminal events in these patients, as HE reduces their survival. Symptoms may include: slowing of EEG rhythm, sleep disorders, changes in personality, cognitive deficit, flapping tremors, reduced level of consciousness, somnolence leading to coma and death. Rifaximin-α, an original compound of Alfa Wassermann, is marketed all over the world under different trademarks (Normix®, Xifaxan®, Spiraxin®, Lormyx®, Flonorm® and others) either directly by Alfa Wassermann’s own subsidiaries or through licensees such as Salix Pharmaceuticals in the US.