Ireland - English - HPRA (Health Products Regulatory Authority)

athlone pharmaceuticals limited - itraconazole - oral solution - triazole derivatives; itraconazole

United States - English - NLM (National Library of Medicine)

genentech, inc. - orlistat (unii: 95m8r751w8) (orlistat - unii:95m8r751w8) - orlistat 120 mg - xenical is indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet. xenical is also indicated to reduce the risk for weight regain after prior weight loss. xenical is indicated for obese patients with an initial body mass index (bmi) ≥30 kg/m2 or ≥27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, dyslipidemia). table 1 illustrates body mass index (bmi) according to a variety of weights and heights. the bmi is calculated by dividing weight in kilograms by height in meters squared. for example, a person who weighs 180 lbs and is 5' 5" would have a bmi of 30. xenical is contraindicated in: - pregnancy [see use in specific populations (8.1)] - patients with chronic malabsorption syndrome - patients with cholestasis - patients with known hypersensitivity to xenical or to any component of this product pregnancy category x xenical is contraindicated during pregnancy, because weight loss offers no potential be

Singapore - English - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - anhydrous sevelamer carbonate - tablet, film coated - 800 mg - anhydrous sevelamer carbonate 800 mg

United States - English - NLM (National Library of Medicine)

h2-pharma llc - orlistat (unii: 95m8r751w8) (orlistat - unii:95m8r751w8) - orlistat 120 mg - xenical is indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet. xenical is also indicated to reduce the risk for weight regain after prior weight loss. xenical is indicated for obese patients with an initial body mass index (bmi) ≥30 kg/m 2 or ≥27 kg/m 2 in the presence of other risk factors (e.g., hypertension, diabetes, dyslipidemia). table 1 illustrates body mass index (bmi) according to a variety of weights and heights. the bmi is calculated by dividing weight in kilograms by height in meters squared. for example, a person who weighs 180 lbs and is 5 ' 5 " would have a bmi of 30. xenical is contraindicated in: - pregnancy [see use in specific populations (8.1)] - patients with chronic malabsorption syndrome - patients with cholestasis - patients with known hypersensitivity to xenical or to any component of this product pregnancy category x xenical is contraindicated during pregnancy, because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. a minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to the obligatory weight gain that occurs in maternal tissues during pregnancy. no embryotoxicity or teratogenicity was seen in animals that received orlistat at doses much higher than the recommended human dose. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard of maternal weight loss to the fetus. animal data reproduction studies were conducted in rats and rabbits at doses up to 800 mg/kg/day. neither study showed embryotoxicity or teratogenicity. this dose is 23 and 47 times the daily human dose calculated on a body surface area (mg/m 2 ) basis for rats and rabbits, respectively. it is not known if xenical is present in human milk. caution should be exercised when xenical is administered to a nursing woman. safety and effectiveness in pediatric patients below the age of 12 have not been established. the safety and efficacy of xenical have been evaluated in obese adolescent patients aged 12 to 16 years. use of xenical in this age group is supported by evidence from adequate and well-controlled studies of xenical in adults with additional data from a 54-week efficacy and safety study and a 21-day mineral balance study in obese adolescent patients aged 12 to 16 years. patients treated with xenical in the 54-week efficacy and safety study (64.8% female, 75% caucasians, 18.8% blacks, and 6.3% other) had a mean reduction in bmi of 0.55 kg/m 2 compared with an average increase of 0.31 kg/m 2 in placebo-treated patients (p=0.001). in both adolescent studies, adverse effects were generally similar to those described in adults and included fatty/oily stool, oily spotting, and oily evacuation. in a subgroup of 152 xenical and 77 placebo patients from the 54-week study, changes in body composition measured by dexa were similar in both treatment groups with the exception of fat mass, which was significantly reduced in patients treated with xenical compared to patients treated with placebo (-2.5 kg vs -0.6 kg, p=0.033). because xenical can interfere with the absorption of fat-soluble vitamins, all patients should take a daily multivitamin that contains vitamins a, d, e, k, and beta-carotene. the vitamin supplement should be taken at least 2 hours before or after xenical [see dosage and administration (2), warnings and precautions (5.1), and clinical pharmacology (12.3)] . plasma concentrations of orlistat and its metabolites m1 and m3 were similar to those found in adults at the same dose level. daily fecal fat excretions were 27% and 7% of dietary intake in xenical and placebo treatment groups, respectively. clinical studies of xenical did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients [see clinical studies (14)] . as with any weight-loss agent, the potential exists for abuse of xenical in inappropriate patient populations (e.g., patients with anorexia nervosa or bulimia). see indications and usage (1) for recommended prescribing guidelines.

United States - English - NLM (National Library of Medicine)

h2-pharma llc - orlistat (unii: 95m8r751w8) (orlistat - unii:95m8r751w8) - orlistat is indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet. orlistat is also indicated to reduce the risk for weight regain after prior weight loss. orlistat is indicated for obese patients with an initial body mass index (bmi) ≥30 kg/m 2 or ≥27 kg/m 2 in the presence of other risk factors (e.g., hypertension, diabetes, dyslipidemia). table 1 illustrates body mass index (bmi) according to a variety of weights and heights. the bmi is calculated by dividing weight in kilograms by height in meters squared. for example, a person who weighs 180 lbs and is 5 ' 5 " would have a bmi of 30. orlistat is contraindicated in: - pregnancy [see use in specific populations (8.1)] - patients with chronic malabsorption syndrome - patients with cholestasis - patients with known hypersensitivity to orlistat or to any component of this product pregnancy category x orlistat is contraindicated during pregnancy, because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. a minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to the obligatory weight gain that occurs in maternal tissues during pregnancy. no embryotoxicity or teratogenicity was seen in animals that received orlistat at doses much higher than the recommended human dose. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard of maternal weight loss to the fetus. animal data reproduction studies were conducted in rats and rabbits at doses up to 800 mg/kg/day. neither study showed embryotoxicity or teratogenicity. this dose is 23 and 47 times the daily human dose calculated on a body surface area (mg/m 2 ) basis for rats and rabbits, respectively. it is not known if orlistat is present in human milk. caution should be exercised when orlistat is administered to a nursing woman. safety and effectiveness in pediatric patients below the age of 12 have not been established. the safety and efficacy of orlistat have been evaluated in obese adolescent patients aged 12 to 16 years. use of orlistat in this age group is supported by evidence from adequate and well-controlled studies of orlistat in adults with additional data from a 54-week efficacy and safety study and a 21-day mineral balance study in obese adolescent patients aged 12 to 16 years. patients treated with orlistat in the 54-week efficacy and safety study (64.8% female, 75% caucasians, 18.8% blacks, and 6.3% other) had a mean reduction in bmi of 0.55 kg/m 2 compared with an average increase of 0.31 kg/m 2 in placebo-treated patients (p=0.001). in both adolescent studies, adverse effects were generally similar to those described in adults and included fatty/oily stool, oily spotting, and oily evacuation. in a subgroup of 152 orlistat and 77 placebo patients from the 54-week study, changes in body composition measured by dexa were similar in both treatment groups with the exception of fat mass, which was significantly reduced in patients treated with orlistat compared to patients treated with placebo (-2.5 kg vs -0.6 kg, p=0.033). because orlistat can interfere with the absorption of fat-soluble vitamins, all patients should take a daily multivitamin that contains vitamins a, d, e, k, and beta-carotene. the vitamin supplement should be taken at least 2 hours before or after orlistat [see dosage and administration (2), warnings and precautions (5.1), and clinical pharmacology (12.3)] . plasma concentrations of orlistat and its metabolites m1 and m3 were similar to those found in adults at the same dose level. daily fecal fat excretions were 27% and 7% of dietary intake in orlistat and placebo treatment groups, respectively. clinical studies of orlistat did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients [see clinical studies (14)] . as with any weight-loss agent, the potential exists for abuse of orlistat in inappropriate patient populations (e.g., patients with anorexia nervosa or bulimia). see indications and usage (1) for recommended prescribing guidelines.

Singapore - English - HSA (Health Sciences Authority)

abbott laboratories (singapore ) private limited - ethinylestradiol; norelgestromin - patch - 600 mcg/patch - ethinylestradiol 600 mcg/patch; norelgestromin 6 mg/patch

Australia - English - Department of Health (Therapeutic Goods Administration)

dentcom corp pty ltd - 61019 - cone beam computed tomography system, head/neck - a cbct is a variation of the traditional computed tomography systems with an intended use by dental professionals. a cbct involves an x-ray unit rotating around the head of a patient thus capturing data via a cone- shaped x- ray beam. this data is then reconstructed via the software and connected computer so as to form a three dimensional image of the patient's anatomy, such include; teeth, oral, maxillofacial, ears, nose and throat region. the intended diagnostic purpose of the ?dental cone-beam computed tomography imaging system? extends into endodontics, implantology and orthodontics. more specifically, this unit demonstrates great advantages in endodontic treatment whereby such a 3d reconstruction visually illustrates anatomical features that conventional intraoral panoramic images cannot. alternatively, its application in implantology offers useful information regarding the assessment and planning of surgical implants. regarding orthodontics, a cbct offers an undistorted view of the dentition that can be used to accurately visualise both erupted and non- erupted teeth, tooth root orientation and anomalous structures which remain undefined in 2d radiography.

Canada - English - Health Canada

janssen inc - itraconazole - capsule - 100mg - itraconazole 100mg - azoles

Canada - English - Health Canada

janssen inc - itraconazole - solution - 10mg - itraconazole 10mg - azoles

Canada - English - Health Canada

jamp pharma corporation - itraconazole - solution - 10mg - itraconazole 10mg - azoles