Canada - English - Health Canada

pharmaceutical partners of canada inc - zinc (zinc sulfate); copper (cupric sulfate); manganese (manganese sulfate); chromium (chromic chloride) - solution - 5mg; 1mg; 0.5mg; 10mcg - zinc (zinc sulfate) 5mg; copper (cupric sulfate) 1mg; manganese (manganese sulfate) 0.5mg; chromium (chromic chloride) 10mcg - replacement preparations

Canada - English - Health Canada

pharmaceutical partners of canada inc - zinc (zinc sulfate); copper (cupric sulfate); manganese (manganese sulfate); chromium (chromic chloride) - solution - 1mg; 0.4mg; 0.1mg; 4mcg - zinc (zinc sulfate) 1mg; copper (cupric sulfate) 0.4mg; manganese (manganese sulfate) 0.1mg; chromium (chromic chloride) 4mcg - replacement preparations

Canada - English - Health Canada

bracco imaging canada - sincalide - powder for solution - 5mcg - sincalide 5mcg - gallbladder function

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

gilead sciences, inc. - idelalisib (unii: yg57i8t5m0) (idelalisib - unii:yg57i8t5m0) - idelalisib 100 mg - zydelig is indicated, in combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (cll) for whom rituximab alone would be considered appropriate therapy due to other co-morbidities. limitations of use zydelig is not indicated and is not recommended for first-line treatment of any patient, including patients with cll, small lymphocytic lymphoma (sll), follicular lymphoma (fl), and other indolent non-hodgkin lymphomas. zydelig is not indicated and is not recommended in combination with bendamustine and rituximab, or in combination with rituximab for the treatment of patients with fl, sll, and other indolent non-hodgkin lymphomas. zydelig is contraindicated in patients with a history of serious hypersensitivity reactions to idelalisib, including anaphylaxis, or patients with a history of toxic epidermal necrolysis with any drug [see warnings and precautions (5.6, 5.7)] . risk summary based on findings in animal studies and the mechanism of action [see clinical pharmac

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

genzyme corporation - eliglustat (unii: dr40j4wa67) (eliglustat - unii:dr40j4wa67) - eliglustat 84 mg - cerdelga is indicated for the long-term treatment of adult patients with gaucher disease type 1 (gd1) who are cyp2d6 extensive metabolizers (ems), intermediate metabolizers (ims), or poor metabolizers (pms) as detected by an fda-cleared test [see dosage and administration (2.1)] . limitations of use : - patients who are cyp2d6 ultra-rapid metabolizers (urms) may not achieve adequate concentrations of cerdelga to achieve a therapeutic effect [see clinical studies (14)] . - a specific dosage cannot be recommended for those patients whose cyp2d6 genotype cannot be determined (indeterminate metabolizers) [see clinical studies (14)] . cerdelga is contraindicated in the following patients based on cyp2d6 metabolizer status due to the risk of cardiac arrhythmias from prolongation of the pr, qtc, and/or qrs cardiac intervals. ems - taking a strong or moderate cyp2d6 inhibitor concomitantly with a strong or moderate cyp3a inhibitor [see drug interactions (7.1)] - moderate or severe hepatic impairment [see use in specific populations (8.7)] - mild hepatic impairment and taking a strong or moderate cyp2d6 inhibitor [see use in specific populations (8.7)] ims - taking a strong or moderate cyp2d6 inhibitor concomitantly with a strong or moderate cyp3a inhibitor [see drug interactions (7.1)] - taking a strong cyp3a inhibitor [see drug interactions (7.1)] - any degree of hepatic impairment [see use in specific populations (8.7)] pms - taking a strong cyp3a inhibitor [see drug interactions (7.1)] - any degree of hepatic impairment [see use in specific populations (8.7)] risk summary available data on cerdelga use in pregnant women includes 20 pregnancies that occurred during the clinical development program and a small number of post-marketing case reports. these data are not sufficient to assess drug-associated risks major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies in pregnant rats administered oral eliglustat during organogenesis, a spectrum of various developmental abnormalities were observed at doses 6 times the recommended human dose. no adverse developmental outcomes were observed with oral administration of eliglustat to pregnant rabbits at dose levels 10 times the recommended human dose [see data] . the estimated background risk of major birth defects and miscarriage in the indicated population is unknown. all pregnancies have a background risk of birth defect, loss or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk women with gaucher disease type 1 have an increased risk of spontaneous abortion, especially if disease symptoms are not treated and controlled pre-conception and during a pregnancy. pregnancy may exacerbate existing gaucher disease type 1 symptoms or result in new disease manifestations. gaucher disease type 1 manifestations may lead to adverse pregnancy outcomes including, hepatosplenomegaly which can interfere with the normal growth of a pregnancy and thrombocytopenia which can lead to increased bleeding and possible hemorrhage. data animal data reproduction studies have been performed in pregnant rats at oral doses up to 120 mg/kg/day (about 6 times the recommended human dose based on body surface area) and in pregnant rabbits at oral doses up to 100 mg/kg/day (about 10 times the recommended human dose based on body surface area) following administration of eliglustat during the period of organogenesis (gestation days 6 to 17 in the rat and 6 to 18 in the rabbit). in rats, at 120 mg/kg/day (about 6 times the recommended human dose based on body surface area), eliglustat increased the number of late resorptions, dead fetuses and post implantation loss, reduced fetal body weight, and caused fetal cerebral variations (dilated cerebral ventricles), fetal skeletal variations (poor bone ossification) and fetal skeletal malformations (abnormal number of ribs or lumbar vertebra). eliglustat-related effects on fetal rats were observed in association with signs of maternal toxicity. eliglustat did not cause fetal harm in rabbits at oral doses up to 100 mg/kg/day (about 10 times the recommended human dose based on body surface area). mild maternal toxicity was observed at the 100 mg/kg/day dose. in a pre and postnatal development study in rats (dosed daily from gestation day 6 to postpartum day 21), eliglustat did not show any significant adverse effects on pre and postnatal development at doses up to 100 mg/kg/day (about 5 times the recommended human dose based on body surface area). risk summary there are no human data available on the presence of eliglustat in human milk, the effects on the breastfed infant, or the effects on milk production. eliglustat and its metabolites were present in the milk of lactating rats [see data] . when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for cerdelga and any potential adverse effects on the breastfed child from cerdelga or from the underlying maternal condition. data in a milk excretion study in the rat, a single oral dose of 30 mg/kg [14 c]-labeled eliglustat was administered to lactating female rats at day 11 postpartum. approximately 0.23% of the administered radioactivity was excreted into the milk within 24 hours of dose administration. the concentration in the milk at 24 hours post dose was 16.3-fold higher than the plasma concentration. safety and effectiveness in pediatric patients have not been established. clinical studies of cerdelga did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. clinical experience has not identified differences in responses between the elderly and younger patients. use cerdelga in patients with renal impairment based on the patient's cyp2d6 metabolizer status [see clinical pharmacology (12.3)] . ems - avoid cerdelga in patients with end-stage renal disease (esrd) (estimated creatinine clearance (eclcr) less than 15 ml/min not on dialysis or requiring dialysis). - no dosage adjustment is recommended in patients with mild, moderate, or severe renal impairment (eclcr at least 15 ml/min). ims and pms - avoid cerdelga in patients with any degree of renal impairment. use cerdelga in patients with hepatic impairment based on cyp2d6 metabolizer status and concomitant use of cyp2d6 or cyp3a inhibitors [see clinical pharmacology (12.3)] . ems - cerdelga is contraindicated in patients with [see contraindications (4)] : severe (child-pugh class c) hepatic impairment moderate (child-pugh class b) hepatic impairment mild (child-pugh class a) hepatic impairment taking a strong or moderate cyp2d6 inhibitor - severe (child-pugh class c) hepatic impairment - moderate (child-pugh class b) hepatic impairment - mild (child-pugh class a) hepatic impairment taking a strong or moderate cyp2d6 inhibitor - reduce dosage frequency of cerdelga 84 mg to once daily [see dosage and administration (2.3)] in patients with mild hepatic impairment taking: a weak cyp2d6 inhibitor a strong, moderate, or weak cyp3a inhibitor - a weak cyp2d6 inhibitor - a strong, moderate, or weak cyp3a inhibitor - no dosage adjustment is recommended in patients with mild hepatic impairment, unless otherwise specified above. ims and pms - cerdelga is contraindicated in patients with any degree of hepatic impairment [see contraindications (4)] .

Canada - English - Health Canada

organon canada inc. - lipase; amylase; protease - capsule (delayed release) - 10800unit; 42000unit; 45000unit - lipase 10800unit; amylase 42000unit; protease 45000unit - digestants

Canada - English - Health Canada

novartis pharmaceuticals canada inc - diclofenac sodium - tablet (delayed-release) - 50mg - diclofenac sodium 50mg - other nonsteroidal antiimflammatory agents

Canada - English - Health Canada

organon canada inc. - lipase; amylase; protease - capsule (delayed release) - 25000unit; 100000unit; 100000unit - lipase 25000unit; amylase 100000unit; protease 100000unit - digestants

Canada - English - Health Canada

astrazeneca canada inc - omeprazole - capsule (delayed release) - 10mg - omeprazole 10mg - proton-pump inhibitors

Canada - English - Health Canada

astrazeneca canada inc - omeprazole - capsule (delayed release) - 40mg - omeprazole 40mg - proton-pump inhibitors