यूनाइटेड किंगडम - अंग्रेज़ी - MHRA (Medicines & Healthcare Products Regulatory Agency)

de pharmaceuticals - amylase; lipase; protease - gastro-resistant granules - 3600unit ; 5000unit ; 200unit

यूनाइटेड किंगडम - अंग्रेज़ी - MHRA (Medicines & Healthcare Products Regulatory Agency)

mawdsley-brooks & company ltd - amylase; lipase; protease - gastro-resistant granules - 3600unit ; 5000unit ; 200unit

ऑस्ट्रेलिया - अंग्रेज़ी - Department of Health (Therapeutic Goods Administration)

marvel health (australia) pty ltd - poliglusam, quantity: 300 mg; fructooligosaccharides, quantity: 300 mg; phaseolus vulgaris, quantity: 62.5 mg (equivalent: phaseolus vulgaris, qty 1.25 g) - tablet, chewable - excipient ingredients: colloidal anhydrous silica; isomalt; maltodextrin; thaumatin; magnesium stearate; flavour - maintain/support general health and wellbeing ; helps decrease/reduce body weight ; helps enhance/promote/increase lean body mass ; helps enhance/promote/increase weight loss ; reduce/decrease/supress hunger/appetite ; maintain/support intestinal health ; helps decrease/reduce dietary fat absorption in digestive system ; aid/assist/helps elimination of dietary fat

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

physicians total care, inc. - pancrelipase lipase (unii: 8myc33932o) (pancrelipase lipase - unii:8myc33932o), pancrelipase protease (unii: 3560d81v50) (pancrelipase protease - unii:3560d81v50), pancrelipase amylase (unii: yoj58o116e) (pancrelipase amylase - unii:yoj58o116e) - pancrelipase lipase 12000 [usp'u] - creon® (pancrelipase) is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy, or other conditions. none. teratogenic effects pregnancy category c: animal reproduction studies have not been conducted with pancrelipase. it is also not known whether pancrelipase can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. creon should be given to a pregnant woman only if clearly needed. the risk and benefit of pancrelipase should be considered in the context of the need to provide adequate nutritional support to a pregnant woman with exocrine pancreatic insufficiency. adequate caloric intake during pregnancy is important for normal maternal weight gain and fetal growth. reduced maternal weight gain and malnutrition can be associated with adverse pregnancy outcomes. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

janssen pharmaceuticals, inc. - pancrelipase lipase (unii: 8myc33932o) (pancrelipase lipase - unii:8myc33932o), pancrelipase amylase (unii: yoj58o116e) (pancrelipase amylase - unii:yoj58o116e), pancrelipase protease (unii: 3560d81v50) (pancrelipase protease - unii:3560d81v50) - pancrelipase lipase 4200 [usp'u] - pancreaze (pancrelipase) is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. none. teratogenic effects pregnancy category c: animal reproduction studies have not been conducted with pancrelipase. it is not known whether pancrelipase can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. pancreaze should be given to a pregnant woman only if clearly needed. the risk and benefit of pancrelipase should be considered in the context of the need to provide adequate nutritional support to a pregnant woman with exocrine pancreatic insufficiency. adequate caloric intake during pregnancy is important for normal maternal weight gain and fetal growth. reduced maternal weight gain and malnutrition can be associated with adverse pregnancy outcomes. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when pancreaze is administered to a nursing

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

allergan, inc. - pancrelipase lipase (unii: 8myc33932o) (pancrelipase lipase - unii:8myc33932o), pancrelipase protease (unii: 3560d81v50) (pancrelipase protease - unii:3560d81v50), pancrelipase amylase (unii: yoj58o116e) (pancrelipase amylase - unii:yoj58o116e) - pancrelipase lipase 3000 [usp'u] - zenpep® (pancrelipase) is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. none. teratogenic effects pregnancy category c: animal reproduction studies have not been conducted with pancrelipase. it is also not known whether pancrelipase can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. zenpep should be given to a pregnant woman only if clearly needed. the risk and benefit of pancrelipase should be considered in the context of the need to provide adequate nutritional support to a pregnant woman with exocrine pancreatic insufficiency. adequate caloric intake during pregnancy is important for normal maternal weight gain and fetal growth. reduced maternal weight gain and malnutrition can be associated with adverse pregnancy outcomes. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when zenpep is administered to a nursing

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

physicians total care, inc. - pancrelipase lipase (unii: 8myc33932o) (pancrelipase lipase - unii:8myc33932o), pancrelipase protease (unii: 3560d81v50) (pancrelipase protease - unii:3560d81v50), pancrelipase amylase (unii: yoj58o116e) (pancrelipase amylase - unii:yoj58o116e) - pancrelipase lipase 10000 [usp'u] - zenpep® (pancrelipase) is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. none. teratogenic effects pregnancy category c: animal reproduction studies have not been conducted with pancrelipase. it is also not known whether pancrelipase can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. zenpep should be given to a pregnant woman only if clearly needed. the risk and benefit of pancrelipase should be considered in the context of the need to provide adequate nutritional support to a pregnant woman with exocrine pancreatic insufficiency. adequate caloric intake during pregnancy is important for normal maternal weight gain and fetal growth. reduced maternal weight gain and malnutrition can be associated with adverse pregnancy outcomes. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when zenpep is administered to

सिंगापुर - अंग्रेज़ी - HSA (Health Sciences Authority)

abbott laboratories (singapore ) private limited - clinical chemistry - the amylase2 assay is used for the quantitation of amylase in human serum, plasma, or urine on the architect c systems. the amylase2 assay is to be used as an aid in the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

aimmune therapeutics, inc - pancrelipase lipase (unii: 8myc33932o) (pancrelipase lipase - unii:8myc33932o), pancrelipase protease (unii: 3560d81v50) (pancrelipase protease - unii:3560d81v50), pancrelipase amylase (unii: yoj58o116e) (pancrelipase amylase - unii:yoj58o116e) - viokace, in combination with a proton pump inhibitor, is indicated for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy in adults. none. published data from case reports with pancrelipase use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. pancrelipase is minimally absorbed systematically; therefore, maternal use is not expected to result in fetal exposure to the drug. animal reproduction studies have not been conducted with pancrelipase. the estimated background risk of major birth defects and miscarriage for 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. there are no data on the presence of pancrelipase in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. pancrelipase is minimally absorbed systemically following oral administration, therefore maternal use is not expected to result in clinically relevant exposure of breastfed infants to the drug. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for viokace and any potential adverse effects on the breastfed child from viokace or from the underlying maternal conditions. the safety and effectiveness of viokace in pediatric patients have not been established. use of viokace in pediatric patients may increase the risk of inadequate treatment of pancreatic insufficiency and result in suboptimal weight gain, malnutrition and/or need for larger doses of pancreatic enzyme replacement due to tablet degradation in the gastric environment of the stomach. high dosages of pancreatic enzyme products have been associated with fibrosing colonopathy and colonic strictures in pediatric patients less than 12 years of age [see warnings and precautions (5.1)] . clinical studies of viokace did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. other reported clinical experience has not identified differences in responses between patients aged 65 years and over and younger adult patients.

सिंगापुर - अंग्रेज़ी - HSA (Health Sciences Authority)

abbott laboratories (singapore ) private limited - clinical chemistry - the amylase2 assay is used for the quantitation of amylase in human serum, plasma, or urine on the alinity c system. the amylase2 assay is to be used as an aid in the diagnosis and treatment of pancreatitis (inflammation of the pancreas).