New Zealand - English - Medsafe (Medicines Safety Authority)

schering-plough a division of schering-plough animal health limited - amylase 30000 usp u (component of pancrelipase); pancrelipase 275mg; protease 30000 usp u (component of pancrelipase); rizolipase 8000 usp u (component of pancrelipase) - capsule - 8k/30k/30kusp u - active: amylase 30000 usp u (component of pancrelipase) pancrelipase 275mg protease 30000 usp u (component of pancrelipase) rizolipase 8000 usp u (component of pancrelipase) excipient: cellacefate colloidal silicon dioxide diethyl phthalate gelatin hydrated silica maize starch opacode povidone propylene glycol propylene glycol monostearate purified talc sodium laurilsulfate sucrose

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

abbvie inc. - pancrelipase amylase (unii: yoj58o116e) (pancrelipase amylase - unii:yoj58o116e), pancrelipase lipase (unii: 8myc33932o) (pancrelipase lipase - unii:8myc33932o), pancrelipase protease (unii: 3560d81v50) (pancrelipase protease - unii:3560d81v50) - pancrelipase amylase 30000 [usp'u] - creon® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. none. risk summary 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 background risk of major birth defects and miscarriage for the indicated populations 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. risk summary 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 creon and any potential adverse effects on the breastfed infant from creon or from the underlying maternal condition. the safety and effectiveness of creon for the treatment of exocrine pancreatic insufficiency have been established in pediatric patients. use of creon for this indication is supported by two adequate and well-controlled trials in adult and pediatric patients 12 years and older (study 1) and in pediatric patients 7 to 11 years of age (study 2) along with supportive data from an open-label, single-arm, study in 18 pediatric patients 4 months to six years of age (study 3). all three study populations consisted of patients with exocrine pancreatic insufficiency due to cystic fibrosis. the safety in pediatric patients 7 years of age and older in studies 1 and 2 were similar to that observed adult patients [see adverse reactions ( 6.1 ) and clinical studies ( 14 )] . in study 3, patients received their usual pancreatic enzyme replacement therapy (mean dose of 7,000 lipase units/kg/day for a mean duration of 18.2 days) followed by creon (mean dose of 7,500 lipase units/kg/day for a mean duration of 12.6 days). the mean daily fat intake was 48 grams during treatment with usual pancreatic enzyme replacement therapy and 47 grams during treatment with creon. adverse reactions that occurred in patients during treatment with creon in study 3 were vomiting, irritability, and decreased appetite [see adverse reactions ( 6.1 )] . dosages exceeding 6,000 lipase units/kg/meal have been reported postmarketing to be associated with fibrosing colonopathy and colonic strictures in pediatric patients less than 12 years of age. if there is a history of fibrosing colonopathy, monitor patients during treatment with creon because some patients may be at risk of progressing to stricture formation. do not exceed the recommended dosage of either 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day in pediatric patients greater than 12 months of age without further investigation [see dosage and administration ( 2.2 ) and warnings and precautions ( 5.1 )] . crushing or chewing creon capsules or mixing the capsule contents in foods having a ph greater than 4.5 can disrupt the protective enteric coating on the capsule contents and result in early release of enzymes, irritation of the oral mucosa, and/or loss of enzyme activity. instruct the patient or caregiver of the following: consume sufficient liquids (juice, water, breast milk, or formula) to ensure complete swallowing, and visually inspect the mouth of pediatric patients less than 12 months of age to ensure no drug is retained in the mouth and irritation of the oral mucosa has not occurred [see dosage and administration ( 2.3 ) and warnings and precautions ( 5.2 ) ] . clinical studies of creon 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.

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

abbott laboratories gmbh - 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, 3000 delayed-release capsules (bulk) pancrelipase, 6000 delayed-release capsules (bulk) pancrelipase, 12000 delayed-release capsules (bulk) pancrelipase, 24000 delayed-release capsules (bulk) pancrelipase, 36000 delayed-release capsules (bulk)

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

technipro pulmomed pty ltd - pancrelipase, quantity: 218.2 mg (equivalent: lipase, qty 25000 bp unit; equivalent: amylase, qty 22500 bp unit; equivalent: protease, qty 1250 bp unit) - capsule, enteric - excipient ingredients: lactose monohydrate; microcrystalline cellulose; crospovidone; colloidal anhydrous silica; magnesium stearate; methacrylic acid copolymer; triethyl citrate; purified talc; simethicone; purified water; glycol/butylene glycol montanate; gelatin; erythrosine; iron oxide red; iron oxide yellow; titanium dioxide - for use in pancreatic enzyme replacement in patients aged 18 months or more suffering with conditions associated with pancreatic exocrine insufficiency such as cystic fibrosis, chronic pancreatitis, post pancreatectomy, post gastrointestinal bypass surgery (eg bilroth ii gastroenterostomy) and ductal obstruction.

Canada - English - Health Canada

bgp pharma ulc - lipase; amylase; protease - granules for suspension, delayed release - 5000unit; 5100unit; 320unit - lipase 5000unit; amylase 5100unit; protease 320unit - digestants

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

crown healthcare (t) ltd, tanzania - amylase kit chemistry reagent -

United States - English - 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® is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. none. risk summary 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. risk summary there are no data on the presence of pancrelipase in either human or animal milk, the effects

United States - English - 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) - zenpep® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. 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 zenpep and any potential adverse effects on the breastfed infant from zenpep or from the underlying maternal conditions. the safety and effectiveness of zenpep for the treatment of exocrine pancreatic insufficiency have been established in pediatric patients. use of zenpep for this indication is supported by an adequate and well-controlled trial in adult and pediatric patients 7 to 17 years of age (study 1) along with supportive data from an open-label, single arm study in 19 pediatric patients 1 to 6 years of age (study 2). both study populations consisted of patients with exocrine pancreatic insufficiency due to cystic fibrosis. the safety in pediatric patients in studies 1 and 2 were similar to that observed in adult patients [see adverse reactions (6.1) and clinical studies (14)] . dosages exceeding 6,000 lipase units/kg/meal have been reported postmarketing to be associated with fibrosing colonopathy and colonic strictures in pediatric patients less than 12 years of age. if there is a history of fibrosing colonopathy, monitor patients during treatment with zenpep because some patients may be at risk of progressing to stricture formation. do not exceed the recommended dosage of either 2,500 lipase units/kg/meal, 10,000 lipase units/kg/day, or 4,000 lipase units/g fat ingested/day in pediatric patients greater than 12 months of age without further investigation. [see dosage and administration (2.2) and warnings and precautions (5.1)] . crushing or chewing zenpep capsules or mixing the capsule contents in foods having a ph greater than 4.5 can disrupt the protective enteric coating on the capsule contents and result in early release of enzymes, irritation of the oral mucosa, and/or loss of enzyme activity. instruct the patient or caregiver of the following: consume sufficient liquids (juice, water, breast milk, or formula) to ensure complete swallowing, and visually inspect the mouth of pediatric patients less than 12 months of age to ensure that no drug is retained in the mouth and irritation of the oral mucosa has not occurred [see dosage and administration (2.3) and warnings and precautions (5.2)] . clinical studies of zenpep 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.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

janssen-cilag ltd - amylase; lipase; protease - gastro-resistant capsule - 22500unit ; 25000unit ; 1250unit

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

essential pharma ltd - amylase; lipase; protease - oral capsule - 3300unit ; 2950unit ; 160unit