Storbritannien - engelsk - MHRA (Medicines & Healthcare Products Regulatory Agency)

essential pharmaceuticals ltd - amylase; lipase; protease - gastro-resistant tablet - 1700unit ; 1900unit ; 110unit

Storbritannien - engelsk - MHRA (Medicines & Healthcare Products Regulatory Agency)

essential pharma ltd - amylase; lipase; protease - powder for gastroenteral or oral liquid - 30000unit ; 25000unit ; 1400unit

Storbritannien - engelsk - MHRA (Medicines & Healthcare Products Regulatory Agency)

essential pharmaceuticals ltd - amylase; protease; lipase - gastro-resistant granules - 4000unit ; 300unit ; 5000unit

Storbritannien - engelsk - MHRA (Medicines & Healthcare Products Regulatory Agency)

viatris uk healthcare ltd - amylase; lipase; protease - gastro-resistant granules - 3600unit ; 5000unit ; 200unit

Storbritannien - engelsk - MHRA (Medicines & Healthcare Products Regulatory Agency)

essential pharma ltd - amylase; lipase; protease - oral capsule - 9000unit ; 8000unit ; 430unit

Storbritannien - engelsk - MHRA (Medicines & Healthcare Products Regulatory Agency)

essential pharmaceuticals ltd - amylase; lipase; protease - gastro-resistant tablet - 5000unit ; 5600unit ; 330unit

Storbritannien - engelsk - MHRA (Medicines & Healthcare Products Regulatory Agency)

waymade healthcare plc - amylase; lipase; protease - oral capsule - 9000unit ; 8000unit ; 430unit

USA - engelsk - NLM (National Library of Medicine)

vivus llc - pancrelipase lipase (unii: 8myc33932o) (pancrelipase lipase - unii:8myc33932o), pancrelipase amylase (unii: yoj58o116e) (pancrelipase amylase - unii:yoj58o116e), pancrelipase protease (unii: 3560d81v50) (pancrelipase protease - unii:3560d81v50) - pancreaze 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 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 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 pancreaze and any potential adverse effects on the breastfed infant from pancreaze or from the underlying maternal condition. the safety and effectiveness of pancreaze for the treatment of exocrine pancreatic insufficiency have been established in pediatric patients. use of pancreaze for this indication is supported by an adequate and well-controlled trial in adult and pediatric patients 8 to 17 years of age (study 1) along with supportive data from a randomized, investigator-blinded, dose-ranging study in 17 pediatric patients aged 6 to 30 months (study 2). both study populations consisted of patients with exocrine pancreatic insufficiency due to cystic fibrosis. the safety in pediatric patients in these studies was 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 pancreaze 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 pancreaze 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 pancreaze 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.

Australien - engelsk - APVMA (Australian Pesticides and Veterinary Medicines Authority)

bioproton pty. ltd. - 6-phytase (i.u.b. no. 3.1.3.26); alpha amylase; beta glucanase; cellulase; protease; xylanase - oral powder, pre-mix - 6-phytase (i.u.b. no. 3.1.3.26) enzyme active 600.0 units/gm; alpha amylase enzyme active 400.0 units/gm; beta glucanase enzyme active 700.0 bio bu/g; cellulase enzyme active 6000.0 bio cu/g; protease enzyme active 700.0 units/gm; xylanase enzyme active 10000.0 bio xu/g - nutrition & metabolism - pigs | poultry | boar | breeders | broiler | chickens | chicks | chooks | day old chicks | gilt | hatchlings | layers | piglet | - improve digestibility of cereal feeds

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

viatris limited - pancreatin 150mg (amylase 8,000 ph eur u, lipase 10,000 ph eur u, total protease 600 ph eur u.); pancreatin 150mg equivalent to amylase 8,000 ph eur u, lipase 10,000 ph eur u, total protease 600 ph eur u. - modified release capsule - 150 mg - active: pancreatin 150mg (amylase 8,000 ph eur u, lipase 10,000 ph eur u, total protease 600 ph eur u.) excipient: acetone dibutyl phthalate dimeticone gelatin hypromellose phthalate iron oxide black iron oxide red iron oxide yellow liquid paraffin macrogol 4000 propyl alcohol titanium dioxide active: pancreatin 150mg equivalent to amylase 8,000 ph eur u, lipase 10,000 ph eur u, total protease 600 ph eur u. excipient: cetyl alcohol dimeticone ferrosoferric oxide gelatin hypromellose phthalate iron oxide red iron oxide yellow macrogol 4000 sodium laurilsulfate titanium dioxide triethyl citrate - creon is indicated for the treatment of pancreatic exocrine insufficiency (pei) in paediatric and adult patients. pancreatic exocrine insufficiency is often associated with, but not limited to: · cystic fibrosis · chronic pancreatitis · post-pancreatectomy · post-gastrointestinal bypass surgery ,(e.g. billroth ii, gastroenterostomy) · ductal obstruction of the pancreas or common bile duct (e.g. from neoplasm).