Austràlia - anglès - 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

Nova Zelanda - anglès - 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).

Nova Zelanda - anglès - Medsafe (Medicines Safety Authority)

viatris limited - pancreatin 300mg (amylase 18,000 ph eur u, lipase 25,000 ph eur u, total protease 1,000 ph eur u.); pancreatin 300mg equivalent to amylase 18,000 ph eur u, lipase 25,000 ph eur u, total protease 1,000 ph eur u; pancreatin 300mg equivalent to amylase 18,000 ph eur u, lipase 25,000 ph eur u, total protease 1,000 ph eur u - modified release capsule - 300 mg - active: pancreatin 300mg (amylase 18,000 ph eur u, lipase 25,000 ph eur u, total protease 1,000 ph eur u.) excipient: acetone dibutyl phthalate dimeticone gelatin hypromellose phthalate iron oxide red iron oxide yellow liquid paraffin macrogol 4000 propyl alcohol titanium dioxide active: pancreatin 300mg equivalent to amylase 18,000 ph eur u, lipase 25,000 ph eur u, total protease 1,000 ph eur u excipient: cetyl alcohol dimeticone gelatin hypromellose phthalate iron oxide red iron oxide yellow macrogol 4000 sodium laurilsulfate titanium dioxide triethyl citrate active: pancreatin 300mg equivalent to amylase 18,000 ph eur u, lipase 25,000 ph eur u, total protease 1,000 ph eur u excipient: cetyl alcohol dimeticone gelatin hypromellose phthalate iron oxide red iron oxide yellow macrogol 4000 sodium laurilsulfate 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).

Nova Zelanda - anglès - Medsafe (Medicines Safety Authority)

viatris limited - pancreatin 60.12mg (3,600 ph. eur. u/amylase, 5,000 ph. eur. u/lipase and 200 ph. eur. u/protease) - modified release granules - 60.12 mg - active: pancreatin 60.12mg (3,600 ph. eur. u/amylase, 5,000 ph. eur. u/lipase and 200 ph. eur. u/protease) excipient: cetyl alcohol dimeticone hypromellose phthalate macrogol 4000 triethyl citrate - for treatment of conditions associated with pancreatic exocrine insufficiency, such as: 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).

Estats Units - anglès - 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.

Malta - anglès - Medicines Authority

mylan ire healthcare limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - lipase, amylase, protease - gastro-resistant capsule - lipase 10000 u amylase 8000 u protease 600 u - digestives, incl. enzymes

Malta - anglès - Medicines Authority

mylan ire healthcare limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - lipase, amylase, protease - gastro-resistant capsule - lipase 25000 u amylase 18000 u protease 1000 u - digestives, incl. enzymes

Estats Units - anglès - NLM (National Library of Medicine)

viatrexx bio incorporated -  amylase (6x, 30k & 200k), cellulase (6x, 30k & 200k), lactase (6x, 30k & 200k), lipase (6x, 30k & 200k), maltase (6x, 30k & 200k), protease (6x, 30k & 200k), sucrase (6x, 30k & 200k) - to support healthy digestion.

Austràlia - anglès - APVMA (Australian Pesticides and Veterinary Medicines Authority)

joy harvest holding pty ltd - oxamyl; methanol; ethylene glycol - liquid concentrate - oxamyl carbamate-methylcarbamate active 240.0 g/l; methanol solvent other 400.0 g/l; ethylene glycol solvent other 331.0 g/l - nematicide

Singapur - anglès - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - flutemetamol [18f] - injection, solution (radiopharmaceutical) - flutemetamol [18f] 150 mbq/ml at reference time