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

atlantic biologicals corps - pancrelipase lipase (unii: 8myc33932o) (pancrelipase lipase - unii:8myc33932o), pancrelipase protease (unii: 3560d81v50) (pancrelipase protease - unii:3560d81v50), pancrelipase amylase (unii: yoj58o116e) (pancrelipase amylase - unii:yoj58o116e) - 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, cauti

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)

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

dna labs, inc. - betaine hydrochloride (unii: jk8u8k4d6k) (betaine - unii:3scv180c9w), bos taurus bile (unii: et3651zlou) (bos taurus bile - unii:et3651zlou), pancrelipase lipase (unii: 8myc33932o) (pancrelipase lipase - unii:8myc33932o), beef liver (unii: w8n8r55022) (beef liver - unii:w8n8r55022), sodium phosphate, dibasic, heptahydrate (unii: 70wt22sf4b) (phosphate ion - unii:nk08v8k8hr), bos taurus pancreas (unii: 1m529tnt1d) (bos taurus pancreas - unii:1m529tnt1d), pepsin (unii: gid333s43j) (pepsin - unii:gid333 - stimulates digestion and absorption.

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

apex energetics inc. - adenosine triphosphate (unii: 8l70q75fxe) (adenosine triphosphate - unii:8l70q75fxe), calcium fluoride (unii: o3b55k4yki) (fluoride ion - unii:q80vpu408o), sodium sulfate (unii: 0ypr65r21j) (sodium sulfate anhydrous - unii:36kcs0r750), strophanthus hispidus seed (unii: mo892vi77k) (strophanthus hispidus seed - unii:mo892vi77k), crataegus laevigata fruit (unii: d5rz7mf1yf) (crataegus laevigata fruit - unii:d5rz7mf1yf), ferrosoferric phosphate (unii: 91gqh8i5f7) (ferrosoferric phosphate - unii:91gqh8i5f7), gelsemium sempervirens root (unii: 639kr60q1q) (gelsemium sempervirens root - unii:639kr60q1q), pancrelipase lipase (unii: 8myc33932o) (pancrelipase lipase - unii:8myc33932o) - for temporary relief of minor: tiredness* dizziness* nervous irritation* numbness and coldness of the limbs* *claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.

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

alexion pharmaceuticals australasia pty ltd - sebelipase alfa, quantity: 2 mg/ml - injection, intravenous infusion - excipient ingredients: citric acid monohydrate; sodium citrate dihydrate; water for injections; albumin - kanuma (sebelipase alfa rce) is indicated for long-term enzyme replacement therapy (ert) in patients of all ages with lysosomal acid lipase deficiency (lal-d).

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

alexion pharmaceuticals, inc. - sebelipase alfa (unii: k4ytu42t8g) (sebelipase alfa - unii:k4ytu42t8g) - sebelipase alfa 2 mg in 1 ml - kanuma® is indicated for the treatment of patients with a diagnosis of lysosomal acid lipase (lal) deficiency. none. risk summary available data with kanuma use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. animal reproductive studies conducted with sebelipase alfa showed no evidence of embryolethality, fetotoxicity, teratogenicity, or abnormal early embryonic development at dosages up to 164 and 526 times the human dosage of 1 mg/kg every other week (based on auc) in rats and rabbits, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. 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. animal data sebelipase alfa administered during the period of organogenesis to rats (on gestation days 6, 9, 12, 15 and 17) and rabbits

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.

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

henry schein animal health - pancrelipase lipase (unii: 8myc33932o) (pancrelipase lipase - unii:8myc33932o), pancrelipase amylase (unii: yoj58o116e) (pancrelipase amylase - unii:yoj58o116e), pancrelipase protease (unii: 3560d81v50) (pancrelipase protease - unii:3560d81v50) - for use in dogs and cats as a digestive aid in replacement therapy where digestion of protein, carbohydrate and fat is inadequate due to exocrine pancreatic insufficiency.

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

henry schein animal health - pancrelipase lipase (unii: 8myc33932o) (pancrelipase lipase - unii:8myc33932o), pancrelipase amylase (unii: yoj58o116e) (pancrelipase amylase - unii:yoj58o116e), pancrelipase protease (unii: 3560d81v50) (pancrelipase protease - unii:3560d81v50) - for use in dogs and cats as a digestive aid in replacement therapy where digestion of protein, carbohydrate and fat is inadequate due to exocrine pancreatic insufficiency. a pancreatic enzyme concentrate of porcine origin.

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

patterson veterinary - pancrelipase lipase (unii: 8myc33932o) (pancrelipase lipase - unii:8myc33932o), pancrelipase amylase (unii: yoj58o116e) (pancrelipase amylase - unii:yoj58o116e), pancrelipase protease (unii: 3560d81v50) (pancrelipase protease - unii:3560d81v50) - for animal use only as a digestive aid in replacement therapy where digestion of protein, carbohydrate and fat is inadequate due to exocrine pancreatic insufficiency.