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)

x-gen pharmaceuticals, inc. - pancrelipase lipase (unii: 8myc33932o) (pancrelipase lipase - unii:8myc33932o) - pancrelipase lipase 5000 [usp'u]

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

digestive care, 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 8000 [usp'u] - pertzye® 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 pertzye and any potential adverse effects on the breastfed infant from pertzye or from the underlying maternal condition. the safety and effectiveness of pertzye for the treatment of exocrine pancreatic insufficiency have been established in pediatric patients. use of pertzye for this indication is supported by a randomized, double-blind, placebo-controlled, crossover study of 24 pediatric patients, 8 years and older with exocrine pancreatic insufficiency due to cystic fibrosis. the safety in pediatric patients 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 pertzye 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 (2.1) and warnings and precautions (5.1)] . crushing or chewing pertzye 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 pertzye 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. instructions for use pertzye (pert-zye) (pancrelipase) delayed-release capsules this instructions for use contains information on how to give pertzye by mouth and through a gastrostomy tube. important information you need to know before taking pertzye: - always take pertzye with a meal or snack. - pertzye capsules should be swallowed whole. do not crush or chew the pertzye capsules or their contents, and do not hold the capsule or capsule contents in your mouth. - drink plenty of liquid to ensure complete swallowing of pertzye capsules or pertzye capsule contents-food mixture. - throw away the pertzye capsule contents-food mixture that is not used. do not save this mixture for later use. giving pertzye to infants (children from birth to 12 months of age) by mouth: the two methods to give pertzye to infants (children from birth to 12 months of age) are described below: a) giving with applesauce before breast or formula feeding - place about 2 teaspoons of applesauce, the kind found in baby food jars that you buy at the store, or other food recommended by your doctor, into a clean container. - carefully open the pertzye capsule by grasping and slightly squeezing both ends of the capsule and then twisting and pulling the capsule apart. pour the capsule contents onto the food in the clean container. throw away the empty pertzye capsule. - carefully mix the capsule contents evenly through the food. be careful not to crush the pertzye capsule contents when mixing. - give the pertzye capsule contents-food mixture to your infant right away. - give your infant 4 ounces (120 ml) of formula or breastfeed your infant right away . - look in your infant's mouth to make sure that all of the medicine is swallowed and there is no pertzye capsule contents-food mixture left in your infant's mouth. b) giving directly into the infant's mouth before breast or formula feeding - carefully open the pertzye capsule by grasping and slightly squeezing both ends of the capsule and then twisting and pulling the capsule apart. empty the capsule contents into your infant's mouth. - give your infant 4 ounces (120 ml) of formula or breastfeed right away. - look in your infant's mouth to make sure that all of the medicine is swallowed and there is no pertzye capsule contents left in your infant's mouth. - throw away the empty pertzye capsule. do not mix the pertzye capsule contents directly into a bottle of breast milk or formula. giving pertzye to children and adults by mouth: - swallow pertzye capsules whole and take them with enough liquid to swallow them right away. - if you have trouble swallowing capsules, follow these instructions for taking pertzye with food: place about 2 teaspoons of applesauce, or other food recommended by your doctor, into a clean container. carefully open the capsules that you will need for the prescribed dose by grasping and slightly squeezing both ends of the capsule and then twisting and pulling the capsule apart. pour the capsule contents onto the food in the clean container. throw away the empty pertzye capsules. carefully mix the capsule contents evenly through the food. be careful not to crush the pertzye capsule contents when mixing. swallow all of the pertzye capsule contents-food mixture right away. drink plenty of water or juice to make sure that all of the medicine is swallowed and there is no pertzye capsule contents-food mixture left in the mouth. - place about 2 teaspoons of applesauce, or other food recommended by your doctor, into a clean container. - carefully open the capsules that you will need for the prescribed dose by grasping and slightly squeezing both ends of the capsule and then twisting and pulling the capsule apart. pour the capsule contents onto the food in the clean container. - throw away the empty pertzye capsules. - carefully mix the capsule contents evenly through the food. be careful not to crush the pertzye capsule contents when mixing. - swallow all of the pertzye capsule contents-food mixture right away. - drink plenty of water or juice to make sure that all of the medicine is swallowed and there is no pertzye capsule contents-food mixture left in the mouth. giving pertzye through a gastrostomy tube: - pertzye 4,000 lipase units capsule contents may be given through a gastrostomy tube that is size 14 french or larger. do not give pertzye through a gastrostomy tube smaller than size 14 french. - do not give more than the contents of 2 pertzye 4,000 lipase units capsules through a gastrostomy tube at a time. - give the pertzye capsule contents-food mixture right away after it is prepared. 1. place at least 2 teaspoons of applesauce, or other food recommended by your doctor, into a clean container. 2. carefully open 1 or 2 of the pertzye capsules, depending on your prescribed dose, by grasping and slightly squeezing both ends of the capsule and then twisting and pulling the capsule apart. pour the capsule contents onto the food in the clean container. throw away the empty pertzye capsules (see figure a ).      figure a 3. carefully mix the capsule contents evenly through the food. be careful not to crush the pertzye capsule contents when mixing. 4. remove the plunger from a 35 ml slip tip syringe. cover the tip of the syringe with your finger. 5. carefully spoon the pertzye capsule contents-food mixture into the slip tip syringe (see figure b ).      figure b 6. replace the plunger partially back into the slip tip syringe. 7. turn the slip tip syringe so the syringe tip is facing upward. remove your finger from the tip of the slip tip syringe. 8. gently shake or tap the slip tip syringe so that the pertzye capsule contents-food mixture moves down towards the plunger. 9. carefully push up slowly on the plunger until the pertzye capsule contents-food mixture fills the syringe tip (see figure c ).      figure c 10. connect the slip tip syringe directly into the gastrostomy tube feeding port. 11. press on the plunger of the slip tip syringe using steady pressure to push all of the pertzye capsule contents-food mixture into the gastrostomy tube feeding port over 10 seconds to 12 seconds (see figure d ).      figure d 12. flush the gastrostomy tube feeding port with about 10 ml of water. 13. if your prescribed dose is more than 2 capsules of pertzye, repeat steps 1 through 12, using only 1 or 2 pertzye capsules at a time, until the prescribed dose is given. storing pertzye: - store pertzye at room temperature between 68ºf to 77ºf (20°c to 25°c). - keep pertzye in a dry place and in the original container or equivalent airtight container. - after opening the bottle, keep it tightly closed between uses to keep your medicine dry (protect it from moisture). - the pertzye bottle contains a desiccant packet to help keep your medicine dry. do not eat or throw away the desiccant packet in your medicine bottle. keep pertzye and all medicines out of the reach of children. manufactured by: digestive care, inc. 1120 win drive bethlehem, pa 18017 u.s. license no. 2184 product of usa © 2024 digestive care, inc. this instructions for use has been approved by the u.s. food and drug administration. revised: 02/2024

United States - English - 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

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® (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

United States - English - 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

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 10440 [usp'u] -       viokace  tablets, in combination with a proton pump inhibitor,  is indicated in adults for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy.       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.       ri

United States - English - 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

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