Malta - Ingliż - Medicines Authority

reckitt benckiser healthcare international limited thane road, nottingham ng90 2db, united kingdom - amylmetacresol, dichlorobenzyl alcohol, levomenthol - lozenge - amylmetacresol 0.6 mg 2,4 dichlorobenzyl alcohol 1.2 mg levomenthol 8 mg - throat preparations

Malta - Ingliż - Medicines Authority

reckitt benckiser healthcare international limited thane road, nottingham ng90 2db, united kingdom - amylmetacresol, dichlorobenzyl alcohol - lozenge - amylmetacresol 0.6 milligram(s) ; 2,4 dichlorobenzyl alcohol 1.2 milligram(s) - throat preparations

Malta - Ingliż - Medicines Authority

reckitt benckiser healthcare international limited thane road, nottingham ng90 2db, united kingdom - amylmetacresol, dichlorobenzyl alcohol - lozenge - amylmetacresol 0.6 mg 2,4 dichlorobenzyl alcohol 1.2 mg - throat preparations

Malta - Ingliż - Medicines Authority

reckitt benckiser healthcare international limited thane road, nottingham ng90 2db, united kingdom - amylmetacresol, dichlorobenzyl alcohol - lozenge - amylmetacresol 0.6 milligram(s) ; 2,4 dichlorobenzyl alcohol 1.2 milligram(s) - throat preparations

Malta - Ingliż - Medicines Authority

reckitt benckiser healthcare international limited thane road, nottingham ng90 2db, united kingdom - amylmetacresol, ascorbic acid, dichlorobenzyl alcohol - lozenge - amylmetacresol 0.6 mg ascorbic acid 100 mg 2,4 dichlorobenzyl alcohol 1.2 mg - throat preparations

Malta - Ingliż - Medicines Authority

reckitt benckiser ireland ltd 7 riverwalk citywest business campus dublin 24 , ireland - amylmetacresol, dichlorobenzyl alcohol - lozenge - 2,4 dichlorobenzyl alcohol 1.2 mg amylmetacresol 0.6 mg - throat preparations

Stati Uniti - Ingliż - 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

Stati Uniti - Ingliż - 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.

Irlanda - Ingliż - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd t/a gerard laboratories - olanzapine - orodispersible tablet - 15 milligram - antipsychotics

Irlanda - Ingliż - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd t/a gerard laboratories - olanzapine - orodispersible tablet - 20 milligram - antipsychotics