판크레아틴(Pancreatin: pancrelipase)

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2021-04-30
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▪ 약물의 분류: 건위소화제

▪ 임신부 약물등급(US FDA): C

▪ 임신부 안전 및 기형발생정보Pancreatin (Ilozyme) is an animal pancreatic extract containing digestive enzymes and used as a digestive aid. The Collaborative Perinatal Project did not find an association between pancreatin use and an increase in adverse pregnancy outcome. According to a report prepared by the European Agency for the Evaluation of Medicinal Products (EMA), no adverse effects were observed in fertility or number of implantations of rats and rabbits treated orally with pancreatin in combination with other enzymes at dose levels under 4000 mg/kg/day. At 4000 mg/kg/day, delayed ossification was observed in fetuses. No information was provided on maternal toxicity at this dose level.

▪ 모유수유부 약물등급(Medication and Mother’s MilK): L3

▪ 모유수유 안전 및 유해성정보We have not located other studies on possible reproductive or lactation effects of this preparation.

▪ 한국마더세이프전문상담센터 DB 정보 (모태독성학2016):

1) 기형발생정보
판크레아틴에 노출된 후 추적된 임신부는 총 377례이었으며 초기 노출 후 자연유산율은 5.0%(19/377)이었다. 임신 37주 이전의 조산률은 3.5%(12/345) 2,500 g 미만의 저체중증은 2.6%(9/343)이었다. 주요기형발생은 3.2%(11/343): pulmonary artery stenosis(1), club foot with knee rigidity(1), brain anomaly with seizure(1), left cryptorchidism(1), right hip mass(2), both club foot and
right wrist drop(1), ileal agenesis(1), horse shoe kidney(1), VSD(1), fetal hydrops(1)가 있었다. 그리고 사산 5례가 있었다.

2) 모유 수유 시 독성 및 적합성 정보
수유부-수유아 9쌍 중 부작용 사례는 없었다.





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