인슐린라이스프로(숙주:EㆍcoliㆍK12RV308,벡터:pHKY694)
Insulin Lispro (Host: E Coli K12RV308, Vector: pHKY694)
원료 코드 M251028 국내 제품 1개 (단일제 1 · 복합제 0) DUR 성분 D000577
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이 성분만 든 제품 (단일제 1)
🌐 해외(미국) 정보 — 인슐린라이스프로(숙주:EㆍcoliㆍK12RV308,벡터:pHKY694)
미국 FDA·NLM 자료 · 2026-10-03 기준이 성분은 한국어 번역이 없습니다(검수 전 자동 번역 게시는 멈춰 두었습니다). 아래는 미국 FDA 원문입니다 — 원문 라벨(DailyMed).
Insulin Analog [EPC]
미국에서 쓰이는 곳(적응증)
영어 원문 (미국 FDA 라벨)
is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ADMELOG is a rapid-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ( 1 )
쓰면 안 되는 경우
영어 원문 (미국 FDA 라벨)
is contraindicated: during episodes of hypoglycemia [see Warnings and Precautions (5.3) ] . in patients who are hypersensitive to insulin lispro or to any of the excipients in ADMELOG [see Warnings and Precautions (5.5) ]. Do not use during episodes of hypoglycemia. ( 4 ) Do not use in patients with hypersensitivity to insulin lispro or any of the excipients in ADMELOG. ( 4 )
주요 경고·주의
영어 원문 (미국 FDA 라벨)
Never share an ADMELOG SoloStar disposable prefilled pen or syringe between patients, even if the needle is changed. ( 5.1 ) Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Make changes to a patient's insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring. ( 5.2 ) Hypoglycemia: May be life-threatening. Monitor blood glucose and increase monitoring frequency with changes to insulin dosage, use of glucose lowering medications, meal pattern, physical activity; in patients with renal or hepatic impairment; and in patients with hypoglycemia unawareness. ( 5.3 , 6 , 7 , 8.6 , 8.7 ) Hypoglycemia Due to Medication Errors: Accidental mix-ups between insulin products can occur. Instruct patients to check insulin labels before injection. ( 5.4 ) Hypersensitivity Reactions: May be life-threatening. Discontinue ADMELOG, monitor and treat if indicated. ( 5.5 ) Hypokalemia: May be life-threatening. Monitor potassium levels in patients at risk of hypokalemia and treat if indicated. ( 5.6 ) Fluid Retention and Heart Failure with Concomitant Use of Thiazolidinediones (TZDs): Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation if heart failure occurs. ( 5.7 ) Hyperglycemia and Ketoacidosis Due to Insulin Pump Device Malfunction: Monitor glucose and administer ADMELOG by subcutaneous injection if pump …
임신·특수 환자
영어 원문 (미국 FDA 라벨)
8.1 Pregnancy Risk Summary Published studies with another insulin lispro product used during pregnancy have not reported an association between insulin lispro and the induction of major birth defects, miscarriage, or adverse maternal or fetal outcomes [see Data ] . There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations ] . Pregnant rats and rabbits were exposed to another insulin lispro product in animal reproduction studies during organogenesis. Fetal growth retardation was observed in offspring of rats exposed to insulin lispro at a dose approximately 3 times the human subcutaneous dose of 1.0 unit/kg/day. No adverse …
미국 제품명 ADMELOG, Humalog Mix50/50 KwikPen, LYUMJEV, LYUMJEV KwikPen, LYUMJEV Tempo Pen, LYUMJEV Junior KwikPen, Humalog Mix75/25, Humalog Mix75/25 KwikPen, Humalog, Humalog KwikPen, Humalog Junior KwikPen, Humalog Tempo Pen
미국 부작용 보고(FAERS)에 많이 나온 증상
미국 FDA에 접수된 이 성분 관련 보고 139,158건 가운데 많이 적힌 증상입니다. 보고 수는 약 때문이라는 증거가 아니며, 많이 쓰는 약일수록 많아집니다. 증상 이름의 한국어는 AI 번역(참고용)이라 영어 원어를 함께 적었습니다.
- 1 혈당 증가blood glucose increased39,316
- 2 투여 용량 오류incorrect dose administered9,539
- 3 혈당 저하blood glucose decreased8,941
- 4 약효 없음drug ineffective8,399
- 5 시력 저하visual impairment5,615
- 6 오심nausea5,014
- 7 권태감malaise4,060
- 8 피로fatigue3,904
- 9 저혈당hypoglycaemia3,901
- 10 약물 용량 누락drug dose omission3,752
- 11 낙상fall3,539
- 12 UNDERDOSE3,385
미국 리콜 기록
FDA 리콜(회수) 기록 4건 중 최근 4건 — 특정 회사·제조번호 제품의 회수로, 국내 제품과는 관계없을 수 있습니다.
- 2024.04.24 · 2등급 · Eli Lilly & Company CGMP Deviations
- 2023.05.24 · 2등급 · Sanofi-Aventis U.S. LLC Lack of Assurance of Sterility: Malformed crimped collar seal
- 2022.05.25 · 1등급(심각) · Cardinal Health Inc. TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
- 2018.07.18 · 2등급 · Sanofi-Aventis U.S. LLC Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
출처: 미국 FDA openFDA(라벨·FAERS·리콜), 미국 국립의학도서관 RxNorm · DailyMed 원문 라벨. 한국어는 오픈드럭 서버 AI(gemma)가 자동 번역한 참고용(사람 검수 전)으로 오역이 있을 수 있으니 반드시 원문을 확인하세요.
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