휴온스헤파린나트륨주사100IU 효능·효과
광고
휴온스헤파린나트륨주사100IU 복용법 (용법·용량)
휴온스헤파린나트륨주사100IU 부작용·주의사항
전체 7개 항목 펼치기/접기
1. 경고
2. 다음 환자에는 투여하지 말 것.
3. 이상반응
4. 일반적 주의
5. 상호작용
6. 임부 및 수유부에 대한 투여
7. 적용상의 주의
휴온스헤파린나트륨주사100IU 성분·함량
1mL 중-3mL, 5mL,10mL포장단위 기준
| 성분 | 영문 | 분량 |
|---|---|---|
| 헤파린나트륨 | Heparin Sodium | 100 아이.유 |
📍 휴온스헤파린나트륨주사100IU 살 수 있는 내 주변 약국
전문의약품은 의사 처방전이 있어야 약국에서 받을 수 있습니다. 재고는 약국에 전화로 확인하세요.
🗺️ 지도에서 찾기🌐 해외(미국) 정보 — 헤파린나트륨
미국 FDA·NLM 자료 · 2026-09-30 기준이 성분은 한국어 번역이 없습니다(검수 전 자동 번역 게시는 멈춰 두었습니다). 아래는 미국 FDA 원문입니다 — 원문 라벨(DailyMed).
미국에서 쓰이는 곳(적응증)
영어 원문 (미국 FDA 라벨)
Heparin Sodium Injection is indicated for: Prophylaxis and treatment of venous thrombosis and pulmonary embolism Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease Atrial fibrillation with embolization Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation) Prevention of clotting in arterial and cardiac surgery Prophylaxis and treatment of peripheral arterial embolism Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures Heparin Sodium Injection is an anticoagulant indicated for (1) Prophylaxis and treatment of venous thrombosis and pulmonary embolism Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease Atrial fibrillation with embolization Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation) Prevention of clotting in arterial and cardiac surgery Prophylaxis and treatment of peripheral arterial embolism Use as an anticoagulant in blood transfusions, extracorporeal circulation, and dialysis procedures
쓰면 안 되는 경우
영어 원문 (미국 FDA 라벨)
The use of heparin sodium is contraindicated in patients with the following conditions: History of heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis [see Warnings and Precautions (5.3)]; Known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see Adverse Reactions (6.1)]; In whom suitable blood coagulation tests, e.g., the whole blood clotting time, partial thromboplastin time, etc., cannot be performed at appropriate intervals (this contraindication refers to full-dose heparin; there is usually no need to monitor coagulation parameters in patients receiving low-dose heparin); An uncontrolled active bleeding state [see Warnings and Precautions (5.4)], except when this is due to disseminated intravascular coagulation. Severe thrombocytopenia (4) When suitable blood coagulation tests, e.g., the whole blood clotting time, partial thromboplastin time, etc., cannot be performed at appropriate intervals (4) An uncontrolled …
주요 경고·주의
영어 원문 (미국 FDA 라벨)
5.1 Fatal Medication Errors Do not use heparin sodium as a “catheter lock flush” product. Heparin sodium is supplied in vials containing various strengths of heparin, including vials that contain a highly concentrated solution of 10,000 units in 1 mL. Fatal hemorrhages have occurred in pediatric patients due to medication errors in which 1 mL heparin sodium vials were confused with 1 mL “catheter lock flush” vials. Carefully examine all heparin sodium vials to confirm the correct vial choice prior to administration of the drug. 5.2 Hemorrhage Avoid using heparin in the presence of major bleeding, except when the benefits of heparin therapy outweigh the potential risks. Hemorrhage can occur at virtually any site in patients receiving heparin. Fatal hemorrhages have occurred. Adrenal hemorrhage (with resultant acute adrenal insufficiency), ovarian hemorrhage, and retroperitoneal hemorrhage have occurred during anticoagulant therapy with heparin [see Adverse Reactions (6.1)]. A higher incidence of bleeding has been reported in patients, particularly women, over 60 years of age [see Clinical Pharmacology (12.3)]. An unexplained fall in hematocrit, fall in blood pressure or any other unexplained symptom should lead to serious consideration of a hemorrhagic event. Use heparin sodium with caution in disease states in which there is increased risk of hemorrhage, including: Cardiovascular - Subacute bacterial endocarditis, severe hypertension. Surgical - During and immediately …
임신·특수 환자
영어 원문 (미국 FDA 라벨)
8.1 Pregnancy Risk Summary There are no available data on heparin sodium use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. In published reports, heparin exposure during pregnancy did not show evidence of an increased risk of adverse maternal or fetal outcomes in humans. No teratogenicity, but early embryo-fetal death was observed in animal reproduction studies with administration of heparin sodium to pregnant rats and rabbits during organogenesis at doses approximately 10 times the maximum recommended human dose (MRHD) of 45,000 units/ day [see DATA] . Consider the benefits and risks of heparin sodium for the mother and possible risks to the …
미국 부작용 보고(FAERS)에 많이 나온 증상
미국 FDA에 접수된 이 성분 관련 보고 14,239건 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 HEPARIN-INDUCED THROMBOCYTOPENIA1,308
- 2 약효 없음drug ineffective1,274
- 3 적응증 외 사용off label use768
- 4 오심nausea755
- 5 약물 과민반응drug hypersensitivity640
- 6 구토vomiting619
- 7 저혈압hypotension571
- 8 호흡 곤란dyspnoea556
- 9 폐색전증pulmonary embolism519
- 10 패혈증sepsis504
- 11 빈혈anaemia493
- 12 발열pyrexia492
미국 리콜 기록
FDA 리콜(회수) 기록 13건 중 최근 5건 — 특정 회사·제조번호 제품의 회수로, 국내 제품과는 관계없을 수 있습니다.
- 2024.09.11 · 1등급(심각) · Baxter Healthcare Corporation Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
- 2023.05.24 · 2등급 · B. Braun Medical Inc Subpotent: Low anti-factor IIa Potency.
- 2023.03.15 · 2등급 · B. Braun Medical Inc Subpotent Drug: low Anti-Factor IIa potency.
- 2023.03.15 · 2등급 · Sagent Pharmaceuticals Inc Labeling: Not elsewhere classified
- 2023.01.11 · 2등급 · Pfizer Inc. Lack of assurance of sterility: Bags have the potential to leak.
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.
허가 정보
- 품목기준코드
- 201004638
- 허가 구분
- 허가 · 완제의약품
- 상태
- 정상
- 저장 방법
- 차광밀봉용기, 실온(1~30℃)보관
- 사용 기간
- 제조일로부터 36 개월
- 포장 단위
- 3mL x 10바이알, 5mL x 10바이알, 10mL x 10바이알
- ATC 코드
- B01AB01
- 표준코드
- 8806706054703, 8806706054710, 8806706054727, 8806706076101, 8806706076118, 8806706076125 외 3개
- 최근 변경
- 2022.12.21
허가 변경 이력
- · 사용상주의사항변경(부작용포함), 2022-12-21
- · 사용상주의사항변경(부작용포함), 2017-09-02
- · 사용상주의사항변경(부작용포함), 2010-12-27
원문: 식약처 의약품안전나라
