클로스트리디움보툴리눔독소A형
Clostridium Botulinum Toxin Type A
원료 코드 M096119 국내 제품 40개 (단일제 40 · 복합제 0) DUR 성분 D001455
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⚠️ DUR 안전사용 기준
- 🤰 임부금기 2등급 임부에 대한 안전성 미확립. 동물실험에서 0.125U/kg/day, 2U/kg/day 이상을 bolus투여한 토끼에서 유산 및 모체독성, 태자기형 나타남(용액용동결건조분말주사제/현탁액용동결건조분말주사제/용액용분말주사제/용액주사제)
이 성분만 든 제품 (단일제 40)
광고
🌐 해외(미국) 정보 — 클로스트리디움보툴리눔독소A형
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).
Acetylcholine Release Inhibitor [EPC]Neuromuscular Blocker [EPC]
미국에서 쓰이는 곳(적응증)
영어 원문 (미국 FDA 라벨)
is an acetylcholine release inhibitor and neuromuscular-blocking agent indicated for: Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/ or procerus muscle activity in adult patients. ( 1.1 ) The treatment of cervical dystonia in adult patients. ( 1.2 ) 1.1 Glabellar Lines DAXXIFY is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. 1.2 Cervical Dystonia DAXXIFY is indicated for the treatment of cervical dystonia in adult patients.
⚠️ 박스 경고(가장 강한 경고)
영어 원문 (미국 FDA 라벨)
WARNING: DISTANT SPREAD OF TOXIN EFFECT The effects of all botulinum toxin products, including DAXXIFY, may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life-threatening, and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity, an unapproved use for DAXXIFY, but symptoms can also occur in adults, particularly in those patients who have an underlying condition that would predispose them to these symptoms [see Warnings and Precautions (5.1) ]. WARNING: DISTANT SPREAD OF TOXIN EFFECT See full prescribing information for complete boxed warning. The effects of DAXXIFY and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life-threatening, and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity, an unapproved use for DAXXIFY, but symptoms can also occur in adults, particularly in those patients who have an underlying condition that would predispose them to these symptoms. ( 5.1 )
쓰면 안 되는 경우
영어 원문 (미국 FDA 라벨)
is contraindicated in: patients with known hypersensitivity to any botulinum toxin preparation, DAXXIFY, or any of the components in the DAXXIFY formulation [see Warnings and Precautions (5.4) ]. the presence of infection at the proposed injection sites. Known hypersensitivity to any botulinum toxin preparation, DAXXIFY, or any of the components in the DAXXIFY formulation. ( 4 ) Infection at the injection sites. ( 4 )
주요 경고·주의
영어 원문 (미국 FDA 라벨)
The potency units of DAXXIFY are not interchangeable with other preparations of other botulinum toxin products. ( 5.2 , 11) Spread of toxin effects, swallowing and breathing difficulties can lead to death. Seek immediate medical attention if respiratory, speech, or swallowing difficulties occur. ( 5.1 ) Adverse event reports have been received involving the cardiovascular system with botulinum toxin products, some with fatal outcomes. Use caution when administering to patients with pre-existing cardiovascular disease. ( 5.5 ) Concomitant neuromuscular disorder may exacerbate clinical effects of treatment. ( 5.6 ) Use with caution in patients with compromised respiratory function or dysphagia. ( 5.7 ) Potential serious adverse reactions after administration of DAXXIFY for unapproved use. ( 5.3 ) 5.1 Spread of Toxin Effect Postmarketing safety data from other approved botulinum toxins suggest that botulinum toxin effects may be observed beyond the site of local injection. The symptoms are consistent with the mechanism of action of botulinum toxin and may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life-threatening, and there have been reports of death related to the spread of toxin effects. The risk of symptoms is greatest in children treated for …
임신·특수 환자
영어 원문 (미국 FDA 라벨)
8.1 Pregnancy Risk Summary There are no available data on DAXXIFY use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, intramuscular administration of DAXXIFY during pregnancy resulted in adverse effects on fetal growth (decreased fetal body weight and skeletal ossification) at maternally toxic doses approximately equivalent to 40 times the maximum recommended human dose (MRHD) ( see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and …
미국 제품명 DAXXIFY, Dysport
미국 부작용 보고(FAERS)에 많이 나온 증상
미국 FDA에 접수된 이 성분 관련 보고 12,343건 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 적응증 외 사용off label use4,777
- 2 약효 없음drug ineffective3,661
- 3 두통headache1,596
- 4 약물 불내성drug intolerance1,333
- 5 미승인 적응증 사용product use in unapproved indication1,310
- 6 오심nausea1,266
- 7 편두통migraine1,176
- 8 통증pain1,144
- 9 어지러움dizziness1,126
- 10 감각저하hypoaesthesia1,110
- 11 피로fatigue1,061
- 12 쇠약asthenia1,034
미국 리콜 기록
FDA 리콜 기록이 없습니다.
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.