빈블라스틴황산염
Vinblastine Sulfate
원료 코드 M223066 국내 제품 1개 (단일제 1 · 복합제 0) DUR 성분 D000642
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이 성분만 든 제품 (단일제 1)
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미국 FDA·NLM 자료 · 2026-10-05 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)
USAGE: Vinblastine Sulfate Injection is indicated in the palliative treatment of the following: I. Frequently Responsive Malignancies • Generalized Hodgkin’s disease (Stages III and IV, Ann Arbor modification of Rye staging system) • Lymphocytic lymphoma (nodular and diffuse, poorly and well differentiated) • Histiocytic lymphoma • Mycosis fungoides (advanced stages) • Advanced carcinoma of the testis • Kaposi’s sarcoma • Letterer-Siwe disease (histiocytosis X) II. Less Frequently Responsive Malignancies • Choriocarcinoma resistant to other chemotherapeutic agents • Carcinoma of the breast, unresponsive to appropriate endocrine surgery and hormonal therapy Current principles of chemotherapy for many types of cancer include the concurrent administration of several antineoplastic agents. For enhanced therapeutic effect without additive toxicity, agents with different dose-limiting clinical toxicities and different mechanisms of action are generally selected. Therefore, although vinblastine sulfate is effective as a single agent in the aforementioned indications, it is usually administered in combination with other antineoplastic drugs. Such combination therapy produces a greater percentage of response than does a single-agent regimen. These principles have been applied, for example, in the chemotherapy of Hodgkin’s disease. Hodgkin's Disease Vinblastine sulfate has been shown to be one of the most effective single agents for the treatment of Hodgkin’s disease. Advanced …
⚠️ 박스 경고(가장 강한 경고)
영어 원문 (미국 FDA 라벨)
Caution: This preparation should be administered by individuals experienced in the administration of vinblastine sulfate. It is extremely important that the intravenous needle or catheter be properly positioned before any vinblastine sulfate is injected. Leakage into surrounding tissue during intravenous administration of vinblastine sulfate may cause considerable irritation. If extravasation occurs, the injection should be discontinued immediately, and any remaining portion of the dose should then be introduced into another vein. Local injection of hyaluronidase and the application of moderate heat to the area of leakage help disperse the drug and are thought to minimize discomfort and the possibility of cellulitis. FOR INTRAVENOUS USE ONLY – FATAL IF GIVEN BY OTHER ROUTES. See WARNINGS for the treatment of patients given intrathecal vinblastine sulfate injection.
쓰면 안 되는 경우
영어 원문 (미국 FDA 라벨)
CONTRAINDICATIONS: Vinblastine sulfate is contraindicated in patients who have significant granulocytopenia unless this is a result of the disease being treated. It should not be used in the presence of bacterial infections. Such infections must be brought under control prior to the initiation of therapy with vinblastine sulfate.
주요 경고·주의
영어 원문 (미국 FDA 라벨)
WARNINGS: This preparation is for intravenous use only. It should be administered by individuals experienced in the administration of vinblastine sulfate. The intrathecal administration of vinblastine sulfate usually results in death. To reduce the potential for fatal medication errors due to incorrect route of administration, vinblastine sulfate injection should be diluted in a flexible plastic container and prominently labeled (as indicated) “FOR INTRAVENOUS USE ONLY – FATAL IF GIVEN BY OTHER ROUTES.’’ After inadvertent intrathecal administration of vinca alkaloids, immediate neurosurgical intervention is required in order to prevent ascending paralysis leading to death. In a very small number of patients, life-threatening paralysis and subsequent death was averted but resulted in devastating neurological sequelae, with limited recovery afterwards. There are no published cases of survival following intrathecal administration of vinblastine sulfate to base treatment on. However, based on the published management of survival cases involving the related vinca alkaloid vincristine sulfate 1-3 , if vinblastine sulfate is mistakenly given by the intrathecal route, the following treatment should be initiated immediately after the injection: 1. Removal of as much CSF as is safely possible through the lumbar access. 2. Insertion of an epidural catheter into the subarachnoid space via the intervertebral space above initial lumbar access and CSF irrigation with lactated Ringer’s …
임신·특수 환자
영어 원문 (미국 FDA 라벨)
Usage in Pregnancy Pregnancy Category D - (See WARNINGS ). Vinblastine sulfate should be given to a pregnant woman only if clearly needed. Animal studies suggest that teratogenic effects may occur.
미국 부작용 보고(FAERS)에 많이 나온 증상
미국 FDA에 접수된 이 성분 관련 보고 1,941건 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 발열성 호중구 감소증febrile neutropenia170
- 2 호중구 감소증neutropenia150
- 3 발열pyrexia124
- 4 오심nausea86
- 5 구토vomiting79
- 6 PULMONARY TOXICITY78
- 7 말초신경병증neuropathy peripheral75
- 8 NEUTROPHIL COUNT DECREASED75
- 9 PANCYTOPENIA75
- 10 적응증 외 사용off label use74
- 11 빈혈anaemia71
- 12 패혈증sepsis70
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.
