藥品名稱
drug name | Yellow fever vaccine, attenuated (Stamaril, 黃熱病注射疫苗) 1 dose/0.5mL/vial |
| 藥檔狀態 | 使用中 （需冷藏） |
成 份
Ingredient | Attenuated yellow fever vaccine (17D strain, grown in chick embryos≧1000U) |
| 單位含量 | 1 dose/0.5mL/vial |
| Dosage Forms | Injection, powder for reconstitution: 0.5 mL/vial |
| 外觀描述 | 針劑/皮下注射 |
| Appearance | injection / SC |
標 示
outward | |
廠商名稱
Manufacturer | 賽諾菲安萬特股份有限公司 |
製 造 商
Manufacturer | SANOFI PASTEUR LIMITED, France |
字 號
Product ID | 專案進口 |
藥理分類
Pharmacologic Category | Biologic and Immunologic Agents/ Immunizations/ Vaccines-Virus (live) |
作用機轉
Mechanism of action | Yellow fever vaccine is a live vaccine that offers active immunization against yellow fever infection at an effective immune response rate of nearly 100% of patients. |
| 用途/適應症 | 黃熱病疫苗 |
| Use |
Active immunization against yellow fever virus, primarily among persons traveling to or living in areas where yellow fever infection exists and laboratory workers who may be exposed to the virus; vaccination may also be required for some international travelers
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衛福部核准適用症狀
MOHW approved indications |
預防黃熱病。
|
| Dose |
Administration: SC
Adults & children ≧ 9 m/o of age: 1 dose (0.5 mL) ≧ 10 days before travel, administered as a single dose.
Vaccine duration: lifelong.
Booster dose every 10 years is recommended for entry into some countries; however, regulation is subject to change, refer to WHO updates before travel.
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懷孕分級
Pregnancy Risk Factor |
C (Risk cannot be ruled out. Human studies are lacking, and animal studies are either positive for fetal risk, or lacking as well. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.)
Lactation: Limited human data / potential toxicity
Contraindicated by the manufacturer in lactating women who are providing breast milk to infants <9 months
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| 禁忌症 |
1.對蛋、雞蛋白或STAMARIL的任何組成成分有過敏反應。
2.曾經對黃熱病疫苗有過嚴重過敏反應者。
3.免疫系統被抑制者。如正在使用類固醇製劑、放射線療法、細胞毒性藥物者。
4.胸腺功能有障礙之病患(包含有胸腺瘤或胸線已切除之病人)
5.有症狀之後天免疫缺乏症候群之病人
6.無症狀之後天免疫缺乏症候群之病人但確定為免疫功能已受損之病人
7.年齡小於六個月之病人
8.正處於發燒之病人
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| Contraindications |
Acute hypersensitivity to egg or chick embryo protein, or any component of the formulation, including gelatin; infants <9 months (per manufacturer); infants <6 months (CDC/ACIP 2010 guidelines); severely immunosuppressed patients (eg HIV infection, leukemia, lymphoma, thymic disease, generalized malignancy, or immunosuppression due to drugs or radiation); lactating women providing breast-milk to infants <9 months
|
| 常見副作用 | 皮膚潮紅、頭痛、注射部位腫痛、肌痛、虛弱無力、噁心、嘔吐、腹瀉、發燒。 |
| Common adverse drug reactions | Skin rash, headache, erythema/pain at injection site, myalgia, weakness, nausea, vomiting, diarrhoea, fever. |
| Adverse Reactions |
1% to 10%:
Dermatologic: Skin rash (3%)
Frequency not defined:
Central nervous system: Headache, malaise
Local: Erythema at injection site, localized edema (at injection site), pain at injection site
Neuromuscular & skeletal: Myalgia, weakness
Miscellaneous: Fever
<1% (Limited to important or life-threatening): Acute disseminated encephalomyelitis, anaphylaxis, brain disease, cranial nerve palsy (bulbar), Guillain-Barre syndrome, hypersensitivity at injection site, hypersensitivity reaction (immediate; including asthma, dyspnea, bronchospasm, pharyngeal edema), residual mass at injection site, urticaria, vaccine-associated neurotropic disease (rare), vaccine-associated viscerotropic disease (rare; may be associated with multi-organ failure)
|
監測
Monitoring |
1.Monitor for syncope for 15 minutes following administration. If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion. Monitor for adverse effects 10 days after vaccination (specifically in the elderly)
2. The vaccine must administered immediately after reconstitution.
3. Live vaccines should not be given within 3 months after administration of intramuscular immune globulin, whole blood or plasma, and within 11 months after administration of intravenous immunoglobulin.
4. Breast feeding should be avoided in theory.
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| 警語與注意事項 | 冷藏儲存，混合後立即使用。 |
| Warnings & precautions | 冷藏儲存，混合後立即使用。 |
| 針劑溶解條件 |
請用所附之溶液泡製，施打前請充分振搖均勻。(1080710仿單資料)
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| 針劑稀釋條件 |
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| 針劑不相容性 |
不可與其他藥品混合。(1080710仿單資料)
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| 針劑施打條件 |
SubQ injection only. Do not administer intradermal, IM, or IV; if inadvertently administered IM, the dose does not need repeated. (ref. Lexicomp 20190710)
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| 針劑保存安定性 |
1.2-8℃冷藏，不可冷凍，避光。(1080710仿單資料)
2.Vaccine must be used within 60 minutes of reconstitution. (ref. Lexicomp 20190710)
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最近修改日期時間
Updated | 7/10/2019 5:27:32 PM |