藥品名稱
drug name | Hepatitis B Recombinant Vaccine (Engerix-B) 安在時B型肝炎疫苗 |
| 藥檔狀態 | 使用中 |
成 份
Ingredient | Hepatitis B Recombinant Vaccine |
| 單位含量 | 20 mcg/mL/vial |
| Dosage Forms | 20 mcg/mL/vial |
| 顏 色 | |
| Color | |
| 形 狀 | |
| Shape | |
| 劑 型 | 針劑/注射 |
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大 小
Size | |
標 示
outward | |
廠商名稱
Manufacturer | 荷商葛蘭素史克藥廠股份有限公司臺灣分公司 |
製 造 商
Manufacturer | GLAXOSMITHKLINE BIOLOGICALS S.A. |
字 號
Product ID | 衛署菌疫輸字第000301號 |
藥理分類
Pharmacologic Category | Biologic and Immunologic Agents / Immunizations / Vaccines-Virus (Inactivated) |
作用機轉
Mechanism of action | Recombinant hepatitis B vaccine is a noninfectious subunit viral vaccine, which confers active immunity via formation of antihepatitis B antibodies. The vaccine is derived from hepatitis B surface antigen (HBsAg) produced through recombinant DNA techniques from yeast cells. The portion of the hepatitis B gene which codes for HBsAg is cloned into yeast which is then cultured to produce hepatitis B vaccine. |
| 用途/適應症 | B肝疫苗 |
| Use |
Immunization against infection caused by all known subtypes of hepatitis B virus (HBV)
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衛福部核准適用症狀
MOHW approved indications |
預防Ｂ型肝炎
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| 常用劑量 | 每天一次，早飯後使用1vial
(藥品劑量會因人或病情增減，請依照醫師指示服用。) |
| Dose |
Note: Regimen consists of 3 doses (0, 1, and 6 months):
First dose given on the elected date, second dose given 1 month later, third dose given 6 months after the first dose;
Routine Immunization Regimen of Three I.M. Hepatitis B Vaccine Doses
Initial dose:
Birth (infants born of HBsAg-negative mothers) to 19 years: 0.5 mL (10 mcg/0.5 mL formulation)
20 years and older: 1 mL (20 mcg/mL formulation)
Dialysis or immunocompromised patients (revaccinate if anti-HBs <10 mIU/mL ;1-2 months after third dose): 2 mL (two 1 mL doses given at different sites using the 20 mcg/mL formulation)
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懷孕分級
Pregnancy Risk Factor |
C
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| 禁忌症 |
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| Contraindications |
persensitivity to yeast, hepatitis B vaccine, or any component of the formulation
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| 常見副作用 | |
| Common adverse drug reactions | |
| Adverse Reactions |
Frequency not defined. The most common adverse effects reported with both products included injection site reactions (>10%).
Cardiovascular: Flushing, hypotension, Central nervous system: Agitation, chills, dizziness, fatigue, fever, headache, insomnia, irritability, lightheadedness, malaise, somnolence, vertigo
Dermatologic: Angioedema, petechiae, pruritus, rash, urticaria
Gastrointestinal: Abdominal pain, appetite decreased, constipation, cramps, diarrhea, dyspepsia, nausea, vomiting
Genitourinary: Dysuria
Local: Injection site reactions: Ecchymosis, erythema, induration, pain, nodule formation, soreness, swelling, tenderness, warmth
Neuromuscular & skeletal: Achiness, arthralgia, back pain, myalgia, neck pain, neck stiffness, paresthesia, shoulder pain, tingling, weakness
Otic: Earache
Respiratory: Cough, pharyngitis, rhinitis, upper respiratory tract infection
Miscellaneous: Diaphoresis, lymphadenopathy, flu-like syndrome
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監測
Monitoring |
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| 警語與注意事項 | 冷藏保存。 |
| Warnings & precautions | |
| 針劑溶解條件 |
不需溶解
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| 針劑稀釋條件 |
不需稀釋
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| 針劑不相容性 |
不應與其他疫苗混合使用。
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| 針劑施打條件 |
Engerix B應以肌肉注射方式注射於成人或兒童的手臂三角肌部位，或新生兒、嬰兒、及幼童的大腿前外側。 Engerix B不可採臀部注射或皮內注射方式投予，因為這種投予方式所產生的免疫反應較低。
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| 針劑保存安定性 |
疫苗應貯存於+2℃至+8℃之間。已經部份使用的疫苗應在同一天內用完。切勿冷凍；如果已經冷凍，則應丟棄不用。
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最近修改日期時間
Updated | 11/4/2019 9:46:54 AM |
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現用藥品
Available
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停用藥品
Picture2
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藥品仿單
Package insert sheet
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二維條碼
QR code
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