藥品名稱
drug name | Hepatitis B Recombinant Vaccine (Engerix-B, 安在時B型肝炎疫苗) 20 mcg/1 mL/vial |
| 藥檔狀態 | 使用中 （需冷藏） |
成 份
Ingredient | Engerix-B Injection recombinant HBsAg |
| 單位含量 | 20 mcg/1 mL/vial |
| Dosage Forms | Injection: hepatitis B surface antigen (recombinant): 20 mcg/mL (1 mL) |
| 外觀描述 | 針劑/注射 |
| Appearance | injection |
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.,Belgium |
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, in individuals considered at high risk of potential exposure to hepatitis B virus or HBsAg-positive materials
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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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| Dose |
Administration: IM
【Adults】:
≧ 20 yrs: 20 mcg/dose at 0, 1, 6 months or at 0, 1, 2 and 12 months.
Alternative regimen (如到高流行地區旅行者，可在出發前一個月內開始接種): 3 doses at 0, 7, 21 days and extra one dose 12 months after day 0.
【Pediatric】:
0-19 yr. of age: 10 mcg (0.5mL) at 0, 1, 6 months or at 0, 1, 2 and 12 months.
Neonates & infants: 10mcg doses
Full-term
HBsAg (+) mother*: 24 hr of birth, and 1、6 months
HBsAg (-) mother: 24 hr of birth, and 1、6 months
Preterm
HBsAg (+) mother*: 24 hr of birth, and 1、2、6 months
HBsAg (-) mother: 24 hr of birth、1、6 months
*Neonate born to HBsAg (+) women should receive a dose of HBIG within 24 hours of birth
基於我國屬B型肝炎高感染地區，帶原母親的B型肝炎病毒含量偏高，且GSK產製B型肝炎疫苗以20mcg/1ml使用於國內幼兒常規接種成效良好，為確保接種效益，故可延續使用20mcg/1 ml。(CDC 2019/3/28公告)
【Dosage Adjustment in Renal Impairment】:
Dialysis: 40 mcg (2mL) x 4 doses at 0, 1, 2, and 6 months
【Dosage Adjustment in Other Conditions】:
Immunocompetent adults (non-dialysis): 20 mcg (1 mL)/dose (adult formulation) x 3 doses at 0, 1, and 6 months.
Note: Refer to CDC guidelines (CDC/ACIP [Schillie 2018]) for other options.
Adults with immunocompromising conditions (off-label use): 40 mcg (2mL) x 4 doses at 0, 1, 2, and 6 months
Note: Some experts consider use of high-dose (40 mcg) hepatitis B vaccine for patients with immunocompromising conditions (eg, HIV infection, cirrhosis, transplantation, receipt of chemotherapy) despite limited data (AASLD [Terrault 2018]; CDC/ACIP [Schillie 2018]; HHS 2018; IDSA [Rubin 2014]).
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懷孕分級
Pregnancy Risk Factor |
C
Lactation:Excretion in breast milk unknown/use caution
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| 禁忌症 |
已知對此疫苗中任何成份過敏者，或先前曾於接種Engerix B 發生過敏者。
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| Contraindications |
Hypersensitivity to yeast, hepatitis B vaccine, or any component of the formulation
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| 常見副作用 | 注射部位紅、痛、腫脹、全身疲倦、發燒、食慾減低、腹瀉。 |
| Common adverse drug reactions | Injection site reactions(erythema, pain, swelling), fatigue, fever, appetite decreased and diarrhea. |
| 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: Body pain, chills, dizziness, drowsiness, fatigue, headache, insomnia, irritability, malaise, paresthesia, tingling sensation, vertigo
Dermatologic: Diaphoresis, pruritus, skin rash, urticaria
Gastrointestinal: Abdominal pain, anorexia, decreased appetite, diarrhea, dyspepsia, nausea, stomach cramps, vomiting
Genitourinary: Dysuria
Hematologic & oncologic: Lymphadenopathy
Hypersensitivity: Angioedema
Infection: Influenza
Local: Bruising at injection site, erythema at injection site, induration at injection site, injection site nodule, itching at injection site, local soreness/soreness at injection site, pain at injection site, swelling at injection site, tenderness at injection site, warm sensation at injection site
Neuromuscular & skeletal: Arthralgia, back pain, myalgia, neck pain, neck stiffness, shoulder pain, weakness
Otic: Otalgia
Respiratory: Cough, pharyngitis, rhinitis, upper respiratory tract infection
Miscellaneous: Fever (≧37.5°C/100°F)
Postmarketing and/or case reports (Limited to important or life-threatening): Acute exacerbations of multiple sclerosis, anaphylaxis, apnea, Bell`s palsy, encephalitis, febrile seizures, Guillain-Barre syndrome, herpes zoster, hypersensitivity reaction, hypoesthesia, increased erythrocyte sedimentation rate, increased liver enzymes, keratitis, lupus-like syndrome, migraine, multiple sclerosis, myelitis, neuropathy, optic neuritis, paralysis, paresis, periarteritis nodosa, peripheral neuropathy, purpura, radiculopathy, seizure, serum-sickness like reaction (may be delayed days to weeks), Stevens-Johnson syndrome, syncope, systemic lupus erythematosus, tachycardia, thrombocytopenia, transverse myelitis, uveitis, vasculitis, visual disturbances
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監測
Monitoring |
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| 警語與注意事項 | 注射用藥。不可採臀部注射或皮內注射方式投予。 |
| Warnings & precautions | Please do NOT eat or swallow the medicine, and store in the refrigerator. |
| 針劑溶解條件 |
不需溶解。(1090409仿單資料)
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| 針劑稀釋條件 |
不需稀釋。(1090409仿單資料)
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| 針劑不相容性 |
不應與其他疫苗混合使用。(1090409仿單資料)
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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。(1090409仿單資料)
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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。(1090409仿單資料)
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最近修改日期時間
Updated | 11/24/2021 4:06:17 PM |
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現用藥品
Available
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停用藥品
Old item
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藥品仿單
Package insert sheet
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衛福部仿單連結
DrugLabelingURL
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二維條碼
QR code
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