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 FormsInjection: hepatitis B surface antigen (recombinant): 20 mcg/mL (1 mL)
外觀描述 針劑/注射
Appearanceinjection
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
衛福部核准適用症狀
MOHW approved indications
預防B型肝炎。
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


【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]).
懷孕分級
Pregnancy Risk Factor
C
Lactation:Excretion in breast milk unknown/use caution
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。
Contraindications Hypersensitivity to yeast, hepatitis B vaccine, or any component of the formulation
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 reactionsInjection 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
監測
Monitoring
警語與注意事項注射用藥。
Warnings & precautionsPlease 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)
針劑稀釋條件 不需稀釋。(1090409仿單資料)
針劑不相容性 不應與其他疫苗混合使用。(1090409仿單資料)
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)
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)
最近修改日期時間
Updated
4/9/2020 9:10:58 AM
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