藥品名稱
drug name | 公費 Hepatitis B Recombinant Vaccine (ENGERIX-B, 安在時Ｂ型肝炎疫苗) 10 mcg/0.5 mL/vial |
| 藥檔狀態 | 使用中 （需冷藏） |
成 份
Ingredient | HEPATITIS B, ANTIGEN, SURFACE |
| 單位含量 | 10 mcg/ 0.5 mL/vial |
| Dosage Forms | Injection: hepatitis B surface antigen (recombinant): 10 mcg/ 0.5 mL/vial |
| 外觀描述 | 針劑/注射 |
| Appearance | injection |
標 示
outward | 藍色蓋子 |
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型肝炎疫苗 |
| 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 y/o: 20 mcg/dose at 0, 1, 6 months
【Pediatric】:
Children & adolescents 0-19 y/o: 10 mcg/dose at 0, 1, 6 months.
Neonates and infants: 10 mcg 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
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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 |
對此疫苗之任一成份過敏者。
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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: Abnormal hepatic function tests, acute exacerbations of multiple sclerosis, agitation, alopecia, anaphylactoid reaction, anaphylaxis, apnea, arthritis, Bell`s palsy, brain disease, bronchospasm, conjunctivitis, constipation, convulsions, eczema, encephalitis, erythema nodosum, erythema multiforme, febrile seizures, Guillain-Barre syndrome, herpes zoster, hypersensitivity reaction, hypoesthesia, increased erythrocyte sedimentation rate, increased liver enzymes, keratitis, lichen planus, limb pain, lupus-like syndrome, meningitis, migraine, multiple sclerosis, myasthenia, myelitis, neuritis, neuropathy, optic neuritis, palpitations, paralysis, paresis, periarteritis nodosa, peripheral neuropathy, petechiae, purpura, radiculopathy, seizure, serum sickness-like reaction (may be delayed days to weeks), Stevens-Johnson syndrome, syncope, systemic lupus erythematosus, tachycardia, thrombocytopenia, tinnitus, transverse myelitis, uveitis, vasculitis, visual disturbance
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監測
Monitoring |
1.幼兒每劑接種劑量為0.5 mL，超過24小時未使用則應丟棄
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| 警語與注意事項 | 限公費病人使用;不可口服.111.9.20換Engerix B |
| Warnings & precautions | 限公費病人使用;不可口服 |
| 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 |
1.注射前需充分搖勻。
2.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。
3.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 |
未開封:貯存於2℃至8℃之間。
本產品都不含防腐劑，一旦單劑量小瓶穿刺後，抽出之疫苗後應迅速使用，並將小瓶丟棄。
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最近修改日期時間
Updated | 9/20/2022 5:08:02 PM |
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現用藥品
Available
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停用藥品
Old item
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衛福部仿單連結
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