藥品名稱
drug name
Purified Inactivated Rabies Vaccine (Verorab vaccine, "巴斯德"狂犬病疫苗) 2.5 IU/ 0.5 mL/vial
藥檔狀態使用中 (需冷藏)
成  份
Ingredient
Purified Inactivated Rabies virus vaccine
單位含量2.5 IU/0.5 mL/vial
Dosage FormsInjectable, Intramuscular : 2.5 units/0.5 mL (「單支盒裝」: 1dose powder in a vial & 0.5mL solvent in a pre-filled syringe)
外觀描述 針劑/小瓶
Appearanceinjection/vial
標  示
outward
廠商名稱
Manufacturer
賽諾菲股份有限公司
製 造 商
Manufacturer
SANOFI PASTEUR, FRANCE
字  號
Product ID
衛部菌疫輸字第000969號
藥理分類
Pharmacologic Category
Biologic and Immunologic Agents/ Immunizations/ Vaccines-Virus (Inactivated)
作用機轉
Mechanism of action
Rabies vaccine is an inactivated virus vaccine which promotes immunity by inducing an active immune response. The production of specific antibodies requires about 7-10 days to develop. Rabies immune globulin or antirabies serum, equine (ARS) is given in conjunction with rabies vaccine to provide immune protection until an antibody response can occur.
用途/適應症 
Use Pre-exposure and postexposure vaccination against rabies.
衛福部核准適用症狀
MOHW approved indications
預防狂犬病。
說明:包括暴露前預防(在可能與狂犬病病毒有所接觸之前)及暴露後預防(在已知或可能接觸狂犬病毒後)
Dose Administration: IM

【Preventive or pre-exposure vaccination】:
Primary immunization: A total of 3 doses, on days 0, 7, and 21 or 28.

Note: Prolonging the interval between doses does not interfere with immunity achieved after the concluding dose of the basic series.


【Postexposure vaccination】: All postexposure treatment should begin with immediate cleansing of the wound with soap and water
Persons not previously immunized:
免疫力正常: 4 doses on days 0, 3, 7, 14 (依據1070725人用狂犬病疫苗短缺因應措施專家研商會議)
免疫力不全: 5 doses on days 0, 3, 7, 14, 28


【Persons who have previously received postexposure prophylaxis with rabies vaccine, received a recommended I.M. pre-exposure series of rabies vaccine or have a previously documented rabies antibody titer considered adequate】: 2 doses on days 0, 3; do not administer rabies immune globulin
懷孕分級
Pregnancy Risk Factor
C
禁忌症 暴露後預防:對需要暴露後預防者而言,疫苗接種沒有相關的禁忌症。
暴露前預防:對本藥之任何成分具嚴重過敏反應病史之患者,皆不應施打疫苗。請注意本疫苗本身可能含有polymyxin B、streptomycin、neomycin。
若病患正處於急性發燒疾病,不可注射疫苗。
Contraindications Pre-exposure prophylaxis: Hypersensitivity to rabies vaccine or any component of the formulation Postexposure prophylaxis: There are no contraindications listed within the FDA-approved manufacturer`s labeling.
常見副作用注射部位反應(疼痛、腫塊)、關節痛、肌肉痛、頭痛、類流感症狀。
Common adverse drug reactionsinjection site reaction(pain, swelling), arthralgia, myalgia, headache and flu-like syndrome.
Adverse Reactions >10%:
Central nervous system: Dizziness, headache, malaise Gastrointestinal: Abdominal pain, nausea Local: Erythema, itching, pain, swelling Neuromuscular & skeletal: Myalgia Miscellaneous: Lymphadenopathy Uncommon, frequency not defined, postmarketing, and/or case reports: Cardiovascular: Circulatory reactions, edema, palpitation Central nervous system: Chills, fatigue, fever >38°C (100°F), Guillain-Barre syndrome, encephalitis, meningitis, multiple sclerosis, myelitis, neuroparalysis, seizures, vertigo Dermatologic: Pruritus, urticaria, urticaria pigmentosa Endocrine & metabolic: Hot flashes Gastrointestinal: Diarrhea, vomiting Local: Hematoma, limb swelling (extensive) Neuromuscular & skeletal: Arthralgia, limb pain, monoarthritis, neuropathy, paralysis (transient), paresthesias (transient), weakness Ocular: Retrobulbar neuritis, visual disturbances Respiratory: Bronchospasm, dyspnea, wheezing Miscellaneous: Allergic reactions, anaphylaxis, hypersensitivity reactions, serum sickness, swollen lymph nodes
監測
Monitoring
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. Antibody response to vaccination is not recommended for otherwise healthy persons who complete the pre-exposure or postexposure regimen. Serologic testing to determine if the antibody titer is at an acceptable level is required for the following persons (booster vaccination recommended if titer is below the acceptable level): Persons with continuous risk of infection: Serologic testing every 6 months Persons with frequent risk of infection: Serologic testing every 2 years Persons who are immunocompromised: Serologic testing after completion of pre-exposure or postexposure prophylaxis series Monitoring of antibody response to vaccination is not recommended for otherwise healthy persons who complete the pre-exposure or postexposure regimen.
警語與注意事項請用新的注射針施打。領藥:第1次持處方簽、使用表;第2至4次持處方簽、接種記錄卡。接種卡需還給病患。
Warnings & precautions 
針劑溶解條件 1.應使用專用的溶劑溶解粉末,並於注射前小心混合均勻。
2.藥品混合配製後,醫療人員應使用新的無菌注射針並選擇適合病人年齡體重的針頭長度,以肌肉注射方式施打於病人。
3.調配完成,應立即使用。(1090526仿單資料)
針劑稀釋條件
針劑不相容性 本產品不可與其他藥物或疫苗混和。(1090526仿單資料)
針劑施打條件 1.限肌肉注射(IM)。
2.成人及滿12個月兒童,請肌肉注射於「上臂三角肌部位 」;未滿12個月幼兒可注射於「大腿前外側」股肌部位。
3.此疫苗不可接種於臀部,因可能會導致免疫反應降低情形。
4.若與狂犬病免疫球蛋白同時施打,必須在不同注射部位接種rabies vaccine,避免疫苗被狂犬病免疫球蛋白中和導致效果下降。(1090526仿單資料)
針劑保存安定性 1.冷藏儲存(2-8°C )。(1090526仿單資料)
2.因原包裝藥品短缺,廠商緊急調度同製造廠每盒5劑裝藥品。原使用品項為「每盒1劑裝」,新包裝品項為「每盒5劑裝(1劑包含1瓶疫苗乾粉+1安瓿溶劑)」。(公告日期: 2015/11/19)
3.原為專案進口藥品,已取得衛福部許可證。(公告日期: 2015/12/01)
4.Verorab包裝已換回「單支盒裝」。(公告日期: 2020/05/26)
最近修改日期時間
Updated
5/26/2020 12:04:34 PM
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