藥品名稱
drug name
Rabies virus vaccine 2.5IU/vial (Verorab),巴斯德狂犬病疫苗
藥檔狀態使用中
成  份
Ingredient
Rabies virus vaccine
單位含量2.5IU/vial
Dosage FormsInjectable, Intramuscular : 2.5 units/0.5 mL
外觀描述 
Appearance 
廠商名稱
Manufacturer
Sanofi pasteur SA
製 造 商
Manufacturer
Sanofi pasteur SA
字  號
Product ID
衛部菌疫輸字第000969號
藥理分類
Pharmacologic Category
Vaccine;Vaccine, Inactivated (Viral)
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 Preexposure and postexposure vaccination against rabies
衛福部核准適用症狀
MOHW approved indications
預防狂犬病。
常用劑量
(藥品劑量會因人或病情增減,請依照醫師指示服用。)
Dose Adult:
Preexposure vaccination:IM: A total of 3 doses, 1 mL each, on days 0, 7, and 21 or 28.
Booster vaccination (for persons with continuous or frequent risk of infection):IM: 1 mL based on antibody titers
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 as above:
Immunocompetent: IM: 4 doses (1 mL each) on days 0, 3, 7, 14 (ACIP [Rupprecht 2010]).
Immunocompromised: IM: 5 doses (1 mL each) on days 0, 3, 7, 14, 28 (ACIP [Rupprecht 2010]).
Note:In addition, patients should receive rabies immune globulin with the first dose (day 0).
Persons who have previously received postexposure prophylaxis with rabies vaccine, received a recommended IM pre-exposure series of rabies vaccine or have a previously documented rabies antibody titer considered adequate: IM: Two doses (1 mL each) on days 0 and 3; do not administer rabies immune globulin

Pediatric:
Preexposure vaccination: Infants, Children, and Adolescents: IM: 1 mL/dose for 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.
— Booster vaccination (for persons with continuous or frequent risk of infection): Infants, Children, and Adolescents: IM: 1 mL/dose based on antibody titers

Postexposure vaccination: Infants, Children, and Adolescents: All postexposure treatment should begin with immediate cleansing of the wound with soap and water (for ~15 minutes); immunization should begin as soon as possible after exposure. On presented dosing, Day 0 is the first day vaccine administered.
— Persons not previously immunized: Administer with rabies immune globulin (RIG):
>> Immunocompetent: 4-dose regimen: IM: 1 mL/dose for 4 doses on days 0, 3, 7, and 14 postexposure (ACIP [Rupprecht 2010])
>> Immunocompromised: 5-dose regimen: IM: 1 mL/dose for 5 doses on days 0, 3, 7, 14, and 28 postexposure (ACIP [Rupprecht 2010])
— Persons who have previously received vaccine (either previous postexposure prophylaxis or preexposure series of vaccination) or have a previously documented rabies antibody titer considered adequate: IM: 1 mL/dose on days 0 and 3 postexposure; do not administer RIG

Geriatric :
Refer to adult dosing.

Renal Impairment:
There are no dosage adjustments provided in the manufacturer`s labeling.

Hepatic Impairment:
There are no dosage adjustments provided in the manufacturer`s labeling.
懷孕分級
Pregnancy Risk Factor
依文獻內容判定系統稽核懷孕分級建置為:C。

UTD
Animal reproduction studies have not been conducted. Pregnancy is not a contraindication to postexposure prophylaxis. Pre-exposure prophylaxis during pregnancy may also be considered if risk of rabies is great. Inactivated vaccines have not been shown to cause increased risks to the fetus (ACIP [Kroger 2021]).

仿單
根據一項對生殖及發育之影響的動物毒性研究顯示,由VERO cells 培養的另一個去活化狂犬病疫苗並不會對雌性動物的生殖能力及胎兒的產前及產後發育造成任何不良的影響。
根據至目前為止少數在懷孕期間接種狂犬病疫苗(去活化“WISTAR Rabies PM/WI 38 1503-3M 病毒株”)的臨床數據顯示,本疫苗無任何的致畸性或胎毒性。基於狂犬病的嚴重性,若為高度感染風險者,懷孕期間應配合一般的疫苗接種時程進行注射。
-----------------------------------------------------------
[FDA(美國食品及藥物管理局)懷孕分級說明:
A:對照試驗無法證實懷孕初期及後期使用會危害胎兒。
B:動物試驗無法證實對胎兒有害,但缺乏人類對照試驗;或動物試驗有副作用報告,但無法證實對懷孕初期及後期之胎兒有害。
C:動物實驗中對胎兒有害但缺乏孕婦對照實驗;或無動物及孕婦試驗。
D:證實對胎兒有害,但疾病對孕婦有生命威脅或較安全藥品無法使用或無效時可使用。
X:證實對胎兒有害,且使用後危害大於可能的益處。孕婦及可能懷孕婦女禁用。]
禁忌症 暴露前接種:已知對活性成分,任何一種賦形劑、polymyxin B、streptomycin、neomycin或任何同類的抗生素、對先前曾注射過的疫苗或其中相同的成分過敏。
當有發燒或急症時,疫苗應延後接種。

暴露後接種:因為狂犬病具有致命性,因此沒有暴露後的接種禁忌。
Contraindications Preexposure prophylaxis: Life-threatening 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 
Common adverse drug reactions 
Adverse Reactions >10%:
Central nervous system: Dizziness, headache, malaise
Dermatologic: Injection site pruritus
Gastrointestinal: Abdominal pain, nausea
Hematologic & oncologic: Lymphadenopathy
Local: Erythema at injection site, pain at injection site, swelling at injection site
Neuromuscular & skeletal: Myalgia
Frequency not defined:
Cardiovascular: Cardiovascular toxicity, edema, palpitations, swelling of injected limb (extensive)
Central nervous system: Chills, encephalitis, fatigue, Guillain-Barre syndrome, meningitis, neuropathy, paralysis (may be transient; includes neuroparalysis), paresthesia (transient), retrobulbar neuritis, seizure, vertigo
Dermatologic: Pruritus, urticaria (including urticaria pigmentosa)
Endocrine & metabolic: Hot flash
Gastrointestinal: Diarrhea, vomiting
Hematologic & oncologic: Adenopathy
Hypersensitivity: Anaphylaxis, hypersensitivity reaction, serum sickness
Local: Hematoma at injection site
Neuromuscular & skeletal: Arthralgia, arthritis (one joint), limb pain, multiple sclerosis, myelitis, weakness
Ophthalmic: Visual disturbance
★高警訊藥品
監測建議

監測
Monitoring
Monitor for anaphylaxis and syncope for 15 minutes following administration (ACIP [Kroger 2017]). 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) (ACIP [Manning 2008]):
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 preexposure or postexposure prophylaxis series
警語與注意事項 
Warnings & precautions 
針劑溶解條件 應使用專用的溶劑溶解粉末,並於注射前小心混合均勻。(1100618仿單資料)
針劑稀釋條件
針劑不相容性 狂犬病免疫球蛋白及狂犬病疫苗絕對不可以混合於同一支注射針筒內或施打於相同部位。不可與其他藥物或其他疫苗混合。(1100618仿單資料)
針劑施打條件 僅可肌肉注射。不可接種於臀部,不可經由靜脈注射。並應與狂犬病疫苗球蛋白施打於不同部位。(1100618仿單資料)
針劑保存安定性 冷藏儲存(2-8度C)。不可冷凍。疫苗應存放於原有的外包裝內,避免日照。(1100618仿單資料)
最近修改日期時間
Updated
6/18/2021 12:35:31 PM
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