藥品名稱
drug name
Meningococcal Vaccine, Group A/C/Y/W-135 (Nimenrix, 4價流行性腦脊髓膜炎結合型疫苗) 0.5mL/vial
藥檔狀態使用中 (需冷藏)
成  份
Ingredient
Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine, Group A/C/Y/W-135 (MCV4)
單位含量0.5 mL/vial
Dosage FormsInjection, solution [preservative free]:0.5mL/vial
外觀描述 針劑/肌肉注射
Appearanceinjection/IM
標  示
outward
廠商名稱
Manufacturer
Pfizer
製 造 商
Manufacturer
GLAXOSMITHKLINE BIOLOGICALS S.A.,Belgium
字  號
Product ID
專案進口
藥理分類
Pharmacologic Category
Biologic and Immunologic Agents/ Immunizations/ Vaccines-Bacteria (Inactivated)
作用機轉
Mechanism of action
Induces immunity against meningococcal disease via the formation of bactericidal antibodies directed toward the polysaccharide capsular components of Neisseria meningitidis serogroups A, C, Y and W-135.
用途/適應症預防流行性腦脊髓膜炎
Use Meningococcal disease prevention: Provide active immunization against invasive meningococcal disease caused by N. meningitidis serogroups A, C, Y, and W-135.
衛福部核准適用症狀
MOHW approved indications
專案進口,無衛署適應症。由疾管署專案進口用於國際旅遊醫療,預防由A, C, W135 and Y型的腦膜炎球菌(Neisseria meningitides) 感染引起的細菌性腦膜炎或菌血症。
Dose Administration Route: IM

Adults & children ≧ 1 y/o:1 dose (0.5 mL)
懷孕分級
Pregnancy Risk Factor
C
仿單︰只有當明確需要且應評估潛在效益明顯超過對胎兒的潛在危險時,才可以在懷孕期間使用。
禁忌症 不可用於對本疫苗內任何成份過敏者
Contraindications Hypersensitivity to any component of the vaccine.
常見副作用嗜睡、嗜睡、疲勞、頭痛、注射部位疼痛紅腫或發燒。
Common adverse drug reactionsDrowsiness, fatigue, headache, pain/erythema/swelling at injection site, or fever.
Adverse Reactions >10%:
Central nervous system: Irritability (infants: 52% to 63%; children: 15% to 41%), drowsiness (infants: 36% to 53%; children: 14% to 28%), fatigue (12% to 29%), headache (16% to 26%)
Gastrointestinal: Anorexia (infants: 33% to 38%; children: 11% to 23%), gastrointestinal symptoms (≦15%; includes diarrhea, nausea, vomiting)
Local: Pain at injection site (19% to 51%), erythema at injection site (infants & children: 25% to 43%; adolescents & adults: 9% to 26%), swelling at injection site (infants & children: 12% to 30%; adolescents & adults: 8% to 19%)
Miscellaneous: Fever (≧38°C: 4% to 9%, infants: 23% to 32%; >40°C: <1%)

1% to 10%:
Local: Hematoma at injection site
監測
Monitoring
Monitor for syncope for at least 15 minutes following administration.
If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.
警語與注意事項肌肉注射給藥。混合泡製完成須立即使用。
Warnings & precautions肌肉注射給藥。混合泡製完成須立即使用。
針劑溶解條件 需以所附的溶劑進行重組,將預充填好的溶劑的針筒接上針頭,刺入裝有乾粉的小瓶中,加入全部的溶劑後,搖晃小瓶使混合均勻。(10807041仿單資料)
針劑稀釋條件
針劑不相容性
針劑施打條件 肌肉注射。
不可靜脈注射、皮下注射或皮內注射。(1080704仿單資料)
針劑保存安定性 未開封:避光儲存於2-8℃。不可冷凍。
配置後:疫苗若未立即施打,可於30℃以下存放8小時。(1080704仿單資料)
最近修改日期時間
Updated
11/27/2019 9:28:58 AM
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