藥品名稱
drug name | Pneumococcal Conjugate Vaccine, 15-Valent (Vaxneuvance sups. for inj., 肺恩賜 肺炎鏈球菌十五價結合型疫苗) 0.5 mL/PFS |
| 藥檔狀態 | 使用中 （需冷藏） |
成 份
Ingredient | Pneumococcal Conjugate Vaccine, 15-Valent |
| 單位含量 | 0.5 mL/PFS |
| Dosage Forms | 每0.5毫升劑量含有肺炎鏈球菌多醣體血清型1、3、4、5、6A、7F、9V、14、18C、19A、19F、22F、23F及33F各2.0 ug，以及多醣體血清型6B 4.0 ug、載體蛋白CRM197 30 ug、L-組胺酸1.55 mg、聚山梨醇酯20 1 mg克、氯化鈉4.50 mg和鋁(磷酸鋁佐劑) 125 ug。本疫苗不含任何防腐劑。 |
| 外觀描述 | 肌肉注射/預充填針筒 |
| Appearance | IM/Pre-filled syringe |
標 示
outward | |
廠商名稱
Manufacturer | 美商默沙東藥廠股份有限公司台灣分公司 |
製 造 商
Manufacturer | MSD INTERNATIONAL GMBH T/A MSD IRELAND |
字 號
Product ID | 衛部菌疫輸字第001198號 |
藥理分類
Pharmacologic Category | Biologic and Immunologic Agents/ Immunizations/ Vaccines-Bacteria |
作用機轉
Mechanism of action | Promotes active immunization against invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F, each of which are individually conjugated to CRM197 protein. |
| 用途/適應症 | 肺炎疫苗 |
| Use |
Pneumococcal disease prevention
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衛福部核准適用症狀
MOHW approved indications |
適用於6週以上兒童及成人的主動免疫接種，以預防由肺炎鏈球菌血清型1、3、4、5、6A、6B、7F、9V、14、18C、19A、19F、22F、23F和33F所引起的侵襲性疾病。
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| Dose |
Administration : IM (每劑0.5 mL)
1、於6週大至6個月大施打第一劑之嬰幼兒疫苗接種時程:
4劑接種時程 (三劑基礎劑後再接種一劑追加劑)
第一劑最早在6至12週大時施打，基礎劑各劑之間的間隔為4至8週。第四劑(追加劑)應在大約11至15個月大時施打，且至少要在第三劑的2個月後施打。
2、7個月大至17歲兒童的補接種疫苗接種時程:
(1)於7至未滿12個月大施打第一劑的嬰兒 (未曾接種肺炎鏈球菌疫苗): 接種三劑。前兩劑施打間隔至少4週。第三劑在12個月大後施打，與第二劑相隔至少2個月。
(2)於12個月大至未滿2歲施打第一劑的兒童 (未曾接種肺炎鏈球菌疫苗): 接種兩劑。兩劑之間間隔2個月。
(3)未曾接種或未完全接種肺炎鏈球菌疫苗之2至未滿18歲的兒童與青少年: 單一劑量。
3、成人:投予單劑的劑量。
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懷孕分級
Pregnancy Risk Factor |
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| 禁忌症 |
對曾對本疫苗之任何成分或白喉類毒素產生嚴重過敏反應(如立即型過敏 [anaphylaxis])的人，切勿投予本疫苗。
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| Contraindications |
Severe hypersensitivity (eg, anaphylaxis) to pneumococcal conjugate vaccine, any component of the formulation, or to diphtheria toxoid.
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| 常見副作用 | 注射部位腫脹疼痛、疲倦、肌痛、頭痛 |
| Common adverse drug reactions | Injection site swelling and pain, fatigue, muscle pain, headache |
| Adverse Reactions |
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for infants, children, adolescents, and adults, unless otherwise indicated.
>10%:
Gastrointestinal: Decreased appetite (infants, children <2 years: 14% to 23%; children ≧2 years, adolescents: 2%)
Local: Erythema at injection site (8% to 28%), induration at injection site (infants, children, adolescents: 7% to 17%), pain at injection site (19% to 76%), swelling at injection site (11% to 22%)
Nervous system: Drowsiness (infants, children <2 years: 22% to 48%; children ≧2 years, adolescents: 3%), fatigue (children, adolescents, adults: 16% to 34%), headache (children, adolescents, adults: 12% to 27%), irritability (infants, children <2 years: 33% to 63%; children ≧2 years, adolescents: 3%)
Neuromuscular & skeletal: Arthralgia (adults: 6% to 13%), myalgia (children, adolescents, adults: 16% to 29%)
Miscellaneous: Fever (infants and children <2 years: 11% to 22%; children ≧2 years, adolescents, adults: ≦4%)
1% to 10%:
Dermatologic: Urticaria (infants, children, adolescents: 1% to 3%)
Local: Injection-site pruritus (adults: 3%)
<1%:
Local: Urticaria at injection site (infants, children <2 years)
Nervous system: Febrile seizure (infants)
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監測
Monitoring |
Monitor for hypersensitivity and syncope for 15 minutes following administration (ACIP [Kroger 2023]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.
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| 警語與注意事項 | 注射在嬰兒大腿前外側，或幼童及成人之上臂三角肌。不應在臀部或神經幹/血管的部位注射。 |
| Warnings & precautions | |
| 針劑溶解條件 |
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| 針劑稀釋條件 |
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| 針劑不相容性 |
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| 針劑施打條件 |
僅供肌肉注射使用。最好注射在嬰兒之大腿前外側，或是幼童及成人之上臂的三角肌。不應在臀部或可能有主要神經幹和/或血管的部位注射疫苗。
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| 針劑保存安定性 |
請冷藏貯存於2-8°C的環境。切勿冷凍。請避免光線照射。
安定性資料顯示在高達25°C的溫度下可穩定48小時。
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最近修改日期時間
Updated | 12/4/2023 1:46:59 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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