藥品名稱
drug name		公費 Pneumococcal Conjugate Vaccine, 13-Valent (Prevenar 13, 沛兒肺炎鏈球菌十三價結合型疫苗) 0.5mL/vial
藥檔狀態使用中 （需冷藏）
成　　份
Ingredient		Pneumococcal Conjugate Vaccine, 13-Valent
單位含量0.5 mL/vial
Dosage FormsInjection: 2 mcg each saccharide for serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F, and 4 mcg of serotype 6B [bound to diphtheria CRM197 protein ~34 mcg] per 0.5 mL (0.5 mL) [contains aluminum, polysorbate 80, and yeast]
外觀描述 針劑/針筒
Appearanceinjection/syringe
標　　示
outward
廠商名稱
Manufacturer		美商惠氏藥廠（亞洲）股份有限公司台灣分公司
製 造 商
Manufacturer		Pfizer Ireland Pharmaceuticals, IRELAND
字　　號
Product ID		衛署菌疫輸字第000906號
藥理分類
Pharmacologic Category		Biologic and Immunologic Agents/ Immunizations/ Vaccines-Bacteria
作用機轉
Mechanism of action		Contains saccharides of capsular antigens of serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F, individually conjugated to CRM197 protein.
用途/適應症 
Use Immunization of infants and children against Streptococcus pneumoniae infection caused by serotypes included in the vaccine and otitis media caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F
Immunization of adults ?50 years against pneumococcal pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes included in the vaccine.
衛福部核准適用症狀
MOHW approved indications		 1.可用於出生2個月至17歲嬰兒及兒童與青少年的主動免疫接種，以預防血清型1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F及23F肺炎鏈球菌(Streptococcus pneumoniae)引起的侵入性疾病。
2.沛兒肺炎鏈球菌十三價結合型疫苗也可用於預防2歲以下嬰幼兒血清型4, 6B, 9V, 14, 18C, 19F及23F肺炎鏈球菌引起的中耳炎。
3.本疫苗可用於18歲(含)以上之成人與老年人的主動免疫接種，以預防血清型1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F及23F肺炎鏈球菌引起的侵入性疾病和肺炎。
Dose Administration Route: IM

【Adults】:
Adults ≧50 years (manufacturers labeling): 0.5 mL as a single dose
Adults ≧19 years with specified underlying medical conditions: Eligible adults should be vaccinated at their next pneumococcal vaccination opportunity
Pneumococcal vaccine naive (no previous PCV13 or PPSV23 vaccine): Administer PCV13 0.5 mL as a single dose followed by 1 dose of PPSV23 8-weeks later.
Previously vaccinated with PPSV23: PCV13 0.5 mL as a single dose ≧1 year after the last dose of PPSV23.

【Pediatrics】:
Primary immunization:
Infants: 2-6 months: 0.5 mL at approximately 2-month intervals for 3 consecutive doses, followed by a fourth dose of 0.5 mL at 12-15 months of age; first dose may be given as young as 6 weeks of age, but is typically given at 2 months of age.

Previously Unvaccinated Infants and Children:
7-11 months: 0.5 mL for a total of 3 doses; 2 doses at least 4 weeks apart, followed by a third dose after the 1-year birthday (12-15 months), separated from the second dose by at least 2 months.
12-23 months: 0.5 mL for a total of 2 doses, separated by at least 2 months.
Healthy Children 24-59 months: 0.5 mL as a single dose.
Children 24-71 months with an underlying medical condition: ACIP recommendations: 0.5 mL for a total of 2 doses, separated by 2 months.

Previously vaccinated with PCV7 and/or PCV13, and with a lapse in vaccine administration(ACIP recommendations):
7-11 months: Previously received 1 or 2 doses: 0.5 mL dose at 7-11 months of age, followed by a second dose >2 months later at 12-15 months of age.
12-23 months:
Previously received 1 dose <12 months of age: 0.5 mL dose, followed by a second dose >2 months later.
Previously received 1 dose at ≧12 months of age: 0.5 mL dose ≧2 months after the most recent dose.
Previously received 2 or 3 doses before age 12 months: 0.5 mL dose >2 months after the most recent dose.
Healthy Children 24-59 months with any incomplete schedule: 0.5 mL dose >2 months after the most recent dose.
Children 24-71 months with an underlying medical condition:
Previously received <3 doses: 0.5 mL dose ≧2 months after the most recent dose, followed by a second dose ≧8 weeks later.
Previously received 3 doses: 0.5 mL as a single dose ≧2 months after the most recent dose.
Previously vaccinated with PCV7 and completed vaccination series of 4 doses (ACIP recommendations):
Children 14-59 months: 0.5 mL as a single supplemental dose ≧2 months after the most recent dose.
Children 24-71 months with an underlying medical condition: 0.5 mL as a single supplemental dose ?2 months after the most recent dose of PCV7 or PPSV23.

Previously vaccinated or not previously vaccinated with PCV7 or PPSV23 (ACIP recommendations): Children 6-18years at high risk for invasive pneumococcal disease: 0.5 mL as a single dose ≧2 months after the most recent dose.

仿單資訊:
兩個月大嬰兒~五歲幼童:
建議選用沛兒肺炎鏈球菌十三價結合型疫苗接種第一劑的嬰幼兒，最好能以此疫苗完成整個疫苗接種時程。

2 ~ 6個月大的嬰兒：
沛兒肺炎鏈球菌十三價結合型疫苗基礎劑應接種三劑，每劑 0.5 mL。通常嬰兒出生2個月時接種第一劑，各劑之間至少間隔1 個月。第一劑的施打時間最早可在出生後6週施打；並建議於年滿12-15個月時施打第四劑。
此外，若將沛兒肺炎鏈球菌十三價結合型疫苗納入一般嬰幼兒的常規疫苗接種計畫時，可以考慮將基礎接種次數改為二劑：滿2個月時接種第一劑，並間隔至少2個月再施打第二劑，年滿12-15個月時再給予第三劑（追加劑）即可。

出生7個月以上至5歲且未曾接種過疫苗的嬰兒及幼兒：
出生7-11個月的嬰兒: 沛兒肺炎鏈球菌十三價結合型疫苗基礎劑應接種二劑，每次接種劑量為0.5 mL，兩劑間隔至少1個月；並建議於年滿 1歲時接種第三劑。
12-23個月大的幼兒: 接種二劑，每次接種劑量為0.5 mL，每次間隔至少2個月。
2-5歲的兒童（未滿6歲）: 接種單一劑量0.5mL即可。

6-17歲兒童及青少年: 接種單一劑量0.5mL即可。

18歲(含)以上的成人與老年人： 接種單一劑量0.5 mL即可。
懷孕分級
Pregnancy Risk Factor		 B
Lactation:Excretion in breast milk unknown/use caution
禁忌症 1. 對此疫苗任一成分或賦形劑過敏或對白喉類毒素過敏的人，均禁止使用沛兒肺炎鏈球菌十三價結合型疫苗。
2. 若有急性嚴重發燒疾病時，應暫緩接種沛兒肺炎鏈球菌十三價結合型疫苗。不過，如果是像感冒這類的輕微感染，則不須因而延後接種疫苗。
Contraindications Hypersensitivity to pneumococcal vaccine or any component of the formula including diphtheria toxoid.
常見副作用發抖、嗜睡、疲倦、發燒、頭痛、皮膚過敏、注射部位疼痛。
Common adverse drug reactionsChills, drowsiness, fatigue, fever, headache, insomnia, irritability, rash, appetite decreased, erythema, limitation of arm motion, pain, swelling, tenderness, arthralgia, myalgia.
Adverse Reactions >10%:
Central nervous system: Chills (adults), drowsiness, fatigue (adults), headache (adults), insomnia, irritability (infants and children)
Dermatologic: Skin rash (adults: >10%; children and infants: >1%; including urticaria-like rash)
Gastrointestinal: Decreased appetite
Local: Erythema at injection site, pain at injection site (adults), swelling at injection site, tenderness at injection site
Neuromuscular & skeletal: Arthralgia (adults), decreased range of motion (arm), myalgia (adults)
Miscellaneous: Fever

1% to 10%:
Dermatologic: Urticaria
Gastrointestinal: Diarrhea, vomiting

<1%, postmarketing, and/or case reports: Anaphylactic shock, anaphylactoid reaction, anaphylaxis, angioedema, apnea, injection site inflammation (dermatitis), injection-site pruritus, crying (abnormal), cyanosis, erythema multiforme, febrile seizures, hypersensitivity reaction (bronchospasm, dyspnea, facial edema), hypotonia, lymphadenopathy (injection site), pallor, seizure, urticaria at injection site


仿單:最常見的副作用是注射部位的局部反應、發燒、不安、食慾減少、睡眠時間增加或減少等。
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.
警語與注意事項注射用藥。
Warnings & precautions肌肉注射。
針劑溶解條件 不需溶解
針劑稀釋條件 不需稀釋
針劑不相容性 目前並沒有藥物不相容性的相關資料，因此沛兒肺炎鏈球菌十三價結合型疫苗絕不可以與其他的藥品混合使用。(1090911仿單資料)
針劑施打條件 肌肉注射。
不可與其他疫苗或藥物混合於同一注射筒。本疫苗應以肌肉注射方式投予。最佳注射位置在嬰兒為大腿前外側的股外側肌 (vastus lateralis muscle)，或是幼童之上臂的三角肌。沛兒肺炎鏈球菌十三價結合型疫苗不可以靜脈輸注方式投予。(1090911仿單資料)
針劑保存安定性 冷藏儲存於2~8°C，不可冷凍。
最近修改日期時間
Updated		9/11/2020 9:34:27 AM
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