藥品名稱
drug name | 公費 Pneumococcal 13-Valent Conjugate Vaccine (Prevenar 13) 沛兒肺炎鏈球菌十三價結合型疫苗 0.5ml/syringe |
| 藥檔狀態 | 使用中 |
成 份
Ingredient | Pneumococcal 13-Valent Conjugate Vaccine |
| 單位含量 | 0.5 mL/Syringe |
| Dosage Forms | Injection, suspension: 2 mcg of each capsular 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 polysorbate 80, and yeast] |
| 外觀描述 | |
| Appearance | |
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 |
字 號
Product ID | 衛署菌疫輸字第000906號 |
藥理分類
Pharmacologic Category | Vaccine; Vaccine, Inactivated (Bacterial) |
作用機轉
Mechanism of action | Promotes active immunization against invasive disease caused by S. pneumoniae capsular serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, all which are individually conjugated to CRM197 protein |
| 用途/適應症 | |
| Use |
Pneumococcal disease prevention:
- Active immunization of infants ≧6 weeks of age, children, adolescents, and adults for prevention of invasive disease caused by Streptococcus pneumoniae serotypes contained in the vaccine
- Active immunization of infants ≧6 weeks of age and children <6 years of age for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F
- Active immunization of adolescents ≧18 years of age and adults for the prevention of pneumonia caused by S. pneumoniae serotypes contained in the vaccine
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衛福部核准適用症狀
MOHW approved indications |
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。 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。 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。
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| 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 |
【Pediatric】
Note: Consult CDC/ACIP annual immunization schedules or National Advisory Committee on Immunization (NACI) guidelines (Canada) for additional information including specific detailed recommendations for catch-up scenarios and/or care of patients with high-risk conditions. According to ACIP, doses administered ≦4 days before minimum interval or age are considered valid; however, local or state mandates may supersede this timeframe (ACIP [Ezeanolue 2020]).
Primary immunization; all patients: Note: Preterm infants should be vaccinated according to their chronological age from birth.
- Infants and Children 6 weeks to 15 months: IM: 0.5 mL per dose for a total of 4 doses given as follows: the first dose may be given as young as 6 weeks of age, but is typically given at 8 weeks (2 months of age); the 3 remaining doses are usually given at 4, 6, and 12 to 15 months of age. The recommended dosing interval is 4 to 8 weeks; dependent upon patient age; the minimum interval between doses in infants <1 year of age is 4 weeks and the minimum interval between the third and fourth dose is 8 weeks
- Canadian recommendations: Healthy infants: IM: May consider a total of three 0.5 mL doses with the first dose administered at 2 months of age, the second dose at 4 months of age, and a third dose at 12 months of age (Canadian National Advisory Committee on Immunizations [NACI] 2016).
Catch-up immunization, healthy patients: ACIP recommendations: Infants and Children 4 months to 6 years: Note: Do not restart the series, refer to current immunization guidelines for specific schedule and timing of dose based on patient age and previous number of doses; IM: 0.5 mL per dose for a total of 1 to 4 doses
High-risk conditions; catch-up or revaccination:
- Infants≧4 months and Children <24 months: For catch-up immunization, refer to Catch-up immunization, healthy patients dosing (CDC/ACIP [Nuorti 2010]).
- Children 2 through 5 years [CDC/ACIP [Nuorti 2010]):
* Pneumococcal vaccine-naive (no previous PCV13): IM: 0.5 mL for a total of 2 doses at least 8 weeks apart
* Previously vaccinated with PCV13:
>> Previously received <3 doses: IM: 0.5 mL dose for a total of 2 doses at least 8 weeks apart and at least 8 weeks after the most recent dose
>> Previously received 3 doses: IM: 0.5 mL as a single dose ≧8 weeks after most recent dose
- Children and Adolescents 6 to 18 years (CDC/ACIP 62[25] 2013):
* Pneumococcal vaccine-naive (no previous PCV13 or PPSV23 vaccine): IM: 0.5 mL as a single dose
* Previously vaccinated with PPSV23 vaccine: If PCV13 has never been administered, give PCV13 vaccine: IM: 0.5 mL as a single dose ≧8 weeks after the last dose of PPSV23 vaccine. The PCV13 vaccine should be administered even if child has previously received PCV7.
【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.
仿單：
適用於：2個月～5歲以下幼童。
接種方法：
6週~6個月嬰兒：接種三劑(每劑至少間隔1個月)，第四劑建議年滿一歲後施打
早產兒(懷孕週數不到37週)：接種三劑(每劑至少間隔1個月)，第四劑建議年滿11月齡後施打
7~11個月嬰兒：接種二劑(每劑至少間隔1個月)，第三劑建議年滿一歲後施打
12~23個月幼兒：接種二劑(每劑至少間隔2個月)
2歲以上兒童：接種一劑
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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：B
UTD:
Animal reproduction studies have not shown adverse fetal effects. Inactivated vaccines have not been shown to cause increased risks to the fetus (ACIP [Ezeanolue 2020]).
仿單:
目前並無任何對孕婦使用肺炎鏈球菌十三價結合型疫苗的資料可供參考，因此，懷孕期間應避免使用沛兒肺炎鏈球菌十三價結合型疫苗。
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[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。]
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| 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。
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| Contraindications |
Severe allergic reaction (eg, anaphylaxis) to pneumococcal vaccine, any component of the formulation, or any diphtheria toxoid-containing vaccine
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| 常見副作用 | |
| Common adverse drug reactions | |
| Adverse Reactions |
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>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
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★高警訊藥品
監測建議 |
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監測
Monitoring |
Monitor for anaphylaxis and syncope for 15 minutes following administration (ACIP [Ezeanolue 2020]). 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 | |
| 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 |
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。(1100113仿單資料)
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| 針劑施打條件 |
應以肌 肉注射方式投予。最好在嬰兒之大腿前外側的股外側肌(vastus lateralis muscle)，或是幼童及成人之上臂的三角肌。沛兒肺炎鏈球菌十價結合 型疫苗不可以靜脈輸注方式投予。(1100113仿單資料)
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| 針劑保存安定性 |
儲存於 2 ~ 8 ℃（冷藏貯存），不可冷凍。開封後需立即使用。
沛兒肺炎鏈球菌十三價結合型疫苗在不超過25°C的溫度下可維持穩定4天。在 這段時間結束時，未使用的沛兒肺炎鏈球菌十三價合型疫苗應予以丟棄。(1100113仿單資料)
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最近修改日期時間
Updated | 1/14/2021 8:53:05 AM |
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現用藥品
Available
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停用藥品
Old item
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藥品仿單
DrugLabeling
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二維條碼
QR code
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