藥品名稱
drug name | Pneumococcal vaccine 25ug/0.5ml/syr (Pneumovax
23) 紐蒙肺多價性肺炎鏈球菌疫苗 |
| 藥檔狀態 | 使用中 |
成 份
Ingredient | Pneumococcal vaccine |
| 單位含量 | 25ug/0.5ml/syr |
| Dosage Forms | 25ug/0.5ml/syr |
| 顏 色 | |
| Color | |
| 形 狀 | |
| Shape | |
| 劑 型 | 注射/針劑 |
| Dose Form | |
大 小
Size | |
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 | MERCK SHARP & DOHME CORP. |
字 號
Product ID | 衛署菌疫輸字第000492號 |
藥理分類
Pharmacologic Category | Immunological Agent/Vaccine |
作用機轉
Mechanism of action | Although there are more than 80 known pneumococcal capsular types, pneumococcal disease is mainly caused by only a few types of pneumococci. Pneumococcal vaccine contains capsular polysaccharides of 23 pneumococcal types of Streptococcal pneumoniae which represent at least 85% to 90% of pneumococcal disease isolates in the United States. The pneumococcal vaccine with 23 pneumococcal capsular polysaccharide types became available in 1983. The 23 capsular pneumococcal vaccine contains purified capsular polysaccharides of pneumococcal types 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F. These are the main pneumococcal types associated with serious infections in the United States. |
| 用途/適應症 | 肺炎疫苗 |
| Use |
預防肺炎鏈球菌性肺炎及肺炎鏈球菌性菌血症。
|
衛福部核准適用症狀
MOHW approved indications |
預防肺炎鏈球菌性肺炎及肺炎鏈球菌性菌血症。
|
| 常用劑量 | 立刻使用25ug
(藥品劑量會因人或病情增減，請依照醫師指示服用。) |
| Dose |
1 dose (0.5 mL) IM or subQ
|
懷孕分級
Pregnancy Risk Factor |
仿單資料：
懷孕危險等級：C：尚無以PNEUMOVAX 23進行之動物生殖試驗。目前亦不知懷孕婦女注射PNEUMOVAX 23後是否會造成胎兒的傷害或影響其生育力。只有在明確知道必要施打本疫苗的情況下，孕婦才能注射本疫苗。
-
[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 |
不可用於對本疫苗內任何成份過敏者。若對疫苗內的任何成份發生急性過敏反應時必須馬上注射Epinephrine(濃度1:1000)。
|
| Contraindications |
Hypersensitivity to pneumococcal vaccine or any component of the formulation
|
| 常見副作用 | |
| Common adverse drug reactions | |
| Adverse Reactions |
Common
Dermatologic: Erythema at injection site (16.4% to 34.5% ), Injection site edema, Injection site induration, Injection site pain (60% to 77.2% .), Injection site reaction
Musculoskeletal: Myalgia (11.9% to 17.3% )
Neurologic: Asthenia, Headache (17.6% to 18.1% )
Other: Fatigue
|
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.
|
| 警語與注意事項 | 冷藏保存。 |
| Warnings & precautions | |
| 針劑溶解條件 |
|
| 針劑稀釋條件 |
|
| 針劑不相容性 |
|
| 針劑施打條件 |
須於皮下或肌肉注射(最好於上臂三角肌或大腿中段外側部位)，且須加注意避免靜脈注射。
|
| 針劑保存安定性 |
須存放在2-8°C。
|
最近修改日期時間
Updated | 10/3/2023 1:10:50 PM |