藥品名稱
drug name | RotaTeq (Rotavirus Vaccine, Live, Oral, Pentavalent; 輪達停口服活性五價輪狀病毒疫苗) 2 mL/vial |
| 藥檔狀態 | 使用中 （需冷藏） |
成 份
Ingredient | Rotavirus Vaccin |
| 單位含量 | 2 mL/vial |
| Dosage Forms | Suspension, oral [preservative free]: G1 ≥2.2×106 infectious units, G2 ≥2.8×106 infectious units, G3 ≥2.2×106 infectious units, G4 ≥2.0×106 infectious units, and P1≥2.3×106 infectious units (2 mL) [bovine and human derived; available in a prefilled, ready-to-use dosing tube] |
| 外觀描述 | 口服/懸浮液劑 |
| Appearance | |
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 & CO.,INC. |
字 號
Product ID | 衛署菌疫輸字第000825號 |
藥理分類
Pharmacologic Category | Biologic and Immunologic Agents/ Immunizations/ Vaccines-Virus (Live) |
作用機轉
Mechanism of action | Live viral vaccine that replicates in the small intestine and induces active immunity |
| 用途/適應症 | 輪狀病毒疫苗 |
| Use |
Immunization to prevent rotavirus gastroenteritis caused by serotypes GI, G2, G3, and G4
|
衛福部核准適用症狀
MOHW approved indications |
預防輪狀病毒所引起的腸胃炎(G1、G2、G3、G4，以及含有P1之G血清型如G9)。
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| Dose |
Pediatrics:
2 mL per dose. Recommended schedule: A three-dose series with initial dose administered at 6-12 weeks of age; subsequent two doses administered at 4-10 week intervals (final third dose should not be given after 32 weeks of age)
|
懷孕分級
Pregnancy Risk Factor |
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| 禁忌症 |
1.已知對此疫苗之任何成分有過敏病史者。
2.接種一劑RotaTeq後出現過敏症狀之嬰兒。
|
| Contraindications |
Hypersensitivity to rotavirus vaccine or any component of the formulation; use in infants with severe combined immunodeficiency disease (SCID)
|
| 常見副作用 | 嘔吐、腹瀉、中耳炎 |
| Common adverse drug reactions | vomiting, diarrhea, ear pain or discharge |
| Adverse Reactions |
Fever, irritability, gastroenteritis, vomiting, diarrhea, urinary tract infection, otitis media, bronchiolitis, pneumonia, bronchospasm, nasopharyngitis
|
監測
Monitoring |
|
| 警語與注意事項 | 僅供口服；切勿注射投予。 |
| 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 |
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| 針劑保存安定性 |
冷藏保存
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最近修改日期時間
Updated | 7/2/2014 6:04:35 PM |