藥品名稱
drug name | RotaTeq (Rotavirus Vaccine, Live, Oral, Pentavalent) 2ml/vial,輪達停口服活性五價輪狀病毒疫苗 |
| 藥檔狀態 | 使用中 |
成 份
Ingredient | Rotavirus Vaccine |
| 單位含量 | 2ml/vial |
| Dosage Forms | 2ml/vial |
| 外觀描述 | |
| Appearance | |
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.美國默克藥廠 |
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 | A live vaccine; replicates in the small intestine and promotes active immunity to rotavirus gastroenteritis. Rotarix is specifically indicated for prevention of rotavirus gastroenteritis caused by serotypes G1, G3, G4, and G9 and RotaTeq is specifically indicated for prevention of rotavirus gastroenteritis caused by serotypes G1, G2, G3, G4, and G9. However, these vaccines may provide immunity to other rotavirus serotypes. |
| 用途/適應症 | |
| Use |
Rotavirus gastroenteritis prevention:
Prevention of rotavirus gastroenteritis in infants 6 to 32 weeks of age caused by the serotypes G1, G2, G3, G4, and G9 when administered as a 3-dose series.
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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P1Ａ〔8〕之G血清型如G9)。
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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 |
Dosage: 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 [Kroger 2021]).
#Primary immunization:
The ACIP recommends completing the vaccine series with the same product whenever possible. If continuing with same product will cause vaccination to be deferred, or if product used previously is unknown, vaccination should be completed with the product available. If RotaTeq was used in any previous doses, or if the specific product used was unknown, a total of 3 doses should be given (CDC/ACIP [Cortese 2009]).
RotaTeq: Infants 6 to 32 weeks of age: Oral: 2 mL per dose for 3 doses, the first dose given at 6 to 12 weeks of age, followed by subsequent doses at 4- to 10-week intervals. Administer all doses by 32 weeks of age.
ACIP recommendations (CDC/ACIP [Cortese 2009]): The first dose can be given at 6 weeks through 14 weeks 6 days of age. The series should not be started in infants 15 weeks. The final dose in the series should be administered by 8 months 0 days of age. The minimum interval between doses is 4 weeks. RotaTeq should be given in 3 doses administered at 2, 4, and 6 months of age. For infants inadvertently administered rotavirus vaccine at 15 weeks of age, the vaccine series may be completed according to schedule. Infants who have had rotavirus gastroenteritis before getting the full course of vaccine should still initiate or complete the recommended schedule; initial infection provides only partial immunity.
#Catch-up immunization: ACIP Recommendations (CDC/ACIP [Cortese 2009]): Oral: Note: Do not restart the series. If doses have been given, begin the catch-up schedule at the applicable dose number and separate doses by 4 weeks; total 3 doses. The series should not be started in infants 15 weeks and 0 days. The final dose in the series should be administered by 8 months 0 days of age. For infants inadvertently administered rotavirus vaccine at 15 weeks of age, the vaccine series should be completed according to schedule and prior to 8 months and 0 days of age. If RotaTeq was used in any previous doses, or if the specific product used was unknown, a total of 3 doses should be given.
Dosing: Renal & Hepatic Impairment: Pediatric
There are no dosage adjustments provided in the manufacturer`s labeling.
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懷孕分級
Pregnancy Risk Factor |
FDA: C
Rotavirus vaccine is not indicated for use in women of reproductive age. Infants living in households with pregnant women may be vaccinated (CDC/ACIP [Cortese 2009]).
仿單: RotaTeq 是一小兒疫苗，不適用於成人。目前沒有以婦女或動物為對象之適當、對照良好的研究。(1100623 仿單資料)
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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.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，不應再接種RotaTeq。
3.有嚴重複合型免疫缺乏症(Individuals with Severe Combined Immunodeficiency Disease, SCID)者。在上市後報告中曾有嚴重複合型免疫缺乏症的嬰兒發生與疫苗病毒相關之腸胃炎案例。(1080822仿單資料)
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| Contraindications |
Hypersensitivity to rotavirus vaccine or any component of the formulation; history of uncorrected congenital malformation of the GI tract (such as Meckel diverticulum) that would predispose the infant for intussusception (Rotarix only); history of intussusception; severe combined immunodeficiency disease.
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| 常見副作用 | |
| Common adverse drug reactions | |
| Adverse Reactions |
Ranges reported; actual percentage may vary between products.
>10%:
Central nervous system: Irritability (≦52%)
Gastrointestinal: Diarrhea (4% to 24%), vomiting (3% to 15%)
Otic: Otitis media (15%)
Miscellaneous: Fussiness (≦52%)
1% to 10%:
Gastrointestinal: Flatulence (2%)
Respiratory: Nasopharyngitis (7%), bronchospasm (1%)
<1%, postmarketing, and/or case reports: Anaphylaxis, angioedema, gastroenteritis (with severe diarrhea and prolonged vaccine viral shedding in infants with SCID), hematochezia, immune thrombocytopenia (ITP), intussusception, Kawasaki syndrome, secondary infection (transmission of vaccine virus from recipient to nonvaccinated contacts), seizure, urticaria
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★高警訊藥品
監測建議 |
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監測
Monitoring |
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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 |
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| 針劑施打條件 |
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| 針劑保存安定性 |
2-8℃下避光儲存，離開冷藏狀態後應盡快投予。應依當地法規拋棄於經過核准的生物廢棄物容器中。(1100623仿單資料)
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最近修改日期時間
Updated | 6/23/2021 4:27:31 PM |
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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
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