藥品名稱
drug name | Poliovirus Vaccine Inactivated (Imovax Polio Injection, 巴斯德小兒麻痺注射疫苗) 0.5 mL/syringe (旅遊醫學門診專用) |
| 藥檔狀態 | 停用 （需冷藏） |
成 份
Ingredient | Poliovirus Vaccine Inactivated |
| 單位含量 | 0.5 mL/syringe |
| Dosage Forms | Suspension for Injection: 0.5 ml [Suspension of 3 types of poliomyelitis virus cultured on the Vero continuous cell line and inactivated with formol] |
| 外觀描述 | 針劑/注射 |
| Appearance | IM, SC |
標 示
outward | |
廠商名稱
Manufacturer | 賽諾菲股份有限公司 |
製 造 商
Manufacturer | SANOFI PASTEUR, FRANCE |
字 號
Product ID | 衛署菌疫輸字第000440號 |
藥理分類
Pharmacologic Category | BIOLOGIC AND IMMUNOLOGIC AGENTS/ Immunizations/ Vaccines-Virus (Inactivated) |
作用機轉
Mechanism of action | As an inactivated virus vaccine, poliovirus vaccine induces active immunity against poliovirus types 1, 2, and 3 infection |
| 用途/適應症 | 小兒麻痺疫苗 |
| Use |
Poliovirus prevention:
Active immunization of infants (≧6 weeks [US labeling]; ≧2 months [Canadian labeling]), children, adolescents, and adults for prevention of poliomyelitis caused by poliovirus types 1, 2, and 3.
ACIP recommends routine vaccination for the following:
All infants and children (first dose given at 2 months of age) (CDC/ACIP, 58[30] 2009)
|
衛福部核准適用症狀
MOHW approved indications |
預防小兒麻痺症。
|
| Dose |
Administration: IM, SC
【Adults】:
Un-vaccinated and increased risk of exposure: 3 doses at 0, 1-2, 6-12 months.
Incompletely vaccinated: with at least 1 previous dose of OPV, <3 doses of IPV, or a combination of OPV and IPV equaling <3 doses, administer at least one 0.5 mL dose of IPV. Additional doses to complete the series may be given if time permits.
Completely vaccinated and at increased risk of exposure: One 0.5 mL dose
【Children & infants, IPV regimen】: 4 doses at 2, 4, 6-18 m/o and booster dose at 4-6 y/o.
|
懷孕分級
Pregnancy Risk Factor |
C
|
| 禁忌症 |
對疫苗中之主成分或其他成分、neomycin、steptomycin和polymyxine B過敏，或先前施打本疫苗後有過敏反應。
有發燒或急性疾病時，應延後使用疫苗。
|
| Contraindications |
Defer vaccination for persons with acute febrile illness until recovery
|
| 常見副作用 | 注射部位泛紅/疼痛、發燒、疲倦、食慾不振、嘔吐、躁動。 |
| Common adverse drug reactions | Tenderness or swelling of injection site, fever, tiredness, anorexia, vomiting, irritability. |
| Adverse Reactions |
Percentages noted with concomitant administration of DTP or DTaP vaccine and observed within 48 hours of injection.
>10%:
Central nervous system: Irritability (7% to 65%; most common in infants 2 months of age), tiredness (4% to 61%)
Gastrointestinal: Anorexia (1% to 17%)
Local: Injection Site: Tenderness (≦ 29%), swelling (≦11%)
1% to 10%:
Central nervous system: Fever >39°C (≦ 4%)
Gastrointestinal: Vomiting (1% to 3%)
Local: Injection site: Erythema (≦ 3%)
Miscellaneous: Persistent crying (≦ 1% reported within 72 hours)
Postmarketing and/or case reports (Limited to important or life-threatening): Allergic reaction, anaphylactic shock, anaphylaxis, febrile seizures, hypersensitivity reactions, lymphadenopathy, seizures; Guillain-Barre syndrome has been temporally related to another inactivated poliovirus vaccine
|
監測
Monitoring |
Monitor for syncope for 15 minutes following administration (NCIRD/ACIP 2011). 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；不可口服 |
| Warnings & precautions | Store under refrigeration 2°C to 8°C. |
| 針劑溶解條件 |
|
| 針劑稀釋條件 |
|
| 針劑不相容性 |
|
| 針劑施打條件 |
|
| 針劑保存安定性 |
應冷藏(2-8℃)且避光儲存。請勿冷凍。(1050815仿單資料)
|
最近修改日期時間
Updated | 9/27/2019 10:51:11 AM |