藥品名稱
drug name | Typhoid Vi Polysaccharide Vaccine (Typhim Vi ,傷寒 疫苗) 0.5 mL/syringe |
| 藥檔狀態 | 停用 （需冷藏） |
成 份
Ingredient | Typhoid Vi Polysaccharide Vaccine |
| 單位含量 | 0.5 mL/syringe |
| Dosage Forms | Injection, solution [inactivated]:0.5mL/syringe |
| 外觀描述 | 針劑/肌肉注射 |
| Appearance | injection / IM |
標 示
outward | |
廠商名稱
Manufacturer | SANOFI PASTEUR |
製 造 商
Manufacturer | SANOFI PASTEUR LIMITED, France |
字 號
Product ID | 專案進口，無衛署藥字號 |
藥理分類
Pharmacologic Category | Biologic and Immunologic Agents/ Immunizations/ Vaccines-Bacteria (Inactivated) |
作用機轉
Mechanism of action | Virulent strains of Salmonella typhi cause disease by penetrating the intestinal mucosa and entering the systemic circulation via the lymphatic vasculature. One possible mechanism of conferring immunity may be the provocation of a local immune response in the intestinal tract induced by oral ingesting of a live strain with subsequent aborted infection. The ability of S. typhi to produce clinical disease (and to elicit an immune response) is dependent on the bacteria having a complete lipopolysaccharide. The live attenuate Ty21a strain lacks the enzyme UDP-4-galactose epimerase so that lipopolysaccharide is only synthesized under conditions that induce bacterial autolysis. Thus, the strain remains avirulent despite the production of sufficient lipopolysaccharide to evoke a protective immune response. Despite low levels of lipopolysaccharide synthesis, cells lyse before gaining a virulent phenotype due to the intracellular accumulation of metabolic intermediates.
Efficacy: Based on a systematic review and meta-analysis, the estimated 2.5 to 3 year cumulative efficacy was 55% (95% confidence interval [CI]: 30% to 70%) for the injectable vaccine and 48% (CI: 34% to 58%) for the oral vaccine (CDC/ACIP [Jackson 2015]). |
| 用途/適應症 | 預防傷寒。 |
| Use |
Active immunization against typhoid fever caused by Salmonella typhi:
Parenteral: Immunization of adults and children ≧2 years of age; complete the vaccine regimen at least 2 weeks before potential exposure to typhoid bacteria.
Not for routine vaccination. In the United States (CDC/ACIP [Jackson 2015]) and Canada, use should be limited to:
- Travelers to areas with a recognized risk of exposure to S. typhi
- Persons with intimate exposure to a household contact with S. typhi fever or a known carrier
- Laboratory technicians with frequent exposure to S. typhi
Additional recommendations: May consider administration to travelers with achlorhydria, or receiving acid suppression therapy; anatomic or functional asplenia (Canadian Immunization Guide)
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衛福部核准適用症狀
MOHW approved indications |
由疾管署專案進口用於國際旅遊醫療，預防傷寒。
|
| Dose |
Administration: IM
Adult & Children ≧2 years: 0.5 mL (25 mcg) given at least 2 weeks as a single dose prior to expected exposure
Reimmunization if repeated or continued exposure to typhoid fever:
Typhim Vi: 0.5 mL every 2 years
|
懷孕分級
Pregnancy Risk Factor |
C
Lactation: Compatible / Administration does not affect the safety of breastfeeding for the mother or the infant.
|
| 禁忌症 |
對本藥或本藥其他成分過敏者禁用。
|
| Contraindications |
Hypersensitivity to any component of the vaccine.
Canadian immunization guidelines also contraindicate oral typhoid vaccine in pregnancy, acute gastrointestinal condition or inflammatory bowel disease.
|
| 常見副作用 | 全身無力、頭痛、注射部位壓痛或發紅、肌肉壓痛、發燒、皮疹、噁心、嘔吐。 |
| Common adverse drug reactions | Malaise, headache, tenderness or pain at injection site, muscle tenderness, fever, pruritus, nausea and vomiting . |
| Adverse Reactions |
Injection (incidence may vary based on age and/or product used):
>10%:
Central nervous system: Malaise (4% to 24%), headache (16% to 20%), generalized ache (1% to 13%)
Local: Tenderness at injection site (97% to 98%), pain at injection site (27% to 41%), induration at injection site (5% to 15%)
Neuromuscular & skeletal: Muscle tenderness (≦16%)
Miscellaneous: Fever (undefined 2% to 32%)
1% to 10%:
Dermatologic: Pruritus (≦8%)
Gastrointestinal: Nausea (≦8%), vomiting (2%)
Local: Injection site: Erythema at injection site (≦5%), swelling at injection site (≦4%)
Neuromuscular & skeletal: Myalgia (3% to 7%)
Miscellaneous: Fever greater than 100 to 101 degrees (2%)
Postmarketing and/or case reports (Limited to important or life-threatening): Anaphylaxis, angioedema, asthma, diarrhea, flu-like symptoms, Guillain-Barre syndrome, hypersensitivity reaction, intestinal perforation (jejunum), loss of consciousness, lymphadenopathy, neck pain, serum sickness, skin rash, syncope (with and without convulsions)
|
監測
Monitoring |
1.After injection, monitor for anaphylaxis and syncope for 15 minutes following administration
2.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 | 肌肉注射。藥品須冷藏。 |
| Warnings & precautions | 肌肉注射 |
| 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 |
肌肉注射，不可靜脈注射。(1080712仿單資料)
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| 針劑保存安定性 |
2-8℃冷藏儲存，不可冷凍。(1080712仿單資料)
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最近修改日期時間
Updated | 7/12/2019 4:12:34 PM |