藥品名稱
drug name
Typhim Vi 0.5mL/syringe (Typhoid Vi polysaccharide vaccine), 傷寒疫苗 [專案進口]
藥檔狀態使用中
成  份
Ingredient
Typhoid Vi Polysaccharide Vaccine
單位含量0.5mL/syringe
Dosage FormsInjection, solution [inactivated]: 0.5mL/SYRI
外觀描述 
Appearance 
廠商名稱
Manufacturer
SANOFI PASTEUR
製 造 商
Manufacturer
SANOFI PASTEUR
字  號
Product ID
專案進口,無衛署藥字號
藥理分類
Pharmacologic Category
Vaccine; Vaccine, Inactivated (Bacterial); Vaccine, Live (Bacterial)
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 
Use Typhoid fever prevention: 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)
衛福部核准適用症狀
MOHW approved indications
專案進口,無衛署適應症。由疾管署專案進口用於國際旅遊醫療,預防傷寒。
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 【Adult】
Initial: 0.5 mL given at least 2 weeks prior to expected exposure.

Reimmunization (with repeated or continued exposure to typhoid fever):
- Typhim Vi: 0.5 mL every 2 years (US labeling) or every 3 years (Canadian labeling)


【Pediatric】
IM: Typhim Vi: Children ≧2 years and Adolescents:
- Primary immunization: 0.5 mL given at least 2 weeks prior to expected exposure
- Reimmunization with repeated or continued exposure to typhoid fever: 0.5 mL; optimal schedule has not been established; a single dose every 2 years is currently recommended for repeated or continued exposure

Additional Canadian labeling and recommendations:
M: Children ≧2 years and Adolescents: Reimmunization (with repeated or continued exposure to typhoid fever): Typhim Vi and Typherix (Canadian product): 0.5 mL; a single dose every 3 years (Canadian labeling).


【Geriatric】
Refer to adult dosing.


【Renal Impairment】
There are no dosage adjustments provided in manufacturer`s labeling.


【Hepatic Impairment】
There are no dosage adjustments provided in manufacturer`s labeling.
懷孕分級
Pregnancy Risk Factor
依文獻內容判定系統稽核懷孕分級建置為:C

UpToDate:
Animal reproduction studies have not been conducted. The manufacturer of the Typhim Vi injection suggests delaying vaccination until the second or third trimester if possible. Untreated typhoid fever may lead to miscarriage or vertical intrauterine transmission causing neonatal typhoid (rare).
-----------------------------------------------------------
[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 對本藥或本藥其他成分過敏者禁用。
Contraindications Hypersensitivity to any component of the vaccine. In addition, the oral vaccine is contraindicated with congenital or acquired immunodeficient state, acute febrile illness.

Note: Canadian immunization guidelines also contraindicate oral typhoid vaccine in pregnancy, acute gastrointestinal condition or inflammatory bowel disease.
常見副作用 
Common adverse drug reactions 
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: Abdominal pain, anaphylaxis, angioedema, arthralgia, asthma, diarrhea, dizziness, flu-like symptoms, Guillain-Barre syndrome, hypersensitivity reaction, hypotension, inflammation at injection site (including angioedema and urticaria), intestinal perforation (jejunum), loss of consciousness, lymphadenopathy, malaise, neck pain, serum sickness, skin rash, syncope (with and without convulsions), tremor, urticaria, vasodilation, weakness
★高警訊藥品
監測建議

監測
Monitoring
After injection, monitor for anaphylaxis and syncope for 15 minutes following administration (ACIP [Ezeanolue 2020]). 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 
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 肌肉注射,不可注射到血管內。(1060626 仿單資料)
針劑保存安定性 2-8℃冷藏儲存,不可冷凍。(1060626 仿單資料)
最近修改日期時間
Updated
2/4/2021 1:32:22 PM
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