藥品名稱
drug name		ADACEL 0.5 ml/vial 自費巴斯德三合一補追疫苗
藥檔狀態使用中
成　　份
Ingredient		Tetanus, diphtheria, pertussis vaccine
單位含量0.5 ml
Dosage FormsInjection, suspension:0.5mL/vial
外觀描述 
Appearance 
廠商名稱
Manufacturer		賽諾菲股份有限公司
製 造 商
Manufacturer		Sanofi Pasteur Limited
字　　號
Product ID		衛署菌疫輸字第000840號
藥理分類
Pharmacologic Category		Vaccine; Vaccine, Inactivated (Bacterial)
作用機轉
Mechanism of action		Promotes active immunity to diphtheria, tetanus, and pertussis by inducing production of specific antibodies.
用途/適應症 
Use Diphtheria, tetanus, and pertussis disease prevention
Adacel(Tdap): Active booster immunization against diphtheria, tetanus, and pertussis in persons 10 to 64 years of age; wound management for the prevention of tetanus.
衛福部核准適用症狀
MOHW approved indications		 適用於4-64歲間之追加疫苗接種，以預防白喉、破傷風、百日咳
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】
[Lexicomp]
Note:?Tdap vaccines (Adacel, Boostrix) are used in patients ?7 years of age; DTaP vaccines (Daptacel, Infanrix) are for use in pediatric patients 6 weeks to <7 years of age. Tdap vaccines contain less diphtheria toxoid and pertussis antigens per dose than DTaP vaccines; the vaccines are not interchangeable. Tdap can be administered regardless of the interval between the last tetanus or diphtheria toxoid-containing vaccine. Tdap or Td can be used for most adults when tetanus vaccination is recommended. Pregnant females should receive a single dose of Tdap dose during each pregnancy (preferably during the early part of 27 to 36 weeks’ gestation) regardless of previous vaccination status (CDC/ACIP [Havers 2020]; CDC/ACIP [Liang 2018]).

．Catch-up immunization (CDC/ACIP [Havers 2020]; CDC/ACIP [Liang 2018]):?Tdap (Adacel, Boostrix):?
　IM:?0.5 mL as a 3-dose series at 0, ?4 weeks, and 6 to 12 months later. At least 1 dose should be Tdap; preferably dose 1, with either Td or Tdap appropriate for doses 2 and 3.?Note:?For persons who have never received a pertussis-, tetanus-, or diphtheria-containing vaccine.

．Booster immunization (CDC/ACIP [Havers 2020]; CDC/ACIP [Liang 2018]):?Tdap (Adacel, Boostrix):?
　IM:?0.5 mL per dose. Any patient who has not previously received a dose of Tdap should receive a dose of Tdap, regardless of interval since last tetanus- or diphtheria-containing vaccine. A booster dose of either Td or Tdap should be administered every 10 years throughout life.

．Tetanus prophylaxis in wound management (CDC/ACIP [Havers 2020]; CDC/ACIP [Liang 2018]):?
　IM:?Tetanus prophylaxis in patients with wounds should be based on if the wound is clean or contaminated and the immunization status of the patient, including time from last tetanus-containing vaccine. Wound management includes use of tetanus toxoid and/or tetanus immune globulin (TIG) where appropriate, wound cleaning, and (if required) surgical debridement and the proper use of antibiotics. Patients with an uncertain or incomplete tetanus immunization status should have additional follow up to ensure a series is completed. Patients with a history of Arthus reaction following a previous dose of a tetanus toxoid-containing vaccine should not receive a tetanus toxoid-containing vaccine until >10 years after the most recent dose even if they have a wound that is neither clean nor minor.

【Pediatric】
[Lexicomp]
Note:?Consult CDC/ACIP annual immunization schedules 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:?CDC (ACIP) Recommendations:
Infants and Children 6 weeks to <7 years:?Note:?Whenever possible, the same product should be used for all doses. Preterm infants should be vaccinated according to their chronological age from birth.
#DTaP (Daptacel, Infanrix): IM: 0.5 mL per dose for a total of 5 doses administered as follows (CDC/ACIP [Liang 2018]):
●Three doses (primary series): Usually given at 2, 4, and 6 months of age; may be given as early as 6 weeks of age and repeated every 4 to 8 weeks.
●Fourth dose (first booster): Given at ~15 to 18 months of age but at least 6 months after third dose. The fourth dose may be given as early as 12 months of age.?Note:?If the fourth dose is inadvertently administered early (≧4 months from the third dose instead of 6 months) and the child is ≧1 year of age, then the fourth dose does not need repeated.
● Fifth dose (second booster): Given at 4 to 6 years of age, prior to starting school or kindergarten; if the fourth dose is given at ≧4 years of age, the fifth dose may be omitted

Catch-up immunization:?CDC (ACIP) Recommendations (CDC/ACIP [Havers 2020]; CDC/ACIP [Liang 2018]):?Note:?Do not restart the series. If doses have been given, begin the below schedule at the applicable dose number.
#Infants and Children who start primary immunization series ≧4 months of age through 6 years (prior to 7th birthday): DTaP (Daptacel, Infanrix): IM: 0.5 mL per dose for a total of 4 to 5 doses depending on number of previous doses and age.
#Children ≧7 years and Adolescents not fully vaccinated against pertussis, or whose vaccination status is not known: Tdap: IM: 0.5 mL as first dose of the catch-up series; if additional doses are needed per catch-up schedule, either Tdap or Td may be used (CDC/ACIP [Havers 2020]).
##Note:?If DTaP was inadvertently given as catch-up dose to a undervaccinated child 7 to 9 years of age, it should count as a Tdap dose in the catch-up series (CDC/ACIP [Havers 2020]).

Booster immunization?(Adacel): Children ≧10 years and Adolescents:?Note:?Tdap can be administered regardless of the interval between the last acellular pertussis, tetanus, or diphtheria toxoid-containing vaccine.
#Children ≧10 years and Adolescents: Tdap (Adacel, Boostrix): IM: 0.5 mL as a single routine booster dose at age 11 or 12 years in children who have completed a childhood vaccination series, followed by additional booster doses of either Td or Tdap every 10 years (CDC/ACIP [Havers 2020]).
##Note:?If Tdap was given either inadvertently or used as part of catch-up dosing at 7 to 9 years of age, it should?not?be counted as the adolescent booster dose and the child should still receive a Tdap booster between ages 11 to 12 years. At age ≧ 10 years, Tdap doses given as part of catch-up series or DTaP doses given inadvertently may count as the adolescent Tdap dose (CDC/ACIP [Havers 2020]).

Tetanus prophylaxis in wound management?(CDC/ACIP [Havers 2020]; CDC/ACIP [Liang 2018]):
#Infants ≧6 weeks and Children ≦6 years: DTaP (Daptacel, Infanrix): Administration of dose should be determined based on patient`s current immunization status with the primary immunization or catch-up dosing series to ensure appropriate minimum dosing intervals maintained; should count as the next dose in the series.
#Children ≧7 years and Adolescents: Tdap (Adacel): IM: 0.5 mL as a single dose.

Tetanus prophylaxis in patients with wounds should be based on if the wound is clean or contaminated and the immunization status of the patient, including time from last tetanus-containing vaccine. Wound management includes use of tetanus toxoid and/or tetanus immune globulin (TIG) where indicated, wound cleaning, and (if required) surgical debridement and the proper use of antibiotics. Patients with an uncertain or incomplete tetanus immunization status should have additional follow-up to ensure a series is completed. Patients with a history of Arthus reaction following a previous dose of a tetanus toxoid-containing vaccine should not receive a tetanus toxoid-containing vaccine until >10 years after the most recent dose even if they have a wound that is neither clean nor minor.

1100621仿單資料
4歲以下的兒童不可接種ADACELR。

【Geriatric】
[Lexicomp]
Booster Immunization:?IM: Adults ?65 years of age:
The Advisory Committee on Immunization Practices (ACIP) recommendations: Refer to adult dosing. In adults ?65 years of age Boostrix should be used if feasible; however, ACIP has concluded that either Tdap vaccine (Boostrix or Adacel) may be used (CDC/ACIP [Havers 2020]; CDC/ACIP [Liang 2018]).

Manufacturer`s labeling: Boostrix: 0.5 mL as a single dose, administered ?5 years after last dose of tetanus toxoid, diphtheria toxoid, and/or pertussis-containing vaccine if received.

Wound management:?IM: Refer to adult dosing.

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

【Hepatic Impairment】
There are no dosage adjustments provided in the manufacturer’s labeling.
懷孕分級
Pregnancy Risk Factor		 [Lexicomp]
In general, maternal use of inactivated vaccines is not associated with increased risks to the fetus (ACIP [Kroger 2021]). In addition, an increased risk of adverse maternal or fetal outcomes, including miscarriage or major birth defects, has not been observed following maternal use of the Tdap vaccine (CDC [Havers 2020]; Moro 2016; Zheteyeva 2012).

All pregnant females should receive a single dose of Tdap during each pregnancy, regardless of previous vaccination status, preferably during the early part of 27 of 36 weeks gestation. Alternately, administration of Tdap can be given immediately postpartum to all females who have not previously been vaccinated with Tdap in order to protect the mother and infant from pertussis (ACIP [Kroger 2021]; CDC/ACIP [Liang 2018]). In case of an ongoing local pertussis epidemic, pregnant females should be vaccinated with Tdap for their own protection as is recommended for nonpregnant females, regardless of fetal gestational age. In addition, if a tetanus toxoid-containing vaccine is needed as standard care for wound management, Tdap is preferred over Td, regardless of fetal gestational age if otherwise indicated. However, if Tdap is used prior to 27 to 36 weeks gestation in these instances, females should not receive more than 1 dose during the same pregnancy (ACOG 718 2017; CDC/ACIP [Havers 2020]).

1100621仿單資料
根據有限的臨床數據顯示，母體在懷孕期間接種ADACEL會干擾出生後嬰兒對其他抗原（例如，白喉、破傷風、小兒麻痺、肺炎鏈球菌）的免疫反應。然而，大多數個案的抗體濃度都維持在具有保護效果的閾值之上。這項觀察的臨床關性尚不清楚。
-----------------------------------------------------------
[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 1. 過敏
已知對ADACELR 的任何成分有全身性過敏反應者，或先前接種本疫苗或接種含有與本疫苗相同的一種或多種成分之某種疫苗後曾出現威脅生命反應者（參閱劑型、組成及包裝），禁止接種ADACELR。若不確定是疫苗中的那種成分引起過敏，則任何成分都不應注射。若仍考慮給予這類病患接種疫苗，應請過敏專科醫師進行評估。
2. 急性精神疾患
施打前一劑含有百日咳的疫苗後，若在7日內出現腦病變（例如，昏迷、意識不清、癲癇發作時間延長）且無法將其歸咎於任何可辨識之病因，則任何含有百日咳之疫苗應禁止使用，包括ADACELR在內。
Contraindications Hypersensitivity to diphtheria toxoid-, tetanus toxoid-, or pertussis-containing vaccine, or any component of the formulation; progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy ; encephalopathy occurring within 7 days of a previous dose of a pertussis-containing vaccine and not attributable to another cause.
常見副作用 
Common adverse drug reactions 
Adverse Reactions [Lexicomp]
Tdap (>10 years).?Adverse reactions may be reported with use of other concomitant vaccines. Adverse reactions occurred with adolescents and adults unless otherwise specified.

>10%:
　-Endocrine & metabolic: Increased arm circumference (adolescents: 1% to 28%)
　-Gastrointestinal: Gastrointestinal signs and symptoms (adolescents: 26%; adults: 8% to 16%), nausea (9% to 13%)
　-Local: Erythema at injection site (6% to 38%; older adults: 11%), pain at injection site (61% to 87%; older adults: 22%), swelling at injection site (7% to 24%; older adults: 8%)
　-Nervous system: Body pain (?30%), chills (8% to 15%), fatigue (24% to 37%; older adults: 13%), headache (30% to 44%; older adults: 12%), malaise (adults: 33%), myasthenia (?30%)
　-Neuromuscular & skeletal: Arthralgia (?11%), joint swelling (?11%), myalgia (58%)
　-Miscellaneous: Fever (?14%; older adults: ?2%)

1% to 10%:
　-Dermatologic: Skin rash (2% to 3%)
　-Gastrointestinal: Diarrhea (10%), vomiting (3% to 5%)
　-Hematologic & oncologic: Benign lymph node hyperplasia (7%)

Postmarketing:
　-Cardiovascular: Myocarditis, swelling of injected limb (including extensive swelling and swelling of adjacent joints), syncope
　-Dermatologic: Cellulitis, erythema of skin, erythematous rash, macular eruption, maculopapular rash, pruritus, rash at injection site, urticaria
　-Hematologic & oncologic: Henoch-Schonlein purpura, lymphadenitis, lymphadenopathy, thrombocytopenia
　-Hypersensitivity: Anaphylaxis, angioedema, arthus reaction, hypersensitivity reaction, nonimmune anaphylaxis
　-Infection: Sterile abscess
　-Local: Abscess at injection site, bruising at injection site, cellulitis at injection site, induration at injection site, inflammation at injection site, injection site nodule, injection site pruritus, residual mass at injection site, warm sensation at injection site
　-Nervous system: Encephalitis, encephalopathy, facial nerve paralysis, Guillain-Barre syndrome, hypoesthesia, hypotonia, loss of consciousness, neuritis (brachial), paresthesia, partial epilepsy, screaming, tonic clonic epilepsy
　-Neuromuscular & skeletal: Back pain, muscle spasm, myelitis, myositis
　-Respiratory: Bronchitis, cough, cyanosis, respiratory tract infection
　-Miscellaneous: Febrile seizures, hypotonic/hyporesponsive episode, sudden infant death syndrome
★高警訊藥品
監測建議
監測
Monitoring		 Monitor for syncope for 15 minutes following administration (ACIP [Kroger 2017]). 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 不需溶解。(1100621仿單資料)
針劑稀釋條件 不需稀釋。(1100621仿單資料)
針劑不相容性 (1100621仿單資料)(1090609仿單資料)
針劑施打條件 肌肉注射。不需稀釋。不可分次給予(劑量<0.5mL)。不可皮下、皮內、臀部、靜脈注射。(1100621仿單資料)
針劑保存安定性 儲存於2-8℃之間，不可冷凍。(1100621仿單資料)
最近修改日期時間
Updated		6/21/2021 9:19:47 AM
台北新店
現用藥品
現用藥品 Available

停用藥品
停用藥品 Old item

View 藥品仿單
藥品仿單 DrugLabeling


二維條碼 QR code