藥品名稱
drug name
Cervarix 0.5ml/vial (Human Papillomavirus Vaccine Type 16/18)保蓓人類乳突病毒第16/18型疫苗
藥檔狀態使用中
成  份
Ingredient
Human Papillomavirus Vaccine Type 16/18
單位含量0.5ml/vial
Dosage FormsInjection, suspension [preservative free]: HPV 16 L1 protein 20 mcg and HPV 18 L1 protein 20 mcg per 0.5 mL (0.5 mL) [contains aluminum, rubber in prefilled syringe; manufactured using Trichoplusia ni (insect cells)]
外觀描述 
Appearance 
廠商名稱
Manufacturer
荷商葛蘭素史克藥廠股份有限公司台灣分公司
製 造 商
Manufacturer
GlaxoSmithKline Biologicals s.a.
字  號
Product ID
衛署菌疫輸字第000856號
藥理分類
Pharmacologic Category
Vaccine; Vaccine, Inactivated (Viral)
作用機轉
Mechanism of action
Contains inactive human papillomavirus (HPV) proteins HPV 16 L1, and HPV 18 L1 which produce neutralizing antibodies to prevent cervical cancer, cervical adenocarcinoma, and cervical neoplasia cause by HPV.

Efficacy: HPV2 has shown to be 95% to 99% effective against HPV types 16 and 18-related cervical disease in females 15 to 25 years of age. In addition, vaccination against HPV types 16 and 18 may prevent ~70% of anogenital cancers and 60% of high-risk precancerous cervical lesions (NACI 2017).
用途/適應症 
Use Prevention of human papillomavirus infection: Prevention in females 9 to 45 years of age of the following diseases caused by oncogenic HPV types 16 and 18: Cervical cancer, cervical intraepithelial neoplasia (CIN) grades 1 to 3 and cervical adenocarcinoma in situ

The Canadian National Advisory Committee on Immunization (NACI) recommends routine vaccination for females between 9 and 26 years of age. It should not be administered in females <9 years but may be administered to females >26 years who are at ongoing risk of exposure (NACI 2017).
衛福部核准適用症狀
MOHW approved indications
Cevarix為一適合9-25歲女性施打之疫苗,可用以預防致癌性人類乳突病毒(HPV)第16 型、第18型所引起之病變: 1.子宮頸癌 2.第2級與第3級子宮頸上皮內贅瘤(CIN)和子宮頸原位腺癌(AIS) 3.第1級子宮頸上皮內贅瘤(CIN) 4.第1級外陰上皮內贅瘤及第1級陰道上皮內贅瘤(VIN/ValN) Cervarix亦可用於26歲以上女性預防致癌性人類乳突病毒(HPV)第16型、第18型所引起之第1級子宮頸上皮內贅瘤(CIN)。
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】
Prevention of human papillomavirus infection: IM: Females≦45 years: 0.5 mL at 0, 1, and 6 months. Administer the second dose 1 to 2.5 months after the first dose; administer the third dose 5 to 12 months after the first dose.

NACI recommendations: Recommended for females≦26 years; may be given to those≧27 years who are at ongoing risk (NACI 2017).

【Pediatric】
Note: Bivalent HPV vaccine has been discontinued from the US market; other HPV vaccines should be used for immunization. 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 [Ezeanolue 2020]).

Primary immunization:
- CDC (ACIP) recommendations: In a 2-dose series, the minimum interval between the first and second dose is 5 months. In a 3-dose schedule, minimum interval between first and second doses is 4 weeks; the minimum interval between the second and third dose is 12 weeks; the minimum interval between first and third doses is 5 months (CDC/ACIP [Meites 2016])
*Non-immunocompromised patients and certain specified medical conditions: Asplenia, asthma, chronic granulomatous disease, chronic liver disease, chronic lung disease, chronic renal disease, central nervous system anatomic barrier defects (eg, cochlear implant), complement deficiency, diabetes, heart disease, or sickle cell disease:
>>> Children≧9 years and Adolescents <15 years: Females: 2-dose series: IM: 0.5 mL at 0, and 6 to 12 months. Administer first dose at age 11 to 12 years; for patients with any history of sexual abuse or assault, vaccination should be started at 9 years of age
>>> Adolescents≧15 years: Females: 3-dose series: IM: 0.5 mL at 0, 1 to 2, and 6 months
* Immunocompromised patients including those with immunocompromising conditions that might reduce cell-mediated or humoral immunity, such as B lymphocyte antibody deficiencies, T lymphocyte complete or partial defects, HIV infection, malignant neoplasms, transplantation, autoimmune disease, or immunosuppressive therapy): Children≧9 years and Adolescents: Females: 3 dose series: IM: 0.5 mL at 0, 1 to 2, and 6 months
- Manufacturer`s labeling: Females: Children≧9 years and Adolescents: IM: 0.5 mL per dose for a total of 3 doses. Administer the second and third doses at 1 and 6 months after initial dose.

【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
依文獻內容判定系統稽核懷孕分級建置為:B

UTD:
Administration of the human papillomavirus vaccine during pregnancy is not recommended. Although exposure to human papillomavirus vaccine has not been causally associated with adverse pregnancy outcomes, until additional information is available the vaccine series (or completion of the series) should be delayed until pregnancy is completed (NACI 2017).

仿單:
從臨床試驗、懷孕資料庫和流行病學試驗中的懷孕婦女資料中,並無發現接種Cervarix會增加新生兒包括生育缺陷在內的不正常情況。並無足夠的資料顯示接種Cervarix是否會增加流產的風險。預計懷孕或懷孕婦女應將接種疫苗的時間延後到懷孕狀態結束之後。
-----------------------------------------------------------
[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 Cervarix不可用於已知對此疫苗之任何成分過敏者
Contraindications Hypersensitivity to any component of the formulation
常見副作用 
Common adverse drug reactions 
Adverse Reactions The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:
Central nervous system: Fatigue (55%)
Local: Pain at injection site (92%), erythema at injection site (48%), swelling at injection site (44%)
Neuromuscular & skeletal: Myalgia (49%), arthralgia (21%)

1% to 10%:
Dermatologic: Urticaria (7%), injection site pruritus (1%)
Genitourinary: Vaginal infection (1%)
Infection: Influenza (3%), infection (chlamydia: 2%)
Respiratory: Nasopharyngitis (4%), pharyngolaryngeal pain (3%), pharyngitis (2%)

<1%, postmarketing, and/or case reports: Anaphylactoid reaction, anaphylaxis, angioedema, erythema multiforme, hypersensitivity reaction, induration at injection site, lymphadenopathy, paresthesia (local), syncope (may be associated with tonic-clonic movements), vasodepressor syncope
★高警訊藥品
監測建議

監測
Monitoring
Gynecologic screening exam, papillomavirus test as per current guidelines; screening for HPV is not required prior to vaccination and screening for cervical cancer should continue as recommended following vaccination. Monitor for anaphylaxis and syncope for 15 minutes following administration (NACI 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
針劑稀釋條件
針劑不相容性 由於缺乏相容性方面的研究,因此不可將本疫苗和其它藥品混合使用。(1100112仿單資料)
針劑施打條件 以肌肉注射的方式施打於上臂三角肌部位。(1100112仿單資料)
針劑保存安定性 請貯存於冰箱中(2°C – 8°C)。切勿冷凍。請存放於原始外盒中,以避免光線照射。(1100112仿單資料)
最近修改日期時間
Updated
1/13/2021 11:53:24 AM
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