藥品名稱
drug name
Human papillomavirus 9-valent vaccine (Gardasil 9, 嘉喜 [九價人類乳突病毒基因重組疫苗]) 0.5 mL/syringe
藥檔狀態使用中 (需冷藏)
成  份
Ingredient
Papillomavirus (HumanTypes第 6,11,16,18,31,33,45,52,58型)
單位含量0.5 mL/syringe
Dosage FormsInjection: 0.5 mL/syringe
外觀描述 針劑/注射
Appearanceinjection
標  示
outward
透明針筒,黑色推筒針劑
廠商名稱
Manufacturer
美商默沙東藥廠股份有限公司台灣分公司
製 造 商
Manufacturer
MERCK SHARP & DOHME Corp.,UNITED STATES
字  號
Product ID
衛部菌疫輸字第001001號
藥理分類
Pharmacologic Category
Biologic and Immunologic Agents/ Immunizations/ Vaccines-Virus (Inactivated)
作用機轉
Mechanism of action
Contains inactive human papillomavirus (HPV) proteins (types 6 L1,11 L1, 16 L1, 18 L1, 31 L1, 33 L1, 45 L1, 52 L1, and 58 L1) which produce neutralizing antibodies to prevent cervical, vulvar, vaginal, and anal cancers, cervical adenocarcinoma, cervical, vaginal, vulvar, and anal neoplasia, and genital warts caused by HPV. Efficacy of HPV 9-valent vaccine against anogenital diseases related to the vaccine HPV types in humans is thought to be mediated by humoral immune responses induced by the vaccine, although the exact mechanism of protection is unknown.
用途/適應症人類乳突疫苗
Use Prevention of human papillomavirus infection:
Females 9 to 26 years of age;
Males 9 through 26 years of age
衛福部核准適用症狀
MOHW approved indications
女孩及女性 GARDASIL 9為一適合9-26歲之女孩及女性施打的疫苗,可用以預防下列由人類乳突病毒(HPV)所引起的病變:
‧ 第16, 18, 31, 33, 45, 52及58型 HPV所引起的子宮頸癌
‧ 第6及11型 HPV所引起的生殖器疣(尖型濕疣)
‧ 第6, 11, 16, 18, 31, 33, 45, 52及58型HPV所引起的第1級子宮頸上皮內贅瘤(CIN 1)、第2級與第3級子宮頸上皮內贅瘤(CIN 2/3) ‧ 第6, 11, 16及18型HPV所引起的子宮頸原位腺癌(AIS)、第2級與第3級外陰上皮內贅瘤(VIN 2/3) 、第2級與第3級陰道上皮內贅瘤(ValN 2/3)

男孩與男性:
‧ GARDASIL 9適用於9-26歲的男孩與男性,藉以預防第6與11型HPV所引起的生殖器疣(尖形濕疣)
Dose Administration Route: IM

【Adults】:
15 ~ ≦45 years: IM: 0.5 mL at 0, 2, and 6 months

【Children ≧9 years & Adolescents <15 years】:
2-dose series: IM: 0.5 mL at 0, and 6 to 12 months. If the second dose is inadvertently administered earlier than 5 months after the first dose, then patient should be converted to a 3-dose series.

3-dose series: IM: 0.5 mL at 0, 2, and 6 months
懷孕分級
Pregnancy Risk Factor
B
Lactation: Excretion in breast milk unknown/use caution
禁忌症 1.對本疫苗活性成分或任何賦型劑過敏者。
2.曾於接種一劑GARDASIL後出現過敏症狀者,不可再接種後續劑次的GARDASIL。
Contraindications Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of this vaccine or human papillomavirus vaccine (recombinant) for types 6, 11, 16, 18
常見副作用注射部位紅腫、疼痛;發燒、噁心、暈眩。
Common adverse drug reactionsInjection site inflamed, pain;fever, nausea, dizzy.
Adverse Reactions Frequency not always defined. Reported incidences are for individuals (females 9 to 26 years of age and males 9 to 15 years of age) who the vaccine is approved for use, unless otherwise specified by a specific population.

>10%:
Central nervous system: Headache (9% to 20%)
Local: Pain at injection site (63% to 90%), swelling at injection site (13% to 49%; swelling increased with successive doses and/or concomitant vaccines), erythema at injection site (7% to 42%; erythema increases with successive doses)

1% to 10%:
Cardiovascular: Syncope
Central nervous system: Dizziness (?3%), fatigue (?2%)
Gastrointestinal: Diarrhea (?1%), upper abdominal pain (?2%), nausea (1% to 4%)
Immunologic: Autoimmune disease (2%)
Local: Itching at injection site (4% to 8%), hematoma at injection site (1% to ?5%), bruising at injection site (2%), induration at injection site (1% to ?2%), bleeding at injection site (1%), injection site nodule (1%), injection site reaction (?1%)
Neuromuscular & skeletal: Myalgia (?1%)
Respiratory: Oropharyngeal pain (1% to 3%)
Miscellaneous: Fever (4% to ?10%)

<1% (Limited to important or life-threatening): Anaphylactoid reaction, hypersomnia, postural orthostatic tachycardia, status asthmaticus, tonsillitis
監測
Monitoring
Screening for HPV is not required prior to vaccination. 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. Continue recommended anal cancer screening.
Females: Gynecologic screening exam, papillomavirus test; screening for cervical cancer should continue per current guidelines following vaccination.
警語與注意事項注射用藥。
Warnings & precautionsAdministration Route: IM
針劑溶解條件
針劑稀釋條件
針劑不相容性 不可稀釋或與其它疫苗混合使用。
針劑施打條件 1.本品僅能以肌肉注射給予(上臂三角肌區或大腿前外側區域較高部位)。
2.使用前請充分搖勻成白色混濁液體,在疫苗維持懸浮液的狀態下將針筒中的全部內容物注入肌肉中。
針劑保存安定性 冷藏避光貯存。
最近修改日期時間
Updated
2/19/2019 12:13:01 PM
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