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 Forms | Injection: 0.5 mL/syringe |
| 外觀描述 | 針劑/注射 |
| Appearance | injection |
標 示
outward | 透明針筒 |
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 LLC, U.S.A. |
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 45 years of age;
Males 9 through 45 years of age
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衛福部核准適用症狀
MOHW approved indications |
GARDASIL 9適用於9至45歲的人施打，使其產生主動免疫反應，以預防下列由人類乳突病毒(HPV)所引起的病變：
‧ 由第6, 11, 16, 18, 31, 33, 45, 52及58型 HPV所引起的子宮頸、外陰、陰道及肛門部位的癌前病變與癌症。
‧ 由第6及11型 HPV所引起的生殖器疣(尖形濕疣)。
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| Dose |
Administration Route: IM
【Adults】:
15 ~ ≦45 years: 0.5 mL x 3 doses at 0, 2, and 6 months
【Children ≧9 years & Adolescents <15 years】:
2-dose series: 0.5 mL x 2 doses at 0, and 6-12 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: 0.5 mL x 3 doses at 0, 2, and 6 months
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懷孕分級
Pregnancy Risk Factor |
B
Lactation: Excretion in breast milk unknown/use caution
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| 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。
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| 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
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| 常見副作用 | 注射部位紅腫、疼痛；發燒、噁心、暈眩。 |
| Common adverse drug reactions | Injection site inflamed, pain；fever, nausea, dizzy. |
| Adverse Reactions |
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Reported incidences are for females 9 to 26 years of age and males 9 to 26 years of age.
>10%:
Local: Erythema at injection site (7% to 42%; increased with successive doses), pain at injection site (63% to 90%), swelling at injection site (13% to 49%; increased with successive doses and/or concomitant vaccines)
Nervous system: Headache (7% to 20%)
1% to 10%:
Dermatologic: Injection site pruritus (1% to 8%)
Gastrointestinal: Diarrhea (≦1%), nausea (1% to 4%), upper abdominal pain (≦2%)
Immunologic: Autoimmune disease (2%)
Local: Bleeding at injection site (1%), bruising at injection site (2%), hematoma at injection site (≦5%), hypersensitivity reaction at injection site (1%), induration at injection site (≦2%), injection site nodule (1%), injection site reaction (≦1%)
Nervous system: Dizziness (≦3%), fatigue (≦2%)
Neuromuscular & skeletal: Myalgia (≦1%)
Respiratory: Oropharyngeal pain (1% to 3%)
Miscellaneous: Fever (2% to 10%)
<1%:
Local: Warm sensation at injection site
Respiratory: Upper respiratory tract infection
Frequency not defined:
Hypersensitivity: Hypersensitivity reaction
Respiratory: Status asthmaticus
Postmarketing:
Cardiovascular: Syncope
Dermatologic: Urticaria
Gastrointestinal: Vomiting
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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.
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| 警語與注意事項 | 注射用藥。 |
| Warnings & precautions | Administration Route: IM |
| 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 |
不可稀釋或與其它疫苗混合使用。
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| 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。
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| 針劑保存安定性 |
冷藏避光貯存。
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最近修改日期時間
Updated | 4/21/2023 2:49:40 PM |
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現用藥品
Available
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停用藥品
Old item
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