藥品名稱
drug name
Human Papillomavirus Vaccine,Quadrivalent (Gardasil, 嘉喜[四價人類乳突病毒(第6,11,16,18型)基因重組疫苗]) 0.5mL/syringe
藥檔狀態停用 (需冷藏)
成  份
Ingredient
Human Papillomavirus Recombinant Vaccine Quadrivalent (types 6, 11, 16, 18)
單位含量0.5 mL/syringe
Dosage FormsInjections [preservative free]: HPV 6 L1 protein 20 mcg, HPV 11 L1 protein 40 mcg, HPV 16 L1 protein 40 mcg, and HPV 18 L1 protein 20 mcg per 0.5 mL (0.5 mL) [contains aluminum, polysorbate 80; manufactured using S. cerevisiae (baker`s yeast)]
外觀描述 透明針筒,淺綠色推筒針劑/注射
Appearanceinjection
標  示
outward
肌肉注射
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., USA
字  號
Product ID
衛署菌疫輸字第000827號
藥理分類
Pharmacologic Category
Biologic and Immunologic Agents/ Immunizations/ Vaccines-Virus (Inactivated)
作用機轉
Mechanism of action
Contains inactive HPV proteins HPV 6 L1, HPV 11 L1, HPV 16 L1, and HPV 18 L1 which produce neutralizing antibodies to prevent cervical cancer, cervical adenocarcinoma, cervical, vaginal and vulvar neoplasia and genital warts caused by HPV.
用途/適應症人類乳突疫苗
Use Prevention of human papillomavirus infection:

Females ≧9 to ≦26 years: Prevention of anal cancer caused by HPV types 16 and 18; anal intraepithelial neoplasia caused by HPV types 6, 11, 16, and 18

Females ≧9 to ≦45 years: Prevention of cervical, vulvar, and vaginal cancer caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; cervical adenocarcinoma in situ, vulvar, vaginal, or cervical intraepithelial neoplasia caused by HPV types 6, 11, 16, and 18

Males ≧9 to ≦26 yearse: Prevention of anal cancer caused by HPV types 16 and 18; anal intraepithelial neoplasia caused by HPV types 6, 11, 16, and 18; genital warts caused by HPV types 6 and 11
衛福部核准適用症狀
MOHW approved indications
9-26 歲女性之預防接種;預防發生疫苗所含的人類乳突病毒第6、11、16及18型所引起的子宮頸癌前期或分化不良的病變和癌症、陰道及外陰部癌前期或分化不良的病變、生殖器疣(俗稱菜花)。

27-45 歲女性之預防接種;預防發生疫苗所含的人類乳突病毒第6、11、16及18型所引起的持續性感染及第1級子宮頸上皮內贅瘤(CIN)、預防發生疫苗所含的人類乳突病毒第6及11型所引起之生殖器疣。

9-26歲男性之預防接種;預防發生人類乳突病毒第6與11型所引起的生殖器疣。
Dose Administration Route: IM

Adults: Females ≦45 years and males ≦26 years: 0.5 mL x 3 doses at 0, 2, and 6 months. Administer the second dose ≧1 month after the first dose and the third dose ≧3 months after the second dose; administer all 3 doses within 12 months.

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


Females 9~13 years: 2 doses of vaccination if series is initiated, 0.5 mL x 2 doses at 0, 6-12 months.
(9-13歲女孩也可以採用2劑接種時程,在第0、6~12個月給予每劑0.5毫升)。 (ref. 仿單)
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 to any component of the vaccine or to a previous dose of the vaccine
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 >10%:
Central nervous system: Headache (8% to 21%)
Local: Pain at injection site (females: 82%; males: 61%), swelling at injection site (females: 24%; males: 14%), erythema at injection site (17% to 22%)
Miscellaneous: Fever (6% to 13%)

1% to 10%:
Central nervous system: Dizziness (≦1%)
Dermatologic: Injection site pruritus (females: 3%)
Gastrointestinal: Nausea (2% to 4%), diarrhea (males: 3%), toothache (females: 2%), vomiting (≦1%)
Local: Hematoma at injection site (females: 3%)
Neuromuscular & skeletal: Limb pain (females: 2% to 3%), arthralgia (≦1%), myalgia (≦1%)
Respiratory: Oropharyngeal pain (males: 3%), upper respiratory tract infection (males: 2%)

<1%, postmarketing, and/or case reports: Acute disseminated encephalomyelitis, anaphylactoid reaction, anaphylaxis, arthropathy (impaired joint movement at injection site), asthma, autoimmune disease, autoimmune hemolytic anemia, bronchospasm, cellulitis, chills, fatigue, Guillain-Barre syndrome, hypersensitivity reaction, immune thrombocytopenia, lymphadenopathy, malaise, neuromuscular disease, pancreatitis, paralysis, pulmonary embolism, syncope (may result in falls or be associated with tonic-clonic movements), transverse myelitis, urticaria, weakness seizure, sepsis, syncope (may result in falls with injury or be associated with tonic-clonic movements), transverse myelitis, urticaria, weakness
監測
Monitoring
Monitor for syncope for 15 minutes following administration.
警語與注意事項注射用藥。
Warnings & precautions 
針劑溶解條件
針劑稀釋條件
針劑不相容性 仿單無資料。
針劑施打條件 肌肉注射施打於上臂三角肌部位。
使用前請充用搖勻。
針劑保存安定性 冷藏2~8℃, 避光儲存
最近修改日期時間
Updated
11/10/2020 5:33:23 PM
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