藥品名稱
drug name | Bexsero Meningococcal Group B Vaccine 0.5 mL/dose/syringe 必思諾B型腦膜炎雙球菌疫苗 |
| 藥檔狀態 | 使用中 |
成 份
Ingredient | Recombinant Neisseria meningitidis group B NHBA fusion protein (Rp287-953), Recombinant Neisseria meningitidis group B NadA protein (Rp961c), Recombinant Neisseria meningitidis group B fHbp fusion protein (Rp936-741), Outer membrane vesicles (OMV) fr |
| 單位含量 | 0.5mL/dose |
| Dosage Forms | 0.5 mL/dose/syringe |
| 顏 色 | |
| Color | |
| 形 狀 | |
| Shape | |
| 劑 型 | 注射/針劑 |
| Dose Form | |
大 小
Size | |
標 示
outward | |
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 Vaccines S.r.l |
字 號
Product ID | 衛部菌疫輸字第001150號 |
藥理分類
Pharmacologic Category | Biologic and Immunologic Agents/ Immunizations/ Vaccines-Virus (Inactivated) |
作用機轉
Mechanism of action | Induces immunity against meningococcal disease caused by serogroup B Neisseria meningitidis (MenB) via the formation of antibodies directed toward the recombinant protein antigens combined together with outer membrane vesicles (OMV) from a group B strain. |
| 用途/適應症 | 預防B型奈瑟氏腦膜炎雙球菌疾病 |
| Use |
適用於2個月以上兒童及成人之主動免疫接種，以預防B型奈瑟氏腦膜炎雙球菌所引起的侵入性腦膜炎雙球菌疾病。
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衛福部核准適用症狀
MOHW approved indications |
適用於2個月以上兒童及成人之主動免疫接種，以預防B型奈瑟氏腦膜炎雙球菌所引起的侵入性腦膜炎雙球菌疾病。
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| 常用劑量 | 立刻使用1vial
(藥品劑量會因人或病情增減，請依照醫師指示服用。) |
| Dose |
Age 2-5 months: primary immunization: 2 doses ≧2 months apart or primary immunization: 3 doses ≧1 month apart. Give 1 booster dose at 12-15 months. At least 6 months after primary immunization
Age 6-11 months: primary immunization: 2 doses ≧2 months apart. Give 1 booster dose at 2 years. At least 2 months after primary immunization
Age 12-23 months: primary immunization: 2 doses ≧2 months apart. Give 1 booster dose, 12-23 month after primary immunization
Age 2-49 years old: primary immunization: 2 doses ≧1 month apart. Give 1 booster dose if exposure to N. meningitides
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懷孕分級
Pregnancy Risk Factor |
仿單:目前並無足夠孕婦接種本疫苗的臨床資料。
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| 禁忌症 |
對「配方與含量」及「賦形劑」段落中所列的活性成分或任何賦形劑過敏者。
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| Contraindications |
Severe hypersensitivity to the meningococcal group B vaccine or any component of the formulation.
|
| 常見副作用 | 頭痛，疲倦，肌肉痛 |
| Common adverse drug reactions | Headache,Fatigue,Myalgia |
| Adverse Reactions |
Dermatologic: Erythema at injection site (11.8% to 50% ), Injection site induration (28% to 32% ), Injection site pain (79.3% to 90% ), Swelling at injection site (13.9% to 18% )
Gastrointestinal: Nausea (Adult and pediatric patients, 18% to 19% ; adolescent patients, 24% )
Musculoskeletal: Arthralgia (12.6% to 21.9% ), Myalgia (15.6% to 49% )
Neurologic: Headache (32.5% to 51.8% )
Other: Fatigue (35% to 54% ), Shivering (12.4% to 25.3% )
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監測
Monitoring |
serologic response to the vaccine (eg, antibody titers) may indicate efficacy.
No specific monitoring has been determined.
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| 警語與注意事項 | 肌肉注射。需冷藏、避光保存。 |
| Warnings & precautions | IM.Refrigerated.Avoid from light. |
| 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 |
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| 針劑施打條件 |
使用此疫苗前請充分振搖，使形成均勻的懸浮液。
深部肌肉注射，最好注射在嬰兒的大腿前外側或年紀較大者的上臂三角肌區域。
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| 針劑保存安定性 |
2-8°C避光儲存
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最近修改日期時間
Updated | 6/20/2022 1:24:31 PM |