藥品名稱
drug name | Meningococcal Group A,C,Y,W-135 vaccine (Menveo / Nimenrix(舊名), 腦寧安 腦膜炎雙球菌四價接合型疫苗) 0.5 mL/vial |
| 藥檔狀態 | 使用中 （需冷藏） |
成 份
Ingredient | Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine, Group A/C/Y/W-135 (MCV4) |
| 單位含量 | 0.5 mL/vial |
| Dosage Forms | Injection, solution [preservative free]: 0.5mL/vial |
| 外觀描述 | 針劑/肌肉注射 |
| Appearance | injection/IM |
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., ITALY |
字 號
Product ID | 衛部菌疫輸字第000968號 |
藥理分類
Pharmacologic Category | Biologic and Immunologic Agents/ Immunizations/ Vaccines-Bacteria (Inactivated) |
作用機轉
Mechanism of action | Induces immunity against meningococcal disease via the formation of bactericidal antibodies directed toward the polysaccharide capsular components of Neisseria meningitidis serogroups A, C, Y and W-135. |
| 用途/適應症 | 預防流行性腦脊髓膜炎 |
| Use |
Meningococcal disease prevention: Provide active immunization against invasive meningococcal disease caused by N. meningitidis serogroups A, C, Y, and W-135.
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衛福部核准適用症狀
MOHW approved indications |
Menveo 可用於幼童(2 歲及以上)、青少年與成人(≦55 歲)的主動免疫接種，以預防腦膜炎雙球菌(Neisseria meningitidis)血清型A、C、W-135與Y 所引起的侵入性疾病。
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| Dose |
Administration Route: IM
【Adults ≦ 55 y/o & children ≧ 2 y/o】：1 dose (0.5 mL)
Exposed to high-risk environment: 1 dose. This dose should be given at least over 5 years after last dose.
【仿單】：
1. 兒童(2歲及以上)、青少年與成人給予1劑Menveo (每劑0.5毫升)。
2. 追加接種：
(1) 對先前曾使用Menveo、其他腦膜炎雙球菌ACWY結合疫苗(ACWY-D)或腦膜炎雙球菌ACWY非結合多醣體疫苗(ACWY-PS)進行基礎疫苗接種的人，可考慮使用Menveo做為追加接種。追加接種腦膜炎雙球菌ACWY疫苗的必要性與時機，應視國內衛生主管機關建議而定。
(2) 暴露於高風險環境者：建議追加接種1劑，且應與最後一次接種間隔至少5年。
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懷孕分級
Pregnancy Risk Factor |
C
仿單︰只有當明確需要且應評估潛在效益明顯超過對胎兒的潛在危險時，才可以在懷孕期間使用。
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| 禁忌症 |
對本疫苗的活性成份或任何賦形劑，包括白喉類毒素(CRM197)，會產生過敏反應，或先前接種含有類似成分的疫苗後有生命脅迫性的過敏反應者禁用Menveo。
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| Contraindications |
Severe hypersensitivity (eg, anaphylaxis) to other meningococcal-containing vaccines or any component of the formulation including diphtheria toxoid or CRM197 (a diphtheria toxin carrier protein) (Menactra and Menveo only).
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| 常見副作用 | 嗜睡、嗜睡、疲勞、頭痛、注射部位疼痛紅腫或發燒。 |
| Common adverse drug reactions | Drowsiness, fatigue, headache, pain/erythema/swelling at injection site, or fever. |
| Adverse Reactions |
>10%:
- Gastrointestinal: Anorexia (8% to 12%; infants: 30%), change in appetite (infants and children: 9% to 23%), diarrhea (infants, children, adolescents, and adults: 7% to 16%; severe diarrhea [infants: ≦2%]), nausea (5% to 12%), vomiting (2% to 3%; infants: 5% to 14%, severe vomiting: <1%)
- Local: Erythema at injection site (infants, children, adolescents, and adults: 4% to 32%), induration at injection site (infants, children, adolescents, and adults: 7% to 19%), pain at injection site (26% to 59%), swelling at injection site (infants, children, adolescents, and adults: 3% to 22%), tenderness at injection site (infants and children: 10% to 41%)
- Nervous system: Drowsiness (infants and children: 11% to 50%), excessive crying (infants and children: 12% to 41%), fatigue (adolescents and adults: 17% to 38%), headache (children: 5% to 18%; adolescents and adults: 19% to 41%), irritability (infants and children: 12% to 57%), malaise (10% to 28%), pain (60%)
- Neuromuscular & skeletal: Arthralgia (3% to 20%), myalgia (10% to 43%)
- Miscellaneous: Fever (infants, children, adolescents, and adults: ≦12%)
1% to 10%:
- Dermatologic: Skin rash (infants, children, adolescents, and adults: 1% to 6%)
- Nervous system: Chills (4% to 10%)
<1%:
- Endocrine & metabolic: Dehydration (infants and children)
- Gastrointestinal: Abdominal pain (children)
- Hepatic: Viral hepatitis
- Hypersensitivity: Angioedema
- Infection: Herpes zoster infection, staphylococcal infection (children)
- Nervous system: Simple partial seizures
- Neuromuscular & skeletal: Herniated disc
- Respiratory: Pneumonia (infants and children; lobar pneumonia [children])
- Miscellaneous: Febrile seizure (children)
Frequency not defined
- Nervous system: Acute disseminated encephalomyelitis, seizure
- espiratory: Wheezing (infants)
Postmarketing:
- Cardiovascular: Hypotension, swelling of injected limb, syncope, vasodepressor syncope
- Dermatologic: Erythema of skin, exfoliation of skin, injection site pruritus, pruritus, urticaria
- Hematologic & oncologic: Lymphadenopathy
- Hepatic: Increased serum alanine aminotransferase
- Hypersensitivity: Anaphylaxis, hypersensitivity reaction
- Local: Cellulitis at injection site, inflammation at injection site
- Nervous system: Balance impairment, Bell’s palsy, dizziness, facial nerve paralysis, Guillain-Barre syndrome, paresthesia, transverse myelitis, vertigo
- Neuromuscular & skeletal: Ostealgia
- Ophthalmic: Blepharoptosis
- Otic: Auditory impairment, otalgia, vestibular disturbance
- Respiratory: Apnea (premature infants), dyspnea, oropharyngeal pain, upper airway swelling
- Miscellaneous: Swelling
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監測
Monitoring |
Monitor for syncope for at least 15 minutes following administration.
If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.
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| 警語與注意事項 | 肌肉注射給藥。混合泡製完成須立即使用。1100401"Pfizer"換廠"GlaxoSmithKline" |
| Warnings & precautions | 肌肉注射給藥。混合泡製完成須立即使用。 |
| 針劑溶解條件 |
使用注射針筒與適當的針頭 (21G)將裝有溶液小瓶中的內容物全部抽出，再注入裝粉末的小瓶來泡製MenA結合疫苗。將小瓶倒置、充分搖勻，直到疫苗溶解，然後抽出0.5mL泡製後的成品。(1100401仿單資料)
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| 針劑稀釋條件 |
不需稀釋
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| 針劑不相容性 |
本品不能與其他藥品混合使用。(1100401仿單資料)
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| 針劑施打條件 |
● 肌肉注射，理想的注射部位是三角肌(上臂)。
● 若同時施打多種疫苗，應於不同注射部位施打。
● 不可靜脈注射、皮下注射或皮內注射。(1100401仿單資料)
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| 針劑保存安定性 |
● 未開封：避光儲存於2-8℃。不可冷凍。
● 配製後：應立即使用完畢。疫苗若未立即施打，保存在25°C(含)以下，化學及產品特性顯示有8小時的安定性。(1100401仿單資料)
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最近修改日期時間
Updated | 4/1/2021 4:57:30 PM |
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Old item
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