藥品名稱
drug name | 成人公費4價流感疫苗 AdimFlu-S (QIS) 0.5 mL/syringe |
| 藥檔狀態 | 停用 |
成 份
Ingredient | Influenza virus vaccine |
| 單位含量 | 0.5mL/syringe |
| Dosage Forms | 0.5mL/syringe |
| 外觀描述 | |
| Appearance | |
廠商名稱
Manufacturer | 國光生物科技股份有限公司 |
製 造 商
Manufacturer | 國光生物科技股份有限公司 |
字 號
Product ID | 衛部菌疫製字第000138號 |
藥理分類
Pharmacologic Category | Vaccine; Vaccine, Inactivated (Viral) |
作用機轉
Mechanism of action | Promotes immunity to seasonal influenza virus by inducing specific antibody production. Preparations from previous seasons must not be used. |
| 用途/適應症 | |
| Use |
預防流感。
說明：本疫苗適用於3歲以上兒童及成人之主動免疫接種，藉以預防此疫苗所涵蓋之兩種A型及兩種B型流感病毒所引起之流感相關疾病。
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衛福部核准適用症狀
MOHW approved indications |
預防流感。 說明：本疫苗適用於3歲以上兒童及成人之主動免疫接種，藉以預防此疫苗所涵蓋之兩種A型及兩種B型流感病毒所引起之流感相關疾病。
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| 常用劑量 | 0
(藥品劑量會因人或病情增減，請依照醫師指示服用。) |
| Dose |
[Adult]
仿單
接種量：3歲以上兒童及成人：一劑0.5mL。
Note: Immunization during coronavirus 2019 (COVID-19) pandemic: Routine vaccination should not be delayed because of the COVID-19 pandemic (CDC 2020; WHO 2020). In general, simultaneous administration of all vaccines for which a patient is eligible (according to current immunization schedules/guidelines) is recommended (ACIP [Ezeanolue 2020]). However, influenza vaccination in patients with suspected or confirmed COVID-19 infection (regardless of symptoms) should be postponed until the patient is no longer acutely ill and/or in isolation to avoid exposure to health care personnel and other patients (CDC/ACIP [Grohskopf 2020]; CDC 2020). Additional information is available from the Centers for Disease Control and Prevention (CDC), the American Academy of Pediatrics, and the Immunization Action Coalition.
Influenza seasons vary in the timing and duration from year to year. In general, vaccination should preferably occur in September and October (in the United States) to ensure optimal immunity prior to onset and for the full duration of influenza activity in the community. Early vaccination (in July or August) for an upcoming influenza season has been associated with suboptimal immunity before the end of an influenza season, particularly in older adults. Vaccination should continue throughout the influenza season as long as vaccine is available. The CDC does not recommend revaccination later in the season for those persons who have already been fully vaccinated. Advisory Committee on Immunization Practices does not have a preference for any inactivated influenza vaccine formulation when used within their specified age indications (CDC/ACIP [Grohskopf 2020]). International considerations: Products with similar names but containing different strains may be circulating globally due to differences in recommendations between northern and southern hemisphere countries. In addition, recommendations related to use of influenza vaccines and approved ages may vary per country.
[Geriatric]
同成人
[renal and hepatic impairment]
There are no dosage adjustments provided in the manufacturer`s labeling.
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懷孕分級
Pregnancy Risk Factor |
依文獻內容判定系統稽核懷孕分級建置為：B
仿單
已有超過2000位孕婦接種其他季節性流感疫苗的研究報告顯示並無任何胎兒產生不良影響。但本疫苗並無針對動物生殖系統的研究，亦無接種於孕婦是否傷害胎兒或影響生殖能力的報告。由於孕婦是流感併發症的高危險族群且可在接種疫苗後提供胎兒保護力，除孕婦已知（或曾有）對本疫苗成分有過敏者外，建議孕婦應依流感流行的適用性優先施打本疫苗。
懷孕及授乳期間可由您的醫師判斷是否應該接種本疫苗。
UTD
Inactivated influenza vaccine (IIV) has not been shown to cause fetal harm when given to pregnant women, although information related to use in the first trimester is relatively limited (CDC/ACIP [Grohskopf 2020]).
Maternal vaccination provides passive immunization to the newborn and decreases the risk of hospitalization due to influenza in infants <6 months of age (ACOG 2018).
The risk for severe illness and complications from influenza infection is increased during pregnancy, particularly during the second and third trimesters (CDC/ACIP [Grohskopf 2020]). Pregnant patients infected with influenza have a higher risk than nonpregnant patients of progression to pneumonia, hospitalization, and ICU admission (ACOG 2018). Influenza vaccination decreases the risk of laboratory-confirmed influenza and hospitalization in pregnant patients (Thompson 2014; Thompson 2019).
The efficacy of influenza vaccination in pregnant patients is similar to nonpregnant adults. Influenza vaccination is recommended annually and should be given to pregnant patients even if they were vaccinated in a prior pregnancy (ACOG 2018). Influenza vaccination with any licensed, recommended, age-appropriate IIV or recombinant influenza vaccine (RIV) is recommended for all patients who are pregnant during the influenza season and who do not otherwise have contraindications to the vaccine. Vaccination may be done at any time during pregnancy (CDC/ACIP [Grohskopf 2020]).
Pregnant patients should observe the same precautions as nonpregnant patients to reduce the risk of exposure to influenza and other respiratory infections (CDC/HHS 2020). When vaccine supply is limited, focus on delivering the vaccine should be given to patients who are pregnant or will be pregnant during the flu season, as well as mothers of newborns and contacts or caregivers of children <5 years of age (CDC/ACIP [Grohskopf 2020]).
Data collection to monitor pregnancy and infant outcomes following exposure to influenza vaccine is ongoing.
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[FDA(美國食品及藥物管理局)懷孕分級說明:
A：對照試驗無法證實懷孕初期及後期使用會危害胎兒。
B：動物試驗無法證實對胎兒有害，但缺乏人類對照試驗；或動物試驗有副作用報告，但無法證實對懷孕初期及後期之胎兒有害。
C：動物實驗中對胎兒有害但缺乏孕婦對照實驗；或無動物及孕婦試驗。
D：證實對胎兒有害，但疾病對孕婦有生命威脅或較安全藥品無法使用或無效時可使用。
X：證實對胎兒有害，且使用後危害大於可能的益處。孕婦及可能懷孕婦女禁用。]
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| 禁忌症 |
曾對於本疫苗中任何成分發生嚴重過敏反應(例如：全身性過敏反應)，或過去曾在注射任何流感疫苗後發生嚴重過敏反應。
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| Contraindications |
Severe allergic reaction (eg, anaphylaxis) to a previous influenza vaccination or to any component of the formulation.
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| 常見副作用 | |
| Common adverse drug reactions | |
| Adverse Reactions |
Incidence of adverse events for the second dose of vaccine (when warranted) was typically milder than first dose.
>10%:
●Gastrointestinal: Anorexia (infants, children, and adolescents: 9% to 32%; adults and older adults: 4% to 8%), diarrhea (4% to 13%), nausea (≦12%), vomiting (infants, children, and adolescents:≦15%; adults and older adults:≦3%)
●Local: Erythema at injection site (1% to 37%), induration at injection site (≦17%), pain at injection site (17% to 67%), swelling at injection site (≦25%), tenderness at injection site (21% to 69%)
●Nervous system: Drowsiness (infants and children: 8% to 38%), fatigue (≦22%), headache (1% to 27%), irritability (infants and children: 2% to 54%), malaise (≦38%), uncontrolled crying (infants and children: 33% to 41%)
●Neuromuscular & skeletal: Arthralgia (4% to 15%), myalgia (8% to 40%)
●Respiratory: Cough (infants, children, and adolescents: 1% to 15%), rhinorrhea (infants and children: 1% to 11%), wheezing
●Miscellaneous: Fever (infants, children, and adolescents: 1% to 16%; adults and older adults: ≦4%)
1% to 10%:
●Dermatologic: Skin rash (infants and children: 1%)
●Gastrointestinal: Change in appetite (children: 10%)
●Local: Bruising at injection site (≦9%)
●Nervous system: Chills (≦7%), shivering (≦9%)
●Respiratory: Flu-like symptoms (infants and children: 1%), nasal congestion (infants, children, and adolescents: 2% to 6%), nasopharyngitis (infants and children: 2%), oropharyngeal pain (adolescents and adults: 2% to 7%)
Frequency not defined: Local: Hematoma at injection site, itching at injection site
Postmarketing:
●Cardiovascular: Chest pain, facial edema, flushing, presyncope, swelling of injected limb (lasting >1 week), syncope (shortly after vaccination), tachycardia, vasculitis (including transient renal involvement), vasodilation
●Dermatologic: Diaphoresis, ecchymoses, erythema multiforme, erythema of skin, pallor, pruritus, rash at injection site, Stevens-Johnson syndrome, urticaria
●Endocrine & metabolic: Hot flash
●Gastrointestinal: Abdominal distress, abdominal pain, dysphagia, gastroenteritis, swollen tongue
●Hematologic & oncologic: Henoch-Schonlein purpura, lymphadenopathy (local), thrombocytopenia
●Hypersensitivity: Anaphylactic shock, anaphylaxis, angioedema, hypersensitivity reaction (including oculorespiratory syndrome, an acute, self-limited reaction with ocular and respiratory symptoms), nonimmune anaphylaxis, serum sickness
●Local: Abscess at injection site, cellulitis at injection site, inflammation at injection site, warm sensation at injection site
●Nervous system: Bell`s palsy, body pain, cranial nerve palsy, dizziness, encephalopathy, facial nerve paralysis, feeling hot, Guillain-Barre syndrome, hypoesthesia, insomnia, myasthenia, neuralgia, neuritis, neuropathy (including brachial plexus), paralysis (including limb), paresthesia, seizure, transverse myelitis, vertigo, voice disorder
●Neuromuscular & skeletal: Asthenia, hypokinesia, limb pain, myelitis (including encephalomyelitis), tremor
●Ophthalmic: Eyelid edema, eye pain, ocular hyperemia, optic neuritis, optic neuropathy, photophobia, swelling of eye
●Respiratory: Bronchospasm, dyspnea, pharyngeal edema, pharyngitis, rhinitis, tonsillitis
●Miscellaneous: Febrile seizure
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★高警訊藥品
監測建議 |
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監測
Monitoring |
Monitor for anaphylaxis and syncope for 15 minutes following administration (ACIP [Ezeanolue 2020]). 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 | |
| Warnings & precautions | |
| 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 |
目前尚無相關臨床試驗數據或研究報告，因此不建議將本劑與其他廠牌季節性流感疫苗混用。 (190909仿單資料)
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| 針劑施打條件 |
肌肉注射。疫苗使用前應先回溫至室溫。使用前請先搖勻。接種前請先以目視觀察確認沒有異常的混濁、呈色、異物和其它異常。(1090909仿單資料)
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| 針劑保存安定性 |
冷藏儲存在 2~8℃，避免凍結。曾經凍結過的疫苗不可使用。請保存於外盒中，避免光線照射。(190909仿單資料)
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最近修改日期時間
Updated | 10/20/2020 2:36:09 PM |
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現用藥品
Available
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停用藥品
Old item
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藥品仿單
DrugLabeling
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病人用藥須知
Patient Med. Guides
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二維條碼
QR code
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