藥品新增

<11C012> COVID-19(Nuvaxovid®) (雙價XBB-Novavax)公費

新藥介紹

<11C012> COVID-19(Nuvaxovid®) (雙價XBB-Novavax)公費

藥理作用/作用機轉

Promotes active immunization against COVID-19 caused by SARS-CoV-2 virus. The vaccine contains a purified recombinant spike (S) antigen of the SARS-Co-V-2 virus. The vaccine then elicits an immune response to the S antigen, which contributes to protection against COVID-19 disease.

適應症/

劑量

本品為多劑型2.5ml/瓶( 0.5ml/劑，5劑/瓶)

IM

【Adult】預防 COVID-19

　●基礎劑：12歲以上需接種2劑，接種間隔至少4周(28天)，12歲至17歲青少年以同廠牌疫苗完成基礎劑接種為原則。

　●基礎加強劑：18歲以上免疫不全及免疫低下者，建議與第2劑接種間隔至少28天接種基礎加強劑。

　●追加劑：12歲以上完成基礎劑且無發生嚴重不良反應，建議與最後1劑基礎劑或基礎加強劑間隔至少12周以上，接種追加劑。

　　*已接種Moderna XBB.1.5疫苗者，無須接種。

【Pediatric】Safety and efficacy not established.

【Geriatric】Refer to adult dosing.

『Renal Impairment: Adult』

No dosage adjustment necessary

『Hepatic Impairment: Adult』

No dosage adjustment necessary

使用禁忌

History of severe allergic reaction (eg, anaphylaxis) to COVID-19 vaccine (subunit) or any component of the formulation

警告/預防

Shoulder injury related to vaccine administration, Syncope

不良反應

Adverse Reactions (Significant): Guillain-Barre syndrome, Hypersensitivity reactions, Local reactions, Myocarditis and pericarditis, Systemic reactions

【>10%】頭痛, 噁心嘔吐, 疼痛, 疲勞Nausea, vomiting, pain at injection site, tenderness at injection site, fatigue, headache, malaise, arthralgia, myalgia

【1% to 10%】 注射部位不適, 發燒Erythema at injection site, swelling at injection site, fever

【<1%】皮疹, 淋巴結腫大, 高血壓, 發冷Cardiomyopathy, heart failure, myocarditis, pericarditis, thromboembolism, cholecystitis, decreased appetite, lymphadenopathy, autoimmune hepatitis, hypersensitivity reaction, cellulitis at injection site, injection-site pruritus, chills, guillain-barre syndrome, uveitis

【Frequency not defined】過敏反應, 心肌炎, 心包膜炎, 感覺異常Anaphylaxis, Hypoesthesia, paresthesia

懷孕用藥分級(FDA)

 

健保規範

  • 藥品說明：

  • 藥品理由：

01)C17_12-17歲青少年

02)C12_18-49歲成人

03)C10_50-64歲成人

04)C11_65-74歲長者

05)C08A_75歲以上長者

其他

開封後冷藏或室溫只可保存6小時。