藥碼
FAB01
藥名
Agalsidase beta 罕病 針 35 mg
英文商品名
事審 Fabrazyme 罕病 針 35 mg
中文商品名
法布瑞梅凍晶注射劑
螢幕名
事審 Fabrazyme 罕病 針 35 mg
劑型
Inj
規格
Agalsidase beta 35 mg/vial
成分
藥理分類
Enzymes
健保碼
YC00005296
ATC碼
適應症
Fabry's disease
藥理
Endocrine-Metabolic Agent
藥動學
"Distribution
Vd, adult: 81 to 570 mL/kg
Vd, pediatric: 247 to 1097 mL/kg
Elimination Half Life
Systemic: 45 to 102 min
"
Vd, adult: 81 to 570 mL/kg
Vd, pediatric: 247 to 1097 mL/kg
Elimination Half Life
Systemic: 45 to 102 min
"
禁忌症
Specific contraindications have not been determined
懷孕分類
Fetal risk is minimal.
哺乳分類
Infant risk cannot be ruled out.
副作用
"Common
Cardiovascular: Hypertension (14% ), Peripheral edema (21% )
Dermatologic: Pruritus (10% ), Rash (20% )
Immunologic: Antibody development (Adults, 79%, pediatric, 69% )
Musculoskeletal: Backache (16% ), Myalgia (14% ), Pain in limb (19% ), Spasm (5% )
Neurologic: Dizziness (21% ), Headache (39% ), Paresthesia (31% )
Respiratory: Cough (33% ), Lower respiratory tract infection (18% ), Nasal congestion (19% ), Upper respiratory infection (44% )
Other: Fatigue (24% ), Feels cold (11% ), Fever (39% ), Pain (16% ), Persistent pain following procedure (25% ), Shivering (43% )
Serious
Cardiovascular: Cardiac arrest
Immunologic: Allergic reaction, Anaphylaxis, Infusion reaction (Approximately 59% )
"
Cardiovascular: Hypertension (14% ), Peripheral edema (21% )
Dermatologic: Pruritus (10% ), Rash (20% )
Immunologic: Antibody development (Adults, 79%, pediatric, 69% )
Musculoskeletal: Backache (16% ), Myalgia (14% ), Pain in limb (19% ), Spasm (5% )
Neurologic: Dizziness (21% ), Headache (39% ), Paresthesia (31% )
Respiratory: Cough (33% ), Lower respiratory tract infection (18% ), Nasal congestion (19% ), Upper respiratory infection (44% )
Other: Fatigue (24% ), Feels cold (11% ), Fever (39% ), Pain (16% ), Persistent pain following procedure (25% ), Shivering (43% )
Serious
Cardiovascular: Cardiac arrest
Immunologic: Allergic reaction, Anaphylaxis, Infusion reaction (Approximately 59% )
"
劑量和給藥方法
1 mg/kg IV infusion every 2 weeks
小兒調整劑量
"Safety and effectiveness not established in pediatric patients under 8 years of age
8 years or older: no dosage adjustment necessary.
"
8 years or older: no dosage adjustment necessary.
"
腎功能調整劑量
No dosage adjustment necessary.
肝功能調整劑量
No dosage adjustment necessary.
安定性
Refrigerate vials of Fabrazyme at 2°C to 8°C (36°F to 46°F). Do not use Fabrazyme after the expiration date on the vial.
藥袋資訊
臨床用途
法布瑞氏症酵素補充治療
主要副作用
過敏、發燒、寒顫、噁心、嘔吐頭痛
泡製方法
儲存方式
請置於 2-8℃ 冷藏儲存
注意事項
其他說明
藥局不備庫 | 藥庫 冰Y23
藥品外觀
顏色
形狀
剝痕
標記1
標記2
其他
健保藥價
109224
自費價
120146.4
仿單
資料庫
健保給付規定