藥品名稱
drug name | 狂犬病免疫球蛋白 Rabies Immune Globulin (Human) (HyperRAB) (HRIG) 300 IU/vial |
| 藥檔狀態 | 使用中 （需冷藏） |
成 份
Ingredient | Rabies Immune Globulin (Human) |
| 單位含量 | 300 IU/vial |
| Dosage Forms | Solution, Injection [preservative free]:HyperRAB: 300 IU/vial |
| 外觀描述 | 針劑/注射 |
| Appearance | injection |
標 示
outward | |
廠商名稱
Manufacturer | Grifols Therapeutics Inc., USA |
製 造 商
Manufacturer | Grifols Therapeutics Inc., USA |
字 號
Product ID | 疾管署 |
藥理分類
Pharmacologic Category | BIOLOGIC AND IMMUNOLOGIC AGENTS/ Immune Globulins/ Immune Globulins |
作用機轉
Mechanism of action | Rabies immune globulin is a solution of globulins dried from the plasma or serum of selected adult human donors who have been immunized with rabies vaccine and have developed high titers of rabies antibody. |
| 用途/適應症 | 狂犬病免疫球蛋白 |
| Use |
Provide passive immunity to rabies in individuals to the disease or virus.
|
衛福部核准適用症狀
MOHW approved indications |
提供被動免疫以預防狂犬病感染。
|
| Dose |
Postexposure prophylaxis: Local wound infiltration or IM, once at the same time as the first dose of rabies vaccine.
Adults and children: 20 IU/kg
|
懷孕分級
Pregnancy Risk Factor |
C
|
| 禁忌症 |
對本品成分有過敏的病人。
|
| Contraindications |
There are no contraindications listed in the manufacturer`s labeling.
Documentation of allergenic cross-reactivity for immune globulins is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.
|
| 常見副作用 | 接種部位疼痛或結節、頭痛、腹痛、腹瀉、腹脹、鼻塞與口咽疼痛。 |
| Common adverse drug reactions | Injection site pain or nodule, headache, abdominal pain, diarrhea, flatulence, nasal congestion and oropharyngeal pain. |
| Adverse Reactions |
>10%:
Central nervous system: Headache (8% to 15%)
Local: Pain at injection site (31% to 33%)
1% to 10%:
Central nervous system: Fatigue (2% to 6%), dizziness (1% to 6%)
Dermatologic: Sunburn (≦3%)
Gastrointestinal: Diarrhea (8%), flatulence (8%), nausea (4%), abdominal pain (1% to 4%)
Genitourinary: Leukocyturia (3% to 5%), hematuria (2% to 4%)
Hematologic & oncologic: Bruise (1% to 3%)
Local: Injection site nodule (8%)
Neuromuscular & skeletal: Myalgia (7% to 9%), arthralgia (≦6%)
Respiratory: Upper respiratory tract infection (9% to 10%), nasal congestion (8%), oropharyngeal pain (8%)
Frequency not defined:
Central nervous system: Malaise
Dermatologic: Skin rash
Genitourinary: Nephrotic syndrome
Hypersensitivity: Anaphylaxis, angioedema
Local: Local soreness/soreness at injection site, tenderness at injection site
Neuromuscular & skeletal: Stiffness (at injection site)
Miscellaneous: Fever (mild)
<1%, postmarketing, and/or case reports: Hypersensitivity reaction, hypoesthesia, limb pain
|
監測
Monitoring |
Blood viscosity: At baseline in patients at risk for hyperviscosity
Signs and symptoms of thrombosis: In patients at risk for thrombosis or thrombotic complications, for at least 24 hours after administration
Signs and symptoms of hypersensitivity: In patients with a history of prior systemic allergic reactions after administration of human immune globulin products
Signs and symptoms of hemolysis
|
| 警語與注意事項 | 給藥前確認「預防接種紀錄卡」有醫師簽章後,由藥師謄寫【藥名】與【批號】於「預防接種紀錄卡」上,交還病人 |
| Warnings & precautions | 請持處方簽、`暴露後狂犬病疫苗及免疫球蛋白使用表`至藥局領藥並存查。 |
| 針劑溶解條件 |
|
| 針劑稀釋條件 |
HyperRAB 300 IU/1mL/Vial (紅色盒子)：經計算劑量後，若需要稀釋時，需以「5%葡萄糖水1比1倍稀釋」後使用。(1080114仿單資料)
HyperRAB S/D 300 IU/2mL/Vial (白色盒子)：若需要稀釋時，需以「生理鹽水將被動免疫製劑適當稀釋 2 至 3 倍」 。
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| 針劑不相容性 |
|
| 針劑施打條件 |
應按建議劑量將免疫球蛋白製劑全部浸潤注射到傷口週圍後，尚有剩餘免疫球蛋白製劑時，應將其注射到最接近患肢同側的深部肌肉（如肌肉注射於同側的上臂肌肉或同側大腿外肌群），以避免影響疫苗的效果。(1080102仿單資料，疑似狂犬病或麗沙病毒動物抓咬傷臨床處置指引)
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| 針劑保存安定性 |
2-8℃冷藏存放。
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最近修改日期時間
Updated | 9/4/2019 3:36:05 PM |