药品信息:
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201952015385237.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- 部分中文VARIZIG处方资料(仅供参考)
【英文名称】VARIZIG
【适用证】
VARIZIG是一种水痘带状疱疹免疫球蛋白(人类),适用于高风险个体的暴露后预防(1)。 高风险群体包括:
免疫功能低下的儿童和成人,
分娩前后不久有水痘的母亲的新生儿,
早产儿,
不到一岁的婴儿,
没有免疫力证据的成年人
孕妇。
VARIZIG施用旨在降低水痘的严重程度。
【用法用量】
VARIZIG的剂量基于体重。 按照下表(2.1)的建议,肌内注射单剂量的VARIZIG:
患者体重(kg);剂量(IU);小瓶数量
≤2.0; 62.5; 0.5
2.1-10.0; 125; 1
10.1-20.0; 250; 2
20.1-30.0; 375; 3
30.1-40.0; 500; 4
> 40.1; 625; 5
丢弃任何部分样品瓶。
肌肉注射剂量应根据患者体型分为两个部位。 每个注射部位不超过3 mL(2.2)。
【禁忌】
---对人免疫球蛋白的过敏性或严重全身反应的病史(4)。
--- IgA缺陷患者具有抗IgA抗体和过敏史(4)。
【使用注意】
- 血栓形成事件(5.1)
- 凝血障碍(5.2)
- 超敏反应(5.3)
- 传染性传染因子(5.4)
【INDICATIONS AND USAGE】
VARIZIG is a Varicella Zoster Immune Globulin (Human) indicated for post- exposure prophylaxis in high risk individuals (1). High risk groups include:
immunocompromised children and adults,
newborns of mothers with varicella shortly before or after delivery,
premature infants,
infants less than one year of age,
adults without evidence of immunity,
pregnant women.
VARIZIG administration is intended to reduce the severity of varicella.
【CONTRAINDICATIONS】
---History of anaphylactic or severe systemic reactions to human immune globulins (4).
---IgA-deficient patients with antibodies against IgA and a history of hypersensitivity (4).
【WARNINGS AND PRECAUTIONS】
--Thrombotic events (5.1)
--Coagulation disorders (5.2)
--Hypersensitivity (5.3)
--Transmissible infectious agents (5.4)
【DOSAGE AND ADMINISTRATION】
Dosing of VARIZIG is based on body weight. Administer a single dose of VARIZIG intramuscularly as recommended in the following table (2.1):
Weight of Patient (kg) ; Dose (IU) ; Number of Vials
≤2.0 ;62.5 ;0.5
2.1–10.0 ;125 ; 1
10.1–20.0 ; 250 ; 2
20.1–30.0 ;375 ;3
30.1–40.0; 500 ;4
>40.1 ;625 ;5
Discard any partial vials.
The intramuscular dose should be divided and administered in two sites, dependent on patient size. Do not exceed 3 mL per injection site (2.2).
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201952015385237.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- |