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  药店国别: 美国药房
产地国家: 德国
所属类别: 作用于免疫系统药物->免疫抑制药物
处方药:处方药
包装规格: 125IU 1溶液/小瓶/盒 1毫升/小瓶/盒
计价单位:
  点击放大  
生产厂家英文名:
GlaxoSmithKline Biologicals SA
该药品相关信息网址1:
https://www.gsksource.com/pharma/content/gsk/source/us/en/brands/rabavert.html
原产地英文商品名:
RabAvert (One Dose Rabies Vaccine) 1mL/vial/box
原产地英文药品名:
Rabies Vaccine
中文参考商品译名:
RabAvert(一剂量狂犬病疫苗)1毫升/小瓶/盒
中文参考药品译名:
狂犬病疫苗
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
rabies vaccine
临床试验期:
完成
中文适应病症参考翻译1:
狂犬病疫苗
药品信息:

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详细处方信息以本药内容附件PDF文件(201952022515832.pdf)的“原文Priscribing Information”为准
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部分中文RabAvert处方资料(仅供参考)

【英文名称】RabAvert

【适用证】

RabAvert适用于暴露前接种疫苗,包括初级系列和加强剂量,以及用于所有年龄组狂犬病的暴露后预防。

通常用1种疫苗产品启动并完成免疫系列。 没有进行临床研究,记录当用第二种疫苗产品完成系列时功效的变化或不良反应的频率。 然而,对于加强免疫,RabAvert显示在接受HDCV初级系列测试的人中引发保护性抗体水平反应

【用法用量】

仅限于肌肉注射。成人,儿童和婴儿的个人剂量为1 mL。

在成人中,通过IM注射到三角肌中来施用疫苗。在小孩和婴儿中,将疫苗注射到大腿的前外侧区域。疫苗注射应避免臀部区域,因为在该区域给药可能导致较低的中和抗体滴度。应注意避免注射到血管和神经中或附近。抽吸后,如果注射器中出现血液或任何可疑的变色,请不要注射但丢弃内容物,并在不同部位使用新剂量的疫苗重复操作。

Preexposure剂量:初次免疫:在美国,ACIP建议每次注射3次,每次注射1次:第0天注射1次,第7天注射1次,第21天或第28天注射1次(关于暴露前接种的标准,见表1)。

加强免疫:肌肉注射个体加强剂量为1 mL。

对接受狂犬病疫苗接种的人进行加强免疫接种,并因职业或爱好原因导致狂犬病暴露风险增加。

【禁忌】

Preexposure预防:

超敏反应:对疫苗或任何疫苗成分过敏的历史构成了接种此疫苗的暴露前的禁忌症。

暴露后预防:鉴于狂犬病几乎总是致命的结果,暴露后预防没有禁忌症,包括怀孕

【使用注意】

如果可以获得合适的产品,被认为有对疫苗或任何疫苗成分存在严重超敏反应风险的患者应接受替代狂犬病疫苗。

过敏反应,脑膜炎; 神经麻痹事件,如脑炎,短暂性麻痹; 格林 - 巴利综合症;脊髓炎; 球后神经炎; 据报道,多发性硬化症与RabAvert的使用暂时相关。 请参阅预防措施和不良反应。 然而,在决定停止免疫接种之前,必须仔细考虑患者患狂犬病的风险。

仅限于肌肉注射。 对于成年人来说,三角肌区是首选的免疫接种地点; 对于小孩和婴儿,优选给予大腿的前外侧区域。 应该避免使用臀区,因为在该区域中给药可能导致较低的中和抗体滴度

【INDICATIONS AND USAGE】

RabAvert is indicated for preexposure vaccination, in both primary series and booster dose, and for postexposure prophylaxis against rabies in all age groups.

Usually an immunization series is initiated and completed with 1 vaccine product. No clinical studies have been conducted that document a change in efficacy or the frequency of adverse reactions when the series is completed with a second vaccine product. However, for booster immunization, RabAvert was shown to elicit protective antibody level responses in persons tested who received a primary series with HDCV

【CONTRAINDICATIONS】

Preexposure Prophylaxis:

Hypersensitivity: History of anaphylaxis to the vaccine or any of the vaccine components constitutes a contraindication to preexposure vaccination with this vaccine.

Postexposure Prophylaxis: In view of the almost invariably fatal outcome of rabies, there is no contraindication to postexposure prophylaxis, including pregnancy

【WARNINGS AND PRECAUTIONS】

Patients considered to be at risk of a severe hypersensitivity reaction to the vaccine or any of the vaccine components should receive an alternative rabies vaccine if a suitable product is available.

Anaphylaxis, meningitis; neuroparalytic events such as encephalitis, transient paralysis; Guillain-Barré Syndrome; myelitis; retrobulbar neuritis; and multiple sclerosis have been reported to be temporally associated with the use of RabAvert. See PRECAUTIONS and ADVERSE REACTIONS. A patient’s risk of developing rabies must be carefully considered, however, before deciding to discontinue immunization.

For intramus cular us e only. For adults, the deltoid area is the preferred site of immunization; for small children and infants, administration into the anterolateral zone of the thigh is preferred. The use of the gluteal region should be avoided, since administration in this area may result in lower neutralizing antibody titers

【DOSAGE AND ADMINISTRATION】

For intramus cular us e only. The individual dose for adults, children, and infants is 1 mL.

In adults, administer vaccine by IM injection into the deltoid muscle. In small children and infants, administer vaccine into the anterolateral zone of the thigh. The gluteal area should be avoided for vaccine injections, since administration in this area may result in lower neutralizing antibody titers. Care should be taken to avoid injection into or near blood vessels and nerves. After aspiration, if blood or any suspicious discoloration appears in the syringe, do not inject but discard contents and repeat procedure using a new dose of vaccine at a different site.

Preexposure Dosage: Primary Immunization: In the US, ACIP recommends 3 injections of 1 mL each: 1 injection on Day 0 and 1 on Day 7, and 1 either on Day 21 or 28 (for criteria for preexposure vaccination, see Table 1).

Booster Immunization: The individual booster dose is 1 mL, given intramuscularly.

Booster immunization is given to persons who have received previous rabies immunization and remain at increased risk of rabies exposure by reasons of occupation or avocation.

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详细处方信息以本药内容附件PDF文件(201952022515832.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

更新日期: 2019-5-14
附件:
201952022515832.pdf    

 
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