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  药店国别: 德国药房
产地国家: 德国
所属类别: 作用于消化系统药物->克罗恩病
处方药:处方药
包装规格: 1 x 2 pens
计价单位:
  点击放大  
生产厂家英文名:
UCB Pharma
该药品相关信息网址1:
https://www.cimzia.com
该药品相关信息网址2:
https://www.drugs.com/cimzia.html
该药品相关信息网址3:
https://en.wikipedia.org/wiki/Certolizumab_pegol
原产地英文商品名:
Cimzia 200mg Injektionslösung in einem Fertigpen 1 x 2 pens
原产地英文药品名:
Certolizumab
中文参考商品译名:
赛妥珠单抗注射液 200 毫克(用于预先填充的注射液) 1 x 2支
中文参考药品译名:
塞妥珠单抗
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Moderate to severe active rheumatoid arthritis in adults
临床试验期:
完成
中文适应病症参考翻译1:
成人中度到重度的活动性风湿关节炎
药品信息:

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 详细处方信息以本药内容附件PDF文件(201883023404125.pdf)的“原文Priscribing Information”为准
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部分CIMZIA处方资料(仅供参考)

CIMZIA(赛妥珠单抗/阿达单抗)

适应症及用法

CIMZIA是表示为一种肿瘤坏死因子(TNF)受体阻滞剂: 减少克罗恩病的症状和体征,并维持临床反应在成人中度至重度活动性疾病,谁也进行了常规治疗反应不足 治疗成人中度至重度活动性类风湿关节炎

【用法用量】

通过皮下注射给药CIMZIA。 CIMZIA初始剂量是400毫克(作为两个皮下注射200毫克给出)。

克罗恩病

最初和在第2周和第4周400毫克。如果响应时,按照400毫克每四个星期 类风湿关节炎

400毫克400毫克最初和在周2和4,然后由200 mg,隔周的维持剂量,每4周,可以考虑

剂型和优势v 200毫克冻干粉末配制用1mL注射用的无菌水,USP 200在单次使用预装玻璃注射器(3毫克/毫升)

禁忌

警告和注意事项v 严重感染 - 不启动CIMZIA在一个活跃的感染。如果感染发展,认真监督,并停止CIMZIA如果变得严重感染. 例淋巴瘤和其他恶性肿瘤已发现的患者接受肿瘤坏死因子阻断剂.

心脏衰竭,恶化或新发,可能会出现.

可能发生过敏性反应或严重的过敏反应.

肝炎乙肝病毒再激活 - 监视乙肝病毒携带者在治疗数月后。如果再活化发生,停止CIMZIA“,并开始抗病毒治疗.

脱髓鞘疾病,加重或新发,可能会出现. 血细胞减少,全血细胞减少症 - 建议患者立即就医,如果症状发展,并考虑:停止CIMZIA.

狼疮样综合征 - 停止CIMZIA综合征进展.

不良反应

最常见的不良反应(发生率≥7%,高于安慰剂):上呼吸道感染,皮疹,泌尿道感染.

药物相互作用

使用生物DMARDs治疗 - 增加严重感染的风险 活疫苗 - 不给CIMZIA

实验室测试 - 可能干扰与APTT测试

GENERIC NAME: certolizumab

BRAND NAME: Cimzia

DRUG CLASS AND MECHANISM: Certolizumab is an injectable synthetic (man-made) protein antibody that binds to tumor necrosis factor alpha (TNFα) in the body and blocks the effects of TNFα in patients with rheumatoid arthritis and Crohn's disease. Adalimumab (Humira) and etanercept (Enbrel) are two other injectable drugs that block TNFα. Inflammation is the body's reaction to injury and is a necessary process for the repair of injury. TNF is a protein that the body produces when there is inflammation. TNF promotes inflammation and the signs of inflammation, which, in the case of arthritis, include fever as well as pain, tenderness, and swelling of joints. In the case of Crohn's disease, the signs of inflammation include fever, abdominal pain, and diarrhea. The unchecked inflammation of rheumatoid arthritis eventually leads to destruction of the joints. The inflammation in Crohn's disease can lead to strictures (narrowing) of the intestine or intestinal perforation. Certolizumab binds to TNF in the body and thereby blocks the effects of TNF. As a result, inflammation and its consequences in the joints and intestine are reduced. In arthritis, the progressive destruction of the joints is slowed or prevented.

GENERIC AVAILABLE: No

PREPARATIONS: Injection (powder): 200 mg. Injection (prefilled syringe): 200 mg

STORAGE: Certolizumab should be stored refrigerated at 2 to 8 C (36 to 46 F). Reconstituted certolizumab should be used within two hours if kept at room temperature or within 24 hours if refrigerated.

PRESCRIBED FOR: Certolizumab is used for treating signs and symptoms of moderate to severe Crohn's disease and maintaining response in adults unresponsive to usual treatment. It is also used for treating rheumatoid arthritis. It may be used alone or combined with methotrexate (Rheumatrex, Trexall) or other drugs used for treating rheumatoid arthritis.

DOSING: Certolizumab is injected under the skin (thigh or abdomen). Injection sites should be rotated. The recommended dose for treating Crohn‘s disease is 400 mg initially (2 injections of 200 mg), followed by 400 mg at weeks 2 and 4. For those who respond, the recommended maintenance dose is 400 mg every 4 weeks. The recommended dose for treating rheumatoid arthritis is 400 mg (2 injections of 200 mg) initially and at weeks 2 and 4, followed by 200 mg every other week.

DRUG INTERACTIONS: Combining anakinra (Kineret), abatacept (Orencia), rituximab (Rituxan) or natalizumab (Tysabri) with certolizumab may result in reduced white blood cells in the blood (neutropenia), serious infections and no additional benefit.

Certolizumab may interfere with the effectiveness of vaccines. Live vaccines, including attenuated vaccines, should not be used while patients are being treated with certolizumab. Certolizumab may interfere with tests of coagulation in patients receiving blood thinners.

PREGNANCY: There are no adequate studies of certolizumab in pregnant women.

NURSING MOTHERS: It is not known whether certolizumab is excreted in breast milk.

SIDE EFFECTS: The most common adverse effects in clinical studies were respiratory tract infections, urinary tract infections, and arthralgia (pain in the joints). Abdominal pain, diarrhea, and intestinal obstruction also may occur. Certolizumab may cause swelling, redness, pain and itching at the site of injection. Like other drugs that block TNFα, use of certolizumab has been associated with serious infections such as tuberculosis, sepsis (bacteria in the blood) and fungal infections. Individuals with active infections should not be treated with certolizumab. Certolizumab may worsen or cause new diseases of the nervous system. Certolizumab also may cause or worsen congestive heart failure. In studies, some patients who used certolizumab or other TNFα blocking drugs developed cancer. Since patients with Crohn's disease have a higher risk of cancers than the general population, the connection between cancer and use of certolizumab is unclear. Other side effects of certolizumab include hypersensitivity (allergic) reactions (including anaphylaxis) and reduced levels in the blood of platelets and red blood cells (aplastic anemia). Certolizumab may increase the risk of reactivating hepatitis B virus in chronic careers of the virus.

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 详细处方信息以本药内容附件PDF文件(201883023404125.pdf)的“原文Priscribing Information”为准
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更新日期: 2018-04-08
附件:
201883023404125.pdf    

 
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