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  药店国别: 美国药房
产地国家: 美国
所属类别: 作用于呼吸系统药物->肺炎
处方药:处方药
包装规格: 10X0.5毫升
计价单位:
  点击放大  
生产厂家英文名:
Wyeth Pharmaceutical Division of Wyeth Holdings LLC, a subsidiary of Pfizer Inc.
该药品相关信息网址1:
https://adult.prevnar13.com/about-prevnar13?cmp=918ddc83-648f-401c-971b-0ff8b3dece45
该药品相关信息网址2:
https://www.rxlist.com/prevnar-13-side-effects-drug-center.htm
原产地英文商品名:
PREVNAR 13 SYR 10X0.5ML (**REFRIGERATED)
原产地英文药品名:
pneumococcal 13-valent conjugate vaccine
中文参考商品译名:
PREVNAR 13 SYR 10X0.5毫升 (*需冷藏)
中文参考药品译名:
肺炎球菌13价结合疫苗
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Pneumococcal vaccine
临床试验期:
完成
中文适应病症参考翻译1:
肺炎球菌疫苗
药品信息:

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详细处方信息以本药内容附件PDF文件(201932717572713.pdf)的“原文Priscribing Information”为准
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部分中文PREVNAR 13处方资料(仅供参考)


【英文名称】
PREVNAR 13

【适用证】

在6周至5周岁(6岁生日之前)的儿童中,Prevnar 13适用于:

---主动免疫预防由肺炎链球菌血清型1,3,4,5引起的侵袭性疾病, 图6A,6B,7F,9V,14,18C,19A,19F和23F。 (1.1)

---用于预防由肺炎链球菌血清型4,6B,9V,14,18C,19F和23F引起的中耳炎的主动免疫。没有中耳炎功效数据可用于血清型1,3,5,6A,7F和19A。 (1.1)

在6岁至17岁(18岁生日之前)的儿童中,Prevnar 13适用于:

---用于预防由肺炎链球菌血清型1,3,4,5,6A,6B,7F,9V,14,18C,19A,19F和23F引起的侵袭性疾病的主动免疫。 (1.2)

在18岁及以上的成年人中,Prevnar 13适用于:用于预防由肺炎链球菌血清型1,3,4,5,6A,6B,7F,9V引起的肺炎和侵袭性疾病的主动免疫,图14,18C,19A,19F和23F。 (1.3)

Prevnar 13使用和有效性的局限性

Prevnar 13不能预防未接种疫苗的肺炎链球菌血清型引起的疾病。 (1.4)

【用法用量】

LIBTAYO的推荐剂量为每3周30分钟静脉输注350毫克。(2.1)

【注意事项】

严重和致命的免疫介导的不良反应:免疫介导的不良反应可能发生在任何器官系统或组织中,包括:免疫介导的肺炎,免疫介导的结肠炎,免疫介导的肝炎,免疫介导的内分泌病, 免疫介导的皮肤病学不良反应和免疫介导的肾炎和肾功能不全。 监测免疫介导的不良反应的症状和体征。 在基线和治疗期间定期评估临床化学,包括肝脏和甲状腺功能。 根据反应的严重程度,扣留或永久停用LIBTAYO并给予皮质类固醇。 (2.2,5.1)

输液相关反应:中断,根据反应的严重程度减慢输注速度或永久停药。 (2.2,5.2)

胚胎 - 胎儿毒性:可能导致胎儿伤害。 告知女性有可能对胎儿造成潜在风险并使用有效避孕措施。 (5.3,8.1,8.3)

【INDICATIONS AND USAGE】

In children 6 weeks through 5 years of age (prior to the 6 birthday), Prevnar 13 is indicated for:

---active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. (1.1)

---active immunization for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. No otitis media efficacy data are available for serotypes 1, 3, 5, 6A, 7F, and 19A. (1.1)

In children 6 years through 17 years of age (prior to the 18 birthday), Prevnar 13 is indicated for:

---active immunization for the prevention of invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. (1.2)

In adults 18 years of age and older, Prevnar 13 is indicated for: active immunization for the prevention of pneumonia and invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. (1.3)

Limitations of Prevnar 13 Use and Effectiveness

Prevnar 13 does not protect against disease caused by S. pneumoniae serotypes that are not in the vaccine. (1.4)

【DOSAGE AND ADMINISTRATION】

The recommended dosage of LIBTAYO is 350 mg as an intravenous infusion over 30 minutes every 3 weeks. (2.1)

【WARNINGS AND PRECAUTIONS】

Severe and Fatal Immune-Mediated Adverse Reactions: Immune-mediated adverse reactions can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions and immunemediated nephritis and renal dysfunction. Monitor for symptoms and signs of immune-mediated adverse reactions. Evaluate clinical chemistries, including liver and thyroid function, at baseline and periodically during treatment. Withhold or permanently discontinue LIBTAYO and administer corticosteroids based on the severity of reaction. (2.2, 5.1)

Infusion-Related Reactions: Interrupt, slow the rate of infusion or permanently discontinue based on severity of reaction. (2.2, 5.2)

Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception. (5.3, 8.1, 8.3)

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详细处方信息以本药内容附件PDF文件(201932717572713.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

更新日期:  2019-3-27
附件:
201932717572713.pdf    

 
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