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  药店国别: 香港药房
产地国家: 美国
所属类别: 抗癌药物->治疗甲状腺癌
处方药:处方药
包装规格: 0.9毫克/小瓶, 2小瓶/盒
计价单位:
  点击放大  
生产厂家英文名:
Genzyme (subsidiary of Sanofi company)
该药品相关信息网址1:
https://thyrogen.com/patients.aspx
该药品相关信息网址2:
https://www.businesswire.com/news/home/20030506005821/en/TheraCom-AdvancePCS-Company-Awarded-Contract-Support-New
原产地英文商品名:
THYROGEN 0.9 mg(thyrotropin alfa for injection) (2 vials kit)
原产地英文药品名:
THYROTROPIN ALFA
中文参考商品译名:
适谪进 0.9毫克(注射用促甲状腺激素α)(2瓶试剂盒)
中文参考药品译名:
促甲狀腺激素α
原产地国家批准上市年份:
2015/04/02
英文适应病症1:
Auxiliary diagnostic preparation for the treatment of thyroid differentiated cancer
临床试验期:
完成
中文适应病症参考翻译1:
甲状腺分化癌治疗之辅助诊断制剂
药品信息:

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 详细处方信息以本药内容附件PDF文件(2018112823450440.pdf)的“原文Priscribing Information”为准
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部分中文促甲状腺素α处方资料(仅供参考)

Genzyme 公司 (subsidiary of Sanofi company)宣布FDA已同意批准注射用促甲状腺素α(thyrotropin alfa,Thyrogen)与射碘(radioiodine)联合用于已施手术的甲状腺癌患者去除、破环残余甲状腺组织的补充适应证。清除残余甲状腺是治疗甲状腺癌的必要措施。本品的新增适应证对于已经过初步治疗的甲状腺癌患者而言具有显著的意义,目前本品不但可以在诊断甲状腺癌复发中使用,且可在清除残余甲状腺放疗手术中使用。

美国癌症协会2007年评估了在美国诊断出33550 甲状腺新病例,大约90%的甲状腺患者的分化程度很高,这些患者为甲状腺残余清除手术的候选者。研究结果表明本品显著提高了患者在治疗期间及治疗后的生活质量。开发新的治疗药物对甲状腺的治疗来说是当务之急,因为在美国所有的女性癌症患者中,甲状腺癌的发病率急速上升。

1998年本品首先在美国获准用于高分化甲状腺癌复发情况的诊断试剂,随后于2001年在欧盟获准。本品增加了诊断的灵敏度,此外,Genzyme 公司的Thyrogen于2005年在欧盟被批准用于甲状腺残余手术中的治疗。

部份中文促甲状腺素α粉针Thyrogen[另名:适诺进冻晶注射剂]处方资料(仅供参考)

成分及性状 : Thyrotropin alfa 1.1mg/vial冻晶注射剂

作用

与甲状腺的上皮细胞或甲状腺分化癌之组织上的甲状腺刺激激素接受体结合后,能刺激碘离子的摄取、刺激甲状腺荷尔蒙之合成、分泌及释出,可作为甲状腺分化癌治疗之辅助诊断制剂

药物动力学

肌肉注射后在3~24小时达到最高血中浓度约116±38MU/L;平均半衰期为25±10小时

适应症

甲状腺分化癌治疗之辅助诊断制剂

剂 量:

每24小时肌肉注射0.9mg,注射两个剂量,或每72小时肌肉注射0.9mg,注射三个剂量。最后一次注射后24小时,给予放射性碘,再隔48小时进行I-131扫描检查或治疗

不良反应

恶心、头痛、无力、寒颤、发烧、感冒症状、呕吐、眩晕、感觉异常等

注意事项

1.仅能肌肉注射不可用静脉注射方式投药。

2.会暂时却显著地使血液中的甲状腺激素浓度上升,因此对有心脏病史或有明显的甲状腺残留组织的病患需谨慎注意。

3.本品使用前才进行稀释,必要时稀释配制好的注射液可在2~8℃下放置24小时。

4.不建议用在因甲状腺癌而停止放射治疗后,作为刺激放射性碘的摄取之用。

5.当停用甲状腺激素而伴随产生甲状腺机能低下的征象或症状时,应避免使用本品。

6.健保对本药采事前专案审查给付。

禁忌

交互作用

目前尚无与其他药品交互作用之资料

储存

贮存于2~8℃

Genzyme announced that the FDA has agreed to approve the use of thyrotropin alfa (Thyrogen) and iodine (radioiodine) for the replacement of thyroid cancer patients with surgically modified thyroid tissue. Clearing residual thyroid is a necessary measure to treat thyroid cancer. The new indications for this product have significant significance for patients with thyroid cancer who have undergone initial treatment. Currently, this product can be used not only in the diagnosis of thyroid cancer recurrence, but also in the removal of residual thyroid radiotherapy.

The American Cancer Society evaluated a new diagnosis of 33,550 new thyroid cases in the United States in 2007. About 90% of thyroid patients have a high degree of differentiation, and these patients are candidates for thyroid residual resection. The results of the study show that this product significantly improves the quality of life of patients during and after treatment. The development of new therapeutic drugs is a priority for the treatment of thyroid cancer, as the incidence of thyroid cancer is rapidly increasing among all female cancer patients in the United States.

In 1998, this product was first approved in the United States as a diagnostic reagent for the recurrence of highly differentiated thyroid cancer, and was subsequently approved in the European Union in 2001. This product increases the sensitivity of the diagnosis. In addition, Genzyme's Thyrogen was approved for treatment in thyroid residual surgery in the European Union in 2005.

Some Chinese thyrotropin alpha powder needle Thyrogen [another name: Shinuojin frozen crystal injection] prescription information (for reference only)

  

Ingredients and traits : Thyrotropin alfa 1.1mg/vial frozen crystal injection

   

Action

Combined with thyroid stimulating hormone receptors on thyroid epithelial cells or tissues of thyroid differentiated cancer, it stimulates the uptake of iodide ions, stimulates the synthesis, secretion and release of thyroid hormones, and can be used as a treatment for thyroid differentiated cancer. Auxiliary diagnostic preparation

   

Pharmacokinetics

After intramuscular injection, the highest blood concentration was about 116±38 MU/L in 3 to 24 hours; the average half-life was 25±10 hours.    

Indications

Auxiliary diagnostic preparation for the treatment of thyroid differentiated cancer

Dose:

Intramuscular injection of 0.9 mg every 24 hours, injection of two doses, or intramuscular injection of 0.9 mg every 72 hours, three doses. Radioactive iodine was given 24 hours after the last injection, and I-131 scan or treatment was performed every 48 hours.

   

Adverse reactions

Nausea, headache, weakness, chills, fever, cold symptoms, vomiting, dizziness, paresthesia, etc.

   

Notes

1. Only intramuscular injection can not be administered by intravenous injection.

2. Temporarily but significantly increases the concentration of thyroid hormone in the blood, so care should be taken for patients with a history of heart disease or with significant thyroid residual tissue.

3. Dilute the product before use. If necessary, dilute the prepared injection solution and leave it at 2~8 °C for 24 hours.

4. It is not recommended for use in stimulating radioactive iodine after stopping radiation therapy due to thyroid cancer.

5. When thyroid hormone is stopped and accompanied by signs or symptoms of hypothyroidism, avoid using this product.

6. Health Insurance pays for the pre-project review of this drug.

   

Contraindications

   

Interaction

There is currently no data to interact with other drugs

   

Save

Stored at 2~8°C

Lot#: 8Y0366 Expiration Date: 4/30/20

*REFRIGERATED

*Special order, can not be cancelled or returned

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 详细处方信息以本药内容附件PDF文件(2018112823450440.pdf)的“原文Priscribing Information”为准
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更新日期: 2018-11-28
附件:
2018112823574926.JPEG    

2018112823450440.pdf    

 
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