美他特龙注射剂 METASTRON(Strontium-89 Chloride Injection)

药店国别:

产地国家:美国

处方药:是

所属类别: 4毫居里/10毫升/小瓶

包装规格: 4毫居里/10毫升/小瓶

计价单位:

生产厂家中文参考译名:

生产厂家英文名:GE Healthcare Ltd.

原产地英文商品名:METASTRON Injection 4 mCi/10mL/Vial

原产地英文药品名:Strontium-89 Chloride

中文参考商品译名:美他特龙注射剂 4毫居里/10毫升/小瓶

中文参考药品译名:锶-89氯化物

简介

部份中文美他特龙处方资料(仅供参考)

商品名:美他特龙

通用名:氯化锶注射液

商品名(英文):stron

别名:氯化锶[89sr]注射液

适应症

本品为转移癌性骨痛的姑息治疗剂,主要用于前列腺癌、乳腺癌等晚期恶性肿瘤骨转移所致骨痛的缓解,是骨痛止痛的一种补充性治疗选择。

用法用量

推荐用量为每次静脉注射100 ~150 mbq(4.0mci)/人次。另外,对于体重较重或较轻的病人可以按1.5mbq~2.0mbq(40~55μci)/kg 来计算给药剂量。虽然没有临床证据清楚地表明较高剂量(150 mbq/人次)会更为有效,但较高剂量已经被使用,没有证据表明其毒性增加,并可以用于某些患者以避免剂量不足。然而,使用高剂量有增加骨髓抑制的潜在风险。

用法药液不需稀释,缓慢静脉注射。重复注射必须间隔3个月以上。对于第一次注射本品后无反应的患者,一般不进行再次注射。本品不适用于儿童。

贮藏

按放射性物品保管规定,置防护容器内室温下贮藏(15~25℃)。包装每瓶装量4ml。 产品作为水溶液装于透明玻璃小瓶中。小瓶用ptfe氯丁基橡胶塞和金属外圈密封。每瓶150mbq。有效期自标定并置入容器之日起,仅限于4周内使用。

英文版说明书

Metastron (Strontium-89 Chloride) InjectionMetastron (Strontium Chloride, SR-89)Indications and DosageINDICATIONS AND USAGEMetastron (Strontium-89 Chloride Injection) is indicated for the relief of bone pain in patients with painful skeletal metastases.The presence of bone metastases should be confirmed prior to therapy.DOSAGE AND ADMINISTRATIONThe recommended dose of Metastron is 148 MBq, 4 mCi, administered by slow intravenous injection (1-2 minutes).Alternatively, a dose of 1.5 – 2.2 MBq/kg, 40-60 µCi/kg body weight may be used.Repeated administrations of Metastron should be based on an individual patient’s response to therapy, current symptoms, and hematologic status, and are generally not recommended at intervals of less than 90 days.The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.RADIATION DOSIMETRYThe estimated radiation dose that would be delivered over time by the intravenous injection of 37 MBq, 1 mCi of Strontium-89 to a normal healthy adult is given in Table 4. Data are taken from the ICRP publication “Radiation Dose to Patients from Radiopharmaceuticals”-ICRP #53, Vol. 18, No. 1-4, Page 171, Pergamon Press, 1988.When blastic osseous metastases are present, significantly enhanced localization of the radiopharmaceutical will occur with correspondingly higher doses to the metastases compared with normal bones and other organs.The radiation dose hazard in handling Strontium-89 Chloride injection during dose dispensing and administration is similar to that from phosphorus-32. The beta emission has a range in water of about 8 mm (max.) and in glass of about 3 mm, but the bremsstrahlung radiation may augment the contact dose.Measured values of the dose on the surface of the unshielded vial are about 65 mR/minute/mCi.It is recommended that the vial be kept inside its transportation shield whenever possible.HOW SUPPLIEDMetastron is supplied in a 10 mL vial containing 148 MBq, 4 mCi. The vial is shipped in a transportation shield with approximately 3 mm lead wall thickness, package insert, and two therapeutic agent warning labels.The vial and its contents should be stored inside its transportation container at room temperature (15-25°C, 59-77°F).The calibration date (for radioactivity content) and expiration date are quoted on the vial label. The expiration date will be 28 days after calibration. Stability studies have shown no change in any of the product characteristics monitored during routine product quality control over the period from manufacture to expiration.This radiopharmaceutical is licensed by the Illinois Emergency Management Agency for distribution to persons licensed pursuant to 32 IL. Adm. Code 330.260 (a) and Part 335 Subpart F.335.5010 or under equivalent licenses of the USNRC or an Agreement State.

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