锶/89锶氯化物(Metastron Injectable 141MBq/3.8mL)

产地国家日本

处方药

所属类别 141毫居里(3.8毫升)/小瓶

包装规格 141毫居里(3.8毫升)/小瓶

计价单位

生产厂家英文名Medi- Physics Co., Ltd.

原产地英文商品名METASTRON Injection(メタストロン注)141mCi(3.8mL)/Vial

原产地英文药品名strontium(89Sr)chloride

中文参考商品译名美他特龙注射剂(メタストロン注)141毫居里(3.8毫升)/小瓶

中文参考药品译名锶(89锶)氯化物

简介:

部份中文锶(89锶)氯化物处方资料(仅供参考)

商品名:Metastron

英文名:strontium(89Sr)chloride

中文名:锶(89锶)氯化物

生产商:Medi- Physics Co.Ltdメタストロン注

药用类別名称:放射性药物

批准日期:2007年9月

商标名:Metastron Injectable

分子式: 89srcl2

分子量: 159.912 放射性核素的特征 (如 89sr)物理半衰期: 31.4 天 (β衰变)初级β射线能量: 高运 1.49 mev (100%)

适应症:固体癌症患者骨闪烁阳性图像骨转移部位的疼痛缓解。

用法与用量:通常情况下, 成年人将能够静态注意2.0mbq/kg 一次, 高达141mbq。在重複管理的情况下, 管理间隔至少为3个月或更长时间。

临床结果:虽然国内恶性肿瘤患者的疼痛部位阳性图像和恶性肿瘤骨转移骨闪烁匹配的临床试验结果如下, 但尚未获得有关该药物在检测中的疗效的充分资讯。69例 (28 例前列腺癌、27例乳腺癌、7例肺癌、7例其他癌症), 静态配药 2.0 mbqkg, 反应为 32/69, 作为镇痛药使用量和疼痛严重程度变化的指标。

包装:141mbq (3.8毫升) 1小瓶

制造商:Medi- Physics Co.Ltd。

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 (1-2minutes).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, 1mCi 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 8mm(max.) and in glass of about 3mm, 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.NDC 17156-524-01The 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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