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
藥用類別名稱
放射性藥物
批准日期：2007年9月
商標名
Metastron Injectable
性状：
(一) 氯化銨 (89sr) (氯化銨 (89sr))
分子式: 89srcl2 分子量: 159.91
2 放射性核素的特徵 (如 89sr)
物理半衰期: 31.4 天 (β衰變)
初級β射線能量: 高達 1.49 mev (100%)
适应症
固體癌症患者骨閃爍陽性圖像骨轉移部位的疼痛緩解
用法与用量
通常情況下, 成年人將能夠靜態注意2.0mbq/kg 一次, 高達141mbq。在重複管理的情況下, 管理間隔至少為3個月或更長時間。
臨床結果
雖然國內惡性腫瘤患者的疼痛部位陽性圖像和惡性腫瘤骨轉移骨閃爍匹配的臨床試驗結果如下, 但尚未獲得有關該藥物在檢測中的療效的充分資訊。
69例 (28 例前列腺癌、27例乳腺癌、7例肺癌、7例其他癌症), 靜態配藥 2.0 mbqkg, 反應為 32/69, 作為鎮痛藥使用量和疼痛嚴重程度變化的指標。
包装
141mbq (3.8毫升) 1小瓶
製造商
Medi- Physics Co.Ltd
注：以上中文不够完整，使用者以原处方资料为准。
完整说明附件：http://www.info.pmda.go.jp/go/pack/4300449A1021_1_04/
Metastron (Strontium-89 Chloride) Injection
Metastron (Strontium Chloride, SR-89)
Indications and Dosage
INDICATIONS AND USAGE
Metastron (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 ADMINISTRATION
The 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 DOSIMETRY
The 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 SUPPLIED
Metastron 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 17156-524-01
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.