n system immediately prior to administration.
RADIATION DOSIMETRY
The 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.
Table 4: Strontium-89 Dosimetry Organ mGy/MBq rad/mCi
Bone Surface 17.0 63.0
Red Bone Marrow 11.0 40.7
Lower Bowel Wall 4.7 17.4
Bladder Wall 1.3 4.8
Testes 0.8 2.9
Ovaries 0.8 2.9
Uterine Wall 0.8 2.9
Kidneys 0.8 2.9
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 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.
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 Illinois Adm. Code 330.260 (a) and Part 335 Subpart F.335.5010 or under equivalent licenses of the USNRC or an Agreement State.
NDC17156-524-01
Manufactured by:
GE Healthcare Ltd.
Amersham England
GE Healthcare
Medi-Physics, Inc.,
3350 North Ridge Avenue
Arlington Heights, IL 60004
Metastron is a trademark of GE Healthcare.
GE and the GE Monogram are trademarks of General Electric Company.
43-9000D
Revised February 2006
METASTRON (Strontium chloride, SR-89)
PRODUCT INFO
Product Code 17156-524 Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route Of Administration INTRAVENOUS DEA Schedule
INGREDIENTS
Name (Active Moiety) Type Strength
Strontium Chloride, SR-89 (Strontium Chloride, SR-89) Active 1MILLICURIE In1MILLILITER
Water Inactive
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color Score
Shape Symbol
Imprint Code Coating
Size
PACKAGING
# NDC Package Description Multilevel Packaging
1 17156-524-01 5VIALIn1BOX contains a VIAL
1 10MILLILITERIn1VIAL This package is contained within the BOX