Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION, POWDER, FOR SOLUTION
**DOSAGE AND ADMINISTRATION** **General Instructions** The recommended adult dose of Technetium Tc 99m-labeled Technescan HDP is 555 MBq (15 mCi) with a range of 370 to 740 MBq (10 to 20 mCi). The recommended pediatric dose is 7.4 MBq (0.20 mCi)/kg with a range of 7.4 to 13 MBq (0.20 to 0.35 mCi)/kg. The recommended minimum total pediatric dose is 37 MBq (1.0 mCi). The maximum total dose injected into a pediatric or adult patient is 740 MBq (20.0 mCi). The maximum dose of oxidronate sodium should not exceed 2 mg. Unit dose preparation instructions should be followed for pediatric patients. The radioactivity of each dose should be measured by a suitable radiation calibration system just prior to administration. The dose should be given intravenously by slow injection. For optimal results imaging should be performed 1 to 4 hours post-injection.
INTRAVENOUS
Medical Information
**INDICATIONS AND USAGE** Technescan HDP Tc 99m is a diagnostic skeletal imaging agent used to demonstrate areas of altered osteogenesis in adult and pediatric patients.
**CONTRAINDICATIONS** None known.
NA
xna
Manufacturer Information
QT INSTRUMENTS (S) PTE LTD
Curium US LLC
Active Ingredients
Documents
Package Inserts
A091i0-in0000-us122018.pdf
Approved: March 17, 2020