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HSA Approval

TECHNESCAN HDP POWDER FOR INJECTION 3.15 mg/vial

SIN10712P

TECHNESCAN HDP POWDER FOR INJECTION 3.15 mg/vial

TECHNESCAN HDP POWDER FOR INJECTION 3.15 mg/vial

February 8, 1999

QT INSTRUMENTS (S) PTE LTD

QT INSTRUMENTS (S) PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantQT INSTRUMENTS (S) PTE LTD
Licence HolderQT INSTRUMENTS (S) PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore 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

OXIDRONATE SODIUM

3.15 mg/vial

Oxidronic acid

Documents

Package Inserts

A091i0-in0000-us122018.pdf

Approved: March 17, 2020

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