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HSA Approval

TECHNESCAN MAG3 KIT 1 mg/vial

SIN06741P

TECHNESCAN MAG3 KIT 1 mg/vial

TECHNESCAN MAG3 KIT 1 mg/vial

December 20, 1991

QT INSTRUMENTS (S) PTE LTD

QT INSTRUMENTS (S) PTE LTD

Regulatory Information

QT INSTRUMENTS (S) PTE LTD

QT INSTRUMENTS (S) PTE LTD

Therapeutic

Prescription Only

Formulation Information

INJECTION, POWDER, FOR SOLUTION

**DOSAGE AND ADMINISTRATION** The suggested dose range employed in the average adult patient (70 kg) for renal function and imaging studies is 185 MBq (5 mCi) to 370 MBq (10 mCi). In pediatric patients the recommended dose range is 2.6 MBq/kg (70 microcurie/kg) to 5.2 MBq/kg (140 microcurie/kg) with a minimum dose of 37 MBq (1 mCi). The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Aseptic procedures and a shielded syringe should be employed in withdrawing doses for administration to patients. The user should wear waterproof gloves during the administration procedure.

INTRAVENOUS

Medical Information

**INDICATIONS AND USAGE** Technetium Tc 99m mertiatide is a renal imaging agent for use in the diagnosis of congenital and acquired abnormalities, renal failure, urinary tract obstruction, and calculi in adults and pediatric patients. (See Pediatric Use – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.) It is a diagnostic aid in providing renal function, split function, renal angiograms, and renogram curves for whole kidney and renal cortex.

**CONTRAINDICATIONS** None known.

NA

xna

Manufacturer Information

QT INSTRUMENTS (S) PTE LTD

Curium US LLC

Active Ingredients

BETIATIDE

1 mg/vial

Betiatide

Documents

Package Inserts

A096i0-in0000-us122018.pdf

Approved: July 26, 2019

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