Myoview Product Monograph

Preparation

The MYOVIEW kit is supplied as a pack of five vials for use in the preparation of a technetium Tc99m tetrofosmin intravenous injection to be used for the scintigraphic delineation of regions of reversible myocardial ischemia in the presence or absence of infarcted myocardium and for the evaluation of ventricular function. Each vial contains a predispensed, sterile, non-pyrogenic, lyophilized mixture of 0.23 mg tetrofosmin [6,9-bis(2-ethoxyethyl)-3,12-dioxa-6,9-diphosphatetradecane], 0.03 mg stannous chloride dihydrate (minimum stannous tin 0.005 mg; maximum total stannous and stannic tin 0.0158 mg), 0.32 mg disodium sulphosalicylate and 1.0 mg sodium D-gluconate, and 1.8 mg sodium hydrogen carbonate. The lyophilized powder is sealed under a nitrogen atmosphere with a rubber closure. The product contains no antimicrobial preservative.

INSTRUCTIONS FOR THE PREPARATION OF MYOVIEW INJECTION USE ASEPTIC TECHNIQUE THROUGHOUT.
The user should wear waterproof gloves and use shielding at all times when handling the reconstituted vial or syringes containing the radioactive agent.
The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

  1. Place one of the vials in a suitable shielding container and sanitize the rubber septum with an isopropyl alcohol swab. Insert a sterile needle (the venting needle) through the rubber septum.
  2. Using a shielded, 10 mL sterile syringe, inject the required activity of up to 240 mCi (8.8 GBq) technetium Tc99m generator eluate (diluted with Sodium Chloride Injection, USP) into the shielded vial (see Cautionary notes 1 and 2). Before removing the syringe from the vial, withdraw 2 mL of gas from above the solution. Remove the venting needle. Mix gently for 10 seconds to ensure complete dissolution of the powder.
  3. Incubate at room temperature for 15 minutes.
  4. Assay the total activity, complete the user radiation label and attach it to the vial.
  5. Visually inspect the reconstituted solution at a safe distance through leaded glass. Do not use if it is not clear or if it contains foreign particulate matter.
  6. Maintain adequate shielding of the radioactive preparation.
  7. Store the reconstituted injection at 2-25°C (36-77°F) and use within 12 hours of preparation.

Please see full prescribing information

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