FDA Label for Dextran 75

The following document was submitted to the FDA by the labeler of this product Anazaohealth Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Description

AnazaoHealth supplies compounded Dextran 75 for the preparation of Tc-99m Dextran 75. Each reaction vial contains 10 mg of Dextran 75, 0.30mg of stannous chloride, 0.73 mg Sodium Citrate and 1 mg of dextrose (lyophilized mixture, under nitrogen atmosphere), per unit dose vial.

Mechanism Of Action

Dextran, when labeled with technetium Tc99m and given intravenously, is distributed throughout the body in much the same way as the patient’s serum, and serves as a suitable tracer with which to transiently image the vascular compartment

Indications And Usage

Technetium Tc99m Dextran by intravenous administration is indicated as a cardiac blood pool imaging agent and as an adjunct in the diagnosis of pericardial effusion, ventricular aneurysm, or GI Bleed

Dosage And Administration

To prepare injection, up to 40 mCi of an oxidant-free sodium pertechnetate Tc 99m solution is aseptically injected into the vial, minimum volume 1ml, mix gently and let Dextran dissolve completely for 10 minutes

Storage And Handling

Injection should be administered within 6 hours after preparation. Before and after reconstitution- Store at room temperature

Package Label.Principal Display Panel

Figure 1

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