DEXTRAN 75 injection, powder, lyophilized, for solution

Dextran 75 by

Drug Labeling and Warnings

Dextran 75 by is a Prescription medication manufactured, distributed, or labeled by AnazaoHealth Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Dear Medical Professional,

Per your order, we have compounded Dextran 75 as a lyophilized powder for injection. The characteristics of this preparation are as follows:

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

INGREDIENTS AND APPEARANCE

DEXTRAN 75 
dextran 75 injection, powder, lyophilized, for solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 51808-210
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTRAN 75 (UNII: JY83SHX053) (DEXTRAN 75 - UNII:JY83SHX053)	DEXTRAN 75	10 mg

Inactive Ingredients
Ingredient Name	Strength
STANNOUS CHLORIDE (UNII: 1BQV3749L5)	0.3 mg
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)	1 mg
SODIUM CITRATE (UNII: 1Q73Q2JULR)	0.73 mg

Product Characteristics
Color		Score	no score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51808-210-01	1 in 1 KIT

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		07/01/2012

Labeler - AnazaoHealth Corporation (011038762)

Establishment
Name	Address	ID/FEI	Business Operations
AnazaoHealth Corporation		011038762	MANUFACTURE(51808-210)