Your browser does not support JavaScript! DEXTRAN 75 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ANAZAOHEALTH CORPORATION]
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DEXTRAN 75 injection, powder, lyophilized, for solution
[AnazaoHealth Corporation]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved drug other
NOTE:THIS DRUG HAS NOT BEEN FOUND BY FDA TO BE SAFE AND EFFECTIVE, AND THIS LABELING HAS NOT BEEN APPROVED BY FDA. For further information about unapproved drugs, click here.
Drug Label Sections

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

29c1fd45-figure-01
DEXTRAN 75 
dextran 75 injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:51808-210
Route of AdministrationINTRAVENOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTRAN 75 (DEXTRAN 75) DEXTRAN 7510 mg
Inactive Ingredients
Ingredient NameStrength
STANNOUS CHLORIDE0.3 mg
ANHYDROUS DEXTROSE1 mg
SODIUM CITRATE0.73 mg
Product Characteristics
Color    Scoreno score
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51808-210-011 in 1 KIT
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other07/01/2012
Labeler - AnazaoHealth Corporation (011038762)
Establishment
NameAddressID/FEIBusiness Operations
AnazaoHealth Corporation011038762MANUFACTURE(51808-210)

Revised: 7/2012
 
AnazaoHealth Corporation

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