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DEXTRAN 75 injection, powder, lyophilized, for solution


  1. No Title 1572555806
  2. No Title 1572456824
  3. Description
  4. Indications And Usage
  5. Dosage And Administration
  6. Package Label.principal Display Panel

No Title 1572555806 

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:

No Title 1572456824 

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 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)

Revised: 7/2012 AnazaoHealth Corporation



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