PYROPHOSPHATE - pyrophosphate injection, powder, lyophilized, for solution 
AnazaoHealth Corporation

Disclaimer: 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.

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Stannous Pyrophosphate

Dear Medical Professional,

Per your order, we have compounded Stannous-Pyrophosphate as a sterile lyophilized powder. The characteristics of this preparation are:

DESCRIPTION

AnazaoHealth compounds Stannous-Pyrophosphate as a sterile lyophilized powder for the preparation of Tc99m Pyrophosphate. Each 10 ml reaction vial contains: 27.6 milligrams sodium pyrophosphate decahydrate, 3.5 milligrams stannous chloride, all lyophilized under an atmosphere of nitrogen. Prior to lyophilization the pH is adjusted with hydrochloric acid. The pH of the reconstituted drug is between 4.5 and 7.5. No bacteriostatic preservative is present

INDICATIONS AND USAGE

Stannous Pyrophosphate is indicated as a blood pool imaging agent which may be used for gated pool imaging and for the detection of sites of gastrointestinal bleeding. When administered intravenously, 15-30 minutes prior to intravenous administration of sodium pertechnetate Tc99m for in vivo red blood cell labeling, approximately 75 percent of the injected activity remains in the blood pool. The modified in vivo/in vitro red blood cell labeling method may also be used for blood pool imaging.

It is also indicated as a skeletal imaging agent used to demonstrate areas of altered osteogenesis, and a cardiac imaging agent used as an adjunct in the diagnosis of acute myocardial infarction.

DOSAGE AND ADMINISTRATION

The recommended adult dose of Tc99m Pyrophosphate Injection is:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Figure 1

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PYROPHOSPHATE 
pyrophosphate injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51808-218
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM PYROPHOSPHATE (UNII: O352864B8Z) (PYROPHOSPHORIC ACID - UNII:4E862E7GRQ) SODIUM PYROPHOSPHATE27.6 mg
Inactive Ingredients
Ingredient NameStrength
STANNOUS CHLORIDE (UNII: 1BQV3749L5) 3.5 mg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51808-218-011 in 1 KIT
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other05/23/2012
Labeler - AnazaoHealth Corporation (011038762)
Establishment
NameAddressID/FEIBusiness Operations
AnazaoHealth Corporation011038762MANUFACTURE(51808-218)

Revised: 5/2012
Document Id: e247d821-b132-4a87-a71a-8bc13c71fcfc
Set id: 30046b6b-09ea-46b1-8e60-61c53e1e7282
Version: 1
Effective Time: 20120523
 
AnazaoHealth Corporation