PYROPHOSPHATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ANAZAOHEALTH CORPORATION]

PYROPHOSPHATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ANAZAOHEALTH CORPORATION]
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NDC 51808-218-01
Set ID 30046b6b-09ea-46b1-8e60-61c53e1e7282
Category HUMAN PRESCRIPTION DRUG LABEL
Packager AnazaoHealth Corporation
Generic Name
Product Class
Product Number
Application Number
  • 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:

    • 5 to 15 mCi for skeletal imaging
    • 10 to 15 mCi for cardiac imaging
    • one-third (0.33) to the entire vial contents, followed 15 to 20 mCi of sodium pertechnetate Tc 99m, for blood pool imaging
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Figure 1

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  • INGREDIENTS AND APPEARANCE
    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)

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