Label: PYROPHOSPHATE injection, powder, lyophilized, for solution
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Contains inactivated NDC Code(s)
NDC Code(s): 51808-218-01 - Packager: AnazaoHealth Corporation
- Category: HUMAN PRESCRIPTION DRUG LABEL
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Drug Label Information
Updated May 23, 2012
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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
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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.
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INGREDIENTS AND APPEARANCE
PYROPHOSPHATE
pyrophosphate injection, powder, lyophilized, for solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51808-218 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM PYROPHOSPHATE (UNII: O352864B8Z) (PYROPHOSPHORIC ACID - UNII:4E862E7GRQ) SODIUM PYROPHOSPHATE 27.6 mg Inactive Ingredients Ingredient Name Strength STANNOUS CHLORIDE (UNII: 1BQV3749L5) 3.5 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51808-218-01 1 in 1 KIT Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 05/23/2012 Labeler - AnazaoHealth Corporation (011038762) Establishment Name Address ID/FEI Business Operations AnazaoHealth Corporation 011038762 MANUFACTURE(51808-218)
