SODIUM CHROMATE 51 solution

Sodium Chromate 51 by

Drug Labeling and Warnings

Sodium Chromate 51 by is a Prescription medication manufactured, distributed, or labeled by AnazaoHealth Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Per your order, we have compounded Chromium 51 as a sterile intravenous injectable dispensed as 1 mL in a 5 mL vial. The characteristics of this preparation are described below

DESCRIPTION

AnazaoHealth’s compounded Cr-51 vial is a sterile, non-pyrogenic diagnostic radiopharmaceutical that consists up to 1 mCi of Cr-51 (precalibrated) in a volume up to 5 mL normal saline and 6 mg/mL benzyl alcohol.

INDICATIONS AND USAGE

Cr51 is indicated for use in determining red blood cell volume or mass, studying red blood cell survival time (in conditions such as hemolytic anemia), and evaluating blood loss

Mechanism of Action

The chromium in this agent is present as the dianionic chromate ion in which form it appears to bind to the red blood cell in two steps, initially by a rapid but reversible attachment to the cell membrane followed by a slower nearly irreversible binding to intracellular hemoglobin and reduction to the anionic state. It has been suggested that the slow rate of uptake is dependent on the rate at which chromate can penetrate the cell membrane. Binding is maintained until the red blood cells are sequestered by the spleen or until elution of the chromium occurs into the plasma. The chromium is then readily excreted mainly in the urine. Once liberated by elution or erythrocyte senescence, chromium 51 is not available for relabeling of red cells.

In normal individuals the erythrocyte survival half-time T ½  as measured by the chromium 51 "random labeling" technique, generally ranges between 25 and 35 days. This apparent short survival time, when compared to the 120 day life span of the red blood cells, is due to the elution of chromium from the cells and to cell damage that probably occurs during the process of withdrawing them from the body and labeling. Subnormal T ½ may be indicative of blood toss, sequestration of red blood cells by the  spleen, or shortened cell viability, as occurs In hemolytic anemia

CONTRAINDICATIONS

There are no known contraindications for this preparation

DOSAGE AND ADMINISTRATION

• The suggested dose range in the average patient (70kg) is:
  Determination of red blood cell volume or mass-0.37 to 1.11 megabecquerels (10 to 30 microcuries).
• Study of red blood cell survival time-5.55 megabecquerels (150 microcuries).
• Evaluation of blood loss-7.40 megabecquerels (200 microcuries)

Figure 1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Figure 2

INGREDIENTS AND APPEARANCE

SODIUM CHROMATE 51 
sodium chromate 51 solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 51808-101
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHROMIUM CR-51 (UNII: 9QAU17N705) (CHROMIUM CR-51 - UNII:9QAU17N705)	CHROMIUM CR-51	1 mCi  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)	30 mg  in 5 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51808-101-02	5 mL in 1 VIAL

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		06/19/2012

Labeler - AnazaoHealth Corporation (011038762)

Establishment
Name	Address	ID/FEI	Business Operations
AnazaoHealth Corporation		011038762	MANUFACTURE(51808-101)