Drugplain

Volumex .025 mCi/mL

Iodinated I-131 Albumin · INJECTION, SOLUTION · Iso-Tex Diagnostics, Inc.

No Recall History
Plain English

Volumex is a injection, solution containing iodinated i-131 albumin at .025 mCi/mL, taken intravenous. Manufactured by Iso-Tex Diagnostics, Inc..

Key Facts

Brand Name
Volumex
Generic Name
Iodinated I-131 Albumin
NDC Code (Product)
50914-7720
Manufacturer
Iso-Tex Diagnostics, Inc.
Strength
.025 mCi/mL
Dosage Form
INJECTION, SOLUTION
Route
INTRAVENOUS
Marketing Status
Application #
BLA017837
Marketing Start
08/01/1993

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Volumex (Iodinated I 131 Allbumin injection) is indicated for use in determinations of total blood and plasma volumes and in protein turnover studies

Dosage & Administration

DOSAGE AND ADMINISTRATION Volumex (Iodinated I 131 Albumin Injection) is administered intravenously. Parenteral drug products should be inspected visually for particulate matter and abnormal coloration prior to administration whenever solution and container permit. Volumex (Iodinated I 131 Albumin Injection) may be colorless to very pale yellow. Solutions with excessive coloration should not be used. When a procedure such as a blood volume or a circulation time determination is to be repeated, the total dosage administered in any one week should not exceed 200 microcuries. To minimize the uptake of radioactive iodine by the thyroid, prior administration of Lugol’s Solution (Strong Iodine Solution USP) may be used. Ten drops of Lugol’s Solution three times daily, beginning at least 24 hours before administration of Volumex and continuing for one or two weeks thereafter, is a suitable dose. Complete assay data for each single unit dose are provided on the container. Note: The expiration date given on the container pertains to the biologic properties of the material and not to the radioactivity level. It is important to make certain that the radioactivity in the dose at the time of ad

Warnings

WARNINGS A few instances of hyperpyrexia and aseptic (chemical) meningeal irritation have been reported with the use of iodinated I 131 albumin in cisternography. Iodinated I 131 Albumin Injection is not approved for use in cisternography.

Contraindications

CONTRAINDICATIONS None known.

Adverse Reactions

ADVERSE REACTIONS Although the immunological properties of albumin human are believed to be virtually unaltered by the iodination process, there is a theoretical possibility that allergic reactions may occur in patients receiving additional doses a number of weeks after an initial dose.

Frequently Asked Questions

What is Volumex used for?

Volumex contains Iodinated I-131 Albumin. It is a injection, solution taken intravenous. Consult your doctor for specific uses.

Is Volumex a controlled substance?

Volumex is not classified as a controlled substance by the DEA.

What is the generic name for Volumex?

The generic name for Volumex is Iodinated I-131 Albumin. There are 1 other brand versions of Iodinated I-131 Albumin.

What is the NDC code for Volumex .025 mCi/mL?

The NDC (National Drug Code) for Volumex .025 mCi/mL is 50914-7720, listed by Iso-Tex Diagnostics, Inc..

Product NDC

50914-7720

Package NDC

50914-7720-8

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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