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 per-
mit.
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 administra-
tion 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 administration is sufficient
for the intended use.
The patient dose should be measured by a suitable radioactivity calibration
system immediately prior to administration.
Note: A shielded syringe may be used for withdrawing and injecting the
iodinated I 131 albumin.
Total Blood and Plasma Volumes
Dosage may range from 5 to 50 microcuries.
Blood Volume Determination
A. Reference Solution
Reference solution is provided with each single unit dose of Volumex. Determine
the radioactivity concentration (net cpm/mL) of the reference solution. Care must
be taken to assure that the reference solution and the blood samples (Step B3)
are assayed using the same geometric configuration.
B. Administration of Dose
1. After withdrawing a background blood sample as described below, insert an
intravenous (IV) line into a large vein in patient’s arm. Inject the entire
Volumex dose (one milliliter) through the IV line for immediate delivery.
Measure the residual radioactivity in the syringe and needle.
2. Destroy syringe after injecting. Do not attempt to resterilize. CAUTION: The
syringe should be disposed of in accordance with the US Nuclear Regulatory
Commission or Agreement State regulations pertaining to the disposal of ra-
dioactive waste.
3. At 12, 18, 24, 30 and 36 minutes after injecting the dose, withdraw blood
samples from the patient with a sterile syringe or evacuated
sample tube containing anti-coagulant.
C. Calculation of Blood Volume
1. Take a known aliquot from each blood sample and determine radioconcentration
in net cpm/mL.
2. Plot the 12, 18, 24, 30 and 36 minute sample counts (net cpm/mL) on semilog-
graph paper using the average count value of each sample and determine the
radioconcentration at injection time (zero time) by drawing a straight line through
the 12, 18, 24, 30 and 36 minute points to zero time. The x ordinate of the
graph is the sample withdrawal time and the logarithmic y ordinate is
radioconcentration in net cpm/mL.
3. Calculate patient’s blood volume (in mL) using the following formula:
Net cpm/mL reference solution blood
Net cpm/mL patient’s blood sample x DF = volume
(in mL)
Sample Blood Volume Calculations
Volume of Blood sample aliquot = 1.0 mL
Volume of Reference Solution aliquot = 1.0 mL
Net counts at zero time = 48,100
Net counts obtained from reference solution aliquot = 52, 430
If, for example, DF, dilution factor of the reference solution = 4000
Using the above formula gives = 52,430 x 4000 = 4360 mL
48,100
Serial Blood Volume Determinations
Iodinated I 131 Albumin Injection is administered in sufficiently low dosage to permit
repetitions as often as required by clinical circumstances. It must be remembered
that it is always necessary to correct for background radioactivity remaining in the
blood from former determinations. Therefore, for each determination after the first
one, a background blood sample must be taken just before the iodinated I 131
albumin is injected.
Background Blood Sample
1. Withdraw background blood sample from large vein in patient’s sampling arm
with a sterile syringe or evacuated sampling tube containing anti-coagulant.
2. Leaving needle in patient’s vein, detach syringe containing blood sample.
3. Attached syringe containing the dose of Volumex to the indwelling IV line
and administer (see instructions under Blood Volume Determination,
Administration of Dose).
4. Determine radioconcentration in net cpm/mL of aliquots taken from back-
ground and postinjection blood samples, and from the reference solution.
The radioconcentration (net cpm/mL) per aliquot of the background blood
sample must be subtracted from the radioconcentration per aliquot of the blood
sample obtained after the injection of iodinated I 131 albumin. The formula
for calculating each blood volume determination after the first one thus becomes:
Net cpm/mL reference solution blood x DF = blood
Net cpm/mL Net cpm/mL volume
postinjection minus background (in mL)
blood sample blood sample
Plasma Volume Determination
The procedure is essentially the same as that for blood volume determination,
except that the blood sample drawn from the patient is centrifuged, the red blood
cells are removed, and net cpm/mL of the plasma is determined. The formula for
calculation of plasma volume, therefore is:
Net cpm/mL reference solution x DF = plasma
Net cpm/mL patient’s plasma sample volume
(in mL)
Protein Turnover Studies
Dosages used have ranged from 10 to 150 microcuries. After injection, a period
of seven days should be allowed before determinations are made to permit the
elimination of any degraded protein in the dose.
Radiation Dosimetry
The estimated absorbed radiation doses to an average patient (70 kg) from an
intravenous injection of 50 microcuries of Iodinated I 131 Albumin Injection USP
are shown in Table 4.
For doses of 10, 25, 75, 150, 500 and 750 microcuries, the estimated absorbed
doses are 0.2, 0.5, 1.5, 3, 10 and 15 times the number of rads given, respectively.
