Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/4031
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CardioGen-82 (Injection, Solution)
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General: As with all radiopharmaceuticals, only the lowest dose of
rubidium Rb 82 necessary to obtain adequate visualization
should be used. A lower dose provides less patient radiation
and is consistent with the achievement of ALARA. Most procedures
do not require use of the maximum dose of rubidium
Rb 82; the dose to be used should be carefully individualized
and factors such as: should be considered. Parenteral drug products should be inspected visually for
particulate matter and discoloration prior to administrationwhenever solution and container permit. An appropriate infusion system labeled for use with
Cardiogen-82 (Rubidium Rb 82 Generator) is required. Please
see DIRECTIONS FOR ELUTING RUBIDIUM CHLORIDE Rb
82 INJECTION below for additional information. . Rubidium Rb 82 assay and strontium Sr 82 breakthrough
should be determined each day the generator is used (See
directions below).<br/>Rubidium-82 Dosage: Rubidium chloride Rb 82 injection obtained from Cardiogen-82
(Rubidium Rb 82 Generator) is intended only for intravenous
administration utilizing an appropriate infusion system that is
labeled for use with the generator. The usual adult (70 kg)
dose (single injection) is 1480 MBq (40 mCi) with a range of
1110-2220 MBq (30-60 mCi). The dose must be administered
at a rate of 50 mL/minute not to exceed a cumulative volume
of 200 mL. . A single dose of 2220 MBq (60 mCi) should not be exceeded.
The radiation dosimetry for a 2220 MBq (60 mCi) dose is
presented in Table 5. No more than 4440 MBq (120 mCi)
should be administered in a multiple injection series. Exceeding the recommended dosing limits should only be
done after due consideration of: (a) the benefits to be obtained
by the patient vs. the risks associated with additional radiation;
(b) previous (or contemplated) procedures involving radiation
which this patient has undergone or might undergo; and (c) the
achievement of ALARA. Further consideration should be given
to the effect of total volume of injectate, which increases with
the number of injections, as discussed under WARNINGS.<br/>Radiation Dosimetry: The estimated absorbed radiation doses to an average adult
patient (70 kg) from an intravenous injection of a recommended
dose of 2220 MBq (60 mCi) of rubidium Rb 82 are shown
in Table 5. Based on data collected by Ryan et al. in two human subjects
(J Nuc Med 25(5): P94) and on rat data of Kearfott (J Nuc Med
23(12):1128-1132. Contaminant levels of Sr-82 and Sr-85
assumed to be 10and 2.5 X 10relative to Rb-82. For strontium, assumed distribution and retention: Bone 50%=���(uniformity distributed throughoutvolume) Testes 0.5%= 1.5 day Remainder 49.5%= 1.5 day
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Cardiogen-82 (Rubidium Rb 82 Generator) contains accelerator
produced strontium Sr 82 adsorbed on stannic oxide in a
lead-shielded column and provides a means for obtaining sterile
nonpyrogenic solutions of rubidium chloride Rb 82 injection.
The chemical form of rubidium 82 isRbCl. The amount (millicuries) of Rb-82 obtained in each elution
will depend on the potency of the generator. When eluted at a rate of 50 mL/minute, each generator eluate
at the end of elution should not contain more than 0.02
microcurie of strontium Sr 82 and not more than 0.2 microcurie
of strontium Sr 85 per millicurie of rubidium chloride Rb 82
injection, and not more than 1 microgram of tin per mL of eluate.<br/>PHYSICAL CHARACTERISTICS: Rubidium Rb 82 decays by positron emission and associated
gamma emission with a physical half-life of 75 seconds.The
annihilation photons released following positron emission
which are useful for detection and imaging studies are shown
in Table 1.<br/>External Radiation: The specific gamma ray constant for Rb-82 is 6.1 R/hour-millicurie
at 1 centimeter. The first half-value layer is 0.7 centimeter
of lead (Pb). A range of values for the relative attenuation
of the radiation emitted by this radionuclide that results from
interposition of various thicknesses of Pb is shown in Table 2.
For example, the use of a 7.0 centimeter thickness of Pb will
attenuate the radiation emitted by a factor of about 1,000. Strontium Sr 82 decays to rubidium Rb 82 with a strontium
Sr 82 half-life of 25 days (600 hrs). The Sr-82 is produced in
an accelerator by proton spallation of molybdenum, Mo (p,
spall) Sr-82 or by the reaction Rb-85 (p, 4n) Sr-82. The Sr-82
produced has no carrier added. To correct for physical decay
of strontium Sr 82, the fractions that remain at selected intervals
after the time of calibration are shown in Table 3. To correct for physical decay of rubidium Rb 82, the fraction
of rubidium chloride Rb 82 injection remaining in all 15 second
intervals up to 300 seconds after time of calibration are shown
in Table 4.
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Following intravenous administration, rubidium Rb 82 rapidly
clears the blood and is extracted by myocardial tissue in a
manner analogous to potassium. In human studies, myocardial
activity was noted within the first minute after injection. When
areas of myocardial infarction are detected with rubidium chloride
Rb 82 injection, they are visualized within two to seven
minutes after injection as photon-deficient or "cold areas" on
the myocardial scan. Uptake is also observed in kidney, liver,
spleen, and lung.
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None known.
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Cardiogen-82 (Rubidium Rb 82 Generator) is supplied in the
form of strontium Sr 82 adsorbed on a hydrous stannic oxide
column with an activity of 90-150 millicuries Sr-82 at calibration
time. The generator is encased in a lead shield surrounded
by a labeled plastic container. Complete assay data for
each generator are provided on the container label. Directions
for determining the activity of rubidium Rb 82 eluted from the
generator are provided in this monograph. Cardiogen-82
(Rubidium Rb 82 Generator) is intended for use only with an
appropriate, properly calibrated infusion system labeled for
use with the generator. Receipt, transfer, handling, possession or use ofthis product is subject to the radioactive materialregulations and licensing requirements of the U.S.Nuclear Regulatory Commission, AgreementStates or Licensing States as appropriate.<br/>DISPOSAL: Hospital personnel should monitor the amount of radioactivity
present at the generator prior to its disposal. The generator
should not be disposed of in regular refuse systems. Storage
and/or disposal of the generator should be in accordance with
the conditions of NRC radioactive materials license pursuant
to 10 CFR, Part 20, or equivalent conditions pursuant to
Agreement State Regulation.<br/>STORAGE: The generator should be stored at 20-25��C (68-77��C) [See
USP].<br/>EXPIRATION DATE: The expiration date is provided on the generator container
label. Due to the short half-life of Rb-82, virtually all the
radioactivity in the eluate decays within 15 minutes from the
end of elution.<br/>DIRECTIONS FOR ELUTING RUBIDIUM Rb 82: An appropriate infusion system labeled for use with
Cardiogen-82 (Rubidium Rb 82 Generator) is required. The
applicable operator's manual should be consulted for detailed
directions on generator hookup, elution, and patient administration.
Prior to use with patients, a thorough understanding of
the use and performance of the system should be established. The Cardiogen-82 (Rubidium Rb 82 Generator) package
insert and the Rb-82 infusion system operator's manual should
be read before beginning elution. Additional information concerning eluting the Cardiogen-82
generator follows:<br/>DIRECTIONS FOR DETERMINATION OF Rb-82
ASSAY AND MEASUREMENT OF Sr-82 AND Sr-85
BREAKTHROUGH: The rubidium chloride Rb 82 assay and strontium Sr 82 and
strontium Sr 85 breakthrough are determined using an ionization
chamber-type dose calibrator. Procedure 1 through 11
below must be performed daily prior to the use of rubidium
chloride Rb 82 injection. The assay of rubidium chloride Rb 82 injection is determined
as follows: To measure the Sr-82 breakthrough in the eluate, proceed as
follows: [Sr-85]R =������������on calibration date x ratio factor on the date[Sr-82] of measurement dose calibration reading (��Ci)Sr-82 (��Ci) =������������������������������������������������[1 + (R) (F)] Example: dose calibrator reading (��Ci) = 0.80Sr-85/Sr-82 ratio (R) = (1.48)Correction factor (F) = 0.4780.80Sr-82 (��Ci) =���������������������������[1 + (1.48)(0.478)]Sr-82 (��Ci) = 0.47 Example:0.47��Ci of Sr-8250 mCi of Rb-82 E.O.E.0.47��Ci Sr-82 = 0.0094 = 9.4 X 10��Ci/mCi Rb-82���������������������50 mCi Rb-82 The Sr-82 content must not be more than 2 x 10��Ci/mCi of
Rb-82 at E.O.E. Example:9.4 x 10x 1.48 = 1.4 x 10��Ci Sr-85/mCi Rb-82 The Sr-85 content must not be more than 0.2��Ci/mCi of Rb-82 at E.O.E.
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General: Data are not available concerning the effect of marked alterations
in blood glucose, insulin, or pH (such as is found in diabetes
mellitus) on the quality of rubidium chloride Rb 82
scans. Attention is directed to the fact that rubidium is physiologically
similar to potassium, and since the transport of potassium
is affected by these factors, the possibility exists that
rubidium may likewise be affected. Rubidium chloride Rb 82 injection must be administered only
with an appropriate infusion system capable of meeting the
performance characteristics previously described. . The drug should be used only
by those practitioners with a thorough understanding of the
use and performance of the infusion system. Repeat doses of Rubidium chloride Rb 82 injection may lead
to an accumulation of the longer lived radioactive contaminants
strontium Sr 82 and strontium Sr 85. Since eluate obtained from the generator is intended for
intravenous administration, aseptic techniques must be strictly
observed in all handling. Only additive free Sodium Chloride
Injection USP should be used to elute the generator. Do not
administer eluate from the generator if there is any evidence of
foreign matter. As in the use of any radioactive material, care should be
taken to minimize radiation exposure to the patient consistent
with proper patient management and to insure minimum radiation
exposure to occupational workers. Radiopharmaceuticals should be used only by physicians
who are qualified by training and experience in the safe use
and handling of radionuclides and whose experience and
training have been approved by the appropriate government
agency authorized to license the use of radionuclides.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: No long-term studies have been performed to evaluate carcinogenic
potential, mutagenicity potential, or to determine
whether rubidium Rb 82 may affect fertility in males or
females.<br/>Pregnancy Category C: Animal reproductive studies have not been conducted with
rubidium Rb 82. It is also not known whether rubidium Rb 82
can cause fetal harm when administered to a pregnant woman
or can affect reproductive capacity. Rubidium Rb 82 should be
given to pregnant women only if the expected benefits to be
gained clearly outweigh the potential hazards. Ideally, examinations using radiopharmaceuticals, especially
those examinations which are elective in nature, in women of
childbearing capability should be performed during the first few
(approximately 10) days following the onset of menses.<br/>Nursing Mothers: It is not known whether rubidium Rb 82 is excreted in human
milk. Due to the short half-life of rubidium Rb 82 (75 sec) it is
unlikely that the drug would be excreted in human milk during
lactation. However, because many drugs are excreted in
human milk, caution should be exercised when rubidium Rb 82
is administered to nursing women.<br/>Pediatric Use: Safety and effectiveness in children have not been established.
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Rubidium Rb-82
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CardioGen-82 (Injection, Solution)
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No adverse reactions specifically attributable to rubidium Rb
82 have been reported during controlled clinical trials.
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Rubidium chloride Rb 82 injection is a myocardial perfusion
agent that is useful in distinguishing normal from abnormal
myocardium in patients with suspected myocardial infarction. Cardiogen-82 (Rubidium Rb 82 Generator) must be used
with an infusion system specifically labeled for use with the
generator and capable of accurate measurement and delivery
of doses of rubidium chloride Rb 82 injection not to exceed a
single dose of 2220 MBq (60 mCi) and a cumulative dose of
4440 MBq (120 mCi) at a rate of 50 mL/min with a maximum
volume per infusion of 100 mL and a cumulative volume not to
exceed 200 mL. These performance characteristics reflect the
conditions of use under which the drug development clinical
trials were conducted. Adequate data from clinical trials to determine precise localization
of myocardial infarction or identification of stress-induced
ischemia have not been collected. Positron emission tomographic (PET) instrumentation is recommended
for use with rubidium chloride Rb 82 injection.
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CardioGen-82
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