Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/4255
Predicate | Object |
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rdf:type | |
rdfs:label |
Choletec (Injection, Powder, Lyophilized, For Solution)
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dailymed-instance:dosage |
The suggested intravenous dose range of Technetium Tc 99m
Mebrofenin in the average patient (70 kg) is: The patient dose should be measured by a suitable radioactivity
calibration system immediately prior to administration. The patient should be in a fasting state, 4 hours is preferable. False
positives (non-visualization) may result if the gallbladder has been
emptied by ingestion of food. An interval of at least 24 hours should be allowed before repeat
examination. Parenteral drug products should be inspected visually for
particulate matter and discoloration prior to administration whenever
solution and container permit.
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dailymed-instance:descripti... |
Each reaction vial contains a nonradioactive, sterile, nonpyrogenic
mixture of 45 mg mebrofenin, 0.54 mg (minimum) stannous fluoride
dihydrate, SnF���2HO and 1.03 mg total tin, maximum (as stannous
fluoride dihydrate, SnF���2HO), not more than 5.2 mg methylparaben,
and 0.58 mg propylparaben. The pH is adjusted with sodium hydroxide
or hydrochloric acid prior to lyophilization. The contents of the vial are
lyophilized and sealed under nitrogen at the time of manufacture. The pH of the reconstituted product is 4.2 to 5.7. The structure of mebrofenin (2,2'-[[2-[(3-Bromo-2,4,6-trimethylphenyl)-amino]-2-oxoethyl]imino] bisacetic acid) is shown
below: When sterile, pyrogen-free sodium pertechnetate Tc 99m injection
is added to the vial, the diagnostic agent Technetium Tc 99m Mebrofenin
is formed for administration by intravenous injection.
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dailymed-instance:clinicalP... |
Mebrofenin is an iminodiacetic acid (HIDA) derivative with no known
pharmacologic action at the recommended doses. Following intravenous administration in normal subjects, Technetium Tc
99m Mebrofenin was rapidly cleared from the circulation. The mean percent
injected dose remaining in the blood at 10 minutes was 17%. The injected
activity was cleared through the hepatobiliary system with visualization of the liver by 5 minutes and maximum liver uptake occurring at 11 minutes post-injection.
Hepatic duct and gallbladder visualization occurred by 10 to 15
minutes and intestinal activity was visualized by 30 to 60 minutes in subjects
with normal hepatobiliary function. The mean percent injected dose excreted
in the urine during the first 3 hours was 1%(0.4 to 2.0%). Elevated serum bilirubin levels increase renal excretion of Tc 99m
HIDA agents. In two studies in which Tc 99m Mebrofenin was administered
to patients having mean elevated serum bilirubin levels of 9.8 mg/dL (1.7
to 46.3 mg/dL), the mean percent injected dose excreted in the urine during
the first 3 hours was 3% (0.2 to 11.5%). The mean percent injected dose
excreted in the urine during 3-24 hours was 14.9% (0.4 to 34.8%). In jaundiced patients, the percent injected dose remaining in the blood
at 10 minutes may be twice as high or more than the level in normals.
Hepatobiliary transit may be delayed and visualization times increased. As
a consequence, the quality of the images obtained frequently diminishes.
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dailymed-instance:activeIng... | |
dailymed-instance:contraind... |
Hypersensitivity to this compound.
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dailymed-instance:supply |
Choletec (Kit for the Preparation of Technetium Tc 99m Mebrofenin) is
supplied in kits of 10 reaction vials. Each vial contains a sterile,
nonpyrogenic lyophilized mixture of 45 mg mebrofenin, 0.54 mg
(minimum) stannous fluoride dihydrate, SnF���2HO and 1.03 mg total
tin, maximum (as stannous fluoride dihydrate, SnF���2HO), not more
than 5.2 mg methylparaben, and 0.58 mg propylparaben. The pH has
been adjusted with hydrochloric acid or sodium hydroxide prior to
lyophilization. The lyophilized vial contents are sealed under nitrogen at
the time of manufacture. The pH of the reconstituted product is 4.2 to
5.7.<br/>Kit Contents: 10 sterile multidose reaction vials.20 pressure-sensitive labels for Technetium Tc 99m Mebrofenin.1 package insert.<br/>Preparation: Preparation of Technetium Tc 99m Mebrofenin is done by the following
aseptic procedure:<br/>Storage: Store the kit as supplied at 20-25��C (68-77��F) [See USP] prior to and
following reconstitution. Use within 18 hours of reconstitution. The U.S. Nuclear Regulatory Commission has approved this reagent kit
for distribution to persons licensed to use byproduct material identified
in��35.200 of 10 CFR Part 35, to persons who hold an equivalent license
issued by an Agreement State, and, outside the United States, to
persons authorized by the appropriate authority.
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dailymed-instance:activeMoi... | |
dailymed-instance:inactiveI... | |
dailymed-instance:precautio... |
General: Contents of the reaction vial are intended only for use in the preparation
of Technetium Tc 99m Mebrofenin and are not to be administered
directly to the patient. Delayed or non-visualization of the gallbladder may occur in the
immediate post-prandial period or after prolonged fasting or parenteral
feeding. Functional biliary obstruction may accompany chronic cholecystitis
or pancreatitis. In addition, patients with hepatocellular disease may show
non-visualization or delayed visualization of the gallbladder. Delayed
intestinal transit may also be noted in such patients. Juvenile hepatitis may
be associated with gallbladder non-visualization and the failure to visualize
activity in the intestine. Administration of meperidine or morphine may
delay intestinal transit of the imaging agent and may result in
nonvisualization. Septic patients may show absent or delayed hepatobiliary
clearance. Thus, a positive finding does not of itself permit a differential
diagnosis of any of the above conditions and should be evaluated in the
light of the total clinical picture and results of other diagnostic modalities. The components of the kit are supplied sterile and nonpyrogenic.
Aseptic procedures normally employed in making additions and withdrawals
from sterile, nonpyrogenic containers should be used during the addition of
the pertechnetate solution and the withdrawal of doses for patient
administration. The Technetium Tc 99m labeling reactions involved in preparing the
agent depend on maintaining the stannous ion in the reduced state. Any
oxidant present in the sodium pertechnetate Tc 99m supply may, thus,
adversely affect the quality of the radiopharmaceutical. Hence, sodium
pertechnetate Tc 99m containing oxidants should not be employed. Radiopharmaceuticals should be used only by physicians who are
qualified by training and experience in the safe use and handling of
radionuclides. 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 ensure minimum radiation exposure to occupational workers. Tc 99m Mebrofenin should be formulated no more than 18 hours
prior to clinical use.<br/>Carcinogenesis, Mutagenesis,
Impairment of Fertility: No long term animal studies have been performed to evaluate
carcinogenic potential or whether Technetium Tc 99m Mebrofenin may
affect fertility in males or females.<br/>Pregnancy:<br/>Pregnancy Category C: Animal reproduction studies have not been conducted with Technetium
Tc 99m Mebrofenin. It is also not known whether Technetium Tc 99m
Mebrofenin can cause fetal harm when administered to a pregnant
woman or can affect reproductive capacity. Technetium Tc 99m
Mebrofenin should be given to a pregnant woman only if the expected
benefits to be gained clearly outweigh the potential hazards.<br/>Nursing Mothers: Technetium Tc 99m is excreted in human milk during lactation.
Therefore, formula feedings should be substituted for breast feedings.<br/>Pediatric Use: Safety and effectiveness in children below the age of 18 have not be established.
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dailymed-instance:genericMe... |
Mebrofenin
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dailymed-instance:fullName |
Choletec (Injection, Powder, Lyophilized, For Solution)
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dailymed-instance:adverseRe... |
Urticaria and rash have been rarely reported with the use of Technetium
Tc 99m Mebrofenin since market introduction. Rare cases of chills and
nausea have been reported with related compounds. Infrequently, death
has been reported in association with the use of this class of agents.
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dailymed-instance:warning |
The theoretical possibility of allergic reactions should be considered in
patients who receive multiple doses.
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dailymed-instance:indicatio... |
Technetium Tc 99m Mebrofenin is indicated as a hepatobiliary imaging agent.
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dailymed-instance:represent... | |
dailymed-instance:routeOfAd... | |
dailymed-instance:name |
Choletec
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