Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/496
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Macrotec (Injection, Powder, Lyophilized, For Suspension)
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| dailymed-instance:dosage |
The patient dose should be measured by a suitable radioactivity
calibration system immediately prior to administration. Mix the contents of the vial by gentle inversion just prior to
withdrawing a patient dose. Mix the contents of the syringe just before
injection. If blood is drawn into the syringe, any unnecessary delay
prior to injection may lead to clot formation. Slow injection is
recommended. Imaging may begin immediately after intravenous injection
of Technetium Tc 99m Albumin Aggregated; follow-up imaging should be
performed as needed.<br/>Lung Imaging: The recommended intravenous dose range for the average
ADULT patient (70 kg) is 37 MBq to 148 MBq (1 to 4 mCi)
Technetium Tc 99m Albumin Aggregated after reconstitution with
oxidant-free Sodium Pertechnetate Tc 99m Injection. The
recommended number of particles per single injection is
200,000-700,000 with suggested number being approximately
350,000. The number of particles available per megabecquerel
(millicurie) dose of Technetium Tc 99m Albumin Aggregated Injection will vary depending on the physical decay of the
technetium Tc 99m that has occurred. The number of particles
available in any specific dose may be estimated by calculating
the number of particles per milliliter. In PEDIATRIC patients, the suggested intravenous doses
employed for perfusion lung imaging are in the range of 0.925
MBq to 1.85 MBq per kilogram (25 to 50��Ci/kg) of body weight
with a usual dose of 1.11 MBq per kilogram (30��Ci/kg), except
in newborns, in whom the administered dose should be 7.4 MBq to
18.5 MBq (200-500��Ci). A minimum dose of 7.4 MBq (200��Ci)
should be employed for this procedure. The number of particles
administered will vary with age and weight of the child as
indicated in Table 4.<br/>Isotopic Venography: The usual dose for unilateral or bilateral isotopic venography of the lower extremities is 74 to 148 MBq (2-4 mCi)
Technetium Tc 99m Albumin Aggregated Injection per limb,
injected intravenously peripheral to the suspected areas of
venous clot formation. For isotopic venography of the lower extremities, the
patient should be supine and properly positioned under the
scintillation camera. For unilateral or bilateral imaging of the
lower extremities, a tourniquet should be applied just above the
malleolus of each leg to be imaged in order to promote deep vein
filling. For simultaneous bilateral imaging, doses should be
administered from separate syringes. Rapid sequential
scintiphotographs should then be taken along the course of
venous flow from the calf to the abdomen. If retention of
radioactivity ("hot spots") occurs in the calf region, the
patient should be instructed to exercise the lower extremities
by flexion and extension of the knees and ankles; reimaging
should be performed after about 15 minutes. Following vein imaging, lung imaging may be performed
without need of additional Technetium Tc 99m Albumin
Aggregated.<br/>LeVeen Shunt Patency: The suggested intraperitoneal dosage range used in the
average patient (70 kg) for peritoneo-venous (LeVeen) shunt
patency evaluation is 37 to 111 megabecquerels (1 to 3
millicuries). Adequate measures should be taken to assure
uniform mixing with peritoneal fluid. Serial images of both the shunt and target organ should be obtained and correlated with
other clinical findings. Alternatively, the drug may be
administered by percutaneous transtubal injection. The suggested
percutaneous transtubal (efferent limb) dosage range for the
average patient (70 kg) is 12 to 37 megabecquerels (0.3 to 1.0
millicurie) in a volume not to exceed 0.5 mL.<br/>Radiation Dosimetry: The estimated absorbed radiation dosesto an
average ADULT patient (70 kg) from an intravenous injection of
148 MBq (4 mCi) of Technetium Tc 99m Albumin Aggregated
Injection are shown in Table 5. Method of calculation: "S", Absorbed-Dose per
Unit Cumulated Activity for Selected Radionuclides and
Organs, MIRD Pamphlet No. 11 (1975) In PEDIATRIC patients, the radiation absorbed doses using
the maximum recommended dose for lung imaging are based on 1.85
MBq (50��Ci) per kilogram of body weight (except in the newborn
where the maximum recommended dose of 18.5 MBq (500��Ci) is
used) and are shown in Table 6, which lists the maximum dosage
for children up to the age of 15 years. Note the recommendations
regarding number of particles to be administered. NOTE: DOSES TO TESTES, OVARIES AND BLADDER INCREASE WITH
VOIDING INTERVAL. Method of Calculation: The following table represents the absorbed radiation
dose resulting from the intraperitoneal administration of 111 megabecquerels (3 millicuries) of Technetium Tc 99m Albumin
Aggregated.<br/>Assumptions:: Calculations for the absorbed radiation dose are based
upon an effective half-time of 3 hours for the open shunt and
6.02 hours for the closed shunt and an even distribution of the
radiopharmaceutical in the peritoneal cavity with no biological
clearance.
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| dailymed-instance:descripti... |
Macrotec is a sterile, nonpyrogenic, Iyophilized preparation of
albumin aggregated. Each 5 mL vial of Macrotec contains 1.5 mg of
Albumin Aggregated, 10.0 mg Albumin Human, 0.07 mg (minimum) stannous
chloride (SnCl���2HO) and 0.19 mg total
tin, maximum (as stannous chloride,
SnCl���2HO), 1.8 mg of sodium chloride
with trace amounts of sodium acetate, acetic acid and hydrochloric acid.
Macrotec contains no preservatives. The pH of the reconstituted product
is between 3.8 and 8.0. The aggregated particles are formed by denaturation of Albumin
Human in a heating and precipitation process. Each vial contains 2���7
million particles, 90% of which are between 10 and 90 microns in size.
The average size is 20 to 40 microns; no particles are greater than 150
microns. Reconstitution of Macrotec with sterile sodium pertechnetate Tc
99m forms an aqueous suspension of Technetium Tc 99m Albumin Aggregated
for diagnostic use by intravenous injection. No less than 90% of thepertechnetate Tc 99m added to the reaction vial is bound to the
aggregates at preparation time and remains bound throughout the 6-hour
lifetime of the suspension.
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Immediately following intravenous injection, more than 80% of the
Albumin Aggregated is trapped in the pulmonary alveolar capillary bed.
The imaging procedure can thus be started as soon as the injection is
complete. Assuming that a sufficient number of radioactive particles
have been used , the distribution of radioactive aggregated particles in the
normally perfused lung is uniform throughout the vascular bed, and willproduce a uniform image. Areas of reduced perfusion will be revealed by
a correspondingly decreased accumulation of the radioactive particles,
and these areas are imaged as areas of decreased photon density. Following administration of Technetium Tc 99m Albumin Aggregated
by intraperitoneal injection, the radiopharmaceutical mixes with the
peritoneal fluid. Clearance from the peritoneal cavity varies from
insignificant, which may occur with complete shunt blockage, to very
rapid clearance with subsequent transfer into the systemic circulation
when the shunt is patent. Serial Images should be obtained of both the shunt and lung
(target organ). However, an adequate evaluation of the difference
between total blockage of the shunt and partial blockage may not be
feasible in all cases. Organ selectivity is a direct result of particle size. Below 1���10
microns the material is taken up by the reticuloendothelial system.
Above 10 microns the aggregates become lodged in the lung capillaries by
a purely mechanical process. The Albumin Aggregated is sufficiently fragile for the capillary
microocclusion to be temporary. Erosion and fragmentation reduce the
particle size, allowing passage of the aggregates through the pulmonary
alveolar capillary bed. The fragments are then accumulated by the
reticuloendothelial system. Lung to liver ratios greater than 20:1 are obtained in the first
few minutes post-injection. Normally, the clearance half-time of the
particles from the lungs is 2 to 3 hours. Studies have shown that when Technetium Tc 99m Albumin Aggregated
is injected peripheral to the suspected point of the disease process,
the radioactive aggregated particles collect at the sites of endothelial
damage and/or clot formation.
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Technetium Tc 99m Albumin Aggregated Injection should not be
administered to patients with severe pulmonary hypertension. The use of Technetium Tc 99m Albumin Aggregated Injection is
contraindicated in persons with a history of hypersensitivity reactions
to products containing human serum albumin.
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| dailymed-instance:supply |
Macrotec (Kit for the Preparation of Technetium Tc 99m Albumin
Aggregated) is supplied as a kit containing 10 reaction vials (5 mL
size), 10 pressure sensitive labels and 1 package insert.<br/>Storage: Store the Macrotec kit refrigerated between 2��to 8��C (36��to 46��F). The
reconstituted preparation should be refrigerated since the
product does not contain a preservative. When reconstituted with sodium pertechnetate Tc 99m,
Macrotec must be used within 6 hours.
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| dailymed-instance:precautio... |
General: In patients with right to left heart shunts, additional
risk may exist due to the rapid entry of Albumin Aggregated into
the systemic circulation. The safety of this agent in such
patients has not been established. Hypersensitivity reactions are possible whenever
protein-containing materials such as pertechnetate labeled
Albumin Aggregated are used in man. Epinephrine, antihistamines
and corticosteroids should be kept available for immediate use. The intravenous administration of any particulate
material such as Albumin Aggregated imposes a temporary, small
mechanical impediment to blood flow. While this effect is
probably physiologically insignificant in most patients, the
administration of Albumin Aggregated is possibly hazardous in
acute cor pulmonale and other states of severely impaired
pulmonary blood flow. The components of the Macrotec (Kit for the Preparation
of Technetium Tc 99m Albumin Aggregated) are sterile and
nonpyrogenic. It is essential to follow directions carefully and
adhere to strict aseptic procedures during preparation. Contents of the vial are intended only for use in the
preparation of Technetium Tc 99m Albumin Aggregated Injection
and are NOT to be
administered directly to the patient. The contents of the kit before preparation are not
radioactive. However, after the sodium pertechnetate Tc 99m is
added, adequate shielding of the final preparation must be
maintained. The technetium Tc 99m labeling reactions involved depend
on maintaining the stannous ion in the reduced state. Hence,
sodium pertechnetate Tc 99m containing oxidants should not be
employed. The preparation contains no bacteriostatic preservative.
Technetium Tc 99m Albumin Aggregated Injection should be stored refrigerated at 2-8��C and discarded 6 hours after formulation. Technetium Tc 99m Albumin Aggregated Injection is a
physically unstable suspension and consequently the particles
settle with time. Failure to agitate the vial adequately before
use may result in non-uniform distribution of radioactive
particles. If blood is drawn into the syringe, unnecessary delay
prior to injection may result in clot formation. 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. As in the use of any other radioactive material, care
should be taken to minimize radiation exposure to patients
consistent with proper patient management, and to minimize
radiation exposure to clinical personnel.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: No long-term animal studies have been performed to
evaluate carcinogenic potential or whether Technetium Tc 99m
Albumin Aggregated Injection affects fertility in males or
females.<br/>Pregnancy Category C: Animal reproduction and teratogenicity studies have not
been conducted with Technetium Tc 99m Albumin Aggregated
Injection. It is also not known whether Technetium Tc 99m
Albumin Aggregated Injection can cause fetal harm when
administered to a pregnant woman or can affect reproductive
capacity. There have been no studies in pregnant women.
Technetium Tc 99m Albumin Aggregated Injection should be given
to a pregnant woman only if clearly needed. Ideally, examinations using radiopharmaceuticals,
especially those 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: Technetium Tc 99m is excreted in human milk during
lactation. Therefore, formula-feedings should be substituted for
breast-feedings.<br/>Pediatric Use: The lowest possible number of particles should be used in
the right-to-left shunting, in neonates and in severe pulmonary
disease.
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| dailymed-instance:genericMe... |
Albumin aggregate and albumin human
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Macrotec (Injection, Powder, Lyophilized, For Suspension)
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| dailymed-instance:adverseRe... |
Although adverse reactions specifically attributable to the
Technetium Tc 99m Albumin Aggregated Injection have not been noted, the
literature contains reports of deaths occurring after the administration
of Albumin Aggregated to patients with pre-existing severe pulmonary
hypertension. Instances of hemodynamic or idiosyncratic reactions topreparations of Technetium Tc 99m Albumin Aggregated have been
reported.
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| dailymed-instance:warning |
The literature contains reports of deaths occurring after the
administration of Albumin Aggregated to patients with pre-existing
severe pulmonary hypertension. Instances of hemodynamic or idiosyncratic
reactions to preparations of Technetium Tc 99m Albumin Aggregated have
been reported. This product contains albumin, a derivative of human blood. Based
on effective donor screening and product manufacturing processes, it
carries an extremely remote risk for transmission of viral diseases. A
theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD)
also is considered extremely remote. No cases of transmission of viral
diseases or CJD have ever been identified for albumin.
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| dailymed-instance:indicatio... |
Lung Imaging: Macrotec (Kit for the Preparation of Technetium Tc 99m
Albumin Aggregated) is a lung imaging agent which may be used as
an adjunct in the evaluation of pulmonary perfusion in adults
and children. It is useful in the early detection of pulmonary
emboli and in the evaluation of the status of the pulmonary
circulation in such conditions as pulmonary neoplasm, pulmonary
tuberculosis and emphysema.<br/>Shunt Imaging: Technetium Tc 99m Albumin Aggregated may be used in
adults as an imaging agent to aid in the evaluation of
peritoneo-venous (LeVeen) shunt patency.<br/>Isotopic Venography: Macrotec is also indicated for use in isotopic venography
as an adjunct in the screening, diagnosis and management of deep
vein thrombosis in the lower extremities. Combined isotopic venography of the lower extremities and
the pulmonary vasculature may be performed.
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Macrotec
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