Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 22 February 2017
PRECAUTIONS General The contents of this kit are not radioactive.
However, after sodium pertechnetate Tc 99m is added,
Contents of the reaction vial are intended only for use in the preparation of technetium Tc 99m mertiatide and are NOT to be administered directly to the patient.
Technetium Tc 99m mertiatide should not be
It is essential that the user follow
The technetium Tc 99m labeling reactions involved in preparing Technescan MAG3 depend on maintaining the stannous ion in the
Any oxidant present in the sodium pertechnetate Tc 99m may
Therefore, sodium pertechnetate Tc 99m containing oxidants should not be employed.
As in the use of any other radioactive material,
Radiopharmaceuticals should be used only by physicians who are qualified by specific training in the
Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with technetium Tc 99m mertiatide.
It is also not known whether this drug can cause fetal
Technetium Tc 99m mertiatide should be given to a pregnant woman only if clearly needed.
Nursing Mothers Technetium Tc 99m is excreted in human milk during lactation, therefore, formula feedings should be substituted for breast feeding.
DOSAGE AND ADMINISTRATION The suggested dose range employed in the
The patient dose should be measured by a
Parenteral drug products should be inspected visually for particulate matter and
Aseptic procedures and a shielded syringe should be employed in withdrawing doses for administration to patients.
The user should wear
|Date Last Revised||13-10-2015|
|Type||HUMAN PRESCRIPTION DRUG|
|Storage and handling||
STORAGE Technescan MAG3 should be stored at
The reconstituted vial should be stored at room temperature (15° to 30°C) and must be used within six hours of preparation.
Radiation Dose Estimates for Tc 99m Mertiatide * Calculated by Oak Ridge Associated Universities, based upon the pediatric phantom series of Christy and Eckerman of Oak Ridge National Laboratories.
The adult radiation absorbed doses were calculated based on data from ten normal volunteers using the Medical Internal Radiation Dose Committee (MIRD) schema.
* * Radioactive doses for 1-, 5-, and 10-year olds are based on a maximum dose of 7.4 MBq/kg (200?Ci/kg).
8-day Old 1-year Old * * 5-year Old * * 10-year Old * * 15-year Old Adult Assumed Weight (kg) 3.4 9.8 19 32 57 70 Tc 99m Mertiatide Dose 37 MBq (1 mCi) 72.52 MBq (1.96 mCi) 140.6 MBq (3.8 mCi) 236.8 MBq (6.4 mCi) 370 MBq (10 mCi) 370 MBq (10 mCi) Organ mSv rem mSv rem mSv rem mSv rem mSv rem mSv rem Gallbladder Wall 2.701 0.27 2.466 0.235 1.547 0.160 1.658 0.166 1.961 0.200 1.628 0.160 Lower
0.481 0.048 0.3626 0.036 Ovaries 0.592 0.058 0.6164 0.061 1.322 0.133 1.5392 0.154 3.330 0.330 2.5900 0.260 Red Marrow 0.1628 0.016 0.1595 0.0161 0.281 0.0277 0.3552 0.0352 0.629 0.063 0.4810 0.050 Testes 0.518 0.051 0.5294 0.053 1.0826 0.110 1.1840 0.122 2.368 0.240 1.628 0.160 Urinary Bladder Wall 11.470 1.1 9.428 0.921 21.090 2.090 23.680 2.368 59.20 6.00 48.1000 4.80 Total Body 0.2405 0.024 0.2176 0.022 0.3656 0.0365 0.4026 0.0410 0.814 0.081 0.6660 0.065
|Marketing authorisation holder||MALLINCKRODT NUCLEAR MEDICINE LLC|