Data from FDA - Curated by EPG Health - Last updated 19 December 2016
PRECAUTIONS Contents of the reaction vial are intended only for use in the preparation of Technetium Tc 99m Medronate and are NOT to be administered directly to the patient.
To minimize the radiation dose to the bladder,
The preparation contains
Both the powdered and reconstituted forms of MDP-25 should be stored at 25°C (77°F); excursions permitted between 15° and 30°C (59° to 86°F).
The reconstituted product should be stored in a
The solution should not be used if it is cloudy.
It is essential to follow
Technetium Tc 99m Medronate as well as other radioactive drugs must be handled with
Once sodium pertechnetate Tc-99 m is added to the vial,
The technetium Tc-99 m labeling reactions involved depend on maintaining the stannous ion in the
Hence, sodium pertechnetate Tc-99 m containing oxidants should not be employed.
Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the
Pregnancy Category C Animal reproduction and teratogenicity studies have not been conducted with Technetium Tc 99m Medronate.
It is also not known whether Technetium Tc-99 m Medronate can cause fetal
There have been
Technetium Tc-99 m should be given to a pregnant woman only if clearly needed.
Nursing Mothers Technetium Tc-99 m is excreted in human milk during lactation.
Therefore, formula feedings should be substituted for breast feedings.
Several reactions have also been reported in association with other radiopharmaceuticals of the diphosphonate class, particularly Technetium Tc 99m Medronate.
These are usually hypersensitivity reactions characterized by
In addition, one case of cardiac
DOSAGE AND ADMINISTRATION The
Optimum scanning time is 1 to 4 hours post-injection.
To minimize the contribution of the bladder content to the image, the patient should void immediately before imaging is started.
The patient dose should be measured by a
Parenteral drug products should be inspected visually for particulate matter and
The solution should not be used if cloudy.
RADIATION DOSIMETRY The estimated absorbed radiation doses to an
Table 4 Radiation Doses2 2 Method of calculation: “S” Absorbed Dose per Unit Cumulated Activity for Selected Radionuclides and Organs, MIRD Pamphlet No. 11, 1975 Tissue Absorbed Radiation Dose mGy/740 MBq rads/20 mCi Total Body Total Bone Red Marrow Kidneys Liver Bladder Wall 2 hr.
The vials are sealed under an atmosphere of nitrogen.
Radioassay information labels with radiation warning symbol and a package insert are supplied in each box.
STORAGE Store the unreconstituted reaction vials at 25?C (77?F); excursions permitted between 15° and 30?C (59° to 86?F).
After labeling with Technetium Tc-99 m, the reconstituted product should be stored at 25?C (77?F) in the
Excursions permitted between 15° and 30?C (59° to 86?F).
DIRECTIONS NOTE: Use aseptic procedures throughout and take precautions to minimize radiation exposure by use of
MDP-25 reaction vials are intended for the preparation of multiple doses of Technetium Tc 99 Medronate and the entire contents of the vial should not be used as a single dose.
Before reconstituting a vial, it should be inspected for
To prepare Technetium Tc 99m Medronate: Remove the
Place the reaction vial in a
Obtain 2 to
Sodium pertechnetate Tc-99 m solutions containing
Using a shielded syringe, add the sodium pertechnetate Tc-99 m solution to the reaction vial aseptically.
Place the lead cap on the reaction vial shield and agitate the shielded reaction vial until the contents are completely dissolved.
Assay the product in a
Withdrawals for administration must be made aseptically using a shielded
Since the reaction vials contain nitrogen to prevent oxidation of the complex, they should not be vented.
If repeated withdrawals are made, minimize the replacement of contents with room air.
Where: Vr = Final volume of in the vial in mL after reconstitution.
C = Concentration of Medronic Acid in mg/mL. Max.
V = Maximum volume to be used for one dose in mL. Min.
V = Minimum volume to be used for one dose in mL.
Prior to reconstitution, determine the radioactive concentration of the sodium pertechnetate Tc-99 m.
Note the volume and activity added to the vial.
It should be between 1.85 - 37.0 GBq (50 - 1000 mCi) in 1 to 10 mL. Calculate the concentration (C) of Medronic acid in the vial after reconstitution.
C (mg/mL) = 25 mg?
Vr (mL) To ensure that the dose contains a maximum of 10 mg, the following formula should be used to calculate the maximum volume (Max.
V) to be dispensed as one dose.
V (mL) = 10 mg?
C (mg/mL) To ensure that a minimum dose of 1 mg is dispensed, the following formula should be used to calculate the minimum volume (Min.
V) to be dispensed as one dose Min.
V = 1 mg?
C (mg/mL) 7.
The finished preparation should be stored at 25?C (77?F);excursions permitted between 15° and 30?C (59° to 86?F) when not in use and
It should also be stored during its life in a
U.S. Nuclear Regulatory Commission for distribution to persons licensed to use by-product material identified in §35.200 to 10 CFR Part 35, to persons who have a similar authorization issued by an
Kirkland Quebec, H9H 4J4 Canada.
Revised: October 2011
|Date Last Revised||01-10-2011|
|Type||HUMAN PRESCRIPTION DRUG|
|Marketing authorisation holder||Jubilant DraxImage Inc|