Jubilant Draximage Inc.
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Jubilant Draximage Inc. Drugs
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![Technetium Tc 99m Medronate (Technetium Tc 99m Medronate) Injection, Powder, For Solution [Jubilant Draximage Inc]](http://recallguide.cwdevelopsp.com/wp-content/themes/recallguide/assets/img/drug-image-placeholder.jpg)
Technetium Tc 99m Medronate
The recommended adult dose, after reconstitution with oxidant-free sodium pertechnetate Tc-99m, is 370 to 740 megabecquerels (10 to 20 millicuries [200 µCi/kg]) by slow intravenous injection over a period of 30 seconds. 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 suitable radioactivity calibration system immediately prior to administration.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. The solution should not be used if cloudy.RADIATION DOSIMETRYThe estimated absorbed radiation doses to an average patient (70 kg) from an intravenous injection of a maximum dose of 740 megabecquerels (20 millicuries) of Technetium Tc 99m Medronate are shown in Table 4. The effective half-life was assumed to be the physical half-life for all calculated values.
Table 4Radiation Doses2
2 Method of calculation: “S” Absorbed Dose per Unit Cumulated Activity for Selected Radionuclides and Organs, MIRD Pamphlet No. 11, 1975 TissueAbsorbed Radiation Dose
mGy/740 MBq
rads/20 mCi
Total Body
Total Bone
Red Marrow
Kidneys
Liver
Bladder Wall
2 hr. void
4.8 hr. void
Ovaries
2 hr. void
4.8 hr. void
Testes
2 hr. void
4.8 hr. void
1.3
7.0
5.6
8.0
0.6
26.0
62.0
2.4
3.4
1.6
2.2
0.13
0.70
0.56
0.80
0.06
2.60
6.20
0.24
0.34
0.16
0.22
HOW SUPPLIED
MDP-25,Kit for the Preparation of Technetium Tc 99m Medronate InjectionProduct No. 500661 (30 vials) Available in boxes consisting of 30 reaction vials, each vial containing in lyophilized form, sterile and non-pyrogenic: Medronic Acid 25.0 mg Stannous Chloride Dihydrate (minimum) 2.0 mg (Maximum tin as stannous chloride dihydrate) 3.0 mg p-Aminobenzoic Acid 5.0 mg The pH is adjusted to 6.8 to 6.9 with HCI or NaOH prior to lyophilization. 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 25ºC (77ºF); excursions permitted between 15° and 30ºC (59° to 86ºF). After labeling with Technetium Tc-99m, the reconstituted product should be stored at 25ºC (77ºF) in the original vial, and be placed in a suitable lead shield. Excursions permitted between 15° and 30ºC (59° to 86ºF). Discard the reconstituted solution after 12 hours.
DIRECTIONS
NOTE: Use aseptic procedures throughout and take precautions to minimize radiation exposure by use of suitable shielding. Use waterproof gloves during the following preparation procedure.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 cracks and/or a melted plug or any other indication that the integrity of the vacuum seal has been compromised.To prepare Technetium Tc 99m Medronate:
Remove the central metal disc from a reaction vial and swab the closure with either an alcohol swab or a suitable bacteriostatic agent.
Place the reaction vial in a suitable lead vial shield (minimum wall thickness 1/8 inch) which has a fitted lead cap. Obtain 2 to 10 mL of sterile, non-pyrogenic sodium pertechnetate Tc-99m, using a shielded syringe.
The recommended maximum amount of Technetium Tc-99m to be added to a reaction vial is 37.0 gigabecquerels (1000 mCi). Sufficient sodium pertechnetate is to be used for the reconstitution of a reaction vial to ensure that the dose of medronate administered does not exceed 10 mg. Sodium pertechnetate Tc-99m solutions containing an oxidizing agent are not suitable for use.
Using a shielded syringe, add the sodium pertechnetate Tc-99m 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. The solution must be clear and free of particulate matter before proceeding.
Assay the product in a suitable calibrator, record the radioassay information on the label with radiation warning symbol, and apply it to the reaction vial.
Withdrawals for administration must be made aseptically using a shielded sterile syringe and needle. 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.
The following steps should be followed to ensure that each reconstituted of Technetium Tc 99m Medronate contains between 1 and 10 mg of medronic acid. 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-99m.
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.
Max. 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 = 1mg ÷ C(mg/mL)
7. The finished preparation should be stored at 25ºC (77ºF);excursions permitted between 15° and 30ºC (59° to 86ºF) when not in use and discarded after 12 hours. It should also be stored during its life in a suitable lead shield.
This reagent kit is approved by the 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 Agreement State, and, outside the United States, to persons authorized by the appropriate authority.
Manufactured by:Jubilant DraxImage Inc.Kirkland Quebec, H9H 4J4 Canada. Revised: October 2011
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Draximage Maa
The recommended intravenous dose range for the average (70 kg) ADULT patient for lung imaging is 37 to 148 megabecquerels (1-4 millicuries) of Technetium Tc 99m Albumin Aggregated Injection after reconstitution with oxidant-free Sodium Pertechnetate Tc 99m Injection. The suggested intraperitoneal dosage range used in the average patient (70 kg) for peritoneovenous (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. The recommended number of particles per single injection is 200 000 to 700 000 with the suggested number being approximately 350 000. Depending on the activity added and volume of the final reconstituted product, the volume of the dose may vary from 0.2 to 1.4 mL.
The number of particles available per 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 in any dose and volume to be administered may be calculated as follows:Assume the average number of particles per vial = 6.0 x 106. If: VTc = volume of solution added to reaction vial D = desired dose to be administered in MBq (mCi) C = concentration at calibration time of sodium pertechnetate solution to be added to the reaction vial in MBq/mL (mCi/mL) Va = volume to be administered in mL P = number of particles in dose to be administered Fr = fraction of technetium Tc-99m remaining after the time of calibration (see Table 3) Then: Va = D and P = Va x 6.0 x 106 C x Fr VTc
In PEDIATRIC patients, the suggested intravenous dose to be employed for perfusion lung imaging is in the range of 0.925 to 1.85 MBq per kilogram (25 to 50 μCi/kg) of body weight; a usual dose is 1.11 MBq per kilogram (30 μCi/kg), except in newborns, in whom the administered dose should be 7.4 to 18.5 MBq (200 to 500 μCi). Not less than the minimum dose of 7.4 MBq (200 μCi) should be employed for this procedure. The number of particles will vary with age and weight of the pediatric patient as indicated in Table 5.
Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration whenever solution and container permit. 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 with drawing 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. For optimum results and because of rapid lung clearance of the radiopharmaceutical, it is suggested that the patient be positioned under the imaging apparatus before administration. Slow injection is recommended. Lung imaging may begin immediately after intravenous injection of the radiopharmaceutical. Due to high kidney uptake, imaging later than one-half hour after administration will yield poor results.
RADIATION DOSIMETRY
The estimated absorbed radiation doses2 to 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 4.
Table 4Absorbed Radiation Doses
2 Method of calculation: “S” Absorbed Dose per Unit Cumulated Activity for Selected Radionuclides and Organs, MIRD Pamphlet No. 11 (1975).Organs
mGy/148 MBq
rads/4 mCi
Total body
Lungs
Liver
Spleen
Kidneys
Bladder Wall
2.0 hr. void
4.8 hr. void
Testes
2.0 hr. void
4.8 hr. void
Ovaries
2.0 hr. void
4.8 hr. void
0.60
8.8
0.72
0.68
0.44
1.2
2.2
0.24
0.26
0.30
0.34
0.060
0.88
0.072
0.068
0.044
0.12
0.22
0.024
0.026
0.030
0.034
In PEDIATRIC patients, the radiation absorbed doses using the maximum recommended dose for lung imaging are based on 1.85 MBq (50 μCi) per kilogram of body weight [except in the newborn where the maximum recommended dose of 18.5 MBq (500 μCi) is used] and are shown in Table 5, which lists the maximum dose for pediatric patients from newborn to adults. Note the recommendations regarding number of particles to be administered. Table 6 represents the absorbed radiation dose resulting from the intraperitoneal administration of 111 megabecquerels (3 millicuries) of technetium Tc 99m albumin aggregated.
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Pentetic Acid
There is currently no dosage information available for this product. We apologize for any inconvenience.
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Sodium Iodide I 131 Diagnostic
The suggested oral dosage ranges employed in the average patient (70 kg) for diagnostic procedures for thyroid function are as follows: Thyroid Uptake:0.185 to 0.555 megabecquerels (5 to 15 microcuries) Scintiscanning:1.85 to 3.70 megabecquerels (50 to 100 microcuries) Localization of Extra-Thyroidal Metastases:37 megabecquerels (1,000 microcuries). General Dosing InformationPatients should be adequately hydrated before and after administration of radioiodide to assure rapid urinary elimination of the iodide that is not absorbed by the thyroid gland.Radition DosimetryThe estimated absorbed radiation doses to an average (70 kg) euthyroid (normal functioning thyroid) patient from an oral dose of 3.70 megabecquerels (100 microcuries) of iodine I-131 are shown in Table 4.
Table 4Estimated Absorbed Radiation Doses froman Oral Dose of 3.70 megabecquerels (100 microcuries)
MIRD DOSE ESTIMATE REPORT No. 5. Summary of Current Radiation Dose Estimates to Humans from I123 , I124, I125, I126, I130, I131 and I132 Sodium Iodide. J. Nucl. Med., 16, No. 9, 857-60 (1975).Tissue
Absorbed radiation doses for 3.70 megabecquerels
(100 microcuries)
Thyroid Uptake
5 %
15 %
25 %
mGy
rads
mGy
rads
mGy
rads
Thyroid
260
26.0
800
80.0
1300
130.0
Stomach wall
1.7
0.17
1.6
0.16
1.4
0.14
Red marrow
0.14
0.014
0.20
0.020
0.26
0.026
Liver
0.20
0.020
0.35
0.035
0.48
0.048
Testes
0.08
0.008
0.09
0.009
0.09
0.009
Ovaries
0.14
0.014
0.14
0.014
0.14
0.014
Total body
0.24
0.024
0.47
0.047
0.71
0.071
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Hicon
The concentrated Sodium Iodide I 131 Solution USP provided with HICON®must not be used for direct administration to patients. It must be diluted and prepared as described in the DRUG HANDLING AND DOSAGE FORM PREPARATION section.The recommended dosage for orally administered Sodium Iodide I 131 Solution USP is based on the thyroid gland uptake as well as the size of the gland. Thyroidal uptake and size should be determined by the physician prior to treatment and may be useful in calculating the therapeutic dose to be administered to the individual patient. Recommended dosages of orally administered Sodium Iodide I-131 are: Disease therapy:Antihyperthyroid Therapy:Oral dose of 148 to 370 megabecquerels (4 to 10 millicuries).Toxic nodular goiters and other serious thyroid conditions may require larger dosages.Antineoplastic – Ablation of normal thyroid tissue:Initial oral dose of 1.1 to 3.7 gigabecquerels (30 to 100 millicuries).Subsequent ablation of metastases with oral dose of 3.7 to 7.4 gigabecquerels (100 to 200 millicuries).General Dosing InformationPatients should be adequately hydrated before and after administration of radioiodide to assure rapid urinary elimination of the iodide that is not absorbed by the thyroid gland.Radiation Dosimetry Following administration of Sodium Iodide I-131, about 40 percent of the activity has an effective half-life of 0.34 days and 60 percent has an effective half-life of 7.61 days. On this basis, the estimated absorbed radiation dose to an average adult (70 kg) from an oral dose of 370 MBq (10 mCi) of Sodium Iodide I-131 is shown in Table 4.
Table 4Absorbed Radiation Doses I-131
Method of Calculation: A Schema for Absorbed-Dose Calculations for Biologically Distributed Radionuclides, MIRD Pamphlet No. 1, J Nucl Med Suppl, 1:7, 1968. Tissue mGy/370 MBq Rads/10 mCi Thyroid 350,000 35,000 Testes 92 9.2 Ovaries 93 9.3 Whole body 160 16.0DRUG HANDLING AND FINAL DOSAGE FORM PREPARATION Drug Handling 1.The concentrated Sodium Iodide I 131 Solution USP provided with HICON® should not be used after the expiration date stated on the container label.2.The solution should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. The solution should not be used if cloudy, discolored, or found to contain particulate matter. However, it is well known that glass tends to darken in the presence of high radioactivity.3.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. Waterproof gloves should be used during the entire handling and administration procedure. Adequate shielding should be maintained during the life of the product.
Preparation of Dilute Sodium Iodide I 131 Solution USP 1.Using the calibration date and radionuclidic concentration on the label of the product vial, calculate the required volume to produce the necessary dose in MBq or mCi.2.Using a shielded syringe, remove the required volume.3.Using the shielded syringe, transfer the required volume to a suitably shielded receiving vial.4.Add diluent solution to the receiving vial to produce a final dose of the desired volume. The recommended diluent is Purified Water USP containing 0.2 % Sodium Thiosulfate USP as a reducing agent. The use of acidic diluents may cause the pH to drop below 7.5 and stimulate the volatilization of Iodine I-131 hydriodic acid.5.The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.6.The finished preparation should not be used after the expiration date stated on the container label.
Preparation of Sodium Iodide I 131 Capsules USP 1.The kit includes one large gelatin capsule and one small gelatin capsule for each dose prepared. Each large capsule is empty and each small capsule contains approximately 300 mg of Dibasic Sodium Phosphate Anhydrous USP as the absorbing buffer.2.Using the calibration date and radionuclidic concentration on the label of the product vial, calculate the required volume to produce the necessary dose in MBq or mCi.3.Open one LARGE capsule by pulling apart the capsule into two pieces as illustrated below:
4.Insert an unopened SMALL capsule into the bottom half of the empty large capsule as illustrated below:
5.With an appropriate syringe, withdraw the required volume of Sodium Iodide I 131 Solution USP (maximum 150 µL) from the vial as illustrated below:
6.Inject into the center of the SMALL capsule through the top as illustrated below:
7.Slip the upper half of the large capsule over the bottom half to completely cover the small capsule and push down gently until locked as illustrated below:
8.After dispensing, the patient dose should be measured in a suitable radioactivity calibration system immediately prior to administration.9.Store the capsule in a suitable polypropylene container and place inside a lead pot until use. The capsule should be used within seven days.HOW SUPPLIED Each HICON® kit of 9.25 GBq to 37 GBq (250 mCi to 1,000 mCi) includes:a) A minimum of one blister package of ten small hard gelatin capsules each containing approximately 300 mg of Dibasic Sodium Phosphate Anhydrous USP as absorbing buffer.b) A minimum of one blister package of ten empty large hard gelatin capsules.c) a 1 mL vial containing 0.25 ml to 1 mL of Sodium Iodide I 131 Solution USP, therapeutic oral solution containing approximately 9.25 GBq to 37 GBq (250mCi to 1,000 mCi) at time of calibration.Each mL of the aqueous product that comes with HICON® contains:37 gigabecquerels of Sodium Iodide I-131< 2.0 mg of Disodium Edetate Dihydrate USP< 22 mg of Sodium Thiosulphate Pentahydrate USP< 40 mg of Dibasic Sodium Phosphate Anhydrous USPComplete assay data are available on the container.*Note that not all filled volumes/radioactivity within the range may be commercially available STORAGE The Sodium Iodide I 131 Solution USP provided with HICON® should be stored between 2o C and 25o C (36o F and 77o F).NDC 65174-880-25 (for 250 mCi vial size)NDC 65174-880-50 (for 500 mCi vial size)NDC 65174-880-00 (for 1,000 mCi vial size)Manufactured by: Jubilant DraxImage Inc., Kirkland, Quebec H9H 4J4, Canada.Revised : August 2011
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