Cardinal Health 414, Llc
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Cardinal Health 414, Llc Drugs
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![Saline Refills (Sodium Bicarbonate, Sodium Chloride) Powder, For Solution [Cardinal Health 414, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=c9d8ef33-46ed-4c60-842c-7d23f12bfcb9&name=Ascent_Leader100label.jpg)
Saline Refills
Directions
Adults and children 4 years and over: use 1-2 packets every 2 hours as needed
Children under 4 years: consult a doctor
Consult Instructions for Use for proper use
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![Kettle Neti Pot (Sodium Bicarbonate, Sodium Chloride) Powder, For Solution [Cardinal Health 414, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d1d5dbf7-0037-4c67-b5ec-c80690e90482&name=Ascent_Leaderlabel.jpg)
Kettle Neti Pot
Directions
Adults and children 4 years and over: use 1-2 packets every 2 hours as needed
Children under 4 years: consult a doctor
Consult Instructions for Use for proper use
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![Ammonia N-13 Injection [Cardinal Health 414, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4c563174-c7cd-4224-b865-4da2f39c21c0&name=image-02.jpg)
Ammonia N-13
2.1 Rest Imaging Study
• Aseptically withdraw Ammonia N-13 Injection, USP from its container and administer 10-20 mCi (0.368 – 0.736 GBq) as a bolus through a catheter inserted into a large peripheral vein. • Start imaging 3 minutes after the injection and acquire images for a total of 10-20 minutes.2.2 Stress Imaging Study
• If a rest imaging study is performed, begin the stress imaging study 40 minutes or more after the first Ammonia N-13 Injection, USP to allow sufficient isotope decay. • Administer a pharmacologic stress-inducing drug in accordance with its labeling. • Aseptically withdraw Ammonia N-13 Injection, USP from its container and administer 10-20 mCi (0.368 – 0.736 GBq) of Ammonia N-13 Injection, USP as a bolus at 8 minutes after the administration of the pharmacologic stress-inducing drug. • Start imaging 3 minutes after the Ammonia N-13 Injection, USP and acquire images for a total of 10-20 minutes.2.3 Patient Preparation
To increase renal clearance of radioactivity and to minimize radiation dose to the bladder, ensure that the patient is well hydrated before the procedure and encourage voiding as soon as a study is completed and as often as possible thereafter for at least one hour.
2.4 Radiation Dosimetry
The converted radiation absorbed doses in rem/mCi are shown in Table 1. These estimates are calculated from the Task Group of Committee 2 of the International Commission on Radiation Protection.1
Table 1: N-13 Absorbed Radiation Dose Per Unit Activity (rem/mCi) for Adults and Pediatric Groups * Upper large intestine; ** Lower large intestineOrgan
Adult
15-year old
10-year old
5-year old
1-year old
Adrenals
0.0085
0.0096
0.016
0.025
0.048
Bladder wall
0.030
0.037
0.056
0.089
0.17
Bone surfaces
0.0059
0.0070
0.011
0.019
0.037
Brain
0.016
0.016
0.017
0.019
0.027
Breast
0.0067
0.0067
0.010
0.017
0.033
Stomach wall
0.0063
0.0078
0.012
0.019
0.037
Small intestine
0.0067
0.0081
00013
0.021
0.041
*ULI
0.0067
0.0078
0.013
0.021
0.037
**LLI
0.0070
0.0078
0.013
0.020
0.037
Heart
0.0078
0.0096
0.015
0.023
0.041
Kidneys
0.017
0.021
0.031
0.048
0.089
Liver
0.015
0.018
0.029
0.044
0.085
Lungs
0.0093
0.011
0.018
0.029
0.056
Ovaries
0.0063
0.0085
0.014
0.021
0.041
Pancreas
0.0070
0.0085
0.014
0.021
0.041
Red marrow
0.0063
0.0078
0.012
0.020
0.037
Spleen
0.0093
0.011
0.019
0.030
0.056
Testes
0.0067
0.0070
0.011
0.018
0.035
Thyroid
0.0063
0.0081
0.013
0.021
0.041
Uterus
0.0070
0.0089
0.014
0.023
0.041
Other tissues
0.0059
0.0070
0.011
0.018
0.035
2.5 Drug Handling
• Inspect Ammonia N-13 Injection, USP visually for particulate matter and discoloration before administration, whenever solution and container permit. • Do not administer Ammonia N-13 Injection, USP containing particulate matter or discoloration; dispose of these unacceptable or unused preparations in a safe manner, in compliance with applicable regulations. • Wear waterproof gloves and effective shielding when handling Ammonia N-13 Injection, USP. • Use aseptic technique to maintain sterility during all operations involved in the manipulation and administration of Ammonia N-13 Injection, USP. The contents of each vial are sterile and non-pyrogenic. • Use appropriate safety measures, including shielding, consistent with proper patient management to avoid unnecessary radiation exposure to the patient, occupational workers, clinical personnel, and other persons. • Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. • Before administration of Ammonia N-13 Injection, USP, assay the dose in a properly calibrated dose calibrator. -
![Kit For The Preparation Of Technetium Tc99m Sestamibi Injection, Powder, Lyophilized, For Solution [Cardinal Health 414, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8626e756-767a-4a14-9188-658b58185254&name=image-04.jpg)
Kit For The Preparation Of Technetium Tc99m Sestamibi
For Myocardial Imaging: The suggested dose range for I.V. administration of Technetium Tc 99m Sestamibi in a single dose to be employed in the average patient (70 Kg) is 370–1110 MBq (10–30 mCi).
For Breast Imaging: The recommended dose range for I.V. administration of Technetium Tc 99m Sestamibi is a single dose of 740–1110 MBq (20–30 mCi).
2.1 Image Acquisition
Breast Imaging: It is recommended that images are obtained with a table overlay to separate breast tissue from the myocardium and liver, and to exclude potential activity that may be present in the opposite breast. For lateral images, position the patient prone with the isolateral arm comfortably above the head, shoulders flat against the table, head turned to the side and relaxed, with the breast imaged pendent through an overlay cutout. The breast should not be compressed on the overlay. For anterior images, position the patient supine with both arms behind the head. For either lateral or anterior images, shield the chest and abdominal organs, or remove them from the field of view.
For complete study, sets of images should be obtained five minutes after the injection, and in the following sequence:
Beginning five minutes after the injection of Technetium Tc 99m Sestamibi:
• ten-minute lateral image of breast with abnormality • ten-minute lateral image of contralateral breast • ten-minute anterior image of both breasts2.2 Radiation Dosimetry
The radiation doses to organs and tissues of an average patient (70 Kg) per 1110 MBq (30 mCi) of Technetium Tc 99m Sestamibi injected intravenously are shown in Table 1.
Table 1 Radiation Absorbed Doses from Tc 99m SestamibiEstimated Radiation Absorbed Dose
REST
2.0 hour void
4.8 hour void
Organ
rads/30 mCi
mGy/1110 MBq
rads/30 mCi
mGy/1110 MBq
Breasts
0.2
2.0
0.2
1.9
Gallbladder Wall
2.0
20.0
2.0
20.0
Small Intestine
3.0
30.0
3.0
30.0
Upper Large Intestine Wall
5.4
55.5
5.4
55.5
Lower Large Intestine Wall
3.9
40.0
4.2
41.1
Stomach Wall
0.6
6.1
0.6
5.8
Heart Wall
0.5
5.1
0.5
4.9
Kidneys
2.0
20.0
2.0
20.0
Liver
0.6
5.8
0.6
5.7
Lungs
0.3
2.8
0.3
2.7
Bone Surfaces
0.7
6.8
0.7
6.4
Thyroid
0.7
7.0
0.7
2.4
Ovaries
1.5
15.5
1.6
15.5
Testes
0.3
3.4
0.4
3.9
Red Marrow
0.5
5.1
0.5
5.0
Urinary Bladder Wall
2.0
20.0
4.2
41.1
Total Body
0.5
4.8
0.5
4.8
STRESS
2.0 hour void
4.8 hour void
Organ
rads/30 mCi
mGy/1110 MBq
rads/30 mCi
mGy/1110 MBq
Breasts
0.2
2.0
0.2
1.8
Gallbladder Wall
2.8
28.9
2.8
27.8
Small Intestine
2.4
24.4
2.4
24.4
Upper Large Intestine Wall
4.5
44.4
4.5
44.4
Lower Large Intestine Wall
3.3
32.2
3.3
32.2
Stomach Wall
0.6
5.3
0.5
5.2
Heart Wall
0.5
5.6
0.5
5.3
Kidneys
1.7
16.7
1.7
16.7
Liver
0.4
4.2
0.4
4.1
Lungs
0.3
2.6
0.2
2.4
Bone Surfaces
0.6
6.2
0.6
6.0
Thyroid
0.3
2.7
0.2
2.4
Ovaries
1.2
12.2
1.3
13.3
Testes
0.3
3.1
0.3
3.4
Red Marrow
0.5
4.6
0.5
4.4
Urinary Bladder Wall
1.5
15.5
3.0
30.0
Total Body
0.4
4.2
0.4
4.2
Radiation dosimetry calculations performed by Radiation Internal Dose Information Center, Oak Ridge Institute for Science and Education, PO Box 117, Oak Ridge, TN 37831-0117, (865) 576-3448.
2.3 Instructions for Preparation
Preparation of the Technetium Tc 99m Sestamibi from the Kit for Preparation of Technetium Tc 99m Sestamibi Injection is done by the following aseptic procedure:
Boiling Water Bath Procedure:
a. Prior to adding the Sodium Pertechnetate Tc 99m Injection to the vial, inspect the vial carefully for the presence of damage, particularly cracks, and do not use the vial if found. Tear off a radiation symbol and attach it to the neck of the vial. b. Waterproof gloves should be worn during the preparation procedure. Remove the plastic disc from the vial and swab the top of the vial closure with alcohol to sanitize the surface. c. Place the vial in a suitable radiation shield with a fitted radiation cap. d. With a sterile shielded syringe, aseptically obtain additive-free, sterile, non-pyrogenic Sodium Pertechnetate Tc 99m Injection [925-5550 MBq, (25–150 mCi)] in approximately 1 to 3 mL. e. Aseptically add the Sodium Pertechnetate Tc 99m Injection to the vial in the lead shield. Without withdrawing the needle, remove an equal volume of headspace to maintain atmospheric pressure within the vial. f. Shake vigorously, about 5 to 10 quick upward-downward motions. g. Remove the vial from the lead shield and place upright in an appropriately shielded and contained boiling water bath, such that the vial is suspended above the bottom of the bath, and boil for 10 minutes. Timing for 10 minutes is begun as soon as the water begins to boil again. Do not allow the boiling water to come in contact with the aluminum crimp. h. Remove the vial from the water bath, place in the lead shield and allow to cool for fifteen minutes. i. Using proper shielding, the vial contents should be visually inspected. Use only if the solution is clear and free of particulate matter and discoloration. j. Assay the reaction vial using a suitable radioactivity calibration system. Record the Technetium Tc 99m concentration, total volume, assay time and date, expiration time and lot number on the vial shield label and affix the label to the shield. k. Store the reaction vial containing the Technetium Tc 99m Sestamibi at 15° to 25°C until use; at such time the product should be aseptically withdrawn. Technetium Tc 99m Sestamibi should be used within six hours of preparation. The vial contains no preservative.Note: Adherence to the above product reconstitution instructions is recommended.
The potential for cracking and significant contamination exists whenever vials containing radioactive material are heated.
Product should be used within 6 hours after preparation.
Final product with radiochemical purity of at least 90% was used in the clinical trials that established safety and effectiveness. The radiochemical purity was determined by the following method.
2.4 Determination of Radiochemical Purity in Technetium Tc 99m Sestamibi
1. Obtain a Baker-Flex Aluminum Oxide coated, plastic TLC plate, #1 B-F, pre-cut to 2.5 cm x 7.5 cm. 2. Dry the plate or plates at 100°C for 1 hour and store in a desiccator. Remove pre-dried plate from the desiccator just prior to use. 3. Apply 1 drop of ethanol* using a 1 mL syringe with a 22–26 gauge needle, 1.5 cm from the bottom of the plate. THE SPOT SHOULD NOT BE ALLOWED TO DRY. 4. Add 2 drops of Technetium Tc 99m Sestamibi solution, side by side on top of the ethanol* spot. Return the plate to a desiccator and allow the sample spot to dry (typically 15 minutes). 5. The TLC tank is prepared by pouring ethanol* to a depth of 3-4 mm. Cover the tank and let it equilibrate for ~10 minutes. 6. Develop the plate in the covered TLC tank in ethanol* for a distance of 5 cm from the point of application. 7. Cut the TLC plate 4 cm from the bottom and measure the Tc 99m activity in each piece by appropriate radiation detector. 8. Calculate the % Tc 99m Sestamibi as:TLC Plate Diagram
*The ethanol used in this procedure should be 95% or greater. Absolute ethanol (99%) should remain at ≥ 95% ethanol content for one week after opening if stored tightly capped, in a cool dry place.
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