16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
DRAXIMAGE® DTPA is supplied as multiple dose kits consisting of 10 mL reaction vials containing a white, lyophilized powder with 20 mg of pentetic acid, 5 mg of p-aminobenzoic acid, 3.73 mg of calcium chloride dihydrate, and not less than 0.25 mg stannous chloride dihydrate and not more than 0.385 mg tin expressed as stannous chloride dihydrate.
The radionuclide is not part of the kit. Before reconstitution and radiolabeling with sodium pertechnetate Tc 99m injection USP, the contents of the kit are not radioactive.
The kits are supplied in the following formats:
Carton containing 30 (thirty) kits NDC 65174.288.30
16.2 Storage and Handling
Store the unreconstituted reaction vials at 25 °C (77 °F); excursions permitted between 15 °C and 30 °C (59 °F and 86 °F).
This radiopharmaceutical is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.
17 PATIENT COUNSELING
Advise patients to hydrate after administration of Tc 99m labeled DRAXIMAGE® DTPA injection and to void frequently to minimize radiation dose [see Dosage and Administration (2.3)].
To minimize the potential of mouth and esophageal activity of Tc 99m labeled DRAXIMAGE® DTPA, advise the patient to rinse their mouth with water and spit it out prior to imaging [see Dosage and Administration (2.3)].
Advise pregnant women of the risk of fetal exposure to radiation if they undergo a radionuclide procedure [see Use in Specific Populations (8.1)].
® Registered Trademark of Jubilant DraxImage Inc.
Jubilant DraxImage Inc., Kirkland,
Quebec, Canada, H9H 4J4.
Revised: May 2022Art Rev.: 1.2
30 Vials Carton
| DRAXIMAGE DTPA kit for the preparation of technetium tc 99m pentetate injection, powder, lyophilized, for solution |
|Product Information |
|Product Type ||HUMAN PRESCRIPTION DRUG ||Item Code (Source) ||NDC:65174-288 |
|Route of Administration ||INTRAVENOUS, RESPIRATORY (INHALATION) ||DEA Schedule || |
|Active Ingredient/Active Moiety |
|Ingredient Name ||Basis of Strength ||Strength |
|Pentetic Acid (Pentetic Acid) ||Pentetic Acid ||20 mg |
|Inactive Ingredients |
|Ingredient Name ||Strength |
| Aminobenzoic Acid ||5 mg |
| Calcium Chloride ||3.73 mg |
| Stannous Chloride ||0.25 mg |
|Product Characteristics |
|Color || ||Score ||no score |
|Shape || ||Size || |
|Flavor || ||Imprint Code || |
|Contains || |
|# ||Item Code ||Package Description ||Multilevel Packaging |
| 1 ||NDC:65174-288-30 ||30 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 KIT ||None |
| Marketing Information |
|Marketing Category ||Application Number or Monograph Citation ||Marketing Start Date ||Marketing End Date |
|NDA ||NDA018511 ||12/29/1989 || |
|Labeler — Jubilant DraxImage Inc., dba Jubilant Radiopharma
|Registrant — Jubilant DraxImage Inc., dba Jubilant Radiopharma (243604761) |
| Establishment |
|Name ||Address ||ID/FEI ||Operations |
|Jubilant HollisterStier General Partnership || ||246762764 ||MANUFACTURE (65174-288) |
Revised: 05/2022 Jubilant DraxImage Inc., dba Jubilant Radiopharma
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