DRAXIMAGE DTPA: Package Insert and Label Information (Page 4 of 4)

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 INFORMATION

Administration Instructions

Intravenous Use

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)].

Inhalation Use

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)].

Pregnancy

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.

Manufactured for:
Jubilant DraxImage Inc., Kirkland,
Quebec, Canada, H9H 4J4.
Revised: May 2022Art Rev.: 1.2

Radioactive Label

Radioactive Label
(click image for full-size original)

Vial Label

Vial Label
(click image for full-size original)

30 Vials Carton

30 Vials Carton
(click image for full-size original)

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
Packaging
# 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 (243604761)
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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