DMSA (Page 2 of 2)

ADVERSE REACTIONS

Rare instances of syncope, fever, nausea and maculopapular skin rash have been reported.

DOSAGE AND ADMINISTRATION

The suggested dose range for slow I.V. administration to be employed in the average patient (70 kg) for renal parenchymal imaging is 74-222 MBq, 2-6 mCi technetium Tc99m succimer injection.

The product must be used between 10 minutes to 4 hours following preparation (see “Preparation” section). Acceptable renal images may be obtained beginning 1 to 2 hours post injection. Any unused portion should be discarded after that time.

The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

Do not use after the expiration date stated on the label. The components of the kit are supplied sterile and pyrogen-free. Aseptic procedures normally employed in making additions and withdrawals from sterile, pyrogen-free containers should be used during addition of sodium pertechnetate Tc99m injection solutions and during the withdrawal of doses for patient administration.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

RADIATION DOSIMETRY

The estimated absorbed radiation doses 2, 3 to an average adult (70 kg) are shown in Table 4.

Table 4. Absorbed Radiation Dose
Tissue mGy /
222 MBq
rads /
6 mCi
Bladder Wall 4.2 0.42
Kidneys (total) 37.8 3.78
Renal Cortices 51.0 5.10
Liver 1.9 0.19
Bone Marrow 1.3 0.13
Ovaries 0.8 0.08
Testes 0.4 0.04
Total Body 0.9 0.09

2
Method of Calculation: A schema for Absorbed-Dose Calculations for Biologically Distributed Radionuclides, Supplement No. 1, MIRD Pamphlet No. 1, J. Nucl. Med., p. 7, 1968.
3
Biological Data: Arnold, R.W; Subramanian, G.; McAfee, J.G.; Blair, R.J.; Thomas, F.D.; Comparison of Tc99m complexes for renal imaging, J. Nucl. Med., 16, pp. 357-367, 1975.

HOW SUPPLIED

Kit Contents

5
Vials containing a freeze-dried mixture of 1.0 mg dimercaptosuccinic acid, 0.42 mg stannous chloride dihydrate [0.38 mg (minimum) stannous chloride dihydrate (SnCl2 •2H2 O) and 0.46 mg (maximum) total tin expressed as stannous chloride dihydrate (SnCl2 •2H2 O)], 0.70 mg ascorbic acid, and 50.0 mg inositol.
5
Labels
1
Package Insert

NDC 017156-525-01

Storage

Store the kit at 2°-8°C (36°-46°F) and protect from light.

Preparation

The following directions must be carefully followed for optimum preparation of technetium Tc99m succimer injection:

Note: Use aseptic procedures throughout and take precautions to minimize radiation exposure by the use of suitable shielding. Waterproof gloves should be worn during the preparation procedure.

  1. Place one of the vials in a suitable shielding container and swab the closure with a bacteriostatic swab.
  2. Using a 10 mL sterile syringe, inject an appropriate amount (see notes 1 and 2) of the eluate from a Tc99m generator into the shielded vial. Before removing the syringe from the vial withdraw an equivalent volume of nitrogen from the space above the solution to normalize the pressure in the vial.
  3. Carefully invert the vial a few times until the powder is completely dissolved.
  4. Assay the total activity, complete the label provided and attach to the vial.
  5. Incubate the vial for at least 10 minutes at room temperature.
  6. Use the preparation between 10 minutes and 4 hours following reconstitution.

Note:

  1. Not more than 1.48 GBq, 40 mCi technetium-99m in a volume of 1-6 mL should be added to the vial.
  2. Before reconstitution, the eluate may be adjusted to the correct radioactive concentration by dilution with preservative-free, non-bacteriostatic saline for injection.
  3. The use of technetium-99m solution complying with the specifications prescribed by the USP Monograph on Sodium Pertechnetate (99mTc) injection will yield a preparation of an appropriate quality.
  4. It is recommended that with proper shielding and equipment, the final formulation be tested for radiochemical purity. If radiochemical purity is not adequate, discard the finished drug.

DISPOSAL

Any unused portion of the Tc99m-labeled kit must be stored and disposed of in accordance with the conditions of NRC radioactive materials license pursuant to 10 CFR Parts 20 and 35 or equivalent conditions pursuant to Agreement state regulation, or other regulatory agency authorized to license the use of radionuclides.

The unlabeled residual materials may be discarded in ordinary trash, provided that the vials and syringes read background with an appropriate low-range survey meter. It is suggested that all identification labels be destroyed before discarding.

This reagent kit is approved for use by persons licensed by the Illinois Emergency Management Agency pursuant to 32 Ill. Code Adm. Section, Section 330.260(a) and 335.4010 or under equivalent licenses of the U.S. Nuclear Regulatory Commission, or an Agreement State.

Manufactured for:
GE Healthcare
Medi-Physics, Inc.
3350 North Ridge Avenue
Arlington Heights, IL 60004
1-800-633-4123 (Toll Free)

By:
GE Healthcare Ltd.
Little Chalfont, HP7 9NA, UK

GE and the GE Monogram are trademarks of General Electric Company.

43-4349H
L/2331/04

Revised February 2006

DMSA
dimercaptosuccinic acid injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17156-525
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dimercaptocuccinic Acid (Dimercaptocuccinic Acid) Dimercaptocuccinic Acid 1 mg
Inactive Ingredients
Ingredient Name Strength
Stannous Chloride Dihydrate 4.2 ug in 1
ascorbic acid 0.70 mg in 1
inositol 50.0 mg in 1
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:17156-525-01 5 VIAL (5 VIAL) in 1 BOX contains a VIAL
1 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (1 VIAL) in 1 VIAL This package is contained within the BOX (17156-525-01)
Labeler — GE Healthcare

Revised: 08/2007 GE Healthcare

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