DMSA - GE Healthcare

R_x ONLY

DIAGNOSTIC - FOR INTRAVENOUS USE

Each vial contains a sterile, pyrogen-free freeze-dried mixture of 1.0 mg dimercaptosuccinic acid, 0.42 mg stannous chloride dihydrate [0.38 mg (minimum) stannous chloride dihydrate (SnCl₂•2H₂O) and 0.46 mg (maximum) total tin expressed as stannous chloride dihydrate (SnCl₂•2H₂O)], 0.70 mg ascorbic acid, and 50.0 mg inositol. After freeze-drying, vials are sealed under a nitrogen atmosphere with a rubber closure. Sodium hydroxide and hydrochloric acid have been used for pH adjustment. When sterile, oxidant-free, pyrogen-free sodium pertechnetate Tc99m injection in isotonic saline is combined with the vial contents, following the instructions provided with the kit, a complex is formed. After 10 minutes incubation the reconstituted solution is ready for intravenous injection.

Chemical Name: meso-2,3-dimercaptosuccinic acid

The succimer component of DMSA consists of more than 90% meso isomer and less than 10% d,l isomer.

Technetium Tc99m decays by isomeric transition with a physical half-life of 6.02 hours¹. The principal photon that is useful for detection and imaging studies is listed in Table 1.

The specific gamma ray constant for technetium Tc99m is 0.78 R/hr-mCi at 1 cm. The first half value layer is 0.017 cm of Pb. To facilitate control of the radiation exposure from millicurie amounts of this radionuclide, the use of a 0.25 cm thickness of Pb will attenuate the radiation emitted by a factor of about 1,000.

To correct for physical decay of this radionuclide, the fractions that remain at selected intervals after the time of calibration are shown in Table 3.

After intravenous administration, technetium Tc99m succimer injection is distributed in the plasma, apparently bound to plasma proteins. There is negligible activity in the red blood cells. The activity is cleared from the plasma with a half-time of about 60 minutes and concentrates in the renal cortex. Approximately 16% of the activity is excreted in the urine within two hours. At six hours about 20% of the dose is concentrated in each kidney.

DMSA is to be used as an aid in the scintigraphic evaluation of renal parenchymal disorders.

None known.

None.

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

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.

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

Kit Contents

• 5Vials 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•2H₂O) and 0.46 mg (maximum) total tin expressed as stannous chloride dihydrate (SnCl₂•2H₂O)], 0.70 mg ascorbic acid, and 50.0 mg inositol.
• 5Labels
• 1Package Insert

NDC 017156-525-01

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