Ultratag
Kit for the Preparation of Technetium Tc 99m Red Blood Cells · Kit
Uses
Technetium Tc 99m red blood cells are used for blood pool imaging, including cardiac first pass and gated equilibrium imaging and for detection of sites of gastrointestinal bleeding.
Dosage and administration
The Instructions for Preparation must be carefully followed for preparing technetium Tc 99m red blood cells using Ultratag™ RBC. The suggested dose range of technetium Tc 99m red blood cells in the average patient (70 kg) is 370 MBq (10 mCi) to 740 MBq (20 mCi). The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Aseptic procedures and a shielded syringe should be employed in preparing and withdrawing doses for administration to patients. The user should wear waterproof gloves during the administration procedure.
Contraindications
None known.
Warnings
None known.
Precautions
General The components of the kit are sterile and nonpyrogenic. It is essential that the user follow the directions carefully and adhere to strict aseptic procedures during preparation. The contents of the kit are intended only for use in the preparation of technetium Tc 99m red blood cells and are NOT to be administered directly to the patient. The contents of this kit are not radioactive. After sodium pertechnetate Tc 99m is added, however, adequate shielding of the final preparation must be maintained. Technetium Tc 99m red blood cells must be handled with care to ensure minimum radiation exposure to the patient, consistent with proper patient management, and to ensure minimum radiation exposure to occupational workers. The labeled red blood cells must be reinjected only into the patient from whom the blood was drawn. Nuclear medicine procedures involving withdrawal and reinjection of blood have the potential for transmission of blood borne pathogens. Procedures should be implemented to avoid administration errors and viral contamination of personnel during blood product labeling. A system of checks similar to the ones used for administering blood transfusions should be routine. Clinical trials were conducted with a variety of prescription and nonprescription medications and showed no significant effect on the in vitro labeling efficiency of Ultratag ™ RBC. Unlike stannous pyrophosphate red blood cell kits, heparinized patients (11) showed minimal interference with Ultratag™ RBC labeling efficiency (95% with heparin, 97% without heparin). It is recommended that the labeled red blood cells be administered within 30 minutes of preparation or as soon as possible thereafter. A small study showed that technetium Tc 99m red blood cells prepared with Ultratag™ RBC have equivalent in vivo labeling efficiency when administered both immediately after preparation (5 patients studied) and at 6 hours after preparation (6 patients studied) with a 24-hour labeling efficiency averaging 97% for both groups. Radiopharmaceuticals should be used only by physicians who are qualified by specific training in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides. Carcinogenesis, Mutagenesis, Impairment of Fertility No long term animal studies have been performed to evaluate carcinogenic or mutagenic potential or to determine the effects on male or female fertility. Pregnancy Animal reproduction studies have not been conducted with technetium Tc 99m red blood cells. It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Technetium Tc 99m red blood cells should be administered to a pregnant woman only if clearly needed. Ideally, examinations using radiopharmaceuticals, especially those elective in nature, of a woman of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses. Nursing Mothers Technetium Tc 99m is excreted in human milk during lactation. Therefore, formula feedings should be substituted for breast feeding. Pediatric Use Safety and efficacy in pediatric patients have not been established.
Side effects
None known.
Pregnancy
Pregnancy Animal reproduction studies have not been conducted with technetium Tc 99m red blood cells. It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Technetium Tc 99m red blood cells should be administered to a pregnant woman only if clearly needed. Ideally, examinations using radiopharmaceuticals, especially those elective in nature, of a woman of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses.
Pediatric use
Pediatric Use Safety and efficacy in pediatric patients have not been established.
Description
Ultratag ™ RBC (Kit for the Preparation of Technetium Tc 99m Red Blood Cells Injection) is a sterile, nonpyrogenic, diagnostic kit for the in vitro preparation of Technetium Tc 99m Red Blood Cells Injection. Each kit consists of three separate nonradioactive components: 1. A 10 milliliter reaction vial containing: Stannous Chloride, Dihydrate (SnCl 2
• 2H 2 O) – 50 mcg minimum Stannous Chloride, Dihydrate (SnCl 2
• 2H 2 O) – 96 mcg theoretical Tin Chloride (Stannous and Stannic), Dihydrate (as SnCl 2
• 2H 2 O) – 105 mcg maximum Sodium Citrate, Dihydrate – 3.67 mg Dextrose, Anhydrous – 5.5 mg Hydrochloric Acid – 0.47 mg Prior to lyophilization, the pH is adjusted to 7.1 to 7.2 with sodium hydroxide. The contents of the vial are lyophilized and stored under argon. 2. Syringe I contains: Sodium Hypochlorite – 0.6 mg in Sterile Water for Injection The total volume of this syringe is 0.6 mL. Sodium hydroxide may have been added for pH adjustment. The pH of this solution is 11 to 13. The syringe must be protected from light to prevent degradation of the light-sensitive sodium hypochlorite. 3. Syringe II contains: Citric Acid, Monohydrate – 8.7 mg Sodium Citrate, Dihydrate – 32.5 mg Dextrose, Anhydrous – 12 mg in Sterile Water for Injection The total volume of this syringe is 1 mL. The pH range of this solution is adjusted to 4.5 to 5.5 with sodium citrate or citric acid as needed.
How supplied
Catalog Number 068. Ultratag™ RBC consists of three separate nonradioactive components: 1. A 10 milliliter reaction vial containing: Stannous Chloride, Dihydrate (SnCl 2
• 2H 2 O) – 50 mcg minimum Stannous Chloride, Dihydrate (SnCl 2
• 2H 2 O) – 96 mcg theoretical Tin Chloride (Stannous and Stannic), Dihydrate (as SnCl 2
• 2H 2 O) – 105 mcg maximum Sodium Citrate, Dihydrate – 3.67 mg Dextrose, Anhydrous – 5.5 mg Hydrochloric Acid – 0.47 mg Prior to lyophilization, the pH is adjusted to 7.1 to 7.2 with sodium hydroxide. The contents of the vial are lyophilized and stored under argon. 2. Syringe I contains: Sodium Hypochlorite – 0.6 mg in Sterile Water for Injection The total volume of this syringe is 0.6 mL. Sodium hydroxide may have been added for pH adjustment. The pH of this solution is 11 to 13. The syringe must be protected from light to prevent degradation of the light-sensitive sodium hypochlorite. 3. Syringe II contains: Citric Acid, Monohydrate – 8.7 mg Sodium Citrate, Dihydrate – 32.5 mg Dextrose, Anhydrous – 12 mg in Sterile Water for Injection The total volume of this syringe is 1 mL. The pH range of this solution is adjusted to 4.5 to 5.5 with sodium citrate or citric acid as needed. Storage The kit should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Syringe I should be protected from light if not stored in the kit tray.
Storage
Storage The kit should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Syringe I should be protected from light if not stored in the kit tray.
Label text from the FDA structured product label by Curium US LLC (revised Jul 2, 2025). Long sections are shortened; the complete label is on DailyMed.
Ultratag NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 69945-068 | Kit | Curium US LLC | NDA |
Frequently asked questions
What is Ultratag used for?
Technetium Tc 99m red blood cells are used for blood pool imaging, including cardiac first pass and gated equilibrium imaging and for detection of sites of gastrointestinal bleeding.
What are the side effects of Ultratag?
None known. See the full label for the complete list.
Who makes Ultratag?
Ultratag is listed by 1 labeler in the FDA NDC directory, including Curium US LLC.