Ultratag RBC KIT FOR THE PREPARATION OF TECHNETIUM TC 99M RED BLOOD CELLS CURIUM US LLC FDA Approved 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.
FunFoxMeds bottle
Applications
NDA019981

Drug Facts

Composition & Profile

Strengths
10 ml 50 mcg 96 mcg 105 mcg 3.67 mg 5.5 mg 0.47 mg 0.6 mg 0.6 ml 8.7 mg 32.5 mg 12 mg 1 ml
Quantities
6 ml 1 ml 10 ml 1 pack
Treats Conditions
Indications And Usage 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

Identifiers & Packaging

Container Type BOTTLE
Packaging

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.; PRINCIPAL DISPLAY PANEL 69945-068-10 Ultratag™ RBC (Kit for the Preparation of Technetium Tc 99m Red Blood Cells Injection) Sterile, non-pyrogenic. For intravenous use after drug preparation. Single-Dose Vial. Discard unused portion. See package insert for directions for use. Do not use sodium pertechnetate Tc 99m solutions containing an oxidizing agent. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Rx only LOT EXP. EACH KIT CONTAINS: 1 10 mL reaction vial containing stannous chloride, dihydrate (SnCl 2•2H 2 0) 50 mcg, minimum, stannous chloride, dihydrate (SnCl 2•2H 2 0) 96 mcg, theoretical, tin chloride (stannous, stannic) dihydrate, as stannous chloride, maximum dihydrate 105 mcg, 3.67 mg sodium citrate dihydrate, 5.5 mg anhydrous dextrose and 0.47 mg hydrochloric acid. The pH is adjusted to 7.1 to 7.2 with NaOH prior to lyophilization. 1 Syringe I Each 0.6 mL contains 0.6 mg sodium hypochlorite (NaOCl). NaOH may have been added for pH adjustment. The pH range of this solution is 11 to 13. Total volume: 0.6 mL. Protect from light. 1 Syringe II Each milliliter contains 8.7 mg citric acid monohydrate, 32.5 mg sodium citrate dihydrate and 12 mg anhydrous dextrose. The pH is adjusted to 4.5 to 5.5 with sodium citrate or citric acid as needed. Total volume: 1 mL. 2 Plastic Syringe Plunger Rods 2 Disposable Hypodermic Needles 1 Package Insert 1 Radioassay Information Label Manufactured by: Curium US LLC Maryland Heights, MO 63043 Made in USA A068K0 R02/2025 CURIUM TM image description

Package Descriptions
  • 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.
  • PRINCIPAL DISPLAY PANEL 69945-068-10 Ultratag™ RBC (Kit for the Preparation of Technetium Tc 99m Red Blood Cells Injection) Sterile, non-pyrogenic. For intravenous use after drug preparation. Single-Dose Vial. Discard unused portion. See package insert for directions for use. Do not use sodium pertechnetate Tc 99m solutions containing an oxidizing agent. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Rx only LOT EXP. EACH KIT CONTAINS: 1 10 mL reaction vial containing stannous chloride, dihydrate (SnCl 2•2H 2 0) 50 mcg, minimum, stannous chloride, dihydrate (SnCl 2•2H 2 0) 96 mcg, theoretical, tin chloride (stannous, stannic) dihydrate, as stannous chloride, maximum dihydrate 105 mcg, 3.67 mg sodium citrate dihydrate, 5.5 mg anhydrous dextrose and 0.47 mg hydrochloric acid. The pH is adjusted to 7.1 to 7.2 with NaOH prior to lyophilization. 1 Syringe I Each 0.6 mL contains 0.6 mg sodium hypochlorite (NaOCl). NaOH may have been added for pH adjustment. The pH range of this solution is 11 to 13. Total volume: 0.6 mL. Protect from light. 1 Syringe II Each milliliter contains 8.7 mg citric acid monohydrate, 32.5 mg sodium citrate dihydrate and 12 mg anhydrous dextrose. The pH is adjusted to 4.5 to 5.5 with sodium citrate or citric acid as needed. Total volume: 1 mL. 2 Plastic Syringe Plunger Rods 2 Disposable Hypodermic Needles 1 Package Insert 1 Radioassay Information Label Manufactured by: Curium US LLC Maryland Heights, MO 63043 Made in USA A068K0 R02/2025 CURIUM TM image description

Overview

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.

Indications & Usage

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 & 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.

Warnings & Precautions
WARNINGS None known.
Contraindications

None known.

Adverse Reactions

None known.

Storage & Handling

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.


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