Label: ULTRATAG RBC- technetium tc 99m-labeled red blood cells kit

Ultratag™ RBC (kit for the preparation of technetium Tc 99m-labeled red blood cells) is a sterile, nonpyrogenic, diagnostic kit for the in vitro preparation of technetium Tc 99m-labeled red blood cells.

Each kit consists of three separate nonradioactive components:

1. A 10 milliliter reaction vial containing:
   
   Stannous Chloride, Dihydrate (SnCl2•2H2O) – 50 ug minimum
   Stannous Chloride, Dihydrate (SnCl2•2H2O) – 96 ug theoretical
   Tin Chloride (Stannous and Stannic), Dihydrate (as SnCl2•2H2O) – 105 ug maximum
   Sodium Citrate, Dihydrate – 3.67 mg
   Dextrose, Anhydrous – 5.50 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 InjectionThe 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 – 12.0 mg in Sterile Water for Injection

The total volume of this syringe is 1.0 mL. The pH range of this solution is adjusted to 4.5 to 5.5 with sodium citrate or citric acid.

Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours.1The principal photon that is useful for detection and imaging is listed in Table 1.

The specific gamma ray constant for technetium Tc 99m is 0.78 R/mCi-hr at 1 cm. The first half-value thickness of lead (Pb) for technetium Tc 99m is 0.017 cm. A range of values for the relative attenuation of the radiation emitted by this radionuclide resulting from the interposition of various thicknesses of lead (Pb) is presented in Table 2. For example, the use of 0.25 cm of lead will decrease the external radiation exposure by a factor of about 1000.

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

In vitro Tc 99m red blood cell labeling is accomplished by adding 1.0 to 3.0 milliliters of autologous whole blood, anticoagulated with heparin or Anticoagulant Citrate Dextrose Solution (ACD), to the reaction vial. A portion of the stannous ion in the reaction vial diffuses across the red blood cell membrane and accumulates intracellularly. The in vitro Tc 99m red blood cell labeling efficiency can decrease in the presence of excess ACD. Excess ACD apparently impairs the diffusion of stannous ion across the red blood cell membrane. Therefore, the ACD concentration used for blood collection should not exceed 0.15 mL ACD per mL of blood. Sodium hypochlorite is then added to the reaction vial to oxidize the extracellular stannous ion. Since the hypochlorite does not cross the red blood cell membrane, the oxidation of stannous ion is selective for the extracellular tin. A citric acid, sodium citrate and dextrose solution is then added to the reaction vial to sequester any residual extracellular stannous ion, rendering it more readily available for oxidation by sodium hypochlorite.

Radioactive labeling of the red blood cells is completed by addition of sodium pertechnetate Tc 99m to the oxidized reaction vial. The pertechnetate Tc 99m diffuses across the red blood cell membrane and is reduced by the intracellular stannous ion. The reduced technetium Tc 99m cannot diffuse out of the red blood cell. The red blood cell labeling is essentially complete within 20 minutes of sodium pertechnetate Tc 99m addition to the reaction vial. Red blood cell labeling efficiency of ≥95% is typically obtained using this in vitro labeling procedure. In vitro Tc 99m red blood cell labeling efficiency can decrease when excessive amounts of Tc 99 are allowed to accumulate in the sodium pertechnetate Tc 99m generator eluate; in this situation, efficiency decreases even further if excess (i.e. >0.15 mL per mL of blood) ACD buffer is used. Therefore, long Tc 99 in-growth times are to be avoided; the use of fresh (≤24 hour in-growth time) sodium pertechnetate Tc 99m generator eluate is recommended. After the labeling procedure is completed, the technetium Tc 99m-labeled red blood cells are then reinjected intravenously into the patient for gamma scintigraphic imaging.

Following intravenous injection, the technetium Tc 99m-labeled red blood cells distribute within the blood pool with an estimated volume of distribution of approximately 5.6% of bodyweight. The technetium Tc 99m is well retained in the blood pool with an estimated biological half-life of approximately 29 hours. Of the total technetium Tc 99m retained in the whole blood pool 24 hours after administration, 95% remains bound to the red blood cells. Approximately 25% of the injected dose is excreted in the urine in the first 24 hours.

Technetium Tc 99m-labeled 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.

None known.

None known.

None known.

The Instructions for Preparation must be carefully followed for preparing technetium Tc 99m-labeled red blood cells using Ultratag™ RBC.

The suggested dose range of technetium Tc 99m-labeled 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.

The estimated radiation doses to an average adult (70 Kg) from an intravenous injection of a maximum dose of 740 MBq (20 mCi) of technetium Tc 99m-labeled red blood cells are shown in Table 4.

These radiation absorbed dose values were calculated using the Medical Internal Radiation Dose (MIRD) Committee Schema.

Catalog Number 068.

Ultratag™ RBC consists of three separate nonradioactive components:

1. A 10 milliliter reaction vial containing:
   
   Stannous Chloride, Dihydrate (SnCl2•2H2O) – 50 ug minimum
   Stannous Chloride, Dihydrate (SnCl2•2H2O) – 96 ug theoretical
   Tin Chloride (Stannous and Stannic), Dihydrate (as SnCl2•2H2O) – 105 ug maximum
   Sodium Citrate, Dihydrate – 3.67 mg
   Dextrose, Anhydrous – 5.50 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 – 12.0 mg in Sterile Water for Injection

The total volume of this syringe is 1.0 mL. The pH range of this solution is adjusted to 4.5 to 5.5 with sodium citrate or citric acid.

1. The kit does not contain an anticoagulant. Therefore, a syringe or vacutainer™ tube treated with ACD or heparin must be used for drawing the patient's blood. The amount of ACD should not exceed 0.15 mL of ACD per mL of blood. The recommended amount of heparin is 10-15 units per mL of blood. Improperly anticoagulated blood will be unsuitable for reinjection.
2. If desired, the labeling yield determination can be carried out as follows:
   
   Transfer 0.2 mL of the technetium Tc99m labeled red blood cells to a centrifuge tube containing 2 mL of 0.9% NaCl. Centrifuge for five minutes and carefully pipet off the diluted plasma. Measure the radioactivity in the plasma and red blood cells separately in a suitable counter. Calculate labeling efficiency as follows:

This reagent kit is approved for distribution to persons licensed by the U.S. Nuclear Regulatory Commission to use byproduct material identified in Section 10 CFR 35.200 or under an equivalent license of an Agreement state.

Curium  and  the  Curium  logo  are  trademarks  of  a Curium company.
©2018 Curium US LLC. All Rights Reserved.

Manufactured by: Curium US LLC
Maryland Heights, MO 63043

Made in USA

A068I0

R12/2018

CURIUM™

Ultratag™ RBC

Kit for the Preparation of Technetium Tc 99m Labeled Red Blood Cells

Sterile, non-pyrogenic. For intravenous use after drug preparation.
See package insert for directions for use.
Do not use sodium pertechnetate Tc 99m solutions containing an oxidizing agent.
Store at controlled room temperature 20º-25°C (68º-77°F).
Protect from light. Rx only

EACH KIT CONTAINS:
1 10mL reaction vial containing stannous chloride, dihydrate (SnCl2•2H2O) 50 µg, minimum, stannous chloride, dihydrate (SnCl2•2H2O) 96 µg, theoretical, tin chloride (stannous, stannic) dihydrate, as stannous chloride, maximum dihydrate 105 µg, 3.67 mg sodium citrate dihydrate and 5.50 mg anhydrous dextrose. 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 12.0 mg anhydrous dextrose. The pH is adjusted to 4.5 to 5.5 with sodium citrate or citric acid. Total volume: 1.0 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

CURIUM™

A068K0

R12/2018