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Kit For The Preparation Of Technetium Tc 99M Red Blood Cells

FDA Drug Information • Also known as: Ultratag Rbc

Brand Names
Ultratag Rbc
Dosage Form
KIT
Product Type
HUMAN PRESCRIPTION DRUG

Description

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.

    • What Is Kit For The Preparation Of Technetium Tc 99M Red Blood Cells Used For?

    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.

    Dosage and Administration

    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.

    Side Effects (Adverse Reactions)

    ADVERSE REACTIONS None known.

    Warnings and Precautions

    WARNINGS None known.

    Contraindications

    CONTRAINDICATIONS None known.

    Pregnancy and Breastfeeding

    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.

    How Supplied

    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.

    • About This Information

    This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

    What are side effects?

    Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

    What are drug interactions?

    Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.