Kit For The Preparation Of Technetium Tc 99M-Labeled Carbon Inhalation Aerosol
FDA Drug Information • Also known as: Technegas
- Brand Names
- Technegas
- Dosage Form
- KIT
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 DESCRIPTION 11.1 Chemical Characteristics TECHNEGAS (kit for the preparation of technetium Tc 99m-labeled carbon inhalation aerosol) is a 1.25 gram black to dark grey graphite carbon crucible (Technegas Crucible). Graphite is a polymorph of the element carbon, appears opaque, and crystallizes in the hexagonal system. The crucible has the following appearance and physical dimensions: Table 3. Physical Dimensions of Crucible Length 31.25 to 32.75 mm Wall Thickness 0.39 to 0.81 mm Base Thickness 0.34 to 0.81 mm Maximum volume capacity 0.12 mL Technegas Crucible when used with sodium pertechnetate Tc 99m injection, USP in the Technegas Plus System (also commonly referred to as TechnegasPlus Technegas Generator or TP), provides technetium Tc 99m-labeled carbon inhalation aerosol in argon gas (Technegas Aerosol), a radioactive diagnostic agent for oral inhalation. During the process of formation of technetium Tc 99m-labeled carbon inhalation aerosol, when dried pertechnetate Tc 99m in Technegas Crucible is heated to 2,750°C (4,982°F) for 15 seconds in the TP using the Alternate Current arc, both the technetium and a portion of the carbon crucible are volatilized. The reduction of pertechnetate Tc 99m results in elemental technetium Tc 99m that serves as a nucleation site for the condensing of the volatile carbon, producing hydrophobic particles made up of a technetium Tc 99m core surrounded by layers of carbon. More than 90% of the technetium Tc 99m activity is technetium Tc 99m-labeled carbon particles. More than 80% of technetium Tc 99m carbon aerosol particles are < 0.92 micrometer in size. The technetium Tc 99m carbon particles are suspended in argon gas as an aerosol for inhalation. The concentration of carbon labeled particles in argon depends on the amount of technetium Tc 99m used but is less than 98 mcg/liter in Technegas Crucible loading of 0.1ml of Sodium Pertechnetate Tc99m. TECHNEGAS Crucible 11.2 Physical Characteristics Technetium-99m decays by...
What Is Kit For The Preparation Of Technetium Tc 99M-Labeled Carbon Inhalation Aerosol Used For?
1 INDICATIONS AND USAGE TECHNEGAS, when used with sodium pertechnetate Tc 99m in the Technegas Plus System, provides technetium Tc 99m-labeled carbon inhalation aerosol (Technegas Aerosol), for use in adults and pediatric patients aged 6 years and older for:
Dosage and Administration
2 DOSAGE AND ADMINISTRATION For adult patients, the recommended activity of sodium pertechnetate Tc 99m injection to be loaded in the Technegas Crucible is 400 MBq to 1,000 MBq (10.8 mCi to 27 mCi) to achieve a lung count rate between 1,500 counts per second (cps) and 2,500 cps at the end of the last respiration. (2.2) For pediatric patients aged 6 years and older, a sufficient amount of Technegas Aerosol should be inhaled to achieve between 500 cps and 1,000 cps at the end of last respiration. The radioactivity to be loaded in the Technegas Crucible is a fraction of the recommended activity for adults adjusted by body weight. (2.2) Administer as soon as possible following preparation and complete inhalation within 10 minutes of preparation. (2.2) For drug handling, breathing techniques, preparation, and dosimetry information, see the full prescribing information. (2.1, 2.3, 2.4, 2.5) 2.1 Radiation Safety-Drug Handling Handle Technegas Aerosol with appropriate safety measures to minimize radiation exposure to the patient and healthcare providers. During preparation and handling, use waterproof gloves and effective shielding [see Warnings and Precautions (5.2)]. Radiopharmaceuticals should be used by or under the control of healthcare providers who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. 2.2 Recommended Dose The activity present in the lungs after each inhalation varies. Follow the pulmonary count rate during oral inhalation of Technegas Aerosol, using a gamma camera equipped with a standard collimator (low energy, low/medium resolution). For adult patients, the recommended activity of sodium pertechnetate Tc 99m injection to be loaded in the Technegas Crucible is 400 MBq to 1,000 MBq (10.8 mCi to 27 mCi) to achieve a lung count rate between 1,500 counts per second (cps) and 2,500 cps at the end of the last respiration. Discontinue Technegas Aerosol administration at that point. For pediatric patients aged 6 years and older, a sufficient amount of Technegas Aerosol should be inhaled until a lung count rate is obtained between 500 cps and 1,000 cps at the end of last respiration. Discontinue administration at that point. The radioactivity to be loaded in the Technegas Crucible for pediatric patients aged 6 years and older is a fraction of the recommended activity for adults, and is adjusted by body weight as listed in Table 1. Table 1. Crucible Loading Activity of Sodium Pertechnetate Tc 99m Injection for Pediatric Patients Aged 6 Years and Older Weight (kg) Crucible Loading Activity MBq (mCi) 10 133 (3.6) 12 154 (4.2) 14 175 (4.7) 16 196 (5.3) 18 217 (5.9) 20 238 (6.4) 22 259 (7) 24 270 (7.6) 26 301 (8.1) 28 315 (8.5) 30 336 (9.1) 32 357 (9.7) 34 378 (10) 36 392 (11) 38 413 (11) 40 434 (12) 42 448 (12) 44 469 (13) 46 490 (13) 48 504 (14) 50 525 (14)...
Side Effects (Adverse Reactions)
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Decreased Oxygen Saturation [see Warnings and Precautions (5.1)] The most common adverse reaction (≥ 1%) was hypoxia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Cyclomedica Australia Pty Ltd at toll free phone number 1-888-8-586-4396 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of Technegas Aerosol was evaluated in 291 patients undergoing ventilation studies with prospective data collection. Patients received an amount of Technegas Aerosol to achieve 1,500 cps to 2,500 cps by oral inhalation. The mean age of patients was 60 years (range:18 to 95 years); distribution by race was 92 % White, 7% Black or African American, 0.3 % Asian, and 0.3 % unreported; and distribution by ethnicity was 4% Hispanic/Latino and 96 % non-Hispanic/Latino. Adverse reactions were reported in 10 patients (3.4%). The adverse reaction occurring at ≥ 1% in patients receiving Technegas Aerosol was hypoxia (1%). Adverse reactions reported at < 1% were dizziness, dysgeusia, cough, dyspnea [not otherwise specified], throat irritation, and upper respiratory tract congestion. In one published study, oxygen saturation was monitored in a series of patients undergoing Technegas Aerosol ventilation scintigraphy for suspected pulmonary embolism (n=28) or pulmonary disease (n=10). Of these 38 patients without pre-oxygenation, oxygen saturation fell to < 90% in 26 (68%) patients and < 85% in 15 (39%) patients. The recorded lowest value for each patient was usually observed after the first or second inhalation.
Contraindications
4 CONTRAINDICATIONS None. None (4)
Pregnancy and Breastfeeding
8.1 Pregnancy Risk Summary Available data with Technegas Aerosol use in pregnant women from several small retrospective studies are insufficient to evaluate for a drug associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. The radiation dose to the fetus after inhalation of Technegas Aerosol has ranged from 0.007 mGy to 0.14 mGy (see Data). Animal reproduction studies have not been conducted with Technegas Aerosol. However, all radiopharmaceuticals, including Technegas Aerosol have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. If considering Technetium Aerosol administration to a pregnant woman, inform the patient of the potential for adverse pregnancy outcomes based on the radiation dose from Technetium Aerosol and the gestational timing of exposure. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. Data Human Data The radiation dose to the fetus after inhalation of Technegas Aerosol was calculated according to the stage of gestation, ranging from 0.007 mGy at the early stage through 3-months of gestation up to 0.011 mGy to 0.14 mGy at 6-months and 9-months of gestation, respectively. No adverse fetal effects or radiation-related risks have been identified for diagnostic procedures involving less than 50 mGy, which represents less than 10 mGy fetal doses.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied TECHNEGAS (kit for the preparation of technetium Tc 99m-labeled carbon inhalation aerosol) is a 1.25 gram single-use black to dark grey oval shape graphite carbon crucible packaged into thermoformed blister packs. Each carton contains five blister packs of 10 single-use Technegas Crucibles (NDC 73814-986-20). The following components are supplied separately by Cyclomedica for the preparation of Technegas Aerosol: Patient Administration Sets (PAS) Technegas Contacts (replacement electrodes)
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.