technegas kit
technetium tc-99m labeled carbon · by cyclomedica
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Overview
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…
How to use
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…
Side effects
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…
Warnings
Important safety information
Decreased Oxygen Saturation: Monitor oxygen saturation with continuous pulse oximetry. If clinically indicated, allow patients to breathe room air throughout the procedure and consider administration of supplemental oxygen before and at any time during the procedure. (5.1) Radiation Exposure Risk: Ensure safe handling and preparation procedures to protect patients and health care providers from unintentional radiation exposure. (2.1, 5.2) 5.1 Decreased Oxygen Saturation Decrease in oxygen saturation may occur during or after the inhalation of Technegas Aerosol. Oxygen saturation nadirs as low as 60% have been reported in a published study [see Adverse Reactions (6.1)]. In an efficacy trial, 79% of patients received supplemental oxygen or had the flow of Technegas Aerosol interrupted. Patients with compromised respiratory function may be at increased risk for decreased oxygen saturation. Monitor oxygen saturation with continuous pulse oximetry. If clinically indicated, allow patients to breathe room air throughout the procedure and consider administration of supplemental oxygen before and at any time during the procedure. 5.2 Radiation Exposure Risk Technegas Aerosol contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling and preparation procedures to…
Dosage forms
AEROSOL
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Frequently asked questions
- What is Technegas Kit?
- 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…
Clinical content sourced from the FDA label via openFDA (U.S. FDA). Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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