Kit For The Preparation Of Technetium Tc 99m-labeled Carbon Inhalation Aerosol
Generic Name: kit for the preparation of technetium tc 99m-labeled carbon inhalation aerosol
Brand Names:
Technegas
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.
Overview
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.
Uses
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: • visualization of pulmonary ventilation • evaluation of pulmonary embolism when paired with perfusion imaging TECHNEGAS, when used with sodium pertechnetate Tc 99m in the Technegas Plus System, provides technetium Tc 99m-labeled carbon inhalation aerosol (Technegas Aerosol), a radioactive diagnostic agent for use in adults and pediatric patients aged 6 years and older for: • visualizationofpulmonaryventilation • evaluationofpulmonaryembolismwhenpairedwithperfusion imaging (1)
Dosage
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.
Side Effects
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.
Warnings
5 WARNINGS AND PRECAUTIONS 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)]. 4 CONTRAINDICATIONS None. None (4)
Pregnancy
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.
Storage
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).
Frequently Asked Questions
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: • visualization of pulmonary ventilation • evaluation of pulmonary embolism when paired with perfusion imaging TECHNEGAS, when used with sodium pertechnetate Tc 99m in the Technegas Plus System, provides technetium Tc 99m-labeled carbon inhalation aerosol (Technegas Aerosol), a radioactive diagnostic agent for use in adults and pediatric patients aged 6 years and older for: • visualizationofpulmonaryventilation • evaluationofpulmonaryembolismwhenpairedwithperfusion imaging (1)
What are the side effects of Kit For The Preparation Of Technetium Tc 99m-labeled Carbon Inhalation Aerosol?▼
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.
Can I take Kit For The Preparation Of Technetium Tc 99m-labeled Carbon Inhalation Aerosol during pregnancy?▼
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.
What are the important warnings for Kit For The Preparation Of Technetium Tc 99m-labeled Carbon Inhalation Aerosol?▼
5 WARNINGS AND PRECAUTIONS 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)]. 4 CONTRAINDICATIONS None. None (4)
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This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.