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.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action When the Technegas Aerosol particles are inhaled, they are mechanically deposited on the epithelium of ventilated pulmonary bronchioles and alveoli. Localization of the aerosol is not mediated by specific pharmacologic receptors; rather the distribution is determined by the aerodynamic function of the lungs. 12.2 Pharmacodynamics Technegas Aerosol has no known pharmacological effects. 12.3 Pharmacokinetics Distribution After inhalation, Technegas Aerosol is adsorbed on the walls of pulmonary bronchioles and alveoli. The distribution within the lungs is determined by the size and aerodynamic properties of the individual particles. Following inhalation, the particles are retained in the lung.
Indications
- 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...
Common Doses
- 95 %
- 1 mL
- 0.1 mL
- 0.12 mL
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.
Contraindications
- 4 CONTRAINDICATIONS None. None (4)
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...
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.