TECHNEGAS
Kit for the preparation of technetium Tc 99m-labeled carbon inhalation aerosol · KIT · Cyclomedica Australia Pty Limited
TECHNEGAS is a kit containing kit for the preparation of technetium tc 99m-labeled carbon inhalation aerosol. Manufactured by Cyclomedica Australia Pty Limited.
Key Facts
- Brand Name
- TECHNEGAS
- Generic Name
- Kit for the preparation of technetium Tc 99m-labeled carbon inhalation aerosol
- NDC Code (Product)
73814-987- Manufacturer
- Cyclomedica Australia Pty Limited
- Dosage Form
- KIT
- Marketing Status
- Application #
- NDA022335
- Marketing Start
- 09/29/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 & 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…
Contraindications
4 CONTRAINDICATIONS None. None (4)
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 re…
Frequently Asked Questions
What is TECHNEGAS used for?
TECHNEGAS contains Kit for the preparation of technetium Tc 99m-labeled carbon inhalation aerosol. It is a kit taken as directed. Consult your doctor for specific uses.
Is TECHNEGAS a controlled substance?
TECHNEGAS is not classified as a controlled substance by the DEA.
What is the generic name for TECHNEGAS?
The generic name for TECHNEGAS is Kit for the preparation of technetium Tc 99m-labeled carbon inhalation aerosol. There are no other listed brand versions of Kit for the preparation of technetium Tc 99m-labeled carbon inhalation aerosol.
What is the NDC code for TECHNEGAS ?
The NDC (National Drug Code) for TECHNEGAS is 73814-987, listed by Cyclomedica Australia Pty Limited.
Other TECHNEGAS Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)