KIT FOR THE PREPARATION OF TECHNETIUM TC 99M-LABELED CARBON INHALATION AEROSOL

Other

Brand names: TECHNEGAS

Oral

Mechanism of Action

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.

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)

Contraindications

• 4 CONTRAINDICATIONS None. None (4)

FDA Warnings

5 WARNINGS AND PRECAUTIONS Decreased Oxygen Saturation: Monitor oxygen saturation with continuous pulse oximetry
1) Radiation Exposure Risk: Ensure safe handling and preparation procedures to protect patients and health care providers from unintentional radiation exposure
Patients with compromised respiratory function may be at increased risk for decreased oxygen saturation
2 Radiation Exposure Risk Technegas Aerosol contributes to a patient’s overall long-term cumulative radiation exposure

Known Side Effects

11 documented side effects by frequency

Drug Not Working

>10%

Fatigue

1-10%

Nausea

1-10%

Itching

1-10%

Vomiting

1-10%

Headache

1-10%

Diarrhea

1-10%

Falls

1-10%

Dizziness

1-10%

Rash

1-10%

Shortness of Breath

1-10%

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Formulations

Dosage Forms

Tablet

Route

Oral