Procedural Precautions

  * Perform all transfer and vial stopper entries using aseptic techniques.  

  * Wear waterproof gloves during the entire preparation procedure and during subsequent patient dose withdrawals from the PULMOTECH MAA vial.  

  * Make all transfers of Sodium Pertechnetate Tc 99m Injection during the preparation procedure with an adequately shielded syringe.  

  * Keep the prepared Technetium Tc 99m Albumin Aggregated Injection in the dispensing vial shield described below (with cap in place) during the useful life of the radioactive preparation. Make all withdrawals and injections of the Technetium Tc 99m Albumin Aggregated Injection with an adequately shielded syringe.



Procedure for the Preparation, Storage, and Handling of Technetium Tc 99m Albumin Aggregated Injection

  1. If PULMOTECH MAA reaction vials are stored in the refrigerator, remove a vial and allow the contents to come to room temperature for approximately 5 minutes.  

  2. Remove the protective cap from the reaction vial and swab the rubber septum with an alcohol swab or a suitable bacteriostatic agent to disinfect the surface.  

  3. Place the vial in a suitable dispensing vial shield fitted with a shielded cap.  

  4. Calculate the amount of Sodium Pertechnetate Tc 99m Injection (2 mL to 13 mL) to be added to the reaction vial. In choosing the amount of Sodium Pertechnetate Tc 99m Injection to be used in the preparation of Technetium Tc 99m Albumin Aggregated Injection ensure that the radioactive dose will contain the desired number of macroaggregated albumin (MAA) particles, while taking into account the number of patients, administered activity, and radioactive decay. The recommended maximum activity of Sodium Pertechnetate Tc 99m Injection to be added to the reaction vial is 6.85 GBq (185 mCi). Calculate the amount of radioactivity per vial required to be added to maintain the number of particles per dose within a recommended range, for adults 200,000 to 700,000 and for pediatric patients as per Table 1 [see Dosage and Administration (2.3, 2.4)].   

  5. After adding Sodium Pertechnetate Tc 99m Injection to the reaction vial in the dispensing vial shield (with cap in place), mix the contents by agitation and allow to stand for a minimum of 15 minutes at room temperature. During or prior to addition of Sodium Pertechnetate Tc 99m Injection do not vent the reaction vial. Once prepared the product will have a turbid white appearance.  

  6. Assay the product in a suitable dose calibrator and record the total activity of Technetium Tc 99m Albumin Aggregated Injection, total volume, number of MAA particles, radioactive concentration, time and date of preparation, onto the radioassay information label and attach it to the dispensing vial shield. 0.9% Sodium Chloride Injection, USP may be used as a diluent for the radiolabeled product to achieve the desired number of particles and radioactivity.  

  7. Prior to withdrawing a dose, gently agitate the contents of the radiolabeled PULMOTECH MAA vial to resuspend any settled technetium Tc 99m albumin aggregated particles. Failure to mix the reaction vial contents adequately before use may result in a non-homogenous suspension with a resulting non-uniform distribution of radioactivity in the lung. Since the vials contain nitrogen to prevent oxidation of the complex, the vials should not be vented. If repeated withdrawals are made from the vial, the contents should not be replaced with air.  

  8. Store the radiolabeled PULMOTECH MAA in the dispensing vial shield in a refrigerator at 2°C to 8°C (36°F to 46°F). Use within 18 hours from the time of radiolabeling. Dispose unused radiolabeled PULMOTECH MAA in compliance with appropriate regulations.