HOW SUPPLIED/STORAGE AND HANDLING
AEROSPAN Inhalation Aerosol is supplied as a pressurized lined aluminum canister in boxes of one. Each canister is supplied with a two-piece plastic purple actuator and gray spacer assembly, and tear-off patient's instructions, including a Patient Information and an illustrated. Instructions for Using Your AEROSPAN Inhalation Aerosol.
The following canister sizes are available: 8.9 g net weight, providing 120 metered actuations (trade size, NDC 75989-550-12); 5.1 g net weight providing 60 metered actuations (hospital size, NDC 75989-550-63); 5.1 g net weight providing 60 metered actuations (professional sample, NDC 75989-550-06).
Prime the inhaler by releasing two test sprays into the air away from the face before first use of AEROSPAN Inhalation Aerosol, and when the inhaler has not been used for more than 2 weeks.
Instruct patients to prepare the inhaler for use by pulling the built-in purple actuator out from the gray spacer and snapping into an "L" shape prior to use.
The appearance of a white ring on the orifice of the actuator and inside the spacer is normal. The performance of AEROSPAN Inhalation Aerosol is not affected by this residue. No cleaning is required.
When not in use, keep AEROSPAN Inhalation Aerosol out of reach of children. Pediatric patients should only administer AEROSPAN Inhalation Aerosol under adult supervision.
The plastic purple actuator and gray spacer assembly supplied as part of AEROSPAN Inhalation Aerosol should not be used with any other product canisters; and the actuator from other products should not be used with an AEROSPAN Inhalation Aerosol canister. Do not separate the purple actuator from the gray spacer. Do not use this product with any external spacer or holding chamber devices.
The labeled amount of medication in each actuation (80 mcg flunisolide) cannot be assured after 120 metered actuations (or 60 metered actuations in the hospital and sample size canisters), even though the canister is not completely empty and will continue to operate. The inhaler (canister plus actuator) should be discarded when the labeled number of actuations have been used.
Avoid spraying in eyes.
Contents under pressure: Do not puncture. Do not use or store near heat or open flame. Protect from freezing temperatures and prolonged exposure to sunlight. Exposure to temperatures above 120°F (49°C) may cause bursting. Never throw into fire or incinerator.
Store at 25 °C (77 °F); excursions permitted to 15 to 30 °C (59 to 86 °F) [see USP Controlled Room Temperature]. For best results, the canister should be at room temperature before use.