ce the cap over the mouthpiece right away after use (See Figure 13).
Figure 13
How to clean your BEVESPI AEROSPHERE inhaler:
Clean the inhaler 1 time each week. It is very important to keep your inhaler clean so that medicine will not build-up and block the spray through the mouthpiece (See Figure 14).
Figure 14
Step 1: Take the canister out of the actuator (See Figure 15). Do not clean the canister or let it get wet.
Figure 15
Step 2: Take the cap off the mouthpiece.
Sep 3: Hold the actuator under the faucet and run warm water through it for about 30 seconds. Turn the actuator upside down and rinse the actuator again through the mouthpiece for about 30 seconds (See Figure 16).
Figure 16
Step 4: Shake off as much water from the actuator as you can.
Step 5: Look into the actuator and the mouthpiece to make sure any medicine build-up has been completely washed away. If there is any build-up, repeat Steps 3 through 5 in the section “How to clean your BEVESPI AEROSPHERE inhaler”.
Step 6: Let the actuator air-dry overnight (See Figure 17). Do not put the canister back into the actuator if it is still wet.
Figure 17
Step 7: When the actuator is dry, gently press the canister down in the actuator (See Figure 18). Do not press down too hard on the canister. This could cause a puff of medicine to be released.
Figure 18
Step 8: Re-prime your BEVESPI AEROSPHERE inhaler after each cleaning. To re-prime the inhaler, shake the inhaler well and press down on the center of the dose indicator 2 times to release a total of 2 puffs into the air away from your face. Your inhaler is now ready to use.
If you do not use your BEVESPI AEROSPHERE for more than 7 days, you will need to re-prime it before use.
To re-prime the inhaler, shake the inhaler well and press down on the center of the dose indicator 2 times to release a total of 2 puffs into the air away from your face. Your inhaler is now ready to use.
BEVESPI and BEVESPI AEROSPHERE are trademarks of the AstraZeneca group of companies.
©AstraZeneca 2016
Manufactured for:
AstraZeneca Pharmaceuticals LP,
Wilmington, DE 19850
By: Aventis Pharma LTD,
Holmes Chapel CW48BE,
United Kingdom
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: October 2016
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
NDC 0310-4600-12
Bevespi Aerosphere
9 mcg/4.8 mcg per inhalation
120 inhalations
for oral inhalation only
PRINCIPAL DISPLAY PANEL NDC 0310-4600-12 Bevespi Aerosphere 9 mcg/4.8 mcg per inhalation 120 inhalations for oral inhalation only
INGREDIENTS AND APPEARANCE
BEVESPI AEROSPHERE
glycopyrrolate and formoterol fumarate aerosol, metered
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0310-4600
Route of Administration RESPIRATORY (INHALATION)
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D) GLYCOPYRROLATE 9 ug
FORMOTEROL FUMARATE (UNII: W34SHF8J2K) (FORMOTEROL - UNII:5ZZ84GCW8B) FORMOTEROL FUMARATE 4.8 ug
INACTIVE INGREDIENTS
Ingredient Name Strength
1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE (UNII: 043IPI2M0K)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
NORFLURANE (UNII: DH9E53K1Y8)
PACKAGING
# Item Code Package |
