Budesonide Structural Formula (Image 01)
Breyna Aerosol, Metered
Product Images NDC 0378-7502
View Photos of Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 19 technical images submitted to the FDA as part of the official labeling for Breyna (NDC 0378-7502). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Mylan Pharmaceuticals Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.
Product Images & Figures Index
Formoterol Fumarate Dihydrate Structrual Formula (Image 02)
Figure 1 Mean Percent Change From Baseline In Pre-dose Fev1 Over 12 Weeks (study 1) (Image 03)
This looks like a table or chart related to a medical study investigating the percent change from baseline in predose FEV. It includes various treatments such as Budesonide/Formoterol and Budesonide administered via inhalation, as well as a placebo. However, the table is incomplete and missing important information such as the units of measurement or the specific outcomes of the study. Therefore, a useful description cannot be generated based solely on this information.*
Figure 2 Mean Percent Change From Baseline In Pre-dose Fev1 Over 12 Weeks (study 2) (Image 04)
This appears to be a table showing the percent change from baseline in predose FEV (a measure of lung function) for four different treatments (Budesonide/Formoterol 80/4.5 mcg, Budesonide 80 mcg, Formoterol 4.5 meq, and Placebo) over a 10-week period. The results suggest that Budesonide/Formoterol had a higher percent change from baseline in FEV compared to the other treatments. The dosages and frequency of inhalations are also provided.*
Figure 3 Mean Percent Change From Baseline In Fev1 On Day Of Randomization (study 1) (Image 05)
The text shows a table with data indicating the percent change from baseline in FEV over 12 hours. The data includes percentages ranging from 10 to 25, with some unidentified characters. The table compares the effects of different treatments, such as Budesonide/Formoterol 160/4.5 mcg, Budesonide 160 mcg, Formoterol 4.5 mcg, Budesonide 160 mcg + Formoterol 4.5 mcg, and Placebo.*
Figure 4 Mean Percent Change From Baseline In Fev1 At End Of Treatment (study 1) (Image 06)
Figure 5 Change From Baseline In Clinic-measured 1-hour Post-dose Fev1 Over 12 Weeks (efficacy And Safety Study In Patients 6 To Less Than 12 Years Of Age) (Image 07)
Figure 6 Mean Percent Change From Baseline In Pre-dose Fev1 Over 6 Months (study 1) (Image 08)
This is a table presenting the percent change from baseline in pre-dose FEV for various treatments including Budesonide/Formoterol 160/4.5 mcg, Budesonide 160 mcg, Formoterol 4.5 mcg, Budesonide 160 mcg + Formoterol 4.5 mcg, and Placebo. The table shows the results after 0, 1, 2, 4, and 6 months of treatment. The treatments involve two inhalations twice daily. The text also includes the trademark symbol for BudesonidelFormoterol MDI 160/4.5 mcg.*
Figure 7 Mean Percent Change From Baseline In 1-hour Post-dose Fev1 Over 6 Months (study 1) (Image 09)
This appears to be a clinical trial report comparing the effectiveness of different inhalation treatments (Budesonide/Formoterol, Budesonide, Formoterol, Budesonide + Form 4.5 mcg) versus a placebo on pulmonary function (FE) in patients with a certain condition for a period of 1 hour post-dose. The results are presented in a table, but without units of measurement or additional context, it is difficult to interpret the findings.*
Instructions For Use Figure 1 (Image 10)
This appears to be a list of different parts or components of a device, including a "Canister", "Inhaler", "Mouthpiece", "Counter", and "Mouthpiece Cover". It is unclear what specific device these parts belong to or what their functions are.*
Instructions For Use Figure 2 (Image 11)
Instructions For Use Figure 3 (Image 12)
Instructions For Use Figure 4 (Image 13)
Instructions For Use Figure 5 (Image 14)
Instructions For Use Counter Image 01 (Image 15)
Instructions For Use Counter Image 02 (Image 16)
Instructions For Use Counter Image 03 (Image 17)
Breyna Inhalation Aerosol 80 Mcg/4.5 Mcg Carton (Image 18)
This document appears to be a label and instructions for use of an inhalation aerosol medication named Breyena, containing the active ingredients budesonide and formoterol, in doses of 80 mcg/4.5 meg, for oral inhalation only. The document provides information such as dosage, proper storage, and disposal instructions. It also warns against storing the medication at temperatures above 120°F and advises to keep it out of the reach of children. There are additional details about the manufacturer, Mylan.*
Breyna Inhalation Aerosol 160 Mcg/4.5 Mcg Carton (Image 19)
BREYNA™ is an inhalation aerosol for oral inhalation only. It contains budesonide and formoterol fumarate dihydrate. One canister provides 120 inhalations. Each inhalation delivers 160 mcg of budesonide and 4.5 mcg of formoterol fumarate dihydrate. It is important to carefully read the accompanying patent information and instructions for use. The inhaler should be discarded after 120 inhalations or within 3 months of opening the foil pouch. It should be kept away from children and stored with the mouthpiece down. Mylan is the pharmaceutical manufacturer of BREYNA™.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
