United States - English - NLM (National Library of Medicine)

teva respiratory, llc - albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e) - albuterol 90 ug - proair respiclick is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. proair respiclick is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older. proair respiclick is contraindicated in patients with a history of hypersensitivity to albuterol and/or severe hypersensitivity to milk proteins. rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate. there have been reports of anaphylactic reactions in patients using inhalation therapies containing lactose [see warnings and precautions (5.6)] . risk summary there are no randomized clinical studies of use of albuterol during pregnancy. available data from published epidemiological studies and postmarketing case reports of pregnancy outcomes following inhaled albuterol use do not consistently demonstrate a risk of major birth defects or miscarriage. there are clinical considerations with use of albuterol in pregnant women [see clinical considerations]. in animal reproduction studies, when albuterol sulfate was administered subcutaneously to pregnant mice there was evidence of cleft palate at less than and up to 9 times the maximum recommended human daily inhalation dose (mrhdid) [see data]. the estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. in the u.s. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk in women with poorly or moderately controlled asthma, there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. pregnant women should be closely monitored and medication adjusted as necessary to maintain optimal control. labor or delivery because of the potential for beta-agonist interference with uterine contractility, use of proair respiclick for relief of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk. proair respiclick has not been approved for the management of pre-term labor. serious adverse reactions, including pulmonary edema, have been reported during or following treatment of premature labor with beta2 -agonists, including albuterol. data animal data in a mouse reproduction study, subcutaneously administered albuterol sulfate produced cleft palate formation in 5 of 111 (4.5%) fetuses at an exposure nine-tenths the maximum recommended human dose (mrhdid) for adults (on a mg/m2 basis at a maternal dose of 0.25 mg/kg) and in 10 of 108 (9.3%) fetuses at approximately 9 times the mrhdid (on a mg/m2 basis at a maternal dose of 2.5 mg/kg). similar effects were not observed at approximately one-eleventh the mrhdid for adults (on a mg/m2 basis at a maternal dose of 0.025 mg/kg). cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated subcutaneously with isoproterenol (positive control). in a rabbit reproduction study, orally administered albuterol sulfate induced cranioschisis in 7 of 19 fetuses (37%) at approximately 750 times the mrhdid (on a mg/m2 basis at a maternal dose of 50 mg/kg). in a rat reproduction study, an albuterol sulfate/hfa-134a formulation administered by inhalation did not produce any teratogenic effects at exposures approximately 80 times the mrhdid (on a mg/m2 basis at a maternal dose of 10.5 mg/kg). a study in which pregnant rats were dosed with radiolabeled albuterol sulfate demonstrated that drug-related material is transferred from the maternal circulation to the fetus. risk summary there are no available data on the presence of albuterol in human milk, the effects on the breastfed child, or the effects on milk production. however, plasma levels of albuterol after inhaled therapeutic doses are low in humans, and if present in breast milk, albuterol has a low oral bioavailability [see clinical pharmacology (12.3)]. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for albuterol and any potential adverse effects on the breastfed child from albuterol or from the underlying maternal condition. the safety and effectiveness of proair respiclick for the treatment or prevention of bronchospasm with reversible obstructive airway disease have been established in pediatric patients 12 to 17 years of age. use of proair respiclick for this indication is supported by evidence from two 12-week clinical trials in 318 patients 12 years of age and older with asthma comparing doses of 180 mcg four times daily with placebo, one long-term safety study in children 12 years of age and older, and one single-dose crossover study comparing doses of 90 and 180 mcg with albuterol sulfate inhalation aerosol (proair® hfa) in 71 patients [see clinical studies (14.1)].   the safety and effectiveness of proair respiclick for treatment of exercise-induced bronchospasm have been established  in children 12 years of age and older. use of proair respiclick for this indication is supported by evidence from one single-dose crossover study in 38 patients age 16 and older with exercise-induced bronchospasm comparing doses of 180 mcg with placebo [see clinical studies (14.2)] . the safety profile for patients ages 12 to 17 was consistent with the overall safety profile seen in these studies. the safety of proair respiclick in children 4 to 11 years of age is based on two single-dose, controlled, crossover studies: one with 61 patients comparing doses of 90 and 180 mcg with matched placebo and albuterol hfa mdi and one with 15 patients comparing a dose of 180 mcg with matched albuterol hfa mdi; and one 3-week clinical trial in 185 patients 4 to 11 years of age with asthma comparing a dose of 180 mcg four times daily with matched albuterol hfa mdi. the effectiveness of proair respiclick in children 4 to 11 years with exercise-induced bronchospasm is extrapolated from clinical trials in patients 12 years of age and older with asthma and exercise-induced bronchospasm, based on data from a single-dose study comparing the bronchodilatory effect of proair respiclick 90 mcg and 180 mcg with placebo in 61 patients with asthma, and data from a 3-week clinical trial in 185 asthmatic children 4 to 11 years of age comparing a dose of 180 mcg albuterol 4 times daily with placebo [see clinical studies (14.1)] . the safety and effectiveness of proair respiclick in pediatric patients below the age of 4 years have not been established. clinical studies of proair respiclick did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. other reported clinical experience has not identified differences in responses between elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see warnings and precautions (5.4, 5.7)]. all beta2 -adrenergic agonists, including albuterol, are known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. proair® respiclick® (prō´ār res-pē-klik) (albuterol sulfate) inhalation powder your proair respiclick inhaler when you are ready to use proair respiclick for the first time, remove the proair respiclick inhaler from the foil pouch. there are 2 main parts of your proair respiclick inhaler including: - the white inhaler with the mouthpiece. see figure a. - the red cap that covers the mouthpiece of the inhaler. see figure a. there is a dose counter in the back of the inhaler with a viewing window that shows you how many doses of medicine you have left. see figure a . figure a - your proair respiclick inhaler contains 200 doses (inhalations). see figure b . - the dose counter shows the number of doses left in your inhaler. - when there are 20 doses left, the dose counter will change to red, and you should refill your prescription or ask your doctor for another prescription. - when the dose counter displays ‘0,’ your inhaler is empty, and you should stop using the inhaler and throw it away. see figure b . figure b important: - always close the cap after each inhalation so your inhaler will be ready for you to take your next dose . do not open the cap unless you are ready for your next dose. - you will hear a “click” sound when the cap is opened fully. if you do not hear the “click” sound the inhaler may not be activated to give you a dose of medicine. - proair respiclick does not have an activation button or medicine canister . when you open the cap, a dose of proair will be activated for delivery of the medicine. - in general, the technique for administering proair respiclick to children is similar to that for adults. children should use proair respiclick under adult supervision, as instructed by the patient’s physician. - do not use a spacer or volume holding chamber with proair respiclick. proair respiclick does not need priming. using your proair respiclick inhaler: important: make sure the red cap is closed before you start using your inhaler. step 1.  open - hold the inhaler upright and open the red cap fully until you feel and hear a “click”. see figure c . - each time you open the red cap and it “clicks”, a dose of proair respiclick is ready to be inhaled. figure c remember: - for the correct use of proair respiclick, hold the inhaler upright as you open the red cap. see figure d . - do not hold the inhaler in any other way as you open the red cap. - do not open the red cap until you are ready to take a dose of proair respiclick. figure d step 2. inhale - before you inhale, breathe out (exhale) through your mouth and push as much air from your lungs as you can. see figure e. - do not exhale into the inhaler mouthpiece. figure e - put the mouthpiece in your mouth and close your lips tightly around it. see figure f. figure f - do not block the vent above the mouthpiece with your lips or fingers. see figure g . figure g - breathe in quickly and deeply through your mouth, to deliver the dose of medicine to your lungs. - remove the inhaler from your mouth. - hold your breath for about 10 seconds or for as long as you comfortably can. - your proair respiclick inhaler delivers your dose of medicine as a very fine powder that you may or may not taste or feel. do not take an extra dose from the inhaler even if you do not taste or feel the medicine. step 3.  close figure h - close the red cap firmly over the mouthpiece. see figure h . - make sure you close the red cap after each inhalation so that the inhaler will be ready for your next dose. - if you need another dose close the red cap and then repeat steps 1-3. storing your proair respiclick inhaler - store proair respiclick at room temperature between 59°f and 77°f (15°c and 25°c). - avoid exposure to extreme heat, cold, or humidity. - keep the red cap on the inhaler closed during storage. - keep your proair respiclick inhaler dry and clean at all times. - do not wash or put any part of your proair respiclick inhaler in water.  replace your inhaler if washed or placed in water. - keep your proair respiclick inhaler and all medicines out of the reach of children. cleaning your proair respiclick inhaler - do not wash or put any part of your proair respiclick inhaler in water.  replace your inhaler if washed or placed in water. - proair respiclick contains a powder and must be kept clean and dry at all times. - if the mouthpiece needs cleaning, gently wipe it with a dry cloth or tissue. replacing your proair respiclick inhaler - the dose counter on the back of your inhaler shows how many doses you have left. do not try to change the numbers for the dose counter.  - when there are 20 doses left, the dose counter color will change to red, and you should refill your prescription or ask your doctor for another prescription. - when the dose counter displays ‘0’ your proair respiclick inhaler is empty, and you should stop using the inhaler and throw it away. - throw away your proair respiclick inhaler 13 months after removing it from the foil pouch for the first time, when the dose counter displays ‘0’, or after the expiration date on the package, whichever comes first. important information - do not open the red cap unless you are taking a dose. repeatedly opening and closing the cap without inhaling a dose will waste the medicine and may damage your inhaler. - your proair respiclick inhaler contains dry powder so it is important that you do not blow or breathe into it. - do not  take the inhaler apart. support - if you have any questions about proair respiclick or how to use your inhaler, go to www.proair.com or call 1-888-482-9522. this instructions for use has been approved by the u.s. food and drug administration. distributed by: teva pharmaceuticals usa, inc.  parsippany, nj 07054 ©2020 teva respiratory, llc. all rights reserved. prorifu-005 revised september 2020

United States - English - NLM (National Library of Medicine)

rebel distributors corp - albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e) - albuterol 90 ug - proair hfa inhalation aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. proair hfa inhalation aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older. proair hfa inhalation aerosol is contraindicated in patients with a history of hypersensitivity to albuterol and any other proair hfa inhalation aerosol components. rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate [see warnings and precautions (5.6 )] . teratogenic effects: pregnancy category c: there are no adequate and well-controlled studies of proair hfa inhalation aerosol or albuterol sulfate in pregnant women. during worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reported in the offspring of patients treated with albuterol. some of the mothers were tak

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e) - proair hfa inhalation aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. proair hfa inhalation aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older. proair hfa inhalation aerosol is contraindicated in patients with a history of hypersensitivity to albuterol and any other proair hfa inhalation aerosol components. rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate [see warnings and precautions (5.6) ] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medications during pregnancy. for more information, contact the mothers to baby pregnancy studies conducted by the organization of teratology information specialists at 1-877-311-8972 or visit http://mothert

United States - English - NLM (National Library of Medicine)

teva respiratory, llc - albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e) - proair® digihaler® is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. proair digihaler is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older. proair digihaler is contraindicated in patients with a history of hypersensitivity to albuterol and/or severe hypersensitivity to milk proteins. rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate. there have been reports of anaphylactic reactions in patients using inhalation therapies containing lactose [see warnings and precautions ( 5.6 )] . risk summary there are no randomized clinical studies of use of albuterol during pregnancy. available data from published epidemiological studies and postmarketing case reports of pregnancy outcomes following inhaled albuterol use do not consistently demonstrate a risk of major birth defects or miscarriage. there are clinical considerations with use of albuterol in pregnant women [see clinical considerations] . in animal reproduction studies, when albuterol sulfate was administered subcutaneously to pregnant mice there was evidence of cleft palate at less than and up to 9 times the maximum recommended human daily inhalation dose (mrhdid) [see data] . the estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. in the u.s. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk in women with poorly or moderately controlled asthma, there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. pregnant women should be closely monitored and medication adjusted as necessary to maintain optimal control. labor or delivery because of the potential for beta-agonist interference with uterine contractility, use of proair digihaler for relief of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk. proair digihaler has not been approved for the management of pre-term labor. serious adverse reactions, including pulmonary edema, have been reported during or following treatment of premature labor with beta2 -agonists, including albuterol. data animal data in a mouse reproduction study, subcutaneously administered albuterol sulfate produced cleft palate formation in 5 of 111 (4.5%) fetuses at an exposure nine-tenths the maximum recommended human dose (mrhdid) for adults (on a mg/m2 basis at a maternal dose of 0.25 mg/kg) and in 10 of 108 (9.3%) fetuses at approximately 9 times the mrhdid (on a mg/m2 basis at a maternal dose of 2.5 mg/kg). similar effects were not observed at approximately one-eleventh the mrhdid for adults (on a mg/m2 basis at a maternal dose of 0.025 mg/kg). cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated subcutaneously with isoproterenol (positive control). in a rabbit reproduction study, orally administered albuterol sulfate induced cranioschisis in 7 of 19 fetuses (37%) at approximately 750 times the mrhdid (on a mg/m2 basis at a maternal dose of 50 mg/kg). in a rat reproduction study, an albuterol sulfate/hfa-134a formulation administered by inhalation did not produce any teratogenic effects at exposures approximately 80 times the mrhdid (on a mg/m2 basis at a maternal dose of 10.5 mg/kg). a study in which pregnant rats were dosed with radiolabeled albuterol sulfate demonstrated that drug-related material is transferred from the maternal circulation to the fetus. risk summary there are no available data on the presence of albuterol in human milk, the effects on the breastfed child, or the effects on milk production. however, plasma levels of albuterol after inhaled therapeutic doses are low in humans, and if present in breast milk, albuterol has a low oral bioavailability [see clinical pharmacology (12.3)] . the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for proair digihaler and any potential adverse effects on the breastfed child from albuterol or from the underlying maternal condition. the safety and effectiveness of proair digihaler for the treatment or prevention of bronchospasm with reversible obstructive airway disease have been established in pediatric patients 12 to 17 years of age. use of proair digihaler for this indication is supported by evidence from two 12-week clinical trials in 318 patients 12 years of age and older with asthma comparing doses of 180 mcg four times daily with placebo, one long-term safety study in children 12 years of age and older, and one single-dose crossover study comparing doses of 90 and 180 mcg with albuterol sulfate inhalation aerosol (proair® hfa) in 71 patients [see clinical studies (14.1 )]. the safety and effectiveness of  proair digihaler for treatment of exercise-induced bronchospasm have been established in children 12 years of age and older. use of proair digihaler for this indication is supported from one single-dose crossover study in 38 patients age 16 and older with exercise-induced bronchospasm comparing doses of 180 mcg with placebo [see clinical studies (14.2 )] . the safety profile for patients ages 12 to 17 was consistent with the overall safety profile seen in these studies. the safety of proair digihaler in children 4 to 11 years of age is based on two single-dose, controlled, crossover studies: one with 61 patients comparing doses of 90 and 180 mcg with matched placebo and albuterol hfa mdi and one with 15 patients comparing a dose of 180 mcg with matched albuterol hfa mdi; and one 3‑week clinical trial in 185 patients 4 to 11 years of age with asthma comparing a dose of 180 mcg four times daily with matched albuterol hfa mdi. the effectiveness of  albuterol sulfate mdpi in children 4 to 11 years with exercise-induced bronchospasm is extrapolated from clinical trials in patients 12 years of age and older with asthma and exercise-induced bronchospasm, based on data from a single-dose study comparing the bronchodilatory effect of albuterol sulfate mdpi 90 mcg and 180 mcg with placebo in 61 patients with asthma, and data from a 3‑week clinical trial in 185 asthmatic children 4 to 11 years of age comparing a dose of 180 mcg albuterol 4 times daily with placebo [see clinical studies (14.1 )] . the safety and effectiveness of proair digihaler in pediatric patients below the age of 4 years have not been established. clinical studies of albuterol sulfate mdpi did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. other reported clinical experience has not identified differences in responses between elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see warnings and precautions (5.4, 5.7 )]. all beta2 -adrenergic agonists, including albuterol, are known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. proair® digihaler® (prō´ār  di´ji haye´´ler) (albuterol sulfate) inhalation powder   your proair digihaler inhaler when you are ready to use proair digihaler for the first time, remove the proair digihaler inhaler from the foil pouch. there are 3 main parts of your proair digihaler inhaler including: - the white inhaler with the mouthpiece. see figure a. - the red cap that covers the mouthpiece and vent of the inhaler. see figure a. - the electronic module. see figure a. there is an electronic module built into the top of the inhaler that records and stores information about inhaler events. the electronic module sends information through bluetooth® wireless technology to a mobile application (app). the electronic module does not control or interfere with delivery of the medicine through the inhaler. there is a dose counter in the back of the inhaler with a viewing window that shows you how many doses of medicine you have left. see figure a. figure a there is an electronic module built into the top of the inhaler that records and stores information about inhaler events. the electronic module sends information through bluetooth® wireless technology to a mobile application (app). the electronic module does not control or interfere with delivery of the medicine through the inhaler. there is a dose counter in the back of the inhaler with a viewing window that shows you how many doses of medicine you have left. see figure a. figure a - your proair digihaler inhaler contains 200 doses (inhalations). see figure b. - the dose counter shows the number of doses left in your inhaler. - when there are 20 doses left, the dose counter will change to red and you should refill your prescription or ask your doctor for another prescription. - when the dose counter displays ‘0’ your inhaler is empty and you should stop using the inhaler and throw it away. see figure b. figure b important: - always close the cap after each inhalation so your inhaler will be ready for you to take your next dose. do not open the cap unless you are ready for your next dose. - you will hear a “click” sound when the cap is opened fully. if you do not hear the “click” sound the inhaler may not be activated to give you a dose of medicine. - proair digihaler does not have an activation button or medicine canister. when you open the cap, a dose of proair digihaler will be activated for delivery of the medicine. - proair digihaler does not need to be wirelessly connected to the mobile application (app) in order for it to work and for you to take your medicine. - in general, the technique for administering proair digihaler to children is similar to that for adults. children should use proair digihaler under adult supervision, as instructed by the patient’s physician. - do not use a spacer or volume holding chamber with proair digihaler. proair digihaler does not need priming. using your proair digihaler inhaler: important: make sure the red cap is closed before you start using your inhaler.   step 1. open using your proair digihaler inhaler: important: make sure the red cap is closed before you start using your inhaler.   step 1. open - hold the inhaler upright and open the red cap fully until you feel and hear a “click”. see figure c . - each time you open the red cap and it “clicks”, a dose of proair digihaler is ready to be inhaled. figure c   remember: figure c   remember: - for the correct use of proair digihaler, hold the inhaler upright as you open the red cap. see figure d. - do not hold the inhaler in any other way as you open the red cap. - do not open the red cap until you are ready to take a dose of proair digihaler.   figure d step 2. inhale before you inhale, breathe out (exhale) through your mouth and push as much air from your lungs as you can. see figure e. do not exhale into the inhaler mouthpiece.     figure e     put the mouthpiece in your mouth and close your lips tightly around it. see figure f.   figure f do not block the vent above the mouthpiece with your lips or fingers. see figure g.   figure g     figure d step 2. inhale - before you inhale, breathe out (exhale) through your mouth and push as much air from your lungs as you can. see figure e. - do not exhale into the inhaler mouthpiece.     figure e         figure e     - put the mouthpiece in your mouth and close your lips tightly around it. see figure f.   figure f   figure f - do not block the vent above the mouthpiece with your lips or fingers. see figure g.   figure g     figure g   - breathe in quickly and deeply through your mouth, to deliver the dose of medicine to your lungs. - remove the inhaler from your mouth. - hold your breath for about 10 seconds or for as long as you comfortably can. - your proair digihaler inhaler delivers your dose of medicine as a very fine powder that you may or may not taste or feel. do not take an extra dose from the inhaler even if you do not taste or feel the medicine. step 3.  close figure h step 3.  close figure h - close the red cap firmly over the mouthpiece. see figure h. - make sure you close the red cap after each inhalation so that the inhaler will be ready for your next dose. - if you need another dose, close the red cap and then repeat steps 1-3. storing your  proair digihaler  inhaler - store proair digihaler at room temperature between 59ºf and 77ºf (15ºc and 25ºc). - avoid exposure to extreme heat, cold, or humidity. - keep the red cap on the inhaler closed during storage. - keep your proair digihaler inhaler dry and clean at all times. - do not wash or put any part of your proair digihaler inhaler in water. replace your inhaler if washed or placed in water. - keep your proair digihaler inhaler and all medicines out of the reach of children. cleaning your  proair digihaler  inhaler - do not wash or put any part of your proair digihaler inhaler in water.   replace your inhaler if washed or placed in water. - proair digihaler contains a powder and must be kept clean and dry at all times. - if the mouthpiece needs cleaning, gently wipe it with a dry cloth or tissue. replacing your  proair digihaler  inhaler - the dose counter on the back of your inhaler shows how many doses you have left. do not try to change the numbers for the dose counter. - when there are 20 doses left, the dose counter color will change to red and you should refill your prescription or ask your doctor for another prescription. - when the dose counter displays ‘0’ your proair digihaler inhaler is empty and you should stop using the inhaler and throw it away. - throw away your proair digihaler inhaler 13 months after removing it from the foil pouch for the first time, when the dose counter displays ‘0’, or after the expiration date on the package, whichever comes first. - proair digihaler contains a lithium – manganese dioxide battery and should be thrown away (disposed of) in accordance with state and local regulations. important information - do not open the red cap unless you are taking a dose. repeatedly opening and closing the cap without inhaling a dose will waste the medicine and may damage your inhaler. - your proair digihaler inhaler contains dry powder so it is important that you do not blow or breathe into it. - do not take the inhaler apart. support - for instructions on setting up the app, go to www.proairdigihaler.com or call teva at 1-888-603-0788. - if you have any questions about proair digihaler, how to use your inhaler, go to www.proairdigihaler.com or call 1-888-603-0788. this device complies with part 15 of the fcc rules. operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. changes or modifications not expressly approved by teva could void the user’s authority to operate the equipment. this instructions for use has been approved by the u.s. food and drug administration. the bluetooth ® word mark and logos are registered trademarks owned by the bluetooth sig, inc. and any use of such marks by teva respiratory, llc is under license. distributed by: teva pharmaceuticals usa, inc. parsippany, nj 07054 ©2020 teva respiratory, llc. all rights reserved. prodhifu-002 revised september 2020

Israel - English - Ministry of Health

novartis israel ltd - glycopyrronium as bromide; indacaterol as acetate; mometasone furoate - hard capsule - mometasone furoate 160 mcg; glycopyrronium as bromide 50 mcg; indacaterol as acetate 150 mcg - mometasone - enerzair breezhaler is indicated as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta2-agonist and an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year.important limitations of use:enerzair breezhaler is not indicated in patients with copd.

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - indacaterol acetate, quantity: 173 microgram (equivalent: indacaterol, qty 150 microgram); mometasone furoate, quantity: 160 microgram; glycopyrronium bromide, quantity: 63 microgram (equivalent: glycopyrronium, qty 50 microgram) - capsule, hard - excipient ingredients: lactose monohydrate; magnesium stearate - enerzair breezhaler is indicated as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta2-agonist and an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year.

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - glycopyrronium bromide, quantity: 63 microgram (equivalent: glycopyrronium, qty 50 microgram); mometasone furoate, quantity: 80 microgram; indacaterol acetate, quantity: 173 microgram (equivalent: indacaterol, qty 150 microgram) - capsule, hard - excipient ingredients: lactose monohydrate; magnesium stearate - enerzair breezhaler is indicated as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta2-agonist and an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

randlab australia pty ltd - clenbuterol hydrochloride - oral paste - clenbuterol hydrochloride anilide/aniline active 41.0 ug/ml - respiratory system - horse | colt | donkey | endurance horse | filly | foal | gelding | high performance horses | horses at stud | mare | pacer | pol - airways obstruction | pulmonary oedema

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

ecolab pty ltd - dodecylbenzene sulfonic acid; formic acid; sulfuric acid - suspension concentrate - dodecylbenzene sulfonic acid emulsifiers & surfactants active 63.0 g/l; formic acid r1 active 65.0 g/l; sulfuric acid mineral-sulfur-acid active 114.0 g/l - dairy cleanser - milk vat - auto wash - sanitiser

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

ecolab pty ltd - nitric acid; ortho phosphoric acid - aqueous concentrate - nitric acid acid-general active 370.0 g/l; ortho phosphoric acid mineral-phosphorus active 127.0 g/l - dairy cleanser - milk vat | bulk milk vat - bacterial prevention, cleansing or disin | disinfecting