A COPD medication delivery device option: an overview of the NEOHALER
|
|
- Andra Beasley
- 5 years ago
- Views:
Transcription
1 A COPD medication delivery device option: an overview of the NEOHALER 2017 Sunovion Pharmaceuticals Inc. All rights reserved 9/17 RESP019-17
2 Indication and Boxed Warning INDICATION ARCAPTA NEOHALER (indacaterol) is a long-acting beta 2 -adrenergic agonist (LABA), SEEBRI NEOHALER (glycopyrrolate) is an anticholinergic, and UTIBRON NEOHALER (indacaterol and glycopyrrolate) is a combination of indacaterol and glycopyrrolate; all are indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Important limitations: ARCAPTA NEOHALER and UTIBRON NEOHALER are not indicated to treat acute deteriorations of COPD and are not indicated to treat asthma. IMPORTANT SAFETY INFORMATION WARNING: ASTHMA-RELATED DEATH Long-acting beta 2 -adrenergic agonists (LABAs) increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of another LABA (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of all LABAs, including indacaterol, the active ingredient in ARCAPTA NEOHALER, and one of the active ingredients in UTIBRON NEOHALER. The safety and efficacy of ARCAPTA NEOHALER or of UTIBRON NEOHALER in patients with asthma have not been established. ARCAPTA NEOHALER and UTIBRON NEOHALER are not indicated for the treatment of asthma. Please see additional Important Safety Information for ARCAPTA NEOHALER, SEEBRI NEOHALER, and UTIBRON NEOHALER on slides of this presentation and accompanying full prescribing information, including BOXED WARNINGS. References: 1. UTIBRON NEOHALER [prescribing information]. 2. SEEBRI NEOHALER [prescribing information]. 3. ARCAPTA NEOHALER [prescribing information]. 2
3 Choosing an appropriate inhalation device is important in the treatment of chronic obstructive pulmonary disease (COPD) 1 For many patients, coordinated breathing can pose a challenge to therapy administration 2 Patients may unintentionally misuse or be nonadherent to COPD treatment, leading to less successful delivery of medication 2-5 According to the 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD): Incorrect inhalation technique, over time, is a major challenge to achieving COPD treatment goals 1 More than two-thirds of patients make at least 1 error using an inhalation device 1 The selection of inhalation device should depend on the patient s ability and preference 1 Note: NEOHALER is for use only with ARCAPTA, SEEBRI, and UTIBRON capsules. References: 1. Global Initiative for Chronic Obstructive Lung Disease (GOLD). 2017: Taffet GE, Donohue JF, Altman PR. Clin Interv Aging. 2014;9: Fulvio B, et al. Int J Chron Obstruct Pulmon Dis. 2015;10: Tashkin DP, et al. Respir Res. 2010;11(149): Restrepo RD, et al. Int J Chron Obstruct Pulmon Dis. 2008;3(3):
4 Inhalation device options for COPD medication delivery Metered-dose inhaler 1-3 Soft-mist inhaler 3 Small and portable Coordination of breathing and actuation required (coordinated breath) No drug preparation; device shaking required Short administration time (seconds) Small and portable Requires specific breathing technique (coordinated breath) Multiple steps for setup and maintenance Short administration time (seconds) Dry-powder inhaler 3-6 Small and portable Breath-actuated Pill insertion required with certain devices Short administration time (seconds) Jet nebulizer 3,7 Can vary in size and portability Tidal breathing (several breaths over time) Multiple steps for setup and maintenance Administration time up to 20 minutes References: 1. Restrepo RD et al. Int J Chron Obstruct Pulmon Dis. 2008;3(3): Tashkin DP. Int J Chron Obstruct Pulmon Dis. 2016;11: Dolovich MB et al. Chest. 2005;127(1): Lavorini F et al. Respir Med. 2008;102(4): Al-Showair RA et al. Respir Med. 2007;101(11): Virchow JC et al. Respir Med. 2008;102(1): Dhand R et al. COPD. 2012;9(1):
5 The NEOHALER device: a delivery option for your COPD patient population
6 Consider attributes of the NEOHALER device1-4 Breath-actuated Audiovisual feedback mechanisms Small and portable For representation purposes only, UTIBRON NEOHALER is shown. ARCAPTA capsules, SEEBRI capsules, and UTIBRON capsules must not be swallowed as the intended effects on the lungs will not be obtained. ARCAPTA capsules, SEEBRI capsules, and UTIBRON capsules are only for oral inhalation and should only be used with the NEOHALER device. References: 1. Tashkin DP. Int J Chron Obstruct Pulmon Dis. 2016;11: UTIBRON NEOHALER [prescribing information]. 3. SEEBRI NEOHALER [prescribing information]. 4. ARCAPTA NEOHALER [prescribing information]. 6
7 NEOHALER feedback mechanisms 1-3 The NEOHALER device allows patients to visualize whether there is any powder left in the capsule giving them the flexibility to inhale any remaining dose On inhalation, the capsule spins around in the chamber, producing a whirring noise. Patients are advised to open the NEOHALER device to ensure the capsule is empty. If any powder remains in the capsule, the patient should inhale the remaining powder. Most people are able to empty the capsule with 1 or 2 inhalations. IMPORTANT SAFETY INFORMATION All LABAs, including indacaterol, are contraindicated in patients with asthma without the use of a long-term asthma-control medication; ARCAPTA NEOHALER is also contraindicated in patients with a history of hypersensitivity to indacaterol or to any of the ingredients, and UTIBRON NEOHALER is contraindicated in patients with a history of hypersensitivity to indacaterol, glycopyrrolate, or to any of the ingredients. SEEBRI NEOHALER is contraindicated in patients with a hypersensitivity to glycopyrrolate or to any of the ingredients. References: 1. UTIBRON NEOHALER [prescribing information]. 2. SEEBRI NEOHALER [prescribing information]. 3. ARCAPTA NEOHALER [prescribing information]. 7
8 The 3 I's are an easy way for patients to remember the detailed instructions Always refer to the Instructions for Use for complete steps.1-3 Summary of the detailed steps: INSERT INHALE 1 UTIBRON or SEEBRI capsule twice daily for 24-hour bronchodilation 1 ARCAPTA capsule once daily for 24-hour bronchodilation Close the inhaler fully. You should hear a "click" as it fully closes Close the NEOHALER and press both piercing buttons together firmly to pierce the capsule, then fully release the buttons Distinct whirring sound during inhalation confirms the capsule is placed within the chamber correctly UTIBRON, SEEBRI, and ARCAPTA capsules are for oral inhalation only and should not be swallowed INSPECT Clear capsule design enables the patient to visualize whether there is any powder left in the capsule giving them the flexibility to inhale any remaining dose For representation purposes only, UTIBRON NEOHALER device and medication are shown. IMPORTANT SAFETY INFORMATION Immediate hypersensitivity reactions have been reported with ARCAPTA NEOHALER, SEEBRI NEOHALER, and UTIBRON NEOHALER. If signs occur, discontinue immediately and institute alternative therapy. ARCAPTA NEOHALER, SEEBRI NEOHALER, and UTIBRON NEOHALER should be used with caution in patients with severe hypersensitivity to milk proteins. References: 1. UTIBRON NEOHALER [prescribing information]. 2. SEEBRI NEOHALER [prescribing information]. 3. ARCAPTA NEOHALER [prescribing information]. 8
9 Summary Patient's ability to correctly take their COPD medication is important for selection of an appropriate device1 Choosing an appropriate inhalation device is important for COPD treatment goals1 The NEOHALER device was designed with patients needs in mind2-5 Breath actuated Provides audiovisual feedback mechanisms An easy way to remember the detailed instructions is to think of the 3 I's: Insert Inhale Inspect Small and portable IMPORTANT SAFETY INFORMATION ARCAPTA capsules, SEEBRI capsules, and UTIBRON capsules must not be swallowed as the intended effects on the lungs will not be obtained. ARCAPTA capsules, SEEBRI capsules, and UTIBRON capsules are only for oral inhalation and should only be used with the NEOHALER device. For representation purposes only, UTIBRON NEOHALER is shown. References: 1. Global Initiative for Chronic Obstructive Lung Disease (GOLD). 2017: Tashkin DP. Int J Chron Obstruct Pulmon Dis. 2016;11: UTIBRON NEOHALER [prescribing information]. 4. SEEBRI NEOHALER [prescribing information]. 5. ARCAPTA NEOHALER [prescribing information]. 9
10 Important Safety Information INDICATION ARCAPTA NEOHALER (indacaterol) is a long-acting beta 2 -adrenergic agonist (LABA), SEEBRI NEOHALER (glycopyrrolate) is an anticholinergic, and UTIBRON NEOHALER (indacaterol and glycopyrrolate) is a combination of indacaterol and glycopyrrolate; all are indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Important limitations: ARCAPTA NEOHALER and UTIBRON NEOHALER are not indicated to treat acute deteriorations of COPD and are not indicated to treat asthma. IMPORTANT SAFETY INFORMATION WARNING: ASTHMA-RELATED DEATH Long-acting beta 2 -adrenergic agonists (LABAs) increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of another LABA (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of all LABAs, including indacaterol, the active ingredient in ARCAPTA NEOHALER, and one of the active ingredients in UTIBRON NEOHALER. The safety and efficacy of ARCAPTA NEOHALER or of UTIBRON NEOHALER in patients with asthma have not been established. ARCAPTA NEOHALER and UTIBRON NEOHALER are not indicated for the treatment of asthma. 10
11 Important Safety Information (cont d) All LABAs, including indacaterol, are contraindicated in patients with asthma without the use of a long-term asthma-control medication; ARCAPTA NEOHALER is also contraindicated in patients with a history of hypersensitivity to indacaterol or to any of the ingredients, and UTIBRON NEOHALER is contraindicated in patients with a history of hypersensitivity to indacaterol, glycopyrrolate, or to any of the ingredients. SEEBRI NEOHALER is contraindicated in patients with a hypersensitivity to glycopyrrolate or to any of the ingredients. ARCAPTA NEOHALER, SEEBRI NEOHALER, or UTIBRON NEOHALER should not be initiated in patients with acutely deteriorating or potentially life-threatening episodes of COPD, or used as rescue therapy for acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting beta 2 -agonist. ARCAPTA NEOHALER or UTIBRON NEOHALER should not be used more often, at higher doses than recommended, or in conjunction with other medicines containing LABAs as an overdose may result. Patients who have been taking inhaled short-acting beta 2 -agonists on a regular basis should be instructed to discontinue their regular use and to use them only for symptomatic relief of acute respiratory symptoms. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Patients using ARCAPTA NEOHALER or UTIBRON NEOHALER should not use another medicine containing a LABA for any reason. Immediate hypersensitivity reactions have been reported with ARCAPTA NEOHALER, SEEBRI NEOHALER, and UTIBRON NEOHALER. If signs occur, discontinue immediately and institute alternative therapy. ARCAPTA NEOHALER, SEEBRI NEOHALER, and UTIBRON NEOHALER should be used with caution in patients with severe hypersensitivity to milk proteins. As with other inhaled medicines, ARCAPTA NEOHALER, SEEBRI NEOHALER, and UTIBRON NEOHALER can produce paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasm occurs following dosing with ARCAPTA NEOHALER, SEEBRI NEOHALER, or UTIBRON NEOHALER, it should be treated immediately with an inhaled, short-acting bronchodilator; ARCAPTA NEOHALER, SEEBRI NEOHALER, or UTIBRON NEOHALER should be discontinued immediately and alternative therapy instituted. 11
12 Important Safety Information (cont d) Indacaterol, like other beta 2 -adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, or symptoms. ARCAPTA NEOHALER or UTIBRON NEOHALER should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Beta 2 -adrenergic agonists may produce significant hypokalemia in some patients. As with other beta 2 -adrenergic agonists, indacaterol should be administered with extreme caution in patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or other drugs known to prolong the QTc interval because these agents may potentiate the action of adrenergic agonists on the cardiovascular system. As with other beta 2 -adrenergic agonists, ARCAPTA NEOHALER and UTIBRON NEOHALER should be used with caution in patients treated with additional adrenergic drugs, non-potassium-sparing diuretics, and beta-blockers. ARCAPTA NEOHALER and UTIBRON NEOHALER, like all medicines containing sympathomimetic amines, should be used with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines. SEEBRI NEOHALER or UTIBRON NEOHALER should be used with caution in patients with narrow-angle glaucoma and in patients with urinary retention. Prescribers and patients should be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema) and of urinary retention (e.g., difficulty passing urine, painful urination), especially in patients with prostatic hyperplasia or bladder-neck obstruction. Patients should be instructed to consult a physician immediately should any signs or symptoms develop. 12
13 Important Safety Information (cont d) In 6 clinical trials, 48% of ARCAPTA NEOHALER patients reported adverse reactions compared with 43% of placebo patients. The most common adverse events reported in 2% of patients taking ARCAPTA NEOHALER, and occurring more frequently than in patients taking placebo, were cough (6.5% vs 4.5%), nasopharyngitis (5.3% vs 2.7%), headache (5.1% vs 2.5%), nausea (2.4% vs 0.9%), and oropharyngeal pain (2.2% vs 0.7%). The most common serious adverse reactions of ARCAPTA NEOHALER patients were COPD exacerbation, pneumonia, angina pectoris, and atrial fibrillation, which occurred at similar rates across treatment groups. The most common adverse events reported in 1% of patients taking SEEBRI NEOHALER, and occurring more frequently than in patients taking placebo, were upper respiratory tract infection (3.4% vs 2.3%), nasopharyngitis (2.1% vs 1.9%), oropharyngeal pain (1.8% vs 1.2%), urinary tract infection (1.4% vs 1.3%), and sinusitis (1.4% vs 0.7%). The most common adverse events reported in 1% of patients taking UTIBRON NEOHALER, and occurring more frequently than in patients taking placebo, were nasopharyngitis (4.1% vs 1.8%), hypertension (2.0% vs 1.4%), back pain (1.8% vs 0.6%), and oropharyngeal pain (1.6% vs 1.2%). ARCAPTA capsules, SEEBRI capsules, and UTIBRON capsules must not be swallowed as the intended effects on the lungs will not be obtained. ARCAPTA capsules, SEEBRI capsules, and UTIBRON capsules are only for oral inhalation and should only be used with the NEOHALER device. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call FDA For additional information, please see accompanying full Prescribing Information, including BOXED WARNINGS and Medication Guides, for ARCAPTA NEOHALER and UTIBRON NEOHALER, and Patient Information for SEEBRI. 13
14 Thank you! UTIBRON,, SEEBRI, and are trademarks of Novartis AG, used under license. ARCAPTA,, and NEOHALER are registered trademarks of Novartis AG, used under license. SUNOVION and are registered trademarks of Sumitomo Dainippon Pharma Co., Ltd. Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon Pharma Co., Ltd. 14 9/17 RESP019-17
Utibron Neohaler. (indacaterol, glycopyrrolate) New Product Slideshow
Utibron Neohaler (indacaterol, glycopyrrolate) New Product Slideshow Introduction Brand name: Utibron Neohaler Generic name: Indacaterol, glycopyrrolate Pharmacological class: Long-acting beta2- agonist
More informationPharmacist Objectives. Pulmonary Update. Outline. Technician Objectives. GOLD Guidelines. COPD Diagnosis 9/22/2017
Pharmacist Objectives Pulmonary Update Patty Marshik, PharmD Associate Professor University of New Mexico College of Pharmacy pmarshik@salud.unm.edu Discuss the new Global Initiative for Chronic Obstructive
More informationDate of Birth: Phone: ( ) Gender: M F. City: State: Zip:
To apply for help in affording your Utibron Neohaler (indacaterol and glycopyrrolate) Inhalation Powder prescription, please mail completed application to: Sunovion Support Prescription Assistance Program
More informationUTIBRON NEOHALER (indacaterol and glycopyrrolate) Inhalation Powder for your COPD symptoms
UTIBRON NEOHALER (indacaterol and glycopyrrolate) Inhalation Powder for your COPD symptoms INDICATION UTIBRON NEOHALER (indacaterol and glycopyrrolate) is a combination of a long-acting beta2-adrenergic
More informationChronic obstructive pulmonary disease (COPD) is a progressive,
INFORMATION for the PHARMACIST This article was sponsored by Boehringer Ingelheim Pharmaceuticals, Inc. Improving Lung Function (FEV 1 ) in COPD Through Appropriate Counseling on Use of Inhaled Medications
More informationARCAPTA NEOHALER (indacaterol) inhalation powder; 75 mcg once daily CLINICAL HIGHLIGHTS
ARCAPTA NEOHALER (indacaterol) inhalation powder; 75 mcg once daily CLINICAL HIGHLIGHTS A long-acting beta 2 -adrenergic agonist (LABA) for the maintenance treatment of airfl ow obstruction in patients
More informationONBREZ BREEZHALER should only be used to treat COPD.
CONSUMER INFORMATION Pr ONBREZ BREEZHALER Indacaterol maleate This leaflet is part III of a three-part "Product Monograph" published when ONBREZ BREEZHALER was approved for sale in Canada and is designed
More informationMEDICATION GUIDE ANORO ELLIPTA
MEDICATION GUIDE ANORO ELLIPTA [a-nor oh e-lip-ta] (umeclidinium and vilanterol inhalation powder) for oral inhalation What is the most important information I should know about ANORO ELLIPTA? ANORO ELLIPTA
More informationComposition Each ml of Ventol solution for inhalation contains 5 mg Salbutamol (as sulphate).
VENTOL Composition Each ml of Ventol solution for inhalation contains 5 mg Salbutamol (as sulphate). Respiratory Solution Action Salbutamol is a short-acting, relatively selective beta2-adrenoceptor agonist.
More information14 41 minutes Vd 218 t ½ 22 to 70 Clearance hours Protein Binding 71%, active metabolite 42% Bioavailability 3%
Brand Name: Yupelri Generic Name: revefenacin Manufacturer: Mylan Drug Class: Anticholinergic Uses: Labeled Uses: inhalation solution for maintenance treatment of COPD 1 Unlabeled Uses: no off-label indications
More informationCOPD Respiratory Antimuscarinics Drug Class Monograph
Line of Business: Medi-Cal Effective Date: May 17, 2017 Revision Date: May 17, 2017 COPD Respiratory Antimuscarinics Drug Class Monograph This policy has been developed through review of medical literature,
More informationSummary of the risk management plan (RMP) for Duaklir Genuair (aclidinium / formoterol fumarate dihydrate)
EMA/605453/2014 Summary of the risk management plan (RMP) for Duaklir Genuair (aclidinium / formoterol fumarate dihydrate) This is a summary of the risk management plan (RMP) for Duaklir Genuair, which
More informationIPRAVENT Respules/Respirator solution (Ipratropium bromide)
Published on: 19 Sep 2014 IPRAVENT Respules/Respirator solution (Ipratropium bromide) Composition IPRAVENT Respules Each 2 ml contains: Ipratropium Bromide BP equivalent to Ipratropium Bromide (anhydrous)
More informationInitial U.S. Approval: 2013
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use BREO ELLIPTA safely and effectively. See full prescribing information for BREO ELLIPTA. BREO ELLIPTA
More informationPATIENT INFORMATION INCRUSE ELLIPTA
PATIENT INFORMATION INCRUSE ELLIPTA [IN-cruise e-lip-ta] (umeclidinium inhalation powder) for oral inhalation What is INCRUSE ELLIPTA? INCRUSE ELLIPTA is an anticholinergic medicine. Anticholinergic medicines
More informationDrug Monograph. Brand Name: Arcapta Neohaler. Generic Name: Indacaterol. Manufacturer¹,²: Novartis
Drug Monograph Brand Name: Arcapta Neohaler Generic Name: Indacaterol Manufacturer¹,²: Novartis Drug Class¹,²,³, : Beta2-Adrenergic Agonist, Long-Acting Uses: Labeled Uses¹,²,³, : Used for long-term maintenance
More informationQUANTITY LIMIT CRITERIA. BROVANA (arformoterol tartrate) SEREVENT DISKUS (salmeterol) STRIVERDI RESPIMAT (olodaterol)
Carelirst. +.V Family of health care plans DRUG CLASS COMBINATIONS QUANTITY LIMIT CRITERIA LONG ACTING BETA2-ADRENERGIC AGONIST, ORAL INHALATION BRAND NAME (generic) LONG-ACTING BETA2-ADRENERGIC AGONISTS:
More information*Sections or subsections omitted from the full prescribing information are not listed. FULL PRESCRIBING INFORMATION
1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SEEBRI NEOHALER safely and effectively. See full prescribing information for SEEBRI NEOHALER. SEEBRI
More informationReference ID:
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ARCAPTA NEOHALER safely and effectively. See full prescribing information for ARCAPTA NEOHALER. ARCAPTA
More informationWARNING: ASTHMA-RELATED DEATH
1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use UTIBRON NEOHALER safely and effectively. See full prescribing information for UTIBRON NEOHALER.
More informationULTIBRO BREEZHALER should only be used to treat COPD. ULTIBRO BREEZHALER should not be used to treat asthma.
PART III: CONSUMER INFORMATION Pr ULTIBRO BREEZHALER Indacaterol (as maleate)/glycopyrronium (as bromide) inhalation powder hard capsules Read this carefully before you start taking ULTIBRO BREEZHALER
More informationNEW ZEALAND DATA SHEET SEREVENT Accuhaler
NEW ZEALAND DATA SHEET SEREVENT Accuhaler Salmeterol xinafoate (50 mcg per inhalation) Presentation SEREVENT Accuhaler is a moulded plastic device containing a foil strip with 60 regularly placed blisters
More informationSee 17 for PATIENT COUNSELING INFORMATION and FDAapproved. Revised: 12/2017
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use BREO ELLIPTA safely and effectively. See full prescribing information for BREO ELLIPTA. BREO ELLIPTA
More informationhydrochloride) from the mouthpiece. PART III: CONSUMER INFORMATION
PART III: CONSUMER INFORMATION Pr Inspiolto Respimat Tiotropium (as Tiotropium Bromide Monohydrate) / Olodaterol (as Olodaterol Hydrochloride) Inhalation Solution Read this carefully before you start taking
More informationPACKAGE INSERT TEMPLATE FOR SALBUTAMOL TABLET & SALBUTAMOL SYRUP
PACKAGE INSERT TEMPLATE FOR SALBUTAMOL TABLET & SALBUTAMOL SYRUP Brand or Product Name [Product name] Tablet 2mg [Product name] Tablet 4mg [Product name] Syrup 2mg/5ml Name and Strength of Active Substance(s)
More informationLONHALA MAGNAIR may be the COPD treatment you ve been looking for
NEBULIZED COPD TREATMENT THAT LETS YOU PORTABLE, BATTERY- POWERED DEVICE LONHALA MAGNAIR may be the COPD treatment you ve been looking for Assembly required. COPD=chronic obstructive pulmonary disease.
More informationNEW ZEALAND DATA SHEET
NEW ZEALAND DATA SHEET NAME OF MEDICINE OXIS TURBUHALER Eformoterol fumarate dihydrate (6 µg per inhalation) PRESENTATION OXIS TURBUHALER is a multidose, inspiratory flow driven, metered dose, dry powder
More informationThe capsule shell contains hypromellose, purified water, carrageenan, potassium chloride and FDC Yellow 6 (110 Sunset Yellow FCF).
CONSUMER INFORMATION Pr SEEBRI BREEZHALER Glycopyrronium inhalation powder hard capsules This leaflet is part III of a three-part "Product Monograph" published when SEEBRI BREEZHALER was approved for sale
More informationASTHALIN Respirator Solution (Salbutamol sulphate)
Published on: 28 Jan 2016 ASTHALIN Respirator Solution (Salbutamol sulphate) Composition Each 1 ml contains: Salbutamol Sulphate IP equivalent to Salbutamol IP.. 5 mg Dosage Form Solution for inhalation
More informationPage 1 of 23. Reference ID:
1 HIGHLIGHTS OF PRESCRIBING INFORMATION 38 Paradoxical bronchospasm: Discontinue TUDORZA 2 39 PRESSAIR and consider other treatments if 3 These highlights do not include all the 40 paradoxical bronchospasm
More information7.2 Part VI.2 Elements for a Public Summary
7.2 Part VI.2 Elements for a Public Summary 7.2.1 Part VI.2.1 Overview of disease epidemiology Chronic obstructive pulmonary disease (COPD) is characterized by persistent airflow limitation that is usually
More informationTRELEGY ELLIPTA (fluticasone-umeclidinium-vilanterol) aerosol powder
TRELEGY ELLIPTA (fluticasone-umeclidinium-vilanterol) aerosol powder Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific
More informationPRODUCT INFOMATION APO-IPRATROPIUM SOLUTION
PRODUCT INFOMATION APO-IPRATROPIUM SOLUTION NAME OF THE MEDICINE Ipratropium bromide. Chemical Name: (1R,3r,5S,8r)-3-[[(2RS)-3-Hydroxy-2-phenylpropanoyl]oxy]-8-methyl-8-(1- methylethyl)-8-azoniabicyclo[3.2.1]octane
More informationYourC SECOND WIND A GUIDE FOR PATIENTS PRESCRIBED BROVANA
CATCH CH C Y YourC SECOND WIND A GUIDE FOR PATIENTS PRESCRIBED BROVANA Nebulized BROVANA (arformoterol tartrate) Inhalation Solution is a long-acting maintenance medication for COPD that may help control
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: Indacaterol/Glycopyrrolate (Utibron Neohaler) Reference Number: CP.PMN.147 Effective Date: 10.01.18 Last Review Date: 07.13.18 Line of Business: Oregon Health Plan Revision Log See Important
More informationIPRAVENT Rotacaps (Ipratropium bromide)
Published on: 10 Jul 2014 IPRAVENT Rotacaps (Ipratropium bromide) Composition IPRAVENT Rotacaps Each capsule contains: Ipratropium Bromide BP, equivalent to Ipratropium Bromide (anhydrous) 40 mcg Excipient..q.s.
More informationThe only COPD Triple Therapy delivered in a single daily inhalation. 1 Improvement in quality of life vs. ICS/LABA. 2
The only COPD Triple Therapy delivered in a single daily inhalation. 1 Improvement in quality of life vs. ICS/LABA. 2 Trelegy Ellipta is indicated for maintenance treatment in adult patients with moderate-to-severe
More informationIMPORTANT: PLEASE READ
IMPORTANT: PLEASE READ PART III: CONSUMER INFORMATION Pr Spiriva Respimat Tiotropium Bromide Monohydrate Inhalation Solution Read this carefully before you start taking SPIRIVA RESPIMAT and each time you
More informationPRODUCT MONOGRAPH. Indacaterol (as maleate)/glycopyrronium (as bromide) inhalation powder hard capsules. 110 mcg/50 mcg per capsule
PRODUCT MONOGRAPH Pr ULTIBRO BREEZHALER Indacaterol (as maleate)/glycopyrronium (as bromide) inhalation powder hard capsules 110 mcg/50 mcg per capsule ULTIBRO BREEZHALER capsules to be used only with
More informationASTHALIN Respules (Salbutamol sulphate)
Published on: 28 Jan 2016 ASTHALIN Respules (Salbutamol sulphate) Composition Each 2.5 ml respule contains: Salbutamol Sulphate IP equivalent to Salbutamol IP. 2.5 mg Normal saline solution.q.s. Dosage
More informationTIOVA Inhaler (Tiotropium bromide)
Published on: 18 Sep 2014 TIOVA Inhaler (Tiotropium bromide) Composition TIOVA Inhaler Each actuation delivers: Tiotropium Bromide Monohydrate IP equivalent to Tiotropium... 9 mcg Suspended in propellant
More informationSummary of risk management plan for Ulunar Breezhaler (Indacaterol/glycopyrronium)
Part VI: Summary of the risk management plan Summary of risk management plan for Ulunar Breezhaler (Indacaterol/glycopyrronium) This is a summary of the RMP for Ulunar Breezhaler. The RMP details important
More informationPATIENT INFORMATION BREO ELLIPTA
PATIENT INFORMATION BREO ELLIPTA [BRE-oh e-lip-ta] (fluticasone furoate and vilanterol inhalation powder) for oral inhalation What is BREO ELLIPTA? BREO ELLIPTA combines an inhaled corticosteroid (ICS)
More informationPART III: CONSUMER INFORMATION
PART III: CONSUMER INFORMATION Pr ANORO ELLIPTA umeclidinium (as bromide) and vilanterol (as trifenatate) dry powder for oral inhalation This leaflet is part III of a three-part "Product Monograph" published
More informationDOSAGE AND ADMINISTRATION For oral inhalation only. (2) once daily. (2)
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TRELEGY ELLIPTA safely and effectively. See full prescribing information for TRELEGY ELLIPTA. TRELEGY
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationCOMBIVENT UDV Product Monograph Page 35 of 39
PART III: CONSUMER INFORMATION Pr Combivent UDV Ipratropium Bromide (as Monohydrate) and Salbutamol (as Salbutamol Sulfate) Nebulizer Solution Read this carefully before you start taking COMBIVENT UDV
More informationPATIENT INFORMATION. ADVAIR DISKUS [AD vair DISK us] (fluticasone propionate and salmeterol inhalation powder) for oral inhalation
PATIENT INFORMATION ADVAIR DISKUS [AD vair DISK us] (fluticasone propionate and salmeterol inhalation powder) for oral inhalation What is ADVAIR DISKUS? ADVAIR DISKUS combines the inhaled corticosteroid
More informationSEROBID Inhaler (Salmeterol xinafoate)
Published on: 10 Jul 2014 SEROBID Inhaler (Salmeterol xinafoate) Composition Each actuation delivers: Salmeterol (as Salmeterol Xinafoate IP) 25 mcg Suspended in propellant HFA 134a.....q.s. Dosage Form
More informationSummary of the risk management plan (RMP) for Laventair (umeclidinium bromide and vilanterol)
EMA/258177/2014 Summary of the risk management plan (RMP) for Laventair (umeclidinium bromide and vilanterol) This is a summary of the risk management plan (RMP) for Laventair, which details the measures
More informationBRICANYL INJECTION. terbutaline sulfate PRODUCT INFORMATION
BRICANYL INJECTION terbutaline sulfate PRODUCT INFORMATION NAME OF THE MEDICINE Terbutaline sulfate, 2-(tert-butylamino)-1-(3,5-dihydroxyphenyl) ethanol sulfate, a sympathomimetic bronchodilator with a
More informationInforMing the PAthway of COPD Treatment 1
InforMing the PAthway of COPD Treatment 1 A landmark trial in over 10,000 symptomatic COPD patients who had experienced at least one exacerbation in the last 12 months 1 (fluticasone furoate/umeclidinium/vilanterol)
More informationDeveloped By Name Signature Date
Patient Group Direction 2156 version 2.0 Administration of Ipratropium 250mcg/ml Nebuliser Solution in Acute Asthma by Registered Practitioners employed by Torbay and South Devon NHS Foundation Date of
More informationVENTOLIN RESPIRATOR SOLUTION
VENTOLIN RESPIRATOR SOLUTION Salbutamol QUALITATIVE AND QUANTITATIVE COMPOSITION VENTOLIN Respirator Solution contains 5mg salbutamol, as sulphate, per ml of solution and is supplied in 10 ml bottles.
More informationHIGHLIGHTS OF PRESCRIBING INFORMATION
US-17028 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SYMBICORT safely and effectively. See full prescribing information for SYMBICORT. SYMBICORT
More informationRECENT MAJOR CHANGES
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TRELEGY ELLIPTA safely and effectively. See full prescribing information for TRELEGY ELLIPTA. TRELEGY
More informationMedical Directive. Activation Date: April 24, 2013 Review due by: December 1, Medical Director: Date: December 1, 2017
Medical Directive Pre and Post Bronchodilator Spirometry Testing and Treatment Initiation Assigned Number: Activation Date: April 24, 2013 Review due by: December 1, 2019 23 Approval Signature & Date Medical
More informationSee 17 for PATIENT COUNSELING INFORMATION and FDAapproved. Revised: 12/2017
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ADVAIR DISKUS safely and effectively. See full prescribing information for ADVAIR DISKUS. ADVAIR
More informationTHE CHALLENGES OF COPD MANAGEMENT IN PRIMARY CARE An Expert Roundtable
THE CHALLENGES OF COPD MANAGEMENT IN PRIMARY CARE An Expert Roundtable This activity is supported by an educational grant from Sunovion Pharmaceuticals Inc. COPD in the United States Third leading cause
More informationyour breathing problems worsen quickly. you use your rescue inhaler, but it does not relieve your breathing problems.
MEDICATION GUIDE ADVAIR DISKUS [ad vair disk us] (fluticasone propionate and salmeterol inhalation powder) for oral inhalation What is the most important information I should know about ADVAIR DISKUS?
More informationLong-acting bronchodilators: their properties and place in treatment
Long-acting bronchodilators: their properties and place in treatment Steve Chaplin MSc, MRPharmS and Paul Walker BMedSci (Hons), MD, FRCP Steve Chaplin and Dr Paul KEY POINTS Walker provide an overview
More informationSalapin: Salbutamol BP 2mg as sulphate in each 5mL of a raspberry cola flavoured, sugar free syrup.
Salapin Salbutamol Syrup 2mg/5mL Qualitative and quantitative composition Salapin: Salbutamol BP 2mg as sulphate in each 5mL of a raspberry cola flavoured, sugar free syrup. Clinical particulars Therapeutic
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: Reference Number: CP.PMN.69 Effective Date: 11/15 Last Review Date: 08/17 Line of Business: Medicaid Revision Log See Important Reminder at the end of this policy for important regulatory
More informationSTRIVERDI RESPIMAT (olodaterol) Inhalation Spray FOR ORAL INHALATION Initial U.S. Approval: 2014
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use STRIVERDI RESPIMAT safely and effectively. See full prescribing information for STRIVERDI RESPIMAT.
More informationPART III: CONSUMER INFORMATION
PART III: CONSUMER INFORMATION Pr ANORO ELLIPTA umeclidinium (as bromide) and vilanterol (as trifenatate) dry powder for oral inhalation This leaflet is part III of a three-part "Product Monograph" published
More informationDUOLIN Rotacaps (Levosalbutamol sulphate + Ipratropium bromide)
Published on: 19 Sep 2014 DUOLIN Rotacaps (Levosalbutamol sulphate + Ipratropium bromide) Composition DUOLIN Rotacaps Each capsule contains: Levosalbutamol sulphate 100 mcg Ipratropium bromide.. 40 mcg
More informationANORO ELLIPTA (umeclidinium and vilanterol inhalation powder), for oral inhalation Initial U.S. Approval: 2013
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ANORO ELLIPTA safely and effectively. See full prescribing information for ANORO ELLIPTA. ANORO ELLIPTA
More informationAIRDUO RESPICLICK (fluticasone-salmeterol) aerosol DULERA (mometasone furoate and formoterol fumarate dihydrate) aerosol
DULERA (mometasone furoate and formoterol fumarate dihydrate) aerosol Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific
More informationOXIS TURBUHALER 4.5 µg/dose and 9 µg/dose ASTRAZENECA
10-14 OXIS TURBUHALER 4.5 µg/dose and 9 µg/dose ASTRAZENECA formoterol fumarate dihydrate Inhalation powder Composition Each delivered dose (i.e. the dose leaving the mouthpiece) from Oxis Turbuhaler contains
More informationNew Drug Update April 2016
New Drug Update 2015-16 April 2016 C. Wayne Weart, Pharm D, FASHP, FAPhA, BCPS Professor of Clinical Pharmacy and Outcome Sciences South Carolina College of Pharmacy Professor of Family Medicine Medical
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Seebri Neohaler) Reference Number: CP.CPA.150 Effective Date: 11.16.16 Last Review Date: 11.17 Line of Business: Commercial Revision Log See Important Reminder at the end of this policy
More informationPresented by UIC College of Nursing
Presented by UIC College of Nursing Describe COPD. Identify red flags for a COPD exacerbation. Identify COPD triggers or risk factors. Differentiate between long-acting inhalers and emergency use inhalers.
More informationChronic Obstructive Pulmonary Disease 1/18/2018
Presented by UIC College of Nursing Describe COPD. Identify red flags for a COPD exacerbation. Identify COPD triggers or risk factors. Differentiate between long acting inhalers and emergency use inhalers.
More informationPRODUCT MONOGRAPH. fluticasone furoate/vilanterol (as trifenatate) dry powder for oral inhalation 100 mcg/25 mcg 200 mcg/25 mcg
PRODUCT MONOGRAPH PrBREO ELLIPTA fluticasone furoate/vilanterol (as trifenatate) dry powder for oral inhalation 100 mcg/25 mcg 200 mcg/25 mcg Inhaled Corticosteroid (ICS) and Bronchodilator (Long-Acting
More informationPRODUCT INFORMATION. IPRAVENT Inhalation Solution Unit Dose NAME OF THE MEDICINE DESCRIPTION. Ipratropium Bromide BP
PRODUCT INFORMATION IPRAVENT Inhalation Solution Unit Dose NAME OF THE MEDICINE Ipratropium Bromide BP Ipratropium bromide is a quaternary isopropyl derivative of atropine. Its chemical name is (1R, 3r,
More informationBetter Living with Obstructive Pulmonary Disease A Patient Guide
Better Living with Obstructive Pulmonary Disease A Patient Guide Second Edition November 2012 Queensland Health a Better Living with Chronic Obstructive Pulmonary Disease A Patient Guide is a joint project
More information*Sections or subsections omitted from the full prescribing information are not listed.
1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LONHALA MAGNAIR safely and effectively. See full prescribing information for LONHALA MAGNAIR. LONHALA
More informationSummary of the risk management plan (RMP) for DuoResp Spiromax (budesonide / formoterol)
EMA/126654/2014 Summary of the risk management plan (RMP) for DuoResp Spiromax (budesonide / formoterol) This is a summary of the risk management plan (RMP) for DuoResp Spiromax, which details the measures
More informationCOPD. Breathing Made Easier
COPD Breathing Made Easier Catherine E. Cooke, PharmD, BCPS, PAHM Independent Consultant, PosiHleath Clinical Associate Professor, University of Maryland School of Pharmacy This program has been brought
More informationNovember Corporate Presentation 2017 INNOVIVA
November 2017 Corporate Presentation Forward-Looking Statements This presentation contains certain forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of
More informationHistory & Development
RSPT 2317 Anticholinergic Bronchodilators () History & Development Prototypical parasympatholytic agent is atropine an alkaloid found naturally in the plants Atropa belladona (nightshade) and Datura species
More informationPRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr TRELEGY ELLIPTA fluticasone furoate/umeclidinium (as bromide)/vilanterol (as trifenatate), dry powder for oral inhalation 100/62.5/25 mcg Inhaled
More informationIMPORTANT: PLEASE READ PART III: CONSUMER INFORMATION
IMPORTANT: PLEASE READ PART III: CONSUMER INFORMATION DUAKLIR GENUAIR aclidinium bromide/ formoterol fumarate dihydrate inhalation powder This leaflet is part III of a three-part "Product Monograph" published
More informationMEDICATION GUIDE. ADVAIR [ad vair] HFA 45/21 (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol
MEDICATION GUIDE ADVAIR [ad vair] HFA 45/21 (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol ADVAIR HFA 115/21 (fluticasone propionate 115 mcg and salmeterol 21 mcg) Inhalation
More informationReference ID:
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use STRIVERDI RESPIMAT safely and effectively. See full prescribing information for STRIVERDI RESPIMAT.
More informationThe legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 15 December 2010
The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 15 December 2010 HIROBRIZ BREEZHALER 150 micrograms, inhalation powder, hard capsules B/10 with inhaler (CIP code:
More informationUsing an Inhaler and Nebulizer
Using an Inhaler and Nebulizer Introduction An inhaler is a handheld device that is used to deliver medication directly to your airways. A nebulizer is an electric or battery powered machine that turns
More informationSupplementary materials
Supplementary materials Table S1 Patient comorbidities by diagnosis Total Asthma n (%) 5348 (148.4) COPD n (%) 4563 (143.4) ACOS n (%) 469 (197.9) No other comorbidities 95 (26.4) 614 (19.3) 27 (11.4)
More informationWhat is the current cost of COPD (Chronic Obstructive Pulmonary Disease) therapies?
What is the current cost of COPD (Chronic Obstructive Pulmonary Disease) therapies? Medicines in the COPD Ellipta portfolio are highlighted in orange on the graph below: Incruse Ellipta (umeclidinium)
More informationPRODUCT INFORMATION VENTOLIN DISKS
PRODUCT INFORMATION VENTOLIN DISKS APPROVED NAME: Salbutamol sulphate B.P. PHYSICAL AND CHEMICAL CHARACTERISTICS: Salbutamol sulphate is a white or almost white odourless powder. It is soluble in 4 parts
More informationSERETIDE EVOHALER. Salmeterol/fluticasone propionate
Abbreviated Prescribing Information based on the International Prescribing Information and prepared to meet the requirements of the GSK International Pharmaceutical Promotional and Marketing Policy. SERETIDE
More informationCOMBIVENT Metered Aerosol Boehringer
COMBIVENT Metered Aerosol Boehringer Composition 1 metered dose contains: (8r)-3*-Hydroxy-8-isopropyl-1*,5*-tropanium bromide (±)-tropate monohydrate (= ipratropium bromide monohydrate) 21 mcg equivalent
More informationCOPD: Treatment Update Property of Presenter. Not for Reproduction. Barry Make, MD Professor of Medicine National Jewish Health
COPD: Treatment Update Barry Make, MD Professor of Medicine National Jewish Health Disclosures Advisory board, consultant, multi-center trial, research funding, Data Safety Monitoring Board (DSMB), or
More informationNEW ZEALAND DATA SHEET
1. PRODUCT NAME Sudomyl, Tablet, 60 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Name and strength of the active substance Pseudoephedrine Hydrochloride 60mg Excipient(s) with known effect For the full
More information3. Identify the importance in the prehospital setting for the administration of nebulized bronchodilator.
TERMINAL OBJECTIVE At the end of this lesson, the EMT-Basic will be able to utilize the assessment findings to formulate a field impression of bronchospasm and understand the administration of nebulized
More informationPART III: CONSUMER INFORMATION
PART III: CONSUMER INFORMATION Pr ANORO ELLIPTA umeclidinium (as bromide) and vilanterol (as trifenatate) dry powder for oral inhalation This leaflet is part III of a three-part "Product Monograph" published
More informationSTRIVERDI RESPIMAT (olodaterol hcl) aerosol
STRIVERDI RESPIMAT (olodaterol hcl) aerosol Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Pharmacy
More informationCore Safety Profile. Pharmaceutical form(s)/strength: Sterile eye drops 1%, 2% Date of FAR:
Core Safety Profile Active substance: Carteolol Pharmaceutical form(s)/strength: Sterile eye drops 1%, 2% P - RMS: SK/H/PSUR/0002/002 Date of FAR: 16.03.2012 4.1 THERAPEUTIC INDICATIONS Ocular hypertension
More information