№ files_lp_3_process_9_44996
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Patient information leaflet outlining correct technique, common errors, maintenance guidance and follow-up schedule for the use of Spiromax inhalers in the management of asthma and chronic obstructive pulmonary disease.
Document type:
Patient information leaflet
Medical device:
Spiromax inhaler
Related conditions:
Asthma; Chronic obstructive pulmonary disease (COPD)
Examples of products:
DuoResp Spiromax; Aerivio Spiromax
Purpose:
Guidance on correct inhaler technique and maintenance
Reassessment interval:
3 months; 6 months; 12 months
Intended audience:
Patients prescribed Spiromax inhalers
Issuing context:
Healthcare professional instruction
Associated resource:
Online video demonstrations
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2026
Region / City:
International
Subject:
Respiratory health, inhaler use
Document type:
Patient instruction leaflet
Organization / Institution:
Healthcare providers / Spiromax manufacturer
Target audience:
Patients with asthma or COPD
Medication mentioned:
Spiromax inhaler
Common issues addressed:
Incorrect inhaler technique, dosage errors
Recommended actions:
Proper usage steps, cleaning, monitoring dose counter
Supplementary material:
Video demonstration link
Frequency of review:
At least annually
Year:
2024
Region / City:
Ramsey County, Minnesota
Topic:
Transition Process for PCA/CSG to CFSS
Document Type:
Workflow Process
Organization:
Ramsey County
Author:
Chakita Lewis
Target Audience:
Case Managers, CFSS Team, Consultation Providers
Period of Validity:
October 1, 2024 – September 30, 2025
Approval Date:
9/29/2024
Revision Date:
9/29/2024
Year:
2026
Region / City:
United Kingdom
Topic:
Undergraduate Program Regulations
Document Type:
Academic Programme Guidelines
Institution:
Various Universities in the UK
Author:
Not specified
Target Audience:
Students enrolled in specific undergraduate healthcare programs
Period of validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2009
Agency:
Maternal and Child Health Bureau
Parent Organization:
Office of Management and Budget
OMB Clearance Number:
0915-0298
Subject:
Burden reassessment of the Discretionary Grant Information System
Document Type:
Administrative report
Geographic Scope:
United States
Sample Size:
9 grantees
Data Collection Method:
Annual time estimation table with follow-up communication
Key Measure:
Estimated annual reporting burden hours
Revised Estimated Burden:
41 hours
Regulatory Context:
Federal Register notice and OMB clearance condition
Year:
2023
Region / City:
Not specified
Topic:
Reassessment of SIS (Supports Intensity Scale)
Document Type:
Request Form
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
Individuals undergoing reassessment for SIS
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2019
Country:
United States
Region:
Puerto Rico; U.S. Virgin Islands
Issuing Agency:
U.S. Department of Agriculture, Food and Nutrition Service
Contractors:
Mathematica Policy Research; Insight Policy Research
Document Type:
Recruiting telephone script
Program:
National School Lunch Program; School Breakfast Program
OMB Control Number:
0584-0606
Expiration Date:
03/31/2019
Target Audience:
State Child Nutrition Agency Directors
Subject:
Cost of producing reimbursable school meals and administrative oversight functions
Related Study:
Outlying Areas Cost Study Feasibility Reassessment
Referenced Regulations:
7 CFR part 235
Year:
2023
Location:
Cadarache, France
Subject:
Nuclear research reactor, material testing, R&D
Document type:
Project status report
Organization:
French Atomic and Alternative Energies Commission (CEA)
Authors:
Dr G. Bignan, F. Carle, Dr JP Chauvin, M. Libessart
Target audience:
Nuclear industry, regulators, R&D institutes
Project phase:
pre-JHR phase before reactor start-up
Key features:
High neutron flux, irradiation loops, in-pile instrumentation, international collaboration
Strategic context:
Supports French nuclear fleet optimization, medical isotope production, and EU nuclear research
Legislative context:
France 2030 plan, multi-annual energy plan (PPE), new nuclear reactor program (EPR2)
End users:
Industrial companies, scientific community, international researchers
Technical objectives:
Material and fuel testing under irradiation, support Generation IV reactor development, advanced modelling and “separate effects” experiments
Year:
2025
Country:
Philippines
Type of Document:
Request for Reassessment Form
Organization:
Enforcement and Compliance Office (ECO)
Author/Submitter:
WESM Compliance Officer or Authorized Company Representative
Covered Billing Period:
Specified in Annex A
Relevant Sections:
Section 7.4 and 7.6 of the Ancillary Services Monitoring Manual
Certified Capacity:
As indicated by the Company
Ancillary Service Type:
Contingency, Regulating, Dispatchable, Others
Supporting Documents:
Reference Documents listed in Annex A
Submission Date:
Specified by the submitter
Position/Designation:
Compliance Officer or Authorized Representative
Validation and Assessment Deadline:
End of the month following the monitored period
Legal Certification:
Sworn affidavit under Philippine law
Year:
2021
Region / City:
Liverpool, United Kingdom
Topic:
Plasma Physics, Fluid Dynamics
Document Type:
Research Paper
Organization / Institution:
University of Liverpool
Author:
M I Hasan, J W Bradley
Target Audience:
Researchers, Academics, Plasma Physicists
Duration:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2025
Note:
Region / City
Topic:
Asthma Treatment
Document Type:
Quick Reference Guide
Organization / Institution:
LSCMMG
Target Audience:
Medical professionals, Patients over 12 years of age
Title of research:
Automating patient inhaler technique when using pressurised Metered Dose Inhalers: testing the functionality and impact of the aflo™ digital respiratory management platform in a randomised controlled trial in a primary care setting
Type of document:
Participant information sheet
Study design:
Randomised controlled trial
Setting:
Primary care
Target population:
Children aged 5 years or over with a diagnosis of asthma
Inclusion criteria:
Diagnosis of asthma; confirmed suitable by GP; access to smartphone and WIFI/4G; currently prescribed a spacer; adherence or symptom control issues
Intervention:
aflo™ digital respiratory management platform and inhaler device
Control:
Standard care
Study duration:
24 weeks
Appointments:
Three visits (baseline, 12 weeks, 24 weeks)
Procedures:
Questionnaires; inhaler technique demonstration; blood pressure measurement; lung function test; spirometry data access; blood sample collection
Sample collection:
Up to 8 ml blood at first appointment
Funding body:
Respiratory Analytics Ltd
Ethics approval:
West Midlands - Edgbaston Research Ethics Committee; MHRA
Compensation:
Travel reimbursement and £20 voucher
Data handling:
Anonymised data analysis; GP access to results
Note:
Year
Topic:
Asthma, Education, Health Management
Document Type:
Assessment Tool
Target Audience:
School personnel, parents, healthcare providers
Year:
2023
Region / City:
Cambridge, England
Subject:
Respiratory medicine, dry powder inhalers, design optimization
Document Type:
Research article
Organization / Institution:
Cambridge Healthcare Innovations, BnL Pharma Solutions, Owlstone Medical
Author:
Heather Jameson, David Harris, Jacob Harker, Karina Joyce, Helen Samuel, Max Allsworth
Target Audience:
Researchers, engineers, professionals in respiratory medicine and inhaler technology
Period of Validity:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Note:
Year
Subject:
Asthma, COPD, Health
Document Type:
Instructional Guide
Organization / Institution:
Somerset CCG
Target Audience:
Patients with asthma or COPD
Context:
Instructional guide for patients on how to properly use the Accuhaler inhaler, including troubleshooting and common mistakes.
Year:
2026
Region / City:
Nottingham, UK
Subject:
Dry powder inhaler testing, aerodynamic particle size distribution
Document Type:
Research article
Institution:
Copley Scientific Ltd
Authors:
Ben Bradley, Mark Copley
Target Audience:
Scientists and laboratory technicians in pharmaceutical R&D and quality control
Tested Devices:
Symbicort® Turbohaler®
Experimental Methods:
Andersen Cascade Impactor (ACI), Next Generation Impactor (NGI), Fast Screening Andersen (FSA), Fast Screening Impactor (FSI)
Key Variables:
Flow rate rise-time, flow resistance, apparatus volume
Study Purpose:
To match flow rate rise-time profiles of abbreviated and full resolution impactors using a variable volume and flow resistance compensator
Year:
2026
Region / City:
Nottingham and Nottinghamshire, UK
Subject:
Prescription medication update
Document Type:
Patient letter
Organization / Institution:
NHS Nottingham and Nottinghamshire Integrated Care Board
Author:
Dr X
Target Audience:
Patients prescribed Fostair®
Medication:
Fostair® (beclometasone/formoterol) and Proxor® (beclometasone/formoterol)
Purpose:
Inform patients of inhaler switch and guidance on use
Date Issued:
2026-03-11
Year:
Not specified
Region / city:
Not specified
Subject:
Inhaler usage, asthma, COPD
Document type:
Instructional guide
Organization:
Not specified
Author:
Not specified
Target audience:
Patients with asthma and COPD
Effective period:
Not specified
Approval date:
Not specified
Modification date:
Not specified
Year:
2026
Region / City:
International
Topic:
Respiratory health, asthma, COPD
Document type:
Patient information leaflet
Organization / Institution:
Pharmaceutical company / Healthcare provider
Author:
Not specified
Target audience:
Patients prescribed Ellipta inhalers
Medication examples:
Relvar Ellipta, Anoro Ellipta, Incruse Ellipta
Common issues addressed:
Incorrect inhaler technique, dose management
Reference materials:
Video demonstration link provided
Review period:
At least annually
Year:
2020
Region:
Australia
Subject:
Asthma treatment; inhaled corticosteroids; combination therapy
Document type:
Regulatory submission summary
Organization:
Pharmaceutical Benefits Advisory Committee (PBAC)
Company:
Chiesi Australia Pty Ltd
Drug:
Fostair® (Beclometasone dipropionate 100 µg + Formoterol fumarate 6 µg)
Population:
Adults with asthma requiring ICS/LABA therapy
Comparator:
Budesonide/Formoterol (BUD/FOR 200/6) and other ICS/LABA formulations
Approval status:
TGA approved 12 February 2020
Therapy type:
Maintenance and reliever therapy (MART)
Clinical claim:
Non-inferior efficacy and safety compared to BUD/FOR 200/6 MART
Endpoints:
Time to first severe exacerbation, exacerbation rate, FEV1, ACQ score, reliever use
Submission type:
Category 2, Authority Required (Streamlined) listing
Context:
Regulatory source detailing clinical efficacy, safety, and PBS listing considerations for BEC/FOR 100/6 as a combined maintenance and reliever asthma therapy.