AirFluSal

Main information

  • Trade name:
  • AirFluSal Forspiro 500/50 fluticasone propionate/salmeterol xinafoate 500/50 microgram/actuation powder for inhalation blister p
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AirFluSal Forspiro 500/50 fluticasone propionate/salmeterol xinafoate 500/50 microgram/actuation powder for inhalation blister p
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220718
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220718

AirFluSal Forspiro 500/50 fluticasone propionate/salmeterol xinafoate 500/50 microgram/actuation powder

for inhalation blister pack

ARTG entry for

Medicine Registered

Sponsor

Sandoz Pty Ltd

Postal Address

54 Waterloo Road,Macquarie Park, NSW, 2113

Australia

ARTG Start Date

28/10/2016

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. AirFluSal Forspiro 500/50 fluticasone propionate/salmeterol xinafoate 500/50 microgram/actuation powder

for inhalation blister pack

Product Type

Single Medicine Product

Effective date

28/10/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

For the regular treatment of asthma where the use of a combination product of fluticasone propionate 500 microgram and salmeterol 50 microgram is

appropriate (see PRECAUTIONS).

This may include:

· Patients on effective maintenance doses of long-acting beta2-agonists and high-dose inhaled corticosteroids

· Patients who are symptomatic on current inhaled high-dose corticosteroid therapy.

For the symptomatic treatment of patients with severe COPD (FEV1<50% predicted normal) and a history of repeated exacerbations who have

significant symptoms despite regular beta-2 agonist bronchodilator therapy. AirFluSal Forspiro 500/50 powder for inhalation is not indicated for the

initiation of bronchodilator therapy in COPD.

Note that Metered Dose Inhaler (MDI) dosage form can be available from other products.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PA/Al/PVC/Al -

polyamide-aluminium

foil-polyvinylchloride/al

uminium foil

2 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

60 doses.

(S4) Prescription Only Medicine

Components

1. AirFluSal Forspiro 500/50 fluticasone propionate/salmeterol xinafoate 500/50 microgram/actuation powder for inhalation blister pack

Dosage Form

Inhalation, powder for

Route of Administration

Oral

Visual Identification

An inhalation device in moulded plastic, with a dose counter indicating 60

doses.

Active Ingredients

fluticasone propionate

500 microgram/actuation

Salmeterol xinafoate

73 microgram/actuation

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 02:12:44 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

18-10-2018

Unauthorized "Surfaz-SN Triple Action Cream" seized from Mississauga store may pose serious health risks

Unauthorized "Surfaz-SN Triple Action Cream" seized from Mississauga store may pose serious health risks

Health Canada seized “Surfaz-SN Triple Action Cream”—an unauthorized skin cream promoted for antifungal, antibacterial and anti-inflammatory use—because it is labelled to contain prescription drugs (betamethasone dipropionate and neomycin sulphate). The product was seized from Kaf African Caribbean Market (2642 Liruma Road, Unit 2A) in Mississauga, Ontario.

Health Canada

1-8-2018

Unauthorized skin creams and lotions sold at various retailers in Quebec may pose serious health risks

Unauthorized skin creams and lotions sold at various retailers in Quebec may pose serious health risks

Health Canada seized eight unauthorized skin lotions and creams from Ayotai Canada because they are labelled to contain a prescription drug (clobetasol propionate or betamethasone dipropionate). The unauthorized lotions and creams were distributed by Ayotai and sold by various retailers in Quebec.

Health Canada

31-5-2018

Fluticasone Propionate Nasal Spray by Apotex Corp: Recall - Due to Potential for Small Glass Particles

Fluticasone Propionate Nasal Spray by Apotex Corp: Recall - Due to Potential for Small Glass Particles

The glass particles could block the actuator and impact the functionality of the pump and expose patients to the glass particles.

FDA - U.S. Food and Drug Administration

31-5-2018

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. is voluntarily recalling one (1) lot of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 Metered Sprays, to the consumer level. The Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays has been found to contain small glass particles. The glass particles could block the actuator and impact the functionality of the pump. The issue was discovered through a customer complaint.

FDA - U.S. Food and Drug Administration

6-11-2018

Trelegy Ellipta (GlaxoSmithKline Trading Services Limited)

Trelegy Ellipta (GlaxoSmithKline Trading Services Limited)

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Europe -DG Health and Food Safety

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Elebrato Ellipta (GlaxoSmithKline Trading Services Limited)

Elebrato Ellipta (GlaxoSmithKline Trading Services Limited)

Elebrato Ellipta (Active substance: fluticasone furoate/umeclidinium/vilanterol) - Centralised - 2-Monthly update - Commission Decision (2018)7417 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4781/WS/1369

Europe -DG Health and Food Safety

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Revinty Ellipta (Glaxo Group Ltd)

Revinty Ellipta (Glaxo Group Ltd)

Revinty Ellipta (Active substance: fluticasone furoate / vilanterol) - Corrigendum - Commission Decision (2014)3040 of Tue, 03 Jul 2018

Europe -DG Health and Food Safety

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Relvar Ellipta (Glaxo Group Ltd)

Relvar Ellipta (Glaxo Group Ltd)

Relvar Ellipta (Active substance: fluticasone furoate/vilanterol) - Corrigendum - Commission Decision (2013)8089 of Tue, 03 Jul 2018

Europe -DG Health and Food Safety

3-5-2018

Avamys (Glaxo Group Ltd)

Avamys (Glaxo Group Ltd)

Avamys (Active substance: Fluticasone furoate) - Centralised - Yearly update - Commission Decision (2018)2773 of Thu, 03 May 2018

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