SIRDUPLA DPI 100/50 fluticasone propionate 100 microgram / salmeterol (as xinafoate) 50 microgram powder for inhalation inhaler

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

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Active ingredient:
fluticasone propionate,salmeterol xinafoate
Available from:
Alphapharm Pty Ltd
Authorization status:
Registered
Authorization number:
301333

Public Summary

Summary for ARTG Entry:

301333

SIRDUPLA DPI 100/50 fluticasone propionate 100 microgram / salmeterol (as xinafoate) 50 microgram

powder for inhalation inhaler

ARTG entry for

Medicine Registered

Sponsor

Alphapharm Pty Ltd

Postal Address

PO Box R1462,ROYAL EXCHANGE, NSW, 1225

Australia

ARTG Start Date

9/09/2019

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. SIRDUPLA DPI 100/50 fluticasone propionate 100 microgram / salmeterol (as xinafoate) 50 microgram

powder for inhalation inhaler

Product Type

Single Medicine Product

Effective date

9/09/2019

Permitted Indications

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

For the regular treatment of asthma, where the use of a combination product is appropriate.,This may include:,·Patients on effective maintenance doses

of long-acting beta-2 agonists and inhaled corticosteroids,·Patients who are symptomatic on current inhaled corticosteroid therapy,·Initiation of

maintenance therapy in those patients with moderate persistent asthma not adequately controlled on 'as needed' reliever medication, and who have

moderate/severe airway limitation and daily symptoms requiring reliever medication every day.,For the symptomatic treatment of patients with severe

COPD (FEV1 less than 50 percent predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta- 2

agonist bronchodilator therapy. SIRDUPLA DPI is not indicated for the initiation of bronchodilator therapy in COPD.

Warnings

See Product Information and Consumer Medicine Information for this product

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Inhaler - dry powder

Plastic

24 Months

Store below 25

degrees Celsius

Not recorded

Protect from direct

sunlight

Protect from Heat

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. SIRDUPLA DPI 100/50 fluticasone propionate 100 microgram / salmeterol (as xinafoate) 50 microgram powder for inhalation inhaler

Dosage Form

Inhalation, powder for

Route of Administration

Inhalation

Visual Identification

A grey disposable plastic inhaler with an integral dose counter, containing

two foil sealed discs each with 30 pre-metered doses

Active Ingredients

Public Summary

Page 1 of

Produced at 30.09.2019 at 10:32:44 AEST

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

fluticasone propionate

100 microgram

salmeterol xinafoate

72.5 microgram

© 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 2 of

Produced at 30.09.2019 at 10:32:44 AEST

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

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