ATECTURA BREEZHALER 125/127.5 indacaterol (as acetate)/mometasone furoate 125/127.5 mcg powder for inhalation in hard capsule with inhaler

Country: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

mometasone furoate, Quantity: 160 microgram; indacaterol acetate, Quantity: 173 microgram (Equivalent: indacaterol, Qty 150 microgram)

Доступно од:

Novartis Pharmaceuticals Australia Pty Ltd

Фармацеутски облик:

Capsule, hard

Састав:

Excipient Ingredients: lactose monohydrate

Пут администрације:

Inhalation

Јединице у пакету:

10 capsules + 1 inhaler (sample and commercial packs), 30 capsules + 1 inhaler

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

Atectura Breezhaler is indicated as a once-daily maintenance treatment of asthma in adults and adolescents 12 years of age and older where use of a combination of long-acting beta2-agonist and inhaled corticosteroid is appropriate:,- patients not adequately controlled with inhaled corticosteroids and "as needed" inhaled short-acting beta2-agonists or,- patients not adequately controlled with long-acting beta2-agonists and low dose of inhaled corticosteroids and "as needed" inhaled short-acting beta2-agonists

Резиме производа:

Visual Identification: Natural transparent capsules containing a white to practically white powder, with the product code 'IM150-160' printed in grey on the body and with a logo printed in grey on the cap; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Статус ауторизације:

Registered

Датум одобрења:

2020-07-21

Информативни летак

Product and Consumer Medicine Information Licence
-------------------------
ACCESS TERMS FOR PRODUCT INFORMATION AND CONSUMER MEDICINE INFORMATION
DOCUMENTS ("LICENCE")
PARTIES
YOU or YOUR means any legal person or entity who accesses or downloads
a PI Document or CMI Document from Our website
and
US, WE or OUR means the COMMONWEALTH OF AUSTRALIA as represented by
the THERAPEUTIC GOODS ADMINISTRATION ABN 40 939 406 804 of 136
Narrabundah Lane, Symonston ACT 2609, Australia.
OPERATIVE PROVISIONS *
NATURE OF AGREEMENT *
1.1  This Licence specifies the terms and conditions of Your access
and use of PI Documents and CMI Documents made available to the
general public by Us via Our website. *
1.2  You acknowledge and agree that accessing PI Documents or CMI
Documents in accordance with this Licence is beneficial to You because
it provides You with product information about therapeutic goods and
is beneficial to Us because it assists Us in our portfolio
responsibilities. *
TERMS OF ACCESS *
2.1  We grant to You a perpetual, non-exclusive, royalty-free,
world-wide, irrevocable and non-transferable licence to download,
store in cache, display, print and copy a single copy or part of a
single copy of a PI Document or CMI Document made available via Our
website. *
2.2  If You wish to use any PI Document or CMI Document for purposes
other than those specified in clause 2.1 of this Licence, You must
seek the permission of the Sponsor. *
2.3  We may remove a PI Document or CMI Document from Our website at
any time in Our sole discretion. *
EXCLUSION OF LIABILITY *
3.1  You acknowledge and agree that You are responsible for making
Your own enquiries to determine whether any PI Document or CMI
Document is accurate, up to date and fit for Your purposes. *
3.2  The PI Document or CMI Document is provided to You for the
purpose of disseminating health information free of charge for the
benefit of the public.  This Licence and any PI Document or CMI
Document made available to You via Our website is not a substitute fo

Карактеристике производа

Product and Consumer Medicine Information Licence
-------------------------
ACCESS TERMS FOR PRODUCT INFORMATION AND CONSUMER MEDICINE INFORMATION
DOCUMENTS ("LICENCE")
PARTIES
YOU or YOUR means any legal person or entity who accesses or downloads
a PI Document or CMI Document from Our website
and
US, WE or OUR means the COMMONWEALTH OF AUSTRALIA as represented by
the THERAPEUTIC GOODS ADMINISTRATION ABN 40 939 406 804 of 136
Narrabundah Lane, Symonston ACT 2609, Australia.
OPERATIVE PROVISIONS *
NATURE OF AGREEMENT *
1.1  This Licence specifies the terms and conditions of Your access
and use of PI Documents and CMI Documents made available to the
general public by Us via Our website. *
1.2  You acknowledge and agree that accessing PI Documents or CMI
Documents in accordance with this Licence is beneficial to You because
it provides You with product information about therapeutic goods and
is beneficial to Us because it assists Us in our portfolio
responsibilities. *
TERMS OF ACCESS *
2.1  We grant to You a perpetual, non-exclusive, royalty-free,
world-wide, irrevocable and non-transferable licence to download,
store in cache, display, print and copy a single copy or part of a
single copy of a PI Document or CMI Document made available via Our
website. *
2.2  If You wish to use any PI Document or CMI Document for purposes
other than those specified in clause 2.1 of this Licence, You must
seek the permission of the Sponsor. *
2.3  We may remove a PI Document or CMI Document from Our website at
any time in Our sole discretion. *
EXCLUSION OF LIABILITY *
3.1  You acknowledge and agree that You are responsible for making
Your own enquiries to determine whether any PI Document or CMI
Document is accurate, up to date and fit for Your purposes. *
3.2  The PI Document or CMI Document is provided to You for the
purpose of disseminating health information free of charge for the
benefit of the public.  This Licence and any PI Document or CMI
Document made available to You via Our website is not a substitute fo