Onbrez Breezhaler 300mcg Inhalation Powder 300 mcg

Страна: Йордания

Език: английски

Източник: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

Активна съставка:

Indacaterol 300 mcg

Предлага се от:

شركة مستودع الأدوية الأردني - The Jordan Drugstore Co

АТС код:

R03AC18

INN (Международно Name):

Indacaterol 300 mcg

дозиране:

300 mcg

Броя в опаковка:

30 Cap

Произведено от:

Novartis Pharma Stein AG (سويسرا)

Каталог на резюме:

37.39 :سعر الجمهور + الضريبة

Листовка

Onbrez
®
Breezhaler
®
prescribing information : approved by Swissmedic 04.03.2014
(2013-PSB/GLC-0645-s)
Page 1 of 17
Novartis Pharma Schweiz AG
Confidential
Application no.: 103351
Case manager/Case assistant initials: uf/sr
ONBREZ
® BREEZHALER
®
Hard capsules containing inhalation powder
COMPOSITION
_Active substance: _Indacaterol, as indacaterol maleate._ _
_Excipients:_ Lactose monohydrate, capsule excipients, gelatin
(capsule shell)._ _
PHARMACEUTICAL FORM AND QUANTITY OF ACTIVE SUBSTANCE PER UNIT
Pharmaceutical form
_Clear, colourless, hard capsules containing 150 µg of inhalation
powder_ with "IDL 150" and
company logo printed in black.
_Clear, colourless, hard capsules containing 300 µg of inhalation
powder_ _ _ with "IDL 300" and
company logo printed in blue.
_Quantity of active substance_
_Hard capsules containing 150 µg indacaterol, corresponding to 194
µg indacaterol maleate _
The delivered dose (i.e. the dose discharged through the mouthpiece of
the Onbrez Breezhaler inhaler)
is 120 µg indacaterol maleate.
_Hard capsules containing 300 µg indacaterol, corresponding to 389
µg indacaterol maleate _
The delivered dose (i.e. the dose discharged through the mouthpiece of
the Onbrez Breezhaler inhaler)
is 240 µg indacaterol maleate.
INDICATIONS/POTENTIAL USES
Onbrez Breezhaler is indicated for maintenance bronchodilator
treatment of airflow obstruction in
adult patients with chronic obstructive pulmonary disease (COPD).
Onbrez
®
Breezhaler
®
prescribing information : approved by Swissmedic 04.03.2014
(2013-PSB/GLC-0645-s)
Page 2 of 17
Novartis Pharma Schweiz AG
Confidential
Application no.: 103351
Case manager/Case assistant initials: uf/sr
DOSAGE/ADMINISTRATION
_Dosage _
_Adults _
The recommended dose of Onbrez Breezhaler is the inhalation of the
content of one 150 µg capsule
once a day, using the Onbrez Breezhaler inhaler. The dose should only
be increased on medical
advice.
The inhalation of the content of one 300 µg capsule once a day, using
the Onbrez Breezhaler inhaler,
has been shown