STRIVERDI RESPIMAT

מדינה: אינדונזיה

שפה: אינדונזית

מקור: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

מרכיב פעיל:

OLODATEROL

זמין מ:

BOEHRINGER INGELHEIM INDONESIA - Indonesia

INN (שם בינלאומי):

OLODATEROL

כמות:

2,5 Mg

טופס פרצבטיות:

CAIRAN INHALASI

יחידות באריזה:

DUS, SINGLE REFILL PACK @ 1 CARTRIDGE

תוצרת:

BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG., GERMANY - Federal Republic of Germany

תאריך אישור:

2020-02-24

מאפייני מוצר

PT. BOEHRINGER INGELHEIM INDONESIA
1
Medical & Regulatory Affairs
CCDS 0270-05
No. 0270-05
23 Mar 2020
STRIVERDI
 RESPIMAT

Olodaterol
COMPOSITION
The
STRIVERDI
®
RESPIMAT
®
is
a
soft
mist
inhaler
delivering
olodaterol
inhalation
solution.
The
delivered
dose
is
2.5
microgram
olodaterol
per
puff
(2
puffs
comprise
one
medicinal dose) and is equivalent to 2.7 microgram olodaterol
hydrochloride.
(INN = olodaterol)
The delivered dose is the dose which is available for the patient
after passing the
mouthpiece.
Excipients**
Benzalkonium chloride, disodium edetate, water, purified, citric acid
(anhydrous)
INDICATIONS
STRIVERDI
®
RESPIMAT
®
is
indicated
as
long-term
once
daily
maintenance
bronchodilator treatment to improve lung function in patients with
COPD.
DOSAGE AND ADMINISTRATION
The recommended dose for adults is 5 microgram olodaterol given as two
puffs from
the
RESPIMAT
once-daily
at
the
same
time
of
the
day.
Do
not
use
STRIVERDI
®
RESPIMAT
®
more than two inhalations every 24 hours _(see Instructions for use)._
_ _
SPECIAL POPULATIONS
Elderly
Elderly patients can use STRIVERDI
®
RESPIMAT
®
at the recommended dose.
Paediatric population
COPD does not normally occur in children. The safety and effectiveness
of STRIVERDI
®
RESPIMAT
®
in the pediatric population have not been established.
Patients with hepatic insufficiency
Patients with mild and morderate hepatic impairment can use STRIVERDI
®
RESPIMAT
®
at the recommended dose.
There are no data available for use of STRIVERDI
®
RESPIMAT
®
in patients with servere
hepatic impairment.
Patients with renal insufficiency
Renally impaired patients can use STRIVERDI
®
RESPIMAT
®
at the recommended dose.
DISETUJUI OLEH BPOM: 03/06/2021
ID: EREG10036412000390
EREG10036412000391
PT. BOEHRINGER INGELHEIM INDONESIA
2
Medical & Regulatory Affairs
CCDS 0270-05
INSTRUCTIONS FOR USE
STRIVERDI RESPIMAT is intended for oral inhalation only. The STRIVERDI
RESPIMAT
cartridge is only intended for use with the STRIVERDI RESPIMAT
inhaler.
To ensure proper administr