Striverdi Respimat Solution for Inhalation 2.5 microgram actuation

Država: Singapur

Jezik: angleščina

Source: HSA (Health Sciences Authority)

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Prenos Navodilo za uporabo (PIL)
29-05-2014
Prenos Lastnosti izdelka (SPC)
02-06-2016

Aktivna sestavina:

OLODATEROL HYDROCHLORIDE 2.7 mcg EQV OLODATEROL

Dostopno od:

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

Koda artikla:

R03AC19

Odmerek:

2.5 mcg/actuation

Farmacevtska oblika:

SOLUTION

Sestava:

OLODATEROL HYDROCHLORIDE 2.7 mcg EQV OLODATEROL 2.5 mcg/actuation

Pot uporabe:

RESPIRATORY (INHALATION)

Tip zastaranja:

Prescription Only

Izdeluje:

Boehringer Ingelheim Pharma GmbH & Co. KG

Status dovoljenje:

ACTIVE

Datum dovoljenje:

2014-05-29

Navodilo za uporabo

                                1 
0270-01 (SG)                                    
                                             
                             20140515 
STRIVERDI
®
   RESPIMAT
®                                             
                
Abcd
 
 
 
COMPOSITION 
 
The STRIVERDI  RESPIMAT is a soft mist
inhaler delivering olodaterol solution for 
inhalation. 
 
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)   
 
 
 DESCRIPTION  
STRIVERDI RESPIMAT solution for inhalation is composed of an
aqueous, multi-dose 
solution of olodaterol hydrochloride for oral inhalation,
delivered by a RESPIMAT inhaler, 
which provides an aerosolized
mist of appropriate particle size for delivery to the lung.
Each 
actuation delivers 2.5 μg of olodaterol from the mouthpiece.
One dose of 5 μg of olodaterol 
consists of two actuations.  
 
STRIVERDI RESPIMAT solution for inhalation is a clear,
colourless solution of olodaterol 
hydrochloride contained in a cartridge. The solution is filled in
a plastic container which is 
crimped into an aluminium cylinder to form the cartridge 
 
INDICATIONS 
 
STRIVERDI  RESPIMAT
 
is indicated for the long term, once-daily maintenance
treatment in 
patients with COPD (including chronic bronchitis and
emphysema) to reduce airflow 
obstruction and to improve quality of life.  
 
 
DOSAGE AND ADMINISTRATION 
 
The recommended
dose for adults is 5 microgram olodaterol given as two
puffs from the 
Respimat inhaler once daily
                                
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Lastnosti izdelka

                                0270- 02 (SG)
20160224
abcd
STRIVERDI
® RESPIMAT
®
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)
DESCRIPTION
STRIVERDI RESPIMAT inhalation solution is composed of an aqueous,
multi-dose solution of
olodaterol hydrochloride for oral inhalation, delivered by a RESPIMAT
inhaler, which provides
an aerosolized mist of appropriate particle size for delivery to the
lung. Each actuation delivers
2.5 μg of olodaterol from the mouthpiece. One dose of 5 μg of
olodaterol consists of two
actuations.
STRIVERDI
RESPIMAT
inhalation
solution
is
a
clear,
colourless
solution
of
olodaterol
hydrochloride contained in a cartridge. The solution is filled in a
plastic container which is
crimped into an aluminium cylinder to form the cartridge
INDICATIONS
STRIVERDI RESPIMAT is indicated for the long term, once-daily
maintenance treatment in
patients with COPD (including chronic bronchitis and emphysema) to
reduce airflow
obstruction and to improve quality of life.
DOSAGE AND ADMINISTRATION
The recommended dose for adults is 5 microgram olodaterol given as two
puffs from the
Respimat inhaler once daily, at the same time of the day (see
Instructions for use).
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20160224
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 moderate hepatic impairment can use STRIVERDI
RESPIMAT at the
recommended dose.
There are no data available for use of STRIVERDI RESPIMAT in pat
                                
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