ULTIBRO BREEZHALER INHALATION POWDER HARD CAPSULE 11050 MCG

Država: Singapur

Jezik: angleščina

Source: HSA (Health Sciences Authority)

Aktivna sestavina:

Glycopyrronium Bromide 63mcg eqv Glycopyrronium; Indacaterol maleate 143mcg eqv Indacaterol (micronized)

Dostopno od:

NOVARTIS (SINGAPORE) PTE LTD

Koda artikla:

Not availabl

Odmerek:

50 mcg

Farmacevtska oblika:

CAPSULE

Sestava:

Glycopyrronium Bromide 63mcg eqv Glycopyrronium 50 mcg; Indacaterol maleate 143mcg eqv Indacaterol (micronized) 110 mcg

Pot uporabe:

BUCCAL

Tip zastaranja:

Prescription Only

Izdeluje:

Novartis Pharma Stein AG

Status dovoljenje:

ACTIVE

Datum dovoljenje:

2014-04-10

Navodilo za uporabo

1 

1. 
NAME OF THE MEDICINAL PRODUCT 

Ultibro™ Breezhaler
®
 110 micrograms/50 micrograms, inhalation powder hard capsules 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each capsule contains 143 µg of indacaterol maleate
equivalent to 110 µg of indacaterol and 63 µg of 
glycopyrronium bromide equivalent to 50 µg of glycopyrronium. 

Each delivered dose (the dose that leaves the
mouthpiece of the inhaler) contains 110 µg of indacaterol 
maleate
equivalent to 85 µg of indacaterol and 54 µg of glycopyrronium bromide
equivalent to 43 µg 
of glycopyrronium. 

Excipient(s) with known effect: 
Each capsule contains 23.5 mg lactose (as monohydrate). 

For the full list of excipients, see section 6.1. 

3. 
PHARMACEUTICAL FORM 

Inhalation powder, hard capsule 

Capsules with transparent yellow cap and
natural transparent body containing a white to almost white 
powder, with the product code “IGP110.50” printed in blue
under two blue bars on the body and the 
company logo (
) printed in black on the cap. 

4. 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

Ultibro Breezhaler is indicated as a once-daily maintenance
bronchodilator treatment to relieve 
symptoms in patients with chronic obstructive
pulmonary disease (COPD). 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

Posology 
The recommended dose is the inhalation of the
content of one capsule once daily using the Ultibro 
Breezhaler inhaler. 

Ultibro Breezhaler is recommended to be administered at the
same time of the day each day. If a dose 
is missed, it should be taken as soon as possible on the same
day. Patients should be instructed not to 
take more than one dose in a day. 

Special populations 
_Elderly population _
Ultibro Breezhaler can be used at the recommended
dose in elderly patients (75

Lastnosti izdelka

1
1.
NAME OF THE MEDICINAL PRODUCT
Ultibro™ Breezhaler
®
110 micrograms/50 micrograms, inhalation powder hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 143 µg of indacaterol maleate equivalent to 110
µg of indacaterol and 63 µg of
glycopyrronium bromide equivalent to 50 µg of glycopyrronium.
Each delivered dose (the dose that leaves the mouthpiece of the
inhaler) contains 110 µg of indacaterol
maleate equivalent to 85 µg of indacaterol and 54 µg of
glycopyrronium bromide equivalent to 43 µg
of glycopyrronium.
Excipient(s) with known effect:
Each capsule contains 23.5 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, hard capsule
Capsules with transparent yellow cap and natural transparent body
containing a white to almost white
powder, with the product code “IGP110.50” printed in blue under
two blue bars on the body and the
company logo (
) printed in black on the cap.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ultibro
Breezhaler
isindicated
as
a
once-daily
maintenance
bronchodilator
treatment
to
relieve
symptoms in patients with chronic obstructive pulmonary disease (COPD)
and for the reduction of
exacerbations of COPD in patients with a history of exacerbations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is the inhalation of the content of one capsule
once daily using the Ultibro
Breezhaler inhaler.
Ultibro Breezhaler is recommended to be administered at the same time
of the day each day. If a dose
is missed, it should be taken as soon as possible on the same day.
Patients should be instructed not to
take more than one dose in a day.
Special populations
_Geriatric patients (75 years or above) _
Ultibro Breezhaler can be used at the recommended dose in elderly
patients (75 years of age and
older).
2
_Renal impairment _
Ultibro Breezhaler can be used at the recommended dose in patients
with mild to moderate renal
impairment. In patients with severe renal impa