ULTIBRO BREEZHALER 11050 MCG

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

GLYCOPYRRONIUM AS BROMIDE; INDACATEROL AS MALEATE

Dostupné z:

NOVARTIS ISRAEL LTD

ATC kód:

R03AC18

Forma lieku:

INHALATION POWDER HARD CAPSULES

Zloženie:

INDACATEROL AS MALEATE 110 MCG; GLYCOPYRRONIUM AS BROMIDE 50 MCG

Spôsob podávania:

INHALATION

Typ predpisu:

Required

Výrobca:

SIEGFRIED BARBERA, S.L., SPAIN

Terapeutické oblasti:

INDACATEROL

Terapeutické indikácie:

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

Dátum Autorizácia:

2019-01-31

Príbalový leták

ULT API MAY23 V 2.1
REF EU SmPC 18Nov2020
Business Use Only
1.
NAME OF THE MEDICINAL PRODUCT
Ultibro
®
Breezhaler
®
110/50 mcg
Inhalation powder hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 143 micrograms of indacaterol maleate equivalent
to 110 micrograms of
indacaterol and 63 micrograms of glycopyrronium bromide equivalent to
50 micrograms of
glycopyrronium.
Each delivered dose (the dose that leaves the mouthpiece of the
inhaler) contains 110 micrograms of
indacaterol maleate equivalent to 85 micrograms of indacaterol and 54
micrograms of glycopyrronium
bromide equivalent to 43 micrograms of glycopyrronium.
Excipient(s) with known effect:
Each capsule contains 23.5mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, hard capsule (inhalation powder).
Capsules with transparent yellow cap and natural transparent body
containing a white to practically
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 maintenance bronchodilator
treatment to relieve symptoms in adult
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 years of age and
older).
_Renal impairment _
Ultibro Breezhaler can be used at the recommended dose in patients
with mild to moderate renal
impairment. In patients with severe renal i

Súhrn charakteristických

ULT API JAN21 V 2.0
REF EU SmPC 18Nov2020
Business Use Only
1.
NAME OF THE MEDICINAL PRODUCT
Ultibro
®
Breezhaler
®
110/50 mcg
Inhalation powder hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 143 micrograms of indacaterol maleate equivalent
to 110 micrograms of
indacaterol and 63 micrograms of glycopyrronium bromide equivalent to
50 micrograms of
glycopyrronium.
Each delivered dose (the dose that leaves the mouthpiece of the
inhaler) contains 110 micrograms of
indacaterol maleate equivalent to 85 micrograms of indacaterol and 54
micrograms of glycopyrronium
bromide equivalent to 43 micrograms of glycopyrronium.
Excipient(s) with known effect:
Each capsule contains 23.5mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, hard capsule (inhalation powder).
Capsules with transparent yellow cap and natural transparent body
containing a white to practically
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 maintenance bronchodilator
treatment to relieve symptoms in adult
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 years of age and
older).
ULT API JAN21 V 2.0
REF EU SmPC 18Nov2020
Business Use Only
_Renal impairment _
Ultibro Breezhaler can be used at the recommended dose in patients
with mild t