Duaklir Genuair
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
11-01-2023
Valmisteyhteenveto
(SPC)
11-01-2023
Julkisesta arviointikertomuksesta
(PAR)
05-12-2014
Aktiivinen ainesosa:
aclidinium bromide, formoterol fumarate dihydrate
Saatavilla:
Covis Pharma Europe B.V.
ATC-koodi:
R03AL
INN (Kansainvälinen yleisnimi):
aclidinium bromide, formoterol
Terapeuttinen ryhmä:
Drugs for obstructive airway diseases,
Terapeuttinen alue:
Pulmonary Disease, Chronic Obstructive
Käyttöaiheet:
Duaklir Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Tuoteyhteenveto:
Revision: 15
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2014-11-19
Pakkausseloste
29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DUAKLIR GENUAIR 340 MICROGRAMS /12 MICROGRAMS INHALATION POWDER
aclidinium/formoterol fumarate dihydrate
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Duaklir Genuair is and what it is used for
2.
What you need to know before you use Duaklir Genuair
3.
How to use Duaklir Genuair
4.
Possible side effects
5.
How to store Duaklir Genuair
6.
Contents of the pack and other information
Instructions for Use
1.
WHAT DUAKLIR GENUAIR IS AND WHAT IT IS USED FOR
WHAT DUAKLIR GENUAIR IS
This medicine contains two active ingredients called aclidinium and
formoterol fumarate dihydrate.
Both belong to a group of medicines called bronchodilators.
Bronchodilators relax the muscles in your
airways, which allows the airways to open more widely and helps you to
breathe more easily. The
Genuair inhaler delivers the active ingredients directly into your
lungs as you breathe in.
WHAT DUAKLIR GENUAIR IS USED FOR
Duaklir Genuair is used for adult patients who have breathing
difficulties due to a lung disease called
chronic obstructive pulmonary disease (COPD), in which the airways and
air sacs in the lungs become
damaged or blocked. By opening the airways, the medicine helps relieve
symptoms such as shortness
of b
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Duaklir Genuair 340 micrograms /12 micrograms inhalation powder
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (the dose leaving the mouthpiece) contains 396
micrograms of aclidinium
bromide (equivalent to 340 micrograms of aclidinium) and 11.8
micrograms of formoterol fumarate
dihydrate. This corresponds to a metered dose of 400 micrograms of
aclidinium bromide (equivalent
to 343 micrograms of aclidinium) and a metered dose of 12 micrograms
of formoterol fumarate
dihydrate.
Excipients with known effect
Each delivered dose contains approximately 11 mg lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder.
White or almost white powder in a white inhaler with an integral dose
indicator and an orange dosage
button.
4.
CLINICAL
PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Duaklir Genuair 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 one inhalation twice daily.
If a dose is missed, it should be taken as soon as possible and the
next dose should be taken at the
usual time. A double dose should not be taken to make up for a
forgotten dose.
_Elderly _
No dose adjustments are required in elderly patients (see section
5.2).
_ _
_Renal impairment _
No dose adjustments are required in patients with renal impairment
(see section 5.2).
_Hepatic impairment _
No dose adjustments are required in patients with hepatic impairment
(see section 5.2).
3
_ _
_Paediatric population_
There is no relevant use of Duaklir Genuair in children and
adolescents (under 18 y
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