Bevespi Aerosphere

Land: Europäische Union

Sprache: Englisch

Quelle: EMA (European Medicines Agency)

Wirkstoff:

glycopyrronium, formoterol fumarate dihydrate

Verfügbar ab:

AstraZeneca AB

ATC-Code:

R03AL07

INN (Internationale Bezeichnung):

glycopyrronium, formoterol fumarate dihydrate

Therapiegruppe:

formoterol and glycopyrronium bromide

Therapiebereich:

Pulmonary Disease, Chronic Obstructive

Anwendungsgebiete:

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

Produktbesonderheiten:

Revision: 6

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2018-12-18

Gebrauchsinformation

29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE USER
BEVESPI AEROSPHERE 7.2 MICROGRAMS/5 MICROGRAMS PRESSURISED INHALATION,
SUSPENSION
glycopyrronium/formoterol fumarate dihydrate
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 Bevespi Aerosphere is and what it is used for
2.
What you need to know before you use Bevespi Aerosphere
3.
How to use Bevespi Aerosphere
4.
Possible side effects
5.
How to store Bevespi Aerosphere
6.
Contents of the pack and other information
Instructions for use
1.
WHAT BEVESPI AEROSPHERE IS AND WHAT IT IS USED FOR
Bevespi Aerosphere contains two active substances called
glycopyrronium and formoterol fumarate
dihydrate. These belong to a group of medicines called long-acting
bronchodilators.
Bevespi Aerosphere is used to make breathing easier for adults who
have a lung disease called chronic
obstructive pulmonary disease (COPD). COPD is a long-term disease of
the airways in the lungs,
which is often caused by smoking. In COPD, the muscles around the
airways tighten which makes
breathing difficult.
The medicine prevents the tightening of the muscles around the
airways, making it easier for air to get
in and out of the lungs.
Bevespi Aerosphere delivers the active substances directly to the
airways in your lungs as you breathe
in. It will help to reduce the effects of COPD on your everyday life.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BEVESPI AEROSPHERE
DO NOT USE BEVESPI AEROSPHERE IF
-
you are allergic to glycopyrronium, formoterol fumarate di

Fachinformation

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Bevespi Aerosphere 7.2 micrograms/5 micrograms pressurised inhalation,
suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single actuation (delivered dose, the dose leaving the
mouthpiece) contains glycopyrronium
bromide 9 micrograms equivalent to 7.2 micrograms of glycopyrronium,
and 5 micrograms of
formoterol fumarate dihydrate.
This corresponds to a metered dose (i.e. the dose leaving the valve)
of glycopyrronium bromide
10.4 micrograms equivalent to 8.3 micrograms of glycopyrronium, and
5.8 microgram of formoterol
fumarate dihydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pressurised inhalation, suspension (pressurised inhalation)
White suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bevespi Aerosphere is indicated as a maintenance bronchodilator
treatment to relieve symptoms in
adult patients with chronic obstructive pulmonary disease (COPD) (see
section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is two inhalations twice daily (two inhalations
in the morning and two
inhalations in the evening).
Patients should be advised not to take more than 2 inhalations 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.
Special populations
_Elderly_
No dose adjustments are required in elderly patients (see section
5.2).
_Renal impairment_
Bevespi Aerosphere can be used at the recommended dose in patients
with mild to moderate renal
impairment. In patients with severe renal impairment or end-stage
renal disease requiring dialysis, it
should be used only if the expected benefit outweighs the potential
risk (see sections 4.4 and 5.2).
_Hepatic impairment_
3
Bevespi Aerosphere can be used at the recommended dose in patients
with mild to moderate hepatic
impairment. There are no relevant data on the use of Bevespi
Ae