Berodual Respimat, oplossing voor inhalatie 20 microgram/ 50 microgram

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

FENOTEROL HYDROBROMIDE 50 µg/dosis ; IPRATROPIUMBROMIDE 1-WATER SAMENSTELLING overeenkomend met ; ; IPRATROPIUMBROMIDE 0-WATER 20 µg/dosis

Beschikbaar vanaf:

Boehringer Ingelheim International GmbH Bingerstrasse 173 D-55216 INGELHEIM AM RHEIN (DUITSLAND)

ATC-code:

R03AL01

INN (Algemene Internationale Benaming):

FENOTEROL HYDROBROMIDE 50 µg/dosis ; IPRATROPIUMBROMIDE 1-WATER SAMENSTELLING overeenkomend met ; ; IPRATROPIUMBROMIDE 0-WATER 20 µg/dosis

farmaceutische vorm:

Inhalatieoplossing

Samenstelling:

BENZALKONIUMCHLORIDE ; DINATRIUMEDETAAT 2-WATER ; WATER, GEZUIVERD ; ZOUTZUUR (E 507),

Toedieningsweg:

Inhalatie

Therapeutisch gebied:

Fenoterol and ipratropium bromide

Product samenvatting:

Hulpstoffen: BENZALKONIUMCHLORIDE; DINATRIUMEDETAAT 2-WATER; WATER, GEZUIVERD; ZOUTZUUR (E 507);

Autorisatie datum:

1900-01-01

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BERODUAL RESPIMAT, OPLOSSING VOOR INHALATIE 20 MICROGRAM/ 50 MICROGRAM
ipratropium bromide monohydrate/fenoterol hydrobromide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Berodual Respimat is and what it is used for
2.
What you need to know before you take Berodual Respimat
3.
How to take Berodual Respimat
4.
Possible side effects
5.
How to store Berodual Respimat
6.
Contents of the pack and other information
1.
WHAT BERODUAL RESPIMAT 20/50 MICROGRAM/DOSE IS AND WHAT IT IS USED FOR
Berodual Respimat is a medicine that contains two active ingredients
(the anticholinergic agent
ipratropim bromide and the beta2-agonist fenoterol hydrobromide) in
combination. Both active
ingredients relax the airway muscles and thus cause the bronchi to
widen.
Berodual Respimat is used to prevent and to treat Bronchial spasms
(bronchospasms) in asthma and
chronic obstructive pulmonary disease (COPD). COPD is a long-term lung
disease that causes
shortness of breath and coughing. A concomitant ant-inflammatory
therapy should be considered.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BERODUAL RESPIMAT
PLEASE READ THE FOLLOWING QUESTIONS CAREFULLY.
If you can answer any of these questions with `YES`
please discuss this with your doctor BEFORE
taking
BERODUAL RESPIMAT
-
are you allergic to the active substances (ipratropium bromide
monohydrate and fenoterol
hydrobromide), to atropine or similar drugs or to the other
ingredients of this medicine?
-
are you taking any other medi

Productkenmerken

1
1.
NAME OF THE MEDICINAL PRODUCT
Berodual Respimat, oplossing voor inhalatie 20 microgram/ 50 microgram
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The delivered dose (the dose that leaves the mouthpiece of the
Berodual Respimat) is 20 microgram
ipratropium bromide monohydrate (equivalent to 19 microgram
ipratropium bromide anhydrous) and
50 microgram fenoterol hydrobromide per puff.
Excipient with known effect: This medicine contains 1.12 microgram
benzalkonium chloride in
each actuation.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation solution
Clear, colourless, inhalation solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Berodual Respimat is indicated for the prevention and treatment of
bronchospasm
_ _
in asthma and
chronic obstructive pulmonary disease (COPD).
Concomitant anti-inflammatory therapy should be considered.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage should be adapted to the individual requirements. The
following dosages are
recommended for adults.
Acute asthma episodes
One actuation of Berodual Respimat is sufficient for prompt relief in
many cases. In more severe
cases, if breathing has not noticeably improved after 5 minutes, one
further actuation may be taken. If
an attack has not been relieved by 2 actuations, further actuations
may be required. In these cases,
patients should be advised to consult the doctor or the nearest
hospital immediately.
Intermittent and long-term treatment
(in asthma Berodual Respimat should be used only on an as-
needed basis)
_Adults:_
1 actuation per administation of Berodual Respimat up to 4 times a
day.
2
The total daily dose should not exceed 6 actuations, because generally
a higher dose is not
likely to provide increased efficacy. However, the risk of potentially
serious adverse reaction
may be increased.
_Paediatric population: _
Berodual Respimat is not recommended for use in children below 18
years due to insufficient
data on safety and efficacy.
Method of administration
This medicinal prod