Berodual N aerosol for inhalation, dosed

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

ipratropium bromide (ipratropium bromide monohydrate), fenoterol (fenoterol hydrobromide)

Available from:

Boehringer Ingelheim Pharma GmbH & Co. KG

ATC code:

R03AL01

INN (International Name):

ipratropium bromide (ipratropium bromide monohydrate), fenoterol (fenoterol hydrobromide)

Dosage:

20mcg/dose+ 50mcg/dose

Pharmaceutical form:

aerosol for inhalation, dosed

Units in package:

10ml (200doses) aluminium container with measuring pump

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-02-11

Summary of Product characteristics

Berodual
HFA
MDt
-
Local
Product
Information
Germany
-
October
2014
(ccDS
0279-03)
ffi
Boehringer
\tlllt/
lneelheim
$ummary
of
Product
Gharacteristics
1.
NAME
CIF
THE
MEDICINAL
PRODUCT
Berodual@
N
Dosier'Aerosol
20
Ug/50
pg
Metered
dose
inhaler,
solution
2.
QUATITATIVE
AND
SUANTITATI\IE
COfVIFO$ITION
Active
product
ingredients:
ipratropium
brornide
and
fenoterol
hydr.obromide
1
metered
dose
contains:
21
pg
ipratropiunr
bromide
1
Hao, corresponding
to
20
prg
ipratropium
bromide
and
50
pg
fenoterolhydrobromide
(metered
dose)
E:xcipient
with
known
effect:
Ethanol
99
%
(alcohol)
(see
section
4.4).
For
the
full
list
of
excipients,
see
Section
6,1.
3.
PHARMACEUTICAL
FORM
Metered
dose
inhaler,
sotution
(10
ml'200
metered
doses)
4.
CLINICAL
PARTICLILAR$
4.1
Therapeuticindications
For
the
prevention
and
treatment
of
dyspnoea
in
chronic
obstructive
airway disorders:
Allergic and
non-allergic
(gndogenous)
bronchial
asthma,
exercise-induced
asthma
and
chrohic
obstructive
bronchitis
with and
wilhout
emphysema,
To
prepare
for
("open
the
lungs")
and
support
aerosol
therapy
with
corticosteroids,
mucolyties,
brine,
cromoglycic
acid
(DSCG)
and
antibiotics'
lVofe;
lf long-term
medication
is necessary,
it
should
always
be
accorrpanied
by
anti-inflammatory
treatment.
4.2
Posology
and
rnethod
of
administration
Po-solocv
The
dosage
depends
on
the
nature
and
severity
of
the
disease,
The
following
dosagos
are
recommended
for
adults
and children
over
6
years:
j,r':
it'Ji:
il
!1'i.^lii:l:.1
i,
Page
1
of
14
Berodual
HfA
MDI
-
Local
Product
lnformation
Germany
*
October
2014
(ccDs
027s-03)
*
For
acute
treatment
of
sudclen
onset
of
bronchial
crarnps
and
attack
of
ciyspnoea,
inhalation
oru
sinsi*
J;;;iroo
pg
of
fenoterothydrobromide
ancl40
pg
of
iprairopiuni
bromide
(2
puffs)
is
recommenclecl'
Generally,
in an
acute
attack
of dyspnoea
one
inhalation
ts
sufficientto
provide
rapid
relief
of
breathing
difficulties.
lf
breathing
has
not
notice.ably
improved
within.S
minutes
of
inhaling
the
tirst
i;
il*;,
;
further
1-2
iuffs
may
be
take.n'
lf
a
sev