Eurobiol 25000 25000U+22500U+1250U (20) glass bottle, (50) glass bottle, (100) glass bottle capsules hard

البلد: أرمينيا

اللغة: الإنجليزية

المصدر: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

العنصر النشط:

multienzymes (lipase, amylase, protease)

متاح من:

Laboratoires Mayoly Spindler

ATC رمز:

A09AA02 օրիգինալ դեղ

INN (الاسم الدولي):

multienzymes (lipase, amylase, protease)

جرعة:

25000U+22500U+1250U (20) glass bottle, (50) glass bottle, (100) glass bottle

الشكل الصيدلاني:

capsules hard

الوحدات في الحزمة:

25000U+22500U+1250U (20) glass bottle, (50) glass bottle, (100) glass bottle

نوع الوصفة الطبية :

OTC

الوضع إذن:

Registered

تاريخ الترخيص:

2015-07-03

خصائص المنتج

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SUMMARY
OF
PRODUCT
CHARACTERISTICS
1)
NAME
OF
TIIE
MEDICINAL
PRODUCT
EUROBIOL
25
00q
U,
gastro-resistant
capsule,
hard.
l;
i
2)
QUALTTATIyE
AND
QUANTTTATTVE
COMPOSTTTON
Porcine
pancfeas
p{wder*
...............2j4.050
-
32t9.875
mg
ij:l
i
t
j:
For
one
capsule.
,l
*Qraritity
conesbon4irig to
an
en4ymatic
activity
of
Lipolytic
activity
.......i.............
.......
25
000
Ph.
Eur.
U
Arnylolytic
4ctivity
............
22
50A
Ph. Eur.
U
Proteolytio
For
a
full
list of excipients,
see
section
6.1.
3)
PHARMACEUTICAL
FORM
Gastro-resistant
capsule,
hard.
i
4)
CLINTCAI,PARTTCULARS
4.1.
Therapeutic indications
Treatment
of exocrine
pancreatic
insufficiency in
adults
and
children
during
:
-
cystic
fibrgsis;
,
-
documentdd
chrbniq
pancreatitis
(especially
the
presence
ofpancreatic
calcifications),
in
tire
presence
of
steatorrhotia
2
6
gl24
h;
-
ceph4lic
oitotal.pancreatic
resections.
4.2.
Posology
and
method
of
administration
Posology
'Ihe
optimal
posology
must
be
determined
and
modulated
over
time
depending on
diet
ancl
patient's
digestive
status,
i.e.
nurrber
ofstools
and steatorrhoea.
The
usual
daify
posology
is:
-
infants
un{it the
age
of
I8
months:
2
capsules
ch{ldren:
4
capqules
adflts:
6
cppiules
EUROBIOL
!e
ddruinistered
in
2
or
3
daily
doses,
taken
during
meals.
Page'J-14
4.4.
Spqciaiyainjnsgland
precautions
for
use
Special;Warninqq
Colonic strictures.have
been
observed
in
other
counhies,
in
children
with
cystic
fibrosis,
during
the
use
of
high
deiily
doses
of
pancreatic
enzyme
replacement
therapy,
presented
in
ihe
gastro-resistant
form.
In
all
cases,,idosep
lyere
at
lpast
4
times
higher
than the
doses
usually
recommended
in
France.
il
r
;
r:ri
Ensurb
tliat
stEatorrhoea
is
)
6
g/24
h before prescribing
EUROBIOL
25 000
U in
patients
with
docurnented
chronic
pancreatitis.
ll;,,:'l
I.
The
rlsk
of
infectious
disease due
to
transmission
of
infectious
agents
camot
be
totally
excluded
during
adminishation
of
medicinal products
containing
animal
pancreas
powder
extracts.
These,
pancreatic
extract