Panzynorm forte 20 000 tablets gastro-resistant, coated

Pajjiż: Armenja

Lingwa: Ingliż

Sors: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredjent attiv:

pancreatin (lipase, amylase, protease)

Disponibbli minn:

KRKA d.d.

Kodiċi ATC:

A09AA02

INN (Isem Internazzjonali):

pancreatin (lipase, amylase, protease)

Dożaġġ:

20000U+ 12000U+ 900U

Għamla farmaċewtika:

tablets gastro-resistant, coated

Unitajiet fil-pakkett:

(10/1x10/) and (30/3x10/) in blister

Tip ta 'preskrizzjoni:

OTC

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

2019-09-09

Fuljett ta 'informazzjoni

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30.07.2019 -
U dated:
26.08.2019
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Karatteristiċi tal-prodott

1.3.l
Panzynorm forte N
SPC,
Labeling and Package
gastro-resistant
tablets
- -
Leaflet
1.
NAME OF THE MEDICINAL PRODUCT
PanzynormO forte 20000 gastro-resistant
tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant
tablet
contains
pancreatin
from porcine pancreas
with enzymatic
activity:
20 000 Ph.
Eur.
Units
of lipase (Lipasum),
12 000 Ph.
Eur.
Units of amylase
(Amylasum),
900 Ph.
Eur.
Units of protease
(Proteasum)
For excipients,
see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant
tablets:
white to slightly grey in colour,
round,
slightly biconvex.
4.
CLINICAL PARTICULARS
4.1
Therapeutic
indications
Panzynorm forte 20000 is indicated in chronic exocrine pancreatic
insufficiency.
4.2
Posology and method of administration
Dosage should be individualized.
Treatment
should be initiated with low doses:
one capsule
three times
daily,
during the main
meals.
If the symptoms
of pancreatic
enzyme deficiency
persist,
the dosage may be gradually
increased.
One to two tablets
during the main meals
(three times
daily)
are usually
sufficient.
Ifnecessary,
the patient
may also take one tablet
during snacks.
The doses may also be higher,
however,
the patient
should take the lowest
dose necessary
to
eliminate the symptoms,
which is particularly
important
in patients
with cystic fibrosis.
Smaller
doses are usually sufficient
in children.
4.3
Contraindications
panzynorm forte 20000 is contraindicated
in hypersensitivity
to proteins
of porcine
origin or
to any of the other
ingredients
of the drug.
panzynorm forte 20000 should not
be taken by patients
with acute pancreatitis
or acute attack
of chronic pancreatitis.
Panzynorm forte 20000 should not
be taken by children with cystic fibrosis
under
15 years
of
age.
4.4
Special warnings
and special
precautions
for use
The coating
of
the
tablet
prevents
_the_
active
pancreatic
enzymes
from damaging
the
oral
mucous
membrane
and protects
the enzymes
from gastric juice.
Patients
should swallow the
tablets whole,
without
chewing them.
In rare patients
with cystic fibro