Nolpaza tablets gastro-resistant

Země: Arménie

Jazyk: angličtina

Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivní složka:

pantoprazole (pantoprazole sodium sesquihydrate)

Dostupné s:

KRKA d.d.

ATC kód:

A02BC02

INN (Mezinárodní Name):

pantoprazole (pantoprazole sodium sesquihydrate)

Dávkování:

40mg

Léková forma:

tablets gastro-resistant

Jednotky v balení:

(14/1x14/) in blister, (28/2x14/) in blister, (56/4x14/) in blister

Druh předpisu:

Prescription

Stav Autorizace:

Registered

Datum autorizace:

2021-08-24

Charakteristika produktu

PI_Text018840_1
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Page 1 of 11
1.
NAME OF THE MEDICINAL PRODUCT
Nolpaza
®
40 mg gastro-resistant tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 40 mg pantoprazole as 45.10 mg
pantoprazole sodium
sesquihydrate.
Excipient:
Each gastro-resistant tablet contains 36 mg sorbitol (E420).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet
Light yellowish brown, oval, slightly biconvex film-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Adults and adolescents 12 years of age and above_
-
Reflux oesophagitis
_ _
_Adults_
-
Eradication of _Helicobacter pylori _(_H. pylori_) in combination with
appropriate antibiotic therapy
in patients with _H. pylori _associated ulcers.
-
Gastric and duodenal ulcers.
-
Zollinger-Ellison syndrome and other pathological hypersecretory
conditions.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND ABOVE_
Reflux oesophagitis
One Nolpaza 40 mg gastro-resistant tablet per day. In individual
cases, the dose may be doubled
(increase to 2 Nolpaza 40 mg gastro-resistant tablets daily),
especially when there has been no
response to other treatment. A 4-week period is usually required for
the treatment of reflux
oesophagitis. If this is not sufficient, healing will usually be
achieved within a further 4 weeks.
PI_Text018840_1
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Page 2 of 11
_ADULTS_
Eradication of _H. pylori_ in combination with two appropriate
antibiotics
In _H. pylori _positive patients with gastric and duodenal ulcers,
eradication of the germ by a
combination therapy should be achieved. Considerations should be given
to official local guidance
(e.g. national recommendations) regarding bacterial resistance and the
appropriate use and prescription
of antibacterial agents. Depending upon the resistance pattern, the
following combinations can be
recommended for the eradication of _H. pylori_:
a)
twice daily one Nolpaza 40 mg gastro-resistant tablet
+ twice da