Nolpaza 40mg powder for solution for injection

Χώρα: Αρμενία

Γλώσσα: Αγγλικά

Πηγή: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Δραστική ουσία:

pantoprazole (pantoprazole sodium)

Διαθέσιμο από:

KRKA d.d.

Φαρμακολογική κατηγορία (ATC):

A02BC02

INN (Διεθνής Όνομα):

pantoprazole (pantoprazole sodium)

Δοσολογία:

40mg

Φαρμακοτεχνική μορφή:

powder for solution for injection

Μονάδες σε πακέτο:

(1) glass vial, (5) glass vial, (10) glass vial

Τρόπος διάθεσης:

Prescription

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2015-07-03

Αρχείο Π.Χ.Π.

1.3.1
Pantoprazole sodium sesquihydrate
SPC, Labeling and Package Leaflet
AM
SmPCPIL140714_1
13.11.2019 – Updated: 13.11.2019
Page 1 of 10
1.
NAME OF THE MEDICINAL PRODUCT
Nolpaza
®
40 mg powder for solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 40 mg of pantoprazole (as sodium sesquihydrate).
_Excipients_
Each vial contains 5.0 mg of sodium citrate dihydrate and sodium
hydroxide q.s.
This medicinal product contains less than 1 mmol sodium (23 mg) per
vial, i.e. is essentially "sodium
free".
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Powder for solution for injection.
White or almost white lzophiliyed, uniform porous cake.
For the solution reconstituted with 10 ml of 0.9% NaCl solution the pH
is approximately 10 and the
osmolality is approximately 382 mOsm/Kg.
For the solution reconstituted with a further 100 ml of 0.9% NaCl
solution or 5% glucose solution the
pH is approximately 9 and 8.5, respectively.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Reflux oesophagitis
-
Gastric and duodenal ulcer
-
Zollinger – Ellison Syndrome and other pathological hypersecretory
conditions
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
This medicine should be administered by a healthcare professional and
under appropriate medical
supervision.
The intravenous administration of pantoprazole is recommended only if
oral application is not
appropriate. Data are available on intravenous use for up to 7 days.
Therefore as soon as oral therapy
is possible, treatment with pantoprazole i.v. should be discontinued
and 40 mg pantoprazole p.o.
should be administered instead.
CONFIDENTIAL
Nolpaza powder for solution for injection 40 mg
VOL: 1; P: 13 / 40
1.3.1
Pantoprazole sodium sesquihydrate
SPC, Labeling and Package Leaflet
AM
SmPCPIL140714_1
13.11.2019 – Updated: 13.11.2019
Page 2 of 10
_Recommended dose_:
Gastric and duodenal ulcer, reflux oesophagitis
The recommended intravenous dose is one vial of pantoprazole (40 mg)
per day.
Zollinger-Ellison Synd