Omeprazol infuus 40 mg, poeder voor oplossing voor intraveneuze infusie

Land: Nederland

Språk: nederlandsk

Kilde: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktiv ingrediens:

OMEPRAZOL NATRIUM, 1-WATER SAMENSTELLING overeenkomend met ; OMEPRAZOL

Tilgjengelig fra:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-kode:

A02BC01

INN (International Name):

OMEPRAZOLE SODIUM, 1-WATER COMPOSITION corresponding to ; OMEPRAZOLE

Legemiddelform:

Poeder voor oplossing voor injectie

Sammensetning:

DINATRIUMEDETAAT 2-WATER ; NATRIUMHYDROXIDE (E 524),

Administreringsrute:

Intraveneus gebruik

Terapeutisk område:

Omeprazole

Produkt oppsummering:

Hulpstoffen: DINATRIUMEDETAAT 2-WATER; NATRIUMHYDROXIDE (E 524);

Autorisasjon dato:

2008-10-08

Informasjon til brukeren

Sandoz B.V.
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Omeprazol infuus 40 mg, poeder voor oplossing voor
intraveneuze infusie, RVG 33438
V11
1.3.1.3 Package Leaflet
Mei 2020
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OMEPRAZOL INFUUS 40 MG, POEDER VOOR OPLOSSING VOOR INTRAVENEUZE
INFUSIE
Omeprazole sodium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, nurse or
pharmacist.
-
If you get any side effects, talk to your doctor, nurse or pharmacist.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What [nationally completed name] is and what it is used for
2. What you need to know before [nationally completed name] is given
to you
3. How [nationally completed name] is given to you
4. Possible side effects
5. How to store [nationally completed name]
6. Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME]_ _IS AND WHAT IT IS USED FOR
[nationally completed name] contains the active substance omeprazole.
It belongs to a group
of medicines called ‘proton pump inhibitors’. They work by
reducing the amount of acid that
your stomach produces.
[nationally completed name] powder for solution for infusion can be
used as an alternative to
oral therapy.
2.
WHAT YOU NEED TO KNOW BEFORE [NATIONALLY COMPLETED NAME] IS GIVEN TO
YOU
YOU MUST NOT BE GIVEN [NATIONALLY COMPLETED NAME]
−
if you are allergic to omeprazole or any of the other ingredients of
this medicine (listed in
section 6).
−
if you are allergic to other proton pump inhibitor medicines (e.g.
pantoprazole,
lansoprazole, rabeprazole, esomeprazole).
−
if you are taking a medicine containing nelfinavir (used for HIV
infection).
Sandoz B.V.
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Omeprazol infuus 40 mg, poeder voor oplossing voor
intraveneuze infusie, RVG 33438
V11
1.3.1.3 Package Leaflet
Mei 2020
If you are not sure, talk to your doctor, nurse or p

Preparatomtale

Sandoz B.V.
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Omeprazol infuus 40 mg, poeder voor oplossing voor
intraveneuze infusie; RVG 33438
V10
1.3.1.1 Summary of Product Characteristics
Mei 2020
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Omeprazol infuus 40 mg, poeder voor oplossing voor intraveneuze
infusie
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder for solution for infusion contains omeprazole
sodium, equivalent to 40
mg omeprazole.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Powder for solution for infusion.
The powder for solution for infusion is a white to almost white
powder.
The reconstituted solution has a pH of about 9-10.5
The osmolarity of the solution reconstituted with100 ml of 5 % glucose
solution is about
0.297Osmol/kg.
The osmolarity of the solution reconstituted with 100 ml of 0.9 %
saline is about 0.282
Osmol/kg
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
[Nationally completed name] for intravenous use is indicated as an
alternative to oral therapy
for the following indications i.e.
Adults
•
Treatment of duodenal ulcers
•
Prevention of relapse of duodenal ulcers
•
Treatment of gastric ulcers
•
Prevention of relapse of gastric ulcers
•
In combination with appropriate antibiotics,
_Helicobacter pylori (H. pylori) _
eradication in
peptic ulcer disease
•
Treatment of NSAID-associated gastric and duodenal ulcers
•
Prevention of NSAID-associated gastric and duodenal ulcers in patients
at risk
Sandoz B.V.
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Omeprazol infuus 40 mg, poeder voor oplossing voor
intraveneuze infusie; RVG 33438
V10
1.3.1.1 Summary of Product Characteristics
Mei 2020
•
Treatment of reflux oesophagitis
•
Long-term management of patients with healed reflux oesophagitis
•
Treatment of symptomatic gastro-oesophageal reflux disease
•
Treatment of Zollinger-Ellison syndrome
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Alternative to oral therapy _
In patients where the use of oral medicinal products is inappropriate,
[Nationally completed
name] IV 40 m