Omeprazol Sandoz infuus 40, poeder voor oplossing voor intraveneuze infusie 40 mg

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

OMEPRAZOL NATRIUM, 1-WATER 42,56 mg/flacon SAMENSTELLING overeenkomend met ; OMEPRAZOL 40 mg/flacon

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

A02BC01

INN (Algemene Internationale Benaming):

OMEPRAZOL NATRIUM, 1-WATER 42,56 mg/flacon SAMENSTELLING overeenkomend met ; OMEPRAZOL 40 mg/flacon

farmaceutische vorm:

Poeder en oplosmiddel voor oplossing voor injectie

Samenstelling:

DINATRIUMEDETAAT 2-WATER ; NATRIUMHYDROXIDE (E 524),

Toedieningsweg:

Intraveneus gebruik

Therapeutisch gebied:

Omeprazole

Product samenvatting:

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

Autorisatie datum:

2008-10-08

Bijsluiter

Sandoz B.V.
Page 1/8
Omeprazol Sandoz
®
infuus 40, poeder voor oplossing
voor intraveneuze infusie 40 mg; RVG 33439
V11
1.3.1.3 Package Leaflet
Juni 2023
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OMEPRAZOL SANDOZ
® INFUUS 40, POEDER VOOR OPLOSSING VOOR INTRAVENEUZE INFUSIE 40 MG
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).
If you are not sure, talk to your doctor, nurse or pharmacist before
you are given this
medicine.
Sandoz B.V.
Page 2/8
Omeprazol Sandoz
®
infuus 40, poeder voor oplossing
voor intra

Productkenmerken

Sandoz B.V.
Page 1/15
Omeprazol Sandoz infuus 40, poeder voor oplossing
voor intraveneuze infusie 40 mg; RVG 33439
V10
1.3.1.1 Summary of Product Characteristics
Juni 2023
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Omeprazol Sandoz
infuus 40, poeder voor oplossing voor intraveneuze infusie 40 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder for solution for infusion contains omeprazole
sodium, equivalent to 40
mg omeprazole.
After reconstitution (see section 6.6), each 1 ml contains 0.4 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
Sandoz B.V.
Page 2/15
Omeprazol Sandoz infuus 40, poeder voor oplossing
voor intraveneuze infusie 40 mg; RVG 33439
V10
1.3.1.1 Summary of Product Characteristics
Juni 2023
•
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
•
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 therap