Omeprazol Sandoz injectie 40 mg, poeder en oplosmiddel voor oplossing voor injectie

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

OMEPRAZOL NATRIUM, 0-WATER SAMENSTELLING overeenkomend met ; OMEPRAZOL

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

A02BC01

INN (Algemene Internationale Benaming):

OMEPRAZOLE SODIUM, 0-WATER COMPOSITION corresponding to ; OMEPRAZOLE

farmaceutische vorm:

Poeder en oplosmiddel voor oplossing voor injectie

Samenstelling:

CITROENZUUR 1-WATER (E 330) ; MACROGOL 400 ; NATRIUMHYDROXIDE (E 524) ; STIKSTOF (HEAD SPACE) (E 941) ; WATER VOOR INJECTIE,

Toedieningsweg:

Parenteraal, Intraveneus gebruik

Therapeutisch gebied:

Omeprazole

Product samenvatting:

Hulpstoffen: CITROENZUUR 1-WATER (E 330); MACROGOL 400; NATRIUMHYDROXIDE (E 524); STIKSTOF (HEAD SPACE) (E 941); WATER VOOR INJECTIE;

Autorisatie datum:

2009-05-19

Bijsluiter

Sandoz B.V.
Page 1/13
Omeprazol Sandoz
®
injectie 40, poeder en
oplosmiddel voor oplossing voor injectie 40 mg
RVG 33289
V13
1.3.1.3 Bijsluiter
Mei 2020
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OMEPRAZOL SANDOZ
® INJECTIE 40 MG, POEDER EN OPLOSMIDDEL VOOR OPLOSSING VOOR INJECTIE
omeprazolnatrium
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 and solvent for solution for
injection 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).
Do not use [nationally completed name] if any of the above apply to
you. If you are not sure, talk to
your doctor, nurse or pharmacist before you are given this medicine.

Productkenmerken

Sandoz B.V.
Page 1/13
Omeprazol Sandoz injectie 40 mg, poeder en
oplosmiddel voor oplossing voor injectie
RVG 33289
V12
1.3.1.1 Samenvatting van de productkenmerken
Mei 2020
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Omeprazol Sandoz injectie 40 mg, poeder en oplosmiddel voor oplossing
voor injectie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder for injection contains omeprazole sodium,
equivalent to 40 mg omeprazole.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
The powder for solution for injection is a white to almost white
powder.
The solvent for solution for injection is clear solution.
The reconstituted solution has a pH of about 8.6
The reconstituted solution, diluted 1:1 with water, has an osmolarity
of about 1.128 Osmol/kg
4.
CLINICAL PARTICULARS
_4.1_
_ _
_ THERAPEUTIC INDICATIONS _
_ _
[nationally completed name] for intravenous use is indicated in
adults, as an alternative to oral
therapy in:
•
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
•
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
Sandoz B.V.
Page 2/13
Omeprazol Sandoz injectie 40 mg, poeder en
oplosmiddel voor oplossing voor injectie
RVG 33289
V12
1.3.1.1 Samenvatting van de productkenmerken
Mei 2020
_4.2_
_ _
_POSOLOGY AND METHOD OF ADMINISTRATION _
_ _
Posology
_Adults _
_Alternative to oral therapy _
In patients where the use of oral medicinal products is inappropriate,
[nationally completed name] IV
4