Cativa 40 mg Pulver till infusionsvätska, lösning

País: Suecia

Idioma: sueco

Fuente: Läkemedelsverket (Medical Products Agency)

Ingredientes activos:

esomeprazolnatrium

Disponible desde:

Grünenthal GmbH

Código ATC:

A02BC05

Designación común internacional (DCI):

esomeprazole sodium

Dosis:

40 mg

formulario farmacéutico:

Pulver till infusionsvätska, lösning

Composición:

esomeprazolnatrium 42,5 mg Aktiv substans

clase:

Apotek

tipo de receta:

Receptbelagt

Área terapéutica:

Esomeprazol

Resumen del producto:

Förpacknings: Injektionsflaska, 1 st; Injektionsflaska, 10 st

Estado de Autorización:

Godkänd

Fecha de autorización:

2003-08-22

Información para el usuario

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
CATIVA 40 MG
POWDER FOR SOLUTION FOR INFUSION
esomeprazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Cativa is and what it is used for
2. What you need to know before Cativa is given to you
3. How Cativa is given to you
4. Possible side effects
5. How to store Cativa
6. Contents of the pack and other information
1. WHAT CATIVA IS AND WHAT IT IS USED FOR
Cativa contains a medicine called esomeprazole. This belongs to a
group of medicines called ‘proton
pump inhibitors’. They work by reducing the amount of acid that your
stomach produces.
Cativa is used for the short-term treatment of certain conditions,
when you are unable to have
treatment by mouth. It is used to treat the following conditions:
Adults

‘Gastroesophageal reflux disease’ (GERD). This is where acid from
the stomach escapes into the
gullet (the tube which connects your throat to your stomach) causing
pain, inflammation and
heartburn.

Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal
Anti-Inflammatory Drugs).
Cativa can also be used to stop stomach ulcers from forming if you are
taking NSAIDs.

Prevention of rebleeding following therapeutic endoscopy for acute
bleeding gastric or duodenal
ulcers.
Children and adolescents aged 1-18 years

‘Gastroesophageal reflux disease’ (GERD). This is where acid from
the stomach escapes into the
gullet (the tube which connects your throat to your stomach) causing
pain, inflammation and
heartburn.
2. WHAT YOU NEED TO KNOW BEFORE CATIVA IS GIVEN TO YOU
YOU MUST NOT BE GIVEN CATIVA:

If you are allergic to esomeprazole or any of th

Ficha técnica

1
Produktinformationen för Cativa 40 mg pulver till infusionsvätska,
lösning, MTnr 19346,
gäller vid det tillfälle då läkemedlet godkändes. Informationen
kommer inte att uppdateras
eftersom läkemedlet inte marknadsförs i Sverige. Av samma anledning
finns inte någon
svensk produktinformation.
Den engelska produktinformationen kommer dock att uppdateras för de
produkter där Sverige
är referensland.
Om läkemedelsnamnet i följande produktinformation inte stämmer med
namnet på
dokumentet, beror det på att läkemedlet i Sverige är godkänt under
ett annat namn.
2
SUMMARY OF THE PRODUCT CHARACTERISTICS
1
N
AME OF THE
M
EDICINAL
P
RODUCT
CATIVA 40 mg Powder for solution for infusion
2
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
Each vial contains esomeprazole 40 mg (as sodium salt).
Each vial contains <1 mmol sodium
For a full list of excipients see section 6.1.
3
P
HARMACEUTICAL
F
ORM
Powder for solution for infusion.
White to off-white porous cake or powder
4
C
LINICAL
P
ARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cativa for infusion is indicated for
_Adults_

gastric antisecretory treatment when the oral route is not possible,
such as:

gastroesophageal reflux disease (GERD) in patients with esophagitis
and/or severe
symptoms of reflux.

healing of gastric ulcers associate with NSAID therapy.

prevention of gastric and duodenal ulcers associated with NSAID
therapy, in patients
at risk.

prevention of rebleeding following therapeutic endoscopy for acute
bleeding gastric or
duodenal ulcers.
_Children and adolescents aged 1-18 years _

gastric antisecretory treatment when the oral route is not possible,
such as:

gastroesophageal reflux disease (GERD) in patients with erosive reflux
esophagitis
and/or severe symptoms of reflux.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
_Gastric antisecretory treatment when the oral route is not possible_
Patients who cannot take oral medication may be treated parenterally
with 20-40 mg once
daily. Patients with reflux oesophagitis sh