Nexium 40 mg Pulver till injektions-/infusionsvätska, lösning

Šalis: Švedija

kalba: švedų

Šaltinis: Läkemedelsverket (Medical Products Agency)

Veiklioji medžiaga:

esomeprazolnatrium

Prieinama:

Orifarm AB

ATC kodas:

A02BC05

INN (Tarptautinis Pavadinimas):

esomeprazole sodium

Dozė:

40 mg

Vaisto forma:

Pulver till injektions-/infusionsvätska, lösning

Sudėtis:

esomeprazolnatrium 42,5 mg Aktiv substans

Recepto tipas:

Receptbelagt

Gydymo sritis:

Esomeprazol

Autorizacija statusas:

Avregistrerad

Leidimo data:

2005-07-20

Pakuotės lapelis

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PACKAGE LEAFLET: INFORMATION FOR THE USER
NEXIUM 40 MG POWDER FOR SOLUTION FOR INJECTION/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 Nexium is and what it is used for
2. What you need to know before Nexium is given to you
3. How Nexium is given to you
4. Possible side effects
5. How to store Nexium
6. Contents of the pack and other information
1. WHAT NEXIUM IS AND WHAT IT IS USED FOR
Nexium 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.
Nexium 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).
Nexium 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 NEXIUM IS GIVEN TO YOU
YOU MUST NOT BE GIVEN NEXIUM:
•
If you are allergic to eso

Prekės savybės

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1
1
NAME
OF
THE
MEDICINAL
PRODUCT
Nexium 40 mg Powder for solution for injection/infusion
2
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
Each vial contains esomeprazole 40 mg (as sodium salt).
Excipient(s) with known effect
This medicinal product contains <1 mmol sodium (23mg) per 40 mg, i.e.
essentially sodium free.
For the full list of excipients see section 6.1.
3
PHARMACEUTICAL
FORM
Powder for solution for injection/infusion
White to off-white porous cake or powder
4
CLINICAL
PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nexium for injection and infusion is indicated in adults for:
•
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.
Nexium for injection and infusion is indicated in children and
adolescents aged 1-18 years for:
•
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 should be treated with 40 mg once
daily. Patients treated
symptomatically for reflux disease should be treated with 20 mg once
daily.
_ _
For healing of gastric ulcers associated with NSAID therapy the usual
dose is 20 mg once daily. For
prevention of gastric and duodenal ulcers associated with NSAID
therapy, patients at risk should be
treated with 20 mg once daily.
_ _
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2
Usually the intravenous treatment duration is short an