NEXIUM POWDER FOR SOLUTION FOR INJECTION AND INFUSION 40 mg

देश: सिंगापुर

भाषा: अंग्रेज़ी

स्रोत: HSA (Health Sciences Authority)

सक्रिय संघटक:

ESOMEPRAZOLE

थमां उपलब्ध:

ASTRAZENECA SINGAPORE PTE LTD

ए.टी.सी कोड:

A02BC05

डोज़:

40 mg

फार्मास्यूटिकल फॉर्म:

INJECTION, POWDER, FOR SOLUTION

रचना:

ESOMEPRAZOLE 40 mg

प्रशासन का मार्ग:

INTRAVENOUS

प्रिस्क्रिप्शन प्रकार:

Prescription Only

द्वारा बनाया गया:

ASTRAZENECA AB

प्राधिकरण का दर्जा:

ACTIVE

प्राधिकरण की तारीख:

2004-12-01

सूचना पत्रक

 
1 
04/AB/SG/GI.000-107-142.7.0 
NEXIUM 40 MG  
esomeprazole 
Powder for solution for injection/infusion 
COMPOSITION 
Each vial contains esomeprazole 40 mg (as sodium salt). 
PHARMACEUTICAL FORM 
Powder for solution for injection/infusion 
White to off-white porous cake or powder 
THERAPEUTIC INDICATIONS 
Nexium for injection and infusion is indicated as an alternative to
oral therapy when oral 
intake is not appropriate: 
  For gastroesophageal reflux disease in patients with
esophagitis and/or severe 
symptoms of reflux. 
  For healing of gastric ulcers associated with
NSAID therapy. 
  For prevention of gastric and duodenal ulcers associated
with NSAID therapy, in 
patients at risk. Patients are considered to be at risk due to
their age (≥60) and/or 
documented history of gastric and/or duodenal ulcers. Controlled
studies do not 
extend beyond 6 months. 
  Prevention
of rebleeding following therapeutic endoscopy for acute
bleeding gastric 
or duodenal ulcers. 
POSOLOGY AND METHOD OF ADMINISTRATION 
_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._  _

2 
Usually the IV treatment duration is short and transfer to oral
treatment should be made as 
soon as possible. 
_Prevention of rebleeding of gastric and duodenal ulcers _
Following therapeutic endoscopy for acute bleeding gastric or
duodenal ulcers, 80 mg should 
be administered as a bo

उत्पाद विशेषताएं

1
NEXIUM
®
(ESOMEPRAZOLE)
1.
NAME OF THE MEDICINAL PRODUCT
Nexium 40 mg
Esomeprazole
Powder for solution for injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains esomeprazole 40 mg (as sodium salt).
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 as an alternative to
oral therapy when oral
intake is not appropriate:
•
For gastroesophageal reflux disease in patients with esophagitis
and/or severe symptoms
of reflux.
•
For healing of gastric ulcers associated with NSAID therapy.
•
For prevention of gastric and duodenal ulcers associated with NSAID
therapy, in
patients at risk. Patients are considered to be at risk due to their
age (≥60) and/or
documented history of gastric and/or duodenal ulcers. Controlled
studies do not extend
beyond 6 months.
•
Prevention of rebleeding following therapeutic endoscopy for acute
bleeding gastric or
duodenal ulcers.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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.
_ _
_ _
2
Usually the IV treatment duration is short and transfer to oral
treatment should be made as
soon as possible.
PREVENTION OF REBLEEDING OF GASTRIC AND DUODENAL ULCERS
Following therapeutic endoscopy for acute bleeding gastric or duodenal
ulcers, 80 mg should
be administered as a bolus infusion over 30 minutes, followed by a
continuous intravenous
infusion of 8 mg/h given ove