NEXIUM

Land: Indonesien

Språk: indonesiska

Källa: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktiva substanser:

ESOMEPRAZOLE SODIUM

Tillgänglig från:

ASTRAZENECA INDONESIA - Indonesia

INN (International namn):

ESOMEPRAZOLE SODIUM

Dos:

42.5 MG

Läkemedelsform:

SERBUK INJEKSI

Enheter i paketet:

DUS, 1 VIAL @ 40 MG

Tillverkad av:

ASTRAZENECA AB - Sweden

Tillstånd datum:

2021-12-31

Produktens egenskaper

NEXIUM
®
40
MG
_esomeprazole_
Powder for solution for
injection/infusion
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 40 mg vial contains esomeprazole sodium 42.5 mg, equivalent to
esomeprazole 40
mg.
For excipients, see section _List of excipients_.
PHARMACEUTICAL FORM
Powder for solution for injection/infusion
White to off-white porous cake or powder
THERAPEUTIC INDICATION
NEXIUM for injection and infusion is indicated for
•
Gastric antisecretory treatment when the oral route is not possible,
such as:
−
gastroesophageal reflux disease in patients with esophagitis and/or
severe
symptoms of reflux.
−
healing of gastric ulcers associated with NSAID
therapy.
•
The short-term maintenance of haemostasis and prevention of rebleeding
in patients
following therapeutic endoscopy for acute bleeding gastric or duodenal
ulcers.
POSOLOGY AND METHOD OF ADMINISTRATION
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.
Usually the IV treatment duration is short and transfer to oral
treatment should be made as
soon as possible.
_Maintenance of haemostasis and 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 over 3 days (72 hours).
The parenteral treatment period should be followed by acid-suppression
therapy with
NEXIUM 40 mg tablets once daily for 4 weeks (see prescribing
information for NEXIUM
gastro-resistant tablets).
DISETUJUI OLEH BPOM : 26/10/2021
ID : EREG10042212100084
METHOD OF ADMINISTRATION
For preparation of reconsti