NEXIUM esomeprazole 40mg (as magnesium trihydrate) tablet bottle

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

esomeprazole magnesium trihydrate

Disponibil de la:

AstraZeneca Pty Ltd

Statutul autorizaţiei:

Registered

Caracteristicilor produsului

NEXIUM
®
Product Information
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AUSTRALIAN PRODUCT INFORMATION
NEXIUM
®
(ESOMEPRAZOLE MAGNESIUM TRIHYDRATE)
MULTIPLE UNIT PELLET SYSTEM
1.
NAME OF THE MEDICINE
Esomeprazole magnesium trihydrate.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient in NEXIUM is esomeprazole magnesium trihydrate,
a
substituted benzimidazole.
The NEXIUM 20 mg and 40 mg tablets are comprised of enteric coated
pellets
containing esomeprazole (as magnesium trihydrate). Contains sugars.
NEXIUM 10 mg granules for oral suspension are comprised of enteric
coated pellets
containing esomeprazole (as magnesium trihydrate). Contains sugars.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
NEXIUM 20 MG TABLETS are a light pink, oblong, biconvex, film-coated
tablet
engraved 20 mg on one side and A/EH on the other side. Each tablet
contains
esomeprazole magnesium trihydrate 22.3 mg as enteric-coated pellets.
NEXIUM 40 MG TABLETS are a pink, oblong, biconvex, film-coated tablet
engraved 40
mg on one side and A/EI on the other side. Each tablet contains
esomeprazole
magnesium trihydrate 44.5 mg as enteric-coated pellets.
NEXIUM 10 MG GRANULES FOR ORAL SUSPENSION are pale yellow fine
granules
(brownish granules may be visible) in a unit dose sachet. Each sachet
contains
esomeprazole magnesium trihydrate 11.1 mg as enteric-coated pellets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NEXIUM is indicated for:
GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
•
treatment of erosive reflux oesophagitis
NEXIUM
®
Product Information
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•
long-term management of patients with healed oesophagitis to prevent
relapse
•
symptomatic treatment of gastro-oesophageal reflux disease (GORD)
PATIENTS REQUIRING NSAID THERAPY
•
short-term treatment of upper gastrointestinal symptoms associated
with
non-steroidal anti-inflammatory drug NSAID (non-selective and COX-2
selective) therapy.
•
healing of gastric ulcers associated with non-steroidal
anti-inflam