ESOMEPRAZOLE AN esomeprazole (as sodium) 40 mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

esomeprazole sodium, Quantity: 42.5 mg (Equivalent: esomeprazole, Qty 40 mg)

Available from:

Juno Pharmaceuticals Pty Ltd

INN (International Name):

Esomeprazole sodium

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: sodium hydroxide; water for injections; disodium edetate

Administration route:

Intravenous

Units in package:

50 x 10mL, 10 x 10mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

The short-term management of Gastro-Oesophageal Reflux Disease (GORD) in patients with oesophagitis and/or severe symptoms of reflux as an alternative when oral therapy is inappropriate.,Prevention of rebleeding in patients following therapeutic endoscopy for acute, bleeding gastric or duodenal ulcers.,Short-term management in patients requiring continued non-steroidal anti-inflammatory drug (NSAID) therapy when oral therapy is inappropriate:,? healing of gastric ulcers associated with NSAID therapy,? prevention of gastric and duodenal ulcers associated with NSAID therapy, in patients at risk,NOTE: Esomeprazole IV should be replaced with oral therapy as soon as practicable.

Product summary:

Visual Identification: Vial containing a white or almost white porous lyophilised powder.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2014-01-30

Patient Information leaflet

Esomeprazole AN CMI
1
ESOMEPRAZOLE AN
_Esomeprazole sodium_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask
about Esomeprazole AN. It does
not contain all the information
that is known about
Esomeprazole AN.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor will have
weighed the risks of your being
given Esomeprazole AN against
the benefits they expect it will
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT
ESOMEPRAZOLE
AN IS USED FOR
Esomeprazole AN will only be
used if you are unable to take
tablets.
_REFLUX OESOPHAGITIS_
Esomeprazole AN is used to treat
reflux oesophagitis or reflux
disease in the short-term. This
can be caused by "washing back"
(reflux) of food and acid from
the stomach into the food pipe
(oesophagus).
Reflux can cause a burning
sensation in the chest rising up to
the throat, also known as
heartburn.
_BLEEDING PEPTIC ULCERS_
Peptic ulcers are ulcers in the
stomach or duodenum (tube
leading out from the stomach).
When these ulcers become
severe enough, they start to
bleed. Esomeprazole AN can be
injected into your veins to treat
these bleeding ulcers. Treatment
with Esomeprazole AN should
be followed with other therapy to
reduce the amount of acid made
by the stomach. This is to help
your ulcer/s to heal.
_UPPER GASTROINTESTINAL _
_SYMPTOMS ASSOCIATED _
_WITH NON-STEROIDAL ANTI- _
_INFLAMMATORY DRUGS _
_(NSAIDS) THERAPY_
If you are unable to eat or drink,
Esomeprazole AN may be given
to treat the symptoms of pain or
discomfort in the stomach caused
by NSAIDs (medicines used to
treat
pain
or
inflammation).
Esomeprazole AN may also be
used to help and prevent ulcers
caused by NSAIDs.
HOW
ESOMEPRAZOLE
AN WORKS
Esomeprazole AN is a type of
medicine called a proton-pump
inhibitor.
Esomeprazole AN works by
decreasing the amount of acid
made by the stomach, t

Summary of Product characteristics

Australian Product Information
Esomeprazole AN PI v7.0
Page | 1
AUSTRALIAN PRODUCT INFORMATION –
ESOMEPRAZOLE AN (ESOMEPRAZOLE (AS SODIUM) 40MG)
POWDER FOR INJECTION
_ _
1 NAME OF THE MEDICINE
Esomeprazole AN contains esomeprazole sodium
2-3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL
FORM
Esomeprazole sodium is a white to yellowish white solid.
Esomeprazole is a proton pump inhibitor and is a substituted
benzimidazole. Esomeprazole
is the S-isomer of omeprazole. It is optically stable _in vivo_, with
negligible conversion to the
R-isomer.
ESOMEPRAZOLE AN is available as a white or almost white lyophilized
powder for injection.
Each vial contains esomeprazole sodium 42.5 mg, equivalent to 40 mg
esomeprazole,
disodium edetate 1.0 mg and sodium hydroxide q.s. for pH adjustment.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The short-term management of Gastro-Oesophageal Reflux Disease (GORD)
in patients with
oesophagitis and/or severe symptoms of reflux as an alternative when
oral therapy is
inappropriate.
Prevention of rebleeding in patients following therapeutic endoscopy
for acute, bleeding
gastric or duodenal ulcers.
Short-term management in patients requiring continued non-steroidal
anti-inflammatory drug
(NSAID) therapy when oral therapy is inappropriate:
−
healing of gastric ulcers associated with NSAID therapy
−
prevention of gastric and duodenal ulcers associated with NSAID
therapy, in
patients at risk
NOTE: ESOMEPRAZOLE IV SHOULD BE REPLACED WITH ORAL THERAPY AS SOON AS
PRACTICABLE.
4.2 DOSE AND METHOD OF ADMINISTRATION
_DOSAGE _
Intravenous esomeprazole should only be used where oral medication is
inappropriate e.g. in
severely ill patients.
Treatment with esomeprazole IV can be given for up to 10 days as part
of a full treatment
period for the specified indications. When oral therapy is possible or
appropriate, intravenous
therapy with esomeprazole should be discontinued and the therapy
should be continued
orally.
ESOMEPRAZOLE AN powder for injection contains no antimicrobial