ESOMEPRAZOLE SUN esomeprazole sodium 40mg powder for injection glass vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

esomeprazole sodium, Quantity: 42.6 mg (Equivalent: esomeprazole, Qty 40 mg)

Available from:

Sun Pharma ANZ Pty Ltd

INN (International Name):

Esomeprazole sodium

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: disodium edetate; sodium hydroxide

Administration route:

Intravenous

Units in package:

1, 10

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 ? Esomeprazole SUN should be replaced with oral therapy as soon as practicable.

Product summary:

Visual Identification: A white to off white lyophilized cake filled in 5ml colorless type-1 tubular glass vial with grey rubber stopper and 20mm grey flip off aluminium seal.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-01-14

Patient Information leaflet

ESOMEPRAZOLE SUN
_esomeprazole sodium _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask
about Esomeprazole SUN. It does
not contain all the information that
is known about Esomeprazole
SUN.
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 SUN 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 SUN
IS USED FOR
Esomeprazole SUN will only be
used if you are unable to take
tablets.
_REFLUX OESOPHAGITIS _
Esomeprazole SUN 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
SUN can be injected into your
veins to treat these bleeding
ulcers. Treatment with
Esomeprazole SUN 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 SUN
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 SUN may also
be used to help and prevent
ulcers caused by NSAIDs.
HOW ESOMEPRAZOLE
SUN WORKS
Esomeprazole SUN is a type
of medicine called a proton-
pump inhibitor.
Esomeprazole SUN works by
decreasing the amount of acid
made by the stomach,

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – ESOMEPRAZOLE SUN
(ESOMEPRAZOLE SODIUM) POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Esomeprazole Sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Esomeprazole SUN (esomeprazole sodium) is available as a powder for
solution that may be
administered
by
either
intravenous
injection
or
intravenous
infusion.
Each
vial
contains
esomeprazole sodium 42.5 mg, equivalent to 40 mg esomeprazole.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Esomeprazole SUN is available as a powder for solution that may be
administered by either
intravenous injection or intravenous infusion.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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
ESOMEPRAZOLE SUN SHOULD BE REPLACED WITH ORAL THERAPY AS SOON AS
PRACTICABLE.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Esomeprazole SUN should only be used where oral medication is
inappropriate eg. in severely ill
patients.
Treatment with Esomeprazole SUN 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 SUN should be discontinued and the therapy should be
continued orally.
Contains no antimicrobial agent. Esomeprazole SUN is for single use in
one patient only. Discard
any remaining contents.
1
GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
_TREATMENT OF EROSIVE REFLUX OESOPHAGITIS _
40 mg once daily.
The dura