OMEPRAZOLE SANDOZ IV omeprazole (as sodium) 40mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

omeprazole sodium, Quantity: 42.56 mg (Equivalent: omeprazole, Qty 40 mg)

Available from:

Sandoz Pty Ltd

INN (International Name):

omeprazole sodium

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: nitrogen; sodium hydroxide; disodium edetate

Administration route:

Intravenous

Units in package:

5 x 10mL vials

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Short-term use when omeprazole cannot be administered orally for, or during, the following conditions. Treatment of duodenal ulcer, gastric ulcer and ulcerative oesophagitis. Treatment of Zollinger-Ellison syndrome. Long-term prevention of relapse in healed severe reflux oesophagitis (grades 3 and 4), and gastric and duodenal peptic ulceration in patients proven to be Helicobacter pylori negative whose ulceration is not associated with ingestion of NSAIDs, when oral therapy is not possible. Omeprazole Sandoz IV should be replaced with oral therapy as soon as practicable

Product summary:

Visual Identification: White to almost white powder.; 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:

2008-02-15

Patient Information leaflet

OMEPRAZOLE SANDOZ IV
1
OMEPRAZOLE
SANDOZ IV
_Omeprazole Powder for Injection _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Omeprazole Sandoz
IV. It does not contain all the
available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT OMEPRAZOLE
SANDOZ IV IS USED FOR
THIS MEDICINE IS USED TO TREAT AND
HELP HEAL PEPTIC ULCERS.
Depending on the position of the
ulcer it is called a gastric or duodenal
ulcer. A gastric ulcer occurs in the
stomach. A duodenal ulcer occurs in
the duodenum which is the tube
leading out of the stomach.
Ulcers can be caused in part by too
much acid being made in the
stomach.
THIS MEDICINE IS ALSO USED TO HELP
PREVENT GASTRIC OR DUODENAL ULCERS
FROM COMING BACK.
_REFLUX OESOPHAGITIS _
This medicine is used to treat and
prevent reflux oesophagitis. This can
be caused by "washing back" (reflux)
of food and acid from the stomach
into the oesophagus (food pipe).
Reflux can cause a burning sensation
in the chest rising up to the throat,
also known as heartburn.
_ZOLLINGER-ELLISON SYNDROME _
THIS MEDICINE IS ALSO USED TO TREAT
A RARE CONDITION CALLED ZOLLINGER-
ELLISON SYNDROME, WHERE THE
STOMACH PRODUCES VERY LARGE
AMOUNTS OF ACID, MUCH MORE THAN
IN ULCERS OR REFLUX DISEASE.
_HOW OMEPRAZOLE SANDOZ IV _
_WORKS _
Omeprazole Sandoz IV belongs to a
group of medicines called proton
pump inhibitors. It works by
decreasing the amount of acid made
by the stomach. This does not stop
food being digested in the normal
way. It helps reduce the pain and also
allows the ulcer to heal.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for

Summary of Product characteristics

191120-Omeprazole Sandoz IV-pi
Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION
OMEPRAZOLE SANDOZ ® (OMEPRAZOLE SODIUM) IV 40 MG POWDER FOR
INJECTION
1.
NAME OF THE MEDICINE
Omeprazole sodium
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of Omeprazole Sandoz IV powder for injection contains
omeprazole sodium, which
occurs as a white or almost white powder, hygroscopic, freely soluble
in water and in alcohol,
soluble in propylene glycol, very slightly soluble in methylene
chloride. The reconstituted
solution appears as a clear, colourless solution.
Each 10 mL glass contains 42.56 mg omeprazole sodium equivalent to 40
mg omeprazole.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Omeprazole Sandoz
®
IV 40 mg powder for injection.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Short-term use when omeprazole cannot be administered orally for, or
during, the following
conditions:
•
treatment of duodenal ulcer, gastric ulcer and ulcerative oesophagitis
•
treatment of Zollinger-Ellison syndrome
•
long-term prevention of relapse in healed severe reflux oesophagitis
(grades 3 and 4),
and gastric and duodenal peptic ulceration in patients proven to be
_Helicobacter pylori_
negative, whose ulceration is not associated with ingestion of NSAIDs,
when oral
therapy is not possible.
Omeprazole Sandoz IV should be replaced with oral therapy as soon as
practicable.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
Omeprazole Sandoz IV should only be used where oral medication is
inappropriate, e.g. in
severely ill patients. Omeprazole Sandoz IV should be replaced with
oral therapy as soon as
practicable. If intravenous therapy is necessary for more than five
days, consideration should
be given to reducing the daily dose.
The product is for single use in one patient only.
_DUODENAL ULCER, GASTRIC ULCER AND ULCERATIVE REFLUX OESOPHAGITIS _
Omeprazole Sandoz IV 40 mg given intravenously once daily is
recommended. This produces
an
immediate
decrease
in
intragastric
acidity
and