PANTOPRAZOLE SANDOZ pantoprazole (as sodium sesquihydrate) 40 mg powder for injection vial

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

pantoprazole sodium sesquihydrate, Quantity: 45.12 mg (Equivalent: pantoprazole, Qty 40 mg)

Verfügbar ab:

Sandoz Pty Ltd

INN (Internationale Bezeichnung):

Pantoprazole sodium

Darreichungsform:

Injection, powder for

Zusammensetzung:

Excipient Ingredients: nitrogen

Verabreichungsweg:

Intravenous

Einheiten im Paket:

10 vials per carton, One vial per carton

Verschreibungstyp:

(S4) Prescription Only Medicine

Anwendungsgebiete:

Pantoprazole Sandoz is indicated for short-term use where oral therapy is not appropriate for the following conditions: 1. Symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion, e.g. duodenal ulcer, gastric ulcer, reflux oesophagitis, gastrointestinal lesions refractory to H2 blockers, Zollinger-Ellison Syndrome. 2. Maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis. Note: Patients who gastric or duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs require treatment with anti-microbial agents in addition to anti-secretory medicines, whether on first presentation or recurrence.

Produktbesonderheiten:

Visual Identification: White to yellowish powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Berechtigungsstatus:

Licence status A

Berechtigungsdatum:

2009-04-21

Gebrauchsinformation

PANTOPRAZOLE SANDOZ
®
1
PANTOPRAZOLE SANDOZ
®
INJECTION
_Pantoprazole sodium _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Pantoprazole
Sandoz.
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 taking 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.
WHAT
PANTOPRAZOLE
SANDOZ IS USED
FOR
This medicine is used to treat
•
ULCERS
Pantoprazole Sandoz is used to treat
and help heal duodenal and gastric
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.
These can be caused in part by too
much acid being made in the
stomach.
•
REFLUX DISEASE
Pantoprazole Sandoz is also used to
treat reflux oesophagitis or reflux
disease. This can be caused by
washing back (reflux) of food and
acid from the stomach into the food
pipe, also known as the oesophagus.
Reflux can cause a burning sensation
in the chest rising up to the throat,
also known as heartburn.
Pantoprazole Sandoz is also used to
prevent reflux oesophagitis from
coming back.
•
ZOLLINGER-ELLISON SYNDROME
Pantoprazole Sandoz is used to treat
a rare condition called Zollinger-
Ellison syndrome, where the stomach
produces very large amounts of acid,
much more than in ulcers and reflux
disease.
This medicine contains the active
ingredient pantoprazole sodium.
Pantoprazole sodium belongs to a
group of medicine called proton
pump inhibitors (PPIs). It works by
decreasing the amount of acid the
stomach makes to give relief from
the symptoms and allow healing to
take place.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it

Fachinformation

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Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION
PANTOPRAZOLE SANDOZ
® (PANTOPRAZOLE SODIUM) POWDER FOR
INJECTION VIAL
1
NAME OF THE MEDICINE
Pantoprazole sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pantoprazole Sandoz 40 mg powder for injection contains 42.29 mg of
pantoprazole sodium
equivalent to 40 mg pantoprazole.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Powder for injection.
Pantoprazole sodium is a white to off-white amorphous powder.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Pantoprazole Sandoz is indicated for short-term use where oral therapy
is not appropriate for
the following conditions:
1. Symptomatic improvement and healing of gastrointestinal diseases
which require a reduction
in acid secretion, e.g. duodenal ulcer, gastric ulcer, reflux
oesophagitis, gastrointestinal lesions
refractory to H
2
blockers, Zollinger-Ellison Syndrome.
2. Maintenance of healed reflux oesophagitis in patients previously
treated for moderate to
severe reflux oesophagitis.
_Note: _
Patients whose gastric or duodenal ulceration is not associated with
ingestion of non-
steroidal anti-inflammatory drugs require treatment with
anti-microbial agents in addition to
anti-secretory medicines, whether on first presentation or recurrence.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_ADULTS _
Duodenal ulcer, gastric ulcer, gastrointestinal lesions
refractory to H
2
blockers, Zollinger-Ellison syndrome
40 mg per day
Reflux oesophagitis
20 - 40 mg per day
Intravenous Pantoprazole Sandoz should be replaced with oral therapy
as soon as practicable.
PREPARATION FOR USE
A ready-to-use solution is prepared by injecting 10 mL Sodium Chloride
Intravenous Infusion
0.9% into the vial containing the dry powder. This solution may be
administered directly or
may be administered after mixing with 100 mL Sodium Chloride
Intravenous Infusion 0.9%.
210730-pantoprazole-sandoz -pi
Page 2 of 14
After preparation, the solution should be administered over 2 to 1