SOMAC pantoprazole 40mg (as sodium) powder for injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pantoprazole sodium, Quantity: 42.3 mg (Equivalent: pantoprazole, Qty 40 mg)

Available from:

Takeda Pharmaceuticals Australia Pty Ltd

INN (International Name):

Pantoprazole sodium

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: sodium hydroxide; disodium edetate

Administration route:

Intravenous

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Short-term use where oral therapy is not appropriate for: 1. Symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion: 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 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 drugs, whether on first presentation or recurrence.

Product summary:

Visual Identification: White to almost white dry substance.; Container Type: Vial; Container Material: Other composite material; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2006-12-22

Patient Information leaflet

SOMAC
®
INJECTION
_pantoprazole sodium_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Somac.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
You should ensure that you speak to
your pharmacist or doctor to obtain
the most up to date information on
this medicine.
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
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT SOMAC IS USED
FOR
•
ULCERS
Somac 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
Somac 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.
Somac is also used to prevent
reflux oesophagitis from coming
back.
•
ZOLLINGER-ELLISON SYNDROME
Somac 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 belongs to a group of
medicines called proton pump
inhibitors (PPIs).
This medicine works by decreasing
the amount of acid the stomach
makes to give relief from the
symptoms and allow healing to take
place.
ASK YO

Summary of Product characteristics

SOMAC IV V13.0 (CCDS V9.0)
_ _
_ _
_Page 1 _
AUSTRALIAN PRODUCT INFORMATION
SOMAC ® (PANTOPRAZOLE SODIUM)
INJECTION
1
NAME OF THE MEDICINE
Pantoprazole sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Somac 40 mg injection, each vial contains 42.3 mg 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 hygroscopic
powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Short-term use where oral therapy is not appropriate for:
1. Symptomatic improvement and healing of gastrointestinal diseases
which require a reduction in
acid secretion:
• 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
drugs, whether on first presentation or recurrence.
4.2
DOSE AND METHOD OF ADMINISTRATION
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 Somac should be replaced with oral therapy as soon as
practicable.
SOMAC IV V13.0 (CCDS V9.0)
_ _
_ _
_Page 2 _
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% or 100 mL
Glucose Intravenous Infusion 5 or 10%. The resulting solution should
be used within 12 hours stored
at 2–8°C, and is for SINGLE USE ONLY.
After preparation, the solution should be adm