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

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

pantoprazole sodium, Quantity: 42.29 mg (Equivalent: pantoprazole, Qty 40 mg)

Tersedia dari:

Sun Pharma ANZ Pty Ltd

INN (Nama Internasional):

Pantoprazole sodium

Bentuk farmasi:

Injection, powder for

Komposisi:

Excipient Ingredients:

Rute administrasi :

Intravenous

Unit dalam paket:

One vial, Ten vials

Jenis Resep:

(S4) Prescription Only Medicine

Indikasi Terapi:

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 whose gastric or duodenal ulceration is not associated with ingestion of nonsteroidal anti-inflammatory drugs require treatment with antimicrobial agents in addition to anti-secretory drugs, whether on first presentation or recurrence.

Ringkasan produk:

Visual Identification: White to off-white coloured lyophilized cake in a colourless glass vial with a grey rubber stopper and sealed with a red aluminium flip-off cap; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Status otorisasi:

Licence status A

Tanggal Otorisasi:

2011-08-16

Selebaran informasi

PANTOPRAZOLE SUN PI V3.0
1 of 5
PANTOPRAZOLE SUN
_Pantoprazole (as Sodium) _
CON
SUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET?
This leafl
et answers some
common questions about
PANTOPRAZOLE SUN. 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
PANTOPRAZOLE SUN
against the benefits this
medicine is expected to have
for you.
Use PANTOPRAZOLE SUN
as directed and follow the
advice given in the leaflet.
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
PANTOPRAZOLE
SUN IS USED FOR
ULCER
S
PANTOPRAZOLE SUN 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 SUN 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 SUN is
also used to prevent reflux
oesophagitis from coming
back.
ZOLLINGER-ELLISON
SYNDROME
PANTOPRAZOLE
SUN 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.
PANTOPRAZOLE SUN
belongs to a group of
medicines called proton pump
inhibitors (PPIs).
PANTOPRAZOLE SUN
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
PANTOPRAZOLE SUN HAS
BEEN PRESCRIBED FO

Karakteristik produk

PANTOPRAZOLE SUN PI v5.0
1
AUSTRALIAN PRODUCT INFORMATION
PANTOPRAZOLE SUN PANTOPRAZOLE (AS SODIUM)
POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Pantoprazole (present as pantoprazole sodium)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pantoprazole 40mg powder for injection contains 42.3mg pantoprazole
sodium. Pantoprazole
sodium is a white to off white amorphous hygroscopic powder.
Solubility is low at neutral pH
and increases with increasing pH.
3
PHARMACEUTICAL FORM
Pantoprazole SUN 40mg powder for injection appears as a white to off
white coloured
lyophilized cake.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
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
nonsteroidal anti-inflammatory drugs require treatment with
antimicrobial agents in addition
to anti-secretory drugs, whether on first presentation or recurrence
4.2
D
OSE AND METHOD OF ADMINISTRATION
_DUODENAL ULCER, GASTRIC ULCER, GASTROINTESTINAL LESIONS REFRACTORY TO
H_
_2_
_-BLOCKERS, _
_ZOLLINGER-ELLISON SYNDROME. _
40 mg/day.
_REFLUX OESOPHAGITIS. _
20 to 40 mg/day.
Intravenous Pantoprazole should be replaced with oral therapy as soon
as practicable.
RENAL IMPAIRMENT
The usual daily dose of 20 or 40 mg can be given.
HEPATIC IMPAIRMENT
Pantoprazole is contraindicated in patients with cirrhosis or severe
liver disease (see
C
ONTRAINDICATIONS
). With milder forms of liver disease, the initial dose should be
reduced.
PANTOPRAZOLE SUN PI v5.0
2
USE IN CHILDREN
There are no data currently available on the use of pantoprazole in
children.
USE IN THE ELDERLY
The usua