RANITIDINE SANDOZ ranitidine 50mg/5mL (as hydrochloride) concentrated injection ampoules

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

有効成分:

ranitidine hydrochloride

から入手可能:

Sandoz Pty Ltd

認証ステータス:

Registered

情報リーフレット

RANITIDINE SANDOZ
®
INJECTION
1
RANITIDINE SANDOZ
®
INJECTION
_ranitidine hydrochloride injection _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Ranitidine Sandoz
Injection.
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 having Ranitidine
Sandoz Injection 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 RANITIDINE
SANDOZ INJECTION IS
USED FOR
The name of your medicine is
Ranitidine Sandoz Injection. It
contains the active ingredient
ranitidine (as hydrochloride).
Ranitidine Sandoz Injection is used
to treat a variety of conditions. If you
are unsure why you have been
prescribed Ranitidine Sandoz
Injection, talk to your doctor.
Ranitidine Sandoz Injection is used
to treat 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.
These can be caused in part by too
much acid being made in the
stomach.
Ranitidine Sandoz Injection is also
used to help stop ulcers from coming
back.
Ranitidine Sandoz Injection is 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.
Ranitidine Sandoz Injection 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 and reflux disease.
Ranitidine Sandoz Injection may be
used to treat scleroderma
oesophagitis. Scleroderma is a rare
conditio

製品の特徴

190808-ranitidine-sandoz-inj-pi
Page 1 of 9
AUSTRALIAN PRODUCT INFORMATION
RANITIDINE SANDOZ
® (RANITIDINE HYDROCHLORIDE) CONCENTRATED
INJECTION
1.
NAME OF THE MEDICINE
Ranitidine hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
Ranitidine
Sandoz
concentrated
injection
ampoule
contains
56
mg
of
ranitidine
hydrochloride equivalent to 50 mg of ranitidine in 5 mL ampoules.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Ranitidine Sandoz concentrated injection is clear brownish-yellow
solution.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
•
Short-term treatment of proven duodenal ulcer and gastric ulcer,
including intravenous
use for prophylaxis against recurrent haemorrhage
•
Maintenance treatment to reduce the risk of relapse in duodenal ulcer
•
Maintenance treatment for periods up to one year to reduce the risk of
relapse in patients
with documented healing of benign gastric ulcer
•
Treatment of gastrinoma (Zollinger-Ellison syndrome)
•
Short-term symptomatic treatment of reflux oesophagitis unresponsive
to conservative
anti-reflux measures and simple drug therapies such as antacids
•
Maintenance treatment to reduce the risk of relapse of reflux
oesophagitis
•
Treatment of scleroderma oesophagitis.
The intravenous injection is indicated where oral treatment is
inappropriate.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
Ranitidine Sandoz Injection may be given as either a slow intravenous
injection of 50 mg (e.g.
5 mL diluted to 20 mL 0.9% sodium chloride and given as a slow
injection over not less than
five minutes), which may be repeated every six to eight hours; or as
an intravenous infusion at
a rate of 25 mg per hour for two hours; the infusion may be repeated
at six to eight hour
intervals.
_Stability in intravenous infusion fluids _
Ranitidine Sandoz Injection has been shown to be physically and
chemically compatible with
the following intravenous infusion fluids: 0.9% Sodium Chloride BP, 5%
Glucose BP, 0.18%
Sodium Chloride