Ondansetron Kabi ondansetron hydrochloride dihydrate 4mg/2mL Solution for Injection glass ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ondansetron hydrochloride dihydrate, Quantity: 2.5 mg/mL (Equivalent: ondansetron, Qty 2 mg/mL)

Available from:

Fresenius Kabi Australia Pty Ltd

INN (International Name):

Ondansetron hydrochloride dihydrate

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium chloride; citric acid monohydrate; sodium citrate dihydrate; water for injections

Administration route:

Intravenous, Intramuscular

Units in package:

2mL x 1, 2mL x 10, 2mL x 5

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Ondansetron injection is indicated for the prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy. Ondansetron injection is also indicated for the prevention and treatment of post-operative nausea and vomiting.

Product summary:

Visual Identification: Clear and colourless solution.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure and restricted flow insert

Authorization status:

Registered

Authorization date:

2012-11-28

Patient Information leaflet

CMI for Ondansetron Kabi
Injection
Dec 2016
Filename: Ondansetron CMI (2016-12) - clean
Page 1 of 2
Change: PI Update
ONDANSETRON KABI
Ondansetron hydrochloride dihydrate
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you use Ondansetron Kabi
Injection.
This leaflet answers some common
questions about Ondansetron Kabi
Injection. It does not contain all of
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 expected benefits of you taking
Ondansetron Kabi Injection against
the risks this medicine could 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 ONDANSETRON KABI
IS USED FOR
Ondansetron Kabi Injection
contains a medicine called
ondansetron. This belongs to a
group of medicines called serotonin
receptor-3 antagonists.
Ondansetron Kabi Injection is used
to help stop the nausea (sick
feeling) and vomiting which can
occur after medical treatments and
operations.
Ondansetron Kabi Injection should
only be used to treat the nausea
and vomiting for which it has been
prescribed.
Your doctor may have prescribed
Ondansetron Kabi Injection for
another reason. If you want more
information, ask your doctor.
Ondansetron Kabi Injection is not
addictive.
BEFORE YOU ARE GIVEN
ONDANSETRON KABI
_DO NOT TAKE IF: _
You must not take Ondansetron
Kabi Injection if:

you are taking apomorphine
(used to treat Parkinson’s
disease).

you have ever had an allergic
reaction to ondansetron or any
of the ingredients listed toward
the end of this leaflet (See
"Ingredients").

you are pregnant, trying to
become pregnant or breast
feeding, unless your doctor says
it is safe.

the expiry date (EXP) printed on
the pack has passed.

the packaging is torn or shows
signs of tampering

the injection solution is coloured,
cloudy or lumpy.
_TELL YOUR DOCTOR

Summary of Product characteristics

Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION ONDANSETRON KABI
(ONDANSETRON HYDROCHLORIDE DIHYDRATE)
1
NAME OF THE MEDICINE
Ondansetron hydrochloride dihydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION / 3 PHARMACEUTICAL
FORM
Ondansetron takes the form of a white to off-white powder with a
melting point of 177°C.
It is sparingly soluble in water and in alcohol, soluble in methanol
and slightly soluble in
methylene chloride. It is soluble in saline (0.9% w/v) to about 8
mg/mL. The pKa of
ondansetron hydrochloride dihydrate as determined by a solubility
procedure is 7.4. The
distribution coefficient between n-octanol and water is pH dependent
with log D = 2.2 at
a pH of 10.6 and log D= 0.6 at a pH of 5.95.
Each ampoule of Ondansetron Kabi contains 2 mg/mL ondansetron (as
hydrochloride
dihydrate) as the active ingredient and the following excipients:
sodium chloride, citric
acid monohydrate, sodium citrate dihydrate, water for injections.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ondansetron injection is indicated for the prevention and treatment of
nausea and
vomiting induced by cytotoxic therapy and radiotherapy. Ondansetron
injection is also
indicated for the prevention and treatment of post-operative nausea
and vomiting.
4.2 DOSE AND METHOD OF ADMINISTRATION
The emetogenic potential of cancer treatment varies according to the
doses and
combinations
of
chemotherapy
and
radiotherapy
regimens
used.
The
dose
of
ondansetron should be flexible in the range of 8 to 32 mg a day and
selected as shown
below. The lowest effective dose should be used.
ADULTS
EMETOGENIC CHEMOTHERAPY AND RADIOTHERAPY
For the control of chemotherapy or radiotherapy induced emesis or
nausea in adults, a
single dose of 8 mg of ondansetron should be administered as a slow
intravenous
injection in not less than 30 seconds, immediately before treatment.
HIGHLY EMETOGENIC CHEMOTHERAPY
A single dose of ondansetron 8 mg by slow intravenous injection in not
less than
30 seconds, immediately before chemotherapy has been shown to be
effective i