ONDANSETRON VIATRIS ondansetron (as hydrochloride dihydrate) 8 mg/4 mL solution for injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ondansetron hydrochloride dihydrate, Quantity: 10 mg (Equivalent: ondansetron, Qty 8 mg)

Available from:

Alphapharm Pty Ltd

INN (International Name):

Ondansetron hydrochloride dihydrate

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intravenous

Units in package:

5 x 4 mL ampoules

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: Glass amber ampoule contains colourless clear liquid, practically odourless, free of visible particles; Container Type: Ampoule; Container Material: Glass Type I Coloured; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2010-05-21

Patient Information leaflet

ONDANSETRON
ALPHAPHARM
_ondansetron hydrochloride dihydrate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you use ONDANSETRON
ALPHAPHARM solution for
injection.
This leaflet answers some common
questions about ONDANSETRON
ALPHAPHARM. It does not contain
all the available information.
It does not take the place of talking to
your doctor.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
ONDANSETRON ALPHAPHARM
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.
You may need to read it again.
WHAT ONDANSETRON
ALPHAPHARM IS
USED FOR
ONDANSETRON ALPHAPHARM
contains a medicine called
ondansetron. This belongs to a group
of medicines called Serotonin
receptor-3 antagonists.
ONDANSETRON ALPHAPHARM
is used to help stop the nausea (sick
feeling) and vomiting which can
occur after medical treatments and
operations.
ONDANSETRON ALPHAPHARM
should only be used to treat the
nausea and vomiting for which it has
been prescribed.
Your doctor may have prescribed
ONDANSETRON ALPHAPHARM
for another reason. If you want more
information, ask your doctor.
ONDANSETRON ALPHAPHARM
injection is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
ONDANSETRON
ALPHAPHARM
_WHEN YOU MUST NOT TAKE IT_
Do not take ONDANSETRON
ALPHAPHARM if you have an
allergy to:
•
any medicine containing (active
ingredient)
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE THIS MEDICINE IF YOU
ARE PREGNANT.
It may affect your developing baby if
you take it during pregnancy.
DO NOT BREAST-FEED IF YOU ARE
TAKING THIS MEDICINE.
The active ingredient in
ONDANSETRON ALPHAPHARM
passes into

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
ONDANSETRON ALPHAPHARM
_Ondansetron hydrochloride dihydrate _
1
NAME OF THE MEDICINE
Ondansetron hydrochloride dihydrate
2
&
3
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
AND
PHARMACEUTICAL FORM
Ondansetron Alphapharm solution for injection contains the following
excipients: citric acid monohydrate,
sodium citrate dihydrate, sodium chloride as well as 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 route of administration and dose
of ondansetron should be flexible in the
range of 8-32 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 in many patients. Higher
doses may be required in some patients, particularly those on high
dose cisplatin, and the doses should be adjusted
according to the severity of the emetogenic challenge. If required,
additional intravenous doses may be given up
to a maximum of 32 mg in 24 hours.
Maximum initial intravenous doses of 16mg should be given by slow
intravenous infusion over at least
15 minutes, since rapid intravenous administration of ondansetron has
been associated with a higher incidence of
transient vi