ONDANSETRON ACCORD ondansetron (as hydrochloride dihydrate) 4 mg/2 mL solution for injection pre-filled syringe

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

ondansetron hydrochloride dihydrate, Quantity: 4.99 mg (Equivalent: ondansetron, Qty 4 mg)

Tersedia dari:

Accord Healthcare Pty Ltd

Bentuk farmasi:

Injection, solution

Komposisi:

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

Rute administrasi :

Intravenous, Intramuscular

Unit dalam paket:

Pack of 1 pre-filled syringe

Jenis Resep:

(S4) Prescription Only Medicine

Indikasi Terapi:

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

Ringkasan produk:

Visual Identification: Clear, colourless solution in an amber glass pre-filled syringe; Container Type: Syringe; Container Material: Glass Type I Coloured; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status otorisasi:

Registered

Tanggal Otorisasi:

2020-11-09

Selebaran informasi

Ondansetron Accord – version 6
1
ONDANSETRON ACCORD
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I BEING GIVEN ONDANSETRON ACCORD?
Ondansetron Accord contains the active ingredient ondansetron. This
belongs to a group of medicines called
antiemetics/antinauseants. Ondansetron Accord is used to prevent the
nausea (feeling sick) and vomiting that may occur after
surgery or after therapy with anticancer medicines (chemotherapy) or
radiation.
For more information, see Section 1. Why am I being given Ondansetron
Accord?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN ONDANSETRON ACCORD?
Do not use if you have ever had an allergic reaction to an any
medicine containing ondansetron or any of the ingredients listed
at the end of this leaflet.
You should also not be given it if you are taking apomorphine (used to
treat Parkinson’s disease).
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Ondansetron Accord?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Ondansetron Accord and affect how it
works.
See Section 3. What if I am taking other medicines?
in the full CMI.
4.
HOW WILL I BE GIVEN ONDANSETRON ACCORD?
Ondansetron Accord is an injection and will be given to you by your
doctor or nurse.
More instructions can be found in Section 4. How do I use Ondansetron
Accord?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN ONDANSETRON ACCORD?
THINGS YOU
SHOULD DO
Tell your doctor before you take any other medicines, whether they
require a prescription or not
For more information, see Section 5. What should I know while I am
being given Ondansetron Accord? in the full CMI.
6.
ARE THERE ANY SIDE EFFECTS?
All medicines can have side effects. If you do experience

Karakteristik produk

Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION
ONDANSETRON ACCORD (ONDANSETRON) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Ondansetron hydrochloride dihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ondansetron
Accord
Injection
contains
2
mg/mL
ondansetron
(as
ondansetron
hydrochloride
dihydrate).
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Ondansetron
Accord
Injection
is
a
clear,
colourless
to
almost
colourless,
sterile,
isotonic,
preservative-free solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Ondansetron Accord injection is indicated:
•
for the prevention and treatment of nausea and vomiting induced by
cytotoxic therapy and
radiotherapy.
•
for the prevention and treatment of post-operative nausea and
vomiting.
4.2
D
OSE 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 to 32 mg a day and selected as
shown below. The lowest effective
dose should be used.
The product is for single use in one patient only. Discard any
residue.
USE IN ADULTS
_Emetogenic chemotherapy and radiotherapy:_
For the control of chemotherapy or radiotherapy induced
emesis or nausea in adults, a single dose of ondansetron 8 mg 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
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.
Intravenous doses of more than 8 mg should be given by slow
intravenous infusion over at l