ONDANSETRON-AFT ondansetron (as hydrochloride dihydrate) 4 mg/2 mL solution for injection ampoule

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

ondansetron hydrochloride dihydrate, Quantity: 4.988 mg (Equivalent: ondansetron, Qty 4 mg)

Disponible desde:

AFT Pharmaceuticals Pty Ltd

formulario farmacéutico:

Injection, solution

Composición:

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

Vía de administración:

Intravenous, Intramuscular

Unidades en paquete:

5 ampoules, 1 ampoule, 10 ampoules

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

Ondansetron 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.

Resumen del producto:

Visual Identification: Clear, colourless, transparent solution, practically free from visible particles; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius

Estado de Autorización:

Registered

Fecha de autorización:

2019-07-04

Información para el usuario

Ondansetron-AFT
1
ONDANSETRON-AFT
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 USING ONDANSETRON-AFT?
Ondansetron-AFT contains the active ingredient ondansetron.
Ondansetron-AFT is used to help stop nausea (feeling sick) and
vomiting which can occur after medical treatments and operations.
For more information, see Section 1. Why am I using Ondansetron-AFT?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ONDANSETRON-AFT?
Do not use if you have ever had an allergic reaction to
Ondansetron-AFT or any of the ingredients listed at the end of the
CMI.
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-AFT?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Ondansetron-AFT and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW IS ONDANSETRON-AFT GIVEN?
•
Your doctor will decide how much Ondansetron-AFT you should receive
and for how long you should receive it.
More instructions can be found in Section 4. How is Ondansetron-AFT
given?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE RECEIVING ONDANSETRON-AFT?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are
receiving Ondansetron-AFT.
•
Keep all of your doctor’s appointments, so that your progress can be
checked.
THINGS YOU
SHOULD NOT DO
•
Do not take any other medicines whether they require a prescription or
not without first telling your
doctor.
DRIVING OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how Ondansetron-AFT affects
you.
•
Ondansetron-AFT may cause dizziness or drowsiness in some people.
LOOKING AFTER
YOUR MEDICINE
•
Ondansetron-AF

Ficha técnica

AUSTRALIAN PI – ONDANSETRON-AFT (ONDANSETRON (AS HYDROCHLORIDE
DIHYDRATE)) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Ondansetron (as hydrochloride dihydrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ondansetron (as hydrochloride dihydrate) 4 mg/2 mL or 8 mg/4 mL
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless, transparent solution, practically free from visible
particles.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Ondansetron 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
D
OSE AND METHOD OF ADMINISTRATION
Note that other dosage forms including tablets, syrup, suppositories
and wafers can be available
from other brands.
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-AFT 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.
To protect against delayed emesis after the first 24 hours,
ondansetron should be continued orally at
a dosage of 8 mg TWICE DAILY, or given rectally as a 16 mg suppository
once daily, for up to 5 days
after a course of 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
cisp