TROPISETRON-AFT tropisetron (as hydrochloride) 5 mg/5 mL solution for injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tropisetron hydrochloride, Quantity: 5.65 mg (Equivalent: tropisetron, Qty 5 mg)

Available from:

AFT Pharmaceuticals Pty Ltd

INN (International Name):

tropisetron hydrochloride

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: acetic acid; sodium acetate trihydrate; sodium chloride; water for injections

Administration route:

Intravenous

Units in package:

1 ampoule, 10 ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

? For the prevention of nausea and vomiting induced by cytotoxic therapy (5mg/5mL ampoule only).

Product summary:

Visual Identification: Clear, colourless to faintly-yellow brown aqueous solution in clear glass ampoule.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2012-11-16

Patient Information leaflet

Tropisetron-AFT CMI (dated: )
Page 1 of 4
TROPISETRON-AFT
_Tropisetron hydrochloride equivalent to Tropisetron 2mg/2 mg and 5
mg/5 mL, solution for injection and infusion_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Tropisetron-AFT.
It does not contain all the available information. It does not take
the place of talking to your doctor or pharmacist.
YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE INFORMATION ON
TROPISETRON-AFT.
All medicines have risks and benefits. Your doctor has weighed the
risks of you having this medicine against the benefits they
expect it will provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TROPISETRON-AFT IS USED FOR
Tropisetron-AFT is used to prevent nausea (feeling sick) and vomiting
caused by surgery and by cancer chemotherapy.
The active ingredient in Tropisetron-AFT is tropisetron. It works by
stopping the action of a substance in the body called
serotonin that is thought to cause the nausea and vomiting.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it for another reason.
Tropisetron-AFT is only available with a doctor's prescription. It is
not addictive.
There is not enough information to recommend its use in children.
BEFORE YOU ARE GIVEN TROPISETRON-AFT
_WHEN YOU MUST NOT BE GIVEN IT_
DO NOT USE TROPISETRON-AFT IF YOU HAVE EVER HAD AN ALLERGY TO:

tropisetron (the active ingredient in Tropisetron-AFT)

any of the other ingredients listed at the end of this leaflet

similar medicines such as ondansetron, granisetron and dolasetron
Some of the symptoms of an allergic reaction 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 USE TROPISETRON-AFT IF YOU ARE PREGNANT. T

Summary of Product characteristics

Page 1 of 10
AUSTRALIAN PRODUCT INFORMATION
TROPISETRON-AFT (TROPISETRON HYDROCHLORIDE) SOLUTION FOR INJECTION
1.
NAME OF THE MEDICINE
Tropisetron (as hydrochloride)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tropisetron hydrochloride is a white or off-white crystalline powder.
It is freely soluble or soluble in
water, sparingly soluble in ethanol (96%) and very slightly soluble in
methylene chloride. The
molecular weight of the free base is 284.4 and of the hydrochloride
salt is 320.8.
Tropisetron-AFT, solution for injection or infusion, contains
tropisetron hydrochloride equivalent to
either 2 mg or 5 mg tropisetron per ampoule.
The pH of the solution is 4.6 – 5.2. The product also contains
acetic acid, sodium acetate trihydrate,
sodium chloride and water for injections.
Excipients with known effect:
Each 1 mL of Tropisetron-AFT solution for injection contains 3.5 mg
sodium
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tropisetron-AFT, solution for injection or infusion, is a clear
colourless to faintly yellow-brown
aqueous solution which contains 1 mg/mL tropisetron in ampoules
containing either 2 mL or 5 mL of
solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the prevention of nausea and vomiting induced by cytotoxic therapy
(5 mg/5 mL ampoule only).
For the treatment and prevention of post-operative nausea and vomiting
in adults (2 mg/2 mL ampoule
only).
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
Page 2 of 10
_PREVENTION OF NAUSEA AND VOMITING INDUCED BY CYTOTOXIC THERAPY _
Tropisetron is recommended as six-day courses of 5 mg per day, given
intravenously on Day 1
immediately before cancer chemotherapy, either as an infusion given
over 15 minutes (see below for
dilution instructions) or as a slow injection (not less than 1
minute), followed by oral administration on
days 2 to 6.
If tropisetron alone produces insufficient antiemetic control, its
therapeutic efficacy may be enhanced
by the addition of dexamethasone.
For infusion, one ampoule may be diluted in 100 m