Tropisetron-AFT

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Tropisetron hydrochloride 1.13 mg/mL equivalent to tropisetron 1 mg/mL

Tilgængelig fra:

AFT Pharmaceuticals Ltd

INN (International Name):

Tropisetron hydrochloride 1.13 mg/mL (equivalent to tropisetron 1 mg/mL)

Dosering:

1 mg/mL

Lægemiddelform:

Solution for injection

Sammensætning:

Active: Tropisetron hydrochloride 1.13 mg/mL equivalent to tropisetron 1 mg/mL Excipient: Acetic acid Sodium acetate trihydrate Sodium chloride Water for injection

Enheder i pakken:

Ampoule, glass, Clear type 1, 5mL, 1 dose unit

Klasse:

Prescription

Recept type:

Prescription

Fremstillet af:

Qilu Pharmaceutical Co Ltd

Terapeutiske indikationer:

Prevention of nausea and vomiting induced by cytoxic therapy (5mg/5mL ampoule only).

Produkt oversigt:

Package - Contents - Shelf Life: Ampoule, glass, Clear type 1, 5mL - 1 dose units - 24 months from date of manufacture stored at or below 30°C - Ampoule, glass, Clear type 1, 2mL - 1 dose units - 24 months from date of manufacture stored at or below 30°C - Ampoule, glass, Clear type 1 5mL - 10 dose units - 24 months from date of manufacture stored at or below 30°C - Ampoule, glass, Clear type 1 2mL - 10 dose units - 24 months from date of manufacture stored at or below 30°C

Autorisation dato:

2012-12-04

Indlægsseddel

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 lea

Produktets egenskaber

1 PRODUCT NAME
TROPISETRON-AFT
tropisetron hydrochloride (equivalent to 2 mg or 5 mg tropisetron) per
ampoule.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains 1 mg of tropisetron
1 2 mL ampoule contains 2 mg of tropisetron
1 5 mL ampoule contains 5 mg of tropisetron
Each 1 mL of Tropisetron-AFT solution for injection contains 3.5 mg
sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection or Infusion
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
_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
mL
of
sodium
chloride
0.9%;
glucose
5%;
potassium
chloride,
sodium
chloride
and
calcium
chloride
intravenous
solution
(Ringer's
solution);
fructose
intravenous
solution
(Levulose
5%);
mannitol
10%; potassium chloride 0.3% and sodium chloride 0.9%; potassium
chloride 0.3% and
glucose 5%. The diluted solutions are physically and chemically stable
for at least 24
hours. However, considering the risk of microbial contamination during
preparation of
the
infusion,
the
solution
should
be
used
within
eight
hours
of
preparation. Any
storage should be at 2-8°C.
Tropisetron-AFT is for single use in one patient only. Discard any
residue.
_Treatment and Prevention of Post-operative Nausea and Vomiting_
Tropisetron is recommende