Navoban

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

Tropisetron hydrochloride

זמין מ:

Novartis Pharmaceuticals Australia Pty Ltd

סיווג:

Medicine Registered

עלון מידע

NAVOBAN(R)
1
NAVOBAN(R)
_tropisetron_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Navoban.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist. 
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available. 
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU. THOSE
UPDATES MAY CONTAIN IMPORTANT
INFORMATION ABOUT THE MEDICINE
AND ITS USE OF WHICH YOU SHOULD BE
AWARE.
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 NAVOBAN IS USED
FOR
Navoban is used to prevent nausea
(feeling sick) and vomiting caused
by surgery and by cancer
chemotherapy. 
The active ingredient in Navoban 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. 
Navoban 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 HAVE
NAVOBAN
_WHEN YOU MUST NOT HAVE IT_
DO NOT HAVE NAVOBAN IF YOU HAVE
EVER HAD AN ALLERGY TO: 
*
tropisetron (the active ingredient
in Navoban)
*
any of the other ingredients listed
at the end of this leaflet
*
similar medicines such as
ondansetron and dolasetron
Some of

מאפייני מוצר

_ _

NAVOBAN® 
(TROPISETRON) 

COMPOSITION 
Capsules containing 5.64 mg tropisetron hydrochloride (equivalent to
5 mg of the base) and 
ampoules (2 or 5 mL) containing 2.26 or 5.64 mg tropisetron
hydrochloride (equivalent to 2 
or 5 mg of the base respectively). 
DESCRIPTION 
Tropisetron hydrochloride is 1
α
H,5
α
H-tropan-3
α
-yl indole-3-carboxylate hydrochloride. 
CAS - 89565-68-4 (tropisetron); CAS - 105826-92-4 (tropisetron
hydrochloride). 

NH
COO
NCH
3
H
.
HCl

Tropisetron hydrochloride is a white or off-white crystalline powder.
 It is soluble >5% in 
water, 1.6% in ethanol (95% v/v)  and poorly soluble (0.02%) in
acetone.  The molecular 
weight of the free base is 284.4 and of the hydrochloride salt is
320.8. 
PHARMACOLOGY 
Tropisetron is a highly potent and selective competitive antagonist of
the 5-HT
3
 receptor, a 
subclass of serotonin receptors located on peripheral neurons and
within the CNS.  Surgery 
and treatment with certain substances, including some chemotherapeutic
agents, may trigger 
the release of serotonin (5-HT) from enterochromaffin-like cells in
the visceral mucosa and 
initiate the emesis reflex and its accompanying feeling of nausea.
 Tropisetron selectively 
blocks the excitation of the presynaptic 5-HT
3
 receptors of the peripheral neurons in this 
reflex, and may exert additional direct actions within the CNS on 5-HT
3
 receptors mediating 
the actions of vagal input to the area postrema.  These effects are
considered to be the 
underlying mechanism of action of the anti-emetic effect of
tropisetron. 
Navoban has a 24-hour duration of action which allows once-a-day
administration. 
In studies where Navoban has been administered over multiple
chemotherapy cycles, 
treatment has remained effective. 
Navoban prevents nausea and vomiting induced by cancer chemotherapy or
surgery without 
causing extrapyramidal side-effects. 
Page 1 of 7 
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Page 2 of 7 
CLINICAL TRIALS ON USE IN POST-OPERATIVE NAUSEA AND VOMITING