TROPISETRON MYX tropisetron (as hydrochloride) 2 mg/2 mL solution for injection or infusion ampoules

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

tropisetron hydrochloride, Quantity: 2.26 mg (Equivalent: tropisetron, Qty 2 mg)

Dostępny od:

Juno Pharmaceuticals Pty Ltd

INN (International Nazwa):

tropisetron hydrochloride

Forma farmaceutyczna:

Injection, solution

Skład:

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

Droga podania:

Intravenous

Sztuk w opakowaniu:

5

Typ recepty:

(S4) Prescription Only Medicine

Wskazania:

For the treatment and prevention of post-operative nausea and vomiting in adults (2 mg/2 mL ampoule only)

Podsumowanie produktu:

Visual Identification: A clear, colourless to very faintly yellow-brown aqueous solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Status autoryzacji:

Licence status A

Data autoryzacji:

2016-04-28

Ulotka dla pacjenta

TROPISETRON MYX™
_tropisetron _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about tropisetron.
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.
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 MYX
IS USED FOR
Tropisetron is used to prevent nausea
(feeling sick) and vomiting caused by
surgery.
The active ingredient in Tropisetron
MYX is tropisetron (as
hydrochloride). 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 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
TROPISETRON MYX
_WHEN YOU MUST NOT HAVE IT _
DO NOT HAVE TROPISETRON IF YOU HAVE
EVER HAD AN ALLERGY TO:
•
tropisetron (the active ingredient in
Tropisetron MYX)
•
any of the other ingredients listed
at the end of this leaflet
•
similar medicines such as
ondansetron and dolasetron
Some of the symptoms of an allergic
reaction may 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 HAVE TROPISETRON IF YOU ARE
PREGNANT.
There is not enough information to
recom

Charakterystyka produktu

Product Information
TROPISETRON MYX™
(TROPISETRON)
NAME OF THE MEDICINE
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).
COO
H NCH
3
.HCL
NH
DESCRIPTION
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.
Tropisetron MYX injection is a clear, colourless to very faintly
yellow-brown aqueous
solution which contains 1mg/mL tropisetron in ampoules containing 2 mL
of solution. The
pH of the solution is 4.6 - 5.2. The ampoules contain as excipients,
glacial acetic acid,
sodium acetate trihydrate, sodium chloride and water for injections.
Product is for single use in one patient only. Discard any residue.
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.
Tropisetron has a 24-hour duration of action which allows once-a-day
administration.
Tropisetron prevents nausea and vomiting induced by surgery without
causing
extrapyramidal side-effects.
v 1.0
1
Product Information
PHARMACOKINETICS
ABSORPTION
The absorption of tropisetron from the gastrointestina