SANCUSO® (Granisetron Transdermal System) 3.1 mg/24 Hours

البلد: ماليزيا

اللغة: الإنجليزية

المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

العنصر النشط:

GRANISETRON

متاح من:

SMART MEDICINE SDN. BHD.

INN (الاسم الدولي):

GRANISETRON

الوحدات في الحزمة:

1pieces Pieces

المصنعة من قبل:

3M Drug Delivery Systems

نشرة المعلومات

_Consumer Medication Information Leaflet (RiMUP) _
Page 1
SANCUSO
® (GRANISETRON TRANSDERMAL SYSTEM) 3.1 MG/24 HOURS
Granisetron (3.1 mg granisetron/24 hours)
WHAT IS IN THIS LEAFLET
1.
WHAT IS SANCUSO USED FOR
2.
HOW SANCUSO WORKS
3.
BEFORE YOU USE SANCUSO
4.
HOW TO USE SANCUSO
5.
WHILE YOU ARE USING IT
6.
SIDE EFFECTS
7.
STORAGE
AND
DISPOSAL
OF
SANCUSO
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER AND PRODUCT
REGISTRATION HOLDER
10.
DATE OF REVISION
Read the Patient Information that
comes with Sancuso before you start
using it and each time you get a
refill.
There
may
be
new
information. This information does
not take the place of talking to your
doctor/pharmacist
about
your
medical condition or your treatment.
If
you
have
any
questions
about
Sancuso,
ask
your
doctor/pharmacist.
WHAT SANCUSO IS USED FOR
Sancuso is a prescription medicine
used to prevent nausea and vomiting
in people receiving some types of
chemotherapy treatment.
IMPORTANT:
Sancuso
contains
granisetron, the same medicine in
Kytril. Do not take Kytril at the same
time you use Sancuso unless your
doctor/pharmacist
tells
you
it
is
alright.
HOW SANCUSO WORKS
Sancuso
is
a
skin
patch
that
slowly
releases the medicine contained in the
adhesive
(glue),
through
clean
and
intact skin areas into your bloodstream
while you wear the patch.
BEFORE YOU USE SANCUSO
_WHEN YOU MUST NOT USE IT _

DO NOT USE SANCUSO IF YOU ARE
ALLERGIC TO ANY OF THE INGREDIENTS
IN SANCUSO
. See the end of this
leaflet for a list of ingredients in
Sancuso
_BEFORE YOU START TO USE IT _
TELL YOUR DOCTOR/PHARMACIST ABOUT ALL
YOUR MEDICAL CONDITIONS, INCLUDING IF
YOU:

are
allergic
to
medical
adhesive
tape, adhesive dressings or other
skin patches

have
pain
or
swelling
in
your
stomach area (abdomen).

are pregnant. It is not known if
Sancuso
will
harm
your
unborn
baby.
Talk
to
your
doctor/pharmacist
if
you
are
pregnant
or
plan
to
become
pregnant.

are breast-feeding or plan to breast-
feed. It is not known if Sancuso
passes into your breast milk.
_TAKING OTHER MEDICINES _
TEL

خصائص المنتج

Version: 5 (Dec 2 017 _MY) 20/12 /2017
1. NAME OF THE MEDICINAL PRODUCT
SANCUSO (Granisetron Transdermal System) 3.1 mg/24 hours
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 52 cm 2 transdermal patch contains 34.3 mg of granisetron releasing 3.1 mg of granisetron per
24 hours.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Transdermal patch.
Thin, translucent, matrix -type, rectangular -shaped transdermal patch with rounded corners.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
SANCUSO transdermal patch is indicated in adults for the prevention of nausea and vomiting
associated with moderately or highly emetogenic chemotherapy, for a planned duration of 3 to 5
consecutive days, where oral anti emetic administration is complicated by factors making swallowing
difficult (see section 5.1).
4.2 Posology and method of administration
Posology
Adults
Apply a single transdermal patch 24 to 48 hours before chemotherapy, as appropriate.
Due to a gradual increase in plasma levels of granisetron following application of the transdermal
patch, a slower onset of efficacy compared to 2 mg oral granisetron may be observed at the start of
chemotherapy; the patch should be applied 24 -48 hours before chemotherapy.
The transdermal patch should be removed a minimum of 24 hours after completion of chemotherapy.
The transdermal patch can be worn for up to 7 days depending on the duration of the chemotherapy
regimen.
Following routine haematological monitoring, the transdermal patch should only be applied to patients
whose chemotherapy treatment is unlikely to be delayed in order to reduce the possibility of
unnecessary exposure to granisetron.
Use of concomitant corticosteroids
The Multinational Association of Supportive Care in Cancer (MASCC) guidelines recommend the
administration of dexamethasone with 5H T3 antagonist prior to chemotherapy. In the pivotal
SANCUSO study, the concomitant use of corticosteroids, e.g. dexamethasone, was permitted provided
it was part of the chemotherapy regimen. Any