Sancuso

Land: Den Europæiske Union

Sprog: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv bestanddel:

granisetron

Tilgængelig fra:

Kyowa Kirin Holdings B.V.

ATC-kode:

A04AA02

INN (International Name):

granisetron

Terapeutisk gruppe:

Antiemetics and antinauseants, , Serotonin (5HT3) antagonists

Terapeutisk område:

Vomiting; Cancer

Terapeutiske indikationer:

Prevention of nausea and vomiting in patients receiving moderately or highly emetogenic chemotherapy, with or without cisplatin, for up to five consecutive days.Sancuso may be used in patients receiving their first chemotherapy regimen or in patients who have previously received chemotherapy.

Produkt oversigt:

Revision: 14

Autorisation status:

Authorised

Autorisation dato:

2012-04-20

Indlægsseddel

20
B.
PACKAGE LEAFLET
21
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SANCUSO 3.1 MG/24 HOURS TRANSDERMAL PATCH
granisetron
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What SANCUSO is and what it is used for
2.
What you need to know before you use SANCUSO
3.
How to use SANCUSO
4.
Possible side effects
5.
How to store SANCUSO
6.
Contents of the pack and other information
1.
WHAT SANCUSO IS AND WHAT IT IS USED FOR
The active substance in SANCUSO is granisetron, which belongs to a
group of medicines called
antiemetics and antinauseants.
SANCUSO is a transdermal (skin) patch used to prevent nausea (feeling
sick) and vomiting (being
sick) in adults receiving chemotherapy treatments (medicines to treat
cancer) lasting 3 to 5 days and
who have difficulty swallowing tablets (for example due to soreness,
dryness or inflammation of the
mouth or throat).
You must talk to a doctor if you do not feel better or if you feel
worse after the first day of
chemotherapy.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SANCUSO
DO NOT USE SANCUSO:
-
if you are allergic to granisetron or any of the other ingredients of
this medicine (listed in
section 6)
-
if you are allergic to any other anti-sickness medicines whose name
ends in “setron” e.g.
ondansetron.
WARNINGS AND PRECAUTIONS
Tell your doctor or nurse before using this treatment if any of the
following applies to you:
-
if you have been told you have a heart disorder or disease
-
if you have pain in your stomach or your stomach is swollen
-
if you have problems with your kidney

Produktets egenskaber

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
SANCUSO 3.1 mg/24 hours transdermal patch
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 5HT
3
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 increa