SANCUSO TRANSDERMAL SYSTEM 3.1 MG/24 HOURS
Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
Patient Information leaflet
(PIL)
02-08-2013
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Active ingredient:
Granisetron
Available from:
KYOWA HAKKO KIRIN (SINGAPORE) PTE. LTD.
ATC code:
A04AA02
Dosage:
34.3 mg/patch
Pharmaceutical form:
PATCH, EXTENDED RELEASE
Administration route:
TRANSDERMAL
Prescription type:
Prescription Only
Manufactured by:
Aveva Drug Delivery Systems, Inc
Authorization date:
2013-08-02
Patient Information leaflet
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 _
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