KYTRIL TABLET 1MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

GRANISETRON HYDROCHLORIDE

Boleh didapati daripada:

DKSH MALAYSIA SDN BHD

INN (Nama Antarabangsa):

GRANISETRON HYDROCHLORIDE

Unit dalam pakej:

2Tablet Tablets; 10Tablet Tablets

Dikeluarkan oleh:

Delpharm Milano s.r.l

Risalah maklumat

_CONSUMER MEDICATION INFORMATION BOOKLET (RIMUP) _
KYTRIL
®
TABLET
Granisetron Hydrochloride (1mg)
Page no.1
WHAT IS IN THIS LEAFLET
1. What Kytril is used for
2. How Kytril works
3. Before you use Kytril
4. How to use Kytril
5. While you are using it
6. Side effects
7. Storage and disposal of
Kytril
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of Revision
WHAT KYTRIL IS USED FOR
KYTRIL contains the active
ingredient granisetron.
It belongs to a group of
medicines called anti-emetics.
KYTRIL is used to prevent and
stop you feeling sick
(nauseous) or being sick
(vomiting). It is especially
useful when you need to have
medical treatment that may
cause you to feel or be sick, for
example, chemotherapy or
radiotherapy.
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.
It is available only with a
doctor's prescription.
HOW KYTRIL WORKS
Granisetron belongs to a class
of medications called 5-HT3
blockers. It works by blocking
one of the body's natural
substances (serotonin) that can
cause vomiting.
BEFORE YOU USE KYTRIL
_- When you must not use it _
Do not take KYTRIL if you
have an allergy to:
•
any medicine containing
granisetron.
•
any of the ingredients
listed at the end of this
leaflet.
Do not take KYTRIL after the
expiry date printed on the pack
or if the packaging is torn or
shows signs of tampering.
There is insufficient
information to recommend oral
dose of KYTRIL in children.
_- Before you start to use it_
Tell your doctor if:
•
you have allergies to any
other medicines, foods,
preservatives, or dyes.
•
you have signs of
intestinal obstruction.
•
you are pregnant or plan to
become pregnant or are
breast-feeding.
Your doctor can discuss
with you the risks and
benefits of taking
KYTRIL if you are
pregnant or breast-feeding.
•
you have used KYTRIL
before, and you became
unwell.
You may need to be given
another medicine instead.
•
you have a heart condition
related t

Ciri produk

PACK INSERT FOR MALAYSIA
KYTRIL
 TABLET
GRANISETRON
ANTIEMETICS, SEROTONIN (5HT3) ANTAGONISTS
1. PHARMACEUTICAL FORM
Kytril is supplied as film-coated tablets and ampoules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: granisetron HCL
White triangular film-coated tablets contain 1 mg of granisetron (free
base equivalent).
3. CLINICAL PARTICULARS
3.1 THERAPEUTIC INDICATIONS
KYTRIL is indicated for the prevention and treatment (control) of
acute
and delayed nausea and vomiting associated with chemo-therapy and
radiotherapy
3.2 DOSAGE AND METHOD OF ADMINISTRATION
3.2.1 STANDARD DOSAGE
CHEMOTHERAPY INDUCED NAUSEA AND VOMITING (CINV)
_ADULTS _
_Prevention:_
1 mg twice a day or 2 mg once a day for up to one week
following chemotherapy. The first dose of Kytril should be
administered
within 1 hour before the start of therapy.
_Treatment:_
There is insufficient information to recommend the oral
administration of KYTRIL in the treatment of CINV in adult patients.
_PEDIATRICS_
There is insufficient information to recommend the oral
admin-istration
of KYTRIL in the prevention and treatment of CINV in pediatric
patients.
RADIOTHERAPY INDUCED NAUSEA AND VOMITING (RINV)
_ADULTS _
Prevention and treatment: 2 mg once a day for up to one week following
radiotherapy. The first dose of KYTRIL should be ad-ministered within
1 hour before the start of therapy.
_PEDIATRICS_
There is insufficient information to recommend oral administra-tion of
Kytril in the prevention and treatment of RINV in children.
3.2.2 SPECIAL DOSAGE INSTRUCTION
Geriatrics: No dosage adjustments required.
Renal impairment: No dosage adjustments required.
Hepatic Impairment: No dosage adjustments required.
3.3 CONTRAINDICATIONS
Kytril is contraindicated in patients with known hypersensitivity to
granisetron or to any of its excipients.
3.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
As Kytril may reduce lower bowel motility, patients with signs of
sub-acute intestinal obstruction should be monitored closely
fol-lowing
administration of Kyt