情報リーフレット
MHRA
Submission: Type II variation GDS 37 consistency updates and QRD
template update less ADR Toxic
skin eruptions
Text Version: 1/8/2013
MHRA Approval Date: 04/09/2014
Text Version: Issue 8 Draft 2
SmPC Version: Issue10 Draft 2
- 1 -
GLAXOSMITHKLINE (LOGO)
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOFRAN® TABLETS 4 MG AND 8 MG
ONDANSETRON (AS HYDROCHLORIDE DIHYDRATE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING 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
about your illness or your medicine, ask your doctor,
nurse or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.
If any of the side effects get serious, or if you notice
any side effects not listed in this
leaflet, please tell your doctor, nurse
or pharmacist (see section 4).
WHAT IS IN THIS LEAFLET:
1 What Zofran tablets are and what they are used for
2 What you need to know before you take Zofran tablets
3 How to take Zofran tablets
4 Possible side effects
5 How to store Zofran tablets
6 Contents of the pack and other information
1 WHAT ZOFRAN TABLETS ARE AND WHAT THEY ARE USED FOR
Zofran tablets contain
a medicine called ondansetron. This belongs to a group
of medicines
called anti-emetics.
Zofran tablets are used for:
preventing nausea and vomiting caused by chemotherapy
[http://www.netdoctor.co.uk/medicines/effect/cancer.shtml](in adults and children) or
radiotherapy for cancer
[http://www.netdoctor.co.uk/cancer/index.shtml](adults only)
preventing nausea and vomiting
after surgery (adults only).
Ask
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製品の特徴
SUMMARY OF PRODUCT CHARACTERISTICS
PRODUCT SUMMARY
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Zofran Tablets 8mg.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Zofran Tablet 8mg is a yellow, oval, film coated tablet engraved
"GXET5" on one face and plain on the other. Each
tablet contains
ondansetron 8mg (as hydrochloride dihydrate).
3.
PHARMACEUTICAL FORM
Film coated tablet.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ADULTS: _
Zofran tablets are indicated for the management of nausea and
vomiting
induced by cytotoxic chemotherapy and radiotherapy.
Zofran tablets are indicated for the prevention
of post-operative nausea and
vomiting (PONV).
For treatment
of established PONV, administration by injection is
recommended.
_PAEDIATRIC POPULATION: _
Zofran is indicated for the management of chemotherapy-induced
nausea and
vomiting (CINV) in children aged ≥6 months.
F
or the prevention and treatment of PONV in children aged ≥1
month
administration by injection is recommended.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
CHEMOTHERAPY AND RADIOTHERAPY INDUCED NAUSEA AND VOMITING
ADULTS:
The emetogenic
potential of cancer treatment varies according to the
doses and
combinations of chemotherapy and radiotherapy regimens used. The
selection
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of dose regimen should be determined
by the severity of the emetogenic
challenge.
_Emetogenic Chemotherapy and
Radiotherapy:_ Zofran can be given either by
rectal, oral (tablets or syrup),
intravenous or intramuscular administration.
For oral administration: 8mg taken1 to 2
hours before chemotherapy or
radiation treatment, followed by 8mg every 12
hours for a maximum of 5 days
to protect against delayed or prolonged emesis.
_For highly emetogenic chemotherapy: _a si
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