ONDANSETRON SZ ODT ondansetron 4 mg orally disintegrating tablet

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

ondansetron, Quantity: 4 mg

Dostupno od:

Dr Reddys Laboratories Australia Pty Ltd

INN (International ime):

Ondansetron

Farmaceutski oblik:

Tablet, orally disintegrating

Sastav:

Excipient Ingredients: aspartame; microcrystalline cellulose; Guar Gum; crospovidone; pregelatinised maize starch; colloidal anhydrous silica; magnesium stearate; mannitol; sodium lauryl sulfate; Flavour

Administracija rute:

Oral

Jedinice u paketu:

4 tablet, 10 tablet, 6 tablets

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

Prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy.

Proizvod sažetak:

Visual Identification: White to off-white, round, biconvex, uncoated tablets embossed '4' on one side and 'O' on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Status autorizacije:

Registered

Datum autorizacije:

2010-11-22

Uputa o lijeku

ONDANSETRON SZ ODT
1
ONDANSETRON SZ ODT
_ORALLY DISINTEGRATING TABLETS _
_Ondansetron _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you start taking Ondansetron
SZ ODT orally disintegrating tablets.
This leaflet answers some common
questions about Ondansetron SZ
ODT orally disintegrating tablets. It
does not contain all of the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Ondansetron
SZ ODT orally disintegrating tablets
against the benefits this medicine is
expected to have for you.
If you have any concerns about
taking this medicine, ask your doctor
or pharmacist.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ONDANSETRON SZ
ODT ORALLY
DISINTEGRATING TABLETS
ARE USED FOR
Ondansetron SZ ODT orally
disintegrating tablets belong to a
group of medicines called
antiemetics.
Ondansetron SZ ODT orally
disintegrating tablets work by
helping to stop the nausea (sick
feeling) and vomiting which can
occur after certain treatments.
'Orally disintegrating' used in the
product name, is the word used for
the special type of tablet which
dissolves in a few seconds when
placed on the tongue. It is easier to
swallow than ordinary tablets.
Ondansetron SZ ODT orally
disintegrating tablets should only be
used to treat the nausea and vomiting
for which they have been prescribed.
Your doctor may have prescribed
Ondansetron SZ ODT orally
disintegrating tablets for another
reason.
Ask your doctor if you have any
questions about why Ondansetron SZ
ODT orally disintegrating tablets
have been prescribed for you.
Ondansetron SZ ODT orally
disintegrating tablets are not
addictive.
BEFORE YOU TAKE
ONDANSETRON SZ ODT
ORALLY DISINTEGRATING
TABLETS
_WHEN YOU MUST NOT TAKE _
_THEM _

Do not take Ondansetron SZ
ODT orally disintegrating tablets
if you are taking apomorphine
(used to treat Parkinson's disease)

Do not take Ondansetron

Svojstava lijeka

AUSTRALIAN PRODUCT INFORMATION – ONDANSETRON SZ ODT
(ONDANSETRON) ORALLY-DISINTEGRATING TABLETS
1
NAME OF THE MEDICINE
Ondansetron
2
& 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
Ondansetron is a white to off white powder with a melting point of
approximately 230°C. It is
insoluble in water. It is soluble in chloroform and acetic acid. The
pKa of ondansetron is 10.4 at
30
o
C (Diluent: water and methanol in the ratio of 35:65).
Ondansetron SZ ODT tablets contain 4 mg or 8 mg of ondansetron.
Ondansetron SZ ODT 4 mg and 8 mg tablets contain the following
excipients: Microcrystalline
cellulose, mannitol, pregelatinised maize starch, crospovidone,
aspartame, guar gum, colloidal
anhydrous silica, magnesium stearate, sodium lauryl sulphate,
Strawberry Guarana 586997
AP0551.
Ondansetron SZ ODT 4 mg orally disintegrating tablets: White to
off-white, round, biconvex,
uncoated tablets embossed ‘4’ on one side and ‘O’ on the other
side.
Ondansetron SZ ODT 8 mg orally disintegrating tablets: White to
off-white, round, biconvex,
uncoated tablets embossed ‘8’ on one side and ‘O’ on the other
side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Prevention and treatment of nausea and vomiting induced by cytotoxic
therapy and
radiotherapy.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The emetogenic potential of cancer treatment varies according to the
doses and combinations of
chemotherapy and radiotherapy regimens used. The route of
administration and dose of
ondansetron should be flexible in the range of 8 to 32 mg a day and
selected as shown below.
The lowest effective dose should be used.
The Ondansetron SZ ODT orally disintegrating tablet is administered by
placing it on top of the
tongue where it dissolves within seconds, and is swallowed.
ADULTS. EMETOGENIC CHEMOTHERAPY AND RADIOTHERAPY For the control of
chemotherapy or
radiotherapy induced emesis or nausea in adults, two oral doses of 8
mg each at 12 hourly
intervals may be given (tablets or orally disintegrating tablets), the
fir