ZOFRAN TABLETS 8 MG

Država: Izrael

Jezik: engleski

Izvor: Ministry of Health

Aktivni sastojci:

ONDANSETRON AS HYDROCHLORIDE DIHYDRATE

Dostupno od:

NOVARTIS ISRAEL LTD

ATC koda:

A04AA01

Farmaceutski oblik:

TABLETS

Sastav:

ONDANSETRON AS HYDROCHLORIDE DIHYDRATE 8 MG

Administracija rute:

PER OS

Tip recepta:

Required

Proizveden od:

ASPEN BAD OLDESLOE GMBH, GERMANY

Terapijska grupa:

ONDANSETRON

Područje terapije:

ONDANSETRON

Terapijske indikacije:

Adults:Zofran is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Zofran is indicated for the prevention and treatment of post-operative nausea and vomiting (PONV). Paediatric Population:Zofran is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy.

Datum autorizacije:

2020-07-31

Uputa o lijeku

:لافطلأا
_يواميكلا _
_جلاعلا_
_ ءارج تاؤيقتلاو نايثغلا جلاعل_
ةحاسم( لفطلا سيياقم رابتعلإا نيعب
ً
اذخآ ةيئاودلا ةعرجلا بيبطلا ددحي
.)مسجلا
_)طقف رابكلا( ةيحارج ةيلمع دعب
تاؤيقتلاو نايثغلا جلاعو عنمل_
ةصاخلا ةيحارجلا ةيلمعلا لبق غلم 16 يه
رابكلل ةيدايتعلإا ةيئاودلا ةعرجلا
.كب
_)طقف رابكلا( دبكلا يف ةديدش وأ ةلدتعم
لكاشم مهيدل نوجلاعم_
.غلم 8 زواجتت لاأ بجي ةيلامجلإا ةيمويلا
ةيئاودلا ةعرجلا
.ةيئاودلا ةعرجلا لوانت نم نيتعاس وأ
ةعاس للاخ نارفوز صارقأ لوعفم أدبي
_‬‬‬‬‬‬‬‬‬‬‬‬‬‮اهب ىصوملا
ةيئاودلا ةعرجلا‬_
_ ‮‮زواجت زوجي لا_
_ةيئاودلا ةعرجلا لوانت نم ةعاس للاخ
تأيقت اذإ_
ةيناث ةرم ةيئاودلا ةعرجلا سفن لوانت •
.بيبطلا هب كاصوأ امم رثكأ نارفوز صارقأ
لوانتت لاف ،لاإو •
.كبيبطل كحإ ،كيدل نايثغلاب روعشلا
رمتسإ اذإ
.اهغضم وأ اهرطش ،اهقحس زوجي لاو ةيلطم
صارقلأا نإ
_ربكأ ةيئاود ةعرج أطخلاب تلوانت اذإ_
بيبطلل
ً
لااح هجوت ،ءاودلا نم أطخلاب لفط علب
اذإ وأ ةطرفم ةيئاود ةعرج تلوانت اذإ
.كعم ءاودلا ةبلع رضحأو ىفشتسملا يف
ئراوطلا ةفرغل وأ
_ءاودلا لوانت تيسن اذإ_
:أيقتت وأ نايثغب رعشت _تنكو_ ةيئاود
ةعرج تيسن اذإ
مث نمو ،نكمي ام عرسأ يف نارفوز صارقأ
لوانت •
.يدايتعلإا دعوملا يف كب صاخلا يلاتلا
صرقلا لوانت •
ةيئاودلا
ةعرجلا
نع ضيوعتلل ة�

Svojstava lijeka

ZOF TAB API APR23 V3
_Page 1 of 13 _
_ _
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Zofran
®
Tablets 4 mg
Zofran
®
Tablets 8 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Zofran Tablet 4mg contains ondansetron 4 mg (as hydrochloride
dihydrate).
Each Zofran Tablet 8mg contains ondansetron 8 mg (as hydrochloride
dihydrate).
Excipients with known effect:
Zofran Tablets 4 mg: contains lactose (anhydrous) 81.875 mg (see
section 4.4).
Zofran Tablets 8 mg: contains lactose (anhydrous) 163.75 mg (see
section 4.4).
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Film coated tablet.
Zofran Tablet 4mg is a yellow, oval, biconvex tablet engraved with
"GXET3"
on one face and plain on the other.
Zofran Tablet 8mg is a yellow, oval, biconvex tablet engraved with
"GXET5"
on one face and plain on the other.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Adults: _
Zofran is indicated for the management of nausea and vomiting induced
by
cytotoxic chemotherapy and radiotherapy.
Zofran is indicated for the prevention and treatment of post-operative
nausea
and vomiting (PONV).
_Paediatric Population: _
Zofran is indicated for the management of nausea and vomiting induced
by
cytotoxic chemotherapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Chemotherapy and radiotherapy induced nausea and vomiting
(CINV and
RINV)
.
_Adults _
ZOF TAB API APR23 V3
_Page 2 of 13 _
_ _
The emetogenic potential of cancer treatment varies according to the
doses and
combinations of chemotherapy and radiotherapy regimens used. The
selection
of dose regimen should be determined by the severity of the emetogenic
challenge.
_Emetogenic Chemotherapy and Radiotherapy_
: Zofran can be given either by
oral (tablets), intravenous or intramuscular administration.
The recomended oral dose is: 8 mg taken 1 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_
To protect against delayed or pro