ZOFRAN INJECTION 2MGML

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

ONDANSETRON AS HYDROCHLORIDE DIHYDRATE

Διαθέσιμο από:

NOVARTIS ISRAEL LTD

Φαρμακολογική κατηγορία (ATC):

A04AA01

Φαρμακοτεχνική μορφή:

SOLUTION FOR INJECTION

Σύνθεση:

ONDANSETRON AS HYDROCHLORIDE DIHYDRATE 2 MG/ML

Οδός χορήγησης:

I.M, I.V

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

GLAXO SMITHKLINE MANUFACTURING S.P.A., ITALY

Θεραπευτική ομάδα:

ONDANSETRON

Θεραπευτική περιοχή:

ONDANSETRON

Θεραπευτικές ενδείξεις:

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 chemotherapy-induced nausea and vomiting (CINV) in children aged ≥6 months, and for the prevention and treatment of PONV in children aged ≥ 1 month.

Ημερομηνία της άδειας:

2013-06-30

Φύλλο οδηγιών χρήσης

אפורל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה אפורל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
) ךיראת
06.2015 םושירה רפסמו תילגנאב רישכת םש
ZOFRAN INJECTION 2MG/ML )049-94-26548( םושירה לעב םש
GLAXOSMITHKLINE )ISRAEL( LTD :
! דבלב תורמחהה טורפל דעוימ הז ספוט
אפורל ןולעב
אפורל ןולעב
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
SPECIAL
WARNINGS
AND
PRECAUTIONS
FOR USE
There have been post-marketing reports describing
patients with serotonin syndrome (including altered
mental
status,
autonomic
instability
and
neuromuscular
abnormalities)
following
the
concomitant
use
of
ondansetron
and
other
serotonergic drugs (including selective serotonin
reuptake
inhibitors
(SSRI)
and
serotonin
noradrenaline
reuptake
inhibitors
(SNRIs)).
If
concomitant treatment with ondansetron and other
serotonergic
drugs
is
clinically
warranted,
appropriate observation of the patient is advised.
The development of serotonin syndrome
has been reported with 5-HT receptor
antagonists alone. Most reports have been
associated with concomitant use of
serotonergic drugs (e.g., selective serotonin
reuptake inhibitors (SSRIs), serotonin and
norepinephrine reuptake inhibitors (SNRIs),
monoamine oxidase inhibitors, mirtazapine,
fentanyl, lithium, tramadol, and intravenous
methylene blue). Some of the reported
cases were fatal. Serotonin syndrome
occurring with overdose of ZOFRAN alone
has also been reported. The majority of
reports of serotonin syndrome related to 5-
HT receptor antagonist use occurred in a
post-anesthesia care unit or an infusion
center.
…
INTERACTIONS
WITH OTHER
MEDICAMENTS
AND OTHER
FORMS OF
INTERACTION
.Caution should be exercised when ondansetron is
coadministered with drugs that prolong the QT
interval and/or cause electrolyte abnormalities. (see
section 4.4)
Use of ondansetron with QT prolonging drugs ma

Αρχείο Π.Χ.Π.

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_ZOF INJ API MAR22 V2.0 _
_UK PI 12Jan2022 _
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_Page 1 of 14_
1.
NAME OF THE MEDICINAL PRODUCT
Zofran
®
Injection 2 mg/mL.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zofran Injection 2 mg/mL:
2 mL glass ampoules each containing 4 mg ondansetron (as hydrochloride
dihydrate) in aqueous
solution for intramuscular or intravenous administration.
4 mL glass ampoules each containing 8 mg ondansetron (as hydrochloride
dihydrate) in aqueous
solution for intravenous or intramuscular administration.
Excipients with a known effect: This product contains 7 mg of sodium
per 4 mg dose (see section
4.4). For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (aqueous solution).
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 chemotherapy-induced nausea
and vomiting (CINV) in
children aged ≥6 months, and for the prevention and treatment of
PONV in children aged ≥ 1 month.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Chemotherapy and Radiotherapy
induced nausea and vomiting (CINV and RINV)
_ _
_Adults: _
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 Zofran should
be flexible in the range of 8-32 mg a day and selected as shown below.
_ _
_Emetogenic chemotherapy and radiotherapy:_
Zofran can be given either by oral (tablets), intravenous
or intramuscular administration.
For most patients receiving emetogenic chemotherapy or radiotherapy
the recommended intravenous
(IV) dose of ondansetron is 8 mg and should be administered as a slow
intravenous injection (in not
less than 30 seconds) or intramuscular injection, immediately before
treatment, follow