ZOFRAN INJECTION 2 mgml

Valsts: Singapūra

Valoda: angļu

Klimata pārmaiņas: HSA (Health Sciences Authority)

Aktīvā sastāvdaļa:

ONDANSETRON HYDROCHLORIDE DIHYDRATE EQV ONDANSETRON

Pieejams no:

SANDOZ SINGAPORE PTE. LTD.

ATĶ kods:

A04AA01

Deva:

4 mg/2 ml

Zāļu forma:

INJECTION

Kompozīcija:

ONDANSETRON HYDROCHLORIDE DIHYDRATE EQV ONDANSETRON 2 mg/mL

Ievadīšanas:

INTRAVENOUS, INTRAMUSCULAR

Receptes veids:

Prescription Only

Ražojis:

GlaxoSmithKline Manufacturing S.P.A

Autorizācija statuss:

ACTIVE

Autorizācija datums:

1990-10-16

Lietošanas instrukcija

 
ZOFRAN™ INJECTION 
ONDANSETRON 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each 1 mL of aqueous solution contains 2 mg ondansetron
as hydrochloride dihydrate. 
PHARMACEUTICAL FORM 
A clear, colourless, sterile solution for injection
or infusion. 
CLINICAL PARTICULARS 
INDICATIONS 
_ADULTS _
_ZOFRAN_ injection is indicated
for the management of nausea and vomiting induced by 
cytotoxic chemotherapy and radiotherapy. 
_ZOFRAN_ is also indicated for the prevention and
treatment of post-operative nausea and 
vomiting. 
PAEDIATRIC POPULATION 
INJECTION AND ORAL FORMULATIONS: 
_ZOFRAN_ is indicated for the management of nausea and
vomiting induced by cytotoxic 
chemotherapy. 
No studies have been conducted on the use of orally administered
ondansetron in the 
prevention or treatment of post-operative nausea and
vomiting; IV injection is 
recommended for this purpose. 
DOSAGE AND ADMINISTRATION 
_ZOFRAN_ is available for oral and
parenteral use to allow the route of administration and 
dosing to be flexible. 
CHEMOTHERAPY AND RADIOTHERAPY INDUCED NAUSEA AND 
VOMITING (CINV AND RINV) 
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. 
•  CINV AND RINV IN ADULTS 
The recommended
intravenous (IV) or intramuscular (IM) dose of _ZOFRAN_ is 8
mg 
administered immediately before treatment. 

For highly emetogenic chemotherapy,
a maximum initial ondansetron dose of 16 mg IV 
infused over 15 minutes may be used.
A single IV dose greater than 16 mg should not be 
given 
due to dose-dependent increase of QT prolongation
risk (_see Warnings and Precautions, _
_Adverse Reactions, Pharmacodynamic Effects_).

The efficacy of _ZOFRAN_ in
highly emetogen

Produkta apraksts

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TRADE NAME
Zofran
TM
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
A clear, colourless, sterile solution for injection or infusion. Each
1 mL of aqueous solution
contains 2 mg ondansetron as hydrochloride dihydrate.
ACTIVE SUBSTANCE
Ondansetron
EXCIPIENTS
Ampoules contain:
Sodium chloride
Citric acid monohydrate
Sodium citrate
Water for Injection
INDICATIONS
ADULTS
_ZOFRAN_
injection is indicated for the management of nausea and vomiting
induced by cytotoxic
chemotherapy and radiotherapy.
_ZOFRAN_
is also indicated for the prevention and treatment of post-operative
nausea and vomiting.
PAEDIATRIC POPULATION_ _
INJECTION AND ORAL FORMULATIONS:_ _
_ZOFRAN_
is indicated for the management of nausea and vomiting
induced by cytotoxic
chemotherapy.
No studies have been conducted on the use of orally administered
ondansetron in the prevention
or treatment of post-operative nausea and vomiting; IV injection is
recommended for this purpose.
DOSAGE REGIMEN AND ADMINISTRATION
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DOSING REGIMEN
CHEMOTHERAPY AND RADIOTHERAPY INDUCED NAUSEA AND VOMITING (CINV
AND RINV)
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.
CINV AND RINV IN ADULTS
The recommended intravenous (IV) or intramuscular (IM) dose of
_ZOFRAN_
is 8 mg administered
immediately before treatment.
For highly emetogenic chemotherapy, a maximum initial ondansetron dose
of 16 mg IV infused
over 15 minutes may be used. A single IV dose greater than 16 mg
should not be given
due to dose-
dependent increase of QT prolongation risk (see sections WARNINGS AND
PRECAUTIONS, ADVERSE
DRUG REACTIONS, CLINICAL PHARMACOLOGY).
The efficacy of
_ZOFRAN_
in highly emetogenic chemotherapy may be enhanced by the addition of
a single IV dose of dexamethasone sodium phosphate 20 mg, administered
prior to chemotherapy.
IV doses greater than 8 mg and up to a maximum of 16 mg must