Ondansetron Hexal 2mgml Injection

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

ONDANSETRON HYDROCHLORIDE DIHYDRATE 2.495 mg/ml EQV ONDANSETRON

Available from:

SANDOZ SINGAPORE PTE. LTD.

ATC code:

A04AA01

Dosage:

2.495mg (2mg)

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

ONDANSETRON HYDROCHLORIDE DIHYDRATE 2.495 mg/ml EQV ONDANSETRON 2 mg/ml

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Solupharm Pharmazeutische Erzeugnisse GmbH

Authorization status:

ACTIVE

Authorization date:

2007-10-02

Summary of Product characteristics

ONDANSETRON HEXAL
® 2 MG/ML INJECTION
(ONDANSETRON HCI DIHYDRATE)
1.
NAME OF THE MEDICINAL PRODUCT
Ondansetron Hexal
®
2 mg/mL Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL solution for injection contains 2 mg ondansetron.
Each 2 mL solution for injection contain 4 mg ondansetron.
Each 4 mL solution for injection contain 8 mg ondansetron.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADULTS
_INJECTION _
Ondansetron Hexal is indicated in the management of nausea and
vomiting induced by cytotoxic
chemotherapy and radiotherapy.
Ondansetron Hexal is also indicated for the prevention and treatment
of post-operative nausea and
vomiting.
PAEDIATRIC POPULATION
_INJECTION AND ORAL FORMULATIONS _
Ondansetron 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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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
Ondansetron Hexal lnjection 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 4.4, 4.8 and 5.1).
The efficacy of ondansetron in highly emetogenic chemotherapy may be
enhanced by the addition of a
single IV dose of dexamethasone sodium phosphate 20 mg,