Ondansetron-DRLA

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Ondansetron hydrochloride dihydrate 10mg equivalent to ondansetron 8 mg

Beschikbaar vanaf:

Dr Reddy's New Zealand Limited

INN (Algemene Internationale Benaming):

Ondansetron hydrochloride dihydrate 10 mg (equivalent to ondansetron 8 mg)

Dosering:

8 mg

farmaceutische vorm:

Film coated tablet

Samenstelling:

Active: Ondansetron hydrochloride dihydrate 10mg equivalent to ondansetron 8 mg Excipient: Colloidal silicon dioxide Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry yellow 03B52246 Purified water Sodium starch glycolate Starch

Eenheden in pakket:

Blister pack, PVC/PVdC, white opaque/hard tempered aluminium foil or clear/aluminium foil paper backed peeable, 4 tablets

klasse:

Prescription

Prescription-type:

Prescription

Geproduceerd door:

Dr Reddy's Laboratories Limited

therapeutische indicaties:

Ondansetron-DRLA tablets and Ondansetron ODT-DRLA tablets are indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Ondansetron-DRLA tablets and Ondansetron ODT-DRLA tablets are also indicated for the prevention of post-operative nausea and vomiting.

Product samenvatting:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC, white opaque/hard tempered aluminium foil or clear/aluminium foil paper backed peeable - 4 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVdC, white opaque/hard tempered aluminium foil or clear/aluminium foil paper backed peeable - 10 tablets - 24 months from date of manufacture stored at or below 25°C

Autorisatie datum:

2008-08-08

Productkenmerken

NEW ZEALAND DATASHEET
1 PRODUCT NAME
Ondansetron-DRLA tablets
Ondansetron ODT-DRLA tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ondansetron hydrochloride dihydrate tablets 4 mg and 8 mg
Ondansetron 4 mg and 8 mg orodispersible tablets
3 PHARMACEUTICAL FORM
Ondansetron-DRLA tablets 4 mg: Light yellow, oval, biconvex film
coated tablet embossed
'OND' on one side and '4' on the other. Each tablet contains
ondansetron 4 mg (as
hydrochloride dihydrate).
Ondansetron-DRLA tablets 8 mg: Dark yellow, oval, biconvex film coated
tablet engraved
'OND' on one face and '8’ on the other. Each tablet contains
ondansetron 8 mg (as
hydrochloride dihydrate).
Ondansetron ODT-DRLA orodispersible tablets 4 mg: White to off-white,
biconvex, uncoated
tablets
embossed
”4”
on
one
side
and
“O”
on
the
other
side.
Each
tablet
contains
ondansetron 4 mg.
Ondansetron ODT-DRLA orodispersible tablets 8 mg: White to off-white,
biconvex, uncoated
tablets
embossed
”8”
on
one
side
and
“O”
on
the
other
side.
Each
tablet
contains
ondansetron 8 mg.
Do not halve the tablet. Dose equivalence when the tablet is divided
has not been
established.
Ondansetron ODT-DRLA orodispersible tablets contains lactose. If you
have been told by
your doctor that you have intolerance to some sugars, contact your
doctor before taking this
medicine.
For a full list of excipients, see section 6.1.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Ondansetron-DRLA
tablets
and Ondansetron ODT-DRLA
tablets
are
indicated
for the
management of nausea and vomiting induced by cytotoxic chemotherapy
and radiotherapy.
Ondansetron-DRLA tablets and Ondansetron ODT-DRLA tablets are also
indicated for the
prevention of post-operative nausea and vomiting.
4.2 Dose and method of administration
Ondansetron is also available for parenteral use to allow the route of
administration and
dosing to be flexible. Place the Ondansetron ODT-DRLA orodispersible
tablet on top of the
tongue, where it will disperse within seconds, then swallow. The film
coated tablets can be
taken