Ondansetron ODT-DRLA

Negara: Selandia Baru

Bahasa: Inggris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Ondansetron 4mg;  

Tersedia dari:

Dr Reddy's New Zealand Limited

INN (Nama Internasional):

Ondansetron 4 mg

Dosis:

4 mg

Bentuk farmasi:

Orodispersible tablet

Komposisi:

Active: Ondansetron 4mg   Excipient: Aspartame Colloidal silicon dioxide Crospovidone Microcrystalline cellulose and guar gum (Avicel CE15) Strawberry flavour (Gurana powder) Isopropyl alcohol Magnesium stearate Mannitol Microcrystalline cellulose Purified water Sodium laurilsulfate Starch

Unit dalam paket:

Blister pack, Al/Al foil paper backed peelable, 4 tablets

Kelas:

Prescription

Jenis Resep:

Prescription

Diproduksi oleh:

Dr Reddy's Laboratories Limited

Indikasi Terapi:

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.

Ringkasan produk:

Package - Contents - Shelf Life: Blister pack, Al/Al foil paper backed peelable - 4 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, Al/Al foil paper backed peelable - 10 tablets - 36 months from date of manufacture stored at or below 30°C

Tanggal Otorisasi:

2008-08-08

Karakteristik produk

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