ZOFRAN ondansetron (as hydrochloride dihydrate) 24 mg tablet blister pack

Country: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

ondansetron hydrochloride dihydrate, Quantity: 30 mg (Equivalent: ondansetron, Qty 24 mg)

Доступно од:

Aspen Pharmacare Australia Pty Ltd

Фармацеутски облик:

Tablet, film coated

Састав:

Excipient Ingredients: lactose; microcrystalline cellulose; pregelatinised maize starch; magnesium stearate; titanium dioxide; hypromellose; triacetin; iron oxide red

Пут администрације:

Oral

Јединице у пакету:

1 tablet, 5 tablets

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

Ondansetron (tablets, syrup, wafters, suppository, and injection) is indicated for the prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy.

Резиме производа:

Visual Identification: Pink, oval, biconvex tablets engraved "GX CF7" on one face and "24" on the other.; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Статус ауторизације:

Licence status A

Датум одобрења:

1999-03-26

Карактеристике производа

1
AUSTRALIAN PRODUCT INFORMATION
ZOFRAN (ONDANSETRON HYDROCHLORIDE DIHYDRATE) INJECTIONS, TABLETS AND
ORAL LIQUID, ZOFRAN (ONDANSETRON) SUPPOSITORIES AND
ZOFRAN ZYDIS (ONDANSETRON) WAFERS
1 NAME OF THE MEDICINE
Ondansetron hydrochloride dihydrate is the therapeutically active
ingredient in
Zofran injections, Zofran tablets and Zofran oral liquid.
Ondansetron is the therapeutically active ingredient in Zofran
suppositories and in
Zofran Zydis wafers.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Zofran 4 mg and 8 mg tablets contain 4 and 8 mg of ondansetron (as
ondansetron
hydrochloride dihydrate) and the following excipients: lactose
monohydrate,
microcrystalline cellulose, pregelatinised maize starch, magnesium
stearate,
hypromellose, titanium dioxide and iron oxide yellow.
Excipients with known effect: sugars as lactose
Zofran 24 mg tablets contain 24 mg of ondansetron (as ondansetron
hydrochloride
dihydrate) and the following excipients: lactose, microcrystalline
cellulose,
pregelatinised maize starch, magnesium stearate and Opadry Pink
YS-1-14593-A
(ARTG PI No: 3522).
Excipients with known effect: sugars as lactose
Zofran oral liquid contains 0.8 mg/mL of ondansetron (as ondansetron
hydrochloride
dihydrate) and the following excipients: citric acid, sodium citrate
dihydrate, sodium
benzoate, sorbitol solution (70 percent) (crystallising), purified
water and Strawberry
Flavouring Liquid SC887891 (ARTG PI No: 140281).
Excipients with known effect: benzoates and sorbitol (12.6g per
recommended
maximum daily dose) which may have a laxative effect or cause
diarrhoea
Zofran Zydis wafers contain 4 and 8 mg of ondansetron and the
following excipients:
gelatin, mannitol, aspartame, sodium methyl hydroxybenzoate, sodium
propyl
hydroxybenzoate and Strawberry Flavouring Liquid SC887891 (ARTG PI No:
140281).
Excipients with known effect: aspartame, hydroxybenzoates and
sulphites.
Each 2 mL Zofran injection contains 4 mg of ondansetron (as
ondansetron
hydrochloride dihydrate) and the following excipients: citric acid
monohydr