ZOFRAN ondansetron (as hydrochloride dihydrate) 4 mg/2 mL injection sterile syringe

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

ondansetron hydrochloride dihydrate, Quantity: 5 mg (Equivalent: ondansetron, Qty 4 mg)

Disponible desde:

Aspen Pharmacare Australia Pty Ltd

Designación común internacional (DCI):

Ondansetron hydrochloride

formulario farmacéutico:

Injection, solution

Composición:

Excipient Ingredients: sodium chloride; water for injections; sodium citrate dihydrate; citric acid monohydrate

Vía de administración:

Intravenous, Intramuscular

Unidades en paquete:

2mL x 5 (pre-filled glass syringes)

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

For the prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy. For the prevention and treatment of post-operative nausea and vomiting. INDICATIONS AS AT 25 July 1994: . For the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy; . For the prevention and treatment post-operative nausea and vomiting. INDICATIONS AS AT 10TH FEBRUARY 1997: The prevention and treatment of post-operative nausea and vomiting in paediatric patients aged 2-12 years.

Resumen del producto:

Visual Identification: Clear colourless liquid, practically free of particles.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Estado de Autorización:

Licence status A

Fecha de autorización:

2006-02-01

Ficha técnica

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