Ondansetron-Baxter

Valsts: Jaunzēlande

Valoda: angļu

Klimata pārmaiņas: Medsafe (Medicines Safety Authority)

Aktīvā sastāvdaļa:

Ondansetron hydrochloride dihydrate 2.49 mg/mL equivalent to 2 mg Ondansetron

Pieejams no:

Baxter Healthcare Ltd

SNN (starptautisko nepatentēto nosaukumu):

Ondansetron hydrochloride dihydrate 2.49 mg/mL (equivalent to 2 mg Ondansetron)

Deva:

2 mg/mL

Zāļu forma:

Solution for injection

Kompozīcija:

Active: Ondansetron hydrochloride dihydrate 2.49 mg/mL equivalent to 2 mg Ondansetron Excipient: Citric acid monohydrate Sodium chloride Sodium citrate dihydrate Water for injection

Vienības iepakojumā:

Ampoule, glass, Type I clear, 2 mL

Klase:

Prescription

Receptes veids:

Prescription

Ražojis:

Cadila Pharmaceuticals Ltd

Ārstēšanas norādes:

The prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy.

Produktu pārskats:

Package - Contents - Shelf Life: Ampoule, glass, Type I clear - 2 mL - 36 months from date of manufacture stored at or below 30°C - Ampoule, glass, Type I clear - 4 mL - 36 months from date of manufacture stored at or below 30°C - Ampoule, glass, Type I clear 4 mL - 5 dose units - 36 months from date of manufacture stored at or below 30°C - Ampoule, glass, Type I clear 2 mL - 5 dose units - 36 months from date of manufacture stored at or below 30°C

Autorizācija datums:

2009-05-15

Produkta apraksts

NEW ZEALAND DATA SHEET
Ondansetron‐Baxter Data Sheet 11 June 2020
Page 1 of 9
Baxter Healthcare Ltd
1 ONDANSETRON‐BAXTER (2mg/mL, solution for injection)
ONDANSETRON‐BAXTER 2mg/mL solution for injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ONDANSETRON‐BAXTER, solution for injection contains 2.49mg
ondansetron hydrochloride dihydrate,
equivalent to 2mg ondansetron, per mL.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
ONDANSETRON‐BAXTER is a colourless solution.
The pH of the solution is 3.30 – 4.00.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
ONDANSETRON‐BAXTER is indicated for:

the prevention and treatment of nausea and vomiting induced by
cytotoxic therapy and
radiotherapy,

the prevention and treatment of post‐operative nausea and vomiting.
4.2
Dose and method of administration
The emetogenic potential of cancer treatment varies according to the
doses and combinations of
chemotherapy and radiotherapy regimens used. The dose of
ONDANSETRON‐BAXTER should be flexible
in the range of 8 ‐ 32mg a day and selected as indicated below. The
lowest effective dose should be
used.
In order to reduce microbiological contamination hazards, the diluted
solutions should be prepared
immediately
prior to use and infusion commenced as soon as practicable after
preparation of the
mixture. The diluted infusion solution should be stored under
refrigeration (2 ‐ 8°C) and used within
24 hours. The product is for single use in one patient only. Any
residue should be discarded.
Administration recommendations: slow intravenous injection (1mg/hour)
from an infusion bag or
syringe pump. The following medicines may be administered via the
Y‐site of the ondansetron giving
set for ondansetron concentrations of 16 to 160micrograms/mL (i.e.
8mg/500mL and 8mg/50mL
respectively).
_Cisplatin _
Concentrations up to 0.48mg/mL (i.e. 240mg in 500mL) administered over
1 ‐ 8 hours.
_5‐fluorouracil _
Concentrations up to 0.8mg/mL (i.e. 2.4g in 3 litres or