Oxaliplatin Accord

Nazione: Nuova Zelanda

Lingua: inglese

Fonte: Medsafe (Medicines Safety Authority)

Principio attivo:

Oxaliplatin 5 mg/mL;  ;  ; Oxaliplatin 5 mg/mL

Commercializzato da:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (Nome Internazionale):

Oxaliplatin 5 mg/mL

Dosaggio:

5 mg/mL

Forma farmaceutica:

Concentrate for infusion

Composizione:

Active: Oxaliplatin 5 mg/mL     Excipient: Lactose monohydrate Water for injection Active: Oxaliplatin 5 mg/mL Excipient: Nitrogen Water for injection

Confezione:

Vial, glass, single dose, Type I, clear tubular, 20 mm grey rubber stopper, 20 mm Al flip off lavender seal, 10 mL

Classe:

Prescription

Tipo di ricetta:

Prescription

Prodotto da:

Umicore Argentina S.A.

Indicazioni terapeutiche:

Oxaliplatin, in combination with fluorouracil and folinic acid, is indicated for adjuvant treatment of stage III (Duke's C) colon cancer after complete resection of the primary tumour.

Dettagli prodotto:

Package - Contents - Shelf Life: Vial, glass, single dose, 15 mL Type I, clear tubular with 20 mm Omniflex Plus 2500/RF rubber stopper and Al flip off cap - 10 mL - 24 months from date of manufacture stored at or below 25°C protect from light. Do not freeze 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze). In Glucose 5% injection 12 hours diluted stored at or below 25°C. In Glucose 5% injection - Vial, glass, single dose, 20 mL Type I, clear tubular with 20 mm Omniflex Plus 2500/RF rubber stopper and Al flip off cap - 20 mL - 24 months from date of manufacture stored at or below 25°C protect from light. Do not freeze. 12 hours diluted stored at or below 25°C. In Glucose 5% injection 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze). In Glucose 5% injection

Data dell'autorizzazione:

2010-03-04

Scheda tecnica

Page 1 of 21
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Oxaliplatin Accord, 5 mg/mL, Concentrated Solution for Infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL concentrate for solution for infusion contains 5 mg oxaliplatin.
Each 10 mL vial contains 50 mg oxaliplatin in concentrated solution
for infusion.
Each 20 mL vial contains 100 mg oxaliplatin in concentrated solution
for infusion.
For a full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrated Solution for Infusion.
Clear, colourless solution, free from visible particles with a pH in
the range of 3.5 and 6.5.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oxaliplatin, in combination with fluorouracil and folinic acid, is
indicated for:
Adjuvant treatment of stage III (Duke's C) colon cancer after complete
resection of the primary tumour.
Treatment of advanced colorectal cancer.
Oxaliplatin Accord is indicated in adults only.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
ADULTS:
In combination with fluorouracil and folinic acid the recommended dose
for the treatment of
advanced colorectal cancer is 85 mg/m
2
intravenously repeated every two weeks, or 130 mg/m
2
repeated every three weeks.
In combination with fluorouracil and folinic acid the recommended dose
for adjuvant treatment is 85
mg/m
2
intravenously repeated every two weeks for 12 cycles (6 months).
DOSE MODIFICATION
Prior to each treatment cycle, patients should be evaluated for
toxicity and the dose of oxaliplatin
adjusted accordingly (see
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
).
_NEUROLOGICAL TOXICITY _
If acute neurological reactions occur e.g. acute pharyngolaryngeal
dysaesthesia, increase the oxaliplatin
infusion time from 2 hours to 6 hours. This decreases C
max
by 30% and may lessen acute toxicities.
If sensory loss or paraesthesia persists longer than 7 days or
interferes with function (grade 2 toxicity),
reduce oxaliplatin dose by 25%.
If sensory loss or paraesthesia interferes with activities of daily
living (grade 3 toxicity), oxaliplatin
should be discont