DBL™ Oxaliplatin for injection

País: Nova Zelanda

Idioma: anglès

Font: Medsafe (Medicines Safety Authority)

ingredients actius:

Oxaliplatin 50mg

Disponible des:

Pfizer New Zealand Limited

Designació comuna internacional (DCI):

Oxaliplatin 50 mg

Dosis:

50 mg

formulario farmacéutico:

Powder for injection

Composición:

Active: Oxaliplatin 50mg Excipient: Lactose monohydrate

Unidades en paquete:

Vial, glass, Type I clear glass, 1 vial, 1 dose unit

clase:

Prescription

tipo de receta:

Prescription

Fabricat per:

Heraeus Deutschland GmbH & Co. KG

indicaciones terapéuticas:

DBL™ Oxaliplatin, in combination with 5-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.

Resumen del producto:

Package - Contents - Shelf Life: Vial, glass, Type I clear glass, 1 vial - 1 dose units - 36 months from date of manufacture stored at or below 30°C. (below 30°C)

Data d'autorització:

2009-01-09

Fitxa tècnica

Version: pfdoxalv10520
Supersedes: pfdoxalvp10120
Page 1 of 25
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME_ _
DBL
™
Oxaliplatin for Injection 20 mg Powder for injection
DBL
™
Oxaliplatin for Injection 50 mg Powder for injection
DBL
™
Oxaliplatin for Injection 100 mg Powder for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of DBL Oxaliplatin for Injection (oxaliplatin powder for
injection) contains either
20 mg, 50 mg or 100 mg oxaliplatin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
DBL Oxaliplatin for Injection is a sterile lyophilised powder for
infusion.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DBL Oxaliplatin, in combination with 5-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.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
In combination with fluorouracil and folinic acid the recommended dose
for the treatment of
advanced colorectal cancer is either 85 mg/m
2
intravenously repeated every two 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 ADJUSTMENTS
Prior to each treatment cycle, patients should be evaluated for
toxicity and the dose of
oxaliplatin adjusted accordingly.
Version: pfdoxalv10520
Supersedes: pfdoxalvp10120
Page 2 of 25
_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 discontinued.
_HAEMATOLOGICAL TOXICITY _
If haematologic