DBL™ Carboplatin Injection

País: Nova Zelândia

Língua: inglês

Origem: Medsafe (Medicines Safety Authority)

Ingredientes ativos:

Carboplatin 10 mg/mL

Disponível em:

Pfizer New Zealand Limited

DCI (Denominação Comum Internacional):

Carboplatin 10 mg/mL

Dosagem:

10 mg/mL

Forma farmacêutica:

Solution for injection

Composição:

Active: Carboplatin 10 mg/mL Excipient: Water for injection

Unidades em pacote:

Vial, 50 mg/5 mL, 5 mL

Classe:

Prescription

Tipo de prescrição:

Prescription

Fabricado por:

Johnson Matthey Pharmaceutical Materials

Indicações terapêuticas:

· advanced stage ovarian cancer of epithelial origin.

Resumo do produto:

Package - Contents - Shelf Life: Vial, 50 mg/5 mL - 5 mL - 18 months from date of manufacture stored at or below 25°C protect from light 24 hours opened stored at or below 25°C protect from light - Vial, 150 mg/15 mL - 15 mL - 18 months from date of manufacture stored at or below 25°C protect from light 24 hours opened stored at or below 25°C protect from light - Vial, 450 mg/45 mL - 45 mL - 18 months from date of manufacture stored at or below 25°C protect from light 24 hours opened stored at or below 25°C protect from light

Data de autorização:

1989-07-21

Características técnicas

Version: pfdcarpi10823
Supersedes: pfdcarpi10223
Page 1 of 14
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME_ _
DBL
™
Carboplatin Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL Carboplatin Injection (all presentations) is a sterile solution of
carboplatin in Water for
Injections. The vials contain 5, 15 or 45 mL of 10 mg/mL carboplatin.
The solution does not
contain any preservatives.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
DBL Carboplatin Injection is a solution for injection.
It is clear, colourless or slightly yellow solution free from
particulates and is presented in vials.
The pH of the injection ranges between 4.0 to 7.0.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Carboplatin is indicated in the treatment of:
•
advanced stage ovarian cancer of epithelial origin
•
small cell lung carcinoma
•
carcinoma of the head and neck
•
carcinoma of the testis
•
paediatric cerebral tumours
•
soft tissue sarcoma
•
neuroblastoma
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
CONTAINS NO ANTIMICROBIAL AGENT. PRODUCT IS FOR SINGLE USE IN ONE
PATIENT ONLY. DISCARD
ANY RESIDUE.
Version: pfdcarpi10823
Supersedes: pfdcarpi10223
Page 2 of 14
Adults: The recommended dose of carboplatin in previously untreated
adults with normal renal
function is 400 mg/m
2
given as a single intravenous infusion over 15 to 60 minutes. Therapy
should not be repeated until four weeks after the previous carboplatin
course.
It is recommended that according to clinical circumstances the initial
dosage may require
reduction by 20 to 25% in patients with risk factors such as
increasing age, previous
myelosuppressive therapy and poor performance status.
Dosage modification may be required when carboplatin is used in
combination with other
myelosuppressive drugs or radiation therapy, to minimise additive
myelosuppressive effects.
Determination of haematologic nadir by weekly blood counts during
initial courses is
recommended for future dosage adjustment and scheduling of
carboplatin.
Impaired Renal Fu