CARBOPLATIN

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CARBOPLATIN

Available from:

Hospira UK Limited

ATC code:

L01XA02

INN (International Name):

CARBOPLATIN

Dosage:

10 Mg/Ml

Pharmaceutical form:

Concentrate for Soln for Inf

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

carboplatin

Authorization status:

Marketed

Authorization date:

1990-07-20

Patient Information leaflet

PACKAGE LEAFLET:
INFORMATION FOR THE USER
CARBOPLATIN 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor.
•
If any of the side effects gets serious, or if you notice any side
effects not listed
in this leaflet, please tell your doctor.
IN THIS LEAFLET
:
1.
What Carboplatin Concentrate for Solution for Infusion is and what it
is used
for
2.
Before you use Carboplatin Concentrate for Solution for Infusion
3.
How to use Carboplatin Concentrate for Solution for Infusion
4.
Possible side effects
5.
How to store Carboplatin Concentrate for Solution for Infusion
6.
Further information
1. WHAT CARBOPLATIN CONCENTRATE FOR SOLUTION FOR
INFUSION IS AND WHAT IT IS USED FOR
Carboplatin Concentrate for Solution for Infusion is an anti-cancer
medicine
(cytotoxic agent). Treatment with an anti-cancer medicine is sometimes
called cancer
chemotherapy.
Carboplatin is used in the treatment of some types of lung cancer and
ovarian cancer.
2. BEFORE YOU USE CARBOPLATIN CONCENTRATE FOR SOLUTION
FOR INFUSION
DO NOT USE CARBOPLATIN CONCENTRATE FOR SOLUTION FOR INFUSION
•
if you have shown signs of hypersensitivity (severe allergy) to
carboplatin or
similar platinum containing medicines in the past
•
if you have severe kidney disease
•
if you have fewer blood cells than normal (your doctor will check this
with a
blood test)
•
if you have a tumour that bleeds
•
if you plan to receive a yellow fever vaccination or have just
received one
Tell your doctor if any of the above applies to you before this
medicine is used.
TAKE SPECIAL CARE WITH CARBOPLATIN CONCENTRATE FOR SOLUTION FOR
INFUSION
•
if you are pregnant or if there is a chance you may be pregnant
•
if you are breast-feeding
•
if you have mild renal disease. Your doctor will want to monitor you
more
regularly
•
if you are elderly (over 65 years old)
•
if you have been treated with cisplat

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Carboplatin 10mg/ml Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1. Advanced ovarian carcinoma of epithelial origin in:
a)
first line therapy
b)
second line therapy after other treatments have failed
2. Small cell carcinoma of the lung.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Carboplatin injection should be used by the intravenous route only.
_Adults:_ The recommended dose of carboplatin in previously untreated
adults with normal renal function is 400mg/m
2
given as a single short term intravenous infusion over 15 to 60
minutes. Alternatively see Calvert formula below.
Dose (mg) = target AUC (mg/ml x min) x [GFR ml/min + 25]
Note: With the Calvert formula, the total dose of carboplatin is
calculated in mg not mg/m
2
.
Therapy should not be repeated until four weeks after the previous
carboplatin course and/or until the neutrophil count
is at least 2,000 cells/mm
3
and the platelet count is at least 100,000 cells/mm
3
.
Carboplatin
10mg/ml
Each 5ml vial contains
50mg carboplatin
Each 15ml vial contains
150mg carboplatin
Each 45ml vial contains
450mg carboplatin
Each 60ml vial contains
600mg carboplatin
Target AUC
Planned Chemotherapy
Patient Treatment Status
5-7 mg/ml.min
single agent carboplatin
previously untreated
4-6 mg/ml.min
single agent carboplatin
previously treated
4-6 mg/ml.min
carboplatin plus
cyclophosphamide
previously untreated
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