Carboplatin 10 mg/ml concentrate for solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Carboplatin

Available from:

Fresenius Kabi Oncology Plc

ATC code:

L01XA; L01XA02

INN (International Name):

Carboplatin

Dosage:

10 milligram(s)/millilitre

Pharmaceutical form:

Concentrate for solution for infusion

Prescription type:

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

Therapeutic area:

Platinum compounds; carboplatin

Authorization status:

Marketed

Authorization date:

2012-02-17

Patient Information leaflet

Ver.: 10
Last modified: 23 March 2017 3:14 PM
Times New Roman 10 pt
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PACKAGE LEAFLET: INFORMATION FOR THE USER
CARBOPLATIN 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION (50 MG/5 ML, 150 MG/15 ML, 450 MG/45 ML AND
600 MG/60 ML)
CARBOPLATIN
The name of this medicine is Carboplatin 10 mg/ml concentrate for
solution for infusion but in the rest of the leaflet it will be called
‘Carboplatin’.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, please ask your doctor or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Carboplatin is and what it is used for
2. What you need to know before you are given Carboplatin
3. How you are given Carboplatin
4. Possible side effects
5. How to store Carboplatin
6. Contents of the pack and other information
1. WHAT CARBOPLATIN IS AND WHAT IT IS USED FOR
WHAT CARBOPLATIN IS
It contains active ingredient carboplatin, which belong to a group of
medicines known as platinum coordination compounds, which are
used to treat cancer.
WHAT CARBOPLATIN IS USED FOR
This medicine is used against advanced cancer of the ovary and small
cell cancer of the lung.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CARBOPLATIN
DO NOT USE CARBOPLATIN:
•
if you are allergic to carboplatin or any of the other ingredients of
this medicine (listed in section 6).
•
if you have severe problems with your kidneys (creatinine clearance
at or below 30 ml/min)
•
if
you
have
an
imbalance
of
your
blood
cells
(severe
myelosuppression)
•
if you have a tumour that bleeds
•
Concomitantly with yellow fever vaccine
If any of these

Summary of Product characteristics

Health Products Regulatory Authority
14 September 2018
CRN008HG8
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Carboplatin 10 mg/ml concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of concentrate for solution for infusion contains 10 mg of
carboplatin.
Each 5 ml vial contains 50 mg carboplatin
Each 15 ml vial contains 150 mg carboplatin
Each 45 ml vial contains 450 mg carboplatin
Each 60 ml vial contains 600 mg carboplatin
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
A clear, colourless solution free from visible particles.
pH- 5.0 to 7.0
Osmolality: 200 - 300 mOsm/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Carboplatin is indicated for the treatment of:
1. advanced ovarian carcinoma of epithelial origin in:
- first line therapy
- second line therapy, after other treatments have failed
2. small cell carcinoma of the lung.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dosage and Administration:
Carboplatin should be used by the intravenous route only. The
recommended
dosage of carboplatin in previously untreated adult patients with
normal kidney
function, i.e. creatinine clearance > 60 ml/min is 400 mg/m² as a
single short term IV
dose administered by a 15 to 60 minutes infusion.
Alternatively, the Calvert formula shown below may be used to
determine dosage:
Health Products Regulatory Authority
14 September 2018
CRN008HG8
Page 2 of 19
Dose (mg) = target AUC (mg/ml x min) x [GFR ml/min + 25]
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
Note: With the Calvert formula, the total dose of carboplatin is
calculated in mg, not
mg/m². Calvert’s formula should not be used in patients who have
received extensive
pretreatment**.
**Patients are considered heavily pretreated if they have