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 Deutschland GmbH

ATC code:

L01XA; L01XA02

INN (International Name):

Carboplatin

Dosage:

10 milligram(s)/millilitre

Pharmaceutical form:

Concentrate for solution for infusion

Therapeutic area:

Platinum compounds; carboplatin

Authorization status:

Marketed

Authorization date:

2012-02-17

Patient Information leaflet

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 apply to you and you have not already discussed this
with your doctor or nurse, it is
recommended to inform the doctor or nurse as soon as possible and
before receiving infusion.
Carboplatin is usually given to patients in hospital. Normally you
must not handle thi

Summary of Product characteristics

Health Products Regulatory Authority
08 February 2024
CRN00DM8N
Page 1 of 12
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 to pale yellow 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:
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**.
Health Products Regulatory Authority
08 February 2024
CRN00DM8N
Page 2 of 12
**Patients are considered heavily pretre