Carboplatin-Teva 10 mg/ml Concentrate for Solution for Infusion

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Carboplatin

Verfügbar ab:

Teva Pharma B.V.

ATC-Code:

L01XA; L01XA02

INN (Internationale Bezeichnung):

Carboplatin

Dosierung:

10 milligram(s)/millilitre

Darreichungsform:

Concentrate for solution for infusion

Verschreibungstyp:

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

Therapiebereich:

Platinum compounds; carboplatin

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

2001-03-09

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE USER
CARBOPLATIN–TEVA 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
carboplatin
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 or pharmacist
or nurse.
• This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, even
if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. WHAT CARBOPLATIN-TEVA IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE CARBOPLATIN-TEVA
3. HOW TO RECEIVE CARBOPLATIN-TEVA
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE CARBOPLATIN-TEVA
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT CARBOPLATIN-TEVA IS AND WHAT IT IS USED FOR
Carboplatin-Teva is a platinum containing compound. It is an
anti-cancer agent, which is used either
alone or in combination with other medicines.
Carboplatin-Teva is used to treat advanced ovarian cancer and lung
cancer (small cell cancer of the
lung).
Ask your doctor or nursing staff if you need additional information.
2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE CARBOPLATIN-TEVA
DO NOT RECEIVE CARBOPLATIN-TEVA IF YOU:

are allergic (hypersensitive) to carboplatin, cisplatin or other
platinum-containing compounds
or any of the other ingredients of this medicine (listed in section 6)

have severe kidney problems

have any bone marrow problems

suffer from significant bleeding (bleeding tumors)

are pregnant, may be pregnant or breast-feeding

are due to receive, or have recently received, the yellow fever
vaccine.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR BEFORE YOU RECEIVE THIS MEDICINE IF YOU:
•
are elderly (over 65 years old).
OTHER PRECAUTIONS WHILST YOU ARE RECEIVING CARBOPLATIN-TEVA:
•
Your nervous system function will be checked regula

Fachinformation

Health Products Regulatory Authority
14 March 2024
CRN00F21G
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Carboplatin-Teva 10 mg/ml Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1ml of concentrate for solution for infusion contains 10mg of
carboplatin.
Each 5ml vial contains 50mg carboplatin;
Each 15 ml vial contains 150mg carboplatin;
Each 45 ml vial contains 450mg carboplatin;
Each 60ml vial contains 600 mg carboplatin.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Clear, colourless to faintly yellow solution, free from particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Carboplatin is indicated for the treatment of:
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
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/m
2
as a single short term IV dose administered by a 15 to 60 minute
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/m
2
. Calvert's formula should not be
used in patients who have received extensive pretreatment**.
** Patients are considered heavily pretreated if they have received
any of the following:
Health Products Regulatory Authority
14 March 2024
CRN00F21G
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