Carboplatin 10 mg/ml Concentrate for Solution for Infusion

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Carboplatin

थमां उपलब्ध:

Accord Healthcare Ireland Ltd.

ए.टी.सी कोड:

L01XA; L01XA02

INN (इंटरनेशनल नाम):

Carboplatin

डोज़:

10 milligram(s)/millilitre

फार्मास्यूटिकल फॉर्म:

Concentrate for solution for infusion

चिकित्सीय क्षेत्र:

Platinum compounds; carboplatin

प्राधिकरण का दर्जा:

Not marketed

प्राधिकरण की तारीख:

2009-01-09

सूचना पत्रक

PACKAGE LEAFLET: INFORMATION FOR THE USER
CARBOPLATIN 10MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
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, ask your doctor, pharmacist or
nurse.
•
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effect not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1. What Carboplatin Infusion is and what it is used for
2. What you need to know before you use Carboplatin Infusion
3. How to use Carboplatin Infusion
4. Possible side effects
5. How to store Carboplatin Infusion
6. Contents of the pack and other information
1. WHAT CARBOPLATIN INFUSION IS AND WHAT IT IS USED FOR
Carboplatin Infusion is an anti-cancer medicine. Treatment with an
anti-cancer medicine is sometimes called cancer
chemotherapy.
Carboplatin Infusion is used in the treatment of some types of lung
cancer and ovarian cancer.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CARBOPLATIN INFUSION
DO NOT USE CARBOPLATIN INFUSION
•
if you are allergic to Carboplatin or to any of the other ingredients
of this medicine (listed in section 6)
•
if you have had hypersensitivity to 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 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.
WARNINGS AND PRECAUTIONS
Talk to your doctor ,pharmacist or nurse before using Carboplatin
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

उत्पाद विशेषताएं

Health Products Regulatory Authority
21 June 2023
CRN00DH3R
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 10mg 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 slightly pale 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
Posology:
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]
Dose (mg) target AUC (mg/ml x min) x fGFR ml/min + 251
​
​
Target AUC
Planned chemotherapy
Patient treatment status
5-7mg/ml .min
single agent Carboplatin
Previously untreated
4-6 mg/ml .min
single agent Carboplatin
Previously treated
4-6mg/ml .min
Carboplatin plus cyclophosphamide
Previously untreated
Note: With the Calvert formula, the total dose of Carboplatin is
calculated in mg, not mg/m2 .
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/mm3 and the platelet count is at least 100,000
cells/mm3.
Health Products Regulatory Authority
21 June 2023
CRN00DH3R
Page 2 of 12
Initi