Carboplatin Cipla Concentrate for Soln for Inf 10mg/ml (150mg/15ml)

देश: माल्टा

भाषा: अंग्रेज़ी

स्रोत: Medicines Authority

सक्रिय संघटक:

CARBOPLATIN

थमां उपलब्ध:

Cipla Europe N.V. Uitbreidingstraat 80, 2600 Antwerp, Belgium

ए.टी.सी कोड:

L01XA02

INN (इंटरनेशनल नाम):

CARBOPLATIN 10 mg/ml

फार्मास्यूटिकल फॉर्म:

CONCENTRATE FOR SOLUTION FOR INFUSION

रचना:

CARBOPLATIN 10 mg/ml

प्रिस्क्रिप्शन प्रकार:

POM

चिकित्सीय क्षेत्र:

ANTINEOPLASTIC AGENTS

प्राधिकरण का दर्जा:

Withdrawn

प्राधिकरण की तारीख:

2016-01-06

सूचना पत्रक

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CARBOPLATIN CIPLA 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 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 Cipla is and what it is used for
2.
What you need to know before you are given Carboplatin Cipla
3.
How Carboplatin Cipla is given
4.
Possible side effects
5.
How to store Carboplatin Cipla
6.
Contents of the pack and other information
1.
WHAT CARBOPLATIN CIPLA IS AND WHAT IT IS USED FOR
This medicine contains carboplatin, which belongs to a group of
medicines known as platinum
coordination compounds, which are used to treat cancer.
Carboplatin Cipla 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 CIPLA
DO NOT USE CARBOPLATIN CIPLA

If you are allergic to carboplatin or to any of the ingredients of
this medicine (listed in section
6)

if you are breast feeding

If you are allergic to another medicine that belongs to the group of
platinum containing
compound.

If you have severe kidney problems

If you have a condition in which the bone marrow cannot make enough
blood cells (sever
myelosuppression)

If you have bleeding tumours

If you are due to receive, or have recently received, yellow fever
vaccine.
If any of the above applies to you and you have not already discussed
this with your doctor or
nurse, you should do so as soon as possible and before receiving an
infusion.
Carboplatin Cipla is usually given to patients in the hospital.
Normally you should not handle this
medicine. Your doctor or nurse will give you the medicine and will
carefully and frequently

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Carboplatin Cipla 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 solution free from visible particles.
pH: 5.00 - 7.00
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Carboplatin Cipla 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/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
5-7mg/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. 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:
•
Mitomycin C
•
Nitrosourea
•
Combination therapy with doxorubicin/ cyclophosphamide/cisplatin,
•
Combination therapy with 5 or more