Carboplatin

Χώρα: Νέα Ζηλανδία

Γλώσσα: Αγγλικά

Πηγή: Medsafe (Medicines Safety Authority)

Δραστική ουσία:

Carboplatin 10 mg/mL;  ;  

Διαθέσιμο από:

Pfizer New Zealand Limited

INN (Διεθνής Όνομα):

Carboplatin 10 mg/mL

Δοσολογία:

10 mg/mL

Φαρμακοτεχνική μορφή:

Solution for injection

Σύνθεση:

Active: Carboplatin 10 mg/mL     Excipient: Nitrogen Water for injection

Μονάδες σε πακέτο:

Vial, plastic, 1 x 5 mL, 5 mL

Kατηγορία:

Prescription

Τρόπος διάθεσης:

Prescription

Κατασκευάζεται από:

Johnson Matthey Pharmaceutical Materials

Περίληψη προϊόντος:

Package - Contents - Shelf Life: Vial, plastic, 1 x 5 mL - 5 mL - 24 months from date of manufacture stored at or below 25°C - Vial, plastic, 1 x 15 mL - 15 mL - 24 months from date of manufacture stored at or below 25°C - Vial, plastic, 1 x 45 mL - 45 mL - 24 months from date of manufacture stored at or below 25°C

Ημερομηνία της άδειας:

1991-01-23

Φύλλο οδηγιών χρήσης

CARBOPLATIN
Page 1
CARBOPLATIN INJECTION
_Carboplatin _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Carboplatin Injection.
It does not contain all the available
information. It does not take the place
of talking to your doctor or pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you using Carboplatin Injection against
the benefits it is expected to have for
you.
IF YOU HAVE ANY CONCERNS ABOUT USING
THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET_._
You may need to read it again.
WHAT CARBOPLATIN
INJECTION IS USED FOR
Carboplatin belongs to a group of
anticancer medicines known as
platinum complexes. Carboplatin
works by preventing the growth of
cancer cells and eventually destroying
them. It is used for cancer of the ovary.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it for
another reason.
This medicine is available only with a
doctor’s prescription.
BEFORE YOU ARE GIVEN
CARBOPLATIN INJECTION
_WHEN YOU MUST NOT BE GIVEN _
_IT _
DO NOT USE CARBOPLATIN INJECTION IF:
you have an allergy to carboplatin,
cisplatin or other medicines
containing platinum
you have kidney disease or poor
kidney function
you have a low blood count
DO NOT USE THIS MEDICINE IF YOU ARE
PREGNANT OR PLANNING TO BECOME
PREGNANT.
It may affect your developing baby if
you take it during pregnancy.
DO NOT BREAST FEED IF YOU ARE USING
THIS MEDICINE.
IF YOU ARE NOT SURE YOU SHOULD BE
GIVEN CARBOPLATIN, TALK TO YOUR
DOCTOR.
_BEFORE YOU ARE GIVEN IT _
TELL YOUR DOCTOR IF YOU HAVE ALLERGIES
TO ANY OTHER MEDICINES, FOODS,
PRESERVATIVES OR DYES.
TELL YOUR DOCTOR IF YOU ARE PREGNANT
OR PLAN TO BECOME PREGNANT.
TELL YOUR DOCTOR IF YOU ARE BREAST-
FEEDING OR PLAN TO BREAST-FEED.
TELL YOUR DOCTOR IF YOU HAVE OR HAVE
HAD ANY OF THE FOLLOWING MEDICAL
CONDITIONS:
any sort of infection e.g. sinusitis,
tooth abscess, etc
abnormal or heavy bleeding
bleeding gums
unusual

Αρχείο Π.Χ.Π.

Version: pfdcarbo10120
Supersedes: pfdcarbo10919
Page 1 of 10
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Carboplatin Injection, 50 mg/5 mL, 150 mg/15 mL and 450 mg/45 mL.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Carboplatin is a sterile, hypotonic, preservative-free solution of
carboplatin 10 mg/mL in Water
for Injections.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of advanced ovarian carcinoma of epithelial origin.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
The recommended dosage for previously untreated adults (normal renal
function) is 400mg/m²
as a single intravenous infusion over 15-60 minutes.
Therapy should not be repeated again until four weeks have elapsed.
In patients with risk factors such as previous myelosuppressive
therapy or in the aged, the initial
dosage may need to be reduced to 20-25%.
Determination of the haematological nadir by weekly blood counts is
recommended for
adjusting future doses and scheduling of carboplatin.
DOSE ADJUSTMENTS
PATIENTS WITH IMPAIRED RENAL FUNCTION
As carboplatin is excreted by the kidney and is nephrotoxic the
optimum dosage should be
determined by frequent monitoring of the haematological nadir and
renal function.
The suggested dosage schedule for patients with impaired renal
function based on creatinine
clearance is:
Creatinine Clearance
Carboplatin Dose
> 40 mL/min
400 mg/m²
20-39 mL/min
250 mg/m²
Version: pfdcarbo10120
Supersedes: pfdcarbo10919
Page 2 of 10
0-19 mL/min
150 mg/m²
PAEDIATRIC POPULATION
Insufficient information is available to make specific
recommendations.
COMBINATION THERAPY
Carboplatin may be used in combination with other anti-neoplastic
agents and hence the dosage
will vary according to the protocol used.
The optimal use of carboplatin in combination with other
myelosuppressive drugs will require
dosage adjustments and frequent haematological monitoring.
METHOD OF ADMINISTRATION
Aluminium reacts with carboplatin causing