PFIZER (Australia) CARBOPLATIN carboplatin 50 mg/5 mL injection vial

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

carboplatin, Quantity: 10 mg/mL

Beschikbaar vanaf:

Pfizer Australia Pty Ltd

farmaceutische vorm:

Injection, solution

Samenstelling:

Excipient Ingredients: water for injections

Toedieningsweg:

Intravenous

Eenheden in pakket:

1 x 5mL

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

For the treatment of advanced ovarian carcinoma of epithelial origin.

Product samenvatting:

Visual Identification: Clear, colourless solution, free from visible particles.; Container Type: Vial; Container Material: PP; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Autorisatie-status:

Registered

Autorisatie datum:

1993-08-18

Bijsluiter

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
FEMALES: DO NOT USE THIS MEDICINE
IF YOU ARE PREGNANT OR PLANNING TO
BECOME PREGNANT. AVOID BECOMING
PREGNANT BY USING EFFECTIVE
CONTRACEPTION DURING TREATMENT
AND UP TO 6 MONTHS AFTER THERAPY.
IT MAY AFFECT YOUR DEVELOPING BABY
IF YOU TAKE IT DURING PREGNANCY.
MALES: TELL YOUR DOCTOR OR
PHARMACIST IF YOUR PARTNER INTENDS
TO BECOME PREGNANT WHILE YOU ARE
BEING GIVEN CARBOPLATIN INJECTION,
OR SHORTLY AFTER YOU HAVE STOPPED
TREATMENT WITH CARBOPLATIN.
Carboplatin may cause birth defects
if either the male or female is using it
at the time of conception. It is
recommended that you use some
kind of birth control while you are
using Carboplatin Injection and for at
least 3 months after you stop
treatment. A barrier metho

Productkenmerken

Version: pfpcarbo10320
Supersedes: pfpcarbo11119
Page 1 of 11
AUSTRALIAN
PRODUCT
INFORMATION
–
CARBOPLATIN INJECTION (CARBOPLATIN)
1.
NAME OF THE MEDICINE
Carboplatin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Carboplatin Injection is a sterile, hypotonic, preservative-free
solution containing carboplatin
10 mg/mL in Water for Injections.
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
DOSAGE
The recommended dosage for previously untreated adults (with normal
renal function) is
400mg /m
2
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 by 20-25%.
Determination of the haematological nadir by weekly blood counts is
recommended for
adjusting future doses and scheduling of carboplatin therapy.
METHOD OF ADMINISTRATION
Prior to administration, carboplatin solutions should be inspected
visually for particulate
matter. Dilutions may be made in Glucose 5% Intravenous Infusion to
concentrations as low
as 0.1 mg/mL. The product and admixture contain no antimicrobial
agent. In order to reduce
microbiological hazards it is recommended that further dilution should
be effected immediately
prior to use and infusion commenced as soon as practicable after
preparation of the admixture.
Infusion should be completed within 24 hours of preparation and any
residue discarded (see
Section 6.6 Special precautions for disposal).
Version: pfpcarbo10320
Supersedes: pfpcarbo11119
Page 2 of 11
Aluminium reacts with carboplatin causing precipitate formation and
loss of potency, therefore
aluminium-containing equipment should not be used for preparation or
administration of
carboplatin.
DOSAGE ADJUSTMENT
RENAL IMPAIRMENT
As carboplatin is excreted by the kidney and is nephrotoxic, the