Carboplatin 450mg/ 45mL injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

carboplatin

Available from:

Novotech Australia Pty Ltd

INN (International Name):

Carboplatin

Class:

Medicine Registered

Authorization status:

Registered

Patient Information leaflet

CONSUMER MEDICINE INFORMATON
CARBOPLATIN INJECTION
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 being
given carboplatin against the benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT CARBOPLATIN INJECTION IS USED FOR
The name of your medicine is Carboplatin Injection. It contains the
active ingredient
carboplatin.
Carboplatin belongs to a group of medicines called antineoplastic or
cytotoxic
medicines. You may also hear of these being called chemotherapy
medicines. This
medicine is classified as a platinum-complex cytotoxic. It is used to
treat certain
cancers. It works by killing cancer cells and/or stopping cancer cells
from growing and
multiplying.
This medicine is used to treat:
• ovarian cancer
• cancer of the testes
• some types of lung cancer
• cancer of the brain and/or spinal cord
• cancer of the head and neck
• neuroblastoma (a cancer of the nerves and adrenal glands)
• a type of cancer called sarcoma.
Carboplatin is often used in combination with other medicines to treat
cancer.
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 not addictive.
This medicine is available only with a doctor's prescription.
BEFORE YOU ARE GIVEN CARBOPLATIN INJECTION
_WHEN YOU MUST NOT BE GIVEN IT _
_ _
YOU SHOULD NOT BE GIVEN CARBOPLATIN INJECTION IF YOU HAVE AN ALLERGY
TO:
•
any medicine containing carboplatin
•
other platinum-containing compounds such as cisplatin or other
medicines
containing platinum.
Some of the symptoms of an allergic reaction may include shortness of
breath,
wheezing or difficulty breathi

Summary of Product characteristics

PRODUCT INFORMATION
NAME OF THE MEDICINE
CARBOPLATIN INJECTION
DESCRIPTION
Carboplatin is an inorganic heavy metal complex chemically known as
platinum,
diamine (1,1-cyclobutane-dicarboxylato(2-)-
_O,O_
’)-(SP-4-2).
Molecular formula: C
6
H
12
N
2
O
4
Pt
Molecular weight: 371.3
CAS Number: 41575-94-4
Carboplatin Injection is a sterile solution of carboplatin in water
for injections. It is
presented in vials containing 5, 15 and 45 mL of 10 mg/mL carboplatin.
The solution
does not contain any preservatives. The pH of the injection ranges
between 5.0 to
7.0.
PHARMACOLOGY
Carboplatin, an analogue of cisplatin, is an antineoplastic agent
which interferes with
DNA intrastrand and interstrand crosslinks in cells exposed to the
drug. DNA
reactivity has been correlated with cytotoxicity.
_ _
_Pharmacokinetics: _
After a one-hour infusion of the drug (dose range 20 to 520
milligrams/m
2
) plasma levels of total platinum and ultrafilterable (free) platinum
decay biphasically following first order kinetics. For ultrafilterable
platinum reported
values for the initial phase of the half life (t
alpha ½
) are about 90 minutes and in the
later phase the half life (t
beta ½
) is about 6 hours. Total platinum elimination has a
similar initial half life while in the later phase the half life of
total platinum may be
greater than 24 hours. Carboplatin is a stable molecule. All free
platinum is in the
form of carboplatin in the first 4 hours.
65% of the carboplatin dose is eliminated in the urine within 24 hours
of
administration with 32% of the dose being excreted as unchanged drug.
Most of the
drug is excreted in the first 6 hours.
Initially protein binding is low. During the first 4 hours after
administration 0 to 29%
of carboplatin is protein bound. By 24 hours 85 to 89% is protein
bound. Excretion of
carboplatin is by glomerular filtration. Patients with poor renal
function have a higher
Area Under Curve for total platinum and a reduction in dosage is
recommended.
1/9
v2 15/6/2010
INDICATIONS
_ _
_Carboplatin is indicated i