CARBOPLATIN ACCORD carboplatin 450 mg/45 mL solution for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

carboplatin, Quantity: 450 mg

Available from:

Accord Healthcare Pty Ltd

INN (International Name):

Carboplatin

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections

Administration route:

Intravenous

Units in package:

1 x 50 mL vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Carboplatin is indicated in the treatment of: advanced stage ovarian cancer of epithelial origin. Small cell lung carcinoma. Carcinoma of the head and neck. Carcinoma of the testis. Paediatric cerebral tumours. Soft tissue sarcoma. Neuroblastoma.

Product summary:

Visual Identification: A clear colourless to slight pale yellow solution in an amber glass vial.; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-11-21

Patient Information leaflet

Carboplatin Accord - version 5
1
CARBOPLATIN ACCORD
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING CARBOPLATIN ACCORD?
Carboplatin Accord contains the active ingredient carboplatin.
Carboplatin Accord is used for the treatment of 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.
For more information, see Section 1. Why am I using Carboplatin
Accord?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CARBOPLATIN ACCORD?
Do not use if you have ever had an allergic reaction to an any
medicine containing carboplatin, other platinum-containing
compounds (cisplatin or oxaliplatin) or mannitol, or any of the
ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Carboplatin Accord?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Carboplatin Accord and affect how it
works.
See Section 3. What if I am taking other medicines? in the full CMI.
4.
HOW DO I USE CARBOPLATIN ACCORD?
Carboplatin Accord is an injection and will be given to you by your
doctor or nurse.
More instructions can be found in Section 4. How do I use Carboplatin
Accord? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CARBOPLATIN ACCORD?
THINGS YOU
SHOULD DO
•
Tell any other doctors, dentists, and pharmacists who are treating you
that you are being treated with
Carboplatin Accord
•
If you become pregnant while taking this medicine, tell your doctor
immediately
•
Keep all your doctor's appointments so that your progress can be
checked.
•
Avoid people with infections.
•
Check with y

Summary of Product characteristics

Page 1 of 11
AUSTRALIAN PRODUCT INFORMATION
CARBOPLATIN ACCORD (CARBOPLATIN) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Carboplatin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL contains 10 mg carboplatin.
1 vial of 5 ml solution for injection contains 50 mg carboplatin.
1 vial of 15 ml solution for injection contains 150 mg carboplatin.
1 vial of 45 ml solution for injection contains 450 mg carboplatin.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Carboplatin Accord Solution for Injection is a clear colourless to
slightly pale-yellow solution
containing carboplatin.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Carboplatin is indicated in the treatment of:
•
advanced stage ovarian cancer of epithelial origin
•
small cell lung carcinoma
•
carcinoma of the head and neck
•
carcinoma of the testis
•
paediatric cerebral tumours
•
soft tissue sarcoma
•
neuroblastoma.
4.2
D
OSE AND METHOD OF ADMINISTRATION
ADULT
The recommended dose of carboplatin in previously untreated adults
with normal renal function is
400 milligrams/m
2
given as a single intravenous (IV) infusion over 15 to 60 minutes.
Therapy should
not be repeated until four weeks after the previous carboplatin
course.
It is recommended that according to clinical circumstances the initial
dosage may require reduction by
20 to 25% in patients with risk factors such as increasing age,
previous myelosuppressive therapy and
poor performance status.
Dosage
modification
may
be
required
when
carboplatin
is
used
in
combination
with
other
myelosuppressive medicines, or radiation therapy, to minimise additive
myelosuppressive effects.
Determination of haematologic nadir by weekly blood counts during
initial courses is recommended for
future dosage adjustment and scheduling of carboplatin.
CHILDREN
Sufficient
usage
of
carboplatin
in
paediatrics
has
not
occurred
to
allow
specific
dosage
recommendations to be made. Physicians are advised to refer to
recently published literature for
information on the c