CABAZITAXEL ACCORD cabazitaxel 60 mg/3 mL concentrated injection vial

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

cabazitaxel, Quantity: 60 mg

Dostupné z:

Accord Healthcare Pty Ltd

Forma lieku:

Injection, concentrated

Zloženie:

Excipient Ingredients: polysorbate 80; ethanol absolute

Spôsob podávania:

Intravenous

Počet v balení:

1

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

CABAZITAXEL ACCORD in combination with prednisone or prednisolone is indicated for the treatment of patients with metastatic castration resistant prostate cancer previously treated with a docetaxel containing regimen. .

Prehľad produktov:

Visual Identification: A clear colourless to pale yellow or brownish yellow solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Stav Autorizácia:

Registered

Dátum Autorizácia:

2021-08-03

Príbalový leták

Cabazitaxel Accord - version 1
1
CABAZITAXEL 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 CABAZITAXEL ACCORD?
Cabazitaxel Accord contains the active ingredient cabazitaxel.
Cabazitaxel Accord is used to treat prostate cancer that has
progressed after having received other chemotherapy.
For more information, see Section 1. Why am I using Cabazitaxel
Accord?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CABAZITAXEL ACCORD?
Do not use if you have ever had an allergic reaction to cabazitaxel 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 YOU OR YOUR PARTNER IS PREGNANT
OR PLANS TO BECOME PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Cabazitaxel Accord?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Cabazitaxel Accord and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE CABAZITAXEL ACCORD?
Cabazitaxel Accord is an injection and will be given to you by your
doctor. The standard dose of Cabazitaxel Accord is 20 mg
per square metre. Your doctor may decide on an alternative dose
depending on your condition.
More instructions can be found in Section 4. How do I use Cabazitaxel
Accord?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CABAZITAXEL ACCORD?
THINGS YOU
SHOULD DO
•
Tell all the doctors, dentists and pharmacists who are treating you
that you are being given
Cabazitaxel Accord.
•
If you are about to be started on any new medicine, tell your doctor
and pharmacist that you are
being given Cabazitaxel Accord.
•
If you plan to have surgery that needs a general anaesthetic, tell
your doctor or dentist that you are
being given this medicine.
DRIVING OR USING
MACHINES
•
Be care

Súhrn charakteristických

Page 1 of 19
AUSTRALIAN PRODUCT INFORMATION
CABAZITAXEL ACCORD (CABAZITAXEL) CONCENTRATED INJECTION
1
NAME OF THE MEDICINE
Cabazitaxel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL contains 20 mg cabazitaxel.
1 vial of 3 mL concentrated injection contains 60 mg cabazitaxel.
Excipients with known effect: absolute ethanol (50 % v/v). For the
full list of excipients, see
SECTION
6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Cabazitaxel Accord 60 mg/3 mL concentrated injection is a sterile,
non-pyrogenic, clear, colourless to
pale yellow or brownish-yellow viscous solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Cabazitaxel Accord in combination with prednisone or prednisolone is
indicated for the treatment of
patients with metastatic castration resistant prostate cancer
previously treated with a docetaxel
containing regimen.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The use of Cabazitaxel Accord should be confined to units specialised
in the administration of
cytotoxics and it should only be administered under the supervision of
a physician experienced in the
use of anticancer chemotherapy.
_ _
Do not use PVC infusion containers (bags or bottles) for the
preparation of the infusion solution.
Do not use polyurethane infusion sets (tubing, filter, pumps) for the
administration of the infusion
solution.
Product is for single use in one patient only. Discard any residue.
PREMEDICATION_ _
Premedicate at least 30 minutes prior to each administration of
Cabazitaxel Accord with the following
intravenous medications to reduce the risk and severity of a
hypersensitivity reaction: antihistamine
(equivalent to dexchlorpheniramine 5 mg or diphenhydramine 25 mg or
equivalent), corticosteroid
(dexamethasone 8 mg or equivalent) and with H
2
antagonist (ranitidine or equivalent).
_ _
Antiemetic prophylaxis is recommended and can be given orally or
intravenously as needed (see
SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
).
_ _
PREPARATION PROCESS
As for any other antineoplastic agent, caution should be exercised