CISPLATIN ACCORD cisplatin 25 mg/25 mL concentrated injection vial

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

cisplatin, Quantity: 1 mg/mL

Beszerezhető a:

Accord Healthcare Pty Ltd

Gyógyszerészeti forma:

Injection, concentrated

Összetétel:

Excipient Ingredients: water for injections; sodium chloride; hydrochloric acid; sodium hydroxide

Az alkalmazás módja:

Intravenous

db csomag:

1

Recept típusa:

(S4) Prescription Only Medicine

Terápiás javallatok:

Cisplatin Accord may be used as a monotherapy or in combination with other chemotherapeutic agents in the treatment of:,? Metastatic non-seminomatous germ cell carcinoma,? Advanced stage, refractory ovarian carcinoma,? Advanced stage, refractory bladder carcinoma,? Refractory squamous cell carcinoma of the head and neck

Termék összefoglaló:

Visual Identification: A clear, colourless to pale yellow solution in an amber glass vial; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Engedélyezési státusz:

Registered

Engedély dátuma:

2018-07-09

Betegtájékoztató

Cisplatin Accord - version 4
1
CISPLATIN 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 CISPLATIN ACCORD?
Cisplatin Accord contains the active ingredient cisplatin. Cisplatin
Accord is used for the treatment of ovarian cancer, cancer of
the testes, cancer of the bladder, cancer of the head and neck.
For more information, see Section 1. Why am I using Cisplatin Accord?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CISPLATIN ACCORD?
Do not use if you have ever had an allergic reaction to an any
medicine containing cisplatin, carboplatin, other platinum-
containing compounds, 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
Cisplatin Accord?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Cisplatin 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 CISPLATIN ACCORD?
Cisplatin 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 Cisplatin
Accord?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CISPLATIN ACCORD?
THINGS YOU
SHOULD DO
•
Be sure to keep all your doctor's appointments.
•
You will have blood and other tests from time to time to check on your
progress and detect any
unwanted side effects.
•
Tell all the doctors, dentists, and pharmacists who are treating you
that you are being given Cisplatin
Accord.
•
If you are about to be started on any new medicine, tell your doctor
or pharmacist that you are being
given Cisplatin Accord.
•
If you plan to have surgery that needs a general anaesthetic, tell
your doctor or dentist that you are
be

Termékjellemzők

1
AUSTRALIAN PRODUCT INFORMATION
CISPLATIN ACCORD CONCENTRATED INJECTION
1
NAME OF THE MEDICINE
Cisplatin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL contains 1 mg cisplatin.
1 vial of 10 mL concentrated injection for infusion contains 10 mg
cisplatin.
1 vial of 25 mL concentrated injection for infusion contains 25 mg
cisplatin.
1 vial of 50 mL concentrated injection for infusion contains 50 mg
cisplatin.
1 vial of 100 mL concentrated injection for infusion contains 100 mg
cisplatin.
Cisplatin is a yellow to orange crystalline powder. It is slightly
soluble in water, sparingly soluble in
dimethylformamide and practically insoluble in ethanol (96 precent).
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Cisplatin Accord is a clear, colourless to pale yellow sterile,
isotonic, preservative free concentrated
injection for infusion.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Cisplatin Accord may be used as a monotherapy or in combination with
other chemotherapeutic agents
in the treatment of:
•
Metastatic non-seminomatous germ cell carcinoma
•
Advanced stage, refractory ovarian carcinoma
•
Advanced stage, refractory bladder carcinoma
•
Refractory squamous cell carcinoma of the head and neck
4.2
D
OSE AND METHOD OF ADMINISTRATION
Cisplatin Accord contains no antimicrobial agent. The product is for
single use in one patient only.
Discard any residue.
ADULTS AND CHILDREN:
MONOTHERAPY
Typical doses and schedules are:
50 – 100 mg/m
2
as a single IV infusion every 3 – 4 weeks over 6 – 8 hours; or
slow IV infusion of 15-20
mg/m
2
/day for 5 days, every 3 – 4 weeks.
Dosage should be reduced in patients with depressed bone marrow
function.
COMBINATION THERAPY
Cisplatin is commonly used in combination therapy with the following
cytotoxic agents:
•
_treatment of testicular cancer: _
vinblastine, bleomycin, actinomycin D;
•
_treatment of ovarian cancer: _
cyclophosphamide, doxorubicin, hexamethylmelamine, fluorouracil;
•
_treatment of head and neck ca