Pfizer (Australia) CISPLATIN 100mg/100mL injection vial

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

cisplatin, Quantity: 100 mg

Dostupné z:

Pfizer Australia Pty Ltd

Forma lieku:

Injection, solution

Zloženie:

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

Spôsob podávania:

Intravenous

Počet v balení:

100mL x 1

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

Cisplatin injection may be used singularly or in combination with other chemotherapeutic agents in the treatment of: - metastatic nonseminomatous germ cell carcinoma; advanced stage, refractory ovarian carcinoma; advanced stage, refractory bladder carcinoma; refractory squamous cell carcinoma of the head and neck

Prehľad produktov:

Visual Identification: A clear, colourless to pale yellow solution, free of visible particulate matter.; Container Type: Vial; Container Material: PP; Container Life Time: 2 Years; Container Temperature: Store between 15-25 degrees Celsius

Stav Autorizácia:

Registered

Dátum Autorizácia:

1994-06-23

Príbalový leták

CISPLATIN INJECTION
_cisplatin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Cisplatin 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 Cisplatin
Injection against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT CISPLATIN
INJECTION IS USED FOR
Cisplatin belongs to a group of
anticancer medicines known as the
platinum complexes. Cisplatin works
by preventing the growth of cancer
cells and eventually destroying them.
It is used for cancer of the ovary,
testis, bladder and also head and neck
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 purpose.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
CISPLATIN INJECTION
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT USE CISPLATIN INJECTION IF
YOU HAVE AN ALLERGY TO:
•
any medicine containing
cisplatin, carboplatin or other
medicines containing platinum
•
any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
CISPLATIN INJECTION SHOULD NOT BE
GIVEN IF:
•
you have kidney disease or poor
kidney function
•
you have a low blood count
•
you have hearing problems.
DO NOT USE THIS MEDICINE IF YOU ARE
PREGNANT OR PLANNING TO BECOME
PREGNANT.
It may affect your developing baby.
FEMALES: TELL YOUR DOCTOR OR
PHARMACIST IF YOU ARE PREGNANT OR
INTEND TO BECOME PREGNANT.
Birth control should be used during
treatment with Cisplatin and for at
least 26 weeks after you stop

Súhrn charakteristických

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AUSTRALIAN
PRODUCT
INFORMATION
–
CISPLATIN INJECTION (CISPLATIN)
1.
NAME OF THE MEDICINE
Cisplatin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cisplatin
Injection
is
a
sterile,
isotonic,
preservative
free
solution
containing
cisplatin
1 mg/mL.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cisplatin Injection may be used singularly or in combination with
other chemotherapeutic
agents in the treatment of:
•
Metastatic nonseminomatous germ cell carcinoma
•
Advanced stage, refractory ovarian carcinoma
•
Advanced stage, refractory bladder carcinoma
•
Refractory squamous cell carcinoma of the head and neck.
4.2 DOSE AND METHOD OF ADMINISTRATION
ADULT AND CHILDREN SINGLE AGENT THERAPY
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;
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•
_treatment of ovarian cancer: _
cyclophosphamide, doxorubicin, hexamethylmelamine, 5-
fluorouracil;
•
_treatment of head and neck cancer:_
bleomycin, methotrexate.
SUBSEQUENT TREATMENT WITH CISPLATIN
A repeat course of cisplatin should not be given until:
•
the serum creatinine is below 140 micromol/L and/or the plasma urea is
below 9 mmol/L
and
•
circulating blood elements are at an acceptable level (platelets at
least 100,000/mm
3
, WBC
at least 4000/mm
3
).
A base line audiogram should be taken and the patient monitored
periodically for auditory
deterioration (see Section 4.4 Special warnings and precautions for
use).
IMPAIRED HEPATIC FUNCTION
Human st