Cisplatin Ebewe

Negara: Selandia Baru

Bahasa: Inggris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Cisplatin 1 mg/mL

Tersedia dari:

Novartis New Zealand Ltd

INN (Nama Internasional):

Cisplatin 1 mg/mL

Dosis:

1 mg/mL

Bentuk farmasi:

Solution for injection

Komposisi:

Active: Cisplatin 1 mg/mL Excipient: Hydrochloric acid Sodium chloride Water for injection

Unit dalam paket:

Vial, glass, Amber glass with butyl rubber stopper and crimp cap 10 mg in 10 mL vial, 10 mL

Kelas:

Prescription

Jenis Resep:

Prescription

Diproduksi oleh:

Heraeus Deutschland GmbH & Co. KG

Indikasi Terapi:

Cisplatin Ebewe is indicated as palliative therapy to be employed as follows: Metastatic Non-seminomatous Germ Cell Carcinoma: In established combination therapy with other approved chemotherapeutic agents in patients with metastatic non-seminomatous germ cell tumours who have already received appropriate surgical and/or radiotherapeutic procedures. Metastatic Ovarian Tumours: Cisplatin Ebewe, as a single agent, is indicated as secondary therapy in patients with metastatic ovarian tumours refractory to standard chemotherapy who have not previously received Cisplatin Ebewe therapy. Advanced and Refractory Carcinoma of the Bladder: Cisplatin Ebewe, as a single agent, is indicated as secondary therapy in patients with advanced stage bladder cancer refractory to standard chemotherapy who have not previously received Cisplatin Ebewe therapy. Squamous Cell Carcinoma of the Head and Neck (Refractory to Standard Chemotherapy): Cisplatin Ebewe, as a single agent, is indicated as secondary therapy in patients with squamous cell carcinoma of the head and neck refractory to standard chemotherapy who have not previously received Cisplatin Ebewe therapy.

Ringkasan produk:

Package - Contents - Shelf Life: Vial, glass, Amber glass with butyl rubber stopper and crimp cap - 10 mL - 24 months unopened stored at or below 25°C protect from light. Do not refrigerate - Vial, glass, Amber glass with butyl rubber stopper and crimp cap - 50 mL - 24 months unopened stored at or below 25°C protect from light. Do not refrigerate - Vial, glass, Amber glass with butyl rubber stopper and crimp cap - 100 mL - 24 months unopened stored at or below 25°C protect from light. Do not refrigerate

Tanggal Otorisasi:

2004-07-26

Selebaran informasi

Cisplatin Ebewe
Cisplatin Ebewe_CMI_v4_Feb 2016
Page 1 of 5
CISPLATIN EBEWE
_Cisplatin (siss-PLAT-in) injection _
CONSUMER MEDICINE INFORMATION
_ _
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Cisplatin Ebewe. 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
Cisplatin Ebewe 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 IN A SAFE PLACE._ _
You may need to read it again.
WHAT CISPLATIN EBEWE
IS USED FOR
Cisplatin Ebewe belongs to a group
of medicines known as
antineoplastic or cytotoxic agents.
You may also hear it referred to as
a chemotherapy medicine.
Cisplatin Ebewe is a platinum-
containing medicine and is used as
an anticancer drug to interfere with
the growth of cancer cells and
eventually destroy them. Cancer
cells are like normal cells which
have changed so that they grow out
of control in the body. Since the
growth of normal body cells may
also be affected by Cisplatin
Ebewe, other effects may also
occur (see Side Effects).
Cisplatin Ebewe may be used
alone or with other anticancer
therapies for the treatment of
ovarian, testicular and head and
neck cancers.
Cisplatin Ebewe has been chosen
as your therapy, as the benefits of
treatment are expected to be
greater than the unwanted or side
effects.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you.
This medicine is available only with
a doctor's prescription
BEFORE YOU ARE GIVEN
CISPLATIN EBEWE
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU SHOULD NOT BE GIVEN
CISPLATIN EBEWE IF YOU HAVE AN
ALLERGY TO CISPLATIN EBEWE, OTHER
PLATINUM-CONTAINING COMPOUNDS
OR ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET.
Symptoms of an allergic reaction to
Cisplatin Ebewe may include:

shortness of breath, wheezing
or diff

Karakteristik produk

NEW ZEALAND DATA SHEET
Page 1 of 12
1 PRODUCT NAME
CISPLATIN EBEWE
®
1 mg/mL Solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains cisplatin 1 mg/mL
10mg in 10mL, 50mg in 50mL and 100mg in 100mL
Excipients with known effect: None
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear colourless sterile aqueous solution.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cisplatin Ebewe is indicated as palliative therapy to be employed as
follows:
METASTATIC NON-SEMINOMATOUS GERM CELL CARCINOMA:
In established combination therapy with other approved
chemotherapeutic agents in patients
with metastatic non-seminomatous germ cell tumours who have already
received appropriate
surgical and/or radiotherapeutic procedures.
METASTATIC OVARIAN TUMOURS:
Cisplatin Ebewe, as a single agent, is indicated as secondary therapy
in patients with
metastatic ovarian tumours refractory to standard chemotherapy who
have not previously
received Cisplatin Ebewe therapy.
ADVANCED AND REFRACTORY CARCINOMA OF THE BLADDER:
Cisplatin Ebewe, as a single agent, is indicated as secondary therapy
in patients with
advanced stage bladder cancer refractory to standard chemotherapy who
have not previously
received Cisplatin Ebewe therapy.
SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK (REFRACTORY TO STANDARD
CHEMOTHERAPY):
Cisplatin Ebewe, as a single agent, is indicated as secondary therapy
in patients with
squamous cell carcinoma of the head and neck refractory to standard
chemotherapy who have
not previously received Cisplatin Ebewe therapy.
NEW ZEALAND DATA SHEET
Page 2 of 12
4.2
DOSE AND METHOD OF ADMINISTRATION
NOTE:
Needles or intravenous sets containing aluminium parts that may come
in contact with
Cisplatin Ebewe should not be used for preparation or administration.
Aluminium reacts with
Cisplatin Ebewe, causing precipitate formation and a loss of potency.
The solution should be used intravenously only and should be
administered by I.V. infusion
only as recommended