Epirubicin Ebewe

Negara: Selandia Baru

Bahasa: Inggris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Epirubicin hydrochloride 2 mg/mL;  

Tersedia dari:

Sandoz New Zealand Limited

INN (Nama Internasional):

Epirubicin hydrochloride 2 mg/mL

Dosis:

2 mg/mL

Bentuk farmasi:

Solution for injection

Komposisi:

Active: Epirubicin hydrochloride 2 mg/mL   Excipient: Hydrochloric acid Sodium chloride Water for injection

Unit dalam paket:

Vial, glass, vial in single vial pack, 5 mL

Kelas:

Prescription

Jenis Resep:

Prescription

Diproduksi oleh:

Synbias Pharma Limited

Indikasi Terapi:

Epirubicin hydrochloride has produced responses in a wide spectrum of neoplastic diseases, and is indicated for the treatment of breast cancer, gastric cancer, ovarian cancer, small cell lung cancer, lymphoma (non-Hodgkin's lymphoma), advanced/ metastatic soft tissue sarcoma, and superficial bladder cancer (Tis, Ta). In bladder cancer, epirubicin hydrochloride is also indicated in the prophylaxis of recurrence after transurethral resection of stage T1 papillary cancers and stage Ta multifocal papillary cancers (grade 2 and 3).

Ringkasan produk:

Package - Contents - Shelf Life: Vial, glass, vial in single vial pack - 5 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, vial in single vial pack - 25 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, vial in single vial pack - 50 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, vial in single vial pack - 100 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Tanggal Otorisasi:

2004-07-26

Selebaran informasi

Epirubicin Ebewe
2303-cmi-clean-epirubicin-ebewe.doc
Page 1 of 5
EPIRUBICIN EBEWE_ _
_Epirubicin (epi-ROO-bi-sin) _
CONSUMER MEDICINE INFORMATION_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Epirubicin Ebewe. It does not
contain all the available
information.
It does not take the place of
talking to your doctor and
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you being
given Epirubicin Ebewe against
the benefits they expect it will
have for you.
This medicine is likely to be
used while you are in hospital. If
possible, please read this leaflet
carefully before this medicine is
given to you. In some cases this
leaflet may be given to you after
the medicine has been used.
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 EPIRUBICIN EBEWE
IS USED FOR
This medicine is used to treat
the following types of cancer:
•
breast cancer
•
gastric (stomach) cancer
•
ovarian cancer
•
small cell lung cancer
•
lymphoma (non-Hodgkin's
lymphoma), a cancer of the
lymph glands
•
soft tissue cancer
•
bladder cancer.
This medicine belongs to a
group of medicines called
antineoplastic or cytotoxic
medicines. You may also hear
of these being called
chemotherapy medicines.
Epirubicin Ebewe is an
anthracycline-type of
chemotherapy medicine. This
medicine works by killing cancer
cells and stopping cancer cells
from growing and multiplying.
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 reason.
Epirubicin Ebewe may be used
alone or in combination with
other medicines to treat cancer.
This medicine is not addictive.
This medicine is available only
with a doctor's prescription.
BEFORE YOU ARE GIVEN
EPIRUBICIN EBEWE
_WHEN YOU MUST NOT BE GIVEN _
_IT _
You must not be given
Epirubicin Ebewe if you have an
allergy to:
•
any medicine containing
Epirubicin
�

Karakteristik produk

230320-Epirubicin Ebewe-ds
Page 1 of 18
NEW ZEALAND DATA SHEET
EPIRUBICIN EBEWE (EPIRUBICIN HYDROCHLORIDE)
1.
PRODUCT NAME
Epirubicin Ebewe solution for injection 2 mg/mL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active: _
Epirubicin hydrochloride
Each vial contains 2 mg/mL of epirubicin hydrochloride
Epirubicin hydrochloride is a red-orange, almost odourless,
hygroscopic powder, sparingly
soluble in water and dilute alcohol.
_List of excipients with known effect:_
Sodium chloride
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection (clear red solution, vials).
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Epirubicin hydrochloride has produced responses in a wide spectrum of
neoplastic diseases,
and is indicated for the treatment of breast cancer, gastric cancer,
ovarian cancer, small cell
lung cancer, lymphoma (non-Hodgkin's lymphoma), advanced/ metastatic
soft tissue sarcoma,
and superficial bladder cancer (Tis, Ta).
In bladder cancer, epirubicin hydrochloride is also indicated in the
prophylaxis of recurrence
after transurethral resection of stage T1 papillary cancers and stage
Ta multifocal papillary
cancers (grade 2 and 3).
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
The safety and efficacy of epirubicin in children has not been
established.
Care in the intravenous administration of epirubicin hydrochloride
will reduce the chance of
perivenous infiltration. It may also decrease the chance of local
reactions, such as urticaria and
erythematous streaking (see Section 4.4 Special warnings and
precautions for use).
_NOTE._
The recommended lifetime cumulative dose limit of epirubicin is 900
mg/m
2
body
surface area.
Under conditions of normal recovery from drug induced toxicity
(particularly bone marrow
depression and stomatitis), the recommended dosage schedule in adults,
as described below, is
as a single intravenous injection administered at 21 day intervals.
Standard doses are 75 to 90 mg/m
2
. Epirubicin produces predominantly haemat