EPIRUBICIN ACCORD epirubicin hydrochloride 200mg/100mL concentrated injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

epirubicin hydrochloride, Quantity: 200 mg

Available from:

Accord Healthcare Pty Ltd

INN (International Name):

epirubicin hydrochloride

Pharmaceutical form:

Injection, concentrated

Composition:

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

Administration route:

Intravesical, Intravenous Infusion

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Epirubicin 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, superficial bladder cancer (Tis; Ta). In bladder cancer, Epirubicin is also indicated in the prophylaxis of recurrence after transurethral resection of stage T1 papillary cancers and stage Ta multifocal papillary cancers (grades 2 and 3).

Product summary:

Visual Identification: Clear red solution in a clear glass vial with white or royal blue flip off seal; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2014-10-09

Patient Information leaflet

Version 3.0
Page 1 of 4
EPIRUBICIN ACCORD
_Epirubicin Hydrochloride Concentrated Injection _
_10 mg/5 mL, 20 mg/10 mL, 50 mg/ 25 mL and 200 mg/100 mL _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Epirubicin Accord.
It does not contain all of 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
using Epirubicin Accord against the
benefits it is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING
EPIRUBICIN ACCORD, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT EPIRUBICIN ACCORD
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
•
SARCOMA
•
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
Accord is an anthracycline-type of
chemotherapy.
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 Accord 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 ACCORD
_WHEN YOU MUST NOT BE GIVEN _
_IT _
DO NOT USE EPIRUBICIN ACCORD IF YOU
HAVE EVER HAD AN ALLERGIC REACTION TO
EPIRUBICIN (THE ACTIVE INGREDIENT IN
EPIRUBICIN ACCORD), OTHER MEDICINES TO
TREAT CANCER OR ANY OF THE INGREDIENTS
LISTED AT THE END OF THIS LEAFLET.
Symptoms of an allergic reaction may
include shortness of breath, wheezing or
difficulty breathing; swelling of the face,

Summary of Product characteristics

Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION
EPIRUBICIN ACCORD (EPIRUBICIN HYDROCHLORIDE)
CONCENTRATED INJECTION
1
NAME OF THE MEDICINE
Epirubicin hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL contains 2 mg epirubicin hydrochloride.
1 vial of 5 mL concentrated injection contains 10 mg epirubicin
hydrochloride.
1 vial of 10 mL concentrated injection contains 20 mg epirubicin
hydrochloride.
1 vial of 25 mL concentrated injection contains 50 mg epirubicin
hydrochloride.
1 vial of 100 mL concentrated injection contains 200 mg epirubicin
hydrochloride.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Epirubicin hydrochloride concentrated injection is a clear, red
solution of epirubicin hydrochloride and
sodium chloride in water for injections. Hydrochloric acid is added as
necessary to adjust the pH.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Epirubicin hydrochloride has produced responses in a wide spectrum of
neoplastic diseases. Epirubicin
Hydrochloride injection 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 injection 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
Epirubicin hydrochloride injection is intended for intravenous or
intravesical administration only. It
must not be administered by the intramuscular, subcutaneous or oral
routes.
If epirubicin hydrochloride is administered as a continuous infusion,
this should preferably take place
via central venous catheter.
Epirubicin Accord is for use in one patient only on one occasion only.
Discard any residue.
Care in the intravenous administration of Epirubicin hydrochloride
injection will reduce the chance of
perivenous
i