DOXORUBICIN ACCORD doxorubicin hydrochloride 200 mg/100 mL concentrated solution for injection vial

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

doxorubicin hydrochloride, Quantity: 2 mg/mL

Διαθέσιμο από:

Accord Healthcare Pty Ltd

INN (Διεθνής Όνομα):

Doxorubicin hydrochloride

Φαρμακοτεχνική μορφή:

Injection, concentrated

Σύνθεση:

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

Οδός χορήγησης:

Intravenous Infusion, Intravesical

Μονάδες σε πακέτο:

1

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

Doxorubicin has been used successfully to produce regression in neoplastic conditions such as: acute leukaemia, Wilms' tumour, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, lymphomas of both Hodgkin's and non-Hodgkin's type, bronchogenic (lung) carcinoma, thyroid carcinoma, hepatomas, ovarian carcinoma, etc. The main antitumour activities are listed in Table 1 of the Product Information. Doxorubicin is also indicated by intravesical administration in the primary management of non-metastatic carcinoma of the bladder. (Tis, T1, T2).

Περίληψη προϊόντος:

Visual Identification: A clear red solution filled in clear glass vial.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Καθεστώς αδειοδότησης:

Licence status A

Ημερομηνία της άδειας:

2011-09-29

Φύλλο οδηγιών χρήσης

Version 4.0
Page 1 of 4
DOXORUBICIN ACCORD
_Doxorubicin hydrochloride Concentrated Injection 10 mg/5 mL and 200
mg/100 mL _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY BEFORE
TREATMENT WITH DOXORUBICIN ACCORD.
This leaflet answers some common
questions about this medicine.
It does not contain all the available
information.
It does not take the place of talking to
your doctor.
All medicines have risks and benefits.
Your doctor has weighed the risks of you
taking Doxorubicin Accord against the
benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING
THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
PLEASE KEEP THIS LEAFLET.
You may need to read it again.
WHAT DOXORUBICIN
ACCORD IS USED FOR
Doxorubicin Accord is used to treat many
types of cancer. Doxorubicin Accord
works by stopping cancer cells from
growing and multiplying. It contains the
active ingredient doxorubicin
hydrochloride.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY DOXORUBICIN
ACCORD HAS BEEN PRESCRIBED FOR YOU.
Doxorubicin Accord is to be given only
under the strict supervision of your
doctor.
Doxorubicin Accord is not addictive.
BEFORE YOU ARE GIVEN IT
_WHEN YOU MUST NOT BE GIVEN _
_DOXORUBICIN ACCORD _
DO NOT HAVE DOXORUBICIN ACCORD IF YOU
ARE ALLERGIC TO DOXORUBICIN ACCORD OR
HAVE HAD AN ALLERGIC REACTION TO ANY
OTHER CANCER MEDICATION E.G.
DAUNORUBICIN, EPIRUBICIN,
MITOZANTRONE.
Symptoms of an allergic reaction to
Doxorubicin Accord 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
•
light-headedness or back pain.
DO NOT HAVE DOXORUBICIN ACCORD IF:
•
you have bone marrow suppression
(reduced number of red or white
blood cells or platelets) caused by
previous treatment with other cancer
medicines or radiation therapy,
symptoms include tiredness, mouth
ulcers or bleeding or bruising more
easily than usual
•
you have a generalised infection
•
you have an irregula

Αρχείο Π.Χ.Π.

Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION
DOXORUBICIN ACCORD (DOXORUBICIN HYDROCHLORIDE)
CONCENTRATED INJECTION
1
NAME OF THE MEDICINE
Doxorubicin hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Doxorubicin hydrochloride concentrated injection is supplied as 10
mg/5 mL and 200 mg/100 mL glass
vials (doxorubicin hydrochloride concentration 2 mg/mL).
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Doxorubicin hydrochloride concentrated injection is a sterile, red
coloured, clear solution of doxorubicin
hydrochloride and sodium chloride in water for injections.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Doxorubicin has been used successfully to produce regression in
neoplastic conditions such as: acute
leukaemia, Wilms' tumour, neuroblastoma, soft tissue and bone
sarcomas, breast carcinoma, lymphomas
of
both
Hodgkin's
and
non-Hodgkin's
type,
bronchogenic
(lung)
carcinoma,
thyroid
carcinoma,
hepatomas, ovarian carcinoma, etc. The main antitumour activities are
listed in Table 1.
Doxorubicin is also indicated by intravesical administration in the
primary management of non-
metastatic carcinoma of the bladder. (Tis, T1, T2).
TABLE 1
DOXORUBICIN ANTITUMOUR ACTIVITY
TUMOUR TYPE
RESPONSE RATE
(%)
MEDIAN DURATION
(MONTH)
FIRST LINE
CHEMOTHERAPY
Established
Activity
Breast
35
3-6
√
Ovary
38
3-6
?
Lung
30
3
?
Sarcoma
30
4
√
Wilms'
66
4
√
Bladder
28
4-6
?
Neuroblastoma
41
4
√
Hodgkin's
36
4-6
?
Non-Hodgkin's
Lymphoma
40
4-6
√
Acute Leukaemia
35
3
?
Hepatoma
32
4-6
√
Thyroid
30
6-10
√
Some
Response
Stomach
30
2-4
√?
Cervix
32
2-6
?
Head & Neck
19
2-4
Testicle
20
3-6
Myeloma
33
3
Endometrial
36
4-6
√?
Unresponsive
Colorectal
Pancreas
Renal
Page 2 of 17
TUMOUR TYPE
RESPONSE RATE
(%)
MEDIAN DURATION
(MONTH)
FIRST LINE
CHEMOTHERAPY
Melanoma
Brain
4.2
D
OSE AND METHOD OF ADMINISTRATION
GENERAL DIRECTIONS:
The use of a Pharmacy Bulk Pack should be restricted to suitably
qualified pharmacists operating in
suitably equipped hospital pharmacies or compoun