IMATINIB RBX imatinib (as mesilate) 400 mg tablet bottle pack

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

imatinib mesilate, Quantity: 478 mg

Verfügbar ab:

Sun Pharma ANZ Pty Ltd

INN (Internationale Bezeichnung):

imatinib mesilate

Darreichungsform:

Tablet, film coated

Zusammensetzung:

Excipient Ingredients: magnesium stearate; hypromellose; purified talc; iron oxide yellow; macrogol 6000; iron oxide red

Verabreichungsweg:

Oral

Einheiten im Paket:

100

Verschreibungstyp:

(S4) Prescription Only Medicine

Anwendungsgebiete:

IMATINIB RBX is indicated for the: ? treatment of patients with chronic myeloid leukaemia (CML) ? treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy ? treatment of adult patients with relapsed or refractory Ph+ ALL as monotherapy ? treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements, where conventional therapies have failed ? treatment of adult patients with aggressive systemic mastocytosis (ASM), where conventional therapies have failed ? treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) ? treatment of patients with KIT (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST) ? adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of KIT (CD117)-positive primary GIST (see Dosage and Administration and Clinical Trials) ? treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).

Produktbesonderheiten:

Visual Identification: Dark yellow to brownish-orange, film-coated, oval tablets, debossed with I and 2 on either side of break line on one side and plain on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Berechtigungsstatus:

Licence status A

Berechtigungsdatum:

2015-11-26

Gebrauchsinformation

IMATINIB RBX
Imatinib (as mesylate)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THE LEAFLET
This leaflet answers some common
questions about IMATINIB RBX.
It does not contain all the available
information about this medicine.
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 taking
IMATINIB RBX against the benefits they
expect it will have for you.
This leaflet was last updated on the
date at the end of this leaflet. More
recent information may be available. The
latest Consumer Medicine Information
is available from https://www.ebs.tga.
gov.au/ and may contain important
information about the medicine and its
use of which you should be aware.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT IMATINIB RBX IS USED FOR
IMATINIB RBX is used to treat adults and
children/adolescents who have chronic
myeloid leukaemia (CML) and acute
lymphoblastic leukaemia with Philadelphia
chromosome positive (Ph-positive ALL).
CML and ALL are types of leukaemia in
which an abnormal chromosome produces
an enzyme that leads to uncontrolled
growth of white blood cells. IMATINIB
RBX kills the abnormal cells while leaving
normal cells alone.
IMATINIB RBX is also used to treat adults
for:
•
myelodysplastic / myeloproliferative
diseases (MDS/MPD).
These are a group of blood diseases in
which some blood cells start growing
out of control.
•
Aggressive systemic mastocytosis
(ASM).
It is a cancer in which certain blood cells,
called “mast” cells, grow out of control.
•
Hypereosinophilic syndrome (HES)
and or chronic eosinophilic leukaemia
(CEL).
These are blood diseases in which some
blood cells, named “eosinophils”, start
growing out of control.
•
dermatofibrosarcoma protuberans
(DFSP).
DFSP is a cancer of the tissue beneath
the skin in which some cells start
growing out of control. IMATINIB
RBX works by slowing the growth of
abn

Fachinformation

Imatinib RBX PI v6
Page 1 of 55
AUSTRALIAN PRODUCT INFORMATION
IMATINIB RBX
IMATINIB (AS MESILATE)
1. NAME OF THE MEDICINE
Imatinib (as mesilate)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg or 400 mg of imatinib
(equivalent to 119.5 mg or 478
mg imatinib mesilate, respectively).
For the full list of excipients, see Section
6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
IMATINIB RBX 100 mg film-coated tablet: dark yellow to brownish
orange, film-coated,
round tablet debossed with ‘I’ and ‘1’ on either side of break
line on one side and plain on other
side of the tablet.
IMATINIB RBX 400 mg film-coated tablet: dark yellow to brownish
orange, film-coated oval
tablet debossed with ‘I’ and ‘2’ on either side of break line
on one side and plain on other side
of the tablet.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
IMATINIB RBX is indicated for the:
•
treatment of patients with chronic myeloid leukaemia (CML)
•
treatment
of
adult
and
paediatric
patients
with
newly
diagnosed
Philadelphia
chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated
with
chemotherapy
•
treatment of adult patients with relapsed or refractory Ph+ ALL as
monotherapy
•
treatment
of
adult
patients
with
myelodysplastic/myeloproliferative
diseases
(MDS/MPD) associated with platelet-derived growth factor receptor
(PDGFR) gene
re-arrangements, where conventional therapies have failed
•
treatment of adult patients with aggressive systemic mastocytosis
(ASM), where
conventional therapies have failed
•
treatment of adult patients with hypereosinophilic syndrome (HES)
and/or chronic
eosinophilic leukaemia (CEL)
•
treatment of patients with KIT (CD117) positive unresectable and/or
metastatic
malignant gastrointestinal stromal tumours (GIST)
•
adjuvant treatment of adult patients at high risk of recurrence
following complete gross
resection of KIT (CD117)-positive primary GIST (see Dosage and
Administration and
Attachment 1
Imatinib RBX PI v6
Page 2 of 55
Clinical