IMATINIB-TEVA imatinib 100 mg film-coated tablets bottle pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

imatinib mesilate, Quantity: 119.469 mg (Equivalent: imatinib, Qty 100 mg)

Available from:

Teva Pharma Australia Pty Ltd

INN (International Name):

imatinib mesilate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: calcium hydrogen phosphate; crospovidone; magnesium stearate; purified water; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; macrogol 4000; polyvinyl alcohol

Administration route:

Oral

Units in package:

500 film-coated tablets, 100 film-coated tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

1) IMATINIB-TEVA (imatinib) is indicated for the treatment of patients with chronic myeloid leukaemia (CML). 2) IMATINIB-TEVA (imatinib) is indicated for the treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy. 3) IMATINIB-TEVA (imatinib) is indicated for the treatment of adult patients with relapsed or refractory Ph+ALL as monotherapy. 4) IMATINIB-TEVA (imatinib) is indicated for the treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene rearrangements, where conventional therapies have failed. 5) IMATINIB-TEVA (imatinib) is indicated for the treatment of adult patients with aggressive systemic mastocytosis (ASM), where conventional therapies have failed. 6) IMATINIB-TEVA (imatinib) is indicated for the treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). 7) IMATINIB-TEVA (imatinib) is indicated for the Treatment of patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST) 8) IMATINIB-TEVA (imatinib) is indicated for the adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of KIT (CD117)-positive primary GIST. 9) IMATINIB-TEVA (imatinib) is indicated for the treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).

Product summary:

Visual Identification: Imatinib tablets 100 mg are dark yellow to brownish orange round film coated tablets debossed with IT and 1 divided by score line on one side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2016-06-10

Patient Information leaflet

Imatinib-Teva
®
CMI Version 1.0
1
IMATINIB-TEVA
®
_FILM-COATED TABLETS _
_contains the active ingredient imatinib (as mesilate) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about imatinib. The
information in this leaflet was last
updated on the date listed on the final
page. More recent information on the
medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK TO
YOUR PHARMACIST OR DOCTOR TO OBTAIN
THE MOST UP TO DATE INFORMATION ON
THE MEDICINE. YOU CAN ALSO
DOWNLOAD THE MOST UP TO DATE LEAFLET
FROM WWW.TEVA.COM.AU.
Those updates may contain important
information about the medicine and its
use of which you should be aware.
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 taking this medicine against the
benefits they expect it will provide.
If you have any concerns about this
medicine, ask your doctor or
pharmacist.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT IMATINIB IS USED
FOR
Imatinib 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 kills the abnormal cells
while leaving normal cells alone.
Imatinib 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.

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 c

Summary of Product characteristics

Teva Pharma Australia Pty Limited Version 7 1
AUSTRALIAN PI – IMATINIB-TEVA
® (IMATINIB (AS MESILATE)) FILM
COATED TABLETS
1
NAME OF THE MEDICINE
The active ingredient is Imatinib (as mesilate).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
IMATINIB-TEVA tablets contain either 100 mg or 400 mg of imatinib (as
mesilate) as the active
ingredient.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
IMATINIB-TEVA 100 mg
film-coated tablet:
contains 100mg of imatinib equivalent to 119.5mg imatinib (as
mesilate)
in a dark yellow to brownish orange round film coated tablet debossed
with IT and 1 divided by score line on one side.
IMATINIB-TEVA 400 mg
film-coated tablet:
contains 400mg of imatinib equivalent to 477.9mg imatinib (as
mesilate)
in a dark yellow to brownish orange oblong film coated tablet debossed
with IT and 4 divided by score line on one side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Imatinib-Teva 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
Ad