Tasigna

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

nilotinib

Διαθέσιμο από:

Novartis Europharm Limited

Φαρμακολογική κατηγορία (ATC):

L01EA03

INN (Διεθνής Όνομα):

nilotinib

Θεραπευτική ομάδα:

Antineoplastic agents

Θεραπευτική περιοχή:

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Θεραπευτικές ενδείξεις:

Tasigna is indicated for the treatment of:adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase,paediatric patients with Philadelphia chromosome positive CML in chronic phase with resistance or intolerance to prior therapy including imatinib.Tasigna is indicated for the treatment of:adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase,adult patients with chronic phase and accelerated phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib. Efficacy data in patients with CML in blast crisis are not available,paediatric patients with chronic phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib.

Περίληψη προϊόντος:

Revision: 45

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2007-11-19

Φύλλο οδηγιών χρήσης

61
B. PACKAGE LEAFLET
62
PACKAGE LEAFLET: INFORMATION FOR THE USER
TASIGNA 50 MG, 150 MG AND 200 MG HARD CAPSULES
nilotinib
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Tasigna is and what it is used for
2.
What you need to know before you take Tasigna
3.
How to take Tasigna
4.
Possible side effects
5.
How to store Tasigna
6.
Contents of the pack and other information
1.
WHAT TASIGNA IS AND WHAT IT IS USED FOR
WHAT TASIGNA IS
Tasigna is a medicine containing an active substance called nilotinib.
WHAT TASIGNA IS USED FOR
Tasigna is used to treat a type of leukaemia called Philadelphia
chromosome positive chronic myeloid
leukaemia (Ph-positive CML). CML is a cancer of the blood which makes
the body produce too many
abnormal white blood cells.
Tasigna is used in adult and paediatric patients with newly diagnosed
CML or in patients with CML
who are no longer benefiting from previous treatment including
imatinib. It is also used in adult and
paediatric patients who experienced serious side effects with previous
treatment and are not able to
continue taking it.
HOW TASIGNA WORKS
In patients with CML, a change in DNA (genetic material) triggers a
signal that tells the body to
produce abnormal white blood cells. Tasigna blocks this signal, and
thus stops the production of these
cells.
63
MONITORING DURING TASIGNA TREATMENT
Regular tests, including blood tests, will be performed during
treatment. These tests will monitor:
-
the amount of blood cells (white blood cells, red blood cells and
platelets) i

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Tasigna 50 mg hard capsules
Tasigna 150 mg hard capsules
Tasigna 200 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tasigna 50 mg hard capsules
One hard capsule contains 50 mg nilotinib (as hydrochloride
monohydrate).
_Excipient with known effect _
One hard capsule contains 39.03 mg lactose monohydrate.
Tasigna 150 mg hard capsules
One hard capsule contains 150 mg nilotinib (as hydrochloride
monohydrate).
_Excipient with known effect _
One hard capsule contains 117.08 mg lactose monohydrate.
Tasigna 200 mg hard capsules
One hard capsule contains 200 mg nilotinib (as hydrochloride
monohydrate).
_Excipient with known effect _
One hard capsule contains 156.11 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Tasigna 50 mg hard capsules
White to yellowish powder in hard gelatin capsule with red opaque cap
and light yellow opaque body,
size 4 with black radial imprint “NVR/ABL” on cap.
Tasigna 150 mg hard capsules
White to yellowish powder in red opaque hard gelatin capsules, size 1
with black axial imprint
“NVR/BCR”.
Tasigna 200 mg hard capsules
White to yellowish powder in light yellow opaque hard gelatin
capsules, size 0 with red axial imprint
“NVR/TKI”.
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tasigna is indicated for the treatment of:
-
adult and paediatric patients with newly diagnosed Philadelphia
chromosome positive chronic
myelogenous leukaemia (CML) in the chronic phase,
-
adult patients with chronic phase and accelerated phase Philadelphia
chromosome positive CML
with resistance or intolerance to prior therapy including imatinib.
Efficacy data in patients with
CML in blast crisis are not available,
-
paediatric patients with chronic phase Philadelphia chromosome
positive CML with resistance
or intolerance to prior therapy including imatinib.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician exper