BOSULIF 500 MG

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

BOSUTINIB AS MONOHYDRATE

Disponible des:

PFIZER PHARMACEUTICALS ISRAEL LTD

Codi ATC:

L01XE14

formulario farmacéutico:

FILM COATED TABLETS

Composición:

BOSUTINIB AS MONOHYDRATE 500 MG

Vía de administración:

PER OS

tipo de receta:

Required

Fabricat per:

PFIZER INC, USA

Área terapéutica:

BOSUTINIB

indicaciones terapéuticas:

Bosulif is indicated for the treatment of adult patients with:• newly diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML).• chronic phase (CP), accelerated phase (AP), and blast phase (BP) Philadelphia chromosome positive chronic myelogenous leukaemia (Ph+ CML) previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.

Data d'autorització:

2019-10-31

Informació per a l'usuari

Bosulif 100 mg, 400 mg and 500 mg , PIL, CC 110623
2023-0083371
1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
BOSULIF
® 100 MG
BOSULIF
® 400 MG
BOSULIF
® 500 MG
FILM-COATED TABLETS
EACH TABLET CONTAINS:
BOSUTINIB (AS MONOHYDRATE) 100 MG, 400 MG OR 500 MG
Inactive ingredients and allergens: see section 2 under 'Important
information about some of this medicine's
ingredients' and section 6 "Further information".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise information
about this medicine. If you have further questions, consult your
doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if it seems to
you that their medical condition is similar to yours.
This medicine is not intended for children and adolescents under 18
years old.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Bosulif is intended for the treatment of adult patients with:
•
newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive
chronic myelogenous
leukaemia (Ph+ CML).
•
chronic phase (CP), accelerated phase (AP), and blast phase (BP)
Philadelphia chromosome positive
chronic myelogenous leukaemia (Ph+ CML) previously treated with one or
more tyrosine kinase
inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib
are not considered appropriate
treatment options.
THERAPEUTIC GROUP:
protein kinase enzyme inhibitors.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or to any of the
other ingredients in this
medicine(listed in section 6).
•
You were told by your doctor that your liver has been damaged and is
not working normally.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE TREATMENT WITH BOSULIF, TELL THE DOCTOR IF:
•
YOU HAVE, OR HAVE HAD IN THE PAST, LIVER PROBLEMS. Tell your doctor if
you have a history of liver
problems including hepati

Fitxa tècnica

Bosulif 100 mg, 400 mg and 500 mg, LPD, Israel, CC 110623
2023-0083371
1
1.
NAME OF THE MEDICINAL PRODUCT
Bosulif
®
100 mg, film-coated tablets
Bosulif
®
400 mg, film-coated tablets
Bosulif
®
500 mg, film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bosulif 100 mg film-coated tablets
Each film-coated tablet contains 100 mg bosutinib (as monohydrate).
Bosulif 400 mg film-coated tablets
Each film-coated tablet contains 400 mg bosutinib (as monohydrate).
Bosulif 500 mg film-coated tablets
Each film-coated tablet contains 500 mg bosutinib (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Bosulif 100 mg film-coated tablets
Yellow oval biconvex, film-coated tablet debossed with “Pfizer” on
one side and “100” on the other
side.
Bosulif 400 mg film-coated tablets
Orange oval biconvex, film-coated tablet debossed with “Pfizer” on
one side and “400” on the other
side.
Bosulif 500 mg film-coated tablets
Red oval biconvex, film-coated tablet debossed with “Pfizer” on
one side and “500” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bosulif is indicated for the treatment of adult patients with:
•
newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive
chronic myelogenous
leukaemia (Ph+ CML).
•
chronic phase (CP), accelerated phase (AP), and blast phase (BP)
Philadelphia chromosome
positive chronic myelogenous leukaemia (Ph+ CML) previously treated
with one or more
tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib
and dasatinib are not
considered appropriate treatment options.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
diagnosis and the treatment of patients
with CML.
Posology
Bosulif 100 mg, 400 mg and 500 mg, LPD, Israel, CC 110623
2023-0083371
2
_Newly-diagnosed CP Ph+ CML _
The recommended dose is 400 mg bosutinib once daily.
_CP, AP, or BP Ph+ CML with resistance or intolerance to prior therapy
_
The r