Bosulif 500mg tablets

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Bosutinib

Tillgänglig från:

Pfizer Ltd

ATC-kod:

L01XE14

INN (International namn):

Bosutinib

Dos:

500mg

Läkemedelsform:

Tablet

Administreringssätt:

Oral

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 08010500; GTIN: 5013457010992

Bipacksedel

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
BOSULIF 100 MG FILM
-
COATED TABLETS
BOSULIF 400 MG FILM-COATED TABLETS
BOSULIF 500 MG FILM
-
COATED TABLETS
bosutinib
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Bosulif is and what it is used for
2.
What you need to know before you take Bosulif
3.
How to take Bosulif
4.
Possible side effects
5.
How to store Bosulif
6.
Content of the pack and other information
1.
WHAT BOSULIF IS AND WHAT IT IS USED FOR
Bosulif contains the active substance bosutinib. It is used to treat
adult patients who have a type of
leukaemia called Philadelphia chromosome-positive (Ph
-
positive) Chronic Myeloid Leukaemia
(CML) and are newly-diagnosed or for whom previous medicines to treat
CML have either not worked
or are not suitable. Ph
-
positive CML is a cancer of the blood which makes the body produce too
many
of a specific type of white blood cell called granulocytes.
If you have any questions about how Bosulif works or why this medicine
has been prescribed for you,
ask your doctor.
2.
WHAT DO YOU NEED TO KNOW BEFORE YOU TAKE BOSULIF
DO NOT TAKE BOSULIF
-
if you are allergic to bosutinib or any of the other ingredients of
this medicine (listed in
section 6).
-
if your doctor has told you that your liver has been damaged and is
not working normally.

Produktens egenskaper

OBJECT 1
BOSULIF 100 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 24-May-2018 | Pfizer
Limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
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 (width: 5.6 mm; length: 10.7 mm) biconvex, film-coated
tablet debossed with “Pfizer” on
one side and “100” on the other side.
Bosulif 400 mg film-coated tablets
Orange oval (width: 8.8 mm; length: 16.9 mm) biconvex, film-coated
tablet debossed with “Pfizer” on
one side and “400” on the other side.
Bosulif 500 mg film-coated tablets
Red oval (width: 9.5 mm; length: 18.3 mm) 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).
• CP, accelerated phase (AP), and blast phase (BP) 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 experienc