Ibrance
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
06-06-2023
Vara einkenni
(SPC)
06-06-2023
Opinber matsskýrsla
(PAR)
06-03-2020
Virkt innihaldsefni:
Palbociclib
Fáanlegur frá:
Pfizer Europe MA EEIG
ATC númer:
L01XE33
INN (Alþjóðlegt nafn):
palbociclib
Meðferðarhópur:
Antineoplastic agents
Lækningarsvæði:
Breast Neoplasms
Ábendingar:
Ibrance is indicated for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer:in combination with an aromatase inhibitor;in combination with fulvestrant in women who have received prior endocrine therapy.In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.
Vörulýsing:
Revision: 16
Leyfisstaða:
Authorised
Leyfisdagur:
2016-11-09
Upplýsingar fylgiseðill
94
B. PACKAGE LEAFLET
95
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IBRANCE 75 MG HARD CAPSULES
IBRANCE 100 MG HARD CAPSULES
IBRANCE 125 MG HARD CAPSULES
palbociclib
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What IBRANCE is and what it is used for
2.
What you need to know before you take IBRANCE
3.
How to take IBRANCE
4.
Possible side effects
5.
How to store IBRANCE
6.
Contents of the pack and other information
1.
WHAT IBRANCE IS AND WHAT IT IS USED FOR
IBRANCE is an anticancer medicine containing the active substance
palbociclib.
Palbociclib works by blocking proteins called cyclin-dependent kinase
4 and 6, which regulate cell
growth and division. Blocking these proteins can slow down growth of
cancer cells and delay the
progression of your cancer.
IBRANCE is used to treat patients with certain types of breast cancer
(hormone receptor-positive,
human epidermal growth factor receptor 2-negative) which have spread
beyond the original tumour
and/or to other organs. It is given together with aromatase inhibitors
or fulvestrant, which are used as
hormonal anticancer therapies.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBRANCE
DO NOT TAKE IBRANCE
-
if you are allergic to palbociclib or any of the other ingredients of
this medicine (listed in
section 6).
-
use of preparations containing St. John’s Wort, an herbal product
used to treat mild depression
and anxiety, should be avoided while you are taking IBRANCE.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before t
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Vara einkenni
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
IBRANCE
75 mg hard capsules
IBRANCE 100 mg hard capsules
IBRANCE 125 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
IBRANCE 75 mg hard capsules
Each hard capsule contains 75 mg of palbociclib.
_Excipients with known effect _
Each hard capsule contains 56 mg of lactose (as monohydrate).
IBRANCE 100 mg hard capsules
Each hard capsule contains 100 mg of palbociclib.
_Excipients with known effect _
Each hard capsule contains 74 mg of lactose (as monohydrate).
IBRANCE 125 mg hard capsules
Each hard capsule contains 125 mg of palbociclib.
_Excipients with known effect _
Each hard capsule contains 93 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
IBRANCE
75 mg hard capsules
Opaque, hard capsule, with a light orange body (printed “PBC 75”
in white) and a light orange cap
(printed “Pfizer” in white). The capsule length is 18.0 ± 0.3 mm.
IBRANCE 100 mg hard capsules
Opaque, hard capsule, with a light orange body (printed “PBC 100”
in white) and a caramel cap
(printed “Pfizer” in white). The capsule length is 19.4 ± 0.3 mm.
IBRANCE 125 mg hard capsules
Opaque, hard capsule, with a caramel body (printed “PBC 125” in
white) and a caramel cap (printed
“Pfizer” in white). The capsule length is 21.7 ± 0.3 mm.
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
IBRANCE is indicated for the treatment of hormone receptor
(HR)-positive, human epidermal growth
factor receptor 2 (HER2)-negative locally advanced or metastatic
breast cancer:
-
in combination with an aromatase inhibitor;
-
in combination with fulvestrant in women who have received prior
endocrine therapy (see
section 5.1).
In pre- or perimenopausal women, the endocrine therapy should be
combined with a luteinizing
hormone-releasing hormone (LHRH) agonist.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with IBRANCE should be initiated and supervised by a
physician experienced
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