IBRANCE CAPSULES 75 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

PALBOCICLIB

متاح من:

PFIZER PHARMACEUTICALS ISRAEL LTD

ATC رمز:

L01XE33

الشكل الصيدلاني:

CAPSULES

تركيب:

PALBOCICLIB 75 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

PFIZER INC, USA

المجال العلاجي:

PALBOCICLIB

الخصائص العلاجية:

IBRANCE is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:- An aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men; or- fulvestrant in patients with disease progression following endocrine therapy

تاريخ الترخيص:

2021-07-31

نشرة المعلومات

Ibrance capsules, PIL, Israel, CC 010223
2021-0068110,
2022-0082722
1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
IBRANCE
® CAPSULES 75 MG
IBRANCE
® CAPSULES 100 MG
IBRANCE
® CAPSULES 125 MG
CAPSULES
Each capsule contains:
palbociclib 75 mg, 100 mg or 125 mg
List of inactive ingredients and allergens in the preparation: 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 any further questions,
consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm them,
even if it seems to you that their illness is similar to yours.
This medicine is intended for women and men over the age of 18.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Ibrance is intended for the treatment of estrogen receptor-positive
and HER2-negative advanced or
metastatic breast cancer, in combination with:
●
An aromatase inhibitor as the first (endocrine-based) combination
therapy in postmenopausal
women or men.
OR
●
Fulvestrant in patients with disease progression following previous
endocrine therapy.
THERAPEUTIC GROUP: antineoplastic, kinase inhibitor.
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 “Further information” in this
leaflet.
SPECIAL WARNINGS ABOUT USING THIS MEDICINE:
BEFORE TREATMENT WITH IBRANCE, TELL YOUR DOCTOR IF:
●
you have fever, chills, or any other symptom of infection.
●
you have impaired liver or kidney function.
●
you have any other medical condition.
●
you are pregnant or plan to become pregnant. For more information, see
section 2 under
"Pregnancy, breastfeeding and fertility".
�

خصائص المنتج

Ibrance capsules 75 mg, 100 mg, 125 mg, LPD, Israel, CC 041223
2022-0077820, 2023-0084987, 2022-0082924
1
FULL PRESCRIBING INFORMATION
NAME OF THE MEDICINAL PRODUCT
Ibrance
®
capsules 75 mg
Ibrance
®
capsules 100 mg
Ibrance
®
capsules 125 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 75 mg, 100 mg or 125 mg Palbociclib
Each 75 mg capsule contains 55.78 of lactose monohydrate.
Each 100 mg capsule contains 74.37 of lactose monohydrate.
Each 125 mg capsule contains 92.96 of lactose monohydrate.
For the full list of excipients, see section 11.
PHARMACEUTICAL FORM
Capsules
1
INDICATIONS AND USAGE
IBRANCE is indicated for the treatment of adult patients with hormone
receptor (HR)-positive, human
epidermal growth factor receptor 2 (HER2)-negative advanced or
metastatic breast cancer in
combination with:
•
an aromatase inhibitor as initial endocrine-based therapy in
postmenopausal women or in men; or
•
fulvestrant in patients with disease progression following endocrine
therapy.
2
DOSAGE AND ADMINISTRATION
2.1
Recommended Dose and Schedule
The recommended dose of IBRANCE is a 125 mg capsule taken orally once
daily for 21 consecutive
days followed by 7 days off treatment to comprise a complete cycle of
28 days. IBRANCE should be
taken with food _[see Clinical Pharmacology (12.3)]_.
Administer the recommended dose of an aromatase inhibitor when given
with IBRANCE. Please refer
to the Full Prescribing Information for the aromatase inhibitor being
used.
When given with IBRANCE, the recommended dose of fulvestrant is 500 mg
administered on Days 1,
15, 29, and once monthly thereafter. Please refer to the Full
Prescribing Information of fulvestrant.
Patients should be encouraged to take their dose of IBRANCE at
approximately the same time each day.
Ibrance capsules 75 mg, 100 mg, 125 mg, LPD, Israel, CC 041223
2022-0077820, 2023-0084987, 2022-0082924
2
If the patient vomits or misses a dose, an additional dose should not
be taken. The next prescribed dose
should be taken at the usual time. IBRANCE cap