FULVENIR

מדינה: ישראל

שפה: אנגלית

מקור: Ministry of Health

מרכיב פעיל:

FULVESTRANT

זמין מ:

BIOAVENIR LTD, ISRAEL

קוד ATC:

L02BA03

טופס פרצבטיות:

SOLUTION FOR INJECTION

הרכב:

FULVESTRANT 50 MG/ML

מסלול נתינה (של תרופות):

I.M

סוג מרשם:

Required

תוצרת:

CHIA TAI TIANGING PHARMACEUTICAL GROUP CO. LTD, CHINA

איזור תרפויטי:

FULVESTRANT

סממני תרפויטית:

Monotherapy :FulVenir is indicated for the treatment of oestrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:not previously treated with endocrine therapy, or with disease relapse on or after adjuvant endocrine therapy; or disease progression on endocrine therapy. Combination Therapy with Palbociclib: FulVenir is indicated for the treatment of HR-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with palbociclib in women with disease progression after endocrine therapy.

תאריך אישור:

2021-12-09

עלון מידע

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) -
1986
This medicine is dispensed with a doctor’s prescription only
FULVENIR
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
FOR INTRAMUSCULAR INJECTION
COMPOSITION:
Each pre-filled syringe (5 ml) contains:
fulvestrant 250 mg
For a list of inactive ingredients and allergens in this medicine, see
section 2 under
‘Important information about some of this medicine’s
ingredients’, and section 6
‘Additional information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
Keep this leaflet in case you need it again. 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.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
•
FulVenir is intended to treat advanced or metastatic breast cancer
expressing estrogen receptors in postmenopausal women not previously
treated with endocrine therapy, or cases of disease
relapse/progression with
or after adjuvant endocrine therapy.
•
FulVenir in combination with the medicine palbociclib is intended to
treat
women with HER2 negative advanced or metastatic breast cancer
expressing estrogen receptors whose disease progressed after previous
endocrine therapy for this disease.
If receiving combination therapy with FulVenir and palbociclib
(Ibrance)
please also read the patient leaflet for palbociclib (Ibrance).
THERAPEUTIC GROUP: estrogen antagonist.
The medicine FulVenir contains the active substance fulvestrant, which
belongs to the group of medicines that block estrogen activity.
Estrogen is a
female sex hormone which can in some cases be involved in the
development of breast cancer.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to fulvestrant or to any of the other
ingredients in this medicine (list