FULVESTRANT SANDOZ

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

FULVESTRANT

Available from:

NOVARTIS ISRAEL LTD

ATC code:

L02BA03

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

FULVESTRANT 50 MG/ML

Administration route:

I.M

Prescription type:

Required

Manufactured by:

EBEWE PHARMA GES.M.B.H NFG.KG, AUSTRIA

Therapeutic area:

FULVESTRANT

Therapeutic indications:

MonotherapyFulvestrant Sandoz® is indicated for the treatment of estrogen 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 therapyCombination Therapy with PalbociclibFulvestrant Sandoz® 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.

Authorization date:

2021-06-22

Patient Information leaflet

01
27.06.22
DOR
BLACK
46287878-01
44097550
3682
ARIAL
8 P
PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s
prescription only
FULVESTRANT SANDOZ
®
SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE
FOR INTRAMUSCULAR INJECTION
COMPOSITION:
Each pre-filled syringe )5 ml( contains:
fulvestrant 250 mg
Each ml contains: fulvestrant 50 mg
For the list of inactive ingredients and allergens
in
this
medicine,
see
section
2
“Important
information
regarding
some
of
the
medicine
ingredients” and section 6 - “Further Information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING
THE MEDICINE.
Keep the leaflet; you may need it again.
This leaflet contains concise information about
the medicine. If you have further questions,
please contact the 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.
1. WHAT IS THE MEDICINE INTENDED FOR?
•
Fulvestrant Sandoz is indicated for the treatment
of estrogen receptor positive, locally advanced
or metastatic breast cancer in postmenopausal
women not previously treated with hormonal
therapy, or with disease relapse/progression on
or after adjuvant endocrine therapy.
•
Fulvestrant Sandoz, in combination with the
medicine palbociclib, is indicated for women
with advanced or metastatic estrogen receptor-
positive and HER2-negative breast cancer,
whose disease has progressed after receiving
prior hormonal therapy for this disease.
When Fulvestrant Sandoz is used in combination
with palbociclib, please read the patient leaflet
for palbociclib as well.
THERAPEUTIC GROUP:
Estrogen antagonist.
Fulvestrant
Sandoz
contains
the
active
ingredient
fulvestrant,
which
belongs
to
the
group of medicines that block estrogen activity.
Estrogen is a female sex hormone that can,
in some cases, be involved in breast cancer
development.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
•
You