Imarsa 250 mg oplossing voor injectie in een voorgevulde spuit

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

FULVESTRANT 50 mg/ml

Beschikbaar vanaf:

Gedeon Richter Plc Gyömrõi út 19-21 1103 BUDAPEST (HONGARIJE)

INN (Algemene Internationale Benaming):

FULVESTRANT 50 mg/ml

farmaceutische vorm:

Oplossing voor injectie

Samenstelling:

BENZYLALCOHOL (E 1519) 100 mg/ml ; BENZYLBENZOAAT ; CASTOROLIE ; ETHANOL 96 % 100 mg/ml

Toedieningsweg:

Intramusculair gebruik

Autorisatie datum:

1900-01-01

Bijsluiter

1
BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER
IMARSA 250 MG OPLOSSING VOOR INJECTIE IN EEN VOORGEVULDE SPUIT
fulvestrant
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Imarsa is and what it is used for
2.
What you need to know before you are given Imarsa
3.
How Imarsa will be given
4.
Possible side effects
5.
How to store Imarsa
6.
Contents of the pack and other information
1.
WHAT IMARSA IS AND WHAT IT IS USED FOR
Imarsa contains the active substance fulvestrant, which belongs to the
group of estrogen blockers.
Estrogens, a type of female sex hormones, can in some cases be
involved in the growth of breast
cancer.
Imarsa
is used either:
-
Alone, to treat postmenopausal women with a type of breast cancer
called estrogen receptor
positive breast cancer that is locally advanced or has spread to other
parts of the body (metastatic),
or
-
In combination with palbociclib to treat women with a type of breast
cancer called hormone
receptor-positive, human epidermal growth factor receptor 2-negative
breast cancer, that is locally
advanced or has spread to other parts of the body (metastatic). Women
who have not reached
menopause will also be treated with a medicine called a luteinizing
hormone releasing hormone
(LHRH) agonist.
When Imarsa is given in combination with palbociclib, it is important
that you also read the package
leaflet for palbociclib. If you have any questions about palbociclib,
please ask your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN IMARSA
YOU SHOULD NOT BE GIVEN

Productkenmerken

1
SAMENVATTING VAN DE PRODUCTKENMERKEN
1.
NAAM VAN HET GENEESMIDDEL
Imarsa 250 mg oplossing voor injectie in een voorgevulde spuit
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe of 5 ml contains 250 mg fulvestrant.
Excipients with known effect (per 5 ml)
Ethanol 96% (alcohol), 500 mg
Benzyl alcohol (E1519), 500 mg
Benzyl benzoate, 750 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe
Clear, colorless to yellow, viscous solution, free from visible
particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fulvestrant is indicated:
-
as monotherapy for the treatment of estrogen receptor positive,
locally advanced or
metastatic breast cancer in postmenopausal women:
o
not previously treated with endocrine therapy, or
o
with disease relapse on or after adjuvant antiestrogen therapy, or
disease
progression on antiestrogen therapy.
-
in combination with palbociclib for the treatment of hormone receptor
(HR)-positive, human
epidermal growth factor receptor 2 (HER2)-negative locally advanced or
metastatic breast
cancer in women who have received prior endocrine therapy (see section
5.1).
In pre- or perimenopausal women, the combination treatment with
palbociclib should be
combined with a luteinizing hormone releasing hormone (LHRH) agonist.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adult females (including elderly) _
The recommended dose is 500 mg at intervals of one month, with an
additional 500 mg dose
given two weeks after the initial dose.
When fulvestrant is used in combination with palbociclib, please also
refer to the Summary of
Product Characteristics of palbociclib.
2
Prior to the start of treatment with the combination of fulvestrant
plus palbociclib, and throughout
its duration, pre/perimenopausal women should be treated with LHRH
agonists according to local
clinical practice.
Special population
_Renal impairment _
No dose adjustments are recommended for patients with mild to moderate
renal impairment
(cre