Fulvestrant Stada 250 mg oplossing voor injectie

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

FULVESTRANT

Beschikbaar vanaf:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

ATC-code:

L02BA03

INN (Algemene Internationale Benaming):

FULVESTRANT

farmaceutische vorm:

Oplossing voor injectie

Samenstelling:

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

Toedieningsweg:

Intramusculair gebruik

Therapeutisch gebied:

Fulvestrant

Autorisatie datum:

2019-08-14

Bijsluiter

FULVESTRANT 250 MG SOLUTION FOR INJECTION
Edition: 2023-10-12
MODULE 1 ADMINISTRATIVE INFORMATION
MODULE1.3 PRODUCT INFORMATION, THE NETHERLANDS
MODULE 1.3.1 SPC, LABELLING AND PACKAGE LEAFLET
Page 1/9
PACKAGE LEAFLET: INFORMATION FOR THE USER
FULVESTRANT STADA 250 MG OPLOSSING VOOR INJECTIE
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 Fulvestrant STADA 250 mg oplossing voor injectie
is and what it is used for
2.
What you need to know before you use Fulvestrant STADA 250 mg
oplossing voor injectie
3.
How to use Fulvestrant STADA 250 mg oplossing voor injectie
4.
Possible side effects
5.
How to store Fulvestrant STADA 250 mg oplossing voor injectie
6.
Contents of the pack and other information
1.
WHAT FULVESTRANT STADA 250 MG OPLOSSING VOOR INJECTIE IS AND WHAT IT
IS USED FOR
Fulvestrant STADA 250 mg oplossing voor injectie 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.
Fulvestrant STADA 250 mg oplossing voor injectie 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

Productkenmerken

FULVESTRANT 250 MG SOLUTION FOR INJECTION
Edition: 2023-07-19
MODULE 1 ADMINISTRATIVE INFORMATION
MODULE1.3 PRODUCT INFORMATION, THE NETHERLANDS
MODULE 1.3.1 SPC, LABELLING AND PACKAGE LEAFLET
Page 1/33
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fulvestrant Stada 250 mg oplossing voor injectie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution.
Each ml solution for injection contains 50 mg fulvestrant.
Excipients with known effect:
Each ml of solution contains 100 mg ethanol (96%), 100 mg benzyl
alcohol and 150 mg benzyl
benzoate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe.
Clear, colourless to yellow, practically free from visible particle,
oily and viscous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fulvestrant STADA 250 mg oplossing voor injectie is indicated:
•
as monotherapy 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 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.
FULVESTRANT 250 MG SOLUTION FOR INJECTION
Edition: 2023-07-19
MODULE 1 ADMINISTRATIVE INFORMATION
MODULE1.3 PRODUCT INFORMATION, THE NETHERLANDS
MODULE 1.3.1 SPC, LABELLING AND PACKAGE LEAFLET
Page 2/33
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 50