Vastaloma 250 mg oplossing voor injectie in een voorgevulde spuit

Country: Holland

Tungumál: hollenska

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

Virkt innihaldsefni:

FULVESTRANT 50 mg/ml

Fáanlegur frá:

Zentiva k.s. U kabelovny 130 102 37 PRAGUE 10 (TSJECHIË)

INN (Alþjóðlegt nafn):

FULVESTRANT 50 mg/ml

Lyfjaform:

Oplossing voor injectie

Samsetning:

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

Stjórnsýsluleið:

Intramusculair gebruik

Leyfisdagur:

1900-01-01

Upplýsingar fylgiseðill

26
SPC-FLVS-CC- v05-day 205
PACKAGE LEAFLET
27
SPC-FLVS-CC- v05-day 205
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Vastaloma 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 Vastaloma is and what it is used for
2.
What you need to know before you are given Vastaloma
3.
How Vastaloma will be given
4.
Possible side effects
5.
How to store Vastaloma
6.
Contents of the pack and other information
1.
WHAT VASTALOMA IS AND WHAT IT IS USED FOR
Vastaloma 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.
Vastaloma
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 Vastaloma 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,

Vara einkenni

1
SPC-FLVS-CC- v05-day 205
SAMENVATTING VAN DE PRODUCTKENMERKEN
2
SPC-FLVS-CC- v05-day 205
1.
NAAM VAN HET GENEESMIDDEL
Vastaloma 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.
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.
3
SPC-FLVS-CC- v05-day 205
Special population
_Renal impairment _
No dose adju