Fulvestrant EVER Pharma 250 mg solution for injection in pre-filled syringe

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Fulvestrant

Mevcut itibaren:

EVER Valinject GmbH

ATC kodu:

L02BA03

INN (International Adı):

Fulvestrant

Doz:

250 milligram(s)

Farmasötik formu:

Solution for injection in pre-filled syringe

Terapötik alanı:

fulvestrant

Yetkilendirme durumu:

Not marketed

Bilgilendirme broşürü

PACKAGE LEAFLET: INFORMATION FOR THE USER
FULVESTRANT EVER PHARMA 250 MG SOLUTION FOR INJECTION IN PRE-FILLED
SYRINGE
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 or pharmacist.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Fulvestrant EVER Pharma is and what it is used for
2. What you need to know before you use Fulvestrant EVER Pharma
3. How to use Fulvestrant EVER Pharma 4. Possible side effects
5. How to store Fulvestrant EVER Pharma
6. Contents of the pack and other information
1. WHAT FULVESTRANT EVER PHARMA IS AND WHAT IT IS USED FOR
Fulvestrant EVER Pharma 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 EVER Pharma 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 Fulvestrant EVER Pharma 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 USE FULVESTRANT EVER PHARMA
DO NOT USE FULVESTRANT EVER PHARMA
-

Ürün özellikleri

Health Products Regulatory Authority
21 December 2023
CRN00D9DN
Page 1 of 17
SUMMARY─OF─PRODUCT─CHARACTERISTICS
1─NAME─OF─THE─MEDICINAL─PRODUCT
Fulvestrant EVER Pharma 250 mg solution for injection in pre-filled
syringe
2─QUALITATIVE─AND─QUANTITATIVE─COMPOSITION
One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution.
Each ml of the solution contains 50 mg fulvestrant.
Excipients with known effect
This medicinal product contains 500 mg of alcohol (ethanol) per
syringe which is equivalent to 10 vol %.
This medicine contains 500 mg benzyl alcohol in each syringe which is
equivalent to 100 mg/ml.

For the full list of excipients, see section 6.1.
3─PHARMACEUTICAL─FORM
Solution for injection in pre-filled syringe.
Clear, colourless to yellow, viscous solution, practically free from
particles.
4─CLINICAL─PARTICULARS
4.1─THERAPEUTIC─INDICATIONS
Fulvestrant EVER Pharma 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.
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 EVER Pharma is used in combination with palbociclib