Faslodex solution for injection

Land: Armenía

Tungumál: enska

Heimild: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Virkt innihaldsefni:

fulvestrant

Fáanlegur frá:

AstraZeneca UK Ltd.

ATC númer:

L02BA03

INN (Alþjóðlegt nafn):

fulvestrant

Skammtar:

50mg/ml, (2) pre-filled syringes, (2) needles

Lyfjaform:

solution for injection

Einingar í pakka:

50mg/ml, (2) pre-filled syringes, (2) needles

Gerð lyfseðils:

Prescription

Leyfisstaða:

Registered

Leyfisdagur:

2020-06-08

Vara einkenni

2
1.
NAME OF THE MEDICINAL PRODUCT
Faslodex 250 mg solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution.
Excipients with known effect (per 5 ml)
Ethanol (96%, 500 mg)
Benzyl alcohol (500 mg)
Benzyl benzoate (750 mg)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to yellow, viscous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Faslodex 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 Faslodex 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 Faslodex plus
palbociclib, and throughout its
duration, pre/perimenopausal women should be treated with LHRH
agonists according to local clinical
practice.
3
Special populations
_Renal impairment _
No dose adjustments are recommended for patients with mild to moderate
renal impairment (creatinine
clearance

30 ml/min). Safety and efficacy have not been evaluated in patients
with severe renal
impairm