Faslodex 250mg/5ml PFS 50 mg/ml

Riik: Jordaania

keel: inglise

Allikas: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

Toimeaine:

Fulvestrant 50 mg/ml

Saadav alates:

مستودع ادوية شاوي و رشيدات و مسنات - Shawi & Rushedat Drug Store

ATC kood:

L02BA03

INN (Rahvusvaheline Nimetus):

Fulvestrant 50 mg/ml

Annus:

50 mg/ml

Ühikuid pakis:

2 PFS X 5ml

Valmistatud:

فيتير فارما (المانيا)

Infovoldik

1
Faslodex 250mg
Fulvestrant
Solution for injection
Qualitative and quantitative composition
One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution.
For a full list of excipients see “List of excipients”.
Pharmaceutical Form
Solution for injection.
Clear, colourless to yellow, viscous solution.
Therapeutic indications
Faslodex is indicated 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.
Posology and method of administration
Posology
Adult females (including the 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.
Special populations
Paediatric patient:
2
Faslodex is not recommended for use in children or adolescents, as
safety and
efficacy have not been established in this age group.
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 impairment (creatinine
clearance < 30 ml/min)
and, therefore, caution is recommended in these patients (see Special
Warnings and
Precautions For Use).
Hepatic impairment:
No dose adjustments are recommended for patients with mild to moderate
hepatic
impairment. However, as fulvestrant exposure may be increased,
Faslodex should
be used with caution in these patients. There are no data in patients
with severe
hepatic impairment (see Contraindications, Special Warnings and
Precautions For
Use and Pharmacokinetic Properties).
Method of administration
Faslodex should be administered as two consecutive 5 ml injections by
slow
intramuscular injection (1-2 minutes/injection), one in each buttock
(gluteal area).
Caution should be taken if injecting Faslodex at the dorsogluteal site
due to th