Faslodex

Country: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Fulvestrant 50 mg/mL;  

Fáanlegur frá:

AstraZeneca Limited

INN (Alþjóðlegt nafn):

Fulvestrant 50 mg/mL

Skammtar:

250 mg/5mL

Lyfjaform:

Solution for injection

Samsetning:

Active: Fulvestrant 50 mg/mL   Excipient: Benzyl alcohol Benzyl benzoate Castor oil Ethanol

Einingar í pakka:

Syringe, glass, Prefilled x 5mL, 5 mL

Tegund:

Prescription

Gerð lyfseðils:

Prescription

Framleitt af:

AstraZeneca UK Ltd

Ábendingar:

FASLODEX is indicated for the treatment of locally advanced or metastatic breast cancer in postmenopausal women of any age: - not previously treated with endocrine therapy, or - previously treated with endocrine therapy (antioestrogen or aromatase inhibitor) therapy, irrespective of whether their postmenopausal status occurred naturally or was artificially induced.

Vörulýsing:

Package - Contents - Shelf Life: Syringe, glass, , cardboard carton containing two pre-filled 5 mL syringes - 1 dose units - 4 years from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Leyfisdagur:

2004-09-15

Upplýsingar fylgiseðill

Faslodex

CMI 160720
1(4)
FASLODEX

FULVESTRANT, 250 MG/ 5 ML, SOLUTION FOR INJECTION
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions people ask about
FASLODEX. It does not contain all the
information that is known about FASLODEX.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor will have weighed
the risks of you taking FASLODEX against the
benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
Keep this leaflet with the medicine. You may need to read it again.
WHAT FASLODEX IS USED FOR
FASLODEX is used to treat oestrogen receptor positive breast cancer
that is locally advanced or has spread to other
parts of the body (metastatic) in women who have been through
menopause.
FASLODEX stops some of the actions of oestrogen within the body.
Oestrogen is a female sex hormone that may
help cancer cells grow in women with breast cancer.
FASLODEX should only be given to women. FASLODEX is not recommended
for use in men or children.
FASLODEX does not kill cancer cells, however it stops or slows their
growth.
Your doctor will have explained why you are being treated with
FASLODEX and will determine what dose to give you.
Follow all directions given to you by your doctor. They may differ
from the information contained in this leaflet.
Your doctor may prescribe this medicine for another use. Ask your
doctor if you want more information.
This medicine in only available with a doctor’s prescription.
FASLODEX is not addictive.
BEFORE YOU ARE GIVEN FASLODEX
_WHEN YOU MUST NOT BE GIVEN THIS MEDICINE _
You should not be given this medicine if you have an allergy to:

fulvestrant or any of the ingredients listed at the end of this
leaflet.
Some of the symptoms of an allergic reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue or other parts of the body

ra

Vara einkenni

F
ASLODEX
Data Sheet 160720
Copyright
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
F
ASLODEX
®
; 250 mg/5 mL; solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 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 liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
F
ASLODEX
is indicated for the treatment of locally advanced or metastatic
breast cancer in
postmenopausal women of any age:

not previously treated with endocrine therapy, or

previously treated with endocrine therapy (antioestrogen or aromatase
inhibitor)
therapy, irrespective of whether their postmenopausal status occurred
naturally or was
artificially induced.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULT FEMALES (INCLUDING THE ELDERLY)
The recommended dose is 500 mg to be administered intramuscularly as
two 5 mL injections,
one in each buttock (gluteal area), at intervals of 1 month with an
additional 500 mg dose given
2 weeks after the initial dose.
It is recommended that the injection be administered slowly (1-2
minutes/injection).
F
ASLODEX
Data Sheet 160720
Copyright
2
Figure 1
CHILDREN
Not recommended for use in children or adolescents as safety and
effectiveness have not
been established in this age group.
PATIENTS WITH RENAL INSUFFICIENCY
No dose adjustments are recommended for patients with a creatinine
clearance greater than
30 mL/min. Safety and efficacy have not been further evaluated in
patients with creatinine
clearance less than 30 mL/min (see section 4.4).
PATIENTS WITH HEPATIC INSUFFICIENCY
No dose adjustments are recommended for patients with Child-Pugh
category A and B hepatic
impairment. The use of F
ASLODEX
has not been evaluated in patients with Child-Pugh C
hepatic impairment (see sections 4.4 and 5.2).
ELDERLY
No dose adjustment is required for