Fulvestrant Ever Pharma

Land: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Fulvestrant 50 mg/mL;  ;  

Fáanlegur frá:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

Skammtar:

250 mg/5mL

Lyfjaform:

Solution for injection

Samsetning:

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

Gerð lyfseðils:

Prescription

Ábendingar:

FULVESTRANT EVER PHARMA is indicated for the treatment of locally advanced or metastatic breast cancer in postmenopausal women of any age: · 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, Type I, 5 ml fill, fluoropolymer coated bromobutyl rubber plunger, in carton - 2 dose units - 24 months from date of manufacture stored at or below 25°C

Leyfisdagur:

2022-03-01

Upplýsingar fylgiseðill

FULVESTRANT EVER PHARMA CMI V1.1 JAN 2023
Page 1 of 4
FULVESTRANT EVER
PHARMA
FULVESTRANT, 250 MG/ 5 ML, SOLUTION FOR INJECTION
CONSUMER MEDICINE INFORMATION
This leaflet answers some of the common questions people ask about
FULVESTRANT EVER PHARMA. It does not
contain all the information that is known about FULVESTRANT EVER
PHARMA.
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 FULVESTRANT EVER
PHARMA 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.
FULVESTRANT EVER PHARMA 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.
FULVESTRANT EVER PHARMA 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.
FULVESTRANT EVER PHARMA should only be given to women. FULVESTRANT
EVER PHARMA is not recommended for use
in men or children.
FULVESTRANT EVER PHARMA does not kill cancer cells, however it stops
or slows their growth.
Your doctor will have explained why you are being treated with
FULVESTRANT EVER PHARMA 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.
FULVESTRANT EVER PHARMA is not addictive.
_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
•

Vara einkenni

1
FULVESTRANT EVER PHARMA DS V1.2 Aug 2023
Page 1 of 13
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Fulvestrant EVER Pharma; 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, slightly yellow to yellow solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fulvestrant EVER Pharma 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).
Children
Not recommended for use in children or adolescents as safety and
effectiveness have not
been established in this age group.
2
FULVESTRANT EVER PHARMA DS V1.2 Aug 2023
Page 2 of 13
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 Fulvestrant EVER Pharma has not been evaluated
in patients with
Child-Pugh C hepatic impairment (see section