FREXIVO INJECTION

দেশ: দক্ষিণ আফ্রিকা

ভাষা: ইংরেজি

সূত্র: South African Health Products Regulatory Authority (SAHPRA)

থেকে পাওয়া:

AstraZeneca Pharmaceuticals (Pty) Ltd

ডোজ:

See ingredients

ফার্মাসিউটিকাল ফর্ম:

INJECTION

রচনা:

EACH 5,0 ml SOLUTION CONTAINS FULVESTRANT 250,0 mg

অনুমোদন অবস্থা:

Registered

তথ্য লিফলেট

Astrazeneca Pharmaceuticals
_ _
Frexivo 250 mg
14 March 2022
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
S4
FREXIVO® 250 MG SOLUTION FOR INJECTION
FULVESTRANT
SUGAR FREE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING FREXIVO
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health care provider
•
FREXIVO has been prescribed for you personally and you should
not share your medicine with other people. It may harm them, even
if their symptoms are the same as yours.
WHAT IS IN THIS LEAFLET
1.
What FREXIVO is and what it is used for
2.
What you need to know before you use FREXIVO
3.
How to use FREXIVO
4.
Possible side effects
5.
How to store FREXIVO
6.
Contents of the pack and other information
1.
WHAT FREXIVO IS AND WHAT IT IS USED FOR
FREXIVO is used to treat breast cancer in postmenopausal women.
FREXIVO is a medicine that stops some of the actions of oestrogen
(female sex hormone)
within the body, which has an effect on the growth
of breast cancer.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FREXIVO
DO NOT USE FREXIVO
•
If you are hypersensitive (allergic) to fulvestrant or any of the
other
ingredients of FREXIVO (listed in section 6).
•
If you have severe liver problems.
•
If you are pregnant or breastfeeding an infant
•
FREXIVO should not be given to children or men.
WARNINGS AND PRECAUTIONS
Tell your doctor or health care provider before being given the
injection:
•
If you have any problems with your liver or kidneys.
•
If you have been told you have a low blood platelet count, a bleeding
disorder or if you use
anticoagulants (medicine to prevent blood clots).
•
If you have osteoporosis (loss of bone density)
Astrazeneca Pharmaceuticals
_ _
Frexivo 250 mg
14 March 2022
•
If you have ever been dependent on alcohol
_Hypersensitivity (allergic) reactions: _
•
Hypersensitivity (allergy), including swelling of the face, lips,
tongue
and/or throat (angioedema) and itchy rash, weals and swelling of

পণ্য বৈশিষ্ট্য

Astrazeneca Pharmaceuticals 14 March 2022
_ _
Frexivo
_ _
SCHEDULING STATUS:
1
NAME OF THE MEDICINE
FREXIVO
® 250 MG SOLUTION FOR INJECTION
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 250 mg/5 ml (5 % m/v) fulvestrant in
a long acting formulation.
This product contains 10 % m/v ethanol (96 %).
For 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
_ _
FREXIVO is indicated for the treatment of oestrogen 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 anti-oestrogen therapy, or
disease progression with an anti-oestrogen.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
In the absence of incompatibility studies, this medicinal product must
not be mixed with other medicinal products.
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).
_ _
Caution should be taken if injecting FREXIVO at the dorsogluteal
_ _
site due to the
proximity of the underlying sciatic nerve.
_ _
Refer to the end of this leaflet for detailed instructions for
assembly,
_ _
handling and disposal of the
syringe and safety needle.
_ _
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:
S 4
Astrazeneca Pharmaceuticals 14 March 2022
_ _
Frexivo
_ _
_ _
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 patie