PIL
Retinofluor 10% and 25%
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_Version 08 _
RETINOFLUOR™
FLUORESCEIN SODIUM INJECTION 10% AND 25%
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Retinofluor. It does not
contain all the available information. It
does not take the place of talking to
your doctor.
All medicines have risks and benefits
.
Your doctor has weighed the risks of
you being given Retinofluor against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR.
KEEP THIS LEAFLET IN A SAFE PLACE.
You may need to read it again.
WHAT RETINOFLUOR IS
USED FOR
Retinofluor is used to highlight blood
vessels in the back of the eye so that a
special camera can be used to take
pictures and analyze the blood
circulation in the eye. This helps
doctors diagnose any problems or
diseases of the eye._ _
This medicine belongs to a group of
medicines called synthetic dyes.
Retinofluor is an orange to red
coloured fluorescent dye.
This medicine works by making the
blood vessels in the eye fluoresce for a
short time so that these vessels can be
more easily seen in a photograph.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it for
another reason.
BEFORE YOU ARE GIVEN
RETINOFLUOR
_WHEN YOU MUST NOT BE GIVEN _
_IT_
_ _
YOU SHOULD NOT BE GIVEN RETINOFLUOR
IF YOU HAVE AN ALLERGY TO:
• any medicine containing
fluorescein sodium
• any of the ingredients listed at the
end of this leaflet
• any other similar medicines such as
synthetic dyes.
Some of the symptoms of an allergic
reaction m
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SPC
PRODUCT INFORMATION
Product Information RETINOFLUOR (Fluorescein Sodium Injection)
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Version 12
RETINOFLUOR
TM
Fluorescein Sodium Injection
NAME OF THE MEDICINE
RETINOFLUOR™
Non-proprietary name: Fluorescein Sodium 10% and Fluorescein Sodium 25% for injection.
Chemical Name: Disodium 2-(6-oxido-3-oxo-3H-xanthen-9-yl) benzoate.
The molecular weight of the compound is 376.3 and the CAS registry number is 518-47-8. The molecular formula is
C
20
H
10
Na
2
O
5.
Structural Formula:
DESCRIPTION
Orange / red solution in rubber capped vial.
Dose Form:
A sterile solution for intravenous administration having the following composition:
Fluorescein sodium 10% injection contains 100 mg in 1 mL (available in 5 and 10 mL vials) and fluorescein sodium 25%
injection contains 250 mg in 1mL (in 5 mL vials) in water for injection, with the pH adjusted using sodium hydroxide and/or
hydrochloric acid. Contains no antimicrobial agent. Product is for single use in one patient only. Discard any residue.
PHARMACOLOGY
Fluorescein sodium has a green-yellow fluorescence which may be used to highlight the vascular perfusion and its
abnormalities.
INDICATIONS
Diagnostic: Intravenous injection of fluorescein sodium dye followed by multiframe photography (angiography) or
ophthalmoscopic evaluation (angioscopy). It is used in evaluation of wide range of retinal and choroidal diseases. It is less
commonly used to evaluate abnormalities of the optic nerve and iris. It may be used in diagnosis and management of
macular and vascul
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