RETINOFLUOR fluorescein sodium 25% injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fluorescein sodium, Quantity: 250 mg/mL

Available from:

Phebra Pty Ltd

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: sodium hydroxide; water for injections; hydrochloric acid

Administration route:

Intravenous

Units in package:

5mL x 10

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 01 JANUARY 1991 : Diagnostic - Intravenous injection of sodium fluorescein dye followed by multiframe photography (angiography) or ophthalmoscopic evaluation (angioscopy). Used in evaluation of wide range of retinal and choroidal diseases. Less commonly used to evaluate abnormalities of the optic nerve and iris. May be used in diagnosis and management of macular and vascular (including diabetes) diseases.

Product summary:

Visual Identification: Clear red solution becoming fluorescent on dilution; Container Type: Vial; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-10-14

Patient Information leaflet

Retinofluor 10% and 25%
Page 1 of 3
_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 may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue or
other parts of the body
•
rash, itching or hives on the skin._ _
YOU SHOULD NOT BE GIVEN THIS
MEDICINE IF YOU ARE PREGNANT.
It may affect your developing baby if
you are given it during pregnancy.
DO NOT BREAST-FEED IF YOU ARE BEING
GIVEN THIS MEDICINE.
The active

Summary of Product characteristics

PRODUCT INFORMATION
Australian Product Information – Retinofluor (Fluorescein Sodium
Injection)
Page 1 of 7
Version 13
RETINOFLUOR™ INJECTION
(FLUORESCEIN SODIUM)
1
NAME OF THE MEDICINE
Fluorescein sodium
2
QUALITATIVE AND QUANTITATIVE 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 1 mL (5 mL vials) in water for
injection.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Retinofluor is an orange/red sterile solution for intravenous
administration.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Diagnostic: Intravenous injection of fluorescein sodium dye followed
by multiframe photography (angiography) or
ophthalmoscopic evaluation (angioscopy). It is used in evaluation of a
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 vascular (including diabetic) diseases.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Product is for single use in one patient only. Discard any residue.
After taking precautions to avoid extravasation (e.g. checking with
the lights on) 10% or 25% fluorescein sodium
injection is rapidly injected in the antecubital vein and then the
room lights turned off.
A recommended dose is 500 mg but this dose may be varied depending on
the patient and the camera used in the
diagnostic procedure and the individual experience of the operator. It
is recommended that the dose be kept as
low as possible.
About ten minutes after the injection, very little of the fluorescein
sodium dye remains in the eye. The retina and
choroidal vessels are stained within 15 seconds and the optic disc
will normally fluoresce for several hours after
injection.
4.3
C
ONTRAINDICATIONS
Sensitivity to fluorescein sodium or any components in the injection.
Concomitant use of contact lenses.
PRODUCT INFORMATION
RETINOFLUOR
™
Australian Product Informa