FLUORESCEIN SERB fluorescein sodium 500mg/5mL injection solution ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fluorescein sodium, Quantity: 100 mg/mL

Available from:

Clinect Pty Ltd

INN (International Name):

Fluorescein sodium

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium hydroxide; water for injections

Administration route:

Intravenous

Units in package:

1 x 5mL ampoule, 10 x 5mL ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Fluorescein angiography of the fundus and of the iris vasculature. This medicinal product is for diagnostic use only.

Product summary:

Visual Identification: Clear orange-yellow solution with yellowish green fluorescence; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2007-02-13

Patient Information leaflet

FLUORESCEIN SERB™
_500MG/5ML_
_fluorescein sodium_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Fluorescein SERB
500mg/5mL.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP-TO-DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP-TO-
DATE LEAFLET FROM
WWW.CLINECT.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Fluorescein
SERB 500mg/5mL against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT FLUORESCEIN
SERB 500MG/5ML IS
USED FOR
This medicine is used to look at the
blood moving through the blood
vessels at the back of your eye(s) so
your doctor can identify any areas of
your eye(s) which may be damaged
or unhealthy.
It is known as a diagnostic agent.
It works by fluorescing when
stimulated by blue light.
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.
This medicine is not addictive.
It is available only with a doctor's
prescription.
BEFORE YOU ARE GIVEN
FLUORESCEIN SERB
500MG/5ML
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT USE FLUORESCEIN SERB
500MG/5ML IF YOU HAVE AN ALLERGY
TO:
•
any medicine containing
fluorescein sodium
•
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

Summary of Product characteristics

1
PRODUCT INFORMATION
FLUORESCEIN SERB™ 500MG/5ML
(fluorescein sodium)
NAME OF THE MEDICINE
Active ingredient:
fluorescein sodium
Chemical name:
disodium 2-(3-oxo-6-oxido-3_H_-xanthen-9-yl)benzoate
Molecular formula:
C
20
H
10
Na
2
O
5
CAS number:
518-47-8
Molecular weight:
376.3
Structural formula:
DESCRIPTION
Fluorescein SERB 500mg/5mL is a sterile solution containing
fluorescein sodium for
intravenous injection. Each 1.0 mL of solution contains 100 mg
fluorescein sodium. One
ampoule of 5mL contains 500 mg fluorescein sodium.
Excipients: Sodium hydroxide for pH adjustment, water for injections.
PHARMACOLOGY
PHARMACODYNAMICS
Pharmacotherapeutic group: Diagnostic agent, ATC code: SO1JA 01.
MECHANISM OF ACTION
Fluorescein SERB 500mg/5mL is a diagnostic dye. When fluorescein
sodium is stimulated by
blue light (465 nm to 490 nm) it shows yellow-green (520 nm to 530 nm)
fluorescence. The
pattern
of fluorescence
facilitates diagnosis
of
pathological
changes
to
the
retinal
blood
circulation.
2
PHARMACOKINETICS
Absorption:
After intravenous injection, fluorescein is rapidly distributed
throughout the body and appears in
the retinal tissues within a few seconds. Intravenous administration
of 188mg fluorescein
sodium resulted in C
max
of 10.9

g/mL and AUC 1350

g.min/mL. Fluorescein appears in the
central artery of the eye, within 7 to 14 seconds after intravenous
administration into the
antecubital vein. The mean peak concentration for the 10% fluorescein
sodium solution in the
retinal artery amounted to 0.5mg/mL.
Distribution:
Fluorescein binds to albumin and red blood cells in a reversible
fashion and the binding is
moderate (

70-80%) during the first hour. About 15-17% is bound to erythrocytes.
Within a few minutes of intravenous administration of fluorescein
sodium, a yellowish
discolouration of the skin occurs, which begins to fade after 6 to 12
hours of dosing. Various
estimates of volume of distribution indicate that fluorescein
distributes well into interstitial space
(0.5 to 0.8L/kg).
Metabolism:
Fl