Fluorescein Novartis

Երկիր: Ավստրալիա

Լեզու: անգլերեն

Աղբյուրը: Department of Health (Therapeutic Goods Administration)

Ակտիվ բաղադրիչ:

Fluorescein sodium

Հասանելի է:

Novartis Pharmaceuticals Australia Pty Ltd

Դաս:

Medicine Registered

Տեղեկատվական թերթիկ

FLUORESCEIN NOVARTIS

_500MG/5ML_
_fluorescein sodium_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Fluorescein Novartis
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.NOVARTIS.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
Novartis 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
NOVARTIS 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 NOVARTIS
500MG/5ML
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT USE FLUORESCEIN NOVARTIS
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

Ապրանքի հատկությունները

1 

FLUORESCEIN NOVARTIS 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 Novartis 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 Novartis 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. 

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 
2 

188mg fluorescein sodium resulted in C
max
 of 10.9
µg/mL and AUC 1350µg.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 a