Skip to Content

FLUORESCEIN SODIUM 100 MG/ML SOLUTION FOR INJECTION

Active substance(s): FLUORESCEIN SODIUM

View full screen / Print PDF » Download PDF ⇩
Transcript
Agence Kidicom
9-13 av. Gambetta 81000 Albi
06 71 07 42 24

5030191

PACKAGE LEAFLET: INFORMATION FOR THE USER

Fluorescein Sodium 100mg/ml Solution for Injection
Fluorescein sodium

INTRAVENOUS USE ONLY

The name of this medicine is Fluorescein Sodium 100mg/ml Solution for
Injection, which will be referred to as Fluorescein Sodium Injection throughout
this leaflet.
Read all of this leaflet carefully before you are given this medicine because
it contains important information for you.

Nom : Fluorescein Sodium GB
Réf. : 207_GB_20161_NO
Version : 2
Code fabricant : 5030191
Date : 22/04/16
Auteur : Nicolas Périé
Format à plat : 127 x 630 mm
Format plié : 127 x 31 mm
Page n° 1 sur 2
0

10

20

30

- Keep this leaflet. You may need to read it again.

Fontes

- If you have any further questions, ask your doctor, pharmacist or nurse.

Helvetica Neue LT Std.

- This medicine has been prescribed for you only. Do not pass it on to others.
It may harm them, even if their signs of illness are the same as yours.

Couleurs

- If you get any side effects talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet.

40

50mm

Noir

Pharmacode

In this leaflet:
1. What Fluorescein Sodium Injection is and what it is used for

34

2. What you need to know before you are given Fluorescein Sodium Injection
3. How to use Fluorescein Sodium Injection
4. Possible side effects
5. How to store Fluorescein Sodium Injection
6. Contents of the pack and other information

1. What Fluorescein Sodium Injection is and what it is used for
Fluorescein Sodium Injection contains the active ingredient fluorescein
sodium which works as a diagnostic stain. It is used in a hospital-based
procedure on the eye called fluorescein angiography of the ocular fundus (part
of the eye). Fluorescein angiography is a test that allows the blood vessels
in the back of the eye to be photographed as a fluorescent dye is injected
into the bloodstream. This will assist your doctor in the diagnosis of diseases
which affect these blood vessels, especially in elderly people and diabetics.
This medicinal product is for diagnostic use only.

2. What you need to know before you are given Fluorescein Sodium
Injection
Do not use Fluorescein Sodium Injection if:
• you are allergic (hypersensitive) to fluorescein sodium or any of the
other ingredients of this medicine (listed in section 6).
If the above applies to you or you are in any doubt you should ask your doctor
or pharmacist for advice before being given this medicine.

Warning and Precautions:
Your doctor or other healthcare professional will give you this medicine
through an injection into one of your veins. Fluorescein Sodium Injection is for
intravenous injection only and MUST NOT be injected into the arteries (arterial
route) or into the spinal column (intrathecal route).

You must tell your doctor if:
• you have previously undergone a hospital procedure on the eye
called fluorescein angiography of the ocular fundus (a part of the eye)
• you have a history of allergy
• you have a history of heart or pulmonary disease
• you are taking drugs known as Beta-blockers
including those applied in eye drops
• you have kidney disease.
Fluorescein sodium can induce serious allergic reactions that are more
frequent in patients who have either experienced an adverse reaction to a
previous administration of the medicine or in patients with a known history of
allergy including food or drug-induced urticaria (red, itchy skin also known as
hives), asthma, eczema and hayfever.
Your doctor will monitor you closely during and after the procedure and will
ensure that appropriate emergency treatment facilities are available in case a
serious reaction occurs.

Taking other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines including medicines obtained without a prescription.
Fluorescein sodium can sometimes interact with other medicines that you
could be taking causing unwanted side effects. It is especially important to tell
your doctor if you are taking any of the following:
• medicines known as beta-blockers. These medicines can be used for
a range of different therapeutic conditions and can be taken either
by mouth or sometimes applied in eye drops. Common examples
of beta-blockers include atenolol, bisoprolol, metoprolol and
propranolol, betaxolol, levobunolol, and timolol
• medicines used for the treatment of gout (known as organic anion
transporters) such as probenecid.

If you are due to have other diagnostic tests including blood, urine,
and X-Ray investigations
Fluorescein Sodium Injection may interfere with the results of some blood and
urine tests within 3 days of having the procedure. If you are having any blood
or urine tests taken,you should tell the doctor or nurse that you have been
given Fluorescein Sodium Injection.
If an X-ray procedure is conducted within 36 hours of injection, the resulting high
visibility of some organs such as the kidneys may lead to misinterpretation of the results.

Pregnancy, breastfeeding and fertility
If you are pregnant or think you may be pregnant prior to using Fluorescein
Sodium Injection, tell your doctor who will decide whether to give you this
medicine or not.
As Fluorescein sodium is excreted in breast milk, stop all breast feeding for
two days after administration of Fluorescein sodium.

Driving or operating machinery
The angiography procedure causes dilation of the pupil. Patients must abstain
from driving a vehicle or operating machinery until the eyesight returns to normal.

Fluorescein Sodium Injection contains sodium
This medicinal product contains 2.54mmol (58.5mg) sodium per dose. This
should be taken into consideration if you are on a controlled sodium diet.

3. How to use Fluorescein Sodium Injection
Adults (including the elderly)
A doctor will administer Fluorescein Sodium 100mg/ml Solution for Injection
into the antecubital vein (the antecubital vein is situated in the arm) usually
through a cannula. This medicine MUST NOT be injected via any other
injection route, including into the arteries (arterial route) or into the spinal
column (intrathecal route).
The exact dose, to be determined by the doctor, is up to a maximum dose of
Fluorescein sodium 500mg (equivalent to one 5ml ampoule) administered by
intravenous injection.

Children and adolescents
Fluorescein Sodium 100mg/ml Solution for Injection should not be used in
people under the age of 18.

Use in patients with kidney problems
If you have a renal (kidney) impairment, the dose should not be adjusted.
If you are on kidney dialysis, your dose may be reduced to half of the normal
recommended dose.
If you have any further questions on the use of this medicine, ask your doctor,
pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
If you have undergone a similar examination, please tell your doctor if you
have experienced an intolerance reaction regardless of how severe it may or
may not have been.
If you experience any of the following reactions during the examination
immediately tell the doctor:
• swelling of the hands, face, lips or tongue
• wheezing or difficulty in breathing
• a sudden, unexpected rash or burning, red or peeling skin
• severe dizziness or fainting
• fast, deep breathing, cold clammy skin and feelings of anxiety.
If the product leaks into the tissue surrounding the site of the injection
(extravasation), a painful inflammatory reaction could occur even leading
to the death of tissue.

Validation
Date :

Signature accompagnée de la mention
« Bon pour à graver » :

NB. La validation concerne aussi bien la
composition graphique en elle-même, que
les textes mis en page et les spécifications
ci-dessus.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide