Fluorescein sodium 500mg/5ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fluorescein sodium

Available from:

SERB

ATC code:

S01JA01

INN (International Name):

Fluorescein sodium

Dosage:

88.3mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: ; GTIN: 5055956400010

Patient Information leaflet

SERB S.A.
Page 1 / 6
Avenue Louise, 480
1050 Brussels - Belgium
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.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or
nurse.

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.

If you get any side effects talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in
this leaflet.
IN THIS LEAFLET:
1.
What Fluorescein Sodium Injection is and what it is used for
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 fluorescei

Summary of Product characteristics

OBJECT 1
FLUORESCEIN SODIUM 100 MG/ML, SOLUTION FOR
INJECTION
Summary of Product Characteristics Updated 16-Jan-2018 | SERB
1. Name of the medicinal product
FLUORESCEIN SODIUM 100 MG/ML, SOLUTION FOR INJECTION
2. Qualitative and quantitative composition
Each 1ml of solution contains 100mg fluorescein sodium (equivalent to
88.3mg fluorescein anhydrous).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection
Clear red solution
4. Clinical particulars
4.1 Therapeutic indications
Fluorescein angiography of the ocular fundus.
This medicinal product is for diagnostic use only.
4.2 Posology and method of administration
Use in adults, including the elderly
One 5ml ampoule of fluorescein sodium 100mg/ml to be injected
intravenously into the antecubital vein
after taking precautions to avoid extravasation.
Use in paediatric patients
Fluorescein Sodium 100mg/ml Solution for Injection has not been
studied in children and dose-adaptation
data are not available. Therefore Fluorescein Sodium 100mg/ml Solution
for Injection should not be used
in patients below 18 years as efficacy and safety in this group has
not been established.
Use in patients with renal insufficiency (glomerular filtration rate
below 20ml/min)
There is limited data regarding the use of Fluorescein Sodium 100mg/ml
Solution for Injection in renally
impaired patients (glomerular filtration rate below 20ml/min) and
indicates, in general, no dose
adjustment is required. Patients with renal impairment will exhibit a
slower excretion rate (see section
5.2)
In dialysis patients: Reduce the dose to 2.5ml (half an ampoule) as an
intravenous injection.
METHOD OF ADMINISTRATION AND FLUORESCENCE ANGIOGRAPHY
Fluorescein Sodium 100 mg/ml Solution for Injection should be used
exclusively by qualified physicians
with technical expertise in performing and interpreting fluorescence
angiography.
This product should only be administered intravenously.
Flush intravenous cannulas with sterile sodium chloride solution
(0.9%) before and after