Anatera 500mg/5ml solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fluorescein sodium

Available from:

Alcon Eye Care UK Ltd

ATC code:

S01JA01

INN (International Name):

Fluorescein sodium

Dosage:

100mg/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: 0300650092944

Patient Information leaflet

EN
PACKAGE LEAFLET:
INFORMATION FOR THE USER
Read all of this leaflet
carefully before you are
given ANATERA® 100 mg/
ml solution for injection.
Keep this leaflet.
You may need to read it
again. If you have any
further questions, please
ask your doctor. If you get
any side effects, talk to
your doctor. This includes
any possible side effects
not listed in this leaflet.
See section 4.
In this leaflet:
1. What ANATERA®
100 mg/ml solution
for injection is and
what it is used for
2. What you need to know
before you are given
ANATERA® 100 mg/ml
solution for injection
3. How ANATERA® 100
mg/ml solution for
injection is given
4. Possible side effects
ANATERA®
100 mg/ml solution for injection
FLUORESCEIN
2
5. How to store
ANATERA® 100 mg/ml
solution for injection
6. Contents of the pack
and other information
7. Information for
the Health care
professional
1. What ANATERA®
100 mg/ml
solution for
injection is
and what it
is used for
ANATERA® 100 mg/ml
solution for injection is a
dye solution that makes
the blood vessels at the
back of your eye visible
during an eye examination
(this procedure is
known as fluorescein
angiography). This
medicine is for diagnostic
use only. It is not used
to treat any condition.
2. What you need
to know before
you are given
ANATERA® 100
mg/ml solution
for injection
You should NOT be given
ANATERA® 100 mg/ml
solution for injection
- if you are
hypersensitive
(allergic) to
fluorescein or any
other ingredients in
ANATERA®
3
100 mg/ml solution
for injection. Tell your
doctor if you think you
are hypersensitive
or allergic to
fluorescein or any
other ingredients in
ANATERA® 100 mg/ml
solution for injection.
Warnings and precautions
Tell your doctor before
you are given ANATERA®
100 mg/ml solution for
injection
- if you have pre-existing
conditions such as
cardiovascular disease
or diabetes mellitus.
- if you have impaired
kidney function. If
necessary, your
doctor will give
a lower dose of
ANATERA® 100 mg/ml
solution for injection.
- if you use medicines
called beta blockers.
Beta bl

Summary of Product characteristics

OBJECT 1
ANATERA 100MG/ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 28-Apr-2017 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
Anatera 100 mg/ml solution for injection
2. Qualitative and quantitative composition
1 ml solution contains 100 mg fluorescein (as 113.2 mg fluorescein
sodium).
One 5 ml vial contains 500 mg fluorescein (as 566 mg fluorescein
sodium).
Contains sodium (from fluorescein sodium and sodium hydroxide) at
amounts up to 1.45%
(approximately 3.15 mmol) per dose.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
Clear, red-orange solution.
4. Clinical particulars
4.1 Therapeutic indications
This medicinal product is for diagnostic use only.
For fluorescein angiography of the ocular fundus.
4.2 Posology and method of administration
POSOLOGY
Use in adults, including the elderly:
Inject 5 ml of Anatera 100 mg/ml solution for injection rapidly into
the antecubital vein after taking
precautions to avoid extravasation. In cases when highly sensitive
imaging systems e.g., scanning laser
ophthalmoscope are used, the dose of this product should be reduced to
2 ml of Anatera 100 mg/ml
solution for injection.
Use in paediatric patients:
Anatera 100 mg/ml solution for injection has not been studied in
children and dose-adaptation data are
not available. Therefore, Anatera 100 mg/ml solution for injection
should not be used in patients below
18 years as efficacy and safety in this group have not been
established.
Use in patients with renal insufficiency (glomerular filtration rate
below 20 ml/min):
Limited experience in renally impaired subjects (glomerular filtration
rate below 20 ml/min) suggests
that, in general, no dose adjustment is required although a longer
excretion rate in patients with renal
impairment is possible (see section 5.2).
Dialysed patients: Reduce dose to 2.5 ml (half a vial).
METHOD OF ADMINISTRATION AND FLUORESCENCE ANGIOGRAPHY
Anatera 100 mg/ml solution for injection should be used exclusively by
qu