ANATERA 100 MG/ML SOLUTION FOR INJECTION

Active substance: FLUORESCEIN SODIUM

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PACKAGE LEAFLET:
EN
INFORMATION FOR THE USER
ANATERA®
100 mg/ml solution for injection
Fluorescein
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 any
of the side effects get
serious, or if you notice
any side effects not listed
in this leaflet, please tell
your doctor.

In this leaflet:
1. What ANATERA®
100 mg/ml solution
for injection is and
what it is used for
2. 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

5. How to store
ANATERA® 100 mg/ml
solution for injection

medicine is for diagnostic
use only. It is not used
to treat any condition.

6. Further information

2. BEFORE YOU
ARE GIVEN
ANATERA®
100 MG/ML
SOLUTION FOR
INJECTION

1. WHAT
ANATERA®
100 MG/ML
SOLUTION FOR
INJECTION IS
AND WHAT IT
IS USED FOR

You should NOT be given
ANATERA® 100 mg/ml
solution for injection

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

- if you are
hypersensitive
(allergic) to
fluorescein or any
other ingredients in
ANATERA®
100 mg/ml solution
for injection. Tell your
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doctor if you think you
are hypersensitive
or allergic to
fluorescein or any
other ingredients in
ANATERA® 100 mg/ml
solution for injection.
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.
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- if you use medicines
called beta blockers.
Beta blockers are
used to treat high
blood pressure and
a number of heart
conditions and are
also used in eye drops
for the treatment of
glaucoma. An allergic
reaction to ANATERA®
100 mg/ml solution for
injection can cause a
sudden drop in blood
pressure. This may
be greater in patients
taking beta blockers
(such as atenolol,
sotalol, propranolol,
metoprolol,
bisoprolol).
- if you have had
a reaction to
fluorescein before.

You may need to be
given another drug to
prevent you feeling
sick.

medicines, including
medicines obtained
without a prescription.
This medicinal product
must not be mixed with
other medicinal products.

- if you are on a
low sodium diet.
ANATERA® 100 mg/ml
solution for injection
contains up to
3.15 mmol (72.45 mg)
sodium per dose.

Pregnancy and
breast feeding
Pregnancy
Tell your doctor if you
are pregnant or are
planning to become
pregnant. If you are
pregnant, ANATERA®
100 mg/ml solution
for injection should
only be used after your
doctor has prescribed
it. Due to limited
experience, caution
should be exercised when
considering the use of

If any of the above applies
to you, or if you are not
sure, please tell your
doctor before you are
given ANATERA® 100 mg/
ml solution for injection.
Taking other medicines
Please tell your doctor
if you are taking or have
recently taken any other
4

As part of your eye
examination, you may be
given eye drops which
increase the size of the
pupil of your eye. This can
temporarily affect your
vision and your ability to
drive or use machines. Do
not drive or use machinery
until your vision has
returned to normal.

ANATERA® 100 mg/
ml solution for injection
during pregnancy.
Breast feeding
Tell your doctor if you
are breast feeding.
Fluorescein, the active
substance in ANATERA®
100 mg/ml solution for
injection, passes into
the mother’s milk where
it is slowly eliminated.
Therefore, after using
ANATERA® 100 mg/
ml solution for injection,
you should not breast
feed for 4 days. During
this period, breast milk
should be expressed
and thrown away.

Important information
about some of the
ingredients of ANATERA®
100 mg/ml solution for
injection
This medicinal product
contains up to 3.15 mmol
(72.45 mg) sodium per
dose. This should be taken
into consideration by
patients on a controlled
sodium diet.

Driving and using
machines
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safety in this group have
not been established.

3. HOW
ANATERA®
100 MG/ML
SOLUTION FOR
INJECTION IS
GIVEN

By injection:
Usually one vial of
ANATERA® 100 mg/
ml solution for injection
is given by injection
into a vein in the arm.
ANATERA® 100 mg/
ml solution for injection
should not be injected
intrathecally or intraarterial.

ANATERA® 100 mg/ml
solution for injection will
be administered by your
doctor. Depending on your
condition your doctor may
modify the dose. However,
since this product has not
been studied in children,
dose-adaptation data for
children are not available.
Therefore, ANATERA®
100 mg/ml solution for
injection should not be
used in patients below
18 years as efficacy and

If you have any further
questions about how
ANATERA® 100 mg/ml
solution for injection is
given, ask your doctor.

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One or more of these
may affect up to 10 in
every 100 people.

4. POSSIBLE SIDE
EFFECTS

Vomiting, stomach
problems, fainting, itching,
escape of blood or fluid
into the tissue, abnormal
sense of taste

Like all medicines,
ANATERA® 100 mg/
ml solution for injection
can cause side effects,
although not everybody
gets them. The following
side effects have been
reported:

Uncommon side effects

Very common side effects

One or more of these
may affect up to 1 in
every 100 people
Headache, dizziness,
sensation of pins and
needles, cough, throat
tightness, abdominal
pain, hives, impaired
speech, pain, feeling
hot, hypersensitivity,
inflammation of the veins

One or more of these may
affect more than 1 in every
10 people.
Nausea
Common side effects
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Rare side effects

skin flushing, pallor, hot
flush, stopping breathing,
fluid on the lungs, asthma,
decreased breathing
function, swelling of
the larynx, shortness of
breath, swelling of the
nose, sneezing.

One or more of these
may affect up to 1 in
every 1000 people.
Severe allergic reaction,
cardiac arrest, low blood
pressure, shock, difficulty
in breathing or wheezing
(bronchospasm)

Not known (frequency
cannot be estimated
from the available data)
Loss of consciousness,
shaking, abnormal or
decreased skin sensation,
rash, cold sweat, skin
inflammation, sweating,
oedema, generalised
weakness, myocardial
infarction.

Very rare side effects
One or more of these may
affect up to 1 in every
10000 people.
Anaphylactic shock,
convulsion, angina
pectoris, slow heart rate,
fast heart rate, high blood
pressure, cramp of blood
vessels, cramp in the calf
muscles, poor circulation,
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After receiving ANATERA®
100 mg/ml solution
for injection, you may
experience a change in the
way things taste. Your skin
may appear yellowish;
this discoloration usually
disappears after 6-12
hours. Your urine also may
appear bright yellow; this
may take 24-36 hours to
return to normal.
After injection,
inflammation of the vein
and blood clots in the
vein may occur. If during
injection the solution leaks
from the vein into the
surrounding tissues, it can
cause damage to the skin
and inflammation of the
veins, nerves and tissues
close to the injection site;
this can lead to severe
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pain. If you notice any
pain or other problems at
the injection site, tell your
doctor; you may need to
be given pain medication
or other treatment to help
with this.
As listed previously,
fluorescein can have
unexpectedly severe side
effects. These are more
likely if you have suffered
a reaction to fluorescein
before or if you suffer
from allergies (food or
drug allergies), eczema,
asthma or hay fever.
If you experience any of
the side effects, or if you
notice any side effects not
listed in this leaflet, please
tell your doctor.

Blood and urine tests
It is possible that
fluorescein may affect
certain blood and urine
tests for 3 to 4 days after
you are given it. If you
have any blood or urine
tests or further X-rays
during this period, tell
your doctor that you have
been given fluorescein.

-

-

5. HOW TO STORE
ANATERA®
100 MG/ML
SOLUTION FOR
INJECTION

-

- Keep out of the reach
and sight of children.
- Do not use ANATERA®
100 mg/ml solution for
injection after the expiry
date which is stated on

-

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the label and outer carton
(marked ‘Exp’). The
expiry date refers to the
last day of that month.
Once opened the
vial must be used
immediately.
Your doctor or nurse
knows how to store
ANATERA® 100 mg/ml
solution for injection:
Do not store above 25°C.
Do not freeze. Keep the
vial in the outer carton
in order to protect from
light.
Do not use ANATERA®
100 mg/ml solution for
injection if the vial is
cracked or damaged in
any way.
The solution is to be
inspected visually for
particulate matter and

discoloration prior to
administration. The
solution should only
be used if the solution
is clear and free from
particles.
- Any unused product or
waste material should
be disposed of in
accordance with local
requirements.

6. FURTHER
INFORMATION
What ANATERA® 100
mg/ml solution for
injection contains
The active substance is
fluorescein.
1 ml of solution contains
100 mg fluorescein (as
113.2 mg fluorescein
sodium).
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One vial with 5 ml contains
500 mg fluorescein (as
566 mg fluorescein sodium).
The other ingredients are
sodium hydroxide and /
or hydrochloric acid (used
to adjust the pH of the
solution) and water for
injections.
What ANATERA®
100 mg/ml solution for
injection looks like and
contents of the pack
ANATERA® 100 mg/ml
solution for injection is a
clear red-orange solution
for injection.
ANATERA® 100 mg/ml
solution for injection is
available in packages
containing 12 vials of 5 ml
solution for injection.

Marketing Authorisation Holder
Alcon Laboratories
(U.K.) Ltd.
Pentagon Park
Boundary Way
Hemel Hempstead
Herts HP2 7UD
United Kingdom
PL00649/0377
This product is also authorised in the EU under the
following names:
Fluorescein ALCON® 10%
Manufacturer
S. A. Alcon-Couvreur N. V.
Rijksweg 14
B-2870 Puurs
Belgium
This leaflet was last approved in May 2013
© 2010, 2013 Novartis

AAA4260-0513
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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.

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