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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 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

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

known as fluorescein
angiography). This
medicine is for diagnostic
use only. It is not used
to treat any condition.

6. Contents of the pack
and other information
7. Information for
the Health care
professional

2. What you need
to know 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

- if you are
hypersensitive
(allergic) to
fluorescein or any
other ingredients in
ANATERA®
2

a lower dose of
ANATERA® 100 mg/ml
solution for injection.

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

3

- 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.

Please tell your doctor
if you are taking or have
recently taken any other
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, breast feeding
and fertility
Pregnancy and fertility
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

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.
Other medicines
4

Driving and using
machines

experience, caution
should be exercised
when considering the use
of ANATERA® 100 mg/
ml solution for injection
during pregnancy.

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.

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 7 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
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into consideration by
patients on a controlled
sodium diet.

used in patients below
18 years as efficacy and
safety in this group have
not been established.

3. How ANATERA®
100 mg/ml
solution for
injection is
given

By injection:

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

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 (into the
spinal canal) or intraarterially (into the
arteries).
If you have any further
questions about how
ANATERA® 100 mg/ml
solution for injection is
given, ask your doctor.
6

Vomiting, stomach
problems, fainting, itching,
escape of blood or fluid
into the tissue.

4. Possible side
effects
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
May affect up to 1
in 100 people

Very common side effects
May affect more than 1 in
10 people

Headache, dizziness,
sensation of pins and
needles, cough, throat
tightness, abdominal
pain, hives, impaired
speech, pain, feeling
hot, hypersensitivity,
inflammation of the veins
Rare side effects

Nausea
Common side effects

May affect up to 1 in 1,000
people

May affect up to 1
in 10 people

Severe allergic reaction,
cardiac arrest, low blood

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Not known (frequency
cannot be estimated
from the available data)
Stroke, chest pain, loss of
consciousness, shaking,
abnormal or decreased
skin sensation, rash, cold
sweat, skin inflammation,
sweating, oedema,
generalised weakness,
myocardial infarction,
throat irritation, skin
discolouration, abnormal
sense of taste and chills.

pressure, shock, difficulty
in breathing or wheezing
(bronchospasm)
Very rare side effects
May affect up to 1 in
10,000 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,
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.

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
8

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
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,
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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
If you get any side effects,
for injection
talk to your doctor or
Reporting of side effects

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

pharmacist. This includes
any possible side effects
not listed in this leaflet.
You can also report side
effects directly via the
national reporting system
(see details below). By
reporting side effects you
can help provide more
information on the safety
of this medicine.
United Kingdom
Yellow Card Scheme
Website:
www.mhra.gov.uk/
yellowcard
10

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. Contents of the
pack and other
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).
One vial with 5 ml contains
500 mg fluorescein (as
566 mg fluorescein sodium).

11

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.
Frimley Business Park,
Frimley, Camberley,
Surrey, GU16 7SR
United Kingdom
PL00649/0377
This product is also authorised in the EU under the
following names:
Fluorescein ALCON® 10% and FLUORESCITE®
100 mg/ml solution for injection

12

Manufacturer
S. A. Alcon-Couvreur N. V.
Rijksweg 14
B-2870 Puurs
Belgium
This leaflet was last revised in October 2014
7. Information for Health care professionals
The complete SmPC is provided as a separate document
in the medicinal pack.
© 2010, 2013, 2014 Novartis

A148142-1214
13

14

15

16

A148142 I ANATER 5mL GB
FORT
WORTH,Alcon

NOTATIONS-DIE VINYL

NEW 12.12.2014
04:35 PM

A148143 I ANATER 5mL GB
FORT
WORTH,Alcon

K
NOTATIONS-DIE VINYL

A

12.15.2014
04 59 PM

FORT
5:04 pm, Dec 15, 2014

SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
ANATERA® 100 mg/ml solution for injection

2

4.5

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

Concomitant intravenous injection of other solutions or the mixing of ANATERA® 100 mg/ml solution for
injection with other solutions should be avoided as the possibility of interactions cannot be excluded.

PHARMACEUTICAL FORM
Solution for injection
Clear, red-orange solution
4.6
4

4.2

CLINICAL PARTICULARS

4.1

Therapeutic indications
This medicinal product is for diagnostic use only.
For fluorescein angiography of the ocular fundus.

Posology

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.

Fertility, Pregnancy and lactation
Pregnancy
There are no or limited data available concerning the use of ANATERA® 100 mg/ml solution for injection in
pregnancy. Animal studies do not indicate teratogenic effects (see section 5.3). As a precautionary measure,
it is preferable to avoid the use of ANATERA® 100 mg/ml solution for Injection during pregnancy.
Breast-feeding
Fluorescein sodium is excreted in human milk following systemic administration for up to 7 days. A risk to the
suckling child cannot be excluded. Following fluorescein angiography, breast-feeding should therefore be
discontinued for 7 days and the milk should be pumped off and discarded during this period.

Posology and method of administration

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.

Interaction with other medicinal products and other forms of interaction
Fluorescein is a relatively inert dye and specific drug interaction studies have not been reported. There are
few case reports on potential interactions with organic anion transporters and interference with certain
laboratory tests. It is possible that fluorescein may influence certain blood and urine values for 3 to 4 days
after application. Caution is advised when performing therapeutic drug monitoring for drugs with a narrow
therapeutic window, e.g. digoxin, quinidine. Compounds that inhibit or compete with the active transport of
organic anions (e.g., probenicid) may affect the systemic profile of fluorescein.
The concomitant use of ANATERA® 100 mg/ml solution for injection with beta-blocking agents (including
eye-drops solutions) may rarely provoke severe anaphylactic reactions. Beta-blocking agents could reduce
the vascular compensation reactions to anaphylactic shock and also reduce the effectiveness of adrenaline
in the presence of cardiovascular collapse that may require intensive pharmacologic therapy and even
resuscitative measures (see section 4.4).

Fertility
Studies have not been performed to evaluate the effect of intravenous administration of fluorescein on
fertility.
4.7

Effects on ability to drive and use machines
If mydriasis is necessary for the examination with fluorescence angiography visual acuity is influenced and
thus affects the ability to react in traffic or use machinery. The patient must be made aware that after
application and until visual acuity returns to normal, driving a vehicle or operating dangerous machinery is
prohibited.

4.8

Undesirable effects

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)

Summary of safety profile
The most frequently reported treatment related undesirable effects were nausea, vomiting, syncope and
pruritus. Less frequent but more severe adverse reactions have been reported shortly after fluorescein
injection such as: angioedema, respiratory disorders (bronchospasm, laryngeal oedema, and respiratory
failure), anaphylactic shock, hypotension, loss of consciousness, convulsion, respiratory arrest, and cardiac
arrest.

Method of administration and fluorescence angiography

Tabulated list of adverse reactions

ANATERA® 100 mg/ml solution for injection should be used exclusively by qualified physicians with technical
expertise in performing and interpreting fluorescence angiography.

The following adverse reactions were assessed to be treatment-related and are classified according to the
following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100),
rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available
data). Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness.

This product should only be administered intravenously.
Flush intravenous cannulas with sterile sodium chloride solution (0.9%) before and after medicinal products
are injected to avoid physical incompatibility reactions. The injection should be administered rapidly (1 ml
per second is normally recommended) into the antecubital vein, after taking precautions to avoid
extravasation using a 23 gauge butterfly needle for injection. Luminescence usually appears in the retina and
choroidal vessels in 7 to 14 seconds.

Uncommon: hypersensitivity
Rare: anaphylactic reaction
Very Rare: anaphylactic shock

For further instructions on the correct administration/use of this product, see sections 6.2 and 6.6.

Nervous system disorders

Common: syncope
Uncommon: dysphasia, paraesthesia, dizziness, headache
Very Rare: convulsion
Not Known: cerebrovascular accident, vertebrobasilar
insufficiency, loss of consciousness, tremor, hypoaesthesia,
dysgeusia

Cardiac disorders

4.3

Immune system disorders

Rare: cardiac arrest
Very Rare: angina pectoris, bradycardia, tachycardia
Not Known: myocardial infarction

Vascular disorders

Uncommon: thrombophlebitis
Rare: hypotension, shock
Very Rare: hypertension, vasospasm, vasodilatation, pallor,
hot flush

Respiratory, thoracic and
mediastinal disorders

Uncommon: cough, throat tightness
Rare: bronchospasm
Very Rare: respiratory arrest, pulmonary oedema, asthma,
laryngeal oedema, dyspnoea, sneezing, nasal oedema
Not Known: throat irritation

Gastrointestinal disorders

Very Common: nausea
Common: abdominal discomfort, vomiting
Uncommon: abdominal pain
Not Known: retching

Skin and subcutaneous tissue disorders

Common: pruritus
Uncommon: urticaria
Not known: rash, cold sweat, eczema, erythema,
hyperhidrosis, skin discolouration

General disorders and administration
site conditions

Common: extravasation
Uncommon: pain, feeling hot
Not known: chest pain, oedema, malaise, asthenia, chills

System Organ Classification

Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
ANATERA® 100 mg/ml solution for injection should not be injected intrathecally or intra-arterially.

4.4. Special warnings and precautions for use
Fluorescein sodium can induce serious intolerance reactions.
The benefit to risk of the angiography procedure should be considered in patients with pre-existing
conditions such as cardiovascular disease, diabetes mellitus, and multiple concomitant drug therapies (in
particular beta-blockers, see section 4.5).
Detailed questioning of each patient must be carried out before the angiography to search for any history of
cardiopulmonary disease or allergy or concomitant medications (such as beta-blocking agents, including
eye-drops solutions). If the examination appears to be really necessary for a patient identified as being at
risk of hypersensitivity reactions and for a patient treated with beta-blocking agents (including eye-drops
solutions), this examination should be performed under the supervision of a physician experienced in
intensive care (resuscitation). Beta-blocking agents could reduce the vascular compensation reactions to
anaphylactic shock and reduce the effectiveness of adrenaline in the case of cardiovascular collapse. Before
any fluorescein sodium injection, the physician should seek information about concomitant treatment with a
beta-blocking agent.
In the event of serious intolerance reactions during a first angiography, the benefit of an additional fluorescein
angiography should be balanced with the risk of severe hypersensitivity reactions (with fatal outcome in
some cases).
These reactions of intolerance are always unpredictable but they are more frequent in patients who have
previously experienced an adverse reaction after fluorescein injection (symptoms other than nausea and
vomiting) in patients with history of allergy such as food or drug induced urticaria, asthma, eczema, allergic
rhinitis or in patients with history of bronchial asthma. Intradermal skin tests are not reliable in predicting
these intolerance reactions and so their use can be dangerous. A specialized allergy consultation should be
undertaken to make this diagnosis.

Description of selected adverse reactions
A yellowish discolouration of the skin could appear but usually disappears within 6 to 12 hours. Urine, which
may also exhibit a bright yellow colouration, returns to its normal colour after 24 to 36 hours.

Premedication can be undertaken. However, the risk of occurrence of severe adverse drug reactions still
remains. Premedication includes mainly oral antihistaminic H1 drugs, followed by corticosteroids, before
injection of fluorescein. Given the low incidence of these adverse reactions, such pre-medication is not
recommended for all patients.
The risk of hypersensitivity reactions with fluorescein sodium requires:
• Close monitoring of the patient by the ophthalmologist performing the examination, throughout the
examination and for at least 30 minutes after;
• Maintaining the infusion line for at least 5 minutes, to treat a possible severe adverse reaction without
delay;
• To have at one’s disposal appropriate material for emergency resuscitation which is based at first on the
installation of a 2nd intravenous line, allowing the restoration of the plasma volume (aqueous solution
polyionic or colloidal substitute of plasma) and the intravenous injection of adrenaline at the recommended
dosage (see section 4.5).
Note:
Extravasation should be avoided due to the high pH of fluorescein solution which can result in severe local
tissue damage (severe pain in the arm for several hours, sloughing of the skin; superficial phlebitis). The
correct intravenous position of the needle tip must be ascertained. When extravasation occurs, the injection
should be immediately discontinued. Appropriate measures must be taken to treat damaged tissue and to
relieve pain.
If an X-ray procedure is conducted within 36 hours of injection (maximum duration of fluorescein elimination
from the body), the resultant high visibility of the excretory organs in the X-ray image may lead to
misinterpretation.
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.

MedDRA Term (v. 16.0)

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows
continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked
to report any suspected adverse reactions via the national reporting system:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
4.9

Overdose
No toxic effects are expected given the minimal risk of overdose with ANATERA® 100 mg/ml solution for
Injection.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: DIAGNOSTIC AGENTS, Colouring agents
ATC code: S01JA01
Fluorescein sodium is a fluorochrome used in medicine as a diagnostic stain. Fluorescein is used to make the
blood vessels of the ocular fundus visible (angiography of the retina and choroid).

5.2

Pharmacokinetic properties
Distribution:
Within 7 to 14 seconds after intravenous administration into antecubital vein, fluorescein usually appears in
the central artery of the eye. Within a few minutes of intravenous administration of fluorescein, a yellowish
discoloration of the skin occurs, which begins to fade 6 to 12 hours after dosing. Various estimates of volume
of distribution indicate that fluorescein distributes well into interstitial space (0.5 L/kg).
Metabolism:
Fluorescein undergoes rapid metabolism to fluorescein monoglucuronide. After intravenous administration
of fluorescein sodium (14 mg/kg) to 7 healthy subjects, approximately 80% of fluorescein in plasma was
converted to glucuronide conjugate after a period of 1 hour post dose, indicating relatively rapid conjugation.
Excretion:
Fluorescein and its metabolites are mainly eliminated via renal excretion. After intravenous administration,
the urine remains slightly fluorescent for 24 to 36 hours. A renal clearance of 1.75 ml/min/kg and a hepatic
clearance (due to conjugation) of 1.50 ml/min/kg have been estimated. The systemic clearance of fluorescein
is essentially complete by 48 to 72 hours after administration of 500 mg fluorescein. Although a longer
excretion rate in patients with renal impairment is possible, limited experience in renally impaired subjects
(glomerular filtration rate below 20 ml/min) suggests that, in general, no dose adjustment is required.

5.3

Preclinical safety data
Non-clinical data for sodium fluorescein reveal no special hazard for humans based on studies of single dose
toxicity.
Fluorescein did not show teratogenic effects in rats and rabbits. Fluorescein crosses the placental barrier.
After the intravenous application of 500 mg/kg intense fluorescence was detectable both in the fetus and the
amniotic fluid.
Studies on mutagenicity did not show any mutagenic effects of fluorescein sodium.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Sodium hydroxide (for pH-adjustment)
Hydrochloric acid (for pH-adjustment)
Water for injections

6.2

Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal
products.
To avoid physical incompatibilities, this product must not be administered simultaneously with other solutions
for injection with acid pH (especially antihistamines) by the same intravenous route (see section 4.2 for
information about cannulas).
Once opened the vial must be immediately used.

6.3

Shelf life
2 years

6.4

Special precautions for storage
Do not store above 25°C.
Do not freeze.
Keep the vial in the outer carton in order to protect from light.

6.5

Nature and contents of container
Glass (type I) vial with grey chlorobutyl coated rubber stopper and aluminum seal with polypropylene flip-off
cap.
Pack containing 12 vials of 5 ml injection solution

6.6

Special precautions for disposal and other handling
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. For single use only. Any unused
product or waste material should be disposed of in accordance with local requirements. Do not use
ANATERA® 100 mg/ml solution for injection if the vial is cracked or damaged in any way.

7

MARKETING AUTHORISATION HOLDER
Alcon Laboratories (UK) Ltd.
Frimley Business Park,
Frimley, Camberley,
Surrey, GU16 7SR
United Kingdom

8

MARKETING AUTHORISATION NUMBER
PL 00649/0377

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
25/04/2012

10

DATE OF REVISION OF THE TEXT
13 October 2014

© 2010, 2014 Novartis

A148143-1214

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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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