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ANEXATE 500MICROGRAMS/5ML SOLUTION FOR INJECTION OR INFUSION

Active substance: FLUMAZENIL

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AU-Nr.

662

Genisys-No.

10130649

GB

Printing Colour:

Pantone Black

Format:

148x594 mm (2 pages)

Folding Format:

148x297 mm

Type Size

11 Punkt

Drawing Norm

16.05.2011 NF4

FY

Patient Information Leaflet

Anexate® 500 micrograms/5 ml

Solution for Injection or Infusion
Flumazenil
Please read all of this leaflet
carefully before you start taking
this medicine.
 Keep this leaflet. You may need to read
it again.
 If you have any further questions,
ask your doctor or nurse.
 If any of the side effects become
serious or troublesome, or if you notice
any side effects not listed in this
leaflet, please tell your doctor or nurse.

You must not be given Anexate if any
of the above apply to you. If you are not
sure, talk to your doctor or nurse before
having Anexate.

Take special care with Anexate

Check with your doctor or nurse before
having Anexate if:
 You have a head injury.
 You have epilepsy and are being
treated with a ‘benzodiazepine’
medicine.
 You are very nervous about having
your operation or medical test.
 You have a history of anxiety.
 You have heart or liver problems.
If any of the above apply to you,
or if you are not sure, talk to your doctor
or nurse before you have Anexate.

In this leaflet:

1. What Anexate is and what
it is used for
2. Before you are given Anexate
3. How Anexate will be given
4. Possible side effects
5. How Anexate is stored
6. Further information

Taking other medicines

Please tell your doctor or nurse
if you are taking or have recently taken
any other medicines. This includes
medicines that you buy without
a prescription and herbal medicines.
This is because Anexate can affect
the way some other medicines work.
Also some other medicines can affect
the way Anexate works.

1. What Anexate is and what
it is used for
Anexate contains a medicine called
flumazenil. It is used to wake you up
after you have been made sleepy by
a medicine called a ‘benzodiazepine’.
Anexate reverses the effects of the
‘benzodiazepine’ medicine. It is used to:
 Wake you up after an operation
or medical test.
 Help you to breathe for yourself
and wake up if you have been on a
ventilator in intensive care.

In particular, tell your doctor or nurse
if you are taking any of the following
medicines:
 ‘Benzodiazepine’ medicines, even
if you have not taken them in the last
few weeks. These include diazepam,
midazolam and temazepam.
 Zopiclone (used to help you sleep).
 Medicines that change your mood or
behaviour. These include medicines
called tranquillizers, anti-depressants
and sedatives.

Anexate is also used in children (more than
1 year old) to wake them up after they have
been given a ‘benzodiazepine’ medicine to
make them sleepy during a medical
procedure.

Pregnancy and breast-feeding

2. Before you are given Anexate

Talk to your doctor or nurse before having
Anexate if you are pregnant, might
become pregnant or are breast-feeding.

You must not be given Anexate if you
are allergic (hypersensitive) to:

 Flumazenil or any of the other
ingredients of Anexate (listed
in Section 6: Further information).
 ‘Benzodiazepine’ medicines.
These include diazepam, midazolam
and temazepam.
You must not be given Anexate if any
of the above apply to you. If you are not
sure, talk to your doctor or nurse before
having Anexate.

Driving and using machines

 Do not drive or use any tools or
machines for at least 24 hours after
having Anexate.
 Do not do anything that is physically
or mentally demanding for at least
24 hours after having Anexate.
This is because the effects of the
‘benzodiazepine’ medicine may return
and you may start to feel
sleepy again.

You must not be
given Anexate if:

Important
information about
some of the
ingredients of Anexate

 You are already taking
a ‘benzodiazepine’
medicine to treat a very serious illness
(such as raised intra-cranial pressure or
status epilepticus).
 You have taken a ‘benzodiazepine’
medicine and certain anti-depressant
medicines at the same time and this
has made you ill. These
anti-depressant medicines (known
as tricyclic or tetracyclic
anti-depressants) include medicines
such as amitriptyline, imipramine
and dothiepin hydrochloride.

This medicine contains 3.7 mg sodium per
ml (18.5 mg per 5 ml
vial). Dosages over
600 micrograms
contain more than
1 mmol sodium (23 mg). To be taken
into consideration by patients on
a controlled sodium diet.

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This information is intended for medical or healthcare professionals only:
INFORMATION FOR HEALTHCARE PROFESSIONALS

Anexate® 500 micrograms/5 ml
Solution for Injection or Infusion
Flumazenil

Please refer to the Summary of Product Characteristics for full prescribing
information.

Presentation

If necessary, this may be repeated at
60 second intervals up to a total dose of
2 mg. If drowsiness recurs, a second
bolus injection of flumazenil may be
administered. An intravenous infusion of
100–400 micrograms per hour has also
been shown to be useful. The dosage and
rate of infusion should be individually
adjusted to achieve the desired level of
sedation.

Clear glass 5 ml ampoules. Excipients
are disodium edetate, glacial acetic acid,
sodium chloride, sodium hydroxide and
water for injections. The solution
is clear and almost colourless.
Cartons of 5 or 25 ampoules.

Posology and method
of administration

Flumazenil must be administered
intravenously by an anaesthetist or a
doctor with experience in anaesthesiology.
flumazenil may be administered either
undiluted or diluted.

Children above 1 year of age

For the reversal of conscious sedation
induced with benzodiazepines in children
> 1 year of age, the recommended
initial dose is 10 micrograms/kg (up to
200 micrograms) administered
intravenously over 15 seconds. If the
desired level of consciousness is not
obtained after waiting an additional
45 seconds, further injection of
10 micrograms/kg may be administered
(up to 200 micrograms) and repeated at
60 second intervals where necessary (a
maximum of 4 times) to a maximum total
dose of 50 micrograms/kg or 1 mg,
whichever is lower. The dose should be
individualised based on the patient’s
response. No data are available on the
safety and efficacy of repeated
administration of flumazenil to children
for re-sedation.

It can be administered together with other
reanimation measures.

Anaesthesiology

The initial dose is 200 micrograms
administered intravenously in 15 seconds.
If the desired degree of consciousness is
not obtained within 60 seconds, a second
dose of 100 micrograms can be
administered . This may be repeated at
60-second intervals where necessary, up to
a maximum total dose of 1 mg. The usual
dose is 300–600 micrograms.

Intensive care

The recommended initial dose of
flumazenil is 300 micrograms
intravenously. If the desired level of
consciousness is not obtained within
60 seconds, a repeat dose of
100 micrograms may be administered.
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.

 Withdrawal symptoms, for example:
- Feeling agitated, anxious, confused,
dizzy, sweaty,
- Having mood swings, distorted
senses, an increased heart rate.
Withdrawal symptoms usually happen
if you are given high doses of Anexate
quickly and/or when you have recently
taken ‘benzodiazepine’ medicines (for
example to help you sleep or to treat
anxiety). This may happen even if you
stopped taking these medicines a few
days or weeks before having Anexate.

3. How Anexate will be given
Anexate will be given to you by a doctor.
It will be given to you as a slow injection
into one of your veins.
The dose of Anexate varies from
one patient to another. It depends
on your age, weight, how well your
liver and kidneys are working
and what you need the medicine for.
The doctor will work out how much
to give you.
If you have any further questions
on the use of this medicine, ask your
doctor or nurse.

The side effects seen in children are
similar to those seen in adults. If Anexate
has been used to wake up children after a
medical test it may cause them to cry
abnormally, feel agitated or be aggressive.

4. Possible side effects
Like all medicines Anexate can cause
side effects, although not everyone gets
them.

If any of the side effects become serious or
troublesome, or if you notice any side
effects not listed in this leaflet, please tell
your doctor or nurse.

Common (affect less than 1 in
10 people):

5. How Anexate is stored

 Feeling sick or being sick especially if
you have also had any opiate drugs (eg
morphine)

 Being aware of your heart rate
(palpitations)
 Feeling anxious or frightened
 These effects are most likely to happen
if you have woken up too quickly.

 Your doctor or pharmacist is
responsible for storing Anexate.
They are also responsible for disposing
of any unused Anexate correctly.
 Keep out of the reach and sight
of children.
 Do not use after the expiry date which
is stated on the pack.
 Anexate does not need any special
storage conditions.

Rare (affect less than 1 in
1,000 people):

6. Further information

Unknown (frequency of people
affected unknown):

The active substance in Anexate
500 micrograms/5 ml solution for
injection or infusion is flumazenil. Each
millilitre (ml) of liquid medicine contains
100 micrograms of flumazenil. Each
ampoule (small glass bottle) contains
500 micrograms of flumazenil
(in 5 ml of liquid).

Uncommon (affect less than 1 in
100 people):

 Sudden swelling of the throat, face, lips
or mouth (anaphylaxis). This can make
it difficult to breathe or swallow.
 Sudden swelling of the hands, feet or
ankles (hypersensitivity)
 Skin rash or itching (hypersensitivity)

What Anexate contains

 Panic attacks (in people who have had
panic attacks in the past)
 Abnormal crying
 Feeling agitated
 Being aggressive
 Convulsions (seizures). These are more
likely in people who already have
epilepsy or severe liver problems or in
people who have taken ‘benzodiazepine’
medicines for a long time. Convulsions
are also more likely in people given
Anexate after an overdose of more than
one medicine, including at least one
‘benzodiazepine’, especially if taken
with certain anti-depressants.
 Increased blood
pressure on waking up
(short lived)
 Increased heart rate on
waking up (short
lived)
 Feeling cold (most
likely to happen if you have woken up
too quickly)
 Redness of the face and neck (flushing).

The other ingredients are disodium
edetate, glacial acetic acid, sodium
chloride, sodium hydroxide and water
for injections.

What Anexate looks like
and contents of the pack

Anexate is a clear almost colourless
liquid (‘solution for injection or infusion’).
This liquid may be further diluted to
make it weaker before it is given to you.
Anexate is supplied in clear glass
ampoules in packs of 5 or 25. Not all
packs may be marketed.

Marketing
Authorisation Holder
and Manufacturer
Roche Products Limited
6 Falcon Way
Shire Park
Welwyn Garden City, AL7 1TW
United Kingdom

This leaflet was last approved in
November 2010
>

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Elderly

No preparations other than those
recommended should be added to the
Anexate ampoule or mixed with the
Anexate infusion solution.

No specific data are available on the use of
Anexate in the elderly, but it should be
remembered that this population is more
sensitive to the effects of benzodiazepines
and should be treated with due caution.

For single use only. Discard any unused
contents.

Use in renal and hepatic
insufficiency:

Shelf life

Unopened: 5 years.
The product should be used immediately
after opening.

No dosage adjustments are necessary in
patients with renal impairment. However,
since flumazenil is primarily metabolised
in the liver, careful titration of dosage is
recommended in patients with impaired
hepatic function.

Special precautions for storage

This medicinal product does not require
any special storage conditions.

The individually titrated, slow injections
or infusions of Anexate should not produce
withdrawal symptoms, even in patients
exposed to high doses of benzodiazepines
and/or for long periods of time. If,
however, unexpected signs of
overstimulation occur, an individually
titrated dose of diazepam (Valium) or
midazolam (Hypnovel) should be given by
slow intravenous injection.

This healthcare professional leaflet
was last approved in November 2010

If a significant improvement in
consciousness or respiratory function is
not obtained after repeated doses of
Anexate, a non-benzodiazepine aetiology
must be assumed.

Instructions for use

Anexate ampoule solution may be
diluted with Sodium Chloride Intravenous
Infusion BP or Dextrose 5% Intravenous
Infusion BP. Chemical and physical
stability has been demonstrated for
24 hours at room temperature.
Anexate infusion should be administered
within 3 hours of preparation.

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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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