ALFENTANIL 5 MG/ML SOLUTION FOR INJECTION

Active substance: ALFENTANIL HYDROCHLORIDE

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PIL FRONT

Page 1

PACKAGE
LEAFLET



Patient
Information
Leaflet



ALFENTANIL
5mg/ml,


Solution
for
Injection



Please
read
all
of
this
leaflet
carefully
before
taking
your
medicine.


• Keep
this
leaflet.
You
may
need
to
read
it
again.


• If
you
have
any
further
questions,
ask
your
doctor
or
pharmacist.

• This
medicine
has
been
prescribed
for
you.
Do
not
pass
it
on
to
others.
It
may
harm
them,
even
if
their
symptoms
are
the
same
as

yours.


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

pharmacist.




In
this
leaflet:


1.
What
is
ALFENTANIL
and
what
is
it
used
for?


2.
Before
you
are
given
ALFENTANIL

3.
How
you
will
be
given
ALFENTANIL

4.
Possible
side
effects


5.
Storing
ALFENTANIL

6.
Further
information






1.
What
is
ALFENTANIL
and
what
is
it
used
for?


What
is
ALFENTANIL?

ALFENTANIL
5
mg/ml,
Solution
for
Injection
is
a
potent
and
short­acting
painkiller.
It
belongs
to
a
group
of
medicines
known
as
opioid

analgesics
which
relieve
or
prevent
pain.


What
is
ALFENTANIL
used
for?

ALFENTANIL
is
used
to
control
pain
and
breathing
when
using
an
artificial
breathing
machine
in
intensive
care.


ALFENTANIL
5
mg/ml,
Solution
for
Injection
will
be
diluted
and
given
as
an
infusion
(a
‘drip’)
into
a
vein.




2.
Before
you
are
given
ALFENTANIL



Always
inform
your
doctor
if
you
are
pregnant,
think
you
might
be
pregnant
or
are
trying
to
become
pregnant.


Always
tell
your
doctor
about
any
medicines
(either
prescribed
by
a
doctor
or
that
you
have
bought)
which
you
have
taken
recently
or
are

taking
now.


Do
not
use
ALFENTANIL:


if
you
are
taking,
or
have
recently
been
taking
(within
the
last
two
weeks),
any
of
the
antidepressant
medicines
known
as

monoamine
oxidase
inhibitors
(MAOIs),
including
moclobemide.


if
you
think
that
you
may
have
had
an
allergic
or
any
other
type
of
reaction
to
ALFENTANIL
or
a
similar
medicine
in
the
past.
An

allergic
reaction
may
be
recognized
as
a
rash,
itching,
swollen
face
or
lips,
or
shortness
of
breath.


if
you
are
pregnant
or
think
that
you
are
pregnant.


If
any
of
the
above
applies
to
you,
tell
the
doctor.


Warnings

Medicines
like
ALFENTANIL
5
mg/ml,
Solution
for
Injection
may
cause
a
drop
in
blood
pressure
and
breathing
rate.
These
effects
are
usually

short‐lived.
It
may
also
cause
the
heart
to
beat
more
slowly.


Particular
care
has
to
be
taken
following
treatment
with
other
medicines
which
have
similar
effects.
Blood
pressure
and
heart
rate
are

therefore
monitored
during
administration
of
ALFENTANIL
and
any
unwanted
effects
of
this
nature
can
be
reversed
with
other
medicines.

Rarely,
the
rhythm
of
the
heart
may
be
altered
and
this
will
be
treated
if
it
occurs.


The
doctor
who
will
be
giving
ALFENTANIL
5
mg/ml,
Solution
for
Injection
will
be
aware
of
the
possibility
of
all
these
unwanted
effects
and

will
take
steps
to
avoid
them.



P0037-09-001/1 Alfentanil Intensive Care 5mg/ml : Section – PIL & SPC 07.12.09

PIL FRONT

Page 2

Special
Precautions

Your
doctor
will
take
special
precautions
when
giving
you
ALFENTANIL
if
any
of
the
points
listed
below
applies
to
you:



The
dose
of
ALFENTANIL
5
mg/ml,
Solution
for
Injection
is
normally
reduced
in
elderly
patients,
and
those
with
some
thyroid

problems
or
liver
disease.


Your
dose
will
be
carefully
monitored
if
you
have
a
history
of
lung
disease,
alcoholism,
kidney
problems
or
if
you
have
been
on

long
term
opioid
therapy.



ALFENTANIL
can
make
the
muscles
stiff.
Your
doctor
will
take
measures
to
avoid
this
happening.



As
with
all
strong
opioid
painkillers,
good
pain
relief
is
accompanied
by
a
lowering
of
the
breathing
rate.
This
may
last
into
the

recovery
period
or
occur
again
during
this
time.
This
effect
may
be
increased
if
you
have
recently
used
similar
medicines
for
pain

relief.
Your
breathing
will
therefore
be
carefully
monitored
until
it
returns
to
normal.


Taking
other
medicines

Always
tell
your
doctor
if
you
are
taking
any
other
medicines
because
taking
some
medicines
together
can
be
harmful.
Remember
that
the

doctor
at
the
hospital
may
not
have
been
informed
if
you
have
recently
begun
a
course
of
treatment
for
another
illness.


Some
medicines
may
affect
the
length
of
time
it
takes
for
the
effects
of
ALFENTANIL
to
wear
off:


cimetidine,
a
medicine
for
ulcers,
stomach‐ache
and
heartburn


erythromycin,
an
antibiotic


diltiazem,
a
medicine
used
for
a
certain
type
of
heart
disorder.


Some
medicines
will
have
some
of
the
same
effects
as
ALFENTANIL.
When
one
or
more
of
these
medicines
is
used
at
the
same
time
as

ALFENTANIL,
the
effects
of
either
may
be
increased.


beta‐blockers
(used
to
treat
high
blood
pressure
and
disorders
of
heart
rhythm)


anaesthetic
agents


drugs
which
depress
the
central
nervous
system
(such
as
tranquillisers
and
sleeping
pills)


benzodiazepines
e.g.
clobazam,
clonazepam
(used
to
treat
epilepsy)


barbiturates
e.g.
phenobarbitone


other
strong
opioid
painkillers.


It
may
also
be
necessary
to
adjust
the
dose
of
ALFENTANIL
5
mg/ml,
Solution
for
Injection
if
you
are
taking
the
following:


certain
medicines
for
fungal
infections,
e.g.
fluconazole,
ketoconazole
and
itraconazole;


certain
medicines
called
antiviral
protease
inhibitors,
e.g.
ritonavir.


If
you
are
not
sure
if
any
of
the
above
apply
to
you,
talk
to
your
doctor
or
pharmacist
before
taking
this
medicine.


Pregnancy
and
breast
feeding

If
you
are
pregnant,
or
think
you
may
be,
you
should
inform
your
doctor.
He/she
will
decide
whether
or
not
you
should
be
given

ALFENTANIL.


ALFENTANIL
may
get
into
breast
milk.
It
is
therefore
recommended
that
you
should
not
breast
feed
for
24
hours
after
treatment.


Driving
and
using
machines

You
should
not
drive
or
operate
machinery
for
24
hours
after
being
given
ALFENTANIL
as
you
may
be
less
alert
than
usual.





3.
How
you
will
be
given
ALFENTANIL



Your
doctor
will
decide
how
much
ALFENTANIL
5
mg/ml,
Solution
for
Injection
you
need.
This
will
depend,
for
example,
on
the
type
of

surgery,
your
body
weight,
age
and
general
health.


ALFENTANIL
5
mg/ml,
Solution
for
Injection
should
be
mixed
with
sodium
chloride
injection,
dextrose
injection
or
compound
sodium
lactate

injection
(Hartmann’s
solution).
These
dilutions
should
be
used
within
24
hours
of
preparation.


The
usual
recommended
dosage
is
as
follows:


Adults:

Your
initial
dose
will
be
2
mg
per
hour.

Sometimes
a
higher
initial
dose
(for
example
5
mg)
is
given
over
a
period
of
10
minutes
to
achieve

more
rapid
control.


Adolescents
and
young
adults
will
be
given
higher
than
the
average
adult
dose.


Elderly:

The
above
amounts
of
ALFENTANIL
5
mg/ml,
Solution
for
Injection
will
be
reduced.


Patients
with
liver
problems
and
hypothyroidism
(underactive
thyroid)
will
also
need
their
dose
of
ALFENTANIL
to
be
reduced
from
the

normal
adult
dosage.




P0037-09-001/1 Alfentanil Intensive Care 5mg/ml : Section – PIL & SPC 07.12.09

PIL BACK

Page 1

Children:
ALFENTANIL 5 mg/ml, Solution for Injection is not usually used to treat children in intensive care.
The usual maximum treatment time with ALFENTANIL infusions is 4 days.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, using Alfentanil can cause side-effects, although not everybody gets them.

To give you an idea of how many patients might get side effects, they have been listed as very common, common, uncommon, rare and very
rare. These mean the following:
Very common
Common
Uncommon
Rare
Very rare

More than 1 in 10 people.
up to 1 in 10 people.
up to 1 in 100 people.
up to 1 in 1,000 people.
fewer than 1 in 10,000 people.

These are the side effects we know about for ALFENTANIL 5 mg/ml, Solution for Injection:




Very common: Feeling or being sick.

Common: Low blood pressure (hypotension); high blood pressure (hypertension), muscle stiffness, twitching, dizziness, slow or
fast heart beat, feeling sleepy, stopping breathing temporarily, lowered breathing rate.

Uncommon: Pain at the site of the injection, shivering, allergic reaction (such as dif�iculty in breathing, skin rash or itching, or
swollen face), headache, irregular heart beat, feeling disorientated, agitation, feeling ‘high’ (euphoria), cough, continued lowered
breathing rate, tightness of the throat, hiccup, itching of the skin, sweating, blurred or ‘double’ vision.

If you think your medicine has affected you in any other way, you should tell the doctor.
See also Section 2, Before you are given ALFENTANIL 5 mg/ml, Solution for Injection, above.

5. Storing ALFENTANIL

Keep out of the reach and sight of children.

You must not be given ALFENTANIL 5 mg/ml, Solution for Injection after the expiry date (month and year) printed after “EXP” on the carton.
The expiry date refers to the last day of that month.
Dilutions made with ALFENTANIL 5 mg/ml, Solution for Injection must be used within 24 hours of preparation.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

6. Further Information

What ALFENTANIL contains:
The name of your medicine is ALFENTANIL 5 mg/ml, Solution for Injection and its active ingredient is ALFENTANIL. Each millilitre contains
5 milligrams of ALFENTANIL (as the hydrochloride).
The solution for injection also contains sodium chloride, water for injections, sodium hydroxide and hydrochloric acid.
This medicinal product contains less than 1 mmol sodium (23 mg) per 5 mg dose, i.e. essentially 'sodium-free'.

What ALFENTANIL looks like and contents of the pack:
It is a solution for injection which comes in 1 millilitre (ml) clear glass ampoules. It is a clear colourless solution.
ALFENTANIL 5 mg/ml, Solution for Injection is supplied in packs of 10 x 1 ml ampoules.
Marketing authorisation holder:
Auden Mckenzie (Pharma Division) Ltd.
Mckenzie House
Bury Street
Ruislip
Middlesex
HA4 7TL
UK

P0037-09-001/1 Alfentanil Intensive Care 5mg/ml : Section – PIL & SPC 07.12.09

PIL BACK

Page 2

Manufacturer:
SNS Pharmaceuticals Ltd
30 Stadium Business Centre
North End Road
Middlesex
HA9 0HT
UK

This lea�let was last approved in February 2010.

For information in large print, on tape, on CD or in Braille, phone 01895 627 420.
ALFENTANIL Intensive Care 5mg/ml, Solution for Injection
PL 17507/0037

Auden Mckenzie

P0037-09-001/1 Alfentanil Intensive Care 5mg/ml : Section – PIL & SPC 07.12.09

SPC FRONT

Page 3

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(Please
detach
prior
to
giving
the
leaflet
to
the
patient)






Information
for
the
Healthcare
Professional



ALFENTANIL
5mg/ml,

Solution
for
Injection






1.

NAME
OF
THE
MEDICINAL
PRODUCT


Alfentanil
5
mg/ml,
Solution
for
Injection





2.

QUALITATIVE
AND
QUANTITATIVE
COMPOSITION


Each
ml
of
Alfentanil
solution
for
injection
contains
5
mg
alfentanil
(as
hydrochloride)
per
ml.




For
a
full
list
of
excipients,
see
section
6.1.





3.

PHARMACEUTICAL
FORM


Solution
for
injection.




A
clear
colourless
solution.





4.

CLINICAL
PARTICULARS



4.1
Therapeutic
indications



Alfentanil
is
a
potent
opioid
analgesic
with
a
very
rapid
onset
of
action.

It
is
indicated
for
analgesia
and
suppression
of
respiratory
activity
in

mechanically
ventilated
patients
on
intensive
care
and
to
provide
analgesic
cover
for
painful
manoeuvres.

It
will
aid
compliance
with

mechanical
ventilation,
and
tolerance
of
the
endotracheal
tube.

Intravenous
bolus
doses
of
Alfentanil
5
mg/ml
(0.5
mg/ml)
may
be
used
to

provide
additional
pain
relief
during
brief
painful
procedures
such
as
physiotherapy,
endotracheal
suction,
etc.

Despite
being
mechanically

ventilated,
patients
may
be
awake
in
the
presence
of
adequate
analgesia.




At
the
proposed
doses,
Alfentanil
has
no
sedative
activity.

Therefore
supplementation
with
an
appropriate
hypnotic
or
sedative
agent
is

recommended.

Admixture
is
not
advisable
due
to
the
need
to
individually
titrate
both
agents.




Alfentanil
given
by
infusion
should
only
be
given
in
areas
where
facilities
are
available
to
deal
with
respiratory
depression
and
where

continuous
monitoring
is
performed.

Alfentanil
should
only
be
prescribed
by
physicians
familiar
with
the
use
of
potent
opioids
when
given

by
continuous
IV
infusion.






4.2
Posology
and
method
of
administration




For
intravenous
infusions.




Dosage


Alfentanil
5
mg/ml
should
be
diluted
with
sodium
chloride
intravenous
infusion
BP,
glucose
intravenous
infusion
BP,
or
compound
sodium

lactate
intravenous
infusion
BP
(Hartmann's
solution).

Such
dilutions
are
compatible
with
plastic
bags
and
giving
sets.

These
dilutions

should
be
used
within
24
hours
of
preparation.




Once
the
patient
has
been
intubated,
mechanical
ventilation
can
be
initiated
using
the
following
dosage
regimen:



The
recommended
initial
infusion
rate
for
mechanically
ventilated
adult
patients
is
2
mg
per
hour
(equivalent
to
0.4
ml
per
hour
of
undiluted

Alfentanil
5
mg/ml).

For
a
70
kg
patient,
this
corresponds
to
approximately
30
micrograms
per
kilogram
per
hour.




More
rapid
control
may
initially
be
gained
by
using
a
loading
dose.

For
example,
a
dose
of
5
mg
may
be
given
in
divided
doses
over
a
period

of
10
minutes,
during
which
time
careful
monitoring
of
blood
pressure
and
heart
rate
should
be
performed.

If
hypotension
or
bradycardia

occurs,
the
rate
of
administration
should
be
reduced
accordingly
and
other
appropriate
measures
instituted.





P0037-09-001/1 Alfentanil Intensive Care 5mg/ml : Section – PIL & SPC 07.12.09

SPC FRONT

Page 4

The
dose
to
produce
the
desired
effects
should
then
be
individually
determined
and
reassessed
regularly
to
ensure
that
the
optimum
dose
is

being
used.




In
clinical
trials,
patient
requirements
have
generally
been
met
with
doses
of
0.5
to
10
mg
alfentanil
per
hour.




Additional
bolus
doses
of
0.5‐1.0
mg
alfentanil
may
be
given
to
provide
analgesia
during
short
painful
procedures.




The
elderly
and
those
patients
with
liver
impairment
and
hypothyroidism
will
require
lower
doses.

Obese
patients
may
require
a
dose
based

on
their
lean
body
mass.




Adolescents
and
young
adults
will
require
higher
than
average
doses.

There
is
little
experience
of
use
of
alfentanil
to
treat
children
in

intensive
care.




The
maximum
recommended
duration
of
treatment
with
alfentanil
infusions
is
4
days.




Present
data
suggest
that
clearance
of
alfentanil
is
unaltered
in
renal
failure.

However
there
is
an
increased
free
fraction
and
hence
dosage

requirements
may
be
less
than
in
the
patient
with
normal
renal
function.






4.3
Contraindications




Known
intolerance
of
alfentanil
or
other
morphinomimetics.
Pregnancy,
and
concurrent
administration
with
monoamine
oxidase
inhibitors.




4.4
Special
warnings
and
special
precautions
for
use




Warnings:


Following
administration
of
Alfentanil,
a
fall
in
blood
pressure
may
occur.
The
magnitude
of
this
effect
may
be
exaggerated
in
the

hypovolaemic
patient
or
in
the
presence
of
concomitant
sedative
medication.
Appropriate
measures
to
maintain
a
stable
arterial
pressure

should
be
taken.



Like
other
opioids,
alfentanil
may
cause
bradycardia,
an
effect
which
may
be
marked
and
rapid
in
onset
but
which
can
be
antagonised
by

atropine.



Particular
care
must
be
taken
following
treatment
with
drugs
which
may
depress
the
heart
or
increase
vagal
tone,
such
as
anaesthetic
agents

or
beta‐blockers
since
they
may
predispose
to
bradycardia
or
hypotension.
Heart
rate
and
blood
pressure
should
therefore
be
monitored

carefully.
If
hypotension
or
bradycardia
occurs,
the
rate
of
administration
of
alfentanil
should
be
reduced
and
other
appropriate
measures

instituted.
Asystole
following
bradycardia
has
been
reported
on
very
rare
occasions
in
non‐atropinised
patients.
Therefore
it
is
advisable
to

be
prepared
to
administer
an
anticholinergic
drug.



Care
must
be
taken
if
the
patient
has
received
monoamine
oxidase
inhibitors
within
the
previous
2
weeks.



Significant
respiratory
depression
and
loss
of
consciousness
will
occur
following
administration
of
alfentanil
in
doses
in
excess
of
1
mg
and
is

dose‐related.
If
necessary
for
assessment
purposes,
naloxone
or
other
specific
antagonists
may
be
administered
to
reverse
the
opioid

respiratory
depression
and
other
pharmacological
effects
of
alfentanil.
More
than
one
dose
of
naloxone
may
be
required
in
view
of
its
short

half
life.



Muscle
rigidity
(morphine‐like
effect)
may
occur,
in
which
case
neuromuscular
blocking
drugs
may
be
helpful.



Precautions:


It
is
wise
to
reduce
the
dosage
in
the
elderly
and
debilitated
patient.
In
hypothyroidism,
pulmonary
disease,
decreased
respiratory
reserve,

alcoholism
and
liver
or
renal
impairment
the
dosage
should
be
titrated
with
care
and
prolonged
monitoring
may
be
required.



Patients
on
chronic
opioid
therapy
or
with
a
history
of
opioid
abuse
may
require
higher
doses.



Non‐epileptic
(myo)clonic
movements
can
occur.



As
with
all
potent
opioids,
profound
analgesia
is
accompanied
by
marked
respiratory
depression,
which
may
persist
into
or
recur
in
the
early

post
infusion
period.
Care
should
therefore
be
taken
throughout
the
weaning
period
and
adequate
spontaneous
respiration
should
be

established
and
maintained
in
the
absence
of
stimulation
or
ventilatory
support.
Following
cessation
of
the
infusion,
the
patient
should
be

closely
observed
for
at
least
6
hours.
Prior
use
of
opioid
medication
may
enhance
or
prolong
the
respiratory
depressant
effects
of
alfentanil.



The
use
of
rapid
bolus
injections
of
opioids
should
be
avoided
in
patients
with
compromised
intracerebral
compliance;
in
such
patients
a

transient
decrease
in
the
mean
arterial
pressure
has
occasionally
been
accompanied
by
a
transient
reduction
of
the
cerebral
perfusion

pressure.



This
medicinal
product
contains
less
than
1
mmol
sodium
(23
mg)
per
5
mg
dose,
i.e.
essentially
'sodium‐free'.





P0037-09-001/1 Alfentanil Intensive Care 5mg/ml : Section – PIL & SPC 07.12.09

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Page 5

4.5
Interaction
with
other
medicinal
products
and
other
forms
of
Interaction



Alfentanil
is
metabolised
mainly
via
the
human
cytochrome
P450
3A4
enzyme.
Available
human
pharmacokinetic
data
indicate
that
the

metabolism
of
alfentanil
may
be
inhibited
by
fluconazole,
erythromycin,
diltiazem
and
cimetidine
(known
cytochrome
P450
3A4
enzyme

inhibitors).
In
vitro
data
suggest
that
other
potent
cytochrome
P450
3A4
enzyme
inhibitors
(e.g.
ketoconazole,
itraconazole,
ritonavir)
may

also
inhibit
the
metabolism
of
alfentanil.
This
could
increase
the
risk
of
prolonged
or
delayed
respiratory
depression.
The
concomitant
use
of

such
drugs
requires
special
patient
care
and
observation;
in
particular,
it
may
be
necessary
to
lower
the
dose
of
Alfentanil.



Treatment
with
drugs
which
may
depress
the
heart
or
increase
vagal
tone,
such
as
beta‐blockers
and
anaesthetic
agents,
may
predispose
to

bradycardia
or
hypotension.
Bradycardia
and
possibly
asystole
can
occur
when
Alfentanil
5
mg/ml
is
combined
with
non‐vagolytic
muscle

relaxants.



Prior
use
of
opioid
premedication,
barbiturates,
benzodiazepines,
neuroleptics,
halogenic
gases
and
other
non‐selective
CNS
depressants

may
enhance
or
prolong
the
respiratory
depressant
effects
of
alfentanil.



If
other
narcotic
or
CNS
depressant
drugs
are
used
concurrently
with
alfentanil,
the
effects
of
the
drugs
can
be
expected
to
be
additive.
When

patients
have
received
such
drugs,
the
dose
of
alfentanil
required
will
be
less
than
usual.
Likewise,
following
the
administration
of
alfentanil,

the
dose
of
other
CNS‐depressant
drugs
should
be
reduced.




4.6
Pregnancy
and
lactation




Animal
studies
are
insufficient
with
respect
to
effects
on
pregnancy.

Although
no
teratogenic
or
acute
embryotoxic
effects
have
been

observed
in
animal
experiments,
the
potential
risk
for
humans
is
unknown.




Alfentanil
should
not
be
used
in
pregnancy
unless
clearly
necessary.

I.V.

administration
during
childbirth
(including
Caesarean
section)
is

not
recommended,
because
alfentanil
crosses
the
placenta
and
because
the
foetal
respiratory
centre
is
particularly
sensitive
to
opiates.

If,

however,
alfentanil
is
administered,
an
antidote
should
always
be
at
hand
for
the
child.




Alfentanil
may
appear
in
breast
milk.

It
is
therefore
recommended
that
breast
feeding
is
not
initiated
within
24
hours
of
treatment.






4.7
Effects
on
ability
to
drive
and
use
machines




Where
early
discharge
is
envisaged,
patients
should
be
advised
not
to
drive
or
operate
machinery
for
the
24
hours
following
administration.






4.8
Undesirable
effects



The
most
frequently
reported
ADRs
(incidence
 10%)
are:
nausea
and
vomiting.
Undesirable
effects
listed
below
in
Table
1
have
been

reported
in
a
clinical
trial
and/or
from
spontaneous
reports
from
post‐marketing
experience.
The
following
terms
and
frequencies
are

applied:
very
common
( 
1/10),
common
( 
1/100
to
<
1/10),
uncommon
( 
1/1000
to
<
1/100),
rare
( 
1/10,000
to
<
1/1000),
very

rare
(<
1/10,000),
and
not
known
(frequency
cannot
be
estimated
from
the
available
data).
Adverse
drug
reactions
from
spontaneous

reports
during
worldwide
postmarketing
experience
with
Alfentanil
that
met
threshold
criteria
are
included.
Unlike
for
clinical
trials,
precise

frequencies
cannot
be
provided
for
spontaneous
reports.
The
frequency
for
these
reports
is
therefore
classified
as
'not
known'.




























P0037-09-001/1 Alfentanil Intensive Care 5mg/ml : Section – PIL & SPC 07.12.09

SPC BACK

Page 3

Table
1
Adverse
drug
reactions
reported
in
clinical
trials
and/or
postmarketing

Body
System/Organ
Class

Frequency
Category


Clinical
trials


Spontaneous
Reportsa


Immune
system
disorders
















Uncommon


Allergic
reactions
(such
as
anaphylaxis,
bronchospasm,

urticaria)









Psychiatric
Disorders
















Common


Somnolence









Uncommon


Disorientation,
Agitation,
Euphoria









Nervous
system
disorders
















Common


Muscle
rigidity
(may
also
involve
thoracic
muscles)

Myoclonic
movements,
Dizziness









Uncommon


Headache









Not
known









Loss
of
consciousness
(Postoperative
period),
Convulsion


Eye
disorders
















Uncommon


Blurred/double
vision









Not
known









Miosis


Cardiac
disorders
















Common


Bradycardia,
Tachycardia









Uncommon


Arrhythmia









Not
known









Cardiac
arrest


Vascular
Disorders
















Common


Hypotension,
Hypertension









Respiratory,
thoracic,
and
mediastinal
disorders
















Common


Apnoea,
Respiratory
depression









Uncommon


Cough,
Recurrence
of
respiratory
depression,

Laryngospasm,
Hiccup









Not
known









Respiratory
arrest
(including
fatal
outcome)


Gastrointestinal
disorders
















Very
common


Nausea,
Vomiting









Skin
and
subcutaneous
tissue
disorders
















Uncommon


Pruritis,
Sweating









General
disorders
and
administration
site

conditions
















Uncommon


Injection
site
pain,
Shivering









Not
known









Pyrexia


a:
Listed
are
only
those
adverse
drug
reactions
that
were
not
identified
in
clinical
trials



P0037-09-001/1 Alfentanil Intensive Care 5mg/ml : Section – PIL & SPC 07.12.09

SPC BACK

Page 4



4.9
Overdose



The
manifestations
of
alfentanil
overdose
are
generally
an
extension
of
its
pharmacological
action,
which
include
the
following:‐






Action:


Bradycardia:

Anticholinergics
such
as
atropine
or
glycopyrrolate;



Hypoventilation
or
apnoea:

O2
administration,
assisted
or
controlled
respiration
and
an
opioid
antagonist
may
be

required;



Muscle
rigidity:

Intravenous
neuromuscular
blocking
agent
may
be
given.




If
hypotension
is
severe
or
persists,
the
possibility
of
hypovolaemia
should
be
considered
and
controlled
with
appropriate
parenteral
fluid

administration.


The
suggested
treatments
given
above
do
not
preclude
the
use
of
other
clinically
indicated
counter
measures.




Body
temperature
and
adequate
fluid
intake
should
be
maintained
and
the
patient
observed
for
24
hours.




A
specific
narcotic
antagonist
(eg
naloxone)
should
be
available
to
treat
respiratory
depression.






5.

PHARMACOLOGICAL
PROPERTIES



5.1
Pharmacodynamic
properties



In
man,
alfentanil
at
therapeutic
doses
has
no
detrimental
effects
on
myocardial
performance.
The
cardiovascular
stability
is
remarkable

both
in
healthy
and
poor‐risk
patients.
The
only
changes
seen
in
blood
pressure
and
heart
rate
were
transient,
slight
decreases
occurring

immediately
after
induction.
The
incidence
and
degree
of
respiratory
depression
is
less
and
of
shorter
duration
after
alfentanil
than
with

fentanyl.
Like
other
narcotic
analgesics,
alfentanil
increases
the
amplitude
of
the
EEG
and
reduces
its
frequency.
Alfentanil
reduces

intraocular
pressure
by
about
45%.
It
blocks
increases
in
plasma
cortisol
and
in
plasma
antidiuretic
and
growth
hormones
throughout

surgery,
and
prevents
increases
in
plasma
catecholamines
up
to,
but
not
during
or
after,
cardiopulmonary
bypass
in
patients
undergoing

open
heart
surgery.



5.2
Pharmacokinetic
properties




After
bolus
injections
ranging
from
2.4
to
125
µg/kg,
plasma
levels
in
man
decay
triexponentially
with
a
terminal
half
life
of
approx.

90

minutes.

Total
distribution
volume
varies
from
0.4
to
1.0
l/kg,
indicating
a
limited
distribution
of
alfentanil
to
the
tissues.

Plasma
clearance,

varying
from
3.3
to
8.3
ml/kg/min
represents
approximately
one
third
of
liver
plasma
flow
indicating
that
elimination
of
alfentanil
is
not

flow
dependent.

Since
only
0.4%
of
the
dose
is
excreted
with
the
urine
as
unchanged
drug,
elimination
of
alfentanil
occurs
mainly
by

metabolism.




These
main
parameters
in
patients
undergoing
surgery
are
similar
to
those
in
healthy
volunteers.

Only
when
the
drug
was
given
as
the
sole

anaesthetic
in
a
continuous
high
infusion
over
about
5
hours
was
the
clearance
of
alfentanil
reduced
resulting
in
a
plasma
half‐life
of
about

200
minutes,
the
distribution
volume
not
being
markedly
changed.




Plasma
protein
binding
of
alfentanil
is
92%,
mainly
due
to
a
strong
binding
to
the
'acute
phase'
α1‐acid‐glycoprotein.

It
is
not
bound
to
the

blood
cells.

Pharmacokinetics
were
comparable
in
rats,
dogs
and
man.

In
children,
alfentanil
has
been
shown
to
have
a
much
shorter
half‐life

than
adults,
whereas
the
elderly
show
a
longer
half‐life
for
alfentanil,
after
IV
bolus
doses.





5.3
Preclinical
safety
data



Preclinical
effects
observed
were
only
at
exposures
considered
sufficiently
in
excess
of
the
maximum
human
exposure
indicating
little

relevance
to
clinical
use.






6.

PHARMACEUTICAL
PARTICULARS



6.1
List
of
excipients



Sodium
chloride


Water
for
injections


Hydrochloric
acid*

Sodium
hydroxide*

*
for
occasional
pH
adjustment
only







P0037-09-001/1 Alfentanil Intensive Care 5mg/ml : Section – PIL & SPC 07.12.09

PIL BACK

Page 5

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3 Shelf life

24 months (unopened).
24 hours (dilutions).

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

Type I Ph Eur clear glass ampoules containing 1 ml.
10 ampoules per carton.

6.6 Special precautions for disposal and other handling

If desired, Alfentanil Solution for Injection can be mixed with sodium chloride injection BP, dextrose injection BP or compound sodium
lactate injection BP (Hartmann's solution). Such dilutions are compatible with plastic bags and giving sets. These dilutions should be used
within 24 hours of preparation.

7. MARKETING AUTHORISATION HOLDER
Auden McKenzie (Pharma Division) Ltd
Mckenzie House
Bury Street
Ruislip
Middlesex
HA4 7TL

8. MARKETING AUTHORISATION NUMBER(S)
PL 17507/0037

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10. DATE OF REVISION OF THE TEXT
Legal category POM

P0037-09-001/1 Alfentanil Intensive Care 5mg/ml : Section – PIL & SPC 07.12.09

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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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