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LEVETIRACETAM MILPHARM 100 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): LEVETIRACETAM

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Pharmacode position may change as per the supplier’s m/c requirement

9770

Package leaflet: Information for the user

Levetiracetam Milpharm 100 mg/ml
concentrate for solution for infusion
Levetiracetam

What is in this leaflet
1. What Levetiracetam
Milpharm is and what it
is used for
2. What you need to
know before you
take Levetiracetam
Milpharm
3. How to take
Levetiracetam
Milpharm
4. Possible side effects
5. How to store
Levetiracetam
Milpharm
6. Contents of the pack
and other information
1. What Levetiracetam
Milpharm is and what
it is used for
Levetiracetam is an
antiepileptic medicine
(a medicine used to treat
seizures in epilepsy).
Levetiracetam Milpharm
is used:
• on its own in adults
and adolescents from
16 years of age with
newly diagnosed
epilepsy, to treat
a certain form of
epilepsy. Epilepsy is
a condition where the
patients have repeated
fits (seizures).
Levetiracetam is
used for the epilepsy
form in which the fits
initially affect only
one side of the brain,
but could thereafter
extend to larger
areas on both sides
of the brain (partial
onset seizures with
or without secondary
generalisation).
Levetiracetam has
been given to you by
your doctor to reduce
the number of fits.
• as an add-on to other
antiepileptic medicines
to treat:
- partial onset
seizures with
or without
generalisation in in
adults, adolescents
and children from
4 years of age
- myoclonic seizures
(short, shocklike jerks of a
muscle or group of
muscles) in adults
and adolescents
from 12 years of
age with juvenile
myoclonic epilepsy.
- primary
generalised tonicclonic seizures
(major fits,
including loss of
consciousness)
in adults and
adolescents from
12 years of age
with idiopathic
generalised
epilepsy (the type
of epilepsy that is
thought to have a
genetic cause).
Levetiracetam Milpharm
concentrate for solution
for infusion is an
alternative for patients
when administration of
the antiepileptic oral
Levetiracetam Milpharm
medicine is temporarily
not feasible.
2. What you need to
know before you
take Levetiracetam
Milpharm
Do not use
Levetiracetam Milpharm:
- if you are allergic
to levetiracetam
pyrrolidone derivatives
or any of the other
ingredients of this
medicine (listed in
section 6).
Warnings and
precautions
Talk to your doctor
before you are given
Levetiracetam Milpharm.
• If you suffer from
kidney problems,
follow your doctor’s
instructions. He/
she may decide if
your dose should be
adjusted.
• If you notice any slow
down in the growth or

unexpected puberty
development of your
child, please contact
your doctor.
• A small number of
people being treated
with anti-epileptics
such as Levetiracetam
Milpharm have
had thoughts of
harming or killing
themselves. If you
have any symptoms
of depression and/
or suicidal ideation,
please contact your
doctor.
Children and
adolescents
Levetiracetam Milpharm
is not indicated in children
and adolescents below
16 years on its own
(monotherapy)
Other medicines and
Levetiracetam Milpharm
Tell your doctor or
pharmacist if you are
taking, have recently
taken or might take any
other medicines,
Do not take macrogol (a
drug used as laxative)
for one hour before and
one hour after taking
levetiracetam as this may
results in a reduction of its
effect.
Pregnancy and breastfeeding
If you are pregnant or
breastfeeding, think
you may be pregnant or
are planning to have a
baby, ask your doctor for
advice before taking this
medicine.
Levetiracetam Milpharm
should not be used during
pregnancy unless clearly
necessary. A risk of birth
defects for your unborn
child cannot be completely
excluded. Levetiracetam
Milpharm has shown
unwanted reproductive
effects in animal studies
at dose levels higher than
you would need to control
your seizures.
Breast-feeding is not
recommended during
treatment.
Driving and using
machines
Levetiracetam Milpharm
may impair your ability to
drive or operate any tools
or machinery, as it may
make you feel sleepy.
This is more likely at the
beginning of treatment or
after an increase in the
dose. You should not drive
or use machines until it
is established that your
ability to perform such
activities is not affected.
Levetiracetam Milpharm
contains sodium
One maximum single dose
of Levetiracetam Milpharm
concentrate contains
2.5 mmol (or 57 mg) of
sodium (0.8 mmol
(or 19 mg) of sodium per
vial). This should be taken
into consideration if you
are on a controlled sodium
diet.
3. How to take
Levetiracetam
Milpharm
A doctor or a nurse
will administer you
Levetiracetam Milpharm
as an intravenous
infusion.
Levetiracetam Milpharm
must be administered
twice a day, once in the
morning and once in the
evening, at about the
same time each day.
The intravenous
formulation is an
alternative to your oral
administration. You
can switch from the
film-coated tablets or
from the oral solution
to the intravenous
formulation or reverse
directly without dose
adaptation. Your total
daily dose and frequency
of administration remain
identical.
Monotherapy
Dose in adults and
adolescents (from
16 years of age):
General dose: between
1000 mg and 3,000 mg
each day.
When you will first start
taking Levetiracetam
Milpharm, your doctor will
prescribe you a lower
dose during 2 weeks
before giving you the
lowest general dose.
Add-on therapy
Dose in adults and
adolescents (12 to 17
years) weighing 50 kg or
more:
General dose: between
1,000 mg and 3,000 mg
each day.
Dose in children
(4 to 11 years) and
adolescents (12 to 17
years) weighing less
than
50 kg:
General dose: between

P15xxxxx

Read all of this leaflet
carefully before
you start taking this
medicine because it
contains important
information for you.
- 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
only. Do not pass it on
to others. It may harm
them, even if their signs
of illness are the same
as yours.
- If you get any side
effects, talk to your
doctor or pharmacist.
This includes any
possible side effects
not listed in this leaflet.
See section 4.


The following
information is intended
for healthcare
professionals only:
Direction for the proper
use of Levetiracetam
Milpharm is provided in
section 3.
One vial of Levetiracetam
Milpharm concentrate
contains 500 mg
levetiracetam (5 ml
concentrate of 100 mg/
Dose Withdrawal
Volume
250 2.5 ml
mg
(half
5 ml
vial)
500 5 ml
mg
(one
5 ml
vial)
1000 10 ml
mg
(two
5 ml
vials)
1500 15 ml
mg
(three
5 ml
vials)

Black

ml). See Table 1 for the
recommended preparation
and administration of
Levetiracetam Milpharm
concentrate to achieve
a total daily dose of 500
mg, 1000 mg, 2000 mg,
or 3000 mg in two divided
doses.
Table 1. Preparation
and administration of
Levetiracetam Milpharm
concentrate

Volume
of
Diluent
100 ml

Infusion
Time
15
minutes

Frequency
of administration
Twice daily

Total
Daily
Dose
500
mg/
day

100 ml

15
Twice daily
minutes

1000
mg/
day

100 ml

15
Twice daily
minutes

2000
mg/
day

100 ml

15
Twice daily
minutes

3000
mg/
day

9770

Method and route of
administration:
Levetiracetam Milpharm is
for intravenous use.
The recommended dose
must be diluted in at least
100 ml of a compatible
diluent and infused over
15-minutes.
For doctors and nurses,
more detailed direction
for the proper use of
Levetiracetam Milpharm is
provided in section 6.
Duration of treatment:
• There is no experience
with administration
of intravenous
levetiracetam for a
longer period than
4 days.
If you stop using
Levetiracetam Milpharm:
If stopping treatment, as
with other antiepileptic
medicines, Levetiracetam
Milpharm should be
discontinued gradually
to avoid an increase of
seizures. Should your
doctor decide to stop your
Levetiracetam Milpharm
treatment, he/she will
instruct you about the
gradual withdrawal of
Levetiracetam Milpharm.
If you have any further
questions on the use of
this medicine, ask your
doctor or pharmacist.
4. Possible side effects
Like all medicines, this
medicine can cause side
effects, although not
everybody gets them.
The most frequently
reported adverse
reactions were
nasopharyngitis,
somnolence (sleepiness),
headache, fatigue
and dizziness. At the
beginning of the treatment
or at dose increase side
effects like sleepiness,
tiredness and dizziness
may be more common.
These effects should
however decrease over
time.
Very common: may affect
more than 1 user in 10
people
• nasopharyngitis;
• somnolence
(sleepiness),
headache.
Common: may affect 1 to
10 users in 100 people
• anorexia (loss of
appetite);
• depression, hostility or
aggression, anxiety,
insomnia, nervousness
or irritability;
• convulsion, balance
disorder (equilibrium
disorder), dizziness
(sensation of
unsteadiness),
lethargy (lack
of energy and
enthusiasm), tremor
(involuntary trembling);
• vertigo (sensation of
rotation);
• cough;
• abdominal pain,
diarrhoea, dyspepsia
(indigestion), vomiting,
nausea;
• rash;
• asthenia/fatigue
(tiredness).
Uncommon: may affect 1
to 10 users in 1000 people
• decreased number
of blood platelets,
decreased number of
white blood cells;
• weight decrease,
weight increase;
• suicide attempt and
suicidal ideation,
mental disorder,
abnormal behaviour,
hallucination, anger,
confusion, panic
attack, emotional
instability/mood
swings, agitation;
• amnesia (loss of
memory), memory
impairment
(forgetfulness),
abnormal coordination/
ataxia (impaired
coordinated
movements),
paraesthesia
(tingling), disturbance
in attention (loss of
concentration);
• diplopia (double
vision), vision blurred;
• elevated/abnormal
values in a liver
function test;
• hair loss, eczema,
pruritus;
• muscle weakness,
myalgia (muscle pain);
• injury.
Rare: may affect 1 to 10
users in 10,000 people
• infection;
• decreased number of
all blood cell types;
• severe hypersensitivity
reactions (DRESS,
anaphylactic reaction
[severe and important
allergic reaction],
Quincke’s oedema
[swelling of the face,
lips, tongue and
throat]);
• decreased blood
sodium concentration;
• suicide, personality
disorders (behavioural
problems), thinking
abnormal (slow
thinking, unable to
concentrate);
• uncontrollable muscle


This medicinal product is
for single use only, any
unused solution should be
discarded.
Levetiracetam concentrate
for solution for infusion is
physically compatible and
chemically stable when
mixed with the following
diluents for at least 24
hours at controlled room
temperature 15-25°C,
over the concentration
range of 2.5 mg/ml to
13 mg/ml.
Diluents:
• Sodium chloride 9 mg/
ml (0.9%) solution for
injection
• Lactated Ringer’s
solution for injection
• Dextrose 50 mg/
ml (5%) solution for
injection

spasms affecting the
head, torso and limbs,
difficulty in controlling
movements,
hyperkinesia
(hyperactivity);
• pancreatitis;
• liver failure, hepatitis;
• skin rash, which may
form blisters and looks
like small targets
(central dark spots
surrounded by a paler
area, with a dark ring
around the edge)
(erythema multiforme),
a widespread
rash with blisters
and peeling skin,
particularly around
the mouth, nose,
eyes and genitals
(Stevens-Johnson
syndrome), and a
more severe form
causing skin peeling
in more than 30% of
the body surface (toxic
epidermal necrolysis).
Reporting of side effects
If you get any side effects,
talk to your doctor or
pharmacist or nurse. This
includes any possible
side effects not listed in
this leaflet. You can also
report side effects directly
via United Kingdom,
Yellow Card Scheme,
Website: www.mhra.gov.
uk/yellowcard
By reporting side effects
you can help provide more
information on the safety
of this medicine.
5. How to store
Levetiracetam
Milpharm
Keep this medicine out
of the sight and reach of
children.
Do not use this medicine
after the expiry date,
which is stated on the vial
and carton box after EXP.
The expiry date refers to
the last day of that month.
This medicinal product
does not require any
special storage conditions.
Chemical and physical
in-use stability has been
demonstrated for 24 hours
at 2-8°C and at 15-25°C.
From a microbiological
point of view, unless the
method of opening/dilution
precludes the risk of
microbial contamination,
the product should be
used immediately. If not
used immediately, inuse storage times and
conditions prior to use are
the responsibility of the
user.
Do not use Levetiracetam
Milpharm if you notice
any particulate matter or
discoloration
Do not throw away any
medicines via wastewater.
Ask your pharmacist how
to throw away medicines
you no longer use. These
measures will help protect
the environment.
6. Contents of the
pack and other
information
What Levetiracetam
Milpharm contains
- The active substance
is levetiracetam,
Each ml of solution for
infusion contains
100 mg of
levetiracetam.
- The other ingredients
are: Sodium chloride,
sodium acetate
trihydrate, acetic
acid, glacial, water for
injection.
What Levetiracetam
Milpharm looks like and
contents of the pack
Levetiracetam Milpharm
concentrate for solution
for infusion is a clear,
colourless solution.
Levetiracetam Milpharm
concentrate for solution
for infusion 5 ml vial is
packed in a cardboard box
of 1 and 10 vials.
Not all pack sizes may be
marketed.
Marketing Authorisation
Holder
Milpharm Limited
Ares block, Odyssey
Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta)
Limited
HF26, Hal Far Industrial
Estate, Hal Far
Birzebbugia, BBG 3000
Malta
This leaflet was last
revised in 10/2016.

P15xxxxx

20 mg per kg bodyweight
and 60 mg per kg
bodyweight each day.

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