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LEVETIRACETAM IBIGEN 100 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): LEVETIRACETAM

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Add-on therapy

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Levetiracetam Ibigen 100 mg/ml concentrate for solution for infusion
Read all of this leaflet carefully before you start using 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 your pharmacist.
• This medicine has been prescribed for you. 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.
What is in this leaflet:
1. What Levetiracetam Infusion is and what it is used for
2. What you need to know before you are given Levetiracetam Infusion
3. How Levetiracetam Infusion is given
4. Possible side effects
5. How to store Levetiracetam Infusion
6. Contents of the pack and other information
1 WHAT LEVETIRACETAM INFUSION IS AND
WHAT IT IS USED FOR
The name of your medicine is Levetiracetam
Ibigen 100 mg/ml concentrate for solution for
infusion - referred to as Levetiracetam Infusion
throughout this leaflet.
Levetiracetam Infusion is an antiepileptic
medicine (a medicine used to treat seizures in
epilepsy).
Levetiracetam Infusion is used:
• on its own in patients from 16 years of age
with newly diagnosed epilepsy, to treat
partial onset seizures with or without
secondary generalisation.
• as an add-on treatment to other antiepileptic
medicines to treat:
• partial onset seizures with or without
generalisation in adults, adolescents and
children from 4 years of age
• myoclonic seizures in patients from 12
years of age with juvenile myoclonic
epilepsy.
• primary generalised tonic-clonic seizures
in adults and adolescents from 12 years of
age with idiopathic generalized epilepsy
Levetiracetam Infusion is an alternative for
patients when administration of oral
Levetiracetam medicine is temporarily not feasible.
2 WHAT YOU NEED TO KNOW BEFORE
YOU ARE GIVEN LEVETIRACETAM
INFUSION
You should not be given Levetiracetam
Infusion
• If you are allergic (hypersensitive) to
levetiracetam 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 Infusion:
• If you suffer from kidney problems. Follow
your doctor’s instructions. He/she may
decide that your dose should be adjusted.
• If you notice any slow down in the growth or
unexpected puberty development of your
child.
• If you notice an increase in seizure severity
(e.g. increased number).
• If you have any symptoms of depression
and/or suicidal thoughts. A small number of
people being treated with anti-epileptics
such as Levetiracetam Infusion have had
thoughts of harming or killing themselves.
Other medicines and Levetiracetam Infusion
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription.

Levetiracetam Infusion with food, drink and
alcohol
You may take Levetiracetam Infusion with or
without food. As a safety precaution, do not
use Levetiracetam Infusion with alcohol.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice
before taking any medicine.
If you are pregnant or if you think you may be
pregnant, please inform your doctor.
Levetiracetam Infusion should not be used
during pregnancy unless clearly necessary.
The potential risk to your unborn child is
unknown.
Levetiracetam 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 Infusion 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 Infusion contains 2.6 mmol (or
59.82 mg) sodium per maximum single dose
[or 0.867 mmol (or 19.94 mg) per vial]. This
should be taken into consideration by patients
on a controlled sodium diet.
3. HOW LEVETIRACETAM INFUSION IS
GIVEN
A doctor or a nurse will administer your
medicine as an intravenous infusion.
It must be administered twice a day: once in
the morning and once in the evening, at about
the same time each day.
This intravenous medicine is an alternative to
the oral medicine. You can switch from the
oral medicine (e.g. film-coated tablets or oral
solution) to the intravenous medicine (or vice
versa ) without changing dose. Your total daily
dose and frequency of administration remain
identical.

Monotherapy
Dose in adults and adolescents (from 16
years of age):
General dose: between 1,000 mg and 3,000
mg each day.
When you first start taking Levetiracetam
Infusion, your doctor will prescribe you a lower
dose for 2 weeks before giving you the lowest
‘general dose’ (above).

INFORMATION FOR THE HEATHCARE PROFESSIONAL

One vial of concentrate contains 500 mg levetiracetam (5 ml concentrate of 100 mg/ml).
See Table 1 for the recommended preparation and administration of Levetiracetam Infusion 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 Infusion.
Withdrawal Volume

Dose in children (4 to 11 years) and
adolescents (12 to 17 years) weighing less
than 50 kg:
General dose: between 20 mg and 60 mg of
levetiracetam per kg of bodyweight each day.
Method and route of administration:
Levetiracetam Infusion will be diluted in at least
100 ml of a compatible diluent and infused
over 15 minutes.
For healthcare professionals, more detailed
directions on the proper use of Levetiracetam
Infusion are provided in section 6.
Duration of treatment:
• Levetiracetam Infusion is used as a chronic
treatment. You should continue treatment
for as long as your doctor has told you.
• Do not stop your treatment without your
doctor’s advice as this could increase your
seizures. Should your doctor decide to stop
your treatment, he/she will instruct you
about the gradual withdrawal of
Levetiracetam Infusion.
• There is no experience with administration of
intravenous levetiracetam for longer than
4 days.
If you stop using Levetiracetam Infusion
As with other antiepileptic medicines,
Levetiracetam Infusion should be discontinued
gradually to avoid an increase of seizures.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Levetiracetam Infusion can
cause side effects, although not everybody
gets them.
You should tell the doctor or nurse immediately
if you experience any of the following serious
side effects:
• Skin rash which may form blisters and looks
like small targets i.e. 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)
• A severe skin rash causing skin peeling in
more than 30% of the body surface (toxic
epidermal necrolysis).
• If you have thoughts of harming or killing
yourself
Other side effects:
Some of the side effects like sleepiness,
tiredness and dizziness may be more common
at the beginning of treatment or after a dose
increase. These effects should however
decrease over time.
Very common (may affect more than 1 in 10
patients)
• nasopharyngitis
• somnolence (sleepiness), headache.
Common (may affect up to 1 to 10 patients)
• anorexia (loss of appetite)
• depression, hostility or aggression, anxiety,
insomnia, nervousness or irritability
• seizures, balance disorder (equilibrium
disorder), dizziness (sensation of
unsteadiness), lethargy, tremor (involuntary
trembling)
• vertigo (sensation of rotation)
• cough
• abdominal pain, diarrhoea, dyspepsia
(indigestion), vomiting, nausea
• rash
• asthenia/fatigue (tiredness).

This medicinal product is for single use only,
any unused solution should be discarded.

The following information is intended for healthcare professionals only:
Directions for the proper use of Levetiracetam Infusion are provided in section 3 above.

Dose

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.

Volume of
diluent

Infusion
Time

Frequency of Total Daily
administration Dose

250 mg 2.5 ml (half 5 ml vial)

100 ml

15 minutes

Twice daily

500 mg/day

500 mg 5 ml (one 5 ml vial)

100 ml

15 minutes

Twice daily

1000 mg/day

1000 mg 10 ml (two 5 ml vials)

100 ml

15 minutes

Twice daily

2000 mg/day

1500 mg 15 ml (three 5 ml vials) 100 ml

15 minutes

Twice daily

3000 mg/day

In use shelf life: from a microbiological point of
view, the product should be used immediately
after dilution. If not used immediately, in-use
storage time and conditions prior to use are
the responsibility of the user and would
normally not be longer than 24 hours at 2 to
8°C, unless dilution has taken place in
controlled and validated aseptic conditions.

Uncommon (may affect up to 1 in 100 patients)
• decreased number of blood platelets,
decreased number of white blood cells
• weight decrease, weight increase
• 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), blurred vision
• abnormal liver function test
• hair loss, eczema, pruritus
• muscle weakness, myalgia (muscle pain)
• injury.
Rare (may affect up to 1 in 1,000 patients)
• infection
• decreased number of all blood cell types
• suicide, personality disorders (behavioural
problems), thinking abnormal (slow thinking,
unable to concentrate)
• uncontrollable muscle spasms affecting the
head, torso and limbs, difficulty in controlling
movements, hyperkinesia (hyperactivity)
• pancreatitis
• hepatic failure, hepatitis
• decreased blood sodium concentration
Reporting of side effects
If you get any side effects talk to your doctor,
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
You can also report side effects directly via the
Yellow Card Scheme at:
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
INFUSION
This medicine does not require any special
storage conditions.
Keep this medicine out of the sight and reach
of children.
Do not use after the expiry date stated on the
carton and vial after EXP.
The expiry date refers to the last day of that
month.
Do not use Levetiracetam Infusion if you notice
any visible signs of deterioration.
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. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Levetiracetam Infusion contains:
The active substance is levetiracetam. Each ml
of solution for infusion contains 100 mg of
levetiracetam
The other ingredients are sodium acetate
trihydrate, sodium chloride, glacial acetic acid,
water for injection
What Levetiracetam Infusion looks like and
the contents of the pack
Levetiracetam Infusion is a clear, colourless,
sterile liquid.
Each 5 ml vial is packed in a cardboard carton.
Each carton contains 1 or 10 vials.
Not all pack sizes may be marketed
Marketing Authorisation Holder
Ibigen Srl, Via Fossignano 2, 04011 Aprilia (LT), Italy
Manufacturer:
Haupt Pharma Wülfing GmbH, Bethelner
Landstrasse 18, 31028 Gronau/Leine, Germany
This leaflet was last revised in 02/2014
22595500

Levetiracetam Infusion was found to be
physically compatible and chemically stable
when mixed with the following diluents for at
least 24 hours and stored in PVC bags at
controlled room temperature 15-25°C:
• Sodium chloride (0.9%) injection
• Lactated Ringer’s injection
• Dextrose 5% injection

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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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