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DESITREND 100 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): LEVETIRACETAM

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Format: 190 x 450 mm – Laetus-Code: 169

MOCKUP

Schrift: 10 p

Package Leaflet: Information for the patient

DESITREND® 100 mg/ml
concentrate for solution for infusion
Levetiracetam
Read all of this leaflet carefully before you or your child 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 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.
What is in this leaflet:
1. What Desitrend is and what it is used for
2. What you need to know before you are given
Desitrend
3. How Desitrend is given
4. Possible side effects
5. How to store Desitrend
6. Contents of the pack and other information
1. What Desitrend is and what it is used for
Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Desitrend 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 seizure
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 adults, adolescents and children from
4 years of age
– myoclonic seizures (short, shock-like jerks of
a muscle or group of muscles) in adults and
adolescents from 12 years of age with juvenile
myoclonic epilepsy
– primary generalised tonic-clonic 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).
Desitrend concentrate for solution for infusion is an
alternative for patients when administration of the
antiepileptic oral Desitrend medicine is temporarily
not feasible.
2. What you need to know before you are given
Desitrend
Do not use Desitrend
• 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 Desitrend
• 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 antiepileptics such as Desitrend 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
• Desitrend is not indicated in children and adolescents below 16 years on its own (monotherapy).

Driving and using machines
Desitrend 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.
Desitrend contains sodium
One maximum single dose of Desitrend concentrate
contains 2.3 mmol (or 53 mg) of sodium (0.77 mmol
(or 17.7 mg) of sodium per ampoule). This should be
taken into consideration if you are on a controlled
sodium diet.
3. How Desitrend is given
A doctor or nurse will administer you Desitrend as
an intravenous infusion.
Desitrend 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 filmcoated tablets, the coated granules in sachet 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 1,000 mg and 3,000 mg
each day.
When you will first start taking Desitrend, your doctor will prescribe you a lower dose (500 mg each
day) during 2 weeks before giving you the lowest
general dose of 1,000 mg.
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 20 mg per kg bodyweight
and 60 mg per kg bodyweight each day.
Method and route of administration:
Desitrend 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 Desitrend 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 Desitrend:
If stopping treatment, as with other antiepileptic
medicines, Desitrend should be discontinued gradually to avoid an increase of seizures. Should your
doctor decide to stop your Desitrend treatment, he/
she will instruct you about the gradual withdrawal of
Desitrend.

Other medicines and Desitrend
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines,
including medicines obtained without a prescription.

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

Pregnancy and breast-feeding
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.
Desitrend should not be used during pregnancy
unless clearly necessary. A risk of birth defects for
your unborn child cannot be completely excluded.
Desitrend 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.

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.

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4. Possible side effects

Very common: may affect more than 1 user in 10
people
• nasopharyngitis;
• somnolence (sleepiness), headache.

03.06.16 10:51

Format: 190 x 450 mm – Laetus-Code: 169

MOCKUP

Schrift: 10 p

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 1,000
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 allergic 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 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. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the 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 Desitrend
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date stated
on the ampoule and carton box after EXP:.
The expiry date refers to the last day of the month.
Do not refrigerate.
Do not use this medicine if you notice particulate
matter or discolouration.
6. Contents of the pack and other information
What Desitrend contains
The active substance is levetiracetam.
Each ml contains 100 mg of levetiracetam.
The 5 ml ampoule contains 500 mg of levetiracetam.
The other ingredients are: sodium acetate trihydrate, glacial acetic acid, sodium chloride, water for
injections.
What Desitrend looks like and contents of the
pack
Desitrend concentrate for solution for infusion (sterile concentrate) is a clear, colourless liquid.
Desitrend concentrate for solution for infusion is
packed in a cardboard box containing 5 and 10
ampoules of 5 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
and manufacturer
Desitin Arzneimittel GmbH
Weg beim Jäger 214
22335 Hamburg
Germany
E-mail: medinfo@desitin.co.uk
This leaflet was last revised in 03/2016

The following information is intended for healthcare professionals only:
Directions for the proper use of Desitrend is provided in section 3.
One ampoule of Desitrend concentrate contains 500 mg levetiracetam (5 ml concentrate of 100 mg/ml).
See Table 1 for the recommended preparation and administration of Desitrend concentrate to achieve a total
daily dose of 500 mg, 1,000 mg, 2,000 mg, or 3,000 mg in two divided doses.
Table 1. Preparation and administration of Desitrend concentrate

Dose


Withdrawal
Volume

Volume of
Diluent

Infusion
Time

Frequency of
Administration

Total Daily
Dose

250 mg


2.5 ml
100 ml
15 minutes
(half 5 ml ampoule)

twice daily

500 mg/day

500 mg


5 ml
100 ml
15 minutes
(one 5 ml ampoule)

twice daily

1,000 mg/day

1,000 mg


10 ml
100 ml
15 minutes
(two 5 ml ampoules)

twice daily

2,000 mg/day

1,500 mg


15 ml
100 ml
15 minutes
(three 5 ml ampoules)

twice daily

3,000 mg/day

This medicinal product is for single use only, any unused solution should be discarded.
In use shelf life: Chemical and physical in-use stability has been demonstrated for 24 hours at 25 °C. 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.
Desitrend concentrate 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.
Diluents:
• Sodium chloride 9 mg/ml (0.9 %) solution for injection
• Lactated Ringer’s solution for injection
• Glucose 50 mg/ml (5 %) solution for 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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