Format: 190 x 450 mm - Laetus-Code: - Schrift: 10 p PROOF

Package Leaflet: Information for the patient

DESITREND® 100 mg/ml

concentrate for solution for infusion

Levetiracetam

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

Desitrend 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 partial onset seizures with or without secondary generalisation.

•    as an add-on to other antiepileptic medicines to treat:

•    partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age

•    myoclonic seizures in adults and adolescents 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 generalised epilepsy.

Desitrend concentrate 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 (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 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.

•    If you notice an increase in seizure severity (e.g. increased number), please contact your doctor.

•    A small number of people being treated with anti-epileptics such as levetiracetam have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.

Other medicines and Desitrend

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Desitrend with food, drink and alcohol

You may use Desitrend with or without food. As a safety precaution, do not use Desitrend 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 should not be used during pregnancy unless clearly necessary. A risk of birth defects for your unborn child cannot be completely excluded. 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

Desitrend may impair your ability to drive or operate any tools or machinery, as Desitrend 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 certain that your ability to do such activities is not affected.

Important information about some of the ingredients of Desitrend

One maximum single dose (1,500 mg) of Desitrend concentrate contains 2.3 mmol (or 53 mg) of sodium. This should be taken into consideration if you are on a controlled sodium diet.

3.    How Desitrend is given

Desitrend is administered as an intravenous infusion by a healthcare professional.

The intravenous formulation is an alternative to your oral administration. Conversion to or from oral to intravenous administration can be done directly without titration. Your total daily dose and frequency of administration remain identical.

Monotherapy

Dosage in adults and adolescents (from 16 years of age):

General dose: between 1,000 mg and 3,000 mg each day.

Desitrend must be administered twice a day, half of the daily dose in the morning and half of the daily dose in the evening, at about the same time each day.

When you will first start receiving Desitrend, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest usual dose.

Add-on therapy

Dosage in adults and adolescents (12 to 17 years) weighing 50 kg or more:

General dose is between 1,000 mg and 3,000 mg each day.

Desitrend must be administered twice a day, half of the daily dose in the morning and half of the daily dose in the evening, at about the same time each day.

Dosage in children (4 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:

General dose is between 20 mg per kg body weight and 60 mg per kg body weight each day.

Desitrend must be administered twice a day, half of the daily dose in the morning and half of the daily dose in the evening, at about the same time each day.

Method and route of administration:

Desitrend will be diluted in at least 100 ml of a compatible diluent and infused over 15 minutes.

For medical or healthcare professionals, more detailed direction for the proper use of Desitrend is provided at the end of the leaflet.

Duration of treatment:

•    Desitrend is used as a chronic treatment. You should continue Desitrend treatment for as long as your doctor has told you.

•    There is no experience with administration of intravenous levetiracetam for a longer period than 4 days.

If you stop using Desitrend:

Do not stop your treatment without your doctor's advice as this could increase your seizures. Should your doctor decide to stop your Desitrend treatment, he/she will instruct you about the gradual withdrawal of Desitrend.

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.

Very common: may affect more than 1 user in 10

•    nasopharyngitis;

•    somnolence (sleepiness), headache.

Common: may affect 1 to 10 users in 100

•    anorexia (loss of appetite);

•    depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;

•    convulsion, 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).

Uncommon: may affect 1 to 10 users in 1,000

•    decreased number of blood platelets, decreased number of white blood cells;

•    weight decrease, weight increase;

•    suicide attempt and suicidal ideation, disturbance of the mind (psychotic disorder), abnormal behaviour, false perception (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;

•    liver function test abnormal;

•    hair loss, eczema, pruritus;

•    muscle weakness, myalgia (muscle pain);

•    injury.

Rare: may affect 1 to 10 users in 10,000

•    infection;

•    decreased number of white blood cells or all types of blood cells;

•    severe hypersensitivity reactions (DRESS);

•    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;

•    hepatic 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).

Some of the side effects like sleepiness, tiredness and dizziness may be more common at the beginning of the treatment or at dosage increase. These effects should however decrease over time.

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: 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 carton box and ampoule after EXP:. The expiry date refers to the last day of that month.

•    Do not refrigerate.

•    Do not use this medicine if you notice particulate matter or discoloration.

6.    Contents of the pack and other information

What Desitrend contains

The active substance is levetiracetam.

Each ml contains 100 mg levetiracetam.

The 5 ml ampoule contains 500 mg 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 is a clear, colourless, sterile liquid.

Desitrend concentrate 5 ml ampoule is packed in a cardboard box of 5 and 10 ampoules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Desitin Arzneimittel GmbH Weg beim Jager 214 22335 Hamburg Telefon: (040) 59101-525 Telefax: (040) 59101-377 E-mail: medinfo@desitin.co.uk

This leaflet was last revised in 05/2014

The following information is intended for medical or healthcare professionals only:

Direction for the proper use of Desitrend is provided in section 3.

See Table 1 for the recommended preparation and administration of Desitrend concentrate for solution for 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 Desitrend concentrate

Dose	Withdrawal Volume	Volume of Diluent	Infusion Time	Frequency of administration	Total Daily Dose
250 mg	2.5 ml (half 5 ml ampoule)	100 ml	15 minutes	twice daily	500 mg/day
500 mg	5 ml (one 5 ml ampoule)	100 ml	15 minutes	twice daily	1000 mg/day
1000 mg	10 ml (two 5 ml ampoules)	100 ml	15 minutes	twice daily	2000 mg/day
1500 mg	15 ml (three 5 ml ampoules)	100 ml	15 minutes	twice daily	3000 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 for solution for 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.

Diluents:

•    Sodium chloride 9 mg/ml (0.9 %) solution for infusion

•    Lactated Ringer's solution for infusion

•    Glucose 50 mg/ml (5 %) solution for infusion

DESITIN

Desitrend _iv-GB PROOF.indd 2 25.04.14 13:53