Levetiracetam Sandoz infuus 100 mg/ml, concentraat voor oplossing voor infusie

Levetiracetam Sandoz infuus is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Levetiracetam Sandoz infuus 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 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 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 generalized epilepsy

Levetiracetam Sandoz infuus concentrate is an alternative for patients when administration of the antiepileptic oral Levetiracetam Sandoz infuus medicine is temporarily not feasible.

Do not use Levetiracetam Sandoz infuus

• If you are allergic (hypersensitive) to levetiracetam or any of the other ingredients of Levetiracetam Sandoz infuusthis medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before you are given Levetiracetam Sandoz infuus

• 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 Sandoz infuus 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 Levetiracetam Sandoz infuus

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

Levetiracetam Sandoz infuus with food, drink and alcohol

You may take Levetiracetam Sandoz infuus with or without food. As a safety precaution, do not use Levetiracetam Sandoz infuus 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 Sandoz infuus 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 Sandoz infuus may impair your ability to drive or operate any tools or machinery, as Levetiracetam Sandoz infuus 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.

Important information about some of the ingredients of Levetiracetam Sandoz infuus:

One maximum single dose of Levetiracetam Sandoz infuus 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.Levetiracetam Sandoz infuus

A doctor or a nurse will administer you Levetiracetam Sandoz infuus as an intravenous infusion.

Levetiracetam Sandoz infuus 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 1,000 mg and 3,000 mg each day.

When you will first start taking Levetiracetam Sandoz infuus, 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 20 mg per kg bodyweight and 60 mg per kg bodyweight each day.

Method and route of administration:

Levetiracetam Sandoz infuus will 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 Sandoz infuus is provided in section 6.

Duration of treatment:

• Levetiracetam Sandoz infuus is used as a chronic treatment. You should continue Levetiracetam Sandoz infuus 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 Levetiracetam Sandoz infuus treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam Sandoz infuus.
• There is no experience with administration of intravenous levetiracetam for a longer period than 4 days.

If you stop using Levetiracetam Sandoz infuus

If stopping treatment, as with other antiepileptic medicines, Levetiracetam Sandoz infuus should be discontinued gradually to avoid an increase of seizures.

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

Like all medicines, Levetiracetam Sandoz infuusthis medicine can cause side effects, although not everybody gets them.

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

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 1000

• 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;
• 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 all blood cell lines;

• 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).

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

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 vial after EXP:

The expiry date refers to the last day of the month.

This medicinal product does not require any special storage conditions.

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.

Do not use Levetiracetam Sandoz infuus if you notice any visible signs of deterioration.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Levetiracetam Sandoz infuus contains:

The active substance is called Levetiracetam. Other ingredients are:

Sodium acetate trihydrate, Sodium chloride, Glacial acetic acid, Water for injection

What Levetiracetam Sandoz infuus looks like and the contents of the pack

Levetiracetam Sandoz infuus is a clear, colourless, concentrate

Levetiracetam Sandoz infuus concentrate 5 ml vial is packed in a cardboard box of

1, 5, 10 vials

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz B.V., Veluwezoom 22, Almere

Correspondentie: Postbus 10332, 1301 AH Almere

Manufacturer

Haupt Pharma Wülfing GmbH

Bethelner Landsrasse 18,

31028 Gronau/Leine

Germany

Lek Pharmaceuticals d.d

Verovškova 57, 1526 Ljubljana

Slovenia

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1, 39179 Barleben

Germany

Marketing Authorisation number:

RVG 108505

This medicines product is authorised in the Member States of the EEA under the following names:

RMS (NL): Levetiracetam Sandoz infuus 100 mg/ml, concentraat voor oplossing

voor	infusie
AT:	Levetiracetam Sandoz 100 mg/ml – Konzentrat zur Herstellung
einer	Infusionslösung
BE:	Levetiracetam Sandoz 100 mg/ml concentraat voor oplossing voor
infusie
ES:	LEVETIRACETAM SANDOZ 100 mg/ml concentrado para
solución para	perfusión EFG
FR:	LEVETIRACETAM Sandoz 100 mg/ml, solution à diluer pour
perfusion
LU:	LEVETIRACETAM Sandoz 100 mg/ml, solution à diluer pour
perfusion

This leaflet was last approved in November 2012.

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The following information is intended for doctor and nurses only:

Direction for the proper use of Levetiracetam Sandoz infuus is provided in section 3.

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

Dose	Withdrawal Volume	Volume	Infusion	Frequency	Total Daily
		of	Time	of	Dose
		diluent		administrati
				on
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	100 ml	15 minutes	Twice daily	3000 mg/day
vials)

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

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.

Levetiracetam Sandoz infuus 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 (0.9%) injection
• Lactated Ringer’s injection
• Dextrose 5% injection