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KEVESY 15 MG/ML SOLUTION FOR INFUSION

Active substance(s): LEVETIRACETAM / LEVETIRACETAM / LEVETIRACETAM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Kevesy

solution for infusion
Kevesy 5 mg/ml solution for infusion
Kevesy 10 mg/ml solution for infusion
Kevesy 15 mg/ml solution for infusion
Levetiracetam
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, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Kevesy is and what it is used for
2. What you need to know before you are given Kevesy
3. How to use Kevesy
4. Possible side effects
5. How to store Kevesy
6. Contents of the pack and other information
1.

WHAT KEVESY IS AND WHAT IT IS USED FOR

Kevesy is an antiepileptic medicine (a medicine used to treat seizures in
epilepsy).
Kevesy 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 generalization
• as an add-on to other antiepileptic medicines to treat:
- partial onset seizures with or without generalisation in patients from 4 years
of age
- myoclonic seizures in patients from 12 years of age with juvenile myoclonic
epilepsy
- primary generalised tonic-clonic seizures in patients from 12 years of age
with idiopathic generalised epilepsy
Kevesy is an alternative for patients when administration of antiepileptic oral
medicine is temporarily not feasible.
2.

WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN KEVESY

Kevesy must not be used
• if you are allergic to levetiracetam or any of the other ingredients of this
medicine (listed in section 6)
Warnings and precautions
Talk to your doctor or nurse before you are given Kevesy
• 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 (for example increased number),
please contact your doctor.
• A small number of people being treated with anti-epileptics such as Kevesy
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 Kevesy
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Kevesy with food, drink and alchohol
Kevesy may be used with or without food. As a safety precaution, do not use
Kevesy with alcohol.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning
to have a baby, ask your doctor for advice before you are given this medicine.
Kevesy should not be used during pregnancy unless clearly necessary. A risk of
birth defects for your unborn child cannot be completely excluded. Kevesy 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
Kevesy may impair your ability to drive or operate any tools or machinery, as
Kevesy 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.
Kevesy contains sodium
Kevesy 5 mg/ml contains 3.50 mg sodium per ml.
Kevesy 10 mg/ml contains 3.23 mg sodium per ml.
Kevesy 15 mg/ml contains 2.40 mg sodium per ml.
To be taken into consideration by patients on a controlled sodium diet.
3.

HOW TO USE KEVESY

Kevesy is administered by a doctor or nurse as an intravenous infusion, in one
of your veins.
Kevesy 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 oral administration (as
film-coated tablets or oral solution). Your doctor may decide to 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):
Recommended dose: between 1000 mg and 3000 mg each day.
When you will first start taking Kevesy, 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 1000 mg and 3000 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:
Kevesy is for intravenous use. The solution for infusion should be administered
over 15-minutes.
Duration of treatment:
• Kevesy is used as a chronic treatment. You should continue Kevesy 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 Kevesy treatment, he/she will instruct
you about the gradual withdrawal of Kevesy.
• There is no experience with administration of intravenous levetiracetam for a
longer period than 4 days.
If you stop using Kevesy
If stopping treatment, as with other antiepileptic medicines, Kevesy 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,
pharmacist or nurse.
4.

POSSIBLE SIDE EFFECTS

Like all medicines this medicine can cause side effects, although not everybody
gets them.
Tell your doctor immediately, or go to your nearest emergency department, if
you experience:
• Weakness, feel light-headed or dizzy or have difficulty breathing, as these
may be signs of a serious allergic (anaphylactic) reaction
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• Swelling of the face, lips, tongue and throat (Quincke’s oedema)
• Flu-like symptoms and a rash on the face followed by an extended rash with
a high temperature, increased levels of liver enzymes seen in blood tests and
an increase in a type of white blood cell (eosinophilia) and enlarged lymph
nodes (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS])
• Symptoms such as low urine volume, tiredness, nausea, vomiting, confusion
and swelling in the legs, ankles or feet, as this may be a sign of sudden
decrease of kidney function
• A skin rash which may form blisters and look like small targets (central dark
spots surrounded by a paler area, with a dark ring atround the edge)
(erythema multiforme)
• A widespread rash with blisters and peeling skin, particularly around the
mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
• A more severe form of rash causing skin peeling in more than 30% of the
body surface (toxic epidermal necrolysis)
• Signs of serious mental changes or if someone around you notices signs of
confusion, somnolence (sleepiness), amnesia (loss of memory), memory
impairment (forgetfulness), abnormal behavior or other neurological signs
including involuntary or uncontrolled movements). These could be symptoms
of an encephalopathy.
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 side effects (may affect more than 1 in 10 people):
• nasopharyngitis (nose and throat inflammation);
• somnolence (sleepiness), headache.
Common side effects (may affect up to 1 in 10 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), tremor (involuntary trembling);
• vertigo (sensation of rotation);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
• rash;
• asthenia/fatigue (tiredness).
Uncommon side effects (may affect up to 1 in 100 people):
• decreased number of blood platelets, decreased number of white blood cells;
• weight decrease, weight increase;
• suicide attempt and suicidal ideation, mental disorder, abnormal behavior,
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 side effects (may affect up to 1 in 1,000 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 spasms affecting the head, torso and limbs, difficulty in
controlling movements, hyperkinesia (hyperactivity);
• pancreatitis (pancreas inflammation);
• liver failure, hepatitis;
• sudden decrease in kidney function
• 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)
• rhabdomyolysis (breakdown of muscle tissue) and associated blood creatine
phosphokinase increase. Prevalence is significantly higher in Japanese
patients when compared to non-Japanese patients.
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 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 KEVESY

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 overwrap,
bag and carton after EXP:.
The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
This medicinal product is for single use only, any unused solution should be
discarded.
Medicinal product with particulate matter or discoloration should not be used.
Do not throw away any medicine via wastewater or household waste. 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 Kevesy contains
The active substance is levetiracetam.
■ Each ml contains 5 mg of levetiracetam.
Each 100 ml bag contains 500 mg of levetiracetam.
■ Each ml contains 10 mg of levetiracetam.
Each 100 ml bag contains 1000 mg of levetiracetam.
■ Each ml contains 15 mg of levetiracetam.
Each 100 ml bag contains 1500 mg of levetiracetam.
The other ingredients are: sodium acetate trihydrate, glacial acetic acid, sodium
chloride, water for injections.
What Kevesy looks like and contents of the pack
Kevesy is a clear, colourless to light yellow solution for infusion that is available
in a single-use, ready-to-use 100 ml dual port bag with an aluminum over wrap.
It is available in three different concentrations in cartons of 10 bags
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
STRAGEN UK Ltd
Castle Court
41 London Road
Reigate
Surrey
RH2 9RJ
Phone: +44 (0)870 351 87 44
Email: info@stragenuk.com
Manufacturer
Facta Farmaceutici S.A
Nucleo Industriale S. atto (loc. S. Nicolo’ A Tordino)
64020 Teramo (TE)
Italy
This leaflet was last revised in 11/2016.

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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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