Levetiracetam Hospira

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

levetiracetam

Available from:

Pfizer Europe MA EEIG

ATC code:

N03AX14

INN (International Name):

levetiracetam

Therapeutic group:

Antiepileptics,

Therapeutic area:

Epilepsy

Therapeutic indications:

Levetiracetam Hospira is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy.Levetiracetam Hospira is indicated as adjunctive therapyin the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.Levetiracetam Hospira concentrate is an alternative for patients when oral administration is temporarily not feasible.

Product summary:

Revision: 24

Authorization status:

Authorised

Authorization date:

2014-01-07

Patient Information leaflet

26
B. PACKAGE LEAFLET
27
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEVETIRACETAM HOSPIRA 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 Levetiracetam Hospira is and what it is used for
2.
What you need to know before you are given Levetiracetam Hospira
3.
How Levetiracetam Hospira is given
4.
Possible side effects
5.
How to store Levetiracetam Hospira
6.
Contents of the pack and other information
1.
WHAT LEVETIRACETAM HOSPIRA IS AND WHAT IT IS USED FOR
Levetiracetam is an antiepileptic medicine (a medicine used to treat
seizures in epilepsy).
Levetiracetam Hospira 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 epileps

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Levetiracetam Hospira 100 mg/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 100 mg of levetiracetam.
Each 5 ml vial contains 500 mg of levetiracetam.
Excipient with known effect:
Each vial contains 19 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Levetiracetam Hospira is indicated as monotherapy in the treatment of
partial onset seizures with or
without secondary generalisation in adults and adolescents from 16
years of age with newly diagnosed
epilepsy.
Levetiracetam Hospira is indicated as adjunctive therapy
•
in the treatment of partial onset seizures with or without secondary
generalisation in adults,
adolescents and children from 4 years of age with epilepsy.
•
in the treatment of myoclonic seizures in adults and adolescents from
12 years of age with
Juvenile Myoclonic Epilepsy.
•
in the treatment of primary generalised tonic-clonic seizures in
adults and adolescents from
12 years of age with Idiopathic Generalised Epilepsy.
Levetiracetam Hospira concentrate is an alternative for patients when
oral administration is
temporarily not feasible.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Levetiracetam therapy can be initiated with either intravenous or oral
administration.
Conversion to or from oral to intravenous administration can be done
directly without titration. The
total daily dose and frequency of administration should be maintained.
_Partial onset seizures _
The recommended dosing for monotherapy (from 16 years of age) and
adjunctive therapy is the same;
as outlined below.
3
_All indications _
_ _
_Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg
or more _
The initial therapeutic dose is 500 mg twice daily. This dose can be
started on the first day of
treatme