Levetiracetam 500mg5ml concentrate for solution for infusion vials

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Levetiracetam

Inapatikana kutoka:

Pfizer Ltd

ATC kanuni:

N03AX14

INN (Jina la Kimataifa):

Levetiracetam

Kipimo:

100mg/1ml

Dawa fomu:

Solution for infusion

Njia ya uendeshaji:

Intravenous

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 04080100; GTIN: 5015997108795

Taarifa za kipeperushi

Page 1 of 8
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 (fits) 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 epilepsy.


Tabia za bidhaa

OBJECT 1
LEVETIRACETAM HOSPIRA 100 MG/ML CONCENTRATE
FOR SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 06-Mar-2017 | Hospira UK
Ltd
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.
_Monotherapy for adults and adolescents from 16 years of age_
The recommended starting dose is 250 mg twice daily which should be
increased to an initial therapeutic
dose of 500 mg twice daily after two weeks. The dose can be further
increased by 25