Levetiracetam 500mg5ml concentrate for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Levetiracetam

Available from:

Bowmed Ibisqus Ltd

ATC code:

N03AX14

INN (International Name):

Levetiracetam

Dosage:

100mg/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04080100; GTIN: 5060130131093

Patient Information leaflet

IBI LEVETIRACETAM 100 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
VERSION 1 CREATED 15.03.13
FONT: VAG ROUNDED LIGHT & BOLD 8PT (AUTO LEADING)
NOW VERSION-11 CREATED 26.01.17
PROFILE SIZE SHOWN IS 140 X 700 (DEPTH AS REQUIRED)
VICTOR DESIGN
V11
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEVETIRACETAM IBIGEN 100 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
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 your
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.
1
WHAT LEVETIRACETAM INFUSION IS AND WHAT
IT IS USED FOR
The name of your medicine is Levetiracetam Ibigen 100
mg/ml concentrate for solution for infusion - referred to
as Levetiracetam Infusion throughout this leaflet.
Levetiracetam is an antiepileptic medicine (a medicine
used to treat seizures in epilepsy).
Levetiracetam Infusion is used:
• on its own in patients 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 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 (short, shock-like jerks of a
muscle or group of muscl

Summary of Product characteristics

OBJECT 1
LEVETIRACETAM 500MG/5ML CONCENTRATE FOR
SOLUTION FOR INFUSION VIALS (100MG/ML IN 5ML VIALS)
Summary of Product Characteristics Updated 29-Dec-2017 | Bowmed
Ibisqus Limited
1. Name of the medicinal product
Levetiracetam Ibigen 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
Excipients with known effect:
Each vial contains 19.94 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 liquid
4. Clinical particulars
4.1 Therapeutic indications
Levetiracetam Ibigen 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 Ibigen 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 Ibigen 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