Lacosamide Fresenius Kabi 10 mg/ml solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lacosamide

Available from:

Fresenius Kabi Deutschland GmbH

ATC code:

N03AX18

INN (International Name):

Lacosamide

Pharmaceutical form:

Solution for infusion

Therapeutic area:

lacosamide

Authorization date:

2022-06-03

Patient Information leaflet

Ver 01, May 2022
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LACOSAMIDE FRESENIUS KABI 10 MG/ML SOLUTION FOR INFUSION
lacosamide
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 or pharmacist.
•
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 Lacosamide Fresenius Kabi is and what it is used for
2.
What you need to know before you use Lacosamide Fresenius Kabi
3.
How to use Lacosamide Fresenius Kabi
4.
Possible side effects
5.
How to store Lacosamide Fresenius Kabi
6.
Contents of the pack and other information
1.
WHAT LACOSAMIDE FRESENIUS KABI IS AND WHAT IT IS USED FOR
WHAT LACOSAMIDE FRESENIUS KABI IS
Lacosamide Fresenius Kabi contains lacosamide. This belongs to a group
of medicines called
“antiepileptic medicines”. These medicines are used to treat
epilepsy.
•
You have been given this medicine to lower the number of fits
(seizures) you have.
WHAT LACOSAMIDE FRESENIUS KABI IS USED FOR
•
Lacosamide Fresenius Kabi is used:
§
on its own and in association with other antiepileptic medicines in
adults, adolescents
and children aged 2 years and older to treat a certain type of
epilepsy characterised by
the occurrence of partial-onset seizure with or without secondary
generalisation. In this
type of epilepsy, fits first affect only one side of your brain.
However, these may then
spread to larger areas on both sides of your brain;
§
in association with other antiepileptic medicines in adults,
adolescents and children
aged 4 years and older to treat primary generalised tonic-clonic
seizures (major fits,
including loss of consciousness) in patients with idiopathic
generalised epilepsy (the
type of epilepsy that is thought to have a genetic cause).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LACOSAMIDE

Summary of Product characteristics

Health Products Regulatory Authority
07 June 2022
CRN00C1DL
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lacosamide Fresenius Kabi 10 mg/ml solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for infusion contains 10 mg lacosamide.
Each vial of 20 ml solution for infusion contains 200 mg lacosamide.
Excipients with known effect:
Each ml of solution for infusion contains 2.99 mg sodium.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear, colourless solution.
pH 3.5‐5.0
Osmolality 260‐340 mOsmol/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lacosamide Fresenius Kabi is indicated as monotherapy in the treatment
of partial‐onset seizures with or without secondary
generalisation in adults, adolescents and children from 2 years of age
with epilepsy.
Lacosamide Fresenius Kabi is indicated as adjunctive therapy
‐ in the treatment of partial‐onset seizures with or without
secondary generalisation in adults, adolescents and children from
2 years of age with epilepsy.
‐ in the treatment of primary generalised tonic‐clonic seizures in
adults, adolescents and children from 4 years of age with
idiopathic generalised epilepsy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The physician should prescribe the most appropriate formulation and
strength according to weight and dose.
Lacosamide therapy can be initiated with either oral administration
(either tablets or syrup) or intravenous administration
(solution for infusion). Solution for infusion is an alternative for
patients when oral administration is temporarily not feasible.
The overall duration of treatment with intravenous lacosamide is at
the physician's discretion; there is experience from clinical
studies with twice daily infusions of lacosamide for up to 5 days in
adjunctive therapy. Conversion to or from oral and
intravenous administration can be done directly without titration. The
total daily dose and twice daily administrat