Lacosamide Adroiq

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

lacosamide

Saadav alates:

Extrovis EU Ltd.

ATC kood:

N03AX18

INN (Rahvusvaheline Nimetus):

lacosamide

Terapeutiline rühm:

Antiepileptics,

Terapeutiline ala:

Epilepsy

Näidustused:

Lacosamide Adroiq 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 Adroiq is indicated as adjunctive therapyin 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.

Toote kokkuvõte:

Revision: 2

Volitamisolek:

Authorised

Loa andmise kuupäev:

2023-05-31

Infovoldik

29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LACOSAMIDE ADROIQ 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 Adroiq is and what it is used for
2.
What you need to know before you use Lacosamide Adroiq
3.
How to use Lacosamide Adroiq
4.
Possible side effects
5.
How to store Lacosamide Adroiq
6.
Contents of the pack and other information
1.
WHAT LACOSAMIDE ADROIQ IS AND WHAT IT IS USED FOR
WHAT LACOSAMIDE ADROIQ IS
Lacosamide Adroiq 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 ADROIQ IS USED FOR
•
Lacosamide Adroiq 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 ADROIQ
DO NOT USE LACOSAMIDE ADROIQ
•
if you are allergic to lacosami

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Lacosamide Adroiq 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.
The pH is between 3.8 and 5.0 and osmolality is between 275 and 320
mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lacosamide Adroiq 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 Adroiq 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 administration should be maintained. Monitor closely patients
w