Lacosamide G.L. 10 mg/ml Infusionsvätska, lösning

Kraj: Szwecja

Język: szwedzki

Źródło: Läkemedelsverket (Medical Products Agency)

Składnik aktywny:

lakosamid

Dostępny od:

G.L. Pharma GmbH

Kod ATC:

N03AX18

INN (International Nazwa):

lacosamide

Dawkowanie:

10 mg/ml

Forma farmaceutyczna:

Infusionsvätska, lösning

Skład:

lakosamid 10 mg Aktiv substans

Typ recepty:

Receptbelagt

Podsumowanie produktu:

Förpacknings: Injektionsflaska, 10 ml; Injektionsflaska, 5 x 10 ml; Ampull, 5 x 20 ml; Ampull, 20 ml

Status autoryzacji:

Godkänd

Data autoryzacji:

2018-06-20

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LACOSAMIDE G.L. 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] is and what it is used for
2.
What you need to know before you use [Lacosamide]
3.
How to use [Lacosamide]
4.
Possible side effects
5.
How to store [Lacosamide]
6.
Contents of the pack and other information
1.
WHAT [LACOSAMIDE] IS AND WHAT IT IS USED FOR
WHAT [LACOSAMIDE] IS
[Lacosamide] 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] IS USED FOR
-
[Lacosamide] 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]
DO NOT USE [LACOSAMIDE]
-
if you are allergic to lacosamide or any of the other ingredients of
this medicine (listed in
section 6). If you are not sure whether

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lacosamide G.L. 10 mg/ml solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for infusion contains 10 mg lacosamide.
Each vial of 10 ml solution for infusion contains 100 mg lacosamide.
Each ampoule of 20 ml solution for infusion contains 200 mg
lacosamide.
Excipients with known effect:
Each ml of solution for infusion contains 3.0 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion
Clear, colourless solution
pH 4.25
Osmolarity 275 to 320 mOsm/kg
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Lacosamide] is indicated as monotherapy in the treatment of
partial-onset seizures with or
without secondary generalisation in adults, adolescents and children
from 4 years of age with
epilepsy.
[Lacosamide] 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 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
Lacosamide therapy can be initiated with either oral or intravenous
administration. 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 trials 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 with known cardiac conduction
problems, on concomitant
medications that prolong PR interval, or with severe cardiac disease
(e.g. myocardial ischemia,
heart failure) w