Lacosamide Fresenius Kabi 10 mg/ml solution for infusion

Pajjiż: Malta

Lingwa: Ingliż

Sors: Malta Medicines Authority

Disponibbli minn:

Fresenius Kabi Italia S.r.l Via Camagre 41, 37063 Isola della Scala (Vr) , Italy

Kodiċi ATC:

N03AX18

INN (Isem Internazzjonali):

LACOSAMIDE 10 mg/ml

Għamla farmaċewtika:

SOLUTION FOR INFUSION

Kompożizzjoni:

LACOSAMIDE 10 mg/ml

Tip ta 'preskrizzjoni:

POM

Żona terapewtika:

ANTIEPILEPTICS

Sommarju tal-prodott:

Licence number in the source country: NOT APPLICAPABLE

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2022-05-27

Fuljett ta 'informazzjoni

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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 10 mg/ml solution for infusion is and
what it is used for
2.
What you need to know before you use Lacosamide Fresenius Kabi 10
mg/ml solution for
infusion
3.
How to use Lacosamide Fresenius Kabi 10 mg/ml solution for infusion
4.
Possible side effects
5.
How to store Lacosamide Fresenius Kabi 10 mg/ml solution for infusion
6.
Contents of the pack and other information
1.
What Lacosamide Fresenius Kabi 10 mg/ml solution for infusion is and
what it is used for
What Lacosamide Fresenius Kabi 10 mg/ml solution for infusion is
Lacosamide Fresenius Kabi 10 mg/ml solution for infusion 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 10 mg/ml solution for infusion is used
for
•
Lacosamide Fresenius Kabi 10 mg/ml solution for infusion 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 an

Karatteristiċi tal-prodott

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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 10 mg/ml solution for infusion 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 10 mg/ml solution for infusion 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