VIMPAT 10 MGML

Šalis: Izraelis

kalba: anglų

Šaltinis: Ministry of Health

Veiklioji medžiaga:

LACOSAMIDE

Prieinama:

NEOPHARM LTD, ISRAEL

ATC kodas:

N03AX18

Vaisto forma:

SOLUTION FOR INFUSION

Sudėtis:

LACOSAMIDE 10 MG / 1 ML

Vartojimo būdas:

I.V

Recepto tipas:

Required

Pagaminta:

UCB PHARMA S.A., BELGIUM

Gydymo sritis:

LACOSAMIDE

Terapinės indikacijos:

Vimpat is indicated as monotherapy and 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.שינוי משטר מינון : 17/5/20204.2 Posology and method of administrationPosologyLacosamide must be taken twice a day (usually once in the morning and once in the evening).Lacosamide may be taken with or without food.If a dose is missed, the patient should be instructed to take the missed dose immediately, and then to take the next dose of lacosamide at the regularly scheduled time. If the patient notices the missed dose within 6 hours of the next one, he/she should be instructed to wait to take the next dose of lacosamide at the regularly scheduled time. Patients should not take a double dose.Adolescents and children weighing 50 kg or more, and adultsThe following table summarises the recommended posology for adolescents and children weighing 50 kg or more, and for adults. More details are provided in the table below. Monotherapy Adjunctive therapyStarting dose 100 mg/day or 200 mg/day 100 mg/daySingle loading dose (if applicable) 200 mg 200 mgTitration (incremental steps) 50 mg twice a day (100 mg/day) at weekly intervals 50 mg twice a day (100 mg/day) at weekly intervalsMaximum recommended dose up to 600 mg/day up to 400 mg/dayMonotherapy The recommended starting dose is 50 mg twice a day which should be increased to an initial therapeutic dose of 100 mg twice a day after one week.Lacosamide can also be initiated at the dose of 100 mg twice a day based on the physician's assessment of required seizure reduction versus potential side effects.Depending on response and tolerability, the maintenance dose can be further increased at weekly intervals by 50 mg twice a day (100 mg/day), up to a maximum recommended daily dose of 300 mg twice a day (600 mg/day). In patients having reached a dose greater than 400 mg/day and who need an additional antiepileptic medicinal product, the posology that is recommended for adjunctive therapy below should be followed.Adjunctive therapy The recommended starting dose is 50 mg twice a day which should be increased to an initial therapeutic dose of 100 mg twice a day after one week. Depending on response and tolerability, the maintenance dose can be further increased at weekly intervals by 50 mg twice a day (100 mg/day), up to a maximum recommended daily dose of 400 mg (200 mg twice a day). Initiation of lacosamide treatment with a loading dose Lacosamide treatment may also be initiated with a single loading dose of 200 mg, followed approximately 12 hours later by a 100 mg twice a day (200 mg/day) maintenance dose regimen. Subsequent dose adjustments should be performed according to individual response and tolerability as described above. A loading dose may be initiated in patients in situations when the physician determines that rapid attainment of lacosamide steady state plasma concentration and therapeutic effect is warranted. It should be administered under medical supervision with consideration of the potential for increased incidence of serious cardiac arrhythmia and central nervous system adverse reactions (see section 4.8). Administration of a loading dose has not been studied in acute conditions such as status epilepticus.DiscontinuationIn accordance with current clinical practice, if lacosamide has to be discontinued, it is recommended this be done gradually (e.g. taper the daily dose by 200 mg/week).In patients who develop serious cardiac arrhythmia, clinical benefit/risk assessment should be performed and if needed lacosamide should be discontinued.

Leidimo data:

2017-12-31

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Prekės savybės

1
1.
NAME OF THE MEDICINAL PRODUCT
Vimpat
®
10 mg/ml
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.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vimpat is indicated as monotherapy and 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.
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) when
lacosamide dose is higher than 400 mg/day (see Method of
administration below and section 4.4).
Lacosamide must be taken twice a day (usually once in the morning and
once in the evening).
_Adolescents and children weighing 50 kg or more, and adults _
The following table summarises the recommended posology for
adolescents and children weighing 50 kg or
more, and for adults. More details are provided in the table below.
2
Monotherapy
Adjunctive therapy
Starting dose
100 mg/day or 200 mg/day
100 mg/day
Single loa