KEPPRA

Riik: Indoneesia

keel: indoneesia

Allikas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Toimeaine:

LEVETIRACETAM

Saadav alates:

GLAXO WELLCOME INDONESIA - Indonesia

INN (Rahvusvaheline Nimetus):

LEVETIRACETAM

Annus:

250 MG

Ravimvorm:

TABLET SALUT SELAPUT

Ühikuid pakis:

DUS,3 BLISTER @ 10 TABLET SALUT SELAPUT

Valmistatud:

UCB PHARMA SA - Belgium

Loa andmise kuupäev:

2019-11-29

Toote omadused

ERS_leaKEPtab_Update PI to NCDS v.10_circ2_1Feb2021
Page 1 of 10
KEPPRA
LEVETIRACETAM
1.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Levetiracetam, 250 mg, film-coated tablet
Each film-coated tablet contains 250 mg of levetiracetam.
Levetiracetam, 500 mg, film-coated tablet
Each film-coated tablet contains 500 mg of levetiracetam.
2.
PHARMACEUTICAL FORM
Levetiracetam, 250 mg, film-coated tablet
Blue, oblong film-coated tablet scored and debossed with the code ucb
and 250 on one side.
The score lines is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
Levetiracetam, 500 mg, film-coated tablet
Yellow, oblong film-coated tablet scored and debossed with the code
ucb and 500 on one side.
The score lines is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
3.
CLINICAL INFORMATION
3.1 INDICATIONS
Levetiracetam is indicated as adjunctive therapy in the treatment of
partial onset seizures with or without
secondary generalisation in patients with epilepsy.
3.2 DOSAGE AND ADMINISTRATION
The film-coated tablets must be taken orally, swallowed with a
sufficient quantity of liquid and may be
taken with or without food. After oral administration the bitter taste
of levetiracetam may be experienced.
The daily dose is administered in two equally divided doses.
ADULTS AND ADOLESCENTS OLDER THAN 16 YEARS
The initial therapeutic dose is 500 mg twice daily. This dose can be
started on the first day of treatment.
Depending upon the clinical response and tolerability, the daily dose
can be increased up to 1,500 mg
twice daily. Dose changes can be made in 500 mg twice daily increases
or decreases every two to four
weeks.
ELDERLY (65 YEARS AND OLDER)
Adjustment of the dose is recommended in elderly patients with
compromised renal function.
CHILDREN
There are insufficient data to recommend the use of levetiracetam in
children and adolescents under
16 years of age.
RENAL IMPAIRMENT
The daily dose must be individualised according to renal function.
Refer to the followin