Keppra tablets film-coated

Država: Armenija

Jezik: angleščina

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivna sestavina:

levetiracetam

Dostopno od:

UCB Pharma S.A.

Koda artikla:

N03AX14

INN (mednarodno ime):

levetiracetam

Odmerek:

500mg

Farmacevtska oblika:

tablets film-coated

Enote v paketu:

(30/3x10/), in blister

Tip zastaranja:

Prescription

Status dovoljenje:

Registered

Datum dovoljenje:

2018-05-05

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Keppra, 250 mg, film-coated tablet
Keppra, 500 mg, film-coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Keppra, 250 mg, film-coated tablet _
Each film-coated tablet contains 250 mg of levetiracetam.
_Keppra, 500 mg, film-coated tablet _
Each film-coated tablet contains 500 mg of levetiracetam.
3.
PHARMACEUTICAL FORM
_Keppra, 250 mg, film-coated tablets _
Blue, oblong and debossed with the code ucb and 250 on one side
_Keppra, 500 mg, film-coated tablets _
Yellow, oblong and debossed with the code ucb and 500 on one side
4.
CLINICAL INFORMATION
4.1 INDICATIONS
Keppra is indicated as monotherapy in the treatment of:

partial onset seizures with or without secondary generalisation in
adults and
adolescents from 16 years of age with newly diagnosed epilepsy.
Keppra is indicated as adjunctive therapy in the treatment of:

partial onset seizures with or without secondary generalisation in
adults,
adolescents, children and infants from 1 year of age with epilepsy,

myoclonic seizures in adults and adolescents from 12 years of age with
juvenile
myoclonic epilepsy,

primary generalised tonic-clonic seizures in adults and adolescents
from 12 years
of age with idiopathic generalised epilepsy.
Levetiracetam concentrate is an alternative for patients (adults and
children from 4 years
of age) when oral administration is temporarily not feasible.
4.2 DOSAGE AND ADMINISTRATION
Levetiracetam therapy can be initiated with either intravenous or oral
administration.
Conversion to or from oral to intravenous administration can be done
directly without
titration. The total daily dose and frequency of administration should
be maintained.
_Film-coated tablets _
The film-coated tablets must be taken orally, swallowed with a
sufficient quantity of
liquid and may be taken with or without food. The daily dose is
administered in two
equally divided doses.
ROUTE OF ADMINISTRATION
For oral use.
ADULTS
MONOTHERAPY
_Adults and adolescents from 16 years of