Leganto

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
18-02-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
18-02-2022
Public Assessment Report Public Assessment Report (PAR)
18-02-2022

Active ingredient:

rotigotine

Available from:

UCB Pharma S.A.  

ATC code:

N04BC09

INN (International Name):

rotigotine

Therapeutic group:

Mediċini Kontra l-Parkinson

Therapeutic area:

Restless Legs Syndrome; Parkinson Disease

Therapeutic indications:

Leganto huwa indikat għat-trattament sintomatiku ta 'sindromu idjopatiku moderat għal sever idjopatiku fl-adulti. Leganto huwa indikat għat-trattament tas-sinjali u s-sintomi tal-istadju bikri tal-marda idjopatika ta ' Parkinson bħala monoterapija (i. mingħajr levodopa) jew flimkien ma 'levodopa, i. matul il-kors tal-marda, permezz ta'l-aħħar stadji meta l-effett ta ' levodopa jonqos ħafna jew isir inkonsistenti u l-varjazzjonijiet tal-effett terapewtiku jseħħu (fl-aħħar tad-doża jew 'on-off' varjazzjonijiet).

Product summary:

Revision: 19

Authorization status:

Irtirat

Authorization date:

2011-06-16

Patient Information leaflet

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
Prodott mediċinali li m’għadux awtorizzat
2
1.
ISEM TAL-PRODOTT MEDIĊINALI
Leganto 1 mg/24 siegħa garża li tipprovdi mediċina li tgħaddi minn
ġol-ġilda
Leganto 3 mg/24 siegħa garża li tipprovdi mediċina li tgħaddi minn
ġol-ġilda
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Leganto 1 mg/24 siegħa garża li tipprovdi mediċina li tgħaddi minn
ġol-ġilda
Kull impjastru jerħi 1 mg ta’ rotigotine kull 24 siegħa. Kull
impjastru ta’ 5 cm
2
fih 2.25 mg ta’
rotigotine.
Leganto 3 mg/24 siegħa garża li tipprovdi mediċina li tgħaddi minn
ġol-ġilda
Kull impjastru jerħi 3 mg ta’ rotigotine kull 24 siegħa. Kull
impjastru ta’ 15 cm
2
fih 6.75 mg ta’
rotigotine.
Għal-lista kompleta ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda.
Irqiqa, _matrix-type_, b’forma kwadra bi truf jagħtu fit-tond, li
tikkonsisti fi tliet saffi.
Leganto 1 mg/24 siegħa garża li tipprovdi mediċina li tgħaddi minn
ġol-ġilda
In-naħa ta’ barra tas-saff ta’ wara hi ta’ kulur kannella ċar
u għandha l-kliem Leganto 1 mg/24 h
stampat fuqha.
Leganto 3 mg/24 siegħa garża li tipprovdi mediċina li tgħaddi minn
ġol-ġilda
In-naħa ta’ barra tas-saff ta’ wara hi ta’ kulur kannella ċar
u għandha l-kliem Leganto 3 mg/24 h
stampat fuqha.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Leganto huwa indikat għat-trattament tas-sintomi tas-sindromu ta’
_Restless Legs_ (RLS) idjopatiku
moderat għal sever fl-adulti.
4.2
POŻOLOGIJA U METODU TA’ KIF GĦANDU JINGĦATA
Pożoloġija
Ir-rakkomandazzjonijiet tad-doża mogħtija huma skont id-doża
nominali.
Doża singola kuljum għandha tinbeda b’ 1 mg/24 siegħa. Id-doża
tista’ tiżdied b’żiediet ta’ 1 mg/24
siegħa kull ġimgħa għal doża massima ta’ 3 mg/24 siegħa, skont
ir-rispons individwali tal-pazjent. Il-
bżonn tal-kontinwazzjoni tat-trattament għandu jerġa jiġi
kunsidrat kull 6 xhur.
Leganto jiġi app
                                
                                Read the complete document

Summary of Product characteristics

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
Prodott mediċinali li m’għadux awtorizzat
2
1.
ISEM TAL-PRODOTT MEDIĊINALI
Leganto 1 mg/24 siegħa garża li tipprovdi mediċina li tgħaddi minn
ġol-ġilda
Leganto 3 mg/24 siegħa garża li tipprovdi mediċina li tgħaddi minn
ġol-ġilda
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Leganto 1 mg/24 siegħa garża li tipprovdi mediċina li tgħaddi minn
ġol-ġilda
Kull impjastru jerħi 1 mg ta’ rotigotine kull 24 siegħa. Kull
impjastru ta’ 5 cm
2
fih 2.25 mg ta’
rotigotine.
Leganto 3 mg/24 siegħa garża li tipprovdi mediċina li tgħaddi minn
ġol-ġilda
Kull impjastru jerħi 3 mg ta’ rotigotine kull 24 siegħa. Kull
impjastru ta’ 15 cm
2
fih 6.75 mg ta’
rotigotine.
Għal-lista kompleta ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda.
Irqiqa, _matrix-type_, b’forma kwadra bi truf jagħtu fit-tond, li
tikkonsisti fi tliet saffi.
Leganto 1 mg/24 siegħa garża li tipprovdi mediċina li tgħaddi minn
ġol-ġilda
In-naħa ta’ barra tas-saff ta’ wara hi ta’ kulur kannella ċar
u għandha l-kliem Leganto 1 mg/24 h
stampat fuqha.
Leganto 3 mg/24 siegħa garża li tipprovdi mediċina li tgħaddi minn
ġol-ġilda
In-naħa ta’ barra tas-saff ta’ wara hi ta’ kulur kannella ċar
u għandha l-kliem Leganto 3 mg/24 h
stampat fuqha.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Leganto huwa indikat għat-trattament tas-sintomi tas-sindromu ta’
_Restless Legs_ (RLS) idjopatiku
moderat għal sever fl-adulti.
4.2
POŻOLOGIJA U METODU TA’ KIF GĦANDU JINGĦATA
Pożoloġija
Ir-rakkomandazzjonijiet tad-doża mogħtija huma skont id-doża
nominali.
Doża singola kuljum għandha tinbeda b’ 1 mg/24 siegħa. Id-doża
tista’ tiżdied b’żiediet ta’ 1 mg/24
siegħa kull ġimgħa għal doża massima ta’ 3 mg/24 siegħa, skont
ir-rispons individwali tal-pazjent. Il-
bżonn tal-kontinwazzjoni tat-trattament għandu jerġa jiġi
kunsidrat kull 6 xhur.
Leganto jiġi app
                                
                                Read the complete document

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Active ingredient rotigotine

rotigotine

ATC code N04BC09

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INN (International Name) rotigotine

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