Stalevo

Country: European Union

Language: Latvian

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
23-02-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
23-02-2023
Public Assessment Report Public Assessment Report (PAR)
13-10-2011

Active ingredient:

levodopu, carbidopa, entacapone

Available from:

Orion Corporation

ATC code:

N04BA03

INN (International Name):

levodopa, carbidopa, entacapone

Therapeutic group:

Anti-Parkinsona zāles

Therapeutic area:

Parkinsona slimība

Therapeutic indications:

Stalevo ir norādīts pieaugušiem pacientiem ar Parkinsona slimības ārstēšanai un beigās deva mehānisko svārstību nav stabilizēts ar levodopa / dopa decarboxylase (DDC)-inhibitors ārstēšana.

Product summary:

Revision: 29

Authorization status:

Autorizēts

Authorization date:

2003-10-17

Patient Information leaflet

                                41
B. LIETOŠANAS INSTRUKCIJA
42
LIETOŠANAS INSTRUKCIJA: INFORMĀCIJA LIETOTĀJAM
STALEVO 50 MG/12,5 MG/200 MG APVALKOTĀS TABLETES
levodopa/carbidopa/entacapone
PIRMS ZĀĻU LIETOŠANAS UZMANĪGI IZLASIET VISU INSTRUKCIJU, JO TĀ
SATUR JUMS SVARĪGU INFORMĀCIJU.
-
Saglabājiet šo instrukciju! Iespējams, ka vēlāk to vajadzēs
pārlasīt.
-
Ja Jums rodas jebkādi jautājumi, vaicājiet ārstam vai farmaceitam.
-
Šīs zāles ir parakstītas tikai Jums. Nedodiet tās citiem. Tās
var nodarīt ļaunumu pat tad, ja šiem
cilvēkiem ir līdzīgas slimības pazīmes.
-
Ja Jums rodas jebkādas blakusparādības, konsultējieties ar ārstu
vai farmaceitu. Tas attiecas arī
uz iespējamām blakusparādībām, kas nav minētas šajā
instrukcijā. Skatīt 4. punktu.
ŠAJĀ INSTRUKCIJĀ VARAT UZZINĀT:
1.
Kas ir Stalevo un kādam nolūkam tās lieto
2.
Kas Jums jāzina pirms Stalevo lietošanas
3.
Kā lietot Stalevo
4.
Iespējamās blakusparādības
5.
Kā uzglabāt Stalevo
6.
Iepakojuma saturs un cita informācija
1.
KAS IR STALEVO UN KĀDAM NOLŪKAM TĀS LIETO
Stalevo viena apvalkotā tablete satur trīs aktīvās vielas
(levodopu, karbidopu un entakaponu). Stalevo
tiek lietots Parkinsona slimības ārstēšanai.
Parkinsona slimību izraisa vielas, kuru sauc par dopamīnu, zems
līmenis smadzenēs. Levodopa
palielina dopamīna daudzumu, tādējādi samazinot Parkinsona
slimības simptomus. Karbidopa un
entakapons uzlabo levodopas pretparkinsonisma iedarbību.
2.
KAS JUMS JĀZINA PIRMS STALEVO LIETOŠANAS
NELIETOJIET STALEVO ŠĀDOS GADĪJUMOS:
-
ja Jums ir alerģija pret levodopu, karbidopu vai entakaponu vai kādu
citu (6. punktā minēto) šo
zāļu sastāvdaļu;
-
ja Jums ir šaura leņķa glaukoma (acu slimība);
-
ja Jums ir virsnieru dziedzeru audzējs;
-
ja lietojat noteiktas zāles depresijas ārstēšanai (selektīvo
MAO-A un MAO-B inhibitoru
kombinācijas, vai neselektīvos MAO inhibitorus);
-
ja Jums jebkad bijis ļaundabīgs neiroleptiskais sindroms (MNS –
tā ir reta reakcija uz zālēm,
kuras lieto s
                                
                                Read the complete document

Summary of Product characteristics

                                1
I PIELIKUMS
ZĀĻU APRAKSTS
2
1.
ZĀĻU NOSAUKUMS
Stalevo 50 mg/12,5 mg/200 mg apvalkotās tabletes
Stalevo 75 mg/18,75 mg/200 mg apvalkotās tabletes
Stalevo 100 mg/25 mg/200 mg apvalkotās tabletes
Stalevo 125 mg/31,25 mg/200 mg apvalkotās tabletes
Stalevo 150 mg/37,5 mg/200 mg apvalkotās tabletes
Stalevo 175 mg/43,75 mg/200 mg apvalkotās tabletes
Stalevo 200 mg/50 mg/200 mg apvalkotās tabletes
2.
KVALITATĪVAIS UN KVANTITATĪVAIS SASTĀVS
50 mg/12,5 mg/200 mg
Viena tablete satur 50 mg levodopas (_levodopa_), 12,5 mg karbidopas
(_carbidopa_) un 200 mg
entakapona (_entacapone_).
Palīgviela ar zināmu iedarbību
Katra tablete satur 1,2 mg saharozes.
75 mg/18,75 mg/200 mg
Viena tablete satur 75 mg levodopas (_levodopa_), 18,75 mg karbidopas
(_carbidopa_) un 200 mg
entakapona (_entacapone_).
Palīgviela ar zināmu iedarbību
Katra tablete satur 1,4 mg saharozes.
100 mg/25 mg/200 mg
Viena tablete satur 100 mg levodopas (_levodopa_), 25 mg karbidopas
(_carbidopa_) un 200 mg
entakapona (_entacapone_).
Palīgviela ar zināmu iedarbību
Katra tablete satur 1,6 mg saharozes.
125 mg/31,25 mg/200 mg
Viena tablete satur 125 mg levodopas (_levodopa_), 31,25 mg karbidopas
(_carbidopa_) un 200 mg
entakapona (_entacapone_).
Palīgviela ar zināmu iedarbību
Katra tablete satur 1,6 mg saharozes.
150 mg/37,5 mg/200 mg
Viena tablete satur 150 mg levodopas (_levodopa_), 37,5 mg karbidopas
(_carbidopa_) un 200 mg
entakapona (_entacapone_).
Palīgvielas ar zināmu iedarbību
Katra tablete satur 1,9 mg saharozes un 2,6 mg nātrija kā
palīgvielu sastāvdaļu.
175 mg/43,75 mg/200 mg
Viena tablete satur 175 mg levodopas (_levodopa_), 43,75 mg karbidopas
(_carbidopa_) un 200 mg
entakapona (_entacapone_).
Palīgviela ar zināmu iedarbību
Katra tablete satur 1,89 mg saharozes.
200 mg/50 mg/200 mg
Viena tablete satur 200 mg levodopas (_levodopa_), 50 mg karbidopas
(_carbidopa_) un 200 mg
3
entakapona (_entacapone_).
Palīgviela ar zināmu iedarbību
Katra tablete satur 2,3 mg saharozes.
Pilnu palīgvielu sarakstu skatīt 6.1. apak
                                
                                Read the complete document

Similar products

Active ingredient levodopu, carbidopa, entacapone

levodopu, carbidopa, entacapone

ATC code N04BA03

N04BA03

Marketed by Orion Corporation

Orion Corporation

INN (International Name) levodopa, carbidopa, entacapone

levodopa, carbidopa, entacapone

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 23-02-2023
Summary of Product characteristics Summary of Product characteristics Bulgarian 23-02-2023
Public Assessment Report Public Assessment Report Bulgarian 13-10-2011
Patient Information leaflet Patient Information leaflet Spanish 23-02-2023
Summary of Product characteristics Summary of Product characteristics Spanish 23-02-2023
Public Assessment Report Public Assessment Report Spanish 13-10-2011
Patient Information leaflet Patient Information leaflet Czech 23-02-2023
Summary of Product characteristics Summary of Product characteristics Czech 23-02-2023
Public Assessment Report Public Assessment Report Czech 13-10-2011
Patient Information leaflet Patient Information leaflet Danish 23-02-2023
Summary of Product characteristics Summary of Product characteristics Danish 23-02-2023
Public Assessment Report Public Assessment Report Danish 13-10-2011
Patient Information leaflet Patient Information leaflet German 23-02-2023
Summary of Product characteristics Summary of Product characteristics German 23-02-2023
Public Assessment Report Public Assessment Report German 13-10-2011
Patient Information leaflet Patient Information leaflet Estonian 23-02-2023
Summary of Product characteristics Summary of Product characteristics Estonian 23-02-2023
Public Assessment Report Public Assessment Report Estonian 13-10-2011
Patient Information leaflet Patient Information leaflet Greek 23-02-2023
Summary of Product characteristics Summary of Product characteristics Greek 23-02-2023
Public Assessment Report Public Assessment Report Greek 13-10-2011
Patient Information leaflet Patient Information leaflet English 23-02-2023
Summary of Product characteristics Summary of Product characteristics English 23-02-2023
Public Assessment Report Public Assessment Report English 13-10-2011
Patient Information leaflet Patient Information leaflet French 23-02-2023
Summary of Product characteristics Summary of Product characteristics French 23-02-2023
Public Assessment Report Public Assessment Report French 13-10-2011
Patient Information leaflet Patient Information leaflet Italian 23-02-2023
Summary of Product characteristics Summary of Product characteristics Italian 23-02-2023
Public Assessment Report Public Assessment Report Italian 13-10-2011
Patient Information leaflet Patient Information leaflet Lithuanian 23-02-2023
Summary of Product characteristics Summary of Product characteristics Lithuanian 23-02-2023
Public Assessment Report Public Assessment Report Lithuanian 13-10-2011
Patient Information leaflet Patient Information leaflet Hungarian 23-02-2023
Summary of Product characteristics Summary of Product characteristics Hungarian 23-02-2023
Public Assessment Report Public Assessment Report Hungarian 13-10-2011
Patient Information leaflet Patient Information leaflet Maltese 23-02-2023
Summary of Product characteristics Summary of Product characteristics Maltese 23-02-2023
Public Assessment Report Public Assessment Report Maltese 13-10-2011
Patient Information leaflet Patient Information leaflet Dutch 23-02-2023
Summary of Product characteristics Summary of Product characteristics Dutch 23-02-2023
Public Assessment Report Public Assessment Report Dutch 13-10-2011
Patient Information leaflet Patient Information leaflet Polish 23-02-2023
Summary of Product characteristics Summary of Product characteristics Polish 23-02-2023
Public Assessment Report Public Assessment Report Polish 13-10-2011
Patient Information leaflet Patient Information leaflet Portuguese 23-02-2023
Summary of Product characteristics Summary of Product characteristics Portuguese 23-02-2023
Public Assessment Report Public Assessment Report Portuguese 13-10-2011
Patient Information leaflet Patient Information leaflet Romanian 23-02-2023
Summary of Product characteristics Summary of Product characteristics Romanian 23-02-2023
Public Assessment Report Public Assessment Report Romanian 13-10-2011
Patient Information leaflet Patient Information leaflet Slovak 23-02-2023
Summary of Product characteristics Summary of Product characteristics Slovak 23-02-2023
Public Assessment Report Public Assessment Report Slovak 13-10-2011
Patient Information leaflet Patient Information leaflet Slovenian 23-02-2023
Summary of Product characteristics Summary of Product characteristics Slovenian 23-02-2023
Public Assessment Report Public Assessment Report Slovenian 13-10-2011
Patient Information leaflet Patient Information leaflet Finnish 23-02-2023
Summary of Product characteristics Summary of Product characteristics Finnish 23-02-2023
Public Assessment Report Public Assessment Report Finnish 13-10-2011
Patient Information leaflet Patient Information leaflet Swedish 23-02-2023
Summary of Product characteristics Summary of Product characteristics Swedish 23-02-2023
Public Assessment Report Public Assessment Report Swedish 13-10-2011
Patient Information leaflet Patient Information leaflet Norwegian 23-02-2023
Summary of Product characteristics Summary of Product characteristics Norwegian 23-02-2023
Patient Information leaflet Patient Information leaflet Icelandic 23-02-2023
Summary of Product characteristics Summary of Product characteristics Icelandic 23-02-2023
Patient Information leaflet Patient Information leaflet Croatian 23-02-2023
Summary of Product characteristics Summary of Product characteristics Croatian 23-02-2023

Search alerts related to this product

Alerts Stalevo levodopu, carbidopa, entacapone levodopa,

Stalevo levodopu, carbidopa, entacapone levodopa,

View documents history

Documents history Documents history

Stalevo