Leflunomide Teva

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
18-03-2014
Summary of Product characteristics Summary of Product characteristics (SPC)
18-03-2014
Public Assessment Report Public Assessment Report (PAR)
18-03-2014

Active ingredient:

leflunomide

Available from:

Teva Pharma B.V.

ATC code:

L04AA13

INN (International Name):

leflunomide

Therapeutic group:

Immunosoppressanti

Therapeutic area:

Artrite, Rewmatika

Therapeutic indications:

Leflunomide huwa indikat għall-kura ta 'pazjenti adulti b'artrite rewmatika attiva bħala' mediċina antirewmatika li timmodifika l-mard '(DMARD). Riċenti jew fl-istess waqt it-trattament b'tossiku għall-fwied jew haematotoxic DMARDs (e. methotrexate) jista 'jirriżulta f'riskju akbar ta' reazzjonijiet avversi serji; għalhekk, il-bidu tat-trattament ta 'leflunomide għandu jiġi kkunsidrat bir-reqqa fir-rigward ta' dawn l-aspetti ta 'benefiċċju / riskju. Barra minn hekk, il-qlib minn leflunomide għal DMARD ieħor, mingħajr wara l-proċedura tat-tneħħija jistgħu wkoll iżidu r-riskju ta ' reazzjonijiet avversi serji anke għal żmien twil wara l-qlib tal -.

Product summary:

Revision: 6

Authorization status:

Irtirat

Authorization date:

2011-03-10

Patient Information leaflet

                                55
B. FULJETT TA' TAGĦRIF
Prodott mediċinali li m’għadux awtorizzat
56
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-UTENT
LEFLUNOMIDE TEVA 10 MG PILLOLI MIKSIJA B'RITA
leflunomide
AQRA SEW DAN IL-FULJETT KOLLU QABEL TIBDA TIEĦU DIN IL-MEDIĊINA
PERESS LI FIH INFORMAZZJONI
IMPORTANTI GĦALIK.
-
Żomm dan il-fuljett. Jista' jkollok bżonn terġa' taqrah.
-
Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib, lill-ispiżjar jew
l-infermier tiegħek.
-
Din il-mediċina ġiet mogħtija lilek biss. M'għandekx tgħaddiha
lil persuni oħra. Tista'
tagħmlilhom il-ħsara, anke jekk ikollhom l-istess sinjali ta’ mard
bħal tiegħek.
-
Jekk ikollok xi effett sekondarju, kellem
lit-tabib, lill-ispiżjar jew l-infermier
tiegħek. Dan
jinkludi xi effett sekondarju possibli li m’huwiex elenkat f’dan
il-fuljett.
F'DAN IL-FULJETT
:
1.
X'inhu Leflunomide Teva u għal xiex jintuża
2.
X’għandek tkun taf qabel ma tieħu Leflunomide Teva
3.
Kif għandek tieħu Leflunomide Teva
4.
Effetti sekondarji possibbli
5.
Kif taħżen Leflunomide Teva
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU
LEFLUNOAMIDE TEVA
U GĦALXIEX JINTUŻA
Leflunomide Teva jappartjeni għall-grupp ta' mediċini msejħa
antirewmatiċi. Fih is-sustanza attiva
leflunomide.
Leflunomide Teva jintuża fuq pazjenti adulti b'artrite rewmatojde
attiva.
L-artrite rewmatojde hija għamla ta’ artrite li tagħab lil
persuna. Is-sintomi jinkludu. infjammazzjoni
tal-ġogi, nefħa, diffikultà fil-movimenti u uġigħ. Sintomi oħra
li jistgħu jeffettwaw il-ġisem kollu
huma n-nuqqas t’aptit, id-deni, nuqqas ta’ enerġija u anemija
(nuqqas taċ-ċelluli ħomor tad-demm).
2.
X’ GĦANDEK TKUN TAF QABEL MA TIEĦU LEFLUNOMIDE TEVA
TIĦUX LEFLUNOMIDE TEVA
-
jekk int
ALLERĠIKU
(tbati minn sensittivita eċċessiva) għal leflunomide (speċjalment
xi reazzjoni
serja tal-ġilda, xi kultant bid-deni, uġigħ fil-ġog, dbabar ħomor
fuq il-ġilda, jew infafet eż.
is-sindromu ta' Stevens-Johnson) jew minn xi sustanza oħra ta' din
il-mediċina (elenkati fis-
                                
                                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 IL-PRODOTT MEDIĊINALI
Leflunomide Teva 10 mg pilloli miksija b’rita
2.
GĦAMLA KWALITTATIVA U KWANTITATTIVA
Kull pillola miksija b’rita fiha 10 mg ta’ leflunomide.
_Eċċipjenti b’effett magħruf _
Kull pillola fiha 97.25 mg ta’ lactose monohydrate u 3.125 mg
lactose anidru.
Għal-lista kompluta
ta’ eċċipjenti, ara s-sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Pillola miksija b’rita.
Pilloli miksija b’rita bojod u tondi li fuqhom hemm intaljat
“10” fuq naħa waħda u “L” fuq in-naħa
l-oħra.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Leflunomide hu indikat għall-kura ta’ pazjenti adulti b’artrite
rewmatojdi bħala "mediċina
antirewmatika li timmodifika l-marda" (DMARD).
Kura riċenti jew konkurrenti b’DMARDs epatotossiċi jew
ematotossiċi (eż. methotrexate) tista’
tirriżulta f'riskju ogħla ta’ reazzjonijiet avversi serji;
għalhekk, il-bidu ta’ kura b’leflunomide għandha
tiġi kkonsidrata bir-reqqa rigward l-aspetti ta’ siwi/ta’ riskju.
Barra minn hekk, meta taqleb minn leflunomide għal DMARD ieħor
mingħajr mal-pazjent isegwi
l-proċedura ta’ tneħħija (ara sezzjoni 4.4) jista’ jwassal
għal riskju ta’ reazzjonijiet avversi serji anke
għal żmien twil wara l-bidla.
4.2
POŻOLOĠIJA U METODU TA’ KIF GĦANDU JINGĦATA
Il-kura għandha tinbeda u tkun taħt is-superviżjoni ta’
speċjalisti b’esperjenza fil-kura tal-artrite
rewmatojdi.
Alanine aminotransferase (ALT) jew glutamopyruvate transferase
fis-serum (SGPT) u għadd sħiħ
taċ-ċelluli tad-demm, li jinkludi l-għadd divrenzjali ta’
ċelluli bojod tad-demm u l-għadd ta’ plejtlits,
għandhom jiġu ċċekjati u bl-istess frekwenza:
•
qabel ma jinbeda leflunomide,
•
kull ġimagħtejn matul l-ewwel sitt xhur ta’ kura, u
•
kull 8 ġimgħata wara dan (ara sezzjoni 4.4).
_Pożoloġija _
Prodott mediċinali li m’għadux awtorizzat
3
•
Fl-artrite rewmatika: Normal
                                
                                Read the complete document

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Active ingredient leflunomide

leflunomide

ATC code L04AA13

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Marketed by Teva Pharma B.V.

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INN (International Name) leflunomide

leflunomide

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