Avaglim

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
17-01-2011
Summary of Product characteristics Summary of Product characteristics (SPC)
17-01-2011
Public Assessment Report Public Assessment Report (PAR)
17-01-2011

Active ingredient:

rosiglitazone, glimepiride

Available from:

SmithKline Beecham Ltd

ATC code:

A10BD04

INN (International Name):

rosiglitazone, glimepiride

Therapeutic group:

Drogi użati fid-dijabete

Therapeutic area:

Diabetes Mellitus, Tip 2

Therapeutic indications:

AVAGLIM hu indikat biss fit-trattament tad-dijabete tat-tip 2 mellitus il-pazjenti li ma jistgħux jiksbu kontroll gliċemiku biżżejjed bl-aħjar dożaġġ ta ' monoterapija b'sulphonylurea, u li għalihom metformin mhux adattat minħabba kontra-indikazzjoni jew intolleranza.

Product summary:

Revision: 11

Authorization status:

Irtirat

Authorization date:

2006-06-27

Patient Information leaflet

                                Prodott mediċinali li m’għadux awtorizzat
50
B. FULJETT TA’ TAGĦRIF
Prodott mediċinali li m’għadux awtorizzat
51
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU
MINNHA
AVAGLIM PILLOLI TA’ 4 MG/4 MG MIKSIJIN B’RITA.
AVAGLIM PILLOLI TA’ 8 MG/4 MG MIKSIJIN B’RITA.
rosiglitazone/glimepiride
AQRA SEW DAN IL-FULJETT KOLLU QABEL TIBDA TIEĦU DIN IL-MEDIĊINA.
-
ŻOMM DAN IL-FULJETT. JISTA JKOLLOK BŻONN TERĠA’ TAQRAH.
-
Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib jew lill-ispiżjar
tiegħek.
-
Din il-mediċina ġiet mogħtija lilek. TAGĦTIHIEX lil persuni oħra.
Tista’ tagħmlilhom il-ħsara,
anki jekk ikollhom l-istess sintomi bħal tiegħek.
-
JEKK XI WIEĦED MILL-EFFETTI SEKONDARJI JIGGRAVA JEW JEKK TINNOTA XI
EFFETTI SEKONDARJI LI
M’HUMIEX IMSEMMIJIN F’DAN IL-FULJETT, JEKK JOGĦĠBOK, GĦID
LIT-TABIB JEW LILL-ISPIŻJAR
TIEGĦEK.
F’DAN IL-FULJETT:
1.
X’INHU AVAGLIM U GĦALXIEX JINTUŻA
2.
QABEL MA TIEĦU AVAGLIM
3.
KIF GĦANDEK TIEĦU AVAGLIM
4.
EFFETTI SEKONDARJI LI JISTA’ JKOLLU
5.
KIF TAĦŻEN AVAGLIM
6.
AKTAR TAGĦRIF
1.
X’INHU AVAGLIM
U GĦALXIEX JINTUŻA
IL-PILLOLI TA’ AVAGLIM HUMA KUMBINAZZJONI TA’ ŻEWĠ MEDIĊINI
DIFFERENTI
li jissejjħu
_rosiglitazone _
u
_glimepiride_
. Dawn iż-żewġ mediċini jintużaw biex jikkuraw
DIJABETE TAT-TIP 2.
Nies li jbatu minn dijabete tat-tip-2 jew ma jagħmlux biżżejjed
insulina (ormon li jikkontrolla il-livelli
ta’ zokkor fid-demm), jew ma jirrispondux normalment għall-insulina
li jagħmel ġisimhom.
Rosiglitazone u glimepiride jaħdmu flimkien biex ġismek jagħmel
użu aħjar mill-insulina li jipproduċi,
u dan jgħin biex inaqqas iz-zokkor fid-demm tiegħek għall-livell
normali..
2.
QABEL MA TIEĦU AVAGLIM
Biex tgħin fl-im
aniġġjar tad-dijabete tiegħek, huwa mportanti li ssegwi kull parir
ta’ dieta jew stil ta'
ħajja mingħand it-tabib tiegħek kif ukoll tieħu Avaglim.
TIEĦUX AVAGLIM:
-
JEKK INTI ALLERĠIKU
_(tbati minn sensittività eċċessiva)_
għal rosiglitazone, glimepiride, jew xi
wie
                                
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Summary of Product characteristics

                                Prodott mediċinali li m’għadux awtorizzat
1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
Prodott mediċinali li m’għadux awtorizzat
2
1.
ISEM TAL-PRODOTT MEDIĊINALI
AVAGLIM 4mg/4mg pilloli miksijin b’rita
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
_ _
Kull pillola fiha rosiglitazone maleate li jikkorrispondi għal 4mg
rosiglitazone u 4 mg glimepiride
Sustanza mhux attiva
- fih lattosju (bejn wieħed u ieħor 104 mg)
Għal-lista kompleta ta’ sustanzi mhux attivi, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Pillola miksija b’rita
Pillola roża, triangolari u magħmula fit-tond li għandha minqux
“gsk” fuq naħa waħda u “4/4” fuq in-
naħa l-oħra.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
AVAGLIM hu indikat biss fit-trattament ta’ pazjenti bid-dijabete
mellitus tip 2 li ma jistgħux jiksbu
kontroll gliċemiku biżżejjed bl-aħjar dożaġġ ta’ monoterapija
b’sulphonylurea, u li għalihom il-
metformin mhux adattat minħabba kontraindikazzjoni jew nuqqas ta’
tolleranza.
4.2
POŻOLOĠIJA U METODU TA’ KIF GĦANDU JINGĦATA
Terapija b’AVAGLIM għandha tkun individwalizzata għal kull
pazjent. Qabel ma tinbeda t-terapija
b’AVAGLIM għandha ssir evalwazzjoni klinika xierqa biex ikun
stabbilit ir-riskju ta’ żvilupp ta’
ipogliċemija (ara sezzjoni 4.4).
AVAGLIM għandu jittieħed darba kuljum ftit qabel jew waqt l-ikel
(normalment l-ewwel ikla sħiħa
tal-ġurnata). Jekk tinqabeż xi do
ża m
’għandhiex tiżdied id-doża li jkun imiss.
_Dwar pazjenti mhux kontrollati adegwatament b’monoterapija ta’
glimepride (tipikament 4 mg). _
Għandu jiġi kkunsidrat l-għoti fl-istess ħin meta pazjent
tinbdielu t-terapija b’AVAGLIM. Meta
klinikament xieraq, tista’ tiġi kkunsidrata bidla diretta minn
terapija bi glimepiride għal dik
b’AVAGLIM. Id-doża tal-bidu hi 4 mg/kuljum rosiglitazone u 4
mg/kuljum glimepiride (mogħtijin
bħala pillola AVAGLIM waħda ta’ 4 mg/4 mg).
_Pazjenti li ma jistgħux jiksbu kontroll gliċemiku b’doża
mill-anqas ta’ nofs il-mass
                                
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Active ingredient rosiglitazone, glimepiride

rosiglitazone, glimepiride

ATC code A10BD04

A10BD04

Marketed by SmithKline Beecham Ltd

SmithKline Beecham Ltd

INN (International Name) rosiglitazone, glimepiride

rosiglitazone, glimepiride

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Avaglim