Staquis

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
08-02-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
08-02-2022
Public Assessment Report Public Assessment Report (PAR)
08-02-2022

Active ingredient:

Crisaborole

Available from:

Pfizer Europe MA EEIG 

ATC code:

D11AH06

INN (International Name):

crisaborole

Therapeutic group:

Preparazzjonijiet oħra dermatoloġiċi

Therapeutic area:

Dermatite, Atopika

Therapeutic indications:

Staquis huwa indikat għall-kura ta ħfief għal moderati-dermatite atopika fl-adulti u f'pazjenti pedjatriċi minn 2-il sena ma ' ≤ 40% - superfiċje tal-ġisem (BSA) milquta.

Product summary:

Revision: 6

Authorization status:

Irtirat

Authorization date:

2020-03-27

Patient Information leaflet

                                24
B. FULJETT TA’ TAGĦRIF
Prodott mediċinali li m’għadux awtorizzat
25
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-PAZJENT
STAQUIS 20 MG/G INGWENT
crisaborole
Dan il-prodott mediċinali huwa suġġett għal monitoraġġ
addizzjonali. Dan ser jippermetti
identifikazzjoni ta’ malajr ta’ informazzjoni ġdida dwar
is-sigurtà. Inti tista’ tgħin billi tirrapporta
kwalunkwe effett sekondarju li jista’ jkollok. Ara t-tmiem ta’
sezzjoni 4 biex tara kif għandek
tirrapporta effetti sekondarji.
AQRA SEW DAN IL-FULJETT KOLLU QABEL TIBDA TUŻA 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
lill-infermier tiegħek.
-
Din il-mediċina ġiet mogħtija lilek biss. M’għandekx tgħaddiha
lil persuni oħra. Tista’
tagħmlilhom il-ħsara anke jekk għandhom l-istess sinjali ta’ mard
bħal tiegħek.
-
Jekk ikollok xi effett sekondarju, kellem lit-tabib, lill-ispiżjar
jew lill-infermier tiegħek. Dan
jinkludi xi effett sekondarju possibbli li mhuwiex elenkat f’dan
il-fuljett. Ara sezzjoni 4.
F᾽DAN IL-FULJETT
1.
X’inhu Staquis u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tuża Staquis
3.
Kif għandek tuża Staquis
4.
Effetti sekondarji possibbli
5.
Kif taħżen Staquis
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU STAQUIS U GĦALXIEX JINTUŻA
Staquis fih is-sustanza attiva crisaborole. Staquis jintuża fuq
il-ġilda biex jikkontrolla s-sintomi ta’
dermatite atopika ħafifa sa moderata f’adulti u fit-tfal minn età
ta’ sentejn. Dermatite atopika, imsejħa
wkoll ekżema atopika, tikkawża infjammazzjoni, ħmura, ħakk, ġilda
xotta u ħxuna tal-ġilda f’nies li
huma suxxettibbli għall-allerġiji. L-ingwent m’għandux jintuża
fuq aktar minn 40% tal-erja tas-
superfiċje ta’ ġismek.
Crisaborole, is-sustanza attiva fi Staquis, huwa maħsub li jaħdem
billi jnaqqas infjammazzjoni u xi
effetti tas-sistema immuni (id-dif
                                
                                Read the complete document

Summary of Product characteristics

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
Prodott mediċinali li m’għadux awtorizzat
2
Dan il-prodott mediċinali huwa suġġett għal monitoraġġ
addizzjonali. Dan ser jippermetti
identifikazzjoni ta’ malajr ta’ informazzjoni ġdida dwar
is-sigurtà. Il-professjonisti tal-kura tas-saħħa
huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata. Ara
sezzjoni 4.8 dwar kif
għandhom jiġu rappurtati reazzjonijiet avversi.
1.
ISEM IL-PRODOTT MEDIĊINALI
Staquis 20 mg/g ingwent
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
1 g ta’ ingwent fiha 20 mg ta’ crisaborole.
Eċċipjenti b’effett magħruf
Propylene glycol, 90 mg/g ta’ ingwent
Għal-lista sħiħa ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Ingwent.
Ingwent abjad għal abjad jagħti fil-griż jew fl-isfar.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Staquis huwa indikat għall-kura ta’ dermatite atopika ħafifa sa
moderata f’adulti u f’pazjenti pedjatriċi
minn età ta’ sentejn b’≤ 40% tal-erja tas-superfiċje
tal-ġisem (_body surface area_ - BSA) affettwata.
4.2
POŻOLOĠIJA U METODU TA’ KIF GĦANDU JINGĦATA
Pożoloġija
_Adulti_
Saff ta’ ingwent jiġi applikat darbtejn kuljum fuq il-partijiet
affettwati.
L-ingwent għandu jiġi applikat biss fuq il-partijiet tal-ġilda
affettwati sa massimu ta’ 40% BSA.
L-ingwent jista’ jintuża fuq il-partijiet kollha tal-ġilda, ħlief
fuq il-qorriegħa. L-użu fuq il-qorriegħa
ma ġiex studjat.
L-ingwent jista’ jintuża darbtejn kuljum sa 4 ġimgħat għal kull
kors ta’ kura. Jekk xi sinjali u/jew
sintomi jippersistu, jew jekk ifeġġu partijiet ġodda affettwati
b’dermatite atopika, jistgħu jintużaw
kors(ijiet) ta’ kura ulterjuri sakemm l-applikazzjoni ma taqbiżx 40
% tal-BSA (ara sezzjoni 5.1).
L-użu tal-ingwent għandu jitwaqqaf jekk is-sinjali u/jew is-sintomi
fuq partijiet affettwati jippersistu
wara 3 korsijiet ta’ kura konsekuttivi ta’ 4 ġimgħat kull
wieħed jew jekk is-sinjali u/jew is-sintomi
jaggravaw matul il-kura.
                                
                                Read the complete document

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Active ingredient Crisaborole

Crisaborole

ATC code D11AH06

D11AH06

Marketed by Pfizer Europe MA EEIG 

Pfizer Europe MA EEIG 

INN (International Name) crisaborole

crisaborole

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