Voriconazole Hikma (previously Voriconazole Hospira)

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Active ingredient:

voriconazole

Available from:

Hikma Farmaceutica (Portugal) S.A.

ATC code:

J02AC03

INN (International Name):

voriconazole

Therapeutic group:

Antimikotiċi għal użu sistemiku

Therapeutic area:

Bacterial Infections and Mycoses; Aspergillosis; Candidiasis

Therapeutic indications:

Voriconazole huwa triazole bi spettru wiesa'li aġent antifungali u hija indikata fl-adulti u t-tfal b'età minn 2 snin u l-fuq kif ġej:trattament ta 'asperġillożi invażiva;it-trattament ta'candidaemia f'pazjenti mhux newtropeniċi;il-kura ta' fluconazole-'infezzjonijiet invażivi serji Candida reżistenti (inkluż C. krusei);il-kura ta'infezzjonijiet fungali serji kkawżati minn Scedosporium spp. u Fusarium spp. Voriconazole għandu jingħata primarjament lil pazjenti b'progressiva, possibbilment ta'theddida għall-ħajja infezzjonijiet. Profilassi ta ' infezzjonijiet fungali invażivi f'riskju għoli alloġeneiċi trapjant ta'ċelloli staminali ematopojetiċi (HSCT)riċevituri.

Product summary:

Revision: 12

Authorization status:

Awtorizzat

Authorization date:

2015-05-27

Patient Information leaflet

                                49
B. FULJETT TA’ TAGĦRIF
50
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-UTENT
VORICONAZOLE HIKMA 200 MG TRAB GĦAL SOLUZZJONI GĦALL-INFUŻJONI
voriconazole
AQRA 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 xi 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, anki 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 possibbli li mhuwiex elenkat f’dan il-fuljett (ara
sezzjoni 4).
X’HEMM F’DAN IL-FULJETT
:
1.
X’inhu Voriconazole Hikma u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tieħu Voriconazole Hikma
3.
Kif għandek tieħu Voriconazole Hikma
4.
Effetti sekondarji possibbli
5.
Kif taħżen Voriconazole Hikma
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU VORICONAZOLE HIKMA U GĦALXIEX JINTUŻA
Voriconazole Hikma fih is-sustanza attiva voriconazole. Voriconazole
Hikma huwa mediċina
antifungali. Huwa jaħdem billi joqtol jew iwaqqaf it-tkabbir
tal-moffa li tikkawża l-infezzjonijiet.
Huwa jintuża għat-trattament tal-pazjenti (adulti u tfal li
għandhom aktar minn sentejn) li għandhom:
•
aspergillosis invażiva (tip ta’ infezzjoni fungali b’
_Aspergillus sp_
),
•
kandidemija (tip ieħor ta’ infezzjoni fungali minħabba
_Candida sp_
) f’pazjenti li m’għandomx
newtropenja (pazjenti li m’għandhomx għadd ta’ ċelloli bojod
tad-demm baxx mhux normali),
•
infezzjonijiet invażivi serji ta’
_Candida sp._
fejn il-moffa hija reżistenti għal fluconazole
(mediċina antifungali oħra),
•
infezzjonijiet fungali serji kkawżati minn
_Scedosporium spp_
. u
_Fusarium spp._
(żewġ
speċi differenti ta’ fungus).
Voriconazole Hikma huwa maħsub għal paz
                                
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Summary of Product characteristics

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
2
1.
ISEM IL-PRODOTT MEDIĊINALI
Voriconazole Hikma 200 mg trab għal soluzzjoni għall-infużjoni
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Kull kunjett fih 200 mg ta’ voriconazole.
Wara r-rikostituzzjoni kull ml fih 10 mg ta’ voriconazole. Ladarba
jiġi rikostitwit jeħtieġ li jiġi
mħallat aktar qabel jingħata.
Eċċipjent b’effett magħruf
Kull kunjett fih 217.6 mg sodju.
Kull kunjett fih 3,200 mg cyclodextrin.
Għal-lista kompluta ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Trab għal soluzzjoni għall-infużjoni (trab għall-infużjoni)
Kejk abjad għal ofwajt lijofilizzat.
Il-pH tas-soluzzjoni rikostitwita hi 4.0 sa 7.0.
Osmolalità: 500 ± 50 mOsm/kg
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Voriconazole huwa aġent antifungali triazole bi spettru wiesa’ li
huwa indikat fl-adulti u fit-tfal ta’
sentejn jew aktar kif ġej:
•
Kura ta’ asperġillosi invażiva.
•
Kura ta’ kandidemija f’pazjenti mhux newtropeniċi.
•
Kura ta’ infezzjonijiet invażivi serji
_Candida_
reżistenti għal fluconazole (fosthom
_C. krusei_
).
•
Kura ta’ infezzjonijiet fungali serji kkawżati minn
_Scedosporium_
spp. u
_Fusarium_
spp.
Voriconazole għandu jingħata primarjament lil pazjenti
b’infezzjonijiet progressivi li jistgħu
jkunu ta’ periklu għall-ħajja.
Profilassi ta’ infezzjonijiet fungali invażivi f’riċevituri
alloġeniċi f’riskju għoli ta’ trapjant ta’
ċelluli steminali ematopojetiċi (hematopoietic stem cell transplant,
HSCT).
4.2
POŻOLOĠIJA U METODU TA’ KIF GĦANDU JINGĦATA
Pożoloġija
Disturbi elettroliti bħal ipokalimja, ipomanjesemija u ipokalċimja
għandhom jiġu mmonitorjati u
korretti, jekk ikun meħtieġ, qabel ma tinbeda u waqt terapija
b’voriconazole (ara sezzjoni 4.4).
3
Huwa rrikmandat li voriconazole jingħata b’rata massima ta’ 3
mg/kg fis-siegħa fuq siegħa jew 3
sigħat.
Trattament
_Adulti_
Vorconazole Hikma 200 mg trab għal soluzzjoni għall-infużjoni hu
għa
                                
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Public Assessment Report Public Assessment Report Bulgarian 01-03-2017
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