Noxafil

Nchi: Umoja wa Ulaya

Lugha: Kimalta

Chanzo: EMA (European Medicines Agency)

Viambatanisho vya kazi:

posaconazole

Inapatikana kutoka:

Merck Sharp and Dohme B.V

ATC kanuni:

J02AC04

INN (Jina la Kimataifa):

posaconazole

Kundi la matibabu:

Antimikotiċi għal użu sistemiku

Eneo la matibabu:

Candidiasis; Mycoses; Coccidioidomycosis; Aspergillosis

Matibabu dalili:

Noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 u 5. 1):- Invasive aspergillosisNoxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections  4. 2 u 5. 1):- Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;- Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;- Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. Ir-refrattorjetà hija definita bħala l-progressjoni tal-infezzjoni jew nuqqas ta 'titjib wara minimu ta' 7 ijiem ta 'dożi terapewtiċi preċedenti ta' terapija antifungali effettiva. Noxafil gastro-resistant tablets are also indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections 4. 2 u 5. 1):- Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. Please refer to the Summary of Product Characteristics of Noxafil oral suspension for use in oropharyngeal candidiasis.  Noxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 u 5. 1):- Invasive aspergillosisNoxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adult and paediatric patients from 2 years of age (see sections 4. 2 u 5. 1):- Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;- Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;- Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. Ir-refrattorjetà hija definita bħala l-progressjoni tal-infezzjoni jew nuqqas ta 'titjib wara minimu ta' 7 ijiem ta 'dożi terapewtiċi preċedenti ta' terapija antifungali effettiva. Noxafil concentrate for solution for infusion is also indicated for prophylaxis of invasive fungal infections in the following adult and paediatric patients from 2 years of age (see sections 4. 2 u 5. 1):- Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (GVHD) and who are at high risk of developing invasive fungal infections. Please refer to the Summary of Product Characteristics of Noxafil oral suspension for use in oropharyngeal candidiasis.  Noxafil gastro resistant powder and solvent for oral suspension is indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age (see sections 4. 2 u 5. 1):- Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;- Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;- Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. Ir-refrattorjetà hija definita bħala l-progressjoni tal-infezzjoni jew nuqqas ta 'titjib wara minimu ta' 7 ijiem ta 'dożi terapewtiċi preċedenti ta' terapija antifungali effettiva. Noxafil gastro-resistant powder and solvent for oral suspension is indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2  years of age:- Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high  risk of developing invasive fungal infections;- Haematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high  risk of developing invasive fungal infections. Please refer to the Summary of Product Characteristics of Noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis. Please refer to the Summary of Product Characteristics of Noxafil oral suspension for use in oropharyngeal candidiasis.  Noxafil oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5. 1): il - każ tal-asperġillożi Invażiva f'pazjenti b'mard li hu refrattarju għal amphotericin B jew itraconazole jew f'pazjenti intolleranti għal dawn il-prodotti mediċinali; l - Fusarjożi f'pazjenti b'mard li hu refrattarju għal amphotericin B jew f'pazjenti intolleranti għal amphotericin B;- Kromoblastomikożi u miċetoma f'pazjenti b'mard li hu refrattarju għal itraconazole jew f'pazjenti intolleranti għal itraconazole;- Kokkidajojdomikożi f'pazjenti b'mard li hu refrattarju għal amphotericin B, itraconazole jew fluconazole jew f'pazjenti intolleranti għal dawn il-prodotti mediċinali;- Kandidijażi orofarinġali: bħala l-kura preferita f'pazjenti li għandhom mard sever jew li huma immunokompromessi, li r-rispons għal terapija topika hija mistennija li tkun fqir. Ir-refrattorjetà hija definita bħala l-progressjoni tal-infezzjoni jew nuqqas ta 'titjib wara minimu ta' 7 ijiem ta 'dożi terapewtiċi preċedenti ta' terapija antifungali effettiva. Noxafil oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients:- Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. Please refer to the Summary of Product Characteristics of Noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis.

Bidhaa muhtasari:

Revision: 37

Idhini hali ya:

Awtorizzat

Idhini ya tarehe:

2005-10-25

Taarifa za kipeperushi

110
B. FULJETT TA’ TAGĦRIF
111
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-UTENT
NOXAFIL 40 MG/ML SUSPENSJONI ORALI
posaconazole
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
lill-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
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 Noxafil u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tieħu Noxafil
3.
Kif għandek tieħu Noxafil
4.
Effetti sekondarji possibbli
5.
Kif taħżen Noxafil
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU NOXAFIL U GЋALXIEX JINTUŻA
Noxafil fih mediċina msejħa posaconazole. Dan jappartjeni għal
grupp ta’ mediċini msejħa
“antifungali”. Jintuża biex jimpedixxi u jikkura bosta
infezzjonijiet fungali differenti.
Din il-mediċina taħdem billi toqtol jew twaqqaf milli jikbru ċerti
tipi ta’ fungi li jistgħu jikkawżaw
infezzjonijiet.
Noxafil jista’ jintuża fl-adulti biex jikkura dawn it-tipi ta’
infezzjonijiet tal-fungu meta mediċini
antifungali oħrajn ma jkunux ħadmu jew inti tkun waqaft teħodhom:
•
infezzjonijiet ikkawżati minn fungu tal-familja tal-
_Aspergillus_
li ma jkunux tjiebu meta jkunu
ġew ikkurati bil-mediċini kontra l-fungu amphotericin B jew
itraconazole jew meta dawn il-
mediċini kellhom jitwaqqfu;
•
infezzjonijiet ikkawżati minn fungu tal-familja
_Fusarium_
li ma jkunux tjiebu meta jkunu ġew
ikkurati b’amphotericin B jew meta amphotericin B kellu jitwaqqaf;
•
infezzjonijiet ikkawżati minn fungu li jikkawża kondizzjonijiet
imsejħin kro

Tabia za bidhaa

1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
2
1.
ISEM IL-PRODOTT MEDIĊINALI
Noxafil 40 mg/mL suspensjoni orali
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
_ _
Kull mL ta’ suspensjoni orali fih 40 mg ta’ posaconazole.
Eċċipjenti b’effett magħruf
Dan il-prodott mediċinali fih madwar 1.75 g ta’ glucose għal kull
5 mL ta’ suspensjoni.
Dan il-prodott mediċinali fih 10 mg ta’ sodium benzoate (E211)
għal kull 5 mL ta’ suspensjoni.
Dan il-prodott mediċinali fih sa 1.25 mg ta’ benzyl alcohol għal
kull 5 mL ta’ suspensjoni.
Dan il-prodott mediċinali fih sa 24.75 mg ta’ propylene glycol
(E1520) għal kull 5 mL ta’ suspensjoni.
Għal-lista kompluta ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Suspensjoni orali
Suspensjoni bajda
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Noxafil suspensjoni orali jintuża għall-kura ta’ infezzjonijiet
tal-fungu f’adulti (ara sezzjoni 5.1):
-
Asperġillożi invażiva f’pazjenti b’mard li hu refrattarju għal
amphotericin B jew itraconazole
jew f’pazjenti intolleranti għal dawn il-prodotti mediċinali;
-
Fusarjożi f’pazjenti b’mard li hu refrattarju għal amphotericin
B jew f’pazjenti intolleranti għal
amphotericin B;
-
Kromoblastomikożi u miċetoma f’pazjenti b’mard li hu refrattarju
għal itraconazole jew
f’pazjenti intolleranti għal itraconazole;
-
Kokkidajojdomikożi f’pazjenti b’mard li hu refrattarju għal
amphotericin B, itraconazole jew
fluconazole jew f’pazjenti intolleranti għal dawn il-prodotti
mediċinali;
-
Kandidijażi orofarinġali: bħala l-kura preferita f’pazjenti li
għandhom mard sever jew li
għandhom is-sistema immuni kompromessa, li jkunu mistennija li
jkollhom rispons fqir għal
terapija topika.
Tkun definita refrattarja meta l-infezzjoni tavvanza jew ma titjiebx
wara mill-anqas 7 ijiem ta’ dożi
terapewtiċi b’terapija effettiva kontra l-fungu li jkunu ngħataw
qabel.
Noxafil suspensjoni orali huwa indikat ukoll għal profilassi ta’
infezzjonijiet tal-fungu invas