Noxafil

Maa: Euroopan unioni

Kieli: kroatia

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

posakonazol

Saatavilla:

Merck Sharp and Dohme B.V

ATC-koodi:

J02AC04

INN (Kansainvälinen yleisnimi):

posaconazole

Terapeuttinen ryhmä:

Antimikotika za sustavnu uporabu

Terapeuttinen alue:

Candidiasis; Mycoses; Coccidioidomycosis; Aspergillosis

Käyttöaiheet:

Noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 i 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 i 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. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. 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 i 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 i 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 i 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. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. 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 i 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 i 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. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. 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):- 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;- Oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. 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.

Tuoteyhteenveto:

Revision: 37

Valtuutuksen tilan:

odobren

Valtuutus päivämäärä:

2005-10-25

Pakkausseloste

1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
Noxafil 40
mg/ml oralna suspenzija
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Jedan ml oralne suspenzije sadrži 40
mg posakonazola.
Pomoćne
tvari
s poznatim učinkom
Ovaj l
ijek sadrži približno 1,75
g glukoze u 5
ml suspenzije.
Ovaj lijek sadrži 10
mg natrijevog benzoata (E211) u 5
ml suspenzije.
Ovaj lijek sadrži do 1,25
mg benzilnog alkohola u 5
ml suspenzije.
Ovaj lijek sadrži do 24,75
mg propilenglikola (E1520) u 5
ml suspenzije.
Za cjeloviti popis pomoćnih tvari vidjeti dio
6.1.
3.
FARMACEUTSKI OBLIK
Oralna suspenzija
Bijela suspenzija
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Noxafil
oralna suspenzija
indicirana je
za liječenje sljedećih gljivičnih infekci
j
a u odraslih osoba
(vidjeti dio 5.1):
-
invazivne aspergiloze u bolesnika koji ne reagiraju na liječenje
amfotericinom B ili
itrakonazolom ili u bolesnika koji ne podnose ove lijekove;
-
fuzarioze u bolesnika koji ne reagiraju na liječenje amfotericinom
B ili u bolesnika koji ne
podnose amfotericin B;
-
kromoblastomikoze i micetoma u bolesnika koji ne reagiraju na
liječenje itrakonazolom ili u
bolesnika koji ne podnose itrakonazol;
-
kokcidioidomikoze u bolesnika koji ne reagiraju na liječenje amfoteri
c
inom B, itrakonazolom ili
flukonazolom ili u bolesnika koji ne podnose ove lijekove;
-
kandidijaze usta i ždrijela, kao prva linija liječenja bolesnika s
teškim oblikom bolesti ili
imunokompromitiranih bolesnika u kojih se očekuje slab odgovor na
topikaln
u terapiju.
Izostanak odgovora na liječenje definira se kao napredovanje
infekcije ili izostanak poboljšanja nakon
najmanje 7
dana primjene terapijskih doza djelotvornih antimikotika.
Noxafil
oralna suspenzija
indicirana je
i za profilaksu invazivnih glj
i
vičnih infekcija u sljedećih
bolesnika:
-
u bolesnika s akutnom mijeloičnom leukemijom (AML) ili
mijelodisplastičnim sindromima
(MDS) koji primaju kemoterapiju za postizanje remisije bolesti za koju
se očekuje da će
izazvati dugotrajnu neutropeniju i u ko
j
ih p

Valmisteyhteenveto

1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
Noxafil 40
mg/ml oralna suspenzija
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Jedan ml oralne suspenzije sadrži 40
mg posakonazola.
Pomoćne
tvari
s poznatim učinkom
Ovaj l
ijek sadrži približno 1,75
g glukoze u 5
ml suspenzije.
Ovaj lijek sadrži 10
mg natrijevog benzoata (E211) u 5
ml suspenzije.
Ovaj lijek sadrži do 1,25
mg benzilnog alkohola u 5
ml suspenzije.
Ovaj lijek sadrži do 24,75
mg propilenglikola (E1520) u 5
ml suspenzije.
Za cjeloviti popis pomoćnih tvari vidjeti dio
6.1.
3.
FARMACEUTSKI OBLIK
Oralna suspenzija
Bijela suspenzija
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Noxafil
oralna suspenzija
indicirana je
za liječenje sljedećih gljivičnih infekci
j
a u odraslih osoba
(vidjeti dio 5.1):
-
invazivne aspergiloze u bolesnika koji ne reagiraju na liječenje
amfotericinom B ili
itrakonazolom ili u bolesnika koji ne podnose ove lijekove;
-
fuzarioze u bolesnika koji ne reagiraju na liječenje amfotericinom
B ili u bolesnika koji ne
podnose amfotericin B;
-
kromoblastomikoze i micetoma u bolesnika koji ne reagiraju na
liječenje itrakonazolom ili u
bolesnika koji ne podnose itrakonazol;
-
kokcidioidomikoze u bolesnika koji ne reagiraju na liječenje amfoteri
c
inom B, itrakonazolom ili
flukonazolom ili u bolesnika koji ne podnose ove lijekove;
-
kandidijaze usta i ždrijela, kao prva linija liječenja bolesnika s
teškim oblikom bolesti ili
imunokompromitiranih bolesnika u kojih se očekuje slab odgovor na
topikaln
u terapiju.
Izostanak odgovora na liječenje definira se kao napredovanje
infekcije ili izostanak poboljšanja nakon
najmanje 7
dana primjene terapijskih doza djelotvornih antimikotika.
Noxafil
oralna suspenzija
indicirana je
i za profilaksu invazivnih glj
i
vičnih infekcija u sljedećih
bolesnika:
-
u bolesnika s akutnom mijeloičnom leukemijom (AML) ili
mijelodisplastičnim sindromima
(MDS) koji primaju kemoterapiju za postizanje remisije bolesti za koju
se očekuje da će
izazvati dugotrajnu neutropeniju i u ko
j
ih p