Noxafil

Maa: Euroopan unioni

Kieli: sloveeni

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

posakonazol

Saatavilla:

Merck Sharp and Dohme B.V

ATC-koodi:

J02AC04

INN (Kansainvälinen yleisnimi):

posaconazole

Terapeuttinen ryhmä:

Antimikotiki za sistemsko uporabo

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 in 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 in 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. Refractoriness je opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. 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 in 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 in 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 in 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. Refractoriness je opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. 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 in 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 in 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. Refractoriness je opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. 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):- Invazivne aspergillosis pri bolnikih z boleznijo, ki je neodzivna, da amphotericin B ali itraconazole ali pri bolnikih, ki ne prenašajo teh zdravil;- Fusariosis pri bolnikih z boleznijo, ki je neodzivna, da amphotericin B ali pri bolnikih, ki so nestrpne amphotericin B;- Chromoblastomycosis in mycetoma pri bolnikih z boleznijo, ki je neodzivna, da itraconazole ali pri bolnikih, ki so nestrpne itraconazole;- Coccidioidomycosis pri bolnikih z boleznijo, ki je neodzivna, da amphotericin B, itraconazole ali fluconazole ali pri bolnikih, ki ne prenašajo teh zdravil;- Žrela kandidoza: kot prvo linijo zdravljenja pri bolnikih, ki imajo hude bolezni ali so immunocompromised, v kateri je odziv na aktualne terapija je pričakovati, da bo slaba. Refractoriness je opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. 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:

Pooblaščeni

Valtuutus päivämäärä:

2005-10-25

Pakkausseloste

109
B. NAVODILO ZA UPORABO
110
NAVODILO ZA UPORABO
NOXAFIL 40 MG/M
L PERORALNA
SUSPENZIJA
posakonazol
PRED
začet
KOM JEMANJA
ZDRAVILA NAT
ančno p
REBERITE NAVODILO, KER VSEBUJE ZA
VAS POMEMBNE
PODATKE!
-
Navodilo shrani
te. Morda ga boste želeli p
onovno prebrati.
-
Č
e imate dodatna vpr
ašan
ja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
-
Zdravilo je bilo pr
edpisano vam ose
bno in ga ne smete dajati drugim. Njim bi lahko celo
škodovalo, čepra
v imajo znake bol
ezni, podobne vašim
.
-
Če
opazite kateri koli n
eželeni uč
inek, se posvetujte z zdravnikom, farmacevtom ali medicinsko
sestro. Posvetujte se t
udi, če
opazite
katere koli neželene uč
inke, ki niso navedeni v tem
navodilu. G
lejte poglavje
4.
KAJ VSEBUJE NAVODILO
1.
Kaj je zdravilo Noxafi
l in za kaj ga uporabljamo
2.
Kaj morate vedeti, prede
n boste vzeli zdr
avilo Noxafil
3.
Kako jemati zdravilo Noxafil
4.
M
ožni neželeni učinki
5.
Shranjevanje zdravila Noxafil
6.
Vsebina pakiranja in dodatne informacije
1.
KAJ JE ZDRAVILO NOXAFIL IN ZA KAJ GA UPORABLJAMO
Zdravilo Noxafil vsebuje u
činkovi
no
posakonazol.
Ta u
čin
kovina
spada v skup
ino zdravil,
imenovanih "antimikot
iki" (protiglivn
a zdravila). Uporablja se za pr
epreč
evanje in zdravljenje
števi
lnih razli
čnih v
rst gl
ivnih okužb.
To zdravilo deluje tako, da un
ič
i nekatere vrste gliv, ki lahko povz
ročajo okužbe
, ali ustavi njihovo
rast.
Zdravilo Noxafil se lahko uporablja pri odraslih bolnikih za
zdravljenje naslednjih vrst glivni
h okužb
,
kadar druga protiglivna zdravila niso bila
učinkov
ita ali so vam jih morali ukiniti:
•
ok
užb, k
i jih pov
zročajo
glive iz
družine
Aspergillus in ki se niso izbo
ljšale m
ed zdravljenjem s
pr
otiglivnima zdra
viloma amfotericin B ali itrakonazol, ali
če
je bilo treba ti dve zdravili ukiniti;
•
o
kužb, ki jih p
o
vzročajo gliv
e iz
družine
Fusarium in ki se niso izbolj
ša
le med zdr
avljenjem z
amfotericinom B
, ali če
je bilo treba amfotericin B ukiniti;
•
okužb z glivami,
ki p
ovzročajo

Valmisteyhteenveto

1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
2
1.
IME ZDRAVILA
Noxafil 40
mg/ml peroralna suspenzija
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
En
ml peroralne suspenzije vsebuje 40
mg posakonazola.
Pomožn
a(e) snov(i)
z znanim uč
inkom:
To zdravilo vsebuje približno 1,75
g glukoze na 5
ml suspenzije.
To zdravilo vsebuje
10 mg
natrijevega benzoat
a (E211) na 5
ml suspenzije.
To zdravilo vsebuje
do 1,25 mg benzilalkohola na 5 ml suspenzije.
To zdravilo vsebuje do 24,75
mg propilenglikola (E1520) na 5
ml suspenzije.
Za celoten seznam pomožnih snovi glejte poglavje
6.1.
3.
FARMACEVTSKA OBLIKA
p
eroralna suspenzija
b
ela suspenzija
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Zdravilo Noxafil
peroralna suspenzija
je indicirano za zdravljenje
naslednjih glivnih okužb pri
odraslih (glejte poglavje
5.1):
-
invazivne aspergiloze pri bolnikih z okužbo, odporn
o
na amfotericin B ali itrakonazol, ter pri
bolnikih, ki ne prenašajo teh zdravil
,
-
fuza
rioze pri bolnikih z okužbo, od
porno na a
mfotericin B, ter pri bolnikih, ki ne prenašajo
amfotericina B
,
-
kromoblastomikoze in micetoma pri bolnikih z okužbo, odporn
o
na itrakonazol
,
ter pri bolnikih,
ki ne prenašajo itrakonazola
,
-
kokcidioidomikoze pr
i bolnikih z okužbo, odporn
o na amfoteric
in B, itrakonazol ali flukonazol
,
ter pri bolnikih, ki ne prenašajo teh zdravil
,
-
orofaringealn
e kandidoze
: kot terapija prve izbire pri bolnikih s hudo okužbo ali pri tistih
z
imunsko pomanjkljivostjo
, pri katerih
pričakujemo, da bo odziv na to
pikalno te
rapijo slab.
Odpornost na zdravilo je opredeljena kot napredovanje okužbe ali
brez
izboljšanja po najmanj
7-dnevnem predhodn
em zdravljenju s terapevtskimi odmerki
učinkovit
ega
antimikotičn
ega zdravila.
Zdravilo Noxafil
peroralna suspenzija
je indicirano
tudi za profilakso invazivnih glivnih okužb pri
:
-
bolnikih, ki prejemajo kemoterapijo za doseganje remisije akutne
mieloične levkemije
(AML)
ali mielodisplastičnih sindromov (MDS) in pri katerih
se zato
pričakuje dolgotrajnejš
a
nevtropenija