Noxafil

Land: Europese Unie

Taal: Noors

Bron: EMA (European Medicines Agency)

Werkstoffen:

posakonazol

Beschikbaar vanaf:

Merck Sharp and Dohme B.V

ATC-code:

J02AC04

INN (Algemene Internationale Benaming):

posaconazole

Therapeutische categorie:

Antimykotika for systemisk bruk

Therapeutisch gebied:

Candidiasis; Mycoses; Coccidioidomycosis; Aspergillosis

therapeutische indicaties:

Noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 og 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 og 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. Refraktivitet er definert som progresjon av infeksjon eller unnlatelse av å forbedre etter minimum 7 dager før terapeutiske doser av effektive soppdrepende behandling. 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 og 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 og 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 og 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. Refraktivitet er definert som progresjon av infeksjon eller unnlatelse av å forbedre etter minimum 7 dager før terapeutiske doser av effektive soppdrepende behandling. 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 og 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 og 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. Refraktivitet er definert som progresjon av infeksjon eller unnlatelse av å forbedre etter minimum 7 dager før terapeutiske doser av effektive soppdrepende behandling. 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. Refraktivitet er definert som progresjon av infeksjon eller unnlatelse av å forbedre etter minimum 7 dager før terapeutiske doser av effektive soppdrepende behandling. 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.

Product samenvatting:

Revision: 37

Autorisatie-status:

autorisert

Autorisatie datum:

2005-10-25

Bijsluiter

90
OPPLYSNING
ER SOM S
KAL ANGIS PÅ Y
TRE EMBALLASJE
YTRE KARTONG
1.
LEGEMIDLETS NAVN
Noxafil 100 mg enterotabletter
posakonazol
2.
D
EKLARASJON AV VIRKESTOFF(ER)
Hver enterotablett
inneholder 100 mg posakonazol.
3.
LISTE OVE
R HJELPESTOFFER
4.
LEGEMIDDELFORM OG INN
HOLD (PAKNINGSST
ØRRELSE)
24
enterotabletter
96
enterotabletter
5.
ADMI
NISTRASJO
NSMÅTE OG -VEI(ER)
Les pakningsvedle
gget før bruk.
Oral bruk
6.
ADVARSEL OM AT LEGEM
IDLET SKAL OPPBEVARES UTILGJENGELIG FOR
BARN
Oppbevares utilgjengeli
g for barn.
7.
EVENTUELLE ANDRE
SP
ESIELLE ADVARSLER
NOXAFIL MIKSTUR, SUSPENSJON OG
TABLETTER SKAL IKKE BRUKES OM HVERANDRE.
8.
UTLØPSDATO
EXP
9.
OPPBEVARINGSBETINGELSER
10.
EVENTUELLE SPESIELLE FORHOLDSREGLER
VED DESTRUKS
JON AV
UBRUKTE LEGEMIDLER
ELLER AVFALL
91
11.
NAVN OG ADRESS
E
PÅ INNEHAVEREN AV MARKEDSFØRINGSTILLATELSEN
Merck Shar
p & Dohme
B.V.
Waarderweg
39
2031 BN Haarlem
Nederland
12.
MARKEDSFØRINGSTILLATELSESNUMMER (NU
MRE)
EU/1/05/320/002
24 tabletter
EU/1/05/320/003
96 tabletter
13.
PRODUKSJONS
NUMMER
Lot
14.
GENE
RELL KLASSIFIKASJON FOR UTLEVERING
15.
BRUKSANVI
SNING
16.
INFORMAS
JON PÅ BLI
NDESKRIFT
noxafil tabletter
17.
SIKKERHETSANORDNING (UNIK IDENTITET
)
– TODIMENSJONAL STREKKODE
Todi
mensjonal st
r
ekkode, inkludert unik
identitet
18.
SIKKERHETSANORDNING (
UNIK IDENTITET)
–
I ET FORMAT LESBART FOR
MENNESKE
R
PC
SN
NN
92
MINST
EKRAV TIL
OPPLYSNING
ER SOM SKAL
ANGIS PÅ
BLISTER
ELLER STRIP
BLISTER
1.
LEGEMIDLETS NAVN
Noxafil 100 mg enterotabletter
posakonazol
2.
NAVN PÅ INNEHAVEREN AV M
ARKEDSFØRINGSTILLAT
ELSEN
MSD
3.
UTLØPSDATO
EXP
4.
PRODUKSJONSNU
MMER
Lot
5.
ANNET
93
OPPLYSNINGER SO
M SKAL ANGI
S PÅ
YTRE EMBALLASJE
YTRE KARTONG
1.
LEGEMIDLETS NAVN
Noxafil 300 mg konsentrat til infusjonsvæske
, oppløsning
posakonazol
2.
DE
KLARASJON
AV VIRKES
TOFF(ER)
Hvert
hetteglass inneholder 300
mg posakonazol.
Hver ml inneholder 18 mg posakonazol.
3.
LI
STE OVER HJELPESTOFFER
Hjelpe
stoffer: Betadex Sulfobutyl
Ether Sodium (SBECD), d
inatriumedet
at, saltsyre og
natriumhydroksid (til pH
-j

Productkenmerken

1
VEDLEGG I
PREPARATOMTALE
2
1.
LEGEMIDLETS NAVN
Noxafil 40
mg/ml mikstur, suspensjon
2.
KVALITATIV OG KVANTITATIV SAMMENSETNING
Hver ml mikstur, suspensjon inneholder 40
mg posakonazol.
Hjelpestoffer
med kjent effekt
Dette legemidl
et inneholder ca
. 1,75
g glukose per 5
ml suspensjon.
Dette legemidlet inneholder
10 mg
natriumbenzoat (
E211) per 5
ml suspensjon
.
Dette legemidlet inneholder
opptil 1,25
mg benzylalkohol
per 5
ml suspensjon
.
Dette legemidlet inneholder
opptil 24,75 mg p
ropylenglykol
(E1520) per 5
ml suspensjon
.
For fullstendig liste over hjelpestoffer
, se pkt. 6.1.
3.
LEGEMIDDELFORM
Mikstur, suspensjon
Hvit suspensjon
4.
KLINISKE OPPLYSNINGER
4.1
INDIKASJONER
Noxafil
mikstur, suspensjon
er indisert for behandlin
g av følgende soppinfeksjoner hos voksne (se
pkt. 5.1):
-
Invasiv aspergillose hos pasienter med sykdom som er motstandsdyktig
mot amfotericin
B eller
itrakonazol, eller hos pasienter som ikke tolererer disse legemidlene;
-
Fusariose hos pasient
er med sykdom s
om er motstandsdyktig mot amfotericin
B eller hos
pasienter som ikke tolererer amfotericin
B;
-
Kromoblastmykose og mycetom hos pasienter med sykdom som er
motstandsdyktig mot
itrakonazol eller hos pasienter som ikke tolererer itrakonazol;
-
Koksidioidomykose
hos pasienter med sykdom som er motstandsdyktig mot amfotericin
B,
itrakonazol eller flukonazol eller hos pasienter som ikke tolererer
disse legemidlene;
-
Orofaryngeal
candidiasis
: som førstelinjebehandling hos pasienter med alvorlig sykdom
eller
som er im
munsupprimerte, og hvor responsen overfor topikal terapi forventes å
være dårlig.
Motstandsdyktighet er definert som progresjon av infeksjon eller mang
el på bedring
etter minimum
7
dager med terapeutiske doser av effektiv soppbehandling.
Noxafil mikstur
, suspensjon
er også indisert som profylakse ved invasive soppinfeksjoner hos
følgende pasienter:
-
Pasienter som får remisjons
-
induksjons kjemoterapi for akutt myelogen
leukemi
(AML) eller
for myelodysplastisk syndrom (MDS) som forventes å
resultere i ved
v