Noxafil

Maa: Euroopan unioni

Kieli: islanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

posakónazól

Saatavilla:

Merck Sharp and Dohme B.V

ATC-koodi:

J02AC04

INN (Kansainvälinen yleisnimi):

posaconazole

Terapeuttinen ryhmä:

Sveppalyf fyrir almenn nota

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 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. Svara ekki meðferð er skilgreint eins og framgangi sýkingu eða bilun til að bæta eftir að minnsta kosti 7 daga áður en lækninga skammta af árangri mikla meðferð. 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. Svara ekki meðferð er skilgreint eins og framgangi sýkingu eða bilun til að bæta eftir að minnsta kosti 7 daga áður en lækninga skammta af árangri mikla meðferð. 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. Svara ekki meðferð er skilgreint eins og framgangi sýkingu eða bilun til að bæta eftir að minnsta kosti 7 daga áður en lækninga skammta af árangri mikla meðferð. 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. Svara ekki meðferð er skilgreint eins og framgangi sýkingu eða bilun til að bæta eftir að minnsta kosti 7 daga áður en lækninga skammta af árangri mikla meðferð. 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:

Leyfilegt

Valtuutus päivämäärä:

2005-10-25

Pakkausseloste

98
UPPLÝSINGAR SEM
EIGA AÐ KOMA F
RAM
Á YTRI UMBÚÐUM
INNRI ASKJA
– PAKKNING 1 (AF 2) (
ÁN BLUE BOX
)
NOXAFIL 300 MG MAGASÝRUÞOLIÐ MIXTÚRUDUFT OG LEYSIR, DREIFA
1.
HEITI LYFS
Noxafil 300 mg magasýruþolið mixtúruduft og leysir, dreifa
posakónazól
PAKKNING 1 (AF 2)
2.
VIRK(T) EFNI
Hver skammta
poki inniheldur
300 mg af posakónazóli.
Eftir blöndun er st
yrkur magsýruþol
innar
mixtúru, dreifu um það bil 30 mg í ml.
3.
HJÁLPAREFNI
Blandað lyfið i
nniheldur metýlparah
ýdroxýbenzó
at (E218)
, própýlparahýdroxýbenzóa
t,
própýlenglýkól (E1520) og so
rbítóllausn (E420). Sjá
frekari upplý
singar í fylgiseðli.
4.
LYFJA
FORM OG INNIH
ALD
Magasýruþolið mixtúruduft og leysir, dreifa
Þessi pakkning inniheldur: 8 skammtapoka, tvær 3 ml og tvær 10 ml
sprautur
með tenntum enda
, tvo
blöndunarbikara, eitt glas með
leysi og eitt milli
stykki fyrir
glas.
5.
AÐFERÐ VIÐ
LYFJ
AGJÖF OG ÍKOMULEIÐ(IR)
Lesið f
ylgiseðilinn
fyrir notkun.
Til inntöku
6.
SÉRSTÖK VA
RNAÐARORÐ UM AÐ
L
YFIÐ SKUL
I GEYM
T ÞAR SEM B
ÖRN
HV
ORKI NÁ TIL NÉ SJÁ
Geymið þar sem börn
hvorki ná ti
l né sjá.
7.
ÖNNUR SÉRSTÖ
K
VARNAÐARO
RÐ, EF MEÐ ÞARF
NOXAFIL M
AGSÝRUÞOLIÐ
MIXTÚRU
DUFT OG LEYSI
, DREIFU MÁ EKKI NOTA Í STAÐINN FYRIR MIXTÚRU, DREIFU
OG ÖFUGT.
8.
FYRNINGARD
AGSETNIN
G
EXP
99
9.
SÉRSTÖK GEYMSLUSKIL
YRÐI
EFTIR BLÖNDUN VERÐUR AÐ
NOTA
MAGASÝRUÞOL
NA MIXTÚRU, DREIFU INNAN 30 MÍNÚTNA.
10.
SÉRSTAKAR
VARÚÐ
ARRÁÐSTAFAN
IR VIÐ F
ÖRGUN LYFJALEI
FA EÐA
ÚRGANGS
VEGNA LYFSINS
ÞAR SEM VIÐ Á
11.
NAFN OG HEI
MILISFANG M
ARKAÐS
LEYFISHA
FA
Merck Sharp &
Dohme B.V
.
Waarderweg 3
9
20
31 BN Haarlem
Holland
12.
MARKAÐSLEYFISNÚMER
EU/1/05/320/005
13.
LOTUNÚMER
Lot
14.
AFGREIÐSL
UTILHÖGUN
15.
NOTKUNARLEIÐBEININGAR
16.
UPPL
ÝSINGAR MEÐ B
LINDRALETRI
noxafil 300 mg mixtúruduft, dreifa
17.
EIN
KVÆMT AUÐKENNI
–
TVÍVÍTT STRIKAMERKI
18.
EINKV
ÆMT AUÐKENNI
–
UPPLÝSING
AR SEM FÓLK GETUR LESIÐ
PC
SN
NN
100
LÁGMARKS UPPLÝS
INGA
R SEM SKULU KOMA FR

Valmisteyhteenveto

1
VIÐAUKI I
SAMANTEKT Á
EIGINLEIKUM LYFS
2
1.
HEITI LYFS
Noxafil 40
mg/ml mixtúra, dreifa
2.
INNIHALDSLÝSING
Hver ml af mixtúru, dreifu inniheldur 40
mg af posakónazóli.
Hjálparefni með þekkta verkun
Lyfið
inniheldur u.þ.b
. 1,75 g
af glúkósa í hverjum 5
ml af dreifu.
Lyfið
inniheldur 10
mg af natríumbensóati (E211) í hverjum 5
ml af dreifu.
Lyfið inniheldur allt að 1,25 mg af bensýlalkóhóli í hverjum 5
ml af dreifu.
Lyfið inniheldur allt að 24,75 mg af
própýlengýkól
i (E1520) í hverjum 5
ml af dreifu.
Sjá lista yfir öll hjálparefni í kafla
6.1.
3.
LYFJAFORM
Mixtúra, dreifa
Hvít dreifa
4.
KLÍNÍSKAR UPPLÝSINGAR
4.1
ÁBENDINGAR
Noxafil
mixtúra, dreifa
er ætluð til meðferðar við
eftirfarandi sveppasýkingum
hjá fullorðnum
(sjá
kafla 5.1):
-
Ífarandi aspergillosis hjá sjúklingum með sjúkdóm sem svarar
ekki amfótericíni B eða
ítrakónazóli eða hjá sjúklingum sem þola þessi lyf ekki;
-
Fusariosis hjá sjúklingum með sjúkdóm sem svarar ekki
amfótericíni B eða h
já sjúklingum s
em
þola e
kki amfótericín B;
-
Chromoblastomycosis og mycetoma hjá sjúklingum með sjúkdóm sem
svarar ekki ítrakónazóli
eða hjá sjúklingum sem þola ekki ítrakónazól;
-
Coccidioidomycosis hjá sjúklingum með sjúkdóm sem svarar ekki
amfótericín
i B, ítrakónazó
li
eða fl
úkónazóli eða hjá sjúklingum sem þola ekki þessi lyf;
-
Hvítsveppasýking í munni og koki: sem fyrsti valkostur hjá
sjúklingum með alvarlegan sjúkdóm
eða sem eru ónæmisskertir, þegar gert er ráð fyrir lítilli
svörun við útvortis meðf
erð.
Skilgreiningin á þ
ví að svara ekki meðferð er versnun á sýkingu eða
engin batamerki
eftir að minnsta
7
daga fyrri meðferðarskammta af virku sveppalyfi.
Noxafil
mixtúra, dreifa
er einnig ætl
u
ð sem fyrirbyggjandi meðferð við ífarandi sveppasýkingum hj
á
eftirtöldum s
júklingum:
-
Sjúklingum sem fá lyfjameðferð við bráðu
mergfrumu
hvítblæði eða merg
rangvaxtarheilkenni
(myelodysplastic syn