Noxafil

Country: European Union

Language: Danish

Source: EMA (European Medicines Agency)

Active ingredient:

posaconazol

Available from:

Merck Sharp and Dohme B.V

ATC code:

J02AC04

INN (International Name):

posaconazole

Therapeutic group:

Antimykotika til systemisk brug

Therapeutic area:

Candidiasis; Mycoses; Coccidioidomycosis; Aspergillosis

Therapeutic indications:

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. Uimodtagelighed over er defineret som progression af infektion eller manglende bedring efter minimum 7 dage før terapeutiske doser af effektiv svampedræbende terapi. 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. Uimodtagelighed over er defineret som progression af infektion eller manglende bedring efter minimum 7 dage før terapeutiske doser af effektiv svampedræbende terapi. 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. Uimodtagelighed over er defineret som progression af infektion eller manglende bedring efter minimum 7 dage før terapeutiske doser af effektiv svampedræbende terapi. 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):- Invasiv aspergillose hos patienter med sygdom, der er refraktære over for amphotericin B eller itraconazol eller patienter, der ikke tåler disse lægemidler;- Fusariosis hos patienter med sygdom, der er refraktære over for amphotericin B eller patienter, der er intolerante over for amphotericin B;- Chromoblastomycosis og mycetoma hos patienter med sygdom, der er refraktære over for itraconazol eller patienter, der er intolerante over for itraconazol;- Coccidioidomycosis hos patienter med sygdom, der er refraktære over for amphotericin B, itraconazol eller fluconazol eller patienter, der ikke tåler disse lægemidler.- Oropharyngeale candidiasis: som første linje behandling til patienter, som har svær sygdom eller er immunsvækkede, i, som reaktion på aktuelle behandling forventes at være fattig. Uimodtagelighed over er defineret som progression af infektion eller manglende bedring efter minimum 7 dage før terapeutiske doser af effektiv svampedræbende terapi. 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 summary:

Revision: 37

Authorization status:

autoriseret

Authorization date:

2005-10-25

Patient Information leaflet

98
MÆRKNING, DER SKA
L ANFØRES
PÅ DEN YDRE EMBALLAGE
YDRE KARTON
– (MED
BLUE BOX)
1.
LÆ
GEMIDLETS NAVN
Noxafil 300 mg
enteropulver o
g solvens til oral suspension
posaconazol
2.
ANGIVELSE AF AKTIVT
STOF/AKTIVE STO
FFER
Hver
foliepose indeh
older 300 mg posaconazol. Efter rekonstitution har den
gastroresistente orale
suspension en koncentration på ca. 30 mg pr. ml.
3.
LISTE OVER HJÆLPESTOFFER
Det rekonstituerede
lægemiddel indeho
lder methylparahydr
oxybenzoat
(E 218),
propylparahydroxybenzoat, propylenglycol (E1520) og sorbitol
opløsning (E 420). Se
indlægssedlen
for yderligere
information.
4.
LÆGEMIDDELFORM OG
INDHOLD
(PAKNIN
GSSTØRRELSE)
Enteropulver og solvens til oral suspension
Denne pakning indeholder (pakning 1): 8 folieposer, to 3 ml og to 10
ml sprøjter med indhak i
spidsen, to blandebægre, en flaske med solvens og en flaskeadapter
; og en pakning
(pakning 2) med:
yderligere seks 3 ml og seks 1
0 ml sprøjter med indhak i spidsen.
5.
ANVEN
DELSESMÅDE OG
ADMINI
STRATION
SVEJ(E)
Læs indlægssedlen
inden brug.
Oral anvendelse
6.
SÆRLIG AD
VARSEL OM
,
AT LÆGEMIDLET SKAL OPBEVA
RES
UTILGÆNGELI
GT FOR BØRN
Opbevares utilgængeligt for børn
.
7.
EVENTUELL
E ANDRE SÆRLIGE ADVARSLER
NOXAFIL ENTERO
PULVER OG SOLVENS TIL
ORA
L SUSPENSION
ER IK
KE INDBYRDES
OMBYTTELIG MED NOXAFIL
ORAL SUSPENSION.
8.
U
DLØBSDATO
EXP
99
9.
SÆRLIGE OPBEVARINGSBETINGE
LSER
EFTER REKONSTITUTION: DEN GASTRORESISTENTE ORALE SUSPENSION SKAL
ANVENDES INDEN F
OR
30 MINUTTER
.
10.
EVENTUELLE SÆRLIGE FO
RHO
LDSREGLER VED BORTSKAFFELSE AF IKKE
ANV
ENDT LÆGEMIDD
EL SAMT AF
FALD HERAF
11.
NAV
N OG ADRE
SS
E PÅ INDEHAVEREN AF MARKED
SFØRINGSTILL
ADELSEN
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
Holland
12.
MARKEDSFØRINGSTIL
LADELSESNUMMER (
-NUMRE)
EU/1/05/320/005
13.
BATCHNUMMER
Lot
14.
GENEREL KLAS
SIFIKATION FOR U
DLEVERIN
G
15.
INSTRUKTIONER
VEDRØRENDE ANVENDELSEN
16.
INFORM
ATION I BRAILLESKRIFT
noxafil 300 mg pulver til oral suspension
17.
EN
TYDIG IDENT
IFIKATOR
– 2D-
STREGKODE
Der er anført en

Summary of Product characteristics

1
BILAG I
PRODUKTRESUM
É
2
1.
LÆGEMIDLETS NAVN
Noxafil 40
mg/ml oral suspension
2.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING
1
ml oral suspension indeholder 40
mg posaconazol.
Hjælpestoffer
, som behandleren skal være opmærksom på
Dette
lægemiddel indeholder ca. 1,75
g glucose p
r. 5
ml suspension.
Dette
lægemiddel indeholder
10 mg natriumbenzoat (E211) pr. 5 ml suspension.
Dette
lægemiddel indeholder
op til 1,25 mg benzylalkohol pr. 5 ml suspension.
Dette
lægemiddel indeholder
op til 24,75 mg propylenglycol (E1520) pr. 5 ml suspension.
Alle hjæ
lpestoffer er anført under pkt.
6.1.
3.
LÆGEMIDDELFORM
Oral suspension
Hvid suspension
4.
KLINISKE OPLYSNINGER
4.1
TERAPEUTISKE INDIKATIONER
Noxafil
oral suspension
er indiceret
til behan
dling af følgende svampeinfe
ktioner hos voksne
(se pkt. 5.1):
-
Invasiv aspergillose hos patienter med sygdom, hvor behandling med
amphotericin
B eller
itraconazol har været utilstrækkelig, eller hos patienter med
intolerans over for disse
lægemidler;
-
Fusari
ose hos patienter med sygdom, hvor behandling med
amphotericin
B har været
utilstrækkelig, eller hos patienter med intolerans over for
amphotericin
B;
-
Chromoblastomykose
og mycetom
a hos patienter med sygdom, hvor behandling med
itraconazol har v
æret utilst
rækkelig, eller hos patienter med intolerans over for itraconazol;
-
Coccidioidomykose hos patienter med sygdom, hvor behandling med
amphotericin
B,
itraconazol eller fluconazol har været utilstrækkelig, eller hos
patienter med intolerans over for
disse lægemidler;
-
Oropharyngeal candidiasis: som first
-
line behandling hos patienter, der har alvorlig sygdom
eller har nedsat immunforsvar, hos hvem respons på lokal behandling
forventes at være dårlig.
Utilstrækkelig behandling defineres som progressio
n af en inf
ektion eller mangel på bedring efter
mindst 7
dages terapeutiske doser af effektiv behandling med antimykotika.
Noxafil
oral suspension
er også indiceret til forebyggelse af invasive svampeinfektioner hos
følgende
patienter:
-
Patienter