Noxafil

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

posaconazole

Saatavilla:

Merck Sharp and Dohme B.V

ATC-koodi:

J02AC04

INN (Kansainvälinen yleisnimi):

posaconazole

Terapeuttinen ryhmä:

Antimycotics for systemic use

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 and 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 and 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 is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.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 and 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 and 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 and 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 is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.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 and 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 and 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 is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.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.Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.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:

Authorised

Valtuutus päivämäärä:

2005-10-25

Pakkausseloste

1
ANNEX I
SUMMARY OF PRO
DUCT C
HARACTERISTICS
2
1.
NAM
E OF THE MEDICINAL PROD
UCT
Noxafil 40 mg/mL
oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMP
OSITION
Each mL
of oral suspension contain
s 40
mg of posaconazole.
Excipients with known effect
This medicinal
p
roduct contain
s appr
oximately 1.75
g of glucose per 5 mL of suspension.
This medic
inal product contains
10 mg
of sodium benzoate (E211) per 5
mL of suspension.
This medicinal product co
nt
ains up to 1.25
mg of benzyl alcohol
per 5 m
L of suspension.
This med
icinal product
conta
ins up to 24.75
mg of
propylene glycol (E1520
) per 5 mL of suspension.
For the full list
of excipients, see section
6.1.
3.
PHARMACEUTICAL
FORM
Oral suspension
Wh
ite suspension
4.
CLINICAL PARTICUL
ARS
4.1
THERAPEUTIC INDICATIO
NS
Noxafil oral suspension is indicated fo
r use in the treatment
of the following
fungal infections in
adults
(see section 5.1):
-
Invasive a
spergillosis in patients with disease that
is
refractory to amphotericin B or
itraconazol
e or in patients who ar
e
intolerant of
these
medicinal produ
cts;
-
Fusariosis in patients
with disease tha
t is refractory to am
photer
icin B or in patients who are
int
olerant of amphotericin B;
-
Chromoblastom
yc
osis and mycetoma in patients with di
sease t
hat is refractory to it
raconazole
or in patie
nts who are int
olerant
of itraconazole;
-
Coccidioidomycosis
in patients with dise
ase th
at is refractory to amphotericin
B, itraconazole or
fluconazole or in patien
ts
who are intolerant of these medicina
l products;
-
Oropharyngeal ca
nd
idiasis: as fi
rst-li
ne therapy in p
atients
who have severe diseas
e or are
immunoco
mpromised, in whom re
sponse
to topical therapy is expected t
o be poor.
Refractoriness is defined as pr
og
ression of infection or failure to im
prove a
fter a minimum of 7
days
of prior thera
peutic
doses of effec
tive an
tifungal therapy
.
Noxafil oral suspension
is also indicated
for pr
ophylaxis of invasive fungal infe
ctions in the following
patients:
-
Patients
receiving remission
-

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRO
DUCT C
HARACTERISTICS
2
1.
NAM
E OF THE MEDICINAL PROD
UCT
Noxafil 40 mg/mL
oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMP
OSITION
Each mL
of oral suspension contain
s 40
mg of posaconazole.
Excipients with known effect
This medicinal
p
roduct contain
s appr
oximately 1.75
g of glucose per 5 mL of suspension.
This medic
inal product contains
10 mg
of sodium benzoate (E211) per 5
mL of suspension.
This medicinal product co
nt
ains up to 1.25
mg of benzyl alcohol
per 5 m
L of suspension.
This med
icinal product
conta
ins up to 24.75
mg of
propylene glycol (E1520
) per 5 mL of suspension.
For the full list
of excipients, see section
6.1.
3.
PHARMACEUTICAL
FORM
Oral suspension
Wh
ite suspension
4.
CLINICAL PARTICUL
ARS
4.1
THERAPEUTIC INDICATIO
NS
Noxafil oral suspension is indicated fo
r use in the treatment
of the following
fungal infections in
adults
(see section 5.1):
-
Invasive a
spergillosis in patients with disease that
is
refractory to amphotericin B or
itraconazol
e or in patients who ar
e
intolerant of
these
medicinal produ
cts;
-
Fusariosis in patients
with disease tha
t is refractory to am
photer
icin B or in patients who are
int
olerant of amphotericin B;
-
Chromoblastom
yc
osis and mycetoma in patients with di
sease t
hat is refractory to it
raconazole
or in patie
nts who are int
olerant
of itraconazole;
-
Coccidioidomycosis
in patients with dise
ase th
at is refractory to amphotericin
B, itraconazole or
fluconazole or in patien
ts
who are intolerant of these medicina
l products;
-
Oropharyngeal ca
nd
idiasis: as fi
rst-li
ne therapy in p
atients
who have severe diseas
e or are
immunoco
mpromised, in whom re
sponse
to topical therapy is expected t
o be poor.
Refractoriness is defined as pr
og
ression of infection or failure to im
prove a
fter a minimum of 7
days
of prior thera
peutic
doses of effec
tive an
tifungal therapy
.
Noxafil oral suspension
is also indicated
for pr
ophylaxis of invasive fungal infe
ctions in the following
patients:
-
Patients
receiving remission
-