NOXAFIL SUSPENSION

País: Israel

Idioma: inglés

Fuente: Ministry of Health

Ingredientes activos:

POSACONAZOLE

Disponible desde:

MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL

Código ATC:

J02AC04

formulario farmacéutico:

SUSPENSION

Composición:

POSACONAZOLE 40 MG/ML

Vía de administración:

PER OS

tipo de receta:

Required

Fabricado por:

MERCK SHARP & DOHME LLC, USA

Grupo terapéutico:

POSACONAZOLE

Área terapéutica:

POSACONAZOLE

indicaciones terapéuticas:

Noxafil is indicated for use in the treatment of the following fungal infections in adults : - 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 is also indicated for prophylaxis of invasive fungal infections in the following patients : - Patients receiving remission- induction chemotherapy for acute myelogenous leukemia ( AML) or myelodysplastic syndromes ( MDS ) expected to result in prologed 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. Zygomycosis in patients intolerant of or with disease that is refractory to alternative therapy

Fecha de autorización:

2023-03-31

Información para el usuario

PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS' REGULATIONS (PREPARATIONS)
- 1986
This medicine
is marketed upon physician’s
prescription
only
NOXAFIL
®
SUSPENSION
40 MG/ML
ORAL S
USPENSION
Each mL
of suspension
contains:
Posaconazole 40
mg
For a list of inactive
ingredients
please refer to section 6. See also section 2.7
“Important
information about some of the ingredients of the medicine”.
READ ALL OF
THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE.
•
This leaflet contains consice
information
about
NOXAFIL
. If you have any further
questions, ask your doctor or pharmacist.
•
This medicine has been
prescribed
for you. Do not pass it on to others. It may harm
them, even if their
medical condition
seems similar to yours.
•
NOXAFIL
suspension
is intended for use in adults (18 years of age and older).
1.
WHAT NOXAFIL IS
INTENDED FOR?
NOXAFIL
is used to prevent and treat different types of fungal infections.
NOXAFIL
is used to treat the following types of fungal
infections
in adults when other
antifungal medicines have not worked or you have had to stop taking
them
:
-
Infections caused by fungi of the
_Aspergillus _
family and are resistant to treatment with
amphotericin B or itraconazole or when
the patient cannot receive these medicines
;
-
Infections caused by fungi of the
_Fusarium _
family and are resistant to treatment with
amphotericin B or when
the patient cannot receive this medicine
;
-
Infections caused by fungi that cause the
conditions
known as
“
chromoblastomycosis
”
and
“
mycetoma
”
and are resistant to treatment with
itraconazole
or when the patient
cannot receive this medicine
;
-
Infections caused by a fungus called
_Coccidioides _
that are resistant to treatment with
amphotericin
B,
itraconazole
or
fluconazole
or when the patient cannot receive these
medicines;
-
Infections in the mouth or throat area (known as “thrush”) caused
by fungi called
_Candida_,
which were not previously treated.
-
Fungal infection called
Zygomycosis,
in patients intolerant

Ficha técnica

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Noxafil
®
40 mg/mL
oral suspension
2.
QUALITATI
VE AND QUANT
ITATIVE COMPOSITION
Each mL
of oral suspension contains 40
mg of posaconazole.
Excipients
with known effect
This medicin
al
product contains approximately 1.75
g of glucose per 5
mL
of suspension.
This medicin
al product contains 10 mg of sodi
um benzoate
per 5 mL
of suspension
.
This medicinal product
contains up to
1.25 mg of benzyl alcohol per 5 mL
of suspension
.
This medicinal product
contains up to
24.75 mg
of propylene glycol
per 5 mL
of suspension
.
For the f
ull list of exci
pients, see section
6.1.
3.
P
HARMACEUTICAL
FORM
Oral suspension
White suspension
4.
CLINICAL PA
RTICULARS
4.1
THERAPEUTIC INDI
CATIONS
Noxafil oral suspension
is indicated for use in the treatment of the following fungal
infections
i
n adults (see se
ction 5.1):
-
Invasive aspergi
llosis in patients with disease that is refractory to amph
otericin B or
itracona
zole or in patients
who are intolerant of
thes
e medicinal products;
-
Fusariosis in patients with disease that is refractory to
amphotericin B
or in patients
who are intoleran
t of amphotericin B;
-
Chromoblastomycosis and mycetoma i
n patients with diseas
e that is refractory
to
itraconazole or i
n pat
ients who are intolerant of itraconazole;
-
Coccidioidomycosis in patients with d
isease that is r
efractory to amphote
ricin B,
itr
aconazole or fluconazole or in patients who are intolerant
of these medicinal
products;
-
Oropharyng
eal candidiasis: as f
irst-
line therapy in patients who have severe disease or
are immunocompromised, in whom
response to top
ical therapy is expe
cted to be poor.
-
Zygomycosis, in patients intolerant of, or with dis
ease that i
s refractor
y to, alternative
therapy.
Refractorines
s is
defined as progression of infection or failure to improve after a
minimum of
7 day
s of prior thera
peutic doses of eff
ective antif
ungal therapy
_._
Noxafil
oral suspension
is also indicated f
or prophylaxis of inva
sive fungal inf