NOXAFIL 100 MG GASTRO-RESISTANT TABLETS

Land: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

POSACONAZOLE

Fáanlegur frá:

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

ATC númer:

J02AC04

Lyfjaform:

GASTRO RESISTANT TABLETS

Samsetning:

POSACONAZOLE 100 MG

Stjórnsýsluleið:

PER OS

Gerð lyfseðils:

Required

Framleitt af:

MERCK SHARP & DOHME LLC, USA

Lækningarsvæði:

POSACONAZOLE

Ábendingar:

Noxafil gastro-resistant tablets are 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.- Zygomycosis in patients intolerant of or with disease that is refractory to alternative therapy.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 patients:- Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (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.

Leyfisdagur:

2021-05-31

Upplýsingar fylgiseðill

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS
(PREPARATIONS) 1986
This medicine
is marketed
upon physician’s
prescription only
NOXAFIL
® 100 MG GASTRO-RESISTANT TABLETS
Each tablet contains:
Posaconazole 100 mg
For a list of inactive ingredients
see section 6 "
FURTHER INFORMATION
".
See also section
2.6
“
Important
information about some of the ingredients of
the medicine”
.
READ ALL OF
THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING
THIS MEDICINE.
•
This leaflet contains concise 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
tablets
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
;
•
infect
ions 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_
and are resist
ant to
treatment with amphotericin B,
itraconazole or fluconazole or when
t
he patient cannot receive these medicines
.
•
f
ungal infection called Zygomycosis, in patients intolerant of or with
disease that is refractory to
alternative therapy.
This medicine
c
an also be used to prevent fungal infections in adult

Vara einkenni

1
1.
NAME OF THE MEDICINAL PRODUCT
Noxafil
®
100 mg gastro-
resistant tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-
resistant tablet contains 100
mg of posaconazole.
For the full list of excipients, see
section 6.1.
3.
PHARMACEUTICAL
FORM
Gastro-
resistant tablet (tablet)
Yellow-
coated, capsule
-
shaped tablet of 17.5
mm length debossed with “100” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Noxafil gastro
-
resistant tablets are in
dicated 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 pr
oducts;
-
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.
-
Zygomycosis
in patients intolerant of or with disease that is refractory to
alternative therapy.
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 patients:
-
Patients receiving remission
-
induction chemotherapy for acute myelogenous
leukaemia (AML)
or myelodysplastic syndromes (MDS) expected t
o 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