NOXAFIL SUSPENSION

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

POSACONAZOLE

Disponível em:

MERCK SHARP & DOHME ISRAEL LTD

Código ATC:

J02AC04

Forma farmacêutica:

SUSPENSION

Composição:

POSACONAZOLE 40 MG/ML

Via de administração:

PER OS

Tipo de prescrição:

Required

Fabricado por:

MERCK SHARP & DOHME CORP., USA

Grupo terapêutico:

POSACONAZOLE

Área terapêutica:

POSACONAZOLE

Indicações terapêuticas:

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

Data de autorização:

2013-07-17

Folheto informativo - Bula

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 SUSPENSION
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 of or with

Características técnicas

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Noxafil
®
40 mg/mL oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each mL of oral suspension contains 40 mg of posaconazole.
Excipients with known effect
This medicinal product contains approximately 1.75 g of glucose per 5
mL of suspension.
This medicinal product contains 10 mg of sodium 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 full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension
White suspension
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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.
-
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 oral suspension is also indicated for prophylaxis of invasive
fungal infections in the
following patients:
2
-