NOXAFIL 300 MG CONCENTRATE FOR SOLUTION FOR INFUSION

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

POSACONAZOLE

Διαθέσιμο από:

MERCK SHARP & DOHME ISRAEL LTD

Φαρμακολογική κατηγορία (ATC):

J02AC04

Φαρμακοτεχνική μορφή:

CONCENTRATE FOR SOLUTION FOR INFUSION

Σύνθεση:

POSACONAZOLE 300 MG/VIAL

Οδός χορήγησης:

I.V

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

MERCK SHARP & DOHME CORP., USA

Θεραπευτική περιοχή:

POSACONAZOLE

Θεραπευτικές ενδείξεις:

Noxafil concentrate for solution for infusion 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.- 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 concentrate f

Ημερομηνία της άδειας:

2017-02-21

Φύλλο οδηγιών χρήσης

Page 1 of 2
AINF-1254857-0000
יאמ
2018
ה/דבכנ ה/אפור
/חקור
ת
ה/דבכנ :ןודנה ליפסקונ
300
יוריעל הסימת תנכהל תזכורמ הסימת ג"מ
NOXAFIL
 300 MG CONCENTRATE FOR SOLUTION FOR INFUSION (POSACONAZOLE)
DOSAGE FORM: Concentrate for solution for infusion
COMPOSITION: Each vial contains 300 mg of posaconazole.
לארשי םהודו פראש קרמ תרבח
MSD)
ולעה ןוכדע לע עדייל תשקבמ (
ן
לש אפורל ליפסקונ
300 הסימת ג"מ
יוריעל הסימת תנכהל תזכורמ
.
היוותהה ןושל ןלהל
:רישכתל תרשואמה
Noxafil concentrate for solution for infusion 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.
-
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 concentrate for solution for infusion 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 prolonged
neutropenia and who
are at high risk of developing invasive fungal infections;
-
Hematopoi

Αρχείο Π.Χ.Π.

1.
NAME OF THE MEDICINAL PRODUCT
Noxafil

300 mg concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 300 mg of posaconazole.
Each mL contains 18 mg of posaconazole.
Excipient with known effect:
Each vial contains 462 mg (20 mmol) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless to yellow liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Noxafil concentrate for solution for infusion 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.
-
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 concentrate for solution for infusion 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 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