Posaconazole SP
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
31-07-2009
Charakterystyka produktu
(SPC)
31-07-2009
Sprawozdanie z oceny publicznego
(PAR)
31-07-2009
Składnik aktywny:
posaconazole
Dostępny od:
Schering-Plough Europe
Kod ATC:
J02AC04
INN (International Nazwa):
posaconazole
Grupa terapeutyczna:
Antimycotics for systemic use
Dziedzina terapeutyczna:
Candidiasis; Mycoses; Coccidioidomycosis; Aspergillosis
Wskazania:
Posaconazole SP 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.Posaconazole SP 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 areat 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.
Podsumowanie produktu:
Revision: 5
Status autoryzacji:
Withdrawn
Data autoryzacji:
2005-10-25
Ulotka dla pacjenta
Medicinal product no longer authorised
25
B. PACKAGE LEAFLET
Medicinal product no longer authorised
26
PACKAGE LEAFLET: INFORMATION FOR THE USER
POSACONAZOLE SP 40 MG/ML ORAL SUSPENSION
posaconazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
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 symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Posaconazole SP is and what it is used for
2.
Before you take Posaconazole SP
3.
How to take Posaconazole SP
4.
Possible side effects
5.
How to store Posaconazole SP
6.
Further information
1.
WHAT POSACONAZOLE SP IS AND WHAT IT IS USED FOR
Posaconazole SP belongs to a group of medicines called triazole
antifungal agents. These medicines
are used to prevent and treat a wide variety of fungal infections.
Posaconazole SP works by killing or
stopping the growth of some types of fungi that can cause infections
in humans.
Posaconazole SP can be used to treat the following types of fungal
infections in adults:
-
Infections caused by fungi of the _Aspergillus_ family that have not
improved during treatment
with the anti-fungal medicines amphotericin B or itraconazole or when
these medicines have
had to be stopped;
-
Infections caused by fungi of the _Fusarium_ family that have not
improved during treatment with
amphotericin B or when amphotericin B has had to be stopped;
-
Infections caused by fungi that cause the conditions known as
chromoblastomycosis and
mycetoma that have not improved during treatment with itraconazole or
when itraconazole has
had to be stopped;
-
Infections due to fungi called _Coccidioides_ that have not improved
during treatment with one or
more of amphotericin B, itraconazole or fluconazole or when these
medic
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Charakterystyka produktu
Medicinal product no longer authorised
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
_ _
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Posaconazole SP 40 mg/ml oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each ml of oral suspension contains 40 mg of posaconazole.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension
White suspension
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Posaconazole SP 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_._
Posaconazole SP 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 and who are at
high risk of de
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