Posaconazole AHCL

Land: Evrópusambandið

Tungumál: enska

Heimild: EMA (European Medicines Agency)

Virkt innihaldsefni:

posaconazole

Fáanlegur frá:

Accord Healthcare S.L.U.

ATC númer:

J02AC04

INN (Alþjóðlegt nafn):

posaconazole

Meðferðarhópur:

Antimycotics for systemic use

Lækningarsvæði:

Mycoses

Ábendingar:

Posaconazole AHCL oral suspension 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.Posaconazole AHCL oral suspension 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 developing invasive fungal infections.

Vörulýsing:

Revision: 6

Leyfisstaða:

Authorised

Leyfisdagur:

2019-07-25

Upplýsingar fylgiseðill

29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE USER
POSACONAZOLE AHCL 40 MG/ML ORAL SUSPENSION
posaconazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist, or
nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Posaconazole AHCL is and what it is used for
2.
What you need to know before you take Posaconazole AHCL
3.
How to take Posaconazole AHCL
4.
Possible side effects
5.
How to store Posaconazole AHCL
6.
Contents of the pack and other information
1.
WHAT POSACONAZOLE AHCL IS AND WHAT IT IS USED FOR
Posaconazole AHCL contains a medicine called posaconazole. This
belongs to a group of medicines
called “antifungals”. It is used to prevent and treat many
different fungal infections.
This medicine works by killing or stopping the growth of some types of
fungi that can cause
infections.
Posaconazole AHCL can be used in adults to treat the following types
of fungal infections when other
antifungal medicines have not worked or you have had to stop taking
them:
-
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

Vara einkenni

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Posaconazole AHCL 40 mg/mL oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of oral suspension contains 40 mg of posaconazole.
Excipient(s) with known effect
This medicinal product contains approximately 1.75 g of glucose per 5
mL of suspension.
This medicinal product contains up to 5.2 mg propylene glycol (E1520)
per 5ml of suspension.
This medicinal product contains 11.4 mg sodium benzoate (E211) in each
5ml of suspension.
This medicinal product contains up to 0.114 mg benzoic acid (E210) in
each 5ml of suspension.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension
White to off-white free flowing suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Posaconazole AHCL 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.
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 AHCL oral suspension is also indicated for prophylaxis of
invasive fungal infections in
the following patients:
-
Patients receiving remission