Posaconazole Accord

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

posaconazole

Διαθέσιμο από:

Accord Healthcare S.L.U.

Φαρμακολογική κατηγορία (ATC):

J02AC04

INN (Διεθνής Όνομα):

posaconazole

Θεραπευτική ομάδα:

Antimycotics for systemic use

Θεραπευτική περιοχή:

Mycoses

Θεραπευτικές ενδείξεις:

Posaconazole Accord is indicated for use in the treatment of the following fungal infections in adults:Invasive aspergillosis;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.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 Accord 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.

Περίληψη προϊόντος:

Revision: 7

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2019-07-25

Φύλλο οδηγιών χρήσης

32
B. PACKAGE LEAFLET
33
PACKAGE LEAFLET: INFORMATION FOR THE USER
POSACONAZOLE ACCORD 100 MG GASTRO-RESISTANT TABLETS
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 Accord is and what it is used for
2.
What you need to know before you take Posaconazole Accord
3.
How to take Posaconazole Accord
4.
Possible side effects
5.
How to store Posaconazole Accord
6.
Contents of the pack and other information
1.
WHAT POSACONAZOLE ACCORD IS AND WHAT IT IS USED FOR
Posaconazole Accord 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 Accord can be used in adults to treat fungal infections
caused by fungi of the
_Aspergillus _
family.
Posaconazole Accord can be used in adults and children from 2 years of
age weighing more than 40 kg
to treat the following types of fungal infections:
-
infections caused by fungi of the
_Aspergillus_
family; that have not improved during
treatment with the antifungal 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

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Posaconazole Accord 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
Yellow coated, capsule shaped tablet of approximate 17.5 mm length and
6.7 mm width, debossed
with “100P” on one side and plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Posaconazole Accord is indicated for use in the treatment of the
following fungal infections in adults
(see sections 4.2 and 5.1):
-
Invasive aspergillosis
Posaconazole Accord gastro-resistant tablets are indicated for use in
the treatment of the following
fungal infections in paediatric patients from 2 years of age weighing
more than 40 kg and adults (see
sections 4.2 and 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.
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 Accord is also indicated for prophylaxis of invasive
fungal infections in the following
paediatric patients from 2 years of age weighing more than 40 kg and
adults (see sections 4.2 and 5.1):
-
Patients receiving remission-induction chemotherapy for acute
myelogenous leukaemia (AML)
or myelodysplastic syndromes (MDS) expected to result