Posaconazol Ohre Pharma 40 mg/ml suspensie voor oraal gebruik

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

POSACONAZOL

Beschikbaar vanaf:

Ohre Pharma

ATC-code:

J02AC04

INN (Algemene Internationale Benaming):

POSACONAZOL

farmaceutische vorm:

Suspensie voor oraal gebruik

Samenstelling:

AARDBEIENSMAAKSTOF ; BENZOËZUUR (E 210) ; CITROENZUUR 1-WATER (E 330) ; DIMETICON (E 900) ; GLUCOSE, VLOEIBAAR ; GLYCEROL (E 422) ; MACROGOLGLYCEROLHYDROXYSTEARAAT ; MACROGOLSTEARAAT, TYPE I ; METHYLCELLULOSE (E 461) ; NATRIUMBENZOAAT (E 211) ; POLYSORBAAT 65 (E 436) ; PROPYLEENGLYCOL (E 1520) ; SILICIUMDIOXIDE (E 551) ; SIMETICON EMULSIE ; SORBINEZUUR (E 200) ; TITAANDIOXIDE (E 171) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; WATER, GEZUIVERD ; XANTHAANGOM (E 415) ; ZWAVELZUUR (E 513)

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Posaconazole

Autorisatie datum:

2019-08-16

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
POSACONAZOL OHRE PHARMA 40 MG/ML SUSPENSIE VOOR ORAAL GEBRUIK
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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What {Invented name} is and what it is used for
2.
What you need to know before you take {Invented name}
3.
How to take {Invented name}
4.
Possible side effects
5.
How to store {Invented name}
6.
Contents of the pack and other information
1.
WHAT {INVENTED NAME} IS AND WHAT IT IS USED FOR
{Invented name} 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.
{Invented name} 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 stopped;
•
infections caused

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Posaconazol Ohre Pharma 40 mg/ml suspensie voor oraal gebruik
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of oral suspension contains 40 mg of posaconazole.
Excipient with known effect:
This medicinal product contains approximately 1.75 g of glucose and
11.4 mg sodium benzoate (E
211) per 5 mL of suspension
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension
White to off-white suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
{Invented name} 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.
{Invented name} 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 trans