Posaconazol Devatis 40 mg/ml suspensie voor oraal gebruik

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

POSACONAZOL 40 mg/ml

Beschikbaar vanaf:

Devatis GmbH Spitalstrasse 22 795 39 LORRACH (DUITSLAND)

ATC-code:

J02AC04

INN (Algemene Internationale Benaming):

POSACONAZOL 40 mg/ml

farmaceutische vorm:

Suspensie voor oraal gebruik

Samenstelling:

CITROENZUUR 1-WATER (E 330) ; GLUCOSE, VLOEIBAAR ; GLYCEROL (E 422) ; KERSENSMAAKSTOF ; NATRIUMBENZOAAT (E 211) ; POLYSORBAAT 80 (E 433) ; PROPYLEENGLYCOL (E 1520) ; SIMETICON EMULSIE ; TITAANDIOXIDE (E 171) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; WATER, GEZUIVERD ; XANTHAANGOM (E 415)

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Posaconazole

Autorisatie datum:

2018-10-01

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
POSACONAZOL DEVATIS 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 Posaconazol Devatis is and what it is used for
2.
What you need to know before you take Posaconazol Devatis
3.
How to take Posaconazol Devatis
4.
Possible side effects
5.
How to store Posaconazol Devatis
6.
Contents of the pack and other information
1.
WHAT POSACONAZOL DEVATIS IS AND WHAT IT IS USED FOR
Posaconazol Devatis 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.
Posaconazol Devatis 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 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
“mycetoma” that have not improved during treatment with
itraconazole or when itraconazole has
had to be stopped

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Posaconazol Devatis 40 mg/ml suspensie voor oraal gebruik
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of oral suspension contains 40 mg of posaconazole.
Excipients with known effect:
This medicinal product contains approximately 1.75 g of glucose, 10 mg
sodium benzoate (E 211) and
14.35 mg propylene glycol (E 1520) 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
Posaconazol Devatis 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.
Posaconazol Devatis 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 infec