Voriconazol Apotex 50 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

VORICONAZOL

Beschikbaar vanaf:

Apotex Europe B.V.

ATC-code:

J02AC03

INN (Algemene Internationale Benaming):

VORICONAZOLE

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CROSCARMELLOSE NATRIUM (E 468) ; LACTOSE 1-WATER ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL (E1203) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Voriconazole

Product samenvatting:

Hulpstoffen: CROSCARMELLOSE NATRIUM (E 468); LACTOSE 1-WATER; MACROGOL 8000; MAGNESIUMSTEARAAT (E 470b); POLYVINYLALCOHOL (E1203); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2016-05-17

Bijsluiter

VORICONAZOLE APOTEX 50 MG, 200 MG FILM-COATED TABLETS
MODULE 1.3
Product Information
Version: 2019-02
MODULE 1.3.1
Package Leaflet
Replaces: 2017-06
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VORICONAZOL APOTEX 50 MG FILMOMHULDE TABLETTEN
VORICONAZOL APOTEX 200 MG FILMOMHULDE TABLETTEN
Voriconazol
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 Voriconazole Apotex is and what it is used for
2.
What you need to know before you take Voriconazole Apotex
3.
How to take Voriconazole Apotex
4.
Possible side effects
5.
How to store Voriconazole Apotex
6.
Content of the pack and other information
1. WHAT VORICONAZOLE APOTEX IS AND WHAT IT IS USED FOR
Voriconazole Apotex contains the active substance voriconazole.
Voriconazole Apotex is an
antifungal medicine. It works by killing or stopping the growth of the
fungi that cause infections.
It is used for the treatment of patients (adults and children over the
age of 2) with:
•
invasive aspergillosis (a type of fungal infection due to _Aspergillus
sp_),
•
candidaemia (another type of fungal infection due to _Candida sp_) in
non-neutropenic patients
(patients without abnormally low white blood cells count),
•
serious invasive _Candida sp. _infections when the fungus is resistant
to fluconazole (another
antifungal medicine),
•
serious fungal infections caused by _Scedosporium sp. _or _Fusarium
sp_. (two different species
of fungi).
Voriconazole Apotex is intended for patients with worsening, possibly
life-threatening, fungal
inf

Productkenmerken

VORICONAZOLE APOTEX 50 MG, 200 MG FILM-COATED TABLETS
MODULE 1.3
Product Information
Version:
2019-02
MODULE 1.3.1
Summary of Product Characteristics
Replaces:
2017-12
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Voriconazol Apotex 50 mg, filmomhulde tabletten
Voriconazol Apotex 200 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 or 200 mg voriconazole
Excipient(s) with known effect:
Voriconazole Apotex 50 mg film-coated tablets:
Each tablet contains 91.00 mg lactose monohydrate.
Voriconazole Apotex 200 mg film-coated tablets:
Each tablet contains 364.00 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
Voriconazole Apotex 50 mg film-coated tablets: White coloured,
round-shaped, film-coated
tablet (size: 7.0 mm) engraved “APO” on one side and “VOR”
over “50” on the other side.
Voriconazole Apotex 200 mg film-coated tablets: White coloured,
modified oval-shaped, bi-
convex film-coated tablet (size: 15.50 x 7.90 mm), engraved “APO”
on one side and “VOR 200”
on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Voriconazole, is a broad-spectrum, triazole antifungal agent and is
indicated in adults and
children aged 2 years and above as follows:
Treatment of invasive aspergillosis.
Treatment of candidemia in non-neutropenic patients.
VORICONAZOLE APOTEX 50 MG, 200 MG FILM-COATED TABLETS
MODULE 1.3
Product Information
Version:
2019-02
MODULE 1.3.1
Summary of Product Characteristics
Replaces:
2017-12
2
Treatment of fluconazole-resistant serious invasive _Candida_
infections (including _C. krusei_).
Treatment of serious fungal infections caused by _Scedosporium_ spp.
and _Fusarium_ spp.
Voriconazole Apotex should be administered primarily to patients with
progressive, possibly
life-threatening infections.
Prophylaxis
of
invasive
fungal
infections
in
high
risk
allogeneic
hematopoietic
stem
cell
transplant (HSCT) recipients.
4.2
POSOLOGY AND METHOD O