Voriconazol Tiefenbacher 200 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

VORICONAZOL

Beschikbaar vanaf:

Alfred Tiefenbacher (GmbH & Co. KG) Van-der-Smissen- Strasse 1 22767 HAMBURG (DUITSLAND)

ATC-code:

J02AC03

INN (Algemene Internationale Benaming):

VORICONAZOLE

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Voriconazole

Product samenvatting:

Hulpstoffen: CROSCARMELLOSE NATRIUM (E 468); GLYCEROLTRIACETAAT (E 1518); HYPROMELLOSE (E 464); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; POVIDON K 30 (E 1201); TITAANDIOXIDE (E 171);

Autorisatie datum:

2013-04-11

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VORICONAZOL TIEFENBACHER 50 MG FILMOMHULDE TABLETTEN
VORICONAZOL TIEFENBACHER 200 MG FILMOMHULDE TABLETTEN
Voriconazole
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 [VORICONAZOLE] is and what it is used for
2.
What you need to know before you take [VORICONAZOLE]
3.
How to take [VORICONAZOLE]
4.
Possible side effects
5.
How to store [VORICONAZOLE]
6.
Content of the pack and other information
1. WHAT [VORICONAZOLE] IS AND WHAT IT IS USED FOR
[VORICONAZOLE] contains the active substance voriconazole.
[VORICONAZOLE] 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] is intended for patients with worsening, possibly
life-threatening, fungal
infections.
Prevention of fungal infections in high risk bone marrow transplant
recipients.
This product should only be taken under the supervision of a doctor.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [VO

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Voriconazol Tiefenbacher 50 mg filmomhulde tabletten
Voriconazol Tiefenbacher 200 mg filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
[For 50 mg strength:]
Each tablet contains 50 mg voriconazole.
Excipients with known effect: lactose monohydrate 67.8 mg, sodium 0.24
mg.
[For 200 mg strength:]
Each tablet contains 200 mg voriconazole.
Excipients with known effect: lactose monohydrate 271.2 mg, sodium
0.97 mg.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
[For 50 mg strength:]
White to off-white, round film-coated tablets
[For 200 mg strength:]
White to off-white, capsule-shaped film-coated tablets
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 candidaemia in non-neutropenic patients.
Treatment of fluconazole-resistant serious invasive _Candida_
infections (including _C. krusei_).
Treatment of serious fungal infections caused by _Scedosporium_ spp.
and _Fusarium_ spp.
[VORICONAZOLE] 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 OF ADMINISTRATION
Posology
Electrolyte disturbances such as hypokalaemia, hypomagnesaemia and
hypocalcaemia should be
monitored and corrected, if necessary, prior to initiation and during
voriconazole therapy (see section
4.4).
[VORICONAZOLE] is available as 50 mg and 200 mg film-coated tablets.
Additionally, other brands
have voriconazole available as 40 mg/ml powder for oral suspension and
as 200 mg powder for solution
for infusion.
Treatment
_Adults_
Therapy must be initiated with the specified loading dose regimen of
either intravenous or oral
voriconazole to achieve plasma