Voriconazol Pfizer 200 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

VORICONAZOL 200 mg/stuk

Beschikbaar vanaf:

Pfizer B.V. Rivium Westlaan 142 2909 LD CAPELLE A/D IJSSEL

ATC-code:

J02AC03

INN (Algemene Internationale Benaming):

VORICONAZOL 200 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

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

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); POVIDON (E 1201); TITAANDIOXIDE (E 171); ZETMEEL, GEPREGELATINEERD;

Autorisatie datum:

1900-01-01

Bijsluiter

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PACKAGE LEAFLET: INFORMATION FOR THE USER
VORICONAZOL PFIZER 50 MG FILMOMHULDE TABLETTEN
VORICONAZOL PFIZER 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, 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 Pfizer is and what it is used for
2.
What you need to know before you take Voriconazole Pfizer
3.
How to take Voriconazole Pfizer
4.
Possible side effects
5.
How to store Voriconazole Pfizer
6.
Content of the pack and other information
1.
WHAT VORICONAZOLE PFIZER IS AND WHAT IT IS USED FOR
Voriconazole Pfizer contains the active substance voriconazole.
Voriconazole Pfizer 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 Pfizer is intended for patients with worsening, possibly
life-threatening, fungal infections.
Prevention of fungal infections in high risk bone marrow transplant
recipients.

Productkenmerken

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1.
NAME OF THE MEDICINAL PRODUCT
Voriconazol Pfizer 50 mg filmomhulde tabletten
Voriconazol Pfizer 200 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 or 200 mg voriconazole.
Excipient with known effect
Voriconazole Pfizer 50 mg film-coated tablets
Each tablet contains 63.42 mg lactose monohydrate.
Voriconazole Pfizer 200 mg film-coated tablets
Each tablet contains 253.675 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Voriconazole Pfizer 50 mg film coated tablets.
White to off-white, round tablet, debossed “Pfizer” on one side
and “VOR50” on the reverse (tablets).
Voriconazole Pfizer 200 mg film-coated tablets
White to off-white, capsule-shaped tablet, debossed “Pfizer” on
one side and “VOR200” on the reverse
(tablets).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Voriconazole Pfizer, 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 Pfizer 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.
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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 Pfizer is also available as 200 mg powder for solution
for infusion and 40 mg/ml powder for
oral suspensio