Voramol 200 mg filmomhulde tabletten

Kraj: Holandia

Język: niderlandzki

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

Składnik aktywny:

VORICONAZOL 200 mg/stuk

Dostępny od:

Alvogen IPCo S.ar.l 5, rue Heienhaff 1736 SENNINGERBERG (LUXEMBURG)

Kod ATC:

J02AC03

INN (International Nazwa):

VORICONAZOL 200 mg/stuk

Forma farmaceutyczna:

Filmomhulde tablet

Skład:

CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Droga podania:

Oraal gebruik

Dziedzina terapeutyczna:

Voriconazole

Podsumowanie produktu:

Hulpstoffen: CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); LACTOSE 1-WATER; MACROGOL 4000; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; POVIDON K 30 (E 1201); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Data autoryzacji:

2015-09-15

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Voramol 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 Voramol is and what it is used for
2.
What you need to know before you take Voramol
3.
How to take Voramol
4.
Possible side effects
5.
How to store Voramol
6.
Contents of the pack and other information
1.
WHAT VORAMOL IS AND WHAT IT IS USED FOR
Voramol contains the active substance voriconazole. Voramol 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 _
spp
_._
),
•
candidaemia (another type of fungal infection due to
_Candida _
spp
_._
) in non-neutropenic patients
(patients without abnormally low white blood cells count),
•
serious invasive
_Candida _
spp
_. _
infections when the fungus is resistant to fluconazole (another
antifungal medicine),
•
serious fungal infections caused by
_Scedosporium _
spp
_. _
or
_Fusarium _
spp. (two different species
of fungi).
Voramol 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 VORAMOL
DO NOT TAKE VORAMOL
-
if you are allergic to voriconazole or any

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Voramol 200 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg voriconazole.
Excipient with known effect:
Each tablet contains 235.08 mg lactose monohydrate.
Each tablet contains 3.4 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White to off-white, oval biconvex film-coated tablet debossed with
“V200” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Voramol 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.
Voramol 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).
Voramol is also available as 200 mg powder for solution for infusion.
Additionally, other brands have
voriconazole available as a 40 mg/ml powder for oral suspension and 50
mg film-coated tablets.
Treatment
_Adults _
Therapy must be initiated with the specified loading dose regimen of
either intravenous or oral
voriconazole to achieve plasma concentrations on Day 1 that are close
to steady state. On the basis of
the high oral bioavailability (96 %; see section 5.2), switching
between intravenous and oral
administration is appropriate when clinically indicated.
Detailed information on dosage recommendation