Voriconazol betapharm 200 mg, poeder voor oplossing voor infusie

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

VORICONAZOL 200 mg/flacon

Beschikbaar vanaf:

Betapharm Arzneimittel GmbH Kobelweg 95 D-86156 AUGSBURG (DUITSLAND)

ATC-code:

J02AC03

INN (Algemene Internationale Benaming):

VORICONAZOL 200 mg/flacon

farmaceutische vorm:

Poeder voor oplossing voor infusie

Samenstelling:

HYDROXYPROPYLBETADEX ; LACTOSE 1-WATER,

Toedieningsweg:

Intraveneus gebruik

Therapeutisch gebied:

Voriconazole

Product samenvatting:

Hulpstoffen: HYDROXYPROPYLBETADEX; LACTOSE 1-WATER;

Autorisatie datum:

2014-12-16

Bijsluiter

131
PACKAGE LEAFLET: INFORMATION FOR THE USER
VORICONAZOL BETAPHARM 200 MG, POEDER VOOR OPLOSSING VOOR INFUSIE
voriconazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 [PRODUCT NAME] is and what it is used for
2.
What you need to know before you use [PRODUCT NAME]
3.
How to use [PRODUCT NAME]
4.
Possible side effects
5.
How to store [PRODUCT NAME]
6.
Content of the pack and other information
1.
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
[PRODUCT NAME] contains the active substance voriconazole. [PRODUCT
NAME] 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).
[PRODUCT NAME] 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 used under the supervision of a doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE [PRODUCT NAME]
DO NOT USE

Productkenmerken

131
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Voriconazol betapharm 200 mg, poeder voor oplossing voor infusie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 200 mg of voriconazole.
After reconstitution each ml contains 10 mg of voriconazole. Once
reconstituted further dilution is
required before administration.
Excipient with known effect
Each vial contains 2,600 mg hydroxypropylbetadex.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion
White to off-white lyophilized powder.
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.
[PRODUCT NAME] 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).
It is recommended that [PRODUCT NAME] is administered at a maximum
rate of 3 mg/kg per hour
over 1 to 3 hours.
131
[PRODUCT NAME] is also available as 50 mg and 200 mg film-coated
tablets. Additionally, other
brands have voriconazole available as a 40 mg/ml powder for oral
suspension.
Not all strengths may be marketed.
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 s