Voriconazole Accord
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
14-06-2023
Valmisteyhteenveto
(SPC)
14-06-2023
Julkisesta arviointikertomuksesta
(PAR)
15-03-2016
Aktiivinen ainesosa:
voriconazole
Saatavilla:
Accord Healthcare S.L.U.
ATC-koodi:
J02AC03
INN (Kansainvälinen yleisnimi):
voriconazole
Terapeuttinen ryhmä:
Antimycotics for systemic use, Triazole derivatives
Terapeuttinen alue:
Aspergillosis; Candidiasis; Mycoses
Käyttöaiheet:
Voriconazole is a broad-spectrum, triazole antifungal agent and is indicated in adults and children aged two 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 Accord should be administered primarily to patients with progressive, possibly life-threatening infections.
Tuoteyhteenveto:
Revision: 17
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2013-05-16
Pakkausseloste
47
B.PACKAGE LEAFLET
48
PACKAGE LEAFLET: INFORMATION FOR THE USER
VORICONAZOLE ACCORD 50 MG FILM-COATED TABLETS
VORICONAZOLE ACCORD 200 MG FILM-COATED TABLETS
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 Accord is and what it is used for
2.
What you need to know before you take Voriconazole Accord
3.
How to take Voriconazole Accord
4.
Possible side effects
5.
How to store Voriconazole Accord
6.
Content of the pack and other information
1.
WHAT VORICONAZOLE ACCORD IS AND WHAT IT IS USED FOR
Voriconazole Accord contains the active substance voriconazole.
Voriconazole Accord 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 Accord 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 u
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Voriconazole Accord 50 mg film-coated tablets
Voriconazole Accord 200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Voriconazole Accord 50 mg film-coated tablets
Each tablet contains 50 mg voriconazole.
Excipient with known effect
Each tablet contains 63 mg lactose (as monohydrate).
Voriconazole Accord 200 mg film-coated tablets
Each tablet contains 200 mg voriconazole.
Excipient with known effect
Each tablet contains 251 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Voriconazole Accord 50 mg film-coated tablets
White to off white, round, approximate 7.0 mm in diameter, film-coated
tablets, debossed with ‘V50’
on one side and plain on the other side.
Voriconazole Accord 200 mg film-coated tablets
White to off white, oval, approximately 15.6 mm in length and 7.8 mm
in width, film-coated tablets,
debossed with ‘V200’ on one side and plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Voriconazole Accord, 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 Accord 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.
3
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 may also be available as powd
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