Voriconazole Xellia 200 mg Powder for Solution for Infusion

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Voriconazole

Inapatikana kutoka:

Xellia Pharmaceuticals ApS

ATC kanuni:

J02AC; J02AC03

INN (Jina la Kimataifa):

Voriconazole

Kipimo:

200 milligram(s)

Dawa fomu:

Powder for solution for infusion

Dawa ya aina:

Product subject to prescription which may not be renewed (A)

Eneo la matibabu:

Triazole derivatives; voriconazole

Idhini hali ya:

Not marketed

Idhini ya tarehe:

2015-08-13

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE USER
VORICONAZOLE XELLIA 200 MG POWDER FOR SOLUTION FOR INFUSION
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 Voriconazole Xellia 200 mg powder for solution for infusion is
and what it is used for
2.
What you need to know before you use Voriconazole Xellia 200 mg powder
for solution for
infusion
3.
How to use Voriconazole Xellia 200 mg powder for solution for infusion
4.
Possible side effects
5.
How to store Voriconazole Xellia 200 mg powder for solution for
infusion
6.
Content of the pack and other information
1. WHAT VORICONAZOLE XELLIA 200 MG POWDER FOR SOLUTION FOR INFUSION IS
AND WHAT IT IS USED FOR
Voriconazole Xellia 200 mg powder for solution for infusion 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 Xellia 200 mg powder for solution for

Tabia za bidhaa

Health Products Regulatory Authority
08 April 2019
CRN00902K
Page 1 of 28
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Voriconazole Xellia 200 mg Powder for Solution for Infusion
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.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for infusion.
White to off-white lyophilised 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.
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).
It is recommended that Voriconazole Xellia 200 mg powder for solution
for infusion is administered at a maximum rate of
3mg/kg per hour over 1 to 3hours.
Other brands have voriconazole available as 50 mg and 200 mg
film-coated tablets and 40 mg/ml powder for oral suspension.
Treatment
_Adults_
Therapy must be initiated with the specified loading dose regimen of
either intravenous or oralv oriconazole to achieve plasma
concentrations on Day1 that are close to steady state. On the basis of
the high oral bioavailability (96%; see