Voriconazole 200mg powder for solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Voriconazole

Available from:

Fresenius Kabi Deutschland GmbH

ATC code:

J02AC; J02AC03

INN (International Name):

Voriconazole

Dosage:

200 milligram(s)

Pharmaceutical form:

Powder for solution for infusion

Prescription type:

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

Therapeutic area:

Triazole derivatives; voriconazole

Authorization status:

Marketed

Authorization date:

2015-10-09

Patient Information leaflet

IE-UK PILVoriconazole 200mg V006
IE-UK-PIL-Voriconazole 200mg-clean.docx
PACKAGE LEAFLET: INFORMATION FOR THE USER
VORICONAZOLE 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.
-
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.
THE NAME OF YOUR MEDICINE IS VORICONAZOLE 200 MG POWDER FOR SOLUTION
FOR INFUSION; IN THE REST OF
THE LEAFLET IT WILL BE CALLED “VORICONAZOLE”.
WHAT IS IN THIS LEAFLET
1.
What Voriconazole is and what it is used for
2.
What you need to know before you use Voriconazole
3.
How to use Voriconazole
4.
Possible side effects
5.
How to store Voriconazole
6.
Contents of the pack and other information
1.
WHAT VORICONAZOLE IS AND WHAT IT IS USED FOR
Voriconazole 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 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 B

Summary of Product characteristics

Health Products Regulatory Authority
14 August 2023
CRN00DMFF
Page 1 of 31
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Voriconazole 200mg 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.
Excipients with known effect
Each vial contains up to 69 mg sodium as sodium hydroxide for pH
adjustment.
Each vial contains 2660 mg cyclodextrin.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Powder for solution for infusion.
White or almost 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 is administered at a maximum rate
of 3 mg/kg per hour over 1 to 3 hours.
Voriconazole is also 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 Voriconazole or oral voriconazole to
achieve plasm