Voriconazole Rowex 200 mg powder for solution for infusion

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Voriconazole

Disponível em:

Rowex Ltd

Código ATC:

J02AC; J02AC03

DCI (Denominação Comum Internacional):

Voriconazole

Dosagem:

200 milligram(s)

Forma farmacêutica:

Powder for solution for infusion

Tipo de prescrição:

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

Área terapêutica:

Triazole derivatives; voriconazole

Status de autorização:

Marketed

Data de autorização:

2014-02-28

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER
VORICONAZOLE ROWEX 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 Rowex is and what it is used for
2.
What you need to know before you use Voriconazole Rowex
3.
How to use Voriconazole Rowex
4.
Possible side effects
5.
How to store Voriconazole Rowex
6.
Contents of the pack and other information
1. WHAT
VORICONAZOLE ROWEX IS AND WHAT IT IS USED FOR
Voriconazole Rowex contains the active substance voriconazole.
Voriconazole Rowex 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 Rowex 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 TAK

Características técnicas

Health Products Regulatory Authority
22 June 2021
CRN00C9S2
Page 1 of 31
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Voriconazole Rowex 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.
Excipients with known effect
Each vial contains up to 228.7 mg of sodium and 3.4 g of
sulfobutylether-β-cyclodextrin sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for infusion.
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 Rowex 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 Rowex 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 or oral Voriconazole Rowex to achieve
plasma concentrations on Day 1 that