Voriconazole Rowex 200mg Film-coated Tablets

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Voriconazole

Disponible des:

Rowex Ltd

Codi ATC:

J02AC; J02AC03

Designació comuna internacional (DCI):

Voriconazole

Dosis:

200 milligram(s)

formulario farmacéutico:

Film-coated tablet

tipo de receta:

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

Área terapéutica:

Triazole derivatives; voriconazole

Estat d'Autorització:

Marketed

Data d'autorització:

2013-07-04

Informació per a l'usuari

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VORICONAZOLE ROWEX 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 Rowex is and what it is used for
2.
What you need to know before you take Voriconazole Rowex
3.
How to take Voriconazole Rowex
4.
Possible side effects
5.
How to store Voriconazole Rowex
6.
Content 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 taken under the supervision of a doctor.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VORICON

Fitxa tècnica

Health Products Regulatory Authority
29 May 2020
CRN009PX9
Page 1 of 26
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Voriconazole Rowex 200mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg voriconazole.
Excipient with known effect
Each film-coated tablet contains 244.2 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, biconvex, capsule shaped film-coated tablets with
'200' debossed on one side and plain on other side.
Length: 15.9 ± 0.3 mm
Thickness 6.20 mm ± 0.30 mm
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).
Voriconazole Rowex is available as 50 mg and 200 mg film-coated
tablets and as a 200 mg powder for solution for infusion.
Voriconazole is also available as 40 mg/ml powder for oral suspension,
however not under this trade name.
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 are close to steady state. On t