VORICONAZOLE APOTEX

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

VORICONAZOLE

Available from:

Apotex Europe B.V.

ATC code:

J02AC03

INN (International Name):

VORICONAZOLE

Dosage:

50 Milligram

Pharmaceutical form:

Film Coated Tablet

Administration route:

oral use

Units in package:

14, 20, 28, 30, 56 and 100 tablets.

Prescription type:

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

Manufactured by:

Apotex Research Private Limited

Therapeutic group:

Antimycotics for systemic use, triazole derivatives

Therapeutic area:

voriconazole

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 candidemia 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 Apotex 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

Authorization status:

Not Marketed

Authorization date:

2015-10-23

Patient Information leaflet

VORICONAZOLE APOTEX 50 MG, 200 MG FILM-COATED TABLETS
MODULE 1.3
Product Information
Version: 2017-06-09
MODULE 1.3.1
Package Leaflet
Replaces: 2016-02
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VORICONAZOLE APOTEX 50 MG FILM-COATED TABLETS
VORICONAZOLE APOTEX 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 Apotex is and what it is used for
2.
What you need to know before you take Voriconazole Apotex
3.
How to take Voriconazole Apotex
4.
Possible side effects
5.
How to store Voriconazole Apotex
6.
Content of the pack and other information
1. WHAT VORICONAZOLE APOTEX IS AND WHAT IT IS USED FOR
Voriconazole Apotex contains the active substance voriconazole.
Voriconazole Apotex 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 Apotex is intended for patients with worsening, possibly
life-threatening, fungal
i

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Voriconazole Apotex 50mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg voriconazole
Excipient(s) with known effect:
Voriconazole Apotex 50 mg film-coated tablets:
Each tablet contains 91.00 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White coloured, round-shaped, film-coated tablet (size: 7.0 mm)
engraved “APO” on one side and “VOR” over “50”
on the other side.
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 candidemia 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
Apotex 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 Apotex is available as 50 mg film-coated tablets and 200
mg film-coated tablets.
Treatment
_Adults _
Therapy must be initiated with the specified loading dose regimen of
either intravenous or oral Voriconazole Apotex
to achieve plasma concentrations on Day 1 that are close to steady
state. On the basis of the high oral bioavailability
(96 %;
see section 5.2),
switching between intravenous
and oral
administration is
appropriate when clinically
indicated.
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