VORICONAZOLE MYLAN

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

VORICONAZOLE

Saadav alates:

McDermott Laboratories Ltd t/a Gerard Laboratories

ATC kood:

J02AC03

INN (Rahvusvaheline Nimetus):

VORICONAZOLE

Annus:

200 Milligram

Ravimvorm:

Film Coated Tablet

Retsepti tüüp:

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

Terapeutiline ala:

voriconazole

Volitamisolek:

Not Marketed

Loa andmise kuupäev:

2014-07-04

Infovoldik

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VORICONAZOLE MYLAN 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 Mylan is and what it is used
for
2.
What you need to know before you take Voriconazole Mylan
3.
How to take Voriconazole Mylan
4.
Possible side
effects
5.
How to store Voriconazole Mylan
6.
Contents of the pack and other
information
1.
WHAT VORICONAZOLE MYLAN IS AND WHAT IT IS USED
FOR
Voriconazole Mylan contains the active substance voriconazole.
Voriconazole Mylan 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 _
species),
•
candidaemia (another type of fungal infection due to
_Candida _
species) in
non-
neutropenic
patients (patients without abnormally low white blood cells
count),
•
serious invasive
_Candida _
species
_. _
infections when the fungus is resistant to
fluconazole
(another antifungal
medicine),
•
serious fungal infections caused by
_Scedosporium _
species
_ _
or
_Fusarium _
species
Voriconazole Mylan 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

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Voriconazole Mylan 200mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg voriconazole.
Excipient with known effect
Each tablet contains 256.4 mg lactose monohydrate (tablet core and
film-coating).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablets
White to off-white film-coated, capsule shaped, biconvex tablet
debossed with “M164” on one side of the tablet and
blank on the other side. Dimensions: 15.5 mm x 7.5 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 Mylan should be administered primarily to patients with
progressive, possibly life-threatening infections.
Prophylaxis of invasive fungal infections in high risk allogeneic
haematopoietic 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 is also available in preparations for intravenous
infusion.
Treatment
_Adults_
Therapy must be initiated with the specified loading dose regimen of
either intravenous voriconazole or Voriconazole
Mylan tablets 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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