Voriconazole Teva 200 mg Film-coated Tablets

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Voriconazole

Dostępny od:

Teva Pharma B.V.

Kod ATC:

J02AC; J02AC03

INN (International Nazwa):

Voriconazole

Dawkowanie:

200 milligram(s)

Forma farmaceutyczna:

Film-coated tablet

Typ recepty:

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

Dziedzina terapeutyczna:

Triazole derivatives; voriconazole

Status autoryzacji:

Marketed

Data autoryzacji:

2013-08-23

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE USER
VORICONAZOLE TEVA 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 Teva 200 mg Film-coated Tablets are and what they
are used for
2.
What you need to know before you take Voriconazole Teva 200 mg
Film-coated Tablets
3.
How to take Voriconazole Teva 200 mg Film-coated Tablets
4.
Possible side effects
5.
How to store Voriconazole Teva 200 mg Film-coated Tablets
6.
Contents of the pack and other information
1.
WHAT VORICONAZOLE TEVA 200 MG FILM-COATED TABLETS ARE AND WHAT THEY
ARE USED FOR
Voriconazole Teva 200 mg Film-coated Tablets contain 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 Teva 200 mg Film-coated Tablets are intended for patients
with worsening, possibly
life-threatening, fungal infections.
Prevention of fungal infe

Charakterystyka produktu

Health Products Regulatory Authority
21 February 2024
CRN00DTDT
Page 1 of 27
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Voriconazole Teva 200 mg 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 250 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White, oblong film-coated tablet (dimensions: approx. 17.2 mm x 7.2
mm) with imprint “V” on one and “200” 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 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 Teva Film-coated Tablets_ 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 Teva Film-coated Tablet _is available as 50 mg and 200
mg film-coated tablets. Further voriconazole containing
pharmaceutical forms, such as powder for solution for infusion and
powder for oral suspension, are available on the market.
Treatment
_Adults_
Therapy must be initiated with the specified loading dose regimen of
either intravenous or oral voriconazole to achieve plasma
concentrations on Day 1 that are close to steady state. On the basis
of the