Voriconazole Teva 200mg Film-coated Tablets

Država: Malta

Jezik: angleščina

Source: Medicines Authority

Aktivna sestavina:

VORICONAZOLE

Dostopno od:

Teva Pharma B.V. Swensweg 5, 2031 GA Haarlem, Netherlands

Koda artikla:

J02AC03

INN (mednarodno ime):

VORICONAZOLE 200 mg

Farmacevtska oblika:

FILM-COATED TABLET

Sestava:

VORICONAZOLE 200 mg

Tip zastaranja:

POM

Terapevtsko območje:

ANTIMYCOTICS FOR SYSTEMIC USE

Status dovoljenje:

Withdrawn

Datum dovoljenje:

2013-06-10

Navodilo za uporabo

Page 1 of 10 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 Film-coated Tablets are and what they are used
for
2.
What you need to know before you take Voriconazole Teva Film-coated
Tablets
3.
How to take Voriconazole Teva Film-coated Tablets
4.
Possible side effects
5.
How to store Voriconazole Teva Film-coated Tablets
6.
Contents of the pack and other information
1.
WHAT VORICONAZOLE TEVA FILM-COATED TABLETS ARE AND WHAT THEY ARE USED
FOR
Voriconazole Teva 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 Film-coated Tablets are intended for patients with
worsening, possibly life-
threatening, fungal infections.
Prevention of fungal infections in high risk bone marrow transplant
recipie

Lastnosti izdelka

Page 1 of 33
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
_VORICONAZOLE 200 MG FILM-COATED TABLETS _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg voriconazole.
Excipient with known effect: each 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 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 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
Page 2 of 33
monitored and corrected, if necessary, prior to initiation and during
voriconazole therapy (see section
4.4).
Voriconazole 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 high oral bioavailability (96 %; see section 5.2), switching
between intravenous and oral
administration i