Voriconazole 50mg tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Voriconazole

Commercializzato da:

Aspire Pharma Ltd

Codice ATC:

J02AC03

INN (Nome Internazionale):

Voriconazole

Dosaggio:

50mg

Forma farmaceutica:

Tablet

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 05020100; GTIN: 5060209731483

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE USER
VORICONAZOLE 50 MG FILM-COATED TABLETS
VORICONAZOLE 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 is and what it is used for
2. What you need to know before you take Voriconazole
3. How to take Voriconazole
4. Possible side effects
5. How to store Voriconazole
6. Contents of the pack and other information
1. WHAT VORICONAZOLE IS AND WHAT IT IS USED FOR
Voriconazole contains 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 cell 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 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 VORICONAZOLE
DO

Scheda tecnica

OBJECT 1
VORICONAZOLE 50MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 04-May-2018 | Aspire Pharma
Ltd
1. Name of the medicinal product
Voriconazole 50 mg film-coated tablets
2. Qualitative and quantitative composition
Each tablet contains 50 mg voriconazole.
Excipient with known effect
Each tablet contains 58.17 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film coated tablet
White to off-white, round biconvex film coated tablets, with code V50
on one side, 7.1 ± 0.2 mm in
diameter.
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 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 is also available as 200 mg film-coated tablets and 200
mg powder for solution for infusion.
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 is
appropriate when clinically indicated.
Detailed information on dosage recommendations is provided in