Voriconazole 50mg tablets

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Voriconazole

Disponível em:

Milpharm Ltd

Código ATC:

J02AC03

DCI (Denominação Comum Internacional):

Voriconazole

Dosagem:

50mg

Forma farmacêutica:

Tablet

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 05020100

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER
voriconazole
VORICONAZOLE 50 MG FILM-COATED TABLETS
VORICONAZOLE 200 MG FILM-COATED TABLETS
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 or pharmacist.
-
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 or pharmacist. 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
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 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 NOT TAKE VORICONAZOLE
If yo

Características técnicas

OBJECT 1
VORICONAZOLE MILPHARM 50 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 10-Nov-2017 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Voriconazole Milpharm 50 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 50 mg voriconazole.
Excipient with known effect: each tablet contains 65.35 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
White, round (diameter 7.1 mm), biconvex, film coated tablets debossed
with 'CC' on one side and '52' 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 Milpharm 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).
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 the
following table:
INTRAVEN