Voriconazole 200mg powder for solution for infusion vials

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Voriconazole

Saadav alates:

Pfizer Ltd

ATC kood:

J02AC03

INN (Rahvusvaheline Nimetus):

Voriconazole

Annus:

200mg

Ravimvorm:

Powder for solution for infusion

Manustamisviis:

Intravenous

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 05020100; GTIN: 5013457011722

Infovoldik

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VORICONAZOLE 200 MG POWDER FOR SOLUTION FOR INFUSION
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 use Voriconazole
4.
Possible side effects
5.
How to store Voriconazole
6.
Content 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 used under the supervision of a doctor.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VORICONAZOLE
DO NOT TAKE VORICONAZO

Toote omadused

OBJECT 1
VORICONAZOLE 200MG POWDER SOLUTION INFUSION
Summary of Product Characteristics Updated 06-Dec-2017 | Pfizer
Limited
1. Name of the medicinal product
Voriconazole Pfizer 200 mg powder for solution for infusion
2. Qualitative and quantitative composition
Each vial contains 200 mg of voriconazole.
After reconstitution each ml contains 10 mg of voriconazole. Once
reconstituted further dilution is
required before administration.
Excipient with known effect
Each vial contains 217.6 mg sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for solution for infusion.
White lyophilised powder.
4. Clinical particulars
4.1 Therapeutic indications
Voriconazole Pfizer, 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 Pfizer 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).
It is recommended that Voriconazole Pfizer is administered at a
maximum rate of 3 mg/kg per hour over
1 to 3 hours.
Voriconazole Pfizer is also available as 50 mg and 200 mg film-coated
tablets and 40 mg/ml powder for
oral suspension.
Treatment
_Adults _
Therapy must be initiated with the specified loading dose regimen of
either intravenous or oral
Voriconazole Pfizer to achieve plasma concentrations on Day 1 that are
close to steady state. On