VORICONAZOLE PHARMA REGULATORY SOLUTIONS 200 Milligram Pdr for Soln for Infusion

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

VORICONAZOLE

Beschikbaar vanaf:

Pharma Regulatory Solutions Ltd

ATC-code:

J02AC03

INN (Algemene Internationale Benaming):

VORICONAZOLE

Dosering:

200 Milligram

farmaceutische vorm:

Pdr for Soln for Infusion

Toedieningsweg:

intravenous infusion

Eenheden in pakket:

30 ml

Prescription-type:

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

Geproduceerd door:

Xellia Pharmaceuticals ApS

Therapeutische categorie:

Antimycotics for systemic use, triazole derivatives

Therapeutisch gebied:

Triazole derivatives

therapeutische indicaties:

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.

Autorisatie-status:

Authorised

Autorisatie datum:

2015-11-27

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
VORICONAZOLE PHARMA REGULATORY SOLUTIONS 200 MG POWDER FOR SOLUTION
FOR INFUSION
Voriconazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Pharma Regulatory Solutions 200 mg powder for
solution for infusion is and
what it is used for
2. What you need to know before you use Voriconazole Pharma Regulatory
Solutions 200 mg
powder for solution for infusion
3. How to use Voriconazole Pharma Regulatory Solutions 200 mg powder
for solution for infusion
4. Possible side effects
5. How to store Voriconazole Pharma Regulatory Solutions 200 mg powder
for solution for infusion
6. Contents of the pack and other information
1. WHAT VORICONAZOLE PHARMA REGULATORY SOLUTIONS 200 MG POWDER FOR
SOLUTION 
    FOR INFUSION IS AND WHAT IT IS USED FOR
Voriconazole Pharma Regulatory Solutions 200 mg powder for solution
for infusion 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),
●

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Voriconazole Pharma Regulatory Solutions 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.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for infusion.
White to off white cake or powder.
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).
It is recommended that Voriconazole Pharma Regulatory Solutions 200 mg powder for solution for infusion is
administered at a maximum rate of 3 mg/kg per hour over 1 to 3 hours.
Voriconazole is also available as film-coated tablets and as an oral suspension.
TREATMENT
_Adults_
Therapy must be initiated with the specified loading dose regimen of either intravenous or o