Voriconazole Ibisqus 200mg powder for solution for infustion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

VORICONAZOLE

Available from:

Istituto Biochimico Italiano G. Lorenzini S.p.A Via Fossignano 2, Aprilia (LT), Italy

ATC code:

J02AC03

INN (International Name):

VORICONAZOLE 200 mg

Pharmaceutical form:

POWDER FOR SOLUTION FOR INFUSION

Composition:

VORICONAZOLE 200 mg

Prescription type:

POM

Therapeutic area:

ANTIMYCOTICS FOR SYSTEMIC USE

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2020-03-13

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
VORICONAZOLE IBISQUS 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 Ibisqus is and what it is used for
2.
What you need to know before you use Voriconazole Ibisqus
3.
How to use Voriconazole Ibisqus
4.
Possible side effects
5.
How to store Voriconazole Ibisqus
6.
Content of the pack and other information
1.
WHAT VORICONAZOLE IBISQUS IS AND WHAT IT IS USED FOR
Voriconazole Ibisqus 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 Ibisqus 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

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Voriconazole Ibisqus 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 216-228 mg of sodium
Each vial contains 3,200 mg cyclodextrin
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 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 hypokalemia, hypomagnesemia and
hypocalcemia should be monitored and
corrected, if necessary, prior to initiation and during voriconazole
therapy (see section 4.4).
It is recommended that Voriconazole is administered at a maximum rate
of 3 mg/kg per hour over 1 to 3
hours.
Other brands of Voriconazole are available as 50 mg and 200 mg
film-coated tablets and 40 mg/ml powder
for oral suspension.
Treatment
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_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
bioavailabi