Voriconazole Ibisqus 200 mg powder for solution for infusion

Country: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Voriconazole

Доступно од:

Instituto Biochimico Italiano G. Lorenzini S.p.A.

АТЦ код:

J02AC; J02AC03

INN (Међународно име):

Voriconazole

Дозирање:

200 milligram(s)

Фармацеутски облик:

Powder for solution for infusion

Терапеутска област:

Triazole derivatives; voriconazole

Статус ауторизације:

Not marketed

Датум одобрења:

2019-04-12

Информативни летак

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 use 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 Ibisqus 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)
•
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 USE VORICONAZOLE

Карактеристике производа

Health Products Regulatory Authority
20 February 2024
CRN00DXQ9
Page 1 of 30
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
_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 st