Voriconazole 200mg powder for solution for infusion

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Voriconazole

זמין מ:

hameln pharma gmbh

קוד ATC:

J02AC03

INN (שם בינלאומי):

Voriconazole

טופס פרצבטיות:

Powder for solution for infusion

איזור תרפויטי:

voriconazole

מצב אישור:

Not marketed

תאריך אישור:

2023-09-22

עלון מידע

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VORICONAZOLE
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 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.
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 used under the supervision of a doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE VORICONAZOLE
DO NOT USE VORICONAZOLE:
-
if y

מאפייני מוצר

Health Products Regulatory Authority
21 March 2024
CRN00F0CK
Page 1 of 30
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Voriconazole 200mg powder for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 200 mg of voriconazole.
After reconstitution (total volume of 20ml) each mL contains 10 mg of
voriconazole. Once reconstituted, further dilution is
required before administration.
Excipients with known effect
Each vial contains 88.74 mg sodium and 2,400 mg hydroxypropylbetadex.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for infusion.
White to off-white lyophilised powder, free of visible evidence of
contamination.
Once reconstituted with either water for injections or sodium chloride
9 mg/mL (0.9 %) solution for injection the pH range is
between 5.0 - 7.0 with an osmolality of 530 mOsmol/kg ± 10 %.
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 is administered at a maximum rate
of 3 mg/kg per hour over 1 to 3 hours.
Treatment
_Adults_
Therapy must be initiated with the specified loading dose