Voriconazole Pfizer 200 mg powder for solution for infusion

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Voriconazole

זמין מ:

Pfizer Healthcare Ireland

קוד ATC:

J02AC; J02AC03

INN (שם בינלאומי):

Voriconazole

כמות:

200 milligram(s)

טופס פרצבטיות:

Powder for solution for infusion

סוג מרשם:

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

איזור תרפויטי:

Triazole derivatives; voriconazole

מצב אישור:

Not marketed

תאריך אישור:

2013-06-07

עלון מידע

Page 1 of 11 2020-0059891, 2019-0050301,
2020-0059895, 2019-0050034, 2020-0060839
PACKAGE LEAFLET: INFORMATION FOR THE USER
VORICONAZOLE PFIZER® 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 Pfizer is and what it is used for
2.
What you need to know before you take Voriconazole Pfizer
3.
How to use Voriconazole Pfizer
4.
Possible side effects
5.
How to store Voriconazole Pfizer
6.
Content of the pack and other information
1.
WHAT VORICONAZOLE PFIZER IS AND WHAT IT IS USED FOR
Voriconazole Pfizer contains the active substance voriconazole.
Voriconazole Pfizer 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 Pfizer is intended for patients with worsening, possibly
life-threatening, fungal infections.
Prevention of fungal infections in high risk bone marrow transplant
recipients.
This produ

מאפייני מוצר

Health Products Regulatory Authority
20 April 2022
CRN00CPWZ
Page 1 of 28
SUMMARY OF PRODUCT CHARACTERISTICS
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.
Excipients with known effect
Each vial contains 221 mg 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 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