Voriconazole Vocate 200 mg powder for solution for infusion

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Veiklioji medžiaga:

VORICONAZOLE

Prieinama:

Vocate Pharmaceuticals S.A 150, Gounari str, 166 74 Glyfada, Athens, Greece

ATC kodas:

J02AC03

INN (Tarptautinis Pavadinimas):

VORICONAZOLE 200 mg

Vaisto forma:

POWDER FOR SOLUTION FOR INFUSION

Sudėtis:

VORICONAZOLE 200 mg

Recepto tipas:

POM

Gydymo sritis:

ANTIMYCOTICS FOR SYSTEMIC USE

Produkto santrauka:

Licence number in the source country: NOT APPLICAPABLE

Autorizacija statusas:

Authorised

Leidimo data:

2020-07-29

Pakuotės lapelis

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PACKAGE LEAFLET: INFORMATION FOR THE USER
VORICONAZOLE VOCATE
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 Vocate is and what it is used for
2.
What you need to know before you take Voriconazole Vocate
3.
How to use Voriconazole Vocate
4.
Possible side effects
5.
How to store Voriconazole Vocate
6.
Content of the pack and other information
1. WHAT VORICONAZOLE VOCATE IS AND WHAT IT IS USED FOR
Voriconazole
Vocate
contains
the
active
substance
voriconazole.
Voriconazole
Vocate
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:
•
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 Vocate 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 TAKE VORICONAZOLE VOCATE
DO NOT TAKE VORICONAZOLE VOCATE:
-

Prekės savybės

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ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Voriconazole Vocate 200 mg powder for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 200mg of voriconazole.
After reconstitution each ml contains 10mg of voriconazole. Once
reconstituted further dilution is
required before administration.
Excipient with known effect
Each vial contains 220.8 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion white to off-white lyophilizate.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Voriconazole Vocate is a broad-spectrum, triazole antifungal agent and
is indicated in adults and children
aged 2 years and above as follows:
-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 Vocate 200 mg powder for solution for infusion 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).
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It is recommended that Voriconazole Vocate 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 regimen of
either intravenous or oral
Voriconazole Vocate to achieve plasma concentrations on Day 1 that are
close to steady state. On the
basis of the high oral bioavailability (96%; see section 5.2),
switching between intravenous and oral
administration is appropriate when cl