Voriconazole Actavis 200 mg Powder for solution for infusion

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Voriconazole

Dostępny od:

Actavis Group PTC ehf

Kod ATC:

J02AC03

INN (International Nazwa):

Voriconazole

Dawkowanie:

200 milligram(s)

Forma farmaceutyczna:

Powder for solution for infusion

Typ recepty:

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

Dziedzina terapeutyczna:

voriconazole

Status autoryzacji:

Marketed

Data autoryzacji:

2016-05-26

Ulotka dla pacjenta

Voriconazole 200mg Powder PIL - Ireland
item no: AAAI9319
print proof no: 02
origination date: 14-04-2016
originated by: NM
revision date: 26-05-2016
revised by: NM
dimensions: 124 x 700
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1. Black
2.
3.
4.
5.
6.
1. Profile
2.
3.
date sent: 18-04-2016
supplier: Nerviano
technically app. date: 18-04-2016
min pt size: 8 pts
TECHNICAL APPROVAL
The following information is intended for healthcare professionals
only:
RECONSTITUTION AND DILUTION INFORMATION
•
Voriconazole Actavis powder for solution for infusion needs to first
be reconstituted with either
19 ml of Water for Injections or 19 ml of 9 mg/ml (0.9%) Sodium
Chloride for Infusion to obtain
an extractable volume of 20 ml of clear concentrate containing 10
mg/ml voriconazole.
•
Discard the Voriconazole Actavis vial if the vacuum does not pull the
diluent into the vial.
•
It is recommended that a standard 20 ml (non-automated) syringe be
used to ensure that
the exact amount (19.0 ml) of Water for Injections or of 9 mg/ml
(0.9%) Sodium Chloride for
Infusion is dispensed.
•
The required volume of the reconstituted concentrate is then added to
a recommended
compatible infusion solution listed below to obtain a final
Voriconazole Actavis solution
containing 0.5 to 5 mg/ml of voriconazole.
•
This medicinal product is for single use only and any unused solution
should be discarded and
only clear solutions without particles should be used.
•
For intravenous infusion only.
•
For storage information, please refer to Section 5 ‘How to store
Voriconazole Actavis’.
_Required Volumes of 10 mg/ml Voriconazole Actavis Concentrate_
VOLUME OF VORICONAZOLE ACTAVIS CONCENTRATE (10 MG/ML) REQUIRED FOR:
BODY WEIGHT
(KG)
3 MG/KG DOSE
(NUMBER OF
VIALS)
4 MG/KG DOSE
(NUMBER OF
VIALS)
6 MG/KG DOSE
(NUMBER OF
VIALS)
8 MG/KG DOSE
(NUMBER OF
VIALS)
9 MG/KG DOSE
(NUMBER OF
VIALS)
10
-
4.0 ml (1)
-
8.0 ml (1)
9.0 ml (1)
15
-
6.0 ml (1)
-
12.0 ml (1)
13.5 ml (1)
20
-
8.0 ml (1)
-
16.0 ml (1)
18.0 ml (1)
2

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Voriconazole Actavis 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:
This medicinal product contains less than 1 mmol sodium (23 mg) per
vial, i.e. essentially ‘sodium-free’.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for infusion.
White or almost 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 Actavis 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 Actavis is administered at a
maximum rate of 3 mg/kg per hour over 1 to 3 hours.
Other strengths and pharmaceutical forms of voriconazole may be
available.
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