Voriconazole Hikma (previously Voriconazole Hospira)

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

voriconazole

Available from:

Hikma Farmaceutica (Portugal) S.A.

ATC code:

J02AC03

INN (International Name):

voriconazole

Therapeutic group:

Antimycotics for systemic use

Therapeutic area:

Bacterial Infections and Mycoses; Aspergillosis; Candidiasis

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.

Product summary:

Revision: 12

Authorization status:

Authorised

Authorization date:

2015-05-27

Patient Information leaflet

44
B. PACKAGE LEAFLET
45
PACKAGE LEAFLET: INFORMATION FOR THE USER
VORICONAZOLE HIKMA 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 Hikma is and what it is used for
2.
What you need to know before you take Voriconazole Hikma
3.
How to take Voriconazole Hikma
4.
Possible side effects
5.
How to store Voriconazole Hikma
6.
Contents of the pack and other information
1.
WHAT VORICONAZOLE HIKMA IS AND WHAT IT IS USED FOR
Voriconazole Hikma contains the active substance voriconazole.
Voriconazole Hikma 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 cell 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 Hikma is intended for patients with worsening, possibly
life-threatening, fungal infections.
Prevention of fungal infections in high risk bone marrow transplant
recipients.
This medicinal product should only be used under the supervision of a
doctor.
2.
WH

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Voriconazole Hikma 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 217.6 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 (powder for infusion)
White to off-white lyophilised cake.
pH of the reconstituted solution is 4.0 to 7.0.
Osmolality: 500± 50 mOsm/kg
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).
3
It is recommended that voriconazole is administered at a maximum rate
of 3 mg/kg per hour over 1 to 3
hours.
_ _
Treatment
_Adults _
Voriconazole Hikma 200 mg powder for solution for infusion is for
intravenous use only. Oral dosage forms
of voriconazole are available from other manufacturers.
Therapy must be initiated with the specified loading dose regimen of
either in