Cresemba

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

isavuconazole

Saatavilla:

Basilea Pharmaceutica Deutschland GmbH

ATC-koodi:

J02AC

INN (Kansainvälinen yleisnimi):

isavuconazole

Terapeuttinen alue:

Aspergillosis

Käyttöaiheet:

Cresemba is indicated in adults for the treatment of:invasive aspergillosismucormycosis in patients for whom amphotericin B is inappropriateConsideration should be given to official guidance on the appropriate use of antifungal agents.

Tuoteyhteenveto:

Revision: 17

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2015-10-15

Pakkausseloste

53
B. PACKAGE LEAFLET
54
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CRESEMBA 200 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
isavuconazole
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.
-
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 Cresemba is and what it is used for
2.
What you need to know before you use Cresemba
3.
How to use Cresemba
4.
Possible side effects
5.
How to store Cresemba
6.
Contents of the pack and other information
1.
WHAT CRESEMBA IS AND WHAT IT IS USED FOR
WHAT CRESEMBA IS
Cresemba is an anti-fungal medicine that contains the active substance
isavuconazole.
HOW CRESEMBA WORKS
Isavuconazole works by killing or stopping the growth of the fungus,
which causes the infection.
WHAT CRESEMBA IS USED FOR
Cresemba is used in adults to treat the following fungal infections:
-
invasive aspergillosis, caused by a fungus in the ‘Aspergillus’
group;
-
mucormycosis, caused by a fungus belonging to the ‘Mucorales’
group in patients for whom a
treatment with amphotericin B is not appropriate.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CRESEMBA
DO NOT USE CRESEMBA:
-
if you are allergic to isavuconazole or any of the other ingredients
of this medicine (listed in
section 6),
-
if you have a heart beat problem called ‘familial short QT
syndrome’,
-
IF YOU ARE USING ANY OF THE FOLLOWING MEDICINES:
-
ketoconazole, used for fungal infections,
-
high doses of ritonavir (more than 200 mg every 12 hours), used for
HIV,
-
rifampicin, rifabutin, used for tuberculosis,
-
carbamazepine, used for epilepsy,
-
barbiturate medicines like phenobarbital, used for epilepsy and sleep
disorders,
-
phenytoin, used for epilepsy,
-
St John’s wort, a herbal medicine used for de

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
CRESEMBA 200 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 200 mg isavuconazole (as 372.6 mg isavuconazonium
sulfate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion
White to yellow powder
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CRESEMBA is indicated in adults for the treatment of
•
invasive aspergillosis
•
mucormycosis in patients for whom amphotericin B is inappropriate (see
sections 4.4 and 5.1)
Consideration should be given to official guidance on the appropriate
use of antifungal agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Early targeted therapy (pre-emptive or diagnostic-driven therapy) may
be instituted pending
confirmation of the disease from specific diagnostic tests. However,
once these results become
available, antifungal therapy should be adjusted accordingly.
_Loading dose_
The recommended loading dose is one vial after reconstitution and
dilution (equivalent to 200 mg of
isavuconazole) every 8 hours for the first 48 hours (6 administrations
in total).
_Maintenance dose_
The recommended maintenance dose is one vial after reconstitution and
dilution (equivalent to 200 mg
of isavuconazole) once daily, starting 12 to 24 hours after the last
loading dose.
Duration of therapy should be determined by the clinical response (see
section 5.1).
For long-term treatment beyond 6 months, the benefit-risk balance
should be carefully considered (see
sections 5.1 and 5.3).
_Switch to oral isavuconazole_
CRESEMBA is also available as hard capsules containing 100 mg
isavuconazole.
On the basis of the high oral bioavailability (98%, see section 5.2),
switching between intravenous and
oral administration is appropriate when clinically indicated.
3
_Elderly_
No dose adjustment is necessary for elderly patients; however the
clinical experience in elderly
patients is limit