Cresemba 200mg powder for concentrate for solution for infusion vials

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Isavuconazonium sulfate

Disponível em:

Pfizer Ltd

DCI (Denominação Comum Internacional):

Isavuconazonium sulfate

Dosagem:

200mg

Forma farmacêutica:

Powder for solution for infusion

Via de administração:

Intravenous

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 05020100; GTIN: 7640137531201

Folheto informativo - Bula

1 Plfeet: 2018-0035141
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CRESEMBA 200 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
Isavuconazole
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 beloning 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 (400 mg every 12 hours), used for HIV,
-
rifampicin, rifabutin, used

Características técnicas

CRESEMBA 200 MG POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 29-Mar-2017 | Basilea
Pharmaceutica International Ltd
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
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
_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, equivalent to 186 mg
isavuconazonium sulfate.
On the basis of the high oral bioavailability (98%, see section 5.2),
switching between intravenous and
oral administration i