Cresemba 100mg Capsule

Nazione: Malesia

Lingua: inglese

Fonte: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Principio attivo:

Isavuconazonium Sulfate

Commercializzato da:

PFIZER (MALAYSIA) SDN. BHD.

INN (Nome Internazionale):

Isavuconazonium Sulfate

Confezione:

14 Capsules

Prodotto da:

SWISSCO SERVICES AG

Foglio illustrativo

Not Applicable.

Scheda tecnica

Page 2 of 23
CRESEMBA
TM
Isavuconazonium sulfate
1.
NAME OF THE MEDICINAL PRODUCT
CRESEMBA 100 mg hard capsules.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
For the full list of excipients, see section 6.1.
Each capsule contains 100 mg isavuconazole (as 186.3 mg
isavuconazonium sulfate).
3.
PHARMACEUTICAL FORM
Hard capsule
Swedish Orange (reddish-brown) capsule body marked with “100” in
black ink and a white cap marked
with "C" in black ink. Capsules length: 24.2 mm.
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
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.
Posology
_Loading dose_
The recommended loading dose is two capsules (equivalent to 200 mg of
isavuconazole) every 8 hours for
the first 48 hours (6 administrations in total).
_Maintenance dose_
Page 3 of 23
The recommended maintenance dose is two capsules (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 intravenous infusion_
CRESEMBA is also available as powder for concentrate for solution for
infusion containing 200 mg
isavuconazole, equivalent to 372 mg isavuconazonium sulfate.
On the basis of the high oral bioavailability (98%, see section 5.2),
switching between intravenous and oral
administration is appropriate when clinically indicated.
Loading dose is not require