Country: Malasja
Lingwa: Ingliż
Sors: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Isavuconazonium Sulfate
PFIZER (MALAYSIA) SDN. BHD.
Isavuconazonium Sulfate
14 Capsules
SWISSCO SERVICES AG
Not Applicable. Aqra d-dokument sħiħ
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 Aqra d-dokument sħiħ