Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 3 BLISTER @ 7 KAPSUL
2022-07-08
POMALID POMALIDOMIDE Capsules 1 mg Capsules 2 mg Capsules 3 mg Capsules 4 mg 1. QUALITATIVE AND QUANTITATIVE COMPOSITION Pomalid 1 mg capsules : Each capsule contains 1 mg of pomalidomide. Pomalid 2 mg capsules : Each capsule contains 2 mg of pomalidomide. Pomalid 3 mg capsules : Each capsule contains 3 mg of pomalidomide. Pomalid 4 mg capsules : Each capsule contains 4 mg of pomalidomide. 2. PHARMACEUTICAL FORM Pomalid 1 mg capsules Hard gelatin capsule, with a yellow body and red cap, with “PLM 1” printed axial rectified in white in the body. Capsule size 4. Pomalid 2 mg capsules Hard gelatin capsule, with an orange body and red cap, with “PLM 2” printed axial rectified in white in the body. Capsule size 2. Pomalid 3 mg capsules Hard gelatin capsule, with a turquoise body and red cap, with “PLM 3” printed axial rectified in white in the body. Capsule size 2. Pomalid 4 mg capsules Hard gelatin capsule, with a dark blue body and red cap, with “PLM 4” printed axial rectified in white in the body. Capsule size 2. 3. THERAPEUTIC INDICATIONS Pomalid in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide. Pomalid in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy. DISETUJUI OLEH BPOM: 21/06/2022 ID: EREG10019112100009; EREG10019112100067; EREG10019112100068; EREG10019112100069 4. POSOLOGY AND METHOD OF ADMINISTRATION Treatment must be initiated and monitored under the supervision of physicians experienced in the management of multiple myeloma. Dosing is continued or modified based upon clinical and laboratory findings (see section 6). POSOLOGY • _POMALIDOMIDE IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE _ The recommended Baca dokumen lengkapnya