Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
RISDIPLAM
MENARINI INDRIA LABORATORIES - Indonesia
RISDIPLAM
60 MG
SIRUP KERING
BOX OF 1 BOTTLE OF 2 G POWDER FOR ORAL SOLUTION + 1 PRESS-IN BOTT...
F. HOFFMANN-LA ROCHE LTD - Switzerland
2021-12-20
_Draft_Evrysdi_PI_MAT_CDS3.0_EN_v1 _ _Page 1 of 23_ EVRYSDI ® Risdiplam Information as set forth in this label only applies to Evrysdi 1. DESCRIPTION 1.1 THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG Pharmacotherapeutic group: Other drugs for disorders of the musculo-skeletal system. ATC code: M09AX10. 1.2 TYPE OF DOSAGE FORM Powder for oral solution. 1.3 ROUTE OF ADMINISTRATION Oral or enteral. 1.4 STERILE/RADIOACTIVE STATEMENT Not applicable. 1.5 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: risdiplam. Excipients: mannitol, isomalt, strawberry flavor, tartaric acid, sodium benzoate, polyethylene glycol, sucralose, ascorbic acid, and disodium edetate dihydrate. Evrysdi is supplied as a powder in an amber glass bottle. Each bottle is filled with 2.0 g of powder contains 60 mg risdiplam. The powder is constituted with purified water or sterile water for injection to yield an oral solution containing 0.75 mg/mL of risdiplam (see section _4.2 Special Instructions for Use, Handling and _ _Disposal_). 2. CLINICAL PARTICULARS 2.1 THERAPEUTIC INDICATION(S) Evrysdi is indicated for the treatment of spinal muscular atrophy (SMA). 2.2 DOSAGE AND ADMINISTRATION Evrysdi oral solution must be constituted by a health care provider (HCP) prior to being dispensed. DISETUJUI OLEH BPOM: 28/10/2021 EREG100364VR12100158 _Draft_Evrysdi_PI_MAT_CDS3.0_EN_v1 _ _Page 2 of 23_ GENERAL SMA treatment should be initiated as early as possible after diagnosis. Evrysdi is taken orally once daily using the oral syringe provided, at approximately the same time each day. The recommended once daily dose of Evrysdi for SMA patients is determined by age and body weight (see_ Table 1_). TABLE 1 DOSING REGIMEN BY AGE AND BODY WEIGHT AGE AND BODY WEIGHT RECOMMENDED DAILY DOSE 2 months to < 2 years of age 0.20 mg/kg ≥ 2 years of age (< 20 kg) 0.25 mg/kg ≥ 2 years of age (≥ 20 kg) 5 mg Dose changes must be made under the supervision of a HCP. Treatment with a daily dose above 5 mg has not been studied. No data are available in infants below Baca dokumen lengkapnya