Riik: Indoneesia
keel: indoneesia
Allikas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 1 AMPLOP @ 2 BLISTER @ 14 TABLET SALUT SELAPUT
2022-12-09
1 EQUFINA ® 50 MG SAFINAMIDE MESYLATE film coated tablets 1. COMPOSITION Brand name Equfina FILM COATED TABLETS 50 mg Active ingredient Safinamide mesylate 65.88 mg (safinamide 50 mg) per tablet Inactive ingredients Lactose hydrate, corn starch, sodium carboxymethyl starch, hydroxypropylcellulose, light anhydrous silicic acid, magnesium stearate, hypromellose, D-mannitol, macrogol 6000, talc, and carnauba wax 2. PRODUCT DESCRIPTION 3. INDICATIONS Equfina is indicated for the treatment of adult patients with idiopathic Parkinson’s disease (PD) for improvement of wearing-off phenomenon as add-on therapy to a stable dose of levodopa (L-dopa) alone or in combination with other PD medicinal products in late-stage PD. 4. PRECAUTIONS CONCERNING INDICATIONS This drug should be used in patients with wearing-off phenomenon despite adjustment of the dose or frequency of levodopa-containing products. 5. CONTRAINDICATIONS This drug is contraindicated to the following patients: 5.1. Patients using other MAO inhibitors (eg, selegiline hydrochloride, rasagiline mesilate) [See 10.1.]. 5.2. Patients using pethidine hydrochloride-containing products, tramadol hydrochloride-containing products, or tapentadol hydrochloride [See 10.1.]. 5.3. Patients using tricyclic antidepressants (eg, amitriptyline hydrochloride, amoxapine, imipramine hydrochloride, clomipramine hydrochloride, dosulepin hydrochloride, trimipramine maleate, nortriptyline hydrochloride, lofepramine hydrochloride), tetracyclic antidepressants (eg, maprotiline hydrochloride, mianserin hydrochloride, setiptiline maleate), selective serotonin reuptake inhibitors (eg, fluvoxamine maleate, paroxetine hydrochloride hydrate, sertraline hydrochloride, escitalopram oxalate), serotonin– noradrenaline reuptake inhibitors (eg, milnacipran hydrochloride, duloxetine Description White round biconvex film-coated tablet Diameter (mm) Approximately 7.1 Thickness (mm) Approximately 3.5 Weight (mg) Approximately 130.0 DISETUJUI OLEH BPOM : 05/10/2022 EREG17180812100034 2 hydrochlorid Lugege kogu dokumenti