EQUFINA

देश: इंडोनेशिया

भाषा: इंडोनेशियाई

स्रोत: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

पैकेज में यूनिट:

DUS, 1 AMPLOP @ 2 BLISTER @ 14 TABLET SALUT SELAPUT

प्राधिकरण की तारीख:

2022-12-09

उत्पाद विशेषताएं

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