BRINTELLIX

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

VORTIOXETINE HYDROBROMIDE

Tersedia dari:

PYRIDAM FARMA TBK - Indonesia

INN (Nama Internasional):

VORTIOXETINE HYDROBROMIDE

Dosis:

12,710 MG

Bentuk farmasi:

TABLET SALUT SELAPUT

Unit dalam paket:

DUS, 2 BLISTER @ 14 TABLET SALUT SELAPUT

Diproduksi oleh:

H. LUNDBECK A/S - Denmark

Tanggal Otorisasi:

2022-04-05

Karakteristik produk

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
See full prescribing information for complete boxed warning.

Increased risk of suicid al thinking and behavior in children,
adolescents, and young adults taking antidepressants (5.1).

Monitor for worsening and emergence of suicidal thoughts
and behaviors (5.1).

BRINTELLIX has not been evaluated for use in pediatric
patients (8.4).
Brintellix
®
film-coated tablets
Vortioxetine (as hydrobromide)
1.
NAME OF THE MEDI CINAL PRODUCT
Brintellix 5 mg film-coated tablets
Brintellix 10 mg film-coated tablets
Brintellix 20 mg film-coated tablets
2.
QUALITATIVE AND Q UANTITATIVE COMPOSITION
Brintellix 5 mg film-coated tablets
Each film-coated tablet contains vortioxetine hydrobromide equivalent
to 5 mg
vortioxetine.
Brintellix 10 mg film-coated tablets
Each film-coated tablet contains vortioxetine hydrobromide equivalent
to 10 mg
vortioxetine.
Brintellix 20 mg film-coated tablets
Each film-coated tablet contains vortioxetine hydrobromide equivalent
to 20 mg
vortioxetine.
For the full list of excipients, see section 6.1.
DISETUJUI OLEH BPOM: 06/07/2021
EREG10019312100073
EREG10019312100074
EREG10019312100075
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Brintellix 5 mg film-coated tablets
Pink, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with
“TL” on one side
and “5” on the other side.
Brintellix 10 mg film-coated tablets
Yellow, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with
“TL” on one
side and “10” on the other side.
Brintellix 20 mg film-coated tablets
Red, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with
“TL” on one side
and “20” on the other side.
4.
CLINICAL PARTICUL ARS
4.1
Terapeutic Indications
Brintellix is indicated for the treatment of major depressive disorder
in adults. The
efficacy of Brintellix was demonstrated in 6 to 8 week studies
(including one study in
the elderly).
4.2
Posology and method of administration
Posology (tablet)
The starting and recommended dose of Brintellix is 10 mg vortioxetine
on