BRINTELLIX

국가: 인도네시아

언어: 인도네시아어

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

유효 성분:

VORTIOXETINE HYDROBROMIDE

제공처:

PYRIDAM FARMA TBK - Indonesia

INN (International Name):

VORTIOXETINE HYDROBROMIDE

복용량:

6,355 MG

약제 형태:

TABLET SALUT SELAPUT

패키지 단위:

DUS, 2 BLISTER @ 14 TABLET SALUT SELAPUT

Manufactured by:

H. LUNDBECK A/S - Denmark

승인 날짜:

2022-04-05

제품 특성 요약

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.

INCREASED RISK OF SUICIDAL 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: 29/12/2021
EREG10019312100276
EREG10019312100277
EREG10019312100278
3.
PHARMACEUTICAL FORM
Film-coated tablet.
B
rintellix 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