UNAMITY

Država: Indonezija

Jezik: indonezijščina

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

Aktivna sestavina:

BARICITINIB

Dostopno od:

PYRIDAM FARMA TBK - Indonesia

INN (mednarodno ime):

BARICITINIB

Odmerek:

2.000 MG

Farmacevtska oblika:

TABLET SALUT SELAPUT

Enote v paketu:

DUS, 4 BLISTER @ 7 TABLET SALUT SELAPUT

Izdeluje:

LILLY DEL CARIBE, INC. - United States of America

Datum dovoljenje:

2021-12-20

Lastnosti izdelka

Unamity_ID_New Indication_leaflet for doctor_proposedTC-V4
Page 1 of 30
UNAMITY
BARICITINIB 2 MG FILM-COATED TABLETS
BARICITINIB 4 MG FILM-COATED TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Unamity 2 mg film-coated tablets
Unamity 4 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Unamity 2 mg film-coated tablets
Each film-coated tablet contains 2 mg baricitinib
Unamity 4 mg film-coated tablets
Each film-coated tablet contains 4 mg baricitinib
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Unamity 2 mg film-coated tablets
Light pink, 9 x 7.5 mm oblong tablets, debossed with “Lilly” on
one side and “2” on the other.
Unamity 4 mg film-coated tablets
Medium pink, 8.5 mm round tablets, debossed with “Lilly” on one
side and “4” on the other.
The tablets contain a recessed area on each side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid arthritis
Baricitinib is indicated for the treatment of moderate to severe
active rheumatoid arthritis in adult
patients who have responded inadequately to one or more
disease-modifying anti-rheumatic drugs.
Baricitinib may be used as monotherapy or in combination with
methotrexate.
Atopic dermatitis
Baricitinib is indicated for the treatment of moderate to severe
atopic dermatitis in adult patients who
are candidates for systemic therapy.
Alopecia areata
Baricitinib is indicated for the treatment of severe alopecia areata
in adult patients (see section 5.1).
DISETUJUI OLEH BPOM: 03/07/2023
EREG10019312200200
EREG10019312200201
Unamity_ID_New Indication_leaflet for doctor_proposedTC-V4
Page 2 of 30
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated by physicians experienced in the
diagnosis and treatment of the
conditions for which this medicinal product is indicated.
Posology
_Rheumatoid arthritis _
The recommended dose of Baricitinib is 4 mg once daily. A dose of 2 mg
once daily is appropriate
for patients such as those aged ≥ 75 years and may be appropriate
fo