OLUMIANT FILM-COATED TABLET 2MG

দেশ: সিঙ্গাপুর

ভাষা: ইংরেজি

সূত্র: HSA (Health Sciences Authority)

সক্রিয় উপাদান:

Baricitinib

থেকে পাওয়া:

DKSH SINGAPORE PTE. LTD.

এটিসি কোড:

L04AA37

ফার্মাসিউটিকাল ফর্ম:

TABLET, FILM COATED

রচনা:

Baricitinib 2.000mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

Prescription Only

Manufactured by:

Lilly del Caribe, Inc.

অনুমোদন অবস্থা:

ACTIVE

অনুমোদন তারিখ:

2018-06-18

পণ্য বৈশিষ্ট্য

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1.
NAME OF THE MEDICINAL PRODUCT
Olumiant film-coated tablets 2mg
Olumiant film-coated tablets 4mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
OLUMIANT FILM-COATED TABLETS 2MG
Each film-coated tablet contains 2mg baricitinib.
OLUMIANT FILM-COATED TABLETS 4MG
Each film-coated tablet contains 4mg baricitinib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
OLUMIANT FILM-COATED TABLETS 2MG
Light pink, oblong, debossed with “Lilly” on one side and “2”
on the other.
OLUMIANT FILM-COATED TABLETS 4MG
Medium pink, round, debossed with “Lilly” on one side and “4”
on the other.
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, or who are
intolerant to one or more
disease-modifying anti-rheumatic drugs. Baricitinib may be used as
monotherapy or in
Page 2 of 37
combination with methotrexate (see sections 4.4, 4.5 and 5.1 for
available data on different
combinations).
Atopic dermatitis
Baricitinib is indicated for the treatment of moderate to severe
atopic dermatitis in adult
patients whose disease is not adequately controlled with topical
prescription therapies or
when those therapies are not advisable.
Alopecia areata
Baricitinib is indicated for the treatment of severe alopecia areata
in adult patients (see
section 5.1).
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 4mg once daily. A dose of 2mg
once daily is
appropriate for patients such as those aged ≥ 75 years and may be
appropriate for patients
with a history of chronic or recurrent infections. A dose of 2mg once
daily may also be
considered for patients who have achieved sustained control of disease
activity with