AUSTEDO 6 MG

Negara: Israel

Bahasa: Inggris

Sumber: Ministry of Health

Bahan aktif:

DEUTETRABENAZINE

Tersedia dari:

ABIC MARKETING LTD, ISRAEL

Bentuk farmasi:

TABLETS EXTENDED RELEASE

Komposisi:

DEUTETRABENAZINE 6 MG

Rute administrasi :

PER OS

Jenis Resep:

Required

Diproduksi oleh:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Indikasi Terapi:

AUSTEDO is indicated in adults for the treatment of: • Chorea associated with Huntington’s disease • Tardive dyskinesia

Tanggal Otorisasi:

2021-01-24

Selebaran informasi

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Karakteristik produk

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AUSTEDO-6mg-9mg-12mg-tabs-SPC-01-2021
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE MEDICINAL PRODUCT
AUSTEDO 6 MG, EXTENDED-RELEASE TABLETS
AUSTEDO 9 MG, EXTENDED-RELEASE TABLETS
AUSTEDO 12 MG, EXTENDED-RELEASE TABLETS
QUALITATIVE AND QUANTITATIVE COMPOSITION
AUSTEDO 6 MG:
Each tablet contains 6mg Deutetrabenazine.
AUSTEDO 9 MG:
Each tablet contains 9mg Deutetrabenazine.
AUSTEDO 12 MG:
Each tablet contains 12mg Deutetrabenazine.
WARNING: DEPRESSION AND SUICIDALITY IN PATIENTS WITH
HUNTINGTON’S DISEASE
AUSTEDO
CAN
INCREASE
THE
RISK
OF
DEPRESSION
AND
SUICIDAL
THOUGHTS
AND
BEHAVIOR
(SUICIDALITY) IN PATIENTS WITH HUNTINGTON’S DISEASE. ANYONE
CONSIDERING THE USE OF AUSTEDO
MUST BALANCE THE RISKS OF DEPRESSION AND SUICIDALITY WITH THE CLINICAL
NEED FOR TREATMENT OF
CHOREA. CLOSELY MONITOR PATIENTS FOR THE EMERGENCE OR WORSENING OF
DEPRESSION, SUICIDALITY,
OR UNUSUAL CHANGES IN BEHAVIOR. PATIENTS, THEIR CAREGIVERS, AND
FAMILIES SHOULD BE INFORMED
OF THE RISK OF DEPRESSION AND SUICIDALITY AND SHOULD BE INSTRUCTED TO
REPORT BEHAVIORS OF
CONCERN PROMPTLY TO THE TREATING PHYSICIAN.
PARTICULAR CAUTION SHOULD BE EXERCISED IN TREATING PATIENTS WITH A
HISTORY OF DEPRESSION OR
PRIOR SUICIDE ATTEMPTS OR IDEATION, WHICH ARE INCREASED IN FREQUENCY
IN HUNTINGTON’S DISEASE.
AUSTEDO IS CONTRAINDICATED IN PATIENTS WHO ARE SUICIDAL, AND IN
PATIENTS WITH UNTREATED OR
INADEQUATELY TREATED DEPRESSION _ [SEE CONTRAINDICATIONS (4) AND
WARNINGS AND PRECAUTIONS _
_(5.1)]._
1.
INDICATIONS AND USAGE
AUSTEDO is indicated in adults for the treatment of:

chorea associated with Huntington’s disease
_[see Clinical Studies_
_(14.1)]_

tardive dyskinesia
_[see Clinical Studies (14.2)]_
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AUSTEDO-6mg-9mg-12mg-tabs-SPC-01-2021
2.
DOSAGE AND ADMINISTRATION
2.1 DOSING INFORMATION
The dose of AUSTEDO is determined individually for each patient based
on reduction of chorea
or tardive dyskinesia and tolerability. When first prescribed to
patients who are not being switched
from tetrabenazine (a related VMAT2 inhibitor)