Pajjiż: Iżrael
Lingwa: Ingliż
Sors: Ministry of Health
DEUTETRABENAZINE
ABIC MARKETING LTD, ISRAEL
TABLETS EXTENDED RELEASE
DEUTETRABENAZINE 6 MG
PER OS
Required
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
AUSTEDO is indicated in adults for the treatment of: • Chorea associated with Huntington’s disease • Tardive dyskinesia
2021-01-24
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Page 1 of 24 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)]_ Page 2 of 24 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) Aqra d-dokument sħiħ