Maa: Armenia
Kieli: englanti
Lähde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
haloperidol
Arpimed LLC
N05AD01
haloperidol
5mg
tablets
(48/2x24/) in blister
Prescription
Registered
2018-10-27
SUMMARY PRODUCT CHARACTERISTIC (SPC) HALOPERIDOL 5 MG TABLETS 1.1 BRAND NAME – HALOPERIDOL 1.2 INTERNATIONAL NON-PROPERTY NAME – HALOPERIDOL 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Haloperidol 5 mg tablet contains: _ACTIVE INGREDIENT:_ haloperidol - 5 mg _For a full list of excipients, see section 6.1. _ 3. PHARMACEUTICAL FORM _Haloperidol, 5 mg tablets _ White or off white scored cylindrical tablets with a few small darker spots and with a risk on one side and a facet on both sides. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adult patients aged 18 years and above • Treatment of schizophrenia and schizoaffective disorder. • Acute treatment of delirium when non-pharmacological treatments have failed. • Treatment of moderate to severe manic episodes associated with bipolar I disorder. • Treatment of acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder. • Treatment of persistent aggression and psychotic symptoms in patients with moderate to severe Alzheimer’s dementia and vascular dementia when nonpharmacological treatments have failed and when there is a risk of harm to self or others. • Treatment of tic disorders, including Tourette’s syndrome, in patients with severe impairment after educational, psychological and other pharmacological treatments have failed. • Treatment of mild to moderate chorea in Huntington’s disease, when other medicinal products are ineffective or not tolerated. Paediatric patients Treatment of: • Schizophrenia in adolescents aged 13 to 17 years when other pharmacological treatments have failed or are not tolerated. • Persistent, severe aggression in children and adolescents aged 6 to 17 years with autism or pervasive developmental disorders, when other treatments have failed or are not tolerated. • Tic disorders, including Tourette’s syndrome, in children and adolescents aged 10 to 17 years with severe impairment after educational, psychological and other pharmacological treatments have fail Lue koko asiakirja