Haloperidol tablets

País: Armènia

Idioma: anglès

Font: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

ingredients actius:

haloperidol

Disponible des:

Arpimed LLC

Codi ATC:

N05AD01

Designació comuna internacional (DCI):

haloperidol

Dosis:

5mg

formulario farmacéutico:

tablets

Unidades en paquete:

(48/2x24/) in blister

tipo de receta:

Prescription

Estat d'Autorització:

Registered

Data d'autorització:

2023-08-05

Fitxa tècnica

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