Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
haloperidol
Arpimed LLC
haloperidol
5mg
tablets
Prescription
SUMMARY PRODUCT CHARACTERISTIC (SPC) HALOPERIDOL 1.5 MG AND 5 MG TABLETS 1.1 BRAND NAME – HALOPERIDOL 1.2 INTERNATIONAL NON-PROPERTY NAME - HALOPERIDOL 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Haloperidol 1.5 mg tablet contains: _ACTIVE INGREDIENT:_ haloperidol – 1.5 mg _For a full list of excipients, see section 6.1. _ 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, 1.5 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. _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 Adults Schizophrenia: treatment of symptoms and prevention of relapse. Other psychoses: especially paranoid. Mania and hypomania. Mental or behavioural problems such as aggression, hyperactivity and self mutilation in the mentally retarded and in patients with organic brain damage. As an adjunct to short term management of moderate to severe psychomotor agitation, excitement, violent or dangerously impulsive behaviour. Intractable hiccup. Restlessness and agitation in the elderly. Gilles de la Tourette syndrome and severe tics. Children (Oral Administration Only) Childhood behavioural disorders, especially when associated with hyperactivity and aggression. Gilles de la Tourette syndrome. Childhood schizophrenia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY: For oral administration. Dosage for all indications should be individually determined and is best initiated and titrated under close clinical supervision. To determine initial dose, consideration should be given to the patient’s age, severity of symptoms and previous response to neuroleptic drugs. Patients who are elderly or debilitated or those with previously rep Прочитать полный документ