RISPERIDONE ASCENT risperidone 4mg film-coated tablet blister pack

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
28-11-2017

Aktivna sestavina:

risperidone, Quantity: 4 mg

Dostopno od:

Medis Pharma Pty Ltd

INN (mednarodno ime):

Risperidone

Farmacevtska oblika:

Tablet, film coated

Sestava:

Excipient Ingredients: colloidal anhydrous silica; maize starch; indigo carmine; hypromellose; magnesium stearate; quinoline yellow; microcrystalline cellulose; lactose monohydrate; titanium dioxide; macrogol 400

Pot uporabe:

Oral

Enote v paketu:

60 tablets

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

Risperidone Ascent is indicated for the treatment of schizophrenia and related psychoses. Risperidone Ascent is indicated for the treatment of behavioural disturbances in dementia. Risperidone Ascent is indicated for the treatment of conduct and other disruptive disorders in children (over 5 years), adolescents and adults with sub average intellectual functioning or mental retardation in whom destructive behaviours (e.g. aggression, impulsivity and self-injurious behaviours) are prominent. (See Clinical Trials for maintenance data).

Povzetek izdelek:

Visual Identification: Green, film-coated, oblong tablet engraved with "R", a breakline and "4" on one side and a plain face on the other.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius

Status dovoljenje:

Licence status A

Datum dovoljenje:

2012-09-26