CLOZAPINE MYLAN clozapine 100 mg tablet blister pack

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

clozapine, Quantity: 100 mg

Commercializzato da:

Viatris Pty Ltd

Forma farmaceutica:

Tablet, uncoated

Composizione:

Excipient Ingredients: lactose monohydrate; colloidal anhydrous silica; maize starch; purified talc; magnesium stearate; povidone

Via di somministrazione:

Oral

Confezione:

100 x 100 mg tablets, 28 tablets, 50 x 100mg tablets

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

CLOZAPINE MYLAN is indicated in treatment-resistant schizophrenic patients only, i.e. schizophrenic patients who are non-responsive to, or intolerant of other antipsychotic drugs. Non-responsiveness is defined as a lack of satisfactory clinical improvement despite the use of adequate doses of at least two classes of marketed antipsychotic drugs prescribed for reasonable durations. Intolerance is defined as the impossibility to achieve adequate benefit with other antipsychotic drugs because of severe and untreatable neurological adverse reactions (extrapyramidal side effects or tardive dyskinesia).

Dettagli prodotto:

Visual Identification: Yellow flat circular tablet with bevelled edge, 10 mm in diameter, angle scored, marked "ZA" on one side and "SANDOZ" on the other.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2020-01-10