দেশ: অস্ট্রেলিয়া
ভাষা: ইংরেজি
সূত্র: Department of Health (Therapeutic Goods Administration)
olanzapine, Quantity: 15 mg
Arrotex Pharmaceuticals Pty Ltd
Olanzapine
Tablet, orally disintegrating
Excipient Ingredients: mannitol; sucralose; microcrystalline cellulose; colloidal anhydrous silica; carmellose calcium; magnesium stearate
Oral
100, 500, 28
(S4) Prescription Only Medicine
- Treatment of schizophrenia and related psychoses;. - Short-term treatment, alone or in combination with lithium or valproate, of acute manic episodes associated with bipolar I disorder;. - Preventing recurrence of manic, mixed or depressive episodes in bipolar I disorder.
Visual Identification: Yellow, round, flat, faced radial edge tablets. Engraved "APO" on one side, "OL" over "15" on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2009-11-26
1 AUSTRALIAN PRODUCT INFORMATION – APO-OLANZAPINE ODT ORALLY DISINTEGRATING TABLETS (OLANZAPINE) 1 NAME OF THE MEDICINE Olanzapine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each orally disintegrating tablet contains 5mg, 10mg, 15mg or 20mg olanzapine, as the active ingredient. EXCIPIENTS WITH KNOWN EFFECT Not applicable For the full list of excipients see section 6.1 List of Excipients 3 PHARMACEUTICAL FORM 5MG ORALLY DISINTEGRATING TABLETS: Yellow, round, flat face radial-edged tablets. Engraved “APO” on one side, “OL” over “5” on the other side. 10MG ORALLY DISINTEGRATING TABLETS: Yellow, round, flat face radial-edged tablets. Engraved “APO” on one side, “OL” over “10” on the other side. 15MG ORALLY DISINTEGRATING TABLETS: Yellow, round, flat face radial-edged tablets. Engraved “APO” on one side, “OL” over “15” on the other side. 20MG ORALLY DISINTEGRATING TABLETS: Yellow, round, flat face radial-edged tablets. Engraved “APO” on one side, “OL” over “20” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of schizophrenia and related psychoses; Short-term treatment, alone or in combination with lithium or valproate, of acute manic episodes associated with bipolar I disorder; Preventing recurrence of manic, mixed or depressive episodes in Bipolar I Disorder. 2 4.2 DOSE AND METHOD OF ADMINISTRATION Olanzapine ODT orally disintegrating tablets are intended for oral administration. The orally disintegrating tablet begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. The orally disintegrating tablet should be handled carefully with dry hands. Direct contact with hands should be avoided if possible. The orally disintegrating tablet may also be stirred into 125mL of water, milk, coffee, orange juice or apple juice and the contents promptly consumed. SCHIZOPHRENIA AND RELATED DISORDERS The recommended starting dose is 5 to 10mg/day, administered as a single d সম্পূর্ণ নথি পড়ুন