APO-OLANZAPINE ODT olanzapine 5 mg orally disintegrating tablet bottle

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

olanzapine, Quantity: 5 mg

Prieinama:

Arrotex Pharmaceuticals Pty Ltd

INN (Tarptautinis Pavadinimas):

Olanzapine

Vaisto forma:

Tablet, orally disintegrating

Sudėtis:

Excipient Ingredients: colloidal anhydrous silica; magnesium stearate; sucralose; mannitol; microcrystalline cellulose; carmellose calcium

Vartojimo būdas:

Oral

Vienetai pakuotėje:

28, 100, 500

Recepto tipas:

(S4) Prescription Only Medicine

Terapinės indikacijos:

- 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.

Produkto santrauka:

Visual Identification: Yellow, round, flat, faced radial edge tablets. Engraved "APO" on one side, "OL" over "5" 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

Autorizacija statusas:

Registered

Leidimo data:

2009-11-26

Prekės savybės

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