APO-OLANZAPINE ODT olanzapine 20 mg orally disintegrating tablet bottle

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

olanzapine, Quantity: 20 mg

제공처:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Olanzapine

약제 형태:

Tablet, orally disintegrating

구성:

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

관리 경로:

Oral

패키지 단위:

28, 100, 500

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

- 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.

제품 요약:

Visual Identification: Yellow, round, flat, faced radial edge tablets. Engraved "APO" on one side, "OL" over "20" 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

승인 상태:

Licence status A

승인 날짜:

2009-11-26

제품 특성 요약

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