OXYCODONE MR APOTEX oxycodone hydrochloride 10mg modified release tablets blister pack

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

公開評価報告書 公開評価報告書 (PAR)
26-11-2017

有効成分:

oxycodone hydrochloride, Quantity: 10 mg

から入手可能:

Arrotex Pharmaceuticals Pty Ltd

INN(国際名):

oxycodone hydrochloride

医薬品形態:

Tablet, modified release

構図:

Excipient Ingredients: titanium dioxide; macrogol 8000; hypromellose; ethylcellulose; colloidal anhydrous silica; magnesium stearate; hyprolose; lactose

投与経路:

Oral

パッケージ内のユニット:

28, 60, 20

処方タイプ:

(S8) Controlled Drug

適応症:

OXYCODONE MR APOTEX modified release tablets are indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive; and ? requires daily, continuous, long-term treatment. OXYCODONE MR APOTEX is not indicated for the use in chronic non-cancer pain other than in exceptional circumstances. OXYCODONE MR APOTEX is not indicated as an as-needed (PRN) analgesia.

製品概要:

Visual Identification: White, round, biconvex film-coated tablet, engraved 'APO' on one side, 'OCD' over '10' on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

認証ステータス:

Licence status A

承認日:

2014-11-21