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

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

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공공 평가 보고서 공공 평가 보고서 (PAR)
26-11-2017

유효 성분:

oxycodone hydrochloride, Quantity: 10 mg

제공처:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

oxycodone hydrochloride

약제 형태:

Tablet, modified release

구성:

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

관리 경로:

Oral

패키지 단위:

28, 60, 20

처방전 유형:

(S8) Controlled Drug

치료 징후:

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.

제품 요약:

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

승인 상태:

Licence status A

승인 날짜:

2014-11-21