CHEMMART OXYCODONE MR oxycodone hydrochloride 15mg modified release tablets blister pack

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
26-11-2017

Aktivna sestavina:

oxycodone hydrochloride, Quantity: 15 mg

Dostopno od:

Arrotex Pharmaceuticals Pty Ltd

INN (mednarodno ime):

oxycodone hydrochloride

Farmacevtska oblika:

Tablet, modified release

Sestava:

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

Pot uporabe:

Oral

Enote v paketu:

60, 28, 20

Tip zastaranja:

(S8) Controlled Drug

Terapevtske indikacije:

CHEMMART OXYCODONE MR 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. CHEMMART OXYCODONE MR is not indicated for the use in chronic non-cancer pain other than in exceptional circumstances. CHEMMART OXYCODONE MR is not indicated as an as-needed (PRN) analgesia.

Povzetek izdelek:

Visual Identification: Grey, round, biconvex film-coated tablet, engraved 'APO' on one side, 'OCD' over '15' 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

Status dovoljenje:

Licence status A

Datum dovoljenje:

2014-11-21