MPL- OXYCODONE/NALOXONE oxycodone hydrochloride / naloxone hydrochloride 10/5 mg modified release tablets blister pack

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

oxycodone hydrochloride, Quantity: 10 mg; naloxone hydrochloride dihydrate, Quantity: 5.45 mg (Equivalent: naloxone hydrochloride?, Qty 5 mg)

Dostupné z:

Mundipharma Pty Ltd

Forma lieku:

Tablet, modified release

Zloženie:

Excipient Ingredients: titanium dioxide; lactose monohydrate; stearyl alcohol; macrogol 3350; ethylcellulose; polyvinyl alcohol; purified talc; magnesium stearate; povidone

Spôsob podávania:

Oral

Počet v balení:

60, 20, 28

Typ predpisu:

(S8) Controlled Drug

Terapeutické indikácie:

MPL-Oxycodone/Naloxone 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.,MPL-Oxycodone/Naloxone modified release tablets are not indicated for use in chronic noncancer pain other than in exceptional circumstances.,MPL-Oxycodone/Naloxone modified release tablets are not indicated as an as-needed (PRN) analgesia.,The naloxone component in a fixed combination with oxycodone is indicated for the therapy and/or prophylaxis of opioid-induced constipation.,MPL-Oxycodone/Naloxone is indicated as second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy.

Prehľad produktov:

Visual Identification: white, oblong tablets marked "OXN" on one side and "10" on other; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Stav Autorizácia:

Registered

Dátum Autorizácia:

2022-10-17