MPL- OXYCODONE/NALOXONE oxycodone hydrochloride / naloxone hydrochloride 15/7.5mg modified release tablet blister pack

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

oxycodone hydrochloride, Quantity: 15 mg; naloxone hydrochloride dihydrate, Quantity: 8.24 mg (Equivalent: naloxone hydrochloride?, Qty 7.5 mg)

Tersedia dari:

Mundipharma Pty Ltd

Bentuk farmasi:

Tablet, modified release

Komposisi:

Excipient Ingredients: hyprolose; ethylcellulose; stearyl alcohol; lactose monohydrate; purified talc; magnesium stearate; titanium dioxide; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black

Rute administrasi :

Oral

Unit dalam paket:

60, 28, 20

Jenis Resep:

(S8) Controlled Drug

Indikasi Terapi:

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.

Ringkasan produk:

Visual Identification: Grey, capsule shaped tablet, OXN marked on one side and 15 on other.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Status otorisasi:

Registered

Tanggal Otorisasi:

2022-10-17