MPL- OXYCODONE/NALOXONE oxycodone hydrochloride / naloxone hydrochloride 40/20 mg modified release tablet blister pack

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

oxycodone hydrochloride, Quantity: 40 mg; naloxone hydrochloride dihydrate, Quantity: 21.8 mg (Equivalent: naloxone hydrochloride?, Qty 20 mg)

Disponible depuis:

Mundipharma Pty Ltd

forme pharmaceutique:

Tablet, modified release

Composition:

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

Mode d'administration:

Oral

Unités en paquet:

20, 60, 28

Type d'ordonnance:

(S8) Controlled Drug

indications thérapeutiques:

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.

Descriptif du produit:

Visual Identification: yellow, oblong tablets marked "OXN" on one side and "40" on other; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Statut de autorisation:

Registered

Date de l'autorisation:

2022-10-17