MPL- OXYCODONE/NALOXONE oxycodone hydrochloride / naloxone hydrochloride 20/10 mg modified release tablet blister pack

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

naloxone hydrochloride dihydrate, Quantity: 10.9 mg (Equivalent: naloxone hydrochloride?, Qty 10 mg); oxycodone hydrochloride, Quantity: 20 mg

Beschikbaar vanaf:

Mundipharma Pty Ltd

farmaceutische vorm:

Tablet, modified release

Samenstelling:

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

Toedieningsweg:

Oral

Eenheden in pakket:

28, 60, 20

Prescription-type:

(S8) Controlled Drug

therapeutische indicaties:

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.

Product samenvatting:

Visual Identification: pink, oblong tablets marked "OXN" on one side and "20" on other; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Autorisatie-status:

Registered

Autorisatie datum:

2022-10-17