Australija - anglų - Department of Health (Therapeutic Goods Administration)

mundipharma pty ltd - naloxone hydrochloride dihydrate, quantity: 10.9 mg (equivalent: naloxone hydrochloride?, qty 10 mg); oxycodone hydrochloride, quantity: 20 mg - tablet, modified release - excipient ingredients: magnesium stearate; povidone; macrogol 3350; stearyl alcohol; titanium dioxide; lactose monohydrate; purified talc; polyvinyl alcohol; iron oxide red; ethylcellulose - 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.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

southern xp ip pty ltd - naloxone hydrochloride dihydrate, quantity: 440 microgram (equivalent: naloxone hydrochloride?, qty 400 microgram) - injection - excipient ingredients: sodium chloride; water for injections; edetate sodium; hydrochloric acid - naloxone is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, codeine, morphine and heroin, and the mixed opioid agonist-antagonist analgesics such as pentazocine. naloxone is also indicated for the diagnosis of suspected acute opioid overdosage.

Izraelis - anglų - Ministry of Health

rafa laboratories ltd - naloxone hydrochloride (as dihydrate); oxycodone hydrochloride - tablets prolonged release - naloxone hydrochloride (as dihydrate) 15 mg; oxycodone hydrochloride 30 mg - oxycodone and naloxone - targin is indicated for the relief of moderate to severe pain.the oxycodone component is indicated for the relief of moderate to severe pain in adults who require continuous around the- clock opioid analgesia for several days or more. the opioid antagonist naloxone is added to counteract opioid-induced constipation by blocking the action of oxycodone at opioid receptors locally in the gut.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

mundipharma pty ltd - oxycodone hydrochloride, quantity: 15 mg; naloxone hydrochloride dihydrate, quantity: 8.24 mg (equivalent: naloxone hydrochloride?, qty 7.5 mg) - tablet, modified release - 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 - 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.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

mundipharma pty ltd - oxycodone hydrochloride, quantity: 10 mg; naloxone hydrochloride dihydrate, quantity: 5.45 mg (equivalent: naloxone hydrochloride?, qty 5 mg) - tablet, modified release - excipient ingredients: titanium dioxide; lactose monohydrate; stearyl alcohol; macrogol 3350; ethylcellulose; polyvinyl alcohol; purified talc; magnesium stearate; povidone - 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.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

mundipharma pty ltd - oxycodone hydrochloride, quantity: 80 mg; naloxone hydrochloride dihydrate, quantity: 43.6 mg (equivalent: naloxone hydrochloride?, qty 40 mg) - tablet, modified release - excipient ingredients: ethylcellulose; stearyl alcohol; lactose monohydrate; purified talc; magnesium stearate; povidone; titanium dioxide; iron oxide yellow; polyvinyl alcohol; macrogol 3350; ferrosoferric oxide - 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.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

mundipharma pty ltd - oxycodone hydrochloride, quantity: 60 mg; naloxone hydrochloride dihydrate, quantity: 32.7 mg (equivalent: naloxone hydrochloride?, qty 30 mg) - tablet, modified release - excipient ingredients: ethylcellulose; stearyl alcohol; lactose monohydrate; purified talc; magnesium stearate; povidone; titanium dioxide; iron oxide red; polyvinyl alcohol; macrogol 3350; ferrosoferric oxide - 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.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

mundipharma pty ltd - oxycodone hydrochloride, quantity: 40 mg; naloxone hydrochloride dihydrate, quantity: 21.8 mg (equivalent: naloxone hydrochloride?, qty 20 mg) - tablet, modified release - excipient ingredients: lactose monohydrate; iron oxide yellow; ethylcellulose; magnesium stearate; polyvinyl alcohol; povidone; titanium dioxide; purified talc; macrogol 3350; stearyl alcohol - 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.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

mundipharma pty ltd - oxycodone hydrochloride, quantity: 5 mg; naloxone hydrochloride dihydrate, quantity: 2.73 mg (equivalent: naloxone hydrochloride?, qty 2.5 mg) - tablet, modified release - excipient ingredients: ethylcellulose; macrogol 3350; brilliant blue fcf aluminium lake; stearyl alcohol; polyvinyl alcohol; titanium dioxide; magnesium stearate; lactose monohydrate; purified talc; hyprolose - 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.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

mundipharma pty ltd - oxycodone hydrochloride, quantity: 30 mg; naloxone hydrochloride dihydrate, quantity: 16.48 mg (equivalent: naloxone hydrochloride?, qty 15 mg) - tablet, modified release - excipient ingredients: povidone; ethylcellulose; stearyl alcohol; lactose monohydrate; purified talc; magnesium stearate; titanium dioxide; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - 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.