Australien - engelska - Department of Health (Therapeutic Goods Administration)

mundipharma pty ltd - oxycodone hydrochloride, quantity: 2.5 mg; naloxone hydrochloride dihydrate, quantity: 1.37 mg (equivalent: naloxone hydrochloride?, qty 1.25 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 - targin modified release tablet is 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.,targin modified release tablet is not indicated for use in chronic non-cancer pain other than in exceptional circumstances.,targin modified release tablet is 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.,targin is indicated as a second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy.

Australien - engelska - 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 - targin modified release tablet is 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.,targin modified release tablet is not indicated for use in chronic non-cancer pain other than in exceptional circumstances.,targin modified release tablet is 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.,targin is indicated as a second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy.

Australien - engelska - 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 - targin modified release tablet is 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.,targin modified release tablet is not indicated for use in chronic non-cancer pain other than in exceptional circumstances.,targin modified release tablet is 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.,targin is indicated as a second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy.

Australien - engelska - 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 - targin modified release tablet is 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.,targin modified release tablet is not indicated for use in chronic non-cancer pain other than in exceptional circumstances.,targin modified release tablet is 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.,targin is indicated as a second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy.

Nya Zeeland - engelska - Medsafe (Medicines Safety Authority)

max health limited - naloxone hydrochloride dihydrate 0.44 mg/ml equivalent to 0.40 mg naloxone hydrochloride - solution for injection - 400 mcg/ml - active: naloxone hydrochloride dihydrate 0.44 mg/ml equivalent to 0.40 mg naloxone hydrochloride excipient: hydrochloric acid sodium chloride water for injection - naloxone hydrochloride injection is indicated for the complete or partial reversal of narcotic depression, including respiratory depression, induced by opioids including natural and synthetic narcotics, propoxyphene, methadone and the narcotic antagonist analgesics: nalbuphine, pentazocine and butorphanol. naloxone hydrochloride is also indicated for the diagnosis of suspected acute opioid overdosage.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

mundipharma pty ltd - naloxone hydrochloride dihydrate, quantity: 2.2 mg/actuation - spray, nasal - excipient ingredients: sodium chloride; hydrochloric acid; sodium citrate dihydrate; nitrogen; sodium hydroxide; purified water - nyxoid is intended as part of the emergency treatment for known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression in:,? the home or other non medical setting,? a health facility setting,for this reason, nyxoid should be carried by persons at risk of, or likely to witness such events.,nyxoid is indicated in adults and children.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - naloxone hydrochloride dihydrate, quantity: 440 microgram/ml (equivalent: naloxone hydrochloride?, qty 400 microgram/ml) - injection, solution - excipient ingredients: water for injections; hydrochloric acid - junalox is indicated for the treatment of opioid overdose.

Australien - engelska - 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.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

indivior pty ltd - naloxone hydrochloride dihydrate, quantity: 2.44 mg (equivalent: naloxone, qty 2 mg); buprenorphine hydrochloride, quantity: 8.64 mg (equivalent: buprenorphine, qty 8 mg) - soluble film - excipient ingredients: acesulfame potassium; maltitol; polyethylene oxide; citric acid; sunset yellow fcf; hypromellose; sodium citrate; titanium dioxide; propylene glycol; purified water; industrial methylated spirit; flavour - for the treatment of opiate dependence within a framework of medical, social, and psychological treatment.

Nya Zeeland - engelska - Medsafe (Medicines Safety Authority)

juno pharmaceuticals nz limited - naloxone hydrochloride dihydrate 440 µg/ml (equiv naloxone hydrochloride 400µg/ml) - solution for injection - 400 mcg/ml - active: naloxone hydrochloride dihydrate 440 µg/ml (equiv naloxone hydrochloride 400µg/ml) excipient: hydrochloric acid water for injection - complete or partial reversal of opioid depression, including respiratory depression, induced by opioids including natural and synthetic opioids, propoxyphene, methadone and the narcotic-antagonist analgesics: nalbuphine, pentazocine and butorphanol. naloxone hydrochloride dihydrate injection is also indicated for the diagnosis of suspected acute opioid overdosage.