Nya Zeeland - engelska - Medsafe (Medicines Safety Authority)

juno pharmaceuticals nz limited - naloxone hydrochloride dihydrate 22 µg/ml (equiv naloxone hydrochloride 20µg/ml) - solution for injection - 40 mcg/2ml - active: naloxone hydrochloride dihydrate 22 µg/ml (equiv naloxone hydrochloride 20µg/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.

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

aa-med pty ltd - buprenorphine hydrochloride,naloxone hydrochloride dihydrate -

Malaysia - engelska - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

idaman pharma sdn. bhd. - naloxone hydrochloride dihydrate -

Kanada - engelska - Health Canada

omega laboratories limited - naloxone hydrochloride (naloxone hydrochloride dihydrate) - solution - 0.4mg - naloxone hydrochloride (naloxone hydrochloride dihydrate) 0.4mg - opiate antagonists

Kanada - engelska - Health Canada

omega laboratories limited - naloxone hydrochloride (naloxone hydrochloride dihydrate) - solution - 1mg - naloxone hydrochloride (naloxone hydrochloride dihydrate) 1mg - opiate antagonists

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

indivior pty ltd - buprenorphine hydrochloride, quantity: 12.96 mg (equivalent: buprenorphine, qty 12 mg); naloxone hydrochloride dihydrate, quantity: 3.66 mg (equivalent: naloxone, qty 3 mg) - soluble film - excipient ingredients: acesulfame potassium; citric acid; maltitol solution; hypromellose; polyethylene oxide; sodium citrate; sunset yellow fcf; flavour; titanium dioxide; propylene glycol; purified water; industrial methylated spirit - treatment of opiate dependence within a framework of medical, social, and pyschological treatment.

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

indivior pty ltd - buprenorphine hydrochloride, quantity: 4.32 mg (equivalent: buprenorphine, qty 4 mg); naloxone hydrochloride dihydrate, quantity: 1.22 mg (equivalent: naloxone, qty 1 mg) - soluble film - excipient ingredients: acesulfame potassium; citric acid; maltitol solution; hypromellose; polyethylene oxide; sodium citrate; sunset yellow fcf; flavour; titanium dioxide; propylene glycol; purified water; industrial methylated spirit - treatment of opiate dependence within a framework of medical, social, and pyschological treatment.

Irland - engelska - HPRA (Health Products Regulatory Authority)

hospira uk ltd - naloxone hydrochloride - solution for injection - 20 microgram/ml

USA - engelska - NLM (National Library of Medicine)

remedyrepack inc. - buprenorphine hydrochloride (unii: 56w8mw3en1) (buprenorphine - unii:40d3scr4gz), naloxone hydrochloride dihydrate (unii: 5q187997ee) (naloxone - unii:36b82amq7n) - buprenorphine and naloxone sublingual tablets are indicated for the maintenance treatment of opioid dependence. buprenorphine and naloxone sublingual tablets should be used as part of a complete treatment plan to include counseling and psychosocial support. buprenorphine and naloxone sublingual tablets are contraindicated in patients with a history of hypersensitivity to buprenorphine or naloxone as serious adverse reactions, including anaphylactic shock, have been reported [see warnings and precautions ( 5.9)]. risk summary the data on use of buprenorphine, one of the active ingredients in buprenorphine and naloxone sublingual tablets, in pregnancy, are limited; however, these data do not indicate an increased risk of major malformations specifically due to buprenorphine exposure. there are limited data from randomized clinical trials in women maintained on buprenorphine that were not designed appropriately to assess the risk of major malformations [ see data ]. observational studies have repor

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

au pharma pty ltd - naloxone hydrochloride dihydrate, quantity: 2.75 mg (equivalent: naloxone hydrochloride?, qty 2.5 mg); oxycodone hydrochloride, quantity: 5 mg - tablet, modified release - excipient ingredients: microcrystalline cellulose; magnesium stearate; hypromellose; silicon dioxide; titanium dioxide; purified talc; brilliant blue fcf aluminium lake; polyvinyl alcohol; macrogol 3350; colloidal anhydrous silica; povidone; sodium lauryl sulfate; polyvinyl acetate - oxonal 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.,oxonal is not indicated for use in chronic non-cancer pain other than in exceptional circumstances.,oxonal 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.,oxonal is not indicated for the treatment of patients with restless legs syndrome.