New Zealand - engelsk - Medsafe (Medicines Safety Authority)

boucher & muir (new zealand) limited t/a bnm group - buprenorphine hydrochloride 2.16mg (equiv 2 mg buprenorphine);  ; naloxone hydrochloride dihydrate 0.61mg (equiv 0.5 mg naloxone);   - sublingual tablet - active: buprenorphine hydrochloride 2.16mg (equiv 2 mg buprenorphine)   naloxone hydrochloride dihydrate 0.61mg (equiv 0.5 mg naloxone)   excipient: acesulfame potassium citric acid monohydrate lactose monohydrate lemon flavour sd01600158 lime flavour sd01620018 magnesium stearate maize starch mannitol povidone sodium citrate - treatment of opiate dependence, within a framework of medical, social and psychological treatment. naloxone is included to deter intravenous misuse of the product.

USA - engelsk - NLM (National Library of Medicine)

bryant ranch prepack - 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 that includes 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 reported on co

USA - engelsk - NLM (National Library of Medicine)

quality care products, llc - 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 that includes 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 reported on co

Canada - engelsk - Health Canada

teva canada limited - naloxone (naloxone hydrochloride dihydrate); buprenorphine (buprenorphine hydrochloride) - tablet - 0.5mg; 2mg - naloxone (naloxone hydrochloride dihydrate) 0.5mg; buprenorphine (buprenorphine hydrochloride) 2mg - opiate partial agonists

Storbritannia - engelsk - MHRA (Medicines & Healthcare Products Regulatory Agency)

wockhardt uk ltd - naloxone hydrochloride dihydrate - solution for injection - 400microgram/1ml

Israel - engelsk - Ministry of Health

bioavenir ltd, israel - naloxone hydrochloride (as dihydrate); oxycodone hydrochloride - tablets prolonged release - oxycodone hydrochloride 10 mg; naloxone hydrochloride (as dihydrate) 5 mg - oxycodone and naloxone - 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.

Israel - engelsk - Ministry of Health

bioavenir ltd, israel - naloxone hydrochloride (as dihydrate); oxycodone hydrochloride - tablets prolonged release - oxycodone hydrochloride 20 mg; naloxone hydrochloride (as dihydrate) 10 mg - oxycodone and naloxone - 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.

Israel - engelsk - Ministry of Health

bioavenir ltd, israel - naloxone hydrochloride (as dihydrate); oxycodone hydrochloride - tablets prolonged release - oxycodone hydrochloride 30 mg; naloxone hydrochloride (as dihydrate) 15 mg - oxycodone and naloxone - 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.

Israel - engelsk - Ministry of Health

bioavenir ltd, israel - naloxone hydrochloride (as dihydrate); oxycodone hydrochloride - tablets prolonged release - oxycodone hydrochloride 40 mg; naloxone hydrochloride (as dihydrate) 20 mg - oxycodone and naloxone - 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.

Israel - engelsk - Ministry of Health

bioavenir ltd, israel - naloxone hydrochloride (as dihydrate); oxycodone hydrochloride - tablets prolonged release - oxycodone hydrochloride 5 mg; naloxone hydrochloride (as dihydrate) 2.5 mg - oxycodone and naloxone - 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.