Malta - English - Medicines Authority

morningside healthcare limited unit c, harcourt way, leicester, le19 1wp, united kingdom - buprenorphine hydrochloride - sublingual tablet - buprenorphine hydrochloride 8 milligram(s) - other nervous system drugs

United States - English - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - buprenorphine (unii: 40d3scr4gz) (buprenorphine - unii:40d3scr4gz) - buprenorphine transdermal system is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. limitations of use buprenorphine transdermal system is contraindicated in patients with: risk summary prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see warnings and precautions (5.3)]. available data with buprenorphine transdermal system in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. in animal reproduction studies, buprenorphine caused an increase in the number of stillborn offspring, reduced litter size, and reduced offspring growth in rats at maternal exposure levels that were approximately 10 times that of human subjects who received one buprenorphine transdermal system 20 mcg/hour, the maximum recommended human dose (mrhd) [see data]. based on animal data, advise pregnant women of the

United States - English - 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 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

United States - English - NLM (National Library of Medicine)

almatica pharma inc. - buprenorphine hydrochloride (unii: 56w8mw3en1) (buprenorphine - unii:40d3scr4gz), naloxone hydrochloride dihydrate (unii: 5q187997ee) (naloxone - unii:36b82amq7n) - buprenorphine and naloxone sublingual film is indicated for treatment of opioid dependence. buprenorphine and naloxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support. buprenorphine and naloxone sublingual film is 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) ] . the data on use of buprenorphine, one of the active ingredients in buprenorphine and naloxone sublingual film, 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 congenital malformations among buprenorphine-

United States - English - NLM (National Library of Medicine)

alvogen, inc. - buprenorphine hydrochloride (unii: 56w8mw3en1) (buprenorphine - unii:40d3scr4gz) - buprenorphine buccal film is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. l i m i t a t i o n s of use - because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioid formulations [see warnings and precautions (5.1)] , reserve buprenorphine buccal film for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. - buprenorphine buccal film is not indicated as an as-needed (prn) analgesic. buprenorphine buccal film is contraindicated in patients with: - significant respiratory depression [see warnings and precautions (5.3)] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscita

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - buprenorphine hydrochloride (unii: 56w8mw3en1) (buprenorphine - unii:40d3scr4gz) - buprenorphine hydrochloride 8 mg - suboxone and subutex are indicated for the treatment of opioid dependence. suboxone and subutex should not be administered to patients who have been shown to be hypersensitive to buprenorphine, and suboxone should not be administered to patients who have been shown to be hypersensitive to naloxone. suboxone and subutex are controlled as schedule iii narcotics under the controlled substances act. buprenorphine is a partial agonist at the mu-opioid receptor and chronic administration produces dependence of the opioid type, characterized by moderate withdrawal upon abrupt discontinuation or rapid taper. the withdrawal syndrome is milder than seen with full agonists, and may be delayed in onset (see warnings)   neonatal withdrawal has been reported in the infants of women treated with subutex during pregnancy (see precautions)  suboxone contains naloxone and if misused parenterally, is highly likely to produce marked and intense withdrawal symptoms in subjects dependent on other opioid agonists.

Ireland - English - HPRA (Health Products Regulatory Authority)

morningside healthcare ltd - buprenorphine hydrochloride - sublingual tablet - 8 milligram(s) - oripavine derivatives; buprenorphine

Ireland - English - HPRA (Health Products Regulatory Authority)

morningside healthcare ltd - buprenorphine hydrochloride - sublingual tablet - 2 milligram(s) - oripavine derivatives; buprenorphine

Ireland - English - HPRA (Health Products Regulatory Authority)

morningside healthcare (malta) limited - buprenorphine hydrochloride - sublingual tablet - 2 milligram(s) - oripavine derivatives; buprenorphine

Ireland - English - HPRA (Health Products Regulatory Authority)

morningside healthcare (malta) limited - buprenorphine hydrochloride - sublingual tablet - 8 milligram(s) - oripavine derivatives; buprenorphine