Israel - English - Ministry of Health

lundbeck israel ltd. - nalmefene as hydrochloride dihydrate - film coated tablets - nalmefene as hydrochloride dihydrate 18.06 mg - nalmefene - selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (drl), without physical withdrawal symptoms and who do not require immediate detoxification.selincro should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption.selincro should be initiated only in patients who continue to have a high drl two weeks after initial assessment.

Israel - English - Ministry of Health

lundbeck israel ltd. - nalmefene as hydrochloride dihydrate - film coated tablets - nalmefene as hydrochloride dihydrate 18.06 mg - nalmefene - selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (drl), without physical withdrawal symptoms and who do not require immediate detoxification.selincro should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption.selincro should be initiated only in patients who continue to have a high drl two weeks after initial assessment.

Australia - English - Department of Health (Therapeutic Goods Administration)

lundbeck australia pty ltd - nalmefene -

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

lannett company, inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hydrochloride 100 mg in 5 ml - oxycodone hydrochloride oral solution (5 mg per ml) , an opioid agonist, is indicated for the relief of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate. oxycodone hydrochloride oral solution 100 mg per 5 ml (20 mg per ml) , an opioid agonist, is indicated for the relief of moderate to severe acute and chronic pain in opioid-tolerant patients. oxycodone hydrochloride oral solution usp, 100 mg per 5 ml (20 mg per ml) may cause fatal respiratory depression when administered to patients not previously exposed to opioids. patients considered to be opioid tolerant are those who are taking at least 30 mg of oral oxycodone per day, or at least 60 mg oral morphine per day, or at least 12 mg hydromorphone per day, or an equianalgesic dose of another opioid, for a week or longer. oxycodone hydrochloride is contraindicated in patients with respiratory depression in the absence of resuscitative equipment. oxycodone hydrochloride is contraindicated in any patient who has or is sus

European Union - English - EMA (European Medicines Agency)

h. lundbeck a/s - nalmefene hydrochloride dihydrate - alcohol-related disorders - drugs used in alcohol dependence - selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking-risk level (see section 5.1), without physical withdrawal symptoms and who do not require immediate detoxification.selincro should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption.selincro should be initiated only in patients who continue to have a high drinking-risk level two weeks after initial assessment.

Israel - English - Ministry of Health

naomi shaco-ezra ltd - buprenorphine hydrochloride; naloxone hydrochloride dihydrate - tablets sublingual - buprenorphine hydrochloride 2.16 mg; naloxone hydrochloride dihydrate 0.61 mg - buprenorphine - buprenorphine - substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. the intention of the naloxone component is to deter intravenous misuse.treatment is intended for use in adults and adolescents over 15 years of age who have agreed to be treated for addiction.

Israel - English - Ministry of Health

naomi shaco-ezra ltd - buprenorphine hydrochloride; naloxone hydrochloride dihydrate - tablets sublingual - buprenorphine hydrochloride 8.64 mg; naloxone hydrochloride dihydrate 2.44 mg - buprenorphine - buprenorphine - substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. the intention of the naloxone component is to deter intravenous misuse.treatment is intended for use in adults and adolescents over 15 years of age who have agreed to be treated for addiction

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

ani pharmaceuticals, inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hydrochloride 100 mg in 5 ml - oxycodone hydrochloride oral solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, [see warnings and precautions (5.2)] , reserve oxycodone hydrochloride oral solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: oxycodone hydrochloride oral solution is contraindicated in patients with: risk summary prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see warnings and precautions (5.4)] . available data with oxycodone hydrochloride oral solution are insufficient to inform a drug-associated risk for major birth defects and miscarriage. animal reproduction studies with oral administrations of oxycodone hydrochloride in rats and rabbits during the period of organogenesis at doses 2.6 and 8.

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

novel laboratories, inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hydrochloride 20 mg in 1 ml - oxycodone hydrochloride oral solution usp, 100 mg per 5 ml (20 mg per ml) an opioid agonist is indicated for the relief of moderate to severe acute and chronic pain in opioid-tolerant patients. oxycodone hydrochloride oral solution usp, 100 mg per 5 ml (20 mg per ml) may cause fatal respiratory depression when administered to patients not previously exposed to opioids. patients considered to be opioid tolerant are those who are taking at least 30 mg of oral oxycodone per day, or at least 60 mg oral morphine per day, or at least 12 mg hydromorphone per day, or an equianalgesic dose of another opioid, for a week or longer. oxycodone hydrochloride is contraindicated in patients with respiratory depression in the absence of resuscitative equipment. oxycodone hydrochloride is contraindicated in any patient who has or is suspected of having paralytic ileus. oxycodone hydrochloride is contraindicated in patients with acute or severe bronchial asthma or hypercarbia. oxycodone hydrochloride is contraindicated in pati

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

major pharmaceuticals - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hydrochloride 20 mg in 1 ml - oxycodone hydrochloride oral solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, [see warnings and precautions (5.2)], reserve oxycodone hydrochloride oral solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: • have not been tolerated, or are not expected to be tolerated, • have not provided adequate analgesia, or are not expected to provide adequate analgesia oxycodone hydrochloride oral solution 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 resuscitative equipment [see warnings and precautions (5.7)] • known or suspected gastrointestinal obstruction, including paralytic ileus [see wa