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

purdue pharma l.p. - nalmefene hydrochloride (unii: k7k69qc05x) (nalmefene - unii:tov02tdp9i) - nalmefene hydrochloride injection is indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids. nalmefene hydrochloride injection is indicated in the management of known or suspected opioid overdose. nalmefene hydrochloride injection is contraindicated in patients with a known hypersensitivity to the product. nalmefene hydrochloride injection is an opioid antagonist with no agonist activity. it has no demonstrated abuse potential, is not addictive, and is not a controlled substance.

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

chengdu shuode pharmaceutical co., ltd - nalmefene hydrochloride (unii: k7k69qc05x) (nalmefene - unii:tov02tdp9i) - nalmefene hydrochloride injection is indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids. nalmefene hydrochloride injection is indicated in the management of known or suspected opioid overdose. nalmefene hydrochloride injection is contraindicated in patients with a known hypersensitivity to the product. nalmefene hydrochloride injection is an opioid antagonist with no agonist activity. it has no demonstrated abuse potential, is not addictive, and is not a controlled substance.

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

indivior inc. - nalmefene hydrochloride (unii: k7k69qc05x) (nalmefene - unii:tov02tdp9i) - opvee nasal spray is indicated for the emergency treatment of known or suspected overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression. opvee nasal spray is intended for immediate administration as emergency therapy in settings where opioids may be present. opvee nasal spray is not a substitute for emergency medical care. opvee nasal spray is contraindicated in patients known to be hypersensitive to nalmefene or to any of the other ingredients. risk summary life-sustaining therapy for opioid overdose should not be withheld (see clinical considerations). there are no available data on nalmefene use in pregnant women to evaluate for a drug-associated risk of major birth defects or miscarriage. in animal reproduction studies, no embryotoxic effects on embryo-fetal development were observed in rats and rabbits treated with nalmefene at exposures at least 6 times (rats) and up to 20 times (rabbits) the exposure at two human nasal doses of 5.4 mg (see data) . the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk an opioid overdose is a medical emergency and can be fatal for the pregnant woman and fetus if left untreated. treatment with opvee for opioid overdose should not be withheld because of potential concerns regarding the effects of opvee on the fetus. data animal data reproduction studies have been performed in rats (up to 1200 mg/m2 /day) and rabbits (up to 2400 mg/m2 /day) by oral administration of nalmefene and in rabbits by intravenous administration up to 96 mg/m2 /day. no effects on embryo-fetal development were observed at exposures at least 6 times (rats) and up to 20 times (rabbits) the exposure corresponding to a human dose of 5.4 mg (two nalmefene nasal sprays) on an auc basis. the treatment in rats did not affect offspring survival. risk summary there are no data on the presence of nalmefene and its metabolites in human milk, the effects of nalmefene on the breastfed child, or the effects on milk production. nalmefene and its metabolites are present in rat milk (see data). when a drug is present in animal milk, it is likely that the drug will be present in human milk. data nalmefene and its metabolites were secreted into rat milk, reaching concentrations approximately three times those in plasma at one hour and decreasing to about half the corresponding plasma concentrations by 24 hours following bolus administration. the concentration of nalmefene in animal milk does not necessarily predict the concentration of drug in human milk. the safety and effectiveness of opvee nasal spray for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression, have been established. use for this indication in this age group is supported by adult studies and pharmacokinetic simulation [see clinical pharmacology (12.3)] . there have been no studies conducted to evaluate the use of opvee nasal spray in pediatric patients. the safety and effectiveness of opvee nasal spray for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression have not been established in pediatric patients younger than 12 years of age. clinical studies of opvee nasal spray did not include subjects aged 65 and over. other reported clinical experience has not identified differences in responses between the elderly and younger patients. geriatric patients have a greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. therefore, the systemic exposure of nalmefene can be higher in these patients. hepatic impairment substantially reduces the clearance of nalmefene [see clinical pharmacology (12.3)]. for single episodes of opioid antagonism, adjustment of opvee nasal spray dosage is not required. renal impairment substantially reduces the clearance of nalmefene [see clinical pharmacology (12.3)]. for single episodes of opioid antagonisms, adjustment of opvee nasal spray dosage is not required. the instructions for use contains information on how to give opvee nasal spray in response to a known or suspected opioid overdose in adults and children 12 years of age and older. you and your family members or caregivers should read the instructions for use that comes with opvee nasal spray before using it. talk to your healthcare provider if you and your family members or caregivers have any questions about the use of opvee nasal spray. - for use in the nose only . - do not remove or test the opvee nasal spray before use. - each opvee nasal spray has 1 dose and cannot be reused. - you do not need to prime opvee nasal spray. - hand is supporting their head. - bend their knee. - turn their face to the side. - get a new opvee nasal spray from the box. - repeat steps 1 through 7 to give another dose of opvee in the other nostril. - if more opvee nasal sprays are available, repeat steps 1 through 7 every 2 to 5 minutes, alternating nostrils, until the person wakes up or medical help arrives. - store opvee nasal spray at room temperature between 59°f to 77°f (15°c to 25°c). - do not freeze opvee nasal spray. - keep opvee nasal spray in its box until ready to use. - protect from light. - replace opvee nasal spray before the expiration date on the box. for more information about opvee nasal spray, go to www.opvee.com or call 1-877-782-6966. opvee® is a registered trademark of indivior inc. ©2023 indivior inc. all rights reserved. manufactured for: indivior inc., north chesterfield, va, 23235, usa this instructions for use has been approved by the u.s. food and drug administration. issued: 06/2023

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

baxter healthcare corporation - nalmefene hydrochloride (unii: k7k69qc05x) (nalmefene - unii:tov02tdp9i) - injection, solution - 1 mg in 1 ml - revex is indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids. revex is indicated in the management of known or suspected opioid overdose. revex is contraindicated in patients with a known hypersensitivity to the product. revex is an opioid antagonist with no agonist activity. it has no demonstrated abuse potential, is not addictive, and is not a controlled substance.

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.

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.

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

lundbeck australia pty ltd - nalmefene -

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

lundbeck ltd - nalmefene hydrochloride - tablet - 18mg

Philippines - English - FDA (Food And Drug Administration)

h. lundbeck a/s; importer: metro drug inc.; distributor: metro drug inc. - nalmefene (as hydrochloride) - film-coated tablet - 18 mg