Canada - inglese - Health Canada

indivior uk limited - buprenorphine - solution (extended release) - 100mg - buprenorphine 100mg - opiate partial agonists

Canada - inglese - Health Canada

indivior uk limited - buprenorphine - solution (extended release) - 300mg - buprenorphine 300mg - opiate agonists

Irlanda - inglese - HPRA (Health Products Regulatory Authority)

indivior europe limited - buprenorphine hydrochloride - sublingual tablet - 0.2 base milligrams - oripavine derivatives; buprenorphine

Irlanda - inglese - HPRA (Health Products Regulatory Authority)

indivior europe limited - buprenorphine hydrochloride - solution for injection - 300 microgram(s)/millilitre - oripavine derivatives; buprenorphine

Stati Uniti - inglese - 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

Israele - inglese - 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.

Israele - inglese - 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

Unione Europea - inglese - EMA (European Medicines Agency)

indivior europe limited - buprenorphine, naloxone - opioid-related disorders - other nervous system drugs - 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.

Canada - inglese - Health Canada

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

Canada - inglese - Health Canada

indivior uk limited - buprenorphine (buprenorphine hydrochloride); naloxone (naloxone hydrochloride dihydrate) - tablet - 8mg; 2mg - buprenorphine (buprenorphine hydrochloride) 8mg; naloxone (naloxone hydrochloride dihydrate) 2mg - opiate partial agonists