FrancophonIA/ELRC3.0 huggingface dataset:
English: However, nalmefene 3-O-sulphate is present in concentrations less than 10% of that of nalmefene and thus considered highly unlikely to be a major contributor to the pharmacological effect of nalmefene.
Danish: Men nalmefen 3O-sulfat findes i koncentrationer, der er mindre end 10% af nalmefens, og det anses derfor som meget usandsynligt, at det bidrager væsentligt til nalmefens farmakologiske effekt.
English: Selincro was prescribed as-needed, which resulted in patients taking Selincro, on average, approximately half of the days.
Danish: Selincro blev ordineret efter behov, hvilket resulterede i, at patienterne tog Selincro ca. halvdelen af dagene i gennemsnit.
English: If you continue treatment with Selincro, or start again after a break in treatment, you will probably not have side effects.
Danish: Hvis du fortsætter behandlingen med Selincro, eller hvis du begynder behandlingen igen efter en pause, vil du sandsynligvis ikke få bivirkninger.
English: Caution is advised if Selincro is prescribed for more than 1 year.
Danish: Der skal udvises forsigtighed, hvis Selincro ordineres i mere end 1 år.
English: Selincro can help you reduce the amount of alcohol you drink, and keep the reduced level of alcohol consumption.
Danish: Selincro kan hjælpe dig med at nedsætte den mængde alkohol, du drikker, og fastholde det nedsatte alkoholforbrug.
English: Most of these adverse reactions resolved during continued treatment and did not recur upon repeated administration.
Danish: De fleste af bivirkningerne forsvandt ved fortsat behandling og opstod ikke igen ved gentaget indgivelse.
English: Blister: Clear PVC/PVdC-aluminium blisters in cardboard boxes Pack sizes of 7, 14, 28, 42, 49 and 98 film-coated tablets
Danish: Blister: Klar PVC/PVdC aluminiumsblistere i papæsker Pakningsstørrelser a 7, 14, 28, 42, 49 og 98 filmovertrukne tabletter
English: If patients develop psychiatric symptoms that are not associated with treatment initiation with Selincro, and/or that are not transient, the prescriber should consider alternative causes of the symptoms and assess the need for continuing treatment with Selincro.
Danish: Hvis patienterne udvikler psykiatriske symptomer, der ikke er forbundet med behandlingsstart med Selincro, og/eller som ikke er forbigående, skal den ordinerende læge overveje alternative årsager til symptomerne og foretage en vurdering af, om det fortsat er nødvendigt at behandle med Selincro.
English: 54% of the total dose is excreted in the urine as nalmefene 3-O-glucuronide, while nalmefene and its other metabolites are present in the urine in amounts of less than 3% each.
Danish: 54% af den totale dosis udskilles via urinen som nalmefen 3-O-glukoronid, mens nalmefen og dets andre metabolitter findes i urinen i mængder under 3% for hver.
English: Nalmefene is an opioid system modulator with a distinct μ, δ, and κ receptor profile.
Danish: Nalmefen er en opioidsystemmodulator med en distinkt μ, δ og κ receptorprofil.
English: The nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, or carcinogenic potential.
Danish: De prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet eller karcinogenicitet.
English: If you take medicines containing opioids, the effects of these medicines will be reduced, or the medicines may not work at all if you take them together with Selincro.
Danish: Hvis du tager medicin, der indeholder opioider, vil virkningen af denne medicin blive nedsat, eller også virker medicinen slet ikke, hvis du tager den sammen med Selincro.
English: Limited clinical data are available on the use of Selincro in patients ≥65 years of age with alcohol dependence.
Danish: Der er begrænsede kliniske data vedrørende anvendelse af Selincro til patienter ≥65 år med alkoholafhængighed.
English: The prescriber should advise patients that it is important to inform their health care professional of last Selincro intake if opioid use becomes necessary.
Danish: Den ordinerende læge skal informere patienten om, at det er vigtigt at oplyse sundhedspersonalet om seneste indtagelse af Selincro, hvis det bliver nødvendigt at anvende et opioid.
English: Selincro is available in packs of 7, 14, 28, 42, 49 or 98 tablets in blister cards.
Danish: Selincro fås i pakninger med 7, 14, 28, 42, 49 eller 98 tabletter i blisterpakninger.
English: Nalmefene was shown to have skin sensitisation potential in the Local Lymph Node Assay in mice after topical application.
Danish: Det blev påvist, at nalmefen havde risiko for at fremkalde hudsensibilisering i ”The Mouse Local Lymph Node Assay” (LLNA) efter topikal anvendelse.
English: Selincro should be temporarily discontinued for 1 week prior to the anticipated use of opioids, for example, if opioid analgesics might be used during elective surgery.
Danish: Selincro skal midlertidigt seponeres 1 uge før forventet brug af opioider, f.eks. hvis der skal bruges opioidanalgetika under elektiv operation.
English: Selincro has not been investigated in patients with unstable psychiatric disease.
Danish: Selincro er ikke blevet undersøgt hos patienter med ustabile psykiatriske lidelser.
English: Studies in animals do not indicate direct harmful effects with respect to fertility, pregnancy, embryonic/foetal development, parturition, or postnatal development.
Danish: Dyreforsøg har ikke vist nogen direkte skadelige virkninger med hensyn til fertilitet, graviditet, embryoets/fostrets udvikling, fødslen eller den postnatale udvikling.
English: Consequently, Selincro may have minor to moderate influence on the ability to drive and use machines and patients should exercise caution particular when starting treatment with Selincro.
Danish: Selincro kan derfor i mindre til moderat grad påvirke evnen til at føre motorkøretøj og betjene maskiner, og patienter skal udvise forsigtighed, særligt når de begynder behandling med Selincro.
English: a Analysis treats patients who withdrew as non-responder b ≥70% reduction from baseline in TAC at Month 6 (28-day period) c 0 to 4 HDDs/month at Month 6 (28-day period)
Danish: a Analysen inkluderer de patienter, der trak sig ud, som non-respondere B ≥70% reduktion fra baseline i TAC ved Måned 6 (28 dages periode) c 0 til 4 HDDs/måned ved Måned 6 (28 dages periode)
English: Selincro with food and alcohol
Danish: Brug af Selincro sammen med mad og alkohol
English: Patients with current or recent opioid addiction.
Danish: Patienter med nuværende eller nylig opioidafhængighed.
English: Hallucination (including hallucination auditory, hallucination tactile, hallucination visual, and somatic hallucination)
Danish: Hallucinationer (inklusive hørehallucinationer, taktile hallucinationer, synshallucinationer og somatiske hallucinationer) Dissociation
English: This is unlikely to present a problem with occasional use, but if long-term concurrent treatment with a potent UGT2B7 inhibitor is initiated, a potential for an increase in nalmefene exposure cannot be excluded (see section 4.4).
Danish: Det er usandsynligt, at det vil give problemer ved lejlighedsvis brug, men ved langvarig samtidig anvendelse af en potent hæmmer af UGT2B7 kan det ikke udelukkes, at der kan forekomme en stigning i optagelsen af nalmefen (se pkt.
English: While these events were generally shortlasting, they could represent alcoholic psychosis, alcohol withdrawal syndrome, or comorbid psychiatric disease.
Danish: Selvom disse bivirkninger generelt var kortvarige, kunne de også være tegn på alkoholpsykose, alkoholabstinenssyndrom eller samtidig psykiatrisk sygdom.
English: A high level of alcohol consumption is defined as drinking more than 60 g of pure alcohol per day for men and more than 40 g of pure alcohol per day for women.
Danish: Et stort alkoholforbrug er defineret som indtagelse af mere end 60 g ren alkohol pr. dag for mænds vedkommende og mere end 40 g ren alkohol pr. dag for kvinders vedkommende.
English: The metabolites are not considered to contribute with significant pharmacological effect on the opioid receptors in humans, except for nalmefene 3-O-sulphate, which has a potency comparable to that of nalmefene.
Danish: Metabolitterne anses ikke for at bidrage med signifikant farmakologisk virkning på opioidreceptorerne hos mennesker på nær nalmefen 3-O-sulfat, som har en styrke svarende til nalmefen.
English: Following oral administration, nalmefene undergoes extensive, rapid metabolism to the major metabolite nalmefene 3-O-glucuronide, with the UGT2B7 enzyme being primarily responsible for the conversion, and with the UGT1A3 and UGT1A8 enzymes as minor contributors.
Danish: Efter peroral administration gennemgår nalmefen en omfattende og hurtig metabolisme til hovedmetabolitten nalmefen 3-O-glukoronid, hvor UGT2B7 enzymet hovedsagelig har ansvaret for omdannelsen og med UGT1A3 og UGT1A8 enzymerne som mindre bidragere.
English: Data from the nonclinical studies, the clinical studies, and the literature do not suggest any form of dependence or abuse potential with Selincro.
Danish: Data fra ikke-kliniske studier, kliniske studier samt fra litteraturen tyder ikke på, at der er risiko for afhængighed eller misbrug af Selincro.
English: As concerns the patients with high or very high DRL at baseline, 35% of patients experienced improvement due to non-pharmacological effects in the period between the initial visit (screening) and randomisation.
Danish: Hvad angår patienterne, som havde et stort eller meget stort alkoholforbrug ved baseline, oplevede 35% af patienterne en forbedring på grund af ikke-farmakologiske virkninger i perioden mellem det første besøg (screeningen) og randomiseringen.
English: The efficacy of Selincro was measured using two co-primary endpoints: the change from baseline to Month 6 in the monthly number of heavy drinking days (HDDs) and the change from baseline to Month 6 in the daily total alcohol consumption (TAC).
Danish: Selincros virkning blev målt ved at bruge to primære endepunkter, nemlig ændringen fra baseline til Måned 6 i det månedlige antal af dage med stort alkoholforbrug - Heavy Drinking Days (HDDs) - og ændringen fra baseline til Måned 6 i det daglige totale alkoholforbrug - Total Alcohol Consumption (TAC).
English: Tachycardia Palpitations
Danish: Takykardi Palpitationer
English: These medicines include certain types of cough and cold medicines, certain medicines for diarrhoea and strong pain killers.
Danish: Det gælder f.eks. visse former for medicin mod hoste og forkølelse, visse lægemidler mod diarré og stærk smertestillende medicin.
English: Selincro is extensively metabolised by the liver and excreted predominantly in the urine.
Danish: Selincro bliver i udstrakt grad omdannet i leveren og udskilles hovedsageligt i urinen.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu .
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: At the randomisation visit, which occurred 1 to 2 weeks later, the DRL was re-assessed and treatment with Selincro was initiated together with a psychosocial intervention (BRENDA) focused on treatment adherence and reduction of alcohol consumption.
Danish: Ved randomiseringen, som fandt sted 1-2 uger senere, blev alkoholforbruget revurderet, og behandling med Selincro blev initieret sammen med psykosocial intervention (BRENDA), der fokuserede på at fremme overholdelsen af behandlingen og på at reducere alkoholforbruget.
English: You may need to stop taking Selincro temporarily.
Danish: Det kan være nødvendigt midlertidigt at stoppe med at tage Selincro.
English: The film-coating of the tablet contains: hypromellose, macrogol 400, titanium dioxide (E171).
Danish: Tablettens filmovertræk indeholder: Hypromellose, macrogol 400, titandioxid (E171).
English: Nalmefene exhibits a dose-independent linear pharmacokinetic profile in the dose interval of 18.06 mg to 72.24 mg, with a 4.4 times increase in Cmax and a 4.3 times increase in AUC0-tau (at or near steady state).
Danish: Nalmefen har en dosisuafhængig lineær farmakokinetisk profil i dosisintervallet 18,06 mg til 72,24 mg med en 4,4 gange øgning i Cmax og en 4,3 gange øgning i AUC0-tau (ved eller nær steady state).
English: - This medicine does not require any special storage conditions.
Danish: • Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: Selincro should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption.
Danish: Selincro bør kun ordineres sammen med løbende psykosocial støtte, der fokuserer på at fremme overholdelsen af behandlingen og på at reducere alkoholforbruget.
English: Limited data are available for Selincro in the 1-month run-out period.
Danish: Der er begrænsede data til rådighed for Selincro i udfasningsperioden af 1 måneds varighed.
English: Patients for whom recent use of opioids is suspected.
Danish: Patienter, der menes at have anvendt opioider for nylig.
English: Selincro is not for patients for whom the treatment goal is immediate abstinence.
Danish: Selincro er ikke beregnet til patienter, hvor behandlingsmålet er omgående afholdenhed.
English: • Periodic safety update reports
Danish: Periodiske, opdaterede sikkerhedsindberetninger (PSURer)
English: Selincro contains the active substance nalmefene.
Danish: Selincro indeholder det aktive stof nalmefen.
English: Based on in vitro studies, no clinically relevant interactions between nalmefene, or its metabolites, and concomitantly administered medicinal products metabolised by the most common CYP450 and UGT enzymes or membrane transporters are anticipated.
Danish: På baggrund af in vitro-studier forventes der ingen klinisk relevante interaktioner mellem nalmefen eller dets metabolitter og andre lægemidler, der anvendes samtidigt og som metaboliseres af de mest almindelige CYP450- og UGT-enzymer eller membrantransportører.
English: Simultaneous intake of alcohol and Selincro does not prevent the intoxicating effects of alcohol.
Danish: Samtidig indtagelse af alkohol og Selincro forhindrer ikke alkoholens berusende virkning.
English: If you have started drinking alcohol without taking Selincro, take one tablet as soon as possible.
Danish: Hvis du er begyndt at drikke alkohol uden først at have taget Selincro, skal du tage én tablet så hurtigt som muligt.
English: - The recommended dose is one tablet on days when you think there is a risk you will drink alcohol - The maximum dose is one tablet per day.
Danish: • Den anbefalede dosis er én tablet på de dage, hvor du mener, der er en risiko for, at du vil drikke alkohol
English: Caution should be exercised when prescribing Selincro to patients with elevated ALAT or ASAT (>3 times ULN) as these patients were excluded from the clinical development programme.
Danish: Der skal udvises forsigtighed, hvis Selincro ordineres til patienter med forhøjede værdier af ALAT eller ASAT (>3x ULN), da disse patienter blev ekskluderet fra det kliniske udviklingsprogram.
English: Your doctor has prescribed Selincro because you were not able to reduce your alcohol consumption on your own.
Danish: Din læge har ordineret Selincro, fordi du ikke alene kunne nedsætte dit alkoholforbrug.
English: If the patient has started drinking alcohol without taking Selincro, the patient should take one tablet as soon as possible.
Danish: Hvis patienten er begyndt at drikke alkohol uden at have taget Selincro, skal patienten så hurtigt som muligt tage én tablet.
English: A study with IV administration suggested that there were no relevant changes in the pharmacokinetics in the elderly as compared to non-elderly adults (see sections 4.2 and 4.4).
Danish: En undersøgelse med intravenøs administration indikerede, at der ikke var relevante ændringer i farmakokinetikken hos ældre sammenlignet med ikke-ældre voksne (se pkt.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: En opdateret RMP skal fremsendes: på anmodning fra Det Europæiske Lægemiddelagentur når risikostyringssystemet ændres, særlig som følge af at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: - In vitro studies have demonstrated that nalmefene is a selective opioid receptor ligand with antagonist activity at the μ and δ receptors and partial agonist activity at the κ receptor.
Danish: - In vitro-forsøg har vist, at nalmefen er en selektiv opioidreceptorligand med antagonistvirkning på μ- og δ-receptorerne og partiel agonistaktivitet på κ-receptoren.
English: If you are 65 years old or above, talk to your doctor or pharmacist before taking Selincro.
Danish: Hvis du 65 år eller derover, skal du kontakte lægen eller apoteket, før du tager Selincro.
English: Further, the Cmax and elimination half-life for nalmefene was up to 1.6 times higher in patients with severe renal impairment.
Danish: Derudover var Cmax og eliminationshalveringstiden for nalmefen op til 1,6 gange højere hos patienter med svært nedsat nyrefunktion.
English: Selincro can be taken with or without food (see section 5.2).
Danish: Selincro kan tages med eller uden mad (se pkt.
English: Patients with a recent history of acute alcohol withdrawal syndrome (including hallucinations, seizures, and delirium tremens).
Danish: Patienter, der for nylig har haft akut alkoholabstinenssyndrom (inklusive hallucinationer, kramper og delirium tremens).
English: The efficacy of Selincro in reducing alcohol consumption in patients with alcohol dependence (DSMIV) was evaluated in two efficacy studies.
Danish: Selincros virkning på reduktion af alkoholforbruget hos patienter med alkoholafhængighed (DSM-IV) blev evalueret i to effektundersøgelser.
English: Patients with a history of delirium tremens, hallucinations, seizures, significant psychiatric comorbidity, or significant abnormalities of liver function as well as those with significant physical withdrawal symptoms at screening or randomisation were excluded.
Danish: Patienter med tidligere delirium tremens, hallucinationer, kramper, signifikant psykiatrisk co-morbiditet eller signifikant leverfunktionsabnormalitet samt patienter med signifikante, fysiske abstinenssymptomer ved screening eller randomisering blev ekskluderet.
English: Microcrystalline cellulose Lactose, anhydrous Crospovidone, type A Magnesium stearate
Danish: Mikrokrystallinsk cellulose Lactose, vandfri Crospovidon, type A Magnesiumstearat
English: Elderly (≥65 years of age) No dose adjustment is recommended for this patient population (see sections 4.4 and 5.2).
Danish: Ældre (≥65 år) Der er ingen anbefalinger om dosisjusteringer for denne patientgruppe (se pkt.
English: Inform your doctor about any other diseases you may have, for example, depression, seizure, liver or kidney disease.
Danish: Fortæl det til lægen, hvis du har andre sygdomme, f.eks. depression, kramper, lever- eller nyresygdom.
English: The following side effects have been reported with Selincro:
Danish: Følgende bivirkninger er set med Selincro:
English: Available pharmacodynamic/toxicological data in animals have shown excretion of nalmefene/metabolites in milk (see section 5.3).
Danish: De tilgængelige farmakodynamiske/toksikologiske data fra dyreforsøg har vist, at nalmefen/metabolitter udskilles i mælk (se pkt.
English: Conversely, concomitant administration with a UGT inducer (for example, dexamethasone, phenobarbital, rifampicin, omeprazole) may potentially lead to subtherapeutic nalmefene plasma concentrations.
Danish: Omvendt kan samtidig administration af en UGT inducer (f.eks. dexamethason, phenobarbital, rifampicin, omeprazol) muligvis medføre subterapeutiske plasmakoncentrationer af nalmefen.
English: Do not take Selincro:
Danish: Tag ikke Selincro:
English: Caution should be exercised if Selincro is prescribed to patients with current psychiatric comorbidity such as major depressive disorder.
Danish: Der skal udvises forsigtighed, hvis Selincro ordineres til patienter med eksisterende psykiatrisk co-morbiditet, såsom moderat til svær depression.
English: Selincro is a white, oval, biconvex, film-coated tablet of 6.0 x 8.75 mm.
Danish: Selincro er en hvid, oval, bikonveks, 6,0 x 8,75 mm filmovertrukket tablet.
English: In patients with mild hepatic impairment, exposure increased 1.5 times and oral clearance decreased by approximately 35%.
Danish: Hos patienter med let nedsat leverfunktion steg eksponeringen 1,5 gange, og den orale clearance faldt med ca. 35%.
English: Nornalmefene is further converted to nornalmefene 3-O-glucuronide and nornalmefene 3O-sulphate.
Danish: Nornalmefen omdannes yderligere til nornalmefen 3-O-glukoronid og nornalmefen 3-O-sulfat.
English: Therefore, caution should be exercised when prescribing Selincro to patients with mild or moderate hepatic or mild or moderate renal impairment, for example, by more frequent monitoring.
Danish: Derfor skal der udvises forsigtighed ved ordinering af Selincro til patienter med let eller moderat nedsat leverfunktion eller let eller moderat nedsat nyrefunktion, f.eks. ved hyppigere kontrol.
English: - In vivo studies have demonstrated that nalmefene reduces alcohol consumption, possibly by modulating cortico-mesolimbic functions.
Danish: - In vivo-forsøg har vist, at nalmefen reducerer alkoholforbruget, muligvis ved at påvirke kortikomesolimbiske funktioner.
English: A small proportion of nalmefene is converted to nalmefene 3-O-sulphate by sulphation and to nornalmefene by CYP3A4/5.
Danish: En lille del af nalmefen omdannes til nalmefen 3-O-sulfat ved sulfatering og til nornalmefen ved CYP3A4/5.
English: - Do not use this medicine if you notice defects in the tablets, such as chipped or broken tablets.
Danish: • Brug ikke lægemidlet, hvis der er fejl i tabletterne, f.eks. hvis tabletterne ikke er hele eller er knækkede.
English: Talk to your doctor or pharmacist before taking Selincro.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Selincro.
English: In this post-hoc target population, more patients receiving nalmefene discontinued (45%) as compared to those receiving placebo (31%).
Danish: I denne post-hoc målpopulation var der flere patienter i nalmefen behandling, der stoppede i undersøgelsen (45%), sammenlignet med de patienter, der fik placebo (31%).
English: For patients with mild, moderate or severe renal impairment the AUC for nalmefene was 1.1 times, 1.4 times and 2.4 times higher, respectively.
Danish: For patienter med let, moderat eller svært nedsat nyrefunktion var AUC for nalmefen hhv.1,1, 1,4 og 2,4 gange højere.
English: No clinically relevant changes were seen in tmax or elimination half-life for any of the groups.
Danish: Der sås ingen klinisk relevante forandringer i tmax eller eliminationshalveringstiden for nogen af grupperne.
English: In patients with moderate hepatic impairment, exposure increased 2.9 times for AUC and 1.7 times for Cmax, while oral clearance decreased by approximately 60%.
Danish: Hos patienter med moderat nedsat leverfunktion steg eksponeringen 2,9 gange for AUC og 1,7 gange for Cmax, mens den orale clearance faldt med ca. 60%.
English: Nalmefene is rapidly absorbed after a single oral administration of 18.06 mg, with a peak concentration (Cmax) of 16.5 ng/ml after approximately 1.5 hours and an exposure (AUC) of 131 ng*h/ml.
Danish: Nalmefen absorberes hurtigt efter en enkelt peroral administration af 18,06 mg med en maksimal koncentration (Cmax) på 16,5 ng/ml efter ca. 1½ time og en eksponering (AUC) på 131 ng*h/ml.
English: The clinical efficacy and the clinical relevance of Selincro were analysed in patients with a high or very high DRL at screening and randomisation.
Danish: Selincros kliniske effekt og kliniske relevans blev analyseret hos patienter med et stort eller meget stort alkoholforbrug ved screening og randomisering.