FrancophonIA/ELRC3.0 huggingface dataset:
English: If Selincro is taken concomitantly with opioid agonists (for example, certain types of cough and cold medicinal products, certain antidiarrhoeal medicinal products, and opioid analgesics), the patient may not benefit from the opioid agonist.
Danish: Hvis Selincro tages samtidig med opioidagonister (f.eks. visse lægemidler mod hoste og forkølelse, visse lægemidler mod diarré og opioidanalgetika), får patienten muligvis ikke gavn af opioidagonisten.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Selincro in all subsets of the paediatric population for the treatment of alcohol dependence (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Selincro i alle undergrupper af den pædiatriske population til behandling af alkoholafhængighed (se pkt.
English: In fertility studies in rats, no effects were observed for nalmefene on fertility, mating, pregnancy, or sperm parameters.
Danish: I fertilitetsforsøg med rotter blev der ikke observeret nogen effekt af nalmefen på fertilitet, parring, drægtighed og spermparametre.
English: The most common adverse reactions were nausea, dizziness, insomnia, and headache.
Danish: De mest almindelige bivirkninger var kvalme, svimmelhed, søvnløshed og hovedpine.
English: The film-coated tablet should not be divided or crushed because nalmefene may cause skin sensitisation when in direct contact with the skin (see section 5.3).
Danish: Den filmovertrukne tablet må ikke deles eller knuses, da nalmefen kan forårsage hudsensibilisering ved direkte kontakt med huden (se pkt.
English: In an emergency situation when opioids must be administered to a patient taking Selincro, the amount of opioid required to obtain the desired effect may be greater than usual.
Danish: Hvis en patient i behandling med Selincro har brug for behandling med et opioid i en nødsituation, kan den dosis opioid, der er nødvendig for at opnå den ønskede virkning, være højere end normalt.
English: It is not known if Selincro is safe to use during pregnancy and breast-feeding.
Danish: Det er uvist, om det er sikkert at bruge Selincro under graviditet og amning.
English: Table 2 Pooled Responder Analysis Results in Patients with a High or Very High DRL at screening and Randomisation
Danish: Tabel 2 Samlede respondentanalyseresultater hos patienter med et stort eller meget stort alkoholforbrug ved screening og randomisering
English: At an initial visit, the patient's clinical status, alcohol dependence, and level of alcohol consumption (based on patient reporting) should be evaluated.
Danish: Ved den første konsultation skal patientens kliniske status, alkoholafhængighed og alkoholforbrug vurderes (baseret på patientens egne oplysninger).
English: - Swallow the tablet whole, do not crush or divide the tablet because Selincro may cause skin sensitisation when in direct contact with the skin.
Danish: • Du skal sluge tabletten hel - du må ikke knuse eller dele den, da Selincro kan forårsage hudirritation, når det kommer i direkte kontakt med huden.
English: Caution should be excercised when taking medicines such as diclofenac (antiinflammatory medicine used to treat, for example, muscle pain), fluconazole (antibiotic used to treat diseases caused by some types of fungus), omeprazole (medicine used to block the production of acid in the stomach), or rifampicin (antibiotic used to treat diseases caused by some types of bacteria) together with Selincro.
Danish: Du skal være forsigtig, hvis du samtidig med Selincro tager medicin som f.eks. diclofenac (antiinflammatorisk (dvs. betændelseshæmmende) medicin, der bruges til at behandle f.eks. muskelsmerter), fluconazol (et antibiotikum, der bruges til at behandle sygdomme forårsaget af visse svampetyper), omeprazol (medicin, der bruges til at hæmme syreproduktionen i maven) eller rifampicin (et antibiotikum, der bruges til at behandle sygdomme forårsaget af visse typer bakterier).
English: Psychiatric effects were reported in clinical studies (see section 4.8).
Danish: Der er rapporteret psykiske bivirkninger i de kliniske undersøgelser (se pkt.
English: There is limited experience in patients with a history of seizure disorders, including alcohol withdrawal seizures.
Danish: Der er begrænset erfaring med patienter, der tidligere har haft kramper inklusive alkoholabstinenskramper.
English: Selincro is used for the reduction of alcohol consumption in adult patients with alcohol dependence who still have a high level of alcohol consumption 2 weeks after the first consultation with their doctor.
Danish: Selincro bruges til at nedsætte alkoholforbruget hos voksne patienter med alkoholafhængighed, hvor alkoholforbruget stadig er stort to uger efter den første konsultation hos lægen.
English: Selincro does not prevent the intoxicating effects of alcohol.
Danish: Selincro forhindrer ikke alkoholens berusende virkning.
English: Studies in rats have shown excretion of nalmefene or its metabolites in milk.
Danish: Undersøgelser med rotter har vist, at nalmefen og dets metabolitter udskilles i brystmælk.
English: Co-administration with medicinal products that are potent inhibitors of the UGT2B7 enzyme (for example, diclofenac, fluconazole, medroxyprogesterone acetate, meclofenamic acid) may significantly increase the exposure to nalmefene.
Danish: Samtidig indtagelse af lægemidler, der er potente hæmmere af UGT2B7-enzymet (f.eks. diclofenac, fluconazol, medroxyprogesteronacetat, meclofenaminsyre), kan øge optagelsen af nalmefen signifikant.
English: Management of an overdose should be observational and symptomatic.
Danish: I tilfælde af overdosering bør patienten observeres, og der bør gives symptomatisk behandling.
English: Caution is advised if Selincro is co-administered with a potent UGT2B7 inhibitor (see section 4.5).
Danish: Der skal udvises forsigtighed, hvis Selincro gives samtidigt med en potent UGT2B7 hæmmer (se pkt.
English: The majority (80%) of the patients included had a high or very high DRL (alcohol consumption >60 g/day for men and >40 g/day for women according to the WHO DRLs of alcohol consumption) at screening, of these 65% maintained a high or very high DRL between screening and randomisation.
Danish: De fleste (80%) af de patienter, der blev inkluderet, havde ved screening et stort eller meget stort alkoholforbrug (alkoholforbrug >60 g dagligt for mænds vedkommende og >40 g dagligt for kvinders vedkommende i henhold til WHO's DRL om alkoholindtagelse).
English: Angioedema Urticaria Pruritus Rash
Danish: Angioødem Urticaria Pruritus Udslæt Erytem
English: In a rabbit embryo-foetal developmental toxicity study, effects on foetuses in terms of reduced foetal weight and delayed ossification, but no major abnormalities were seen.
Danish: I et studie af embryo/føtal udviklingstoksicitet hos kaniner sås der virkninger på fostrene i form af reduceret føtalvægt og forsinket knogledannelse, men ingen større anomalier.
English: Each film-coated tablet contains 18.06 mg nalmefene (as hydrochloride dihydrate).
Danish: Én filmovertrukket tablet indeholder 18,06 mg nalmefen (som hydrochloriddihydrat).
English: Administration of a single oral dose of nalmefene 18.06 mg to patients with mild, moderate or severe renal impairment, classified using the estimated glomerular filtration rate, resulted in an increased exposure to nalmefene relative to that in healthy subjects.
Danish: Administration af en enkelt oral dosis på 18,06 mg nalmefen til patienter med let, moderat eller svært nedsat nyrefunktion, klassificeret efter den estimerede glomerulære filtrationshastighed, resulterede i en øget eksponering for nalmefen sammenlignet med raske forsøgspersoner.
English: Very common Insomnia Common
Danish: Meget almindelig Søvnløshed Almindelig
English: Metabolism by glucuronide conjugation is the primary mechanism of clearance for nalmefene, with renal excretion being the main route of elimination of nalmefene and its metabolites.
Danish: Nalmefens primære clearancemekanisme er metabolisme ved glukuronidkonjugering, og den væsentligste udskillelsesvej for nalmefen og dets metabolitter er via nyrerne.
English: Patients taking opioid agonists (such as opioid analgesics, opioids for substitution therapy with opioid agonists (e.g. methadone) or partial agonists (e.g. buprenorphine)) (see section 4.4).
Danish: Patienter, der tager opioidagonister (såsom opioidanalgetika, opioider til substitutionsbehandling med opioidagonister (f.eks. metadon) eller partielle agonister (f.eks. buprenorphin)) (se pkt.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Selincro therapy, taking into account the benefit of breast-feeding to the child and the benefit of therapy to the woman.
Danish: Det skal besluttes, om amningen skal ophøre, eller om man skal ophøre med/afstå fra behandling med Selincro, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Selincro should be initiated only in patients who continue to have a high DRL two weeks after initial assessment.
Danish: Selincro bør kun ordineres til patienter, som fortsat har et stort alkoholforbrug to uger efter den første vurdering.
English: Titanium dioxide (E171)
Danish: Hypromellose Macrogol 400 Titandioxid (E171)
English: Selincro is not recommended during pregnancy.
Danish: Selincro bør ikke anvendes under graviditeten.
English: Selincro is for oral use.
Danish: Selincro er til oral anvendelse.
English: For the inactive major metabolite nalmefene 3-O-glucuronide, the AUC and Cmax were up to 5.1 times and 1.8 times higher in patients with severe renal impairment, respectively (see sections 4.3 and 4.4).
Danish: For den inaktive hovedmetabolit nalmefen-3-O-glukuronid var AUC og Cmax op til hhv. 5,1 og 1,8 gange højere hos patienter med svært nedsat nyrefunktion (se pkt.
English: The majority of the patients had low (55% had a score of 0-13) or intermediate (36% had a score of 14-21) alcohol dependence according to the Alcohol Dependence Scale.
Danish: Målt på en skala over alkoholafhængighed - Alcohol Dependence Scale - havde de fleste af patienterne en lav alkoholafhængighed (55% havde en score på 0-13) eller en intermediær alkoholafhængighed (36% havde en score på 14-21).
English: Occupancy data obtained in a PET study after single and repeated daily dosing with 18.06 mg nalmefene show 94% to 100% receptor occupancy within 3 hours after dosing, which suggests that nalmefene readily crosses the blood-brain barrier.
Danish: Data indsamlet i en (PET) undersøgelse viste 94% til 100% receptorbinding inden for 3 timer efter en enkelt og gentagen daglig dosering med 18,06 mg nalmefen, hvilket tyder på, at nalmefen let krydser blodhjernebarrieren.
English: The tablet core: microcrystalline cellulose, anhydrous lactose, crospovidone (type A), magnesium stearate.
Danish: Tabletkernen: Mikrokrystallinsk cellulose, vandfri laktose, crospovidon (type A), magnesiumstearat.
English: Film-coated tablet (tablet) White, oval, biconvex, 6.0 x 8.75 mm film-coated tablet engraved with “S” on one side
Danish: Hvid, oval, bikonveks, 6,0 x 8,75 mm filmovertrukket tablet med ”S” præget på den ene side af tabletten.
English: Selincro is to be taken as-needed: On each day the patient perceives a risk of drinking alcohol, one tablet should be taken, preferably 1-2 hours prior to the anticipated time of drinking.
Danish: Hver dag patienten erkender at have en risiko for at indtage alkohol, skal patienten tage én tablet helst 1-2 timer før det tidspunkt, hvor patienten forventer at drikke.
English: The patient's response to treatment and the need for continued pharmacotherapy should be evaluated on a regular
Danish: Patientens respons på behandlingen og behovet for fortsat farmakoterapi skal vurderes regelmæssigt (f.eks. en gang om måneden) (se pkt.
English: Caution should be exercised when using medicinal products containing opioids (for example, cough medicines, opioid analgesics (see section 4.5)).
Danish: Der skal udvises forsigtighed ved brug af lægemidler, der indeholder opioider (f.eks. hostemedicin, opioidanalgetika (se pkt.
English: Very Common Dizziness Headache
Danish: Meget almindelig Svimmelhed Hovedpine
English: Patients with acute symptoms of opioid withdrawal.
Danish: Patienter med akutte opioidabstinenssymptomer.
English: Very Common Nausea Common
Danish: Meget almindelig Kvalme Almindelig
English: If you and your doctor have decided that your immediate goal is abstinence (not drinking any alcohol), you should not take Selincro because Selincro is indicated for reduction of alcohol consumption.
Danish: Du skal ikke tage Selincro, hvis du og din læge har besluttet, at dit umiddelbare mål er afholdenhed (ikke at drikke alkohol overhovedet), fordi Selincro er beregnet til at nedsætte alkoholforbruget.
English: Selincro is not recommended if you are pregnant.
Danish: Du bør ikke tage Selincro, hvis du er gravid.
English: Selincro contains lactose
Danish: Selincro indeholder laktose
English: If you are breast-feeding, you and your doctor should make a decision whether to discontinue breastfeeding or to discontinue Selincro therapy, taking into account the benefit of breast-feeding to the child and the benefit of therapy to you.
Danish: Hvis du ammer, skal du og din læge beslutte, om du skal holde op med at amme, eller om du skal stoppe behandlingen med Selincro under hensyntagen til barnets fordele ved amningen og dine fordele ved behandlingen.
English: In Study 2, the proportion of patients who withdrew was higher in the Selincro group than in the placebo group (30% versus 28%, respectively).
Danish: I undersøgelse 2 var andelen af patienter, som trak sig ud af undersøgelsen, større i gruppen behandlet med Selincro end i gruppen behandlet med placebo (hhv. 30% og 28%).
English: Caution should be exercised when prescribing Selincro to patients ≥65 years of age (see sections 4.2 and 5.2).
Danish: Der skal udvises forsigtighed ved ordinering af Selincro til patienter ≥65 år (se pkt.
English: Few cases of side effects of seeing, hearing or sensing things that are not there or feeling detached from oneself have been reported.
Danish: Der er rapporteret få tilfælde af bivirkninger, hvor patienten har set, hørt eller fornemmet ting, som ikke var der eller har følt sig ved siden af sig selv, men hyppigheden af disse bivirkninger kan ikke beregnes ud fra de foreliggende data.
English: - Selincro is for oral use.
Danish: • Selincro er til oral brug.
English: At the initial visit, the patients' clinical status, social situation, and alcohol consumption pattern were evaluated (based on patient reporting).
Danish: Patienternes kliniske status, sociale situation og alkoholforbrugsmønter blev evalueret ved det første besøg (baseret på patientens egne oplysninger).
English: Other medicines and Selincro
Danish: Brug af anden medicin sammen med Selincro
English: - Do not use this medicine after the expiry date (EXP) that is printed on the blister and carton.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Side effects such as disturbance in attention, feeling abnormal, nausea, dizziness, somnolence, insomnia, and headache may occur when beginning Selincro treatment.
Danish: Bivirkninger som f.eks. koncentrationsvanskeligheder, følelse af at være unormal, kvalme, svimmelhed, døsighed, søvnløshed og hovedpine kan forekomme, når man begynder behandling med Selincro.
English: - Your doctor will follow up with you on a regular basis, for example, monthly after you start treatment with Selincro; the actual frequency will depend on your progress.
Danish: • Din læge vil regelmæssigt lave opfølgende kontrol, f.eks. en gang om måneden, efter du er startet i Selincro behandling.
English: Administration of a single dose of nalmefene 18.06 mg to patients with mild or moderate hepatic impairment increased exposure relative to that in healthy subjects.
Danish: Administration af en enkelt dosis nalmefen 18,06 mg til patienter med let eller moderat nedsat leverfunktion øgede eksponeringen i forhold til raske forsøgspersoner.
English: However, the effect of nalmefene and alcohol in combination did not exceed the sum of the effects of each substance when taken alone.
Danish: Der synes at være en lille nedsættelse af kognitiv og psykomotorisk formåen efter indgivelse af nalmefen, men virkningen af samtidig indtagelse af nalmefen og alkohol oversteg ikke den samlede virkning af hvert stof, når det blev taget alene.
English: Each film-coated tablet contains 60.68 mg lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Én filmovertrukket tablet indeholder 60,68 mg lactose.
English: Disturbance in attention Paraesthesia Hypoaesthesia
Danish: Opmærksomhedsforstyrrelser Paræstesi
English: If you forget to take Selincro
Danish: Hvis du har glemt at tage Selincro
English: CARTON FOR BLISTERS
Danish: ÆSKE TIL BLISTERPAKNINGER
English: 52% of these patients had a high or very high DRL at baseline; of these, 52% (representing 27% of the total population) continued to have a high or very high DRL at randomisation.
Danish: Af disse patienter havde 52% (hvilket svarede til 27% af den samlede population) fortsat et stort eller meget stort alkoholforbrug ved randomiseringen.
English: Selincro 18 mg tablet nalmefene
Danish: Selincro 18 mg tablet nalmefen
English: What you need to know before you take Selincro
Danish: Det skal du vide, før du begynder at tage Selincro
English: Vomiting Dry mouth Diarrhoea
Danish: Opkastning Mundtørhed Diarré
English: Malaise Feeling abnormal
Danish: Generel utilpashed Generel unormal følelse
English: Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Danish: Selincro bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: If you stop taking Selincro
Danish: Hvis du holder op med at tage Selincro
English: The majority of these reactions were mild or moderate, associated with treatment initiation, and of short duration (a few hours to a few days).
Danish: Hovedparten af disse bivirkninger var milde eller moderate, sås i forbindelse med opstart af behandling og var kortvarige (varede fra nogle få timer til nogle få dage).
English: The majority of these reactions were mild or moderate, occurred at the beginning of treatment and lasted for a few hours to a few days.
Danish: De fleste af bivirkningerne var milde eller moderate, opstod i starten af behandlingen og varede fra nogle få timer til nogle få dage.
English: However, the frequency of these side effects cannot be estimated from the available data.
Danish: Andre bivirkninger (kan ikke fastsættes ud fra de eksisterende data)
English: Sleep disorder
Danish: Søvnforstyrrelser Konfusion Rastløshed
English: The majority of these reactions were mild or moderate, associated with treatment initiation, and of short duration.
Danish: Hovedparten af disse bivirkninger var milde eller moderate, sås i forbindelse med opstart af behandling og var kortvarige.
English: Both studies were randomised, double-blind, parallel-group and placebo-controlled, and after 6 months of treatment, patients who received Selincro were re-randomised to receive either placebo or Selincro in a 1-month run-out period.
Danish: Efter 6 måneders behandling blev de patienter, der fik Selincro, randomiseret igen til enten at få placebo eller Selincro i en udfasningsperiode på 1 måned.
English: An increase in still-born pups and decrease in post-natal viability of pups was observed in prepostnatal toxicity studies in rats.
Danish: I præ-/postnatale toksicitetsstudier med rotter sås der en stigning i antallet af dødfødte unger og et fald i postnatal levedygtighed hos ungerne.
English: - if you are allergic to nalmefene or any of the other ingredients of this medicine (listed in section 6) - if you are taking medicines containing opioids, for example, methadone or buprenorphine or pain killers (such as morphine, oxycodone or other opioids) - if you are or have recently been dependent on opioids.
Danish: - Hvis du tager medicin, der indeholder opioider, f.eks. metadon eller buprenorphin eller smertestillende medicin (såsom morfin, oxycodon eller andre opioider).
English: double-blind, parallel-group, placebo-controlled 1-year study.
Danish: Begge undersøgelser var randomiserede, dobbeltblinde, parallelgruppe- og placebokontrollerede.
English: Administration of high-fat food increases the total exposure (AUC) by 30% and the peak concentration (Cmax) by 50%; the time to peak concentration (tmax) is delayed by 30 min (tmax is 1.5 hours).
Danish: Indtagelse af mad med højt fedtindhold øger den samlede eksponering (AUC) med 30% og den maksimale koncentration (Cmax) med 50%.
English: (such as seeing, hearing or sensing things that are not there, seizures and shakiness)
Danish: • Du ser, hører eller fornemmer ting, som ikke er der
English: Pharmacokinetic data after oral administration of nalmefene to patients with severe hepatic impairment are not available (see sections 4.3 and 4.4).
Danish: Der findes ikke tilgængelige farmakokinetiske data efter peroral administration af nalmefen til patienter med svært nedsat leverfunktion (se pkt.
English: Very common (may affect more than 1 in 10 people) - feeling sick - dizziness - inability to sleep - headache
Danish: Meget almindelige (kan påvirke flere end 1 person ud af 10)
English: Adverse reactions such as disturbance in attention, feeling abnormal, nausea, dizziness, somnolence, insomnia, and headache may occur following administration of nalmefene (see section 4.8).
Danish: Bivirkninger såsom koncentrationsvanskeligheder, en følelse af at være unormal, kvalme, svimmelhed, somnolens, søvnløshed og hovedpine kan forekomme efter administration af nalmefen (se pkt.
English: Selincro 18 mg film-coated tablets nalmefene
Danish: Selincro 18 mg filmovertrukne tabletter nalmefen
English: - Each film-coated tablet contains 18.06 milligram nalmefene (as hydrochloride dihydrate) - The other ingredients are:
Danish: • Én filmovertrukket tablet indeholder 18,06 mg nalmefen (som hydrochloriddihydrat)
English: Selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (DRL) [see section 5.1], without physical withdrawal symptoms and who do not require immediate detoxification.
Danish: Selincro er indiceret til reduktion af alkoholforbruget hos voksne alkoholafhængige patienter, som har et stort alkoholforbrug (Drinking Risk Level (DRL)) [se pkt.
English: Selincro 18 mg film-coated tablets
Danish: Selincro 18 mg filmovertrukne tabletter.
English: No dose adjustment is recommended for patients with mild or moderate renal impairment (see sections 4.4 and 5.2).
Danish: Der er ingen anbefalinger om dosisjusteringer for patienter med let eller moderat nedsat leverfunktion (se pkt.
English: Post-hoc efficacy analysis in patients who maintained a high or very high DRL at randomisation In Study 1, the proportion of patients who withdrew was higher in the Selincro group than in the placebo group (50% versus 32%, respectively).
Danish: I undersøgelse 1 var andelen af patienter, som trak sig ud af undersøgelsen, større i gruppen behandlet med Selincro end i gruppen behandlet med placebo (hhv. 50% og 32%).
English: The TAC was 100 g/day at baseline in the Selincro group (n=141) and 101 g/day at baseline in the placebo group (n=42).
Danish: Det daglige totale alkoholforbrug var 100 g dagligt ved baseline i Selincro gruppen (n=141) og 101 g dagligt ved baseline i placebogruppen (n=42).
English: The TAC was 102 g/day at baseline in the Selincro group (n=171) and 99 g/day at baseline in the placebo group (n=167).
Danish: Det daglige totale alkoholforbrug var 102 g dagligt ved baseline i Selincro gruppen (n=171) og 99 g dagligt ved baseline i placebogruppen (n=167).