FrancophonIA/ELRC3.0 huggingface dataset:
English: Medicines that inhibit the enzyme CYP3A4 may give rise to increased concentrations of buprenorphine.
Danish: Lægemidler, der hæmmer enzymet CYP3A4, kan forårsage øgede koncentrationer af buprenorphin.
English: A dietary dose of 100 ppm (estimated exposure approximately 2.4 x for buprenorphine at a human dose of 17.2 mg buprenorphine/naloxone based on AUC, plasma levels of naloxone were below the limit of detection in rats) had no adverse effect on fertility in females.
Danish: Tilskud på 100 ppm (beregnet eksponering ca. 2,4x for buprenorphin ved en human dosis på 17,2 mg buprenorphin/naloxon baseret på AUC, plasmaniveauer for naloxon var under detektionsgrænsen hos rotter) havde ingen utilsigtet virkning på fertiliteten hos hunner.
English: Buprenorphine/naloxone has minor to moderate influence on the ability to drive and use machines when administered to opioid dependent patients.
Danish: Buprenorphin/naloxon påvirker mindre til moderat grad evnen til at føre motorkøretøj eller betjene maskiner, når det administreres til opioidafhængige patienter.
English: Naloxone can be eliminated more rapidly than buprenorphine, allowing for a return of previously controlled buprenorphine overdose symptoms, so a continuing infusion may be necessary.
Danish: Naloxon kan elimineres hurtigere end buprenorphin, hvilket giver risiko for tilbagevenden af tidligere kontrollerede symptomer på buprenorphin overdosering.
English: This product should be used with care in patients with asthma or respiratory insufficiency (e.g. chronic obstructive pulmonary disease, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, pre-existing respiratory depression or kyphoscoliosis (curvature of spine leading to potential shortness of breath)).
Danish: Dette lægemiddel bør anvendes med forsigtighed hos patienter med astma eller respirationsinsufficiens (f.eks. kronisk obstruktiv lungesygdom, cor pulmonale, nedsat respiratorisk reserve, hypoxi, hyperkapni, eksisterende respirationsdepression eller kyfoskoliose (krumning af rygsøjlen, der potentielt kan medføre stakåndethed)).
English: Table 3 summarizes the results from a clinical trial in which the exposure after single-dose administration of buprenorphine/naloxone sublingual tablet was determined in healthy subjects, and in subjects with hepatic impairment.
Danish: Tabel 3 sammenfatter resultaterne fra et klinisk forsøg, hvor eksponeringen efter enkeltdosisadministration af buprenorphin/naloxon sublingual resoriblet blev fastlagt hos raske forsøgspersoner, og hos forsøgspersoner med nedsat leverfunktion.
English: Symptoms of overdose may include breathing more slowly and weakly than normal, feeling more sleepy than normal, reduction in the size of the pupils, low blood pressure, feeling sick, vomit and/or slurred speech.
Danish: Symptomer på en overdosis kan omfatte langsommere og svagere vejrtrækning end normalt, følelse af at være mere søvnig end normalt, mindre pupiller, lavt blodtryk, følelse af at være skidt tilpas, opkastning og/eller sløret tale.
English: Buprenorphine is an opioid partial agonist/antagonist which binds to the μ and κ (kappa) opioid receptors of the brain.
Danish: Buprenorphin er en partiel opioidagonist/-antagonist, som binder sig til μ og κ (kappa) opioidreceptorerne i hjernen.
English: Naloxone is an antagonist at μ-opioid receptors.
Danish: Naloxon er en μ-opioidreceptor-antagonist.
English: Oedema peripheral
Danish: Perifere ødemer
English: The lowest dose studied represented exposure multiples of 1x for buprenorphine and 5 x for naloxone at the maximum human therapeutic dose calculated on a mg/m² basis.
Danish: Den laveste, undersøgte dosis repræsenterede eksponering for 1x buprenorphin og 5x for naloxon ved den maksimale humane terapeutiske dosis udregnet på basis af mg/m².
English: Prior to treatment initiation, consideration should be given to the type of opioid dependence (i.e. long- or short-acting opioid), the time since last opioid use and the degree of opioid dependence.
Danish: Sikkerhedsforanstaltninger før administration af lægemidlet Før behandlingsstart bør opioidafhængighedstype (dvs. langtids- eller korttidsvirkende opioid), varighed siden sidste brug af opioid og graden af opioidafhængighed tages i betragtning.
English: • Naltrexone and nalmefene (drugs used to treat addictive disorders) as they may prevent the therapeutic effects of Zubsolv.
Danish: • Naltrexon og nalmefen (lægemidler, der anvendes til behandling af afhængighed), da de kan forhindre Zubsolvs terapeutiske virkning.
English: In a double-blind, double-dummy, parallel-group study comparing buprenorphine ethanolic solution to a full agonist active control, 162 subjects were randomised to receive the ethanolic sublingual solution of buprenorphine at 8 mg/day (a dose which is roughly comparable to a dose of 12 mg/day of buprenorphine/naloxone), or two relatively low doses of active control, one of which was low enough to serve as an alternative to placebo, during a 3 to10 day induction phase, a 16-week maintenance phase and a 7-week detoxification phase.
Danish: I et dobbeltblindet, dobbelt-dummy, parallel-gruppestudie til sammenligning af buprenorphinethanolopløsning med en ren agonist som aktiv kontrol blev 162 forsøgspersoner randomiseret til at få den sublinguale ethanolopløsning af buprenorphin ved 8 mg/dag (en dosis, som stort set svarer til en dosis buprenorphin/naloxon på 12 mg/dag), eller to relativt lave doser af den aktive kontrol, hvoraf den ene var lav nok til at tjene som alternativ til placebo, i en indledende fase på 3 til 10 dage, en 16ugers vedligeholdelsesfase og en 7-ugers afvænningsfase.
English: This product may cause drowsiness, dizziness, or impaired thinking, especially during treatment induction and dose adjustment.
Danish: Dette lægemiddel kan forårsage sløvhed, svimmelhed eller nedsat tankevirksomhed, særligt i forbindelse med indledende behandling og dosisjustering.
English: • sudden withdrawal syndrome caused by taking product too soon after use of illicit opioids, drug withdrawal syndrome in newborn
Danish: • pludselige abstinenser forårsaget af at tage produktet for hurtigt efter brug af ulovlige opioider,
English: Your doctor will determine the best dose for you.
Danish: Lægen vil fastlægge den dosis, der er bedst for dig.
English: Below is a list of examples of these types of medicines: - other opioid containing medicines such as methadone, certain pain killers and cough suppressants - some anti-depressants (used to treat depression) such as isocarboxazid, phenelzine, selegiline, tranylcypromine, valproate and monoamine oxidase inhibitors (MAOIs) may increase the effects of this medicine - sedative Hı receptor antagonists (used to treat allergic reactions) such as diphenhydramine and chlorphenamine - barbiturates (used to cause sleep or sedation) such as phenobarbital, secobarbital - tranquilisers (used to cause sleep or sedation) such as chloral hydrate - clonidine (used to treat high blood pressure) and related medicines may extend the effects of this medicine
Danish: Nedenfor er en liste med eksempler på disse typer medicin: - andre opioider, som indeholder medicin såsom metadon, visse smertestillende midler og hostedæmpende midler - nogle antidepressiva (som bruges til behandling af depression), såsom isocarboxazid, phenelzin, selegilin, tranylcypromin, valproat og monoaminooxidase-hæmmere (MAOhæmmere), kan øge virkningen af dette lægemiddel - sederende Hı receptorantagonister (som bruges til behandling af allergiske reaktioner), såsom diphenhydramin og chlorphenamin - barbiturpræparater (som bruges til at frembringe søvn eller sedation), såsom phenobarbital, secobarbital - beroligende midler (som bruges til at frembringe søvn eller sedation), såsom chloralhydrat - clonidin (som bruges til behandling af forhøjet blodtryk) og relateret medicin kan forlænge dette lægemiddels virkning
English: Never open the blister in advance.
Danish: Åbn aldrig en blister, før det er nødvendigt.
English: For subjects randomised to either active treatment, dosing began with 8 mg of buprenorphine on Day 1, followed by 16 mg (two 8 mg) of buprenorphine on Day 2.
Danish: Hos forsøgspersoner, der var randomiseret til en af de aktive behandlinger, startede doseringen med 8 mg buprenorphin på Dag 1, efterfulgt af 16 mg (to 8 mg) buprenorphin på Dag 2.
English: Due to the long half-life of buprenorphine, neonatal monitoring for several days should be considered at the end of pregnancy, to prevent the risk of respiratory depression or withdrawal syndrome in neonates.
Danish: På grund af buprenorphins lange halveringstid bør det sidst i graviditeten overvejes at monitorere moderen og fostret i flere dage for at nedsætte risikoen for respirationsdepression eller abstinenssymptomer hos den nyfødte.
English: Naloxone is metabolised in the liver, primarily by glucuronide conjugation, and excreted in the urine.
Danish: Naloxon metaboliseres i leveren, primært ved glukuronidkonjugering, og udskilles i urinen.
English: • swelling of the face, lips, tongue or throat which may cause difficulty in swallowing or breathing, severe hives/nettle rash.
Danish: • hævelse af ansigt, læber, tunge eller svælg, som kan gøre det vanskeligt at synke eller trække vejret, alvorlig nældefeber/udslæt.
English: The most commonly reported treatment related adverse reactions reported during the pivotal clinical trials were constipation and symptoms commonly associated with drug withdrawal (i.e. insomnia, headache, nausea, hyperhidrosis and pain).
Danish: De hyppigst rapporterede behandlingsrelaterede bivirkninger, der blev indberettet i de pivotale kliniske studier, var obstipation og symptomer, der almindeligvis forbindes med opioidafvænning (dvs. søvnløshed, hovedpine, kvalme, hyperhidrose og smerter).
English: The recommended starting dose in adults and adolescents over 15 years of age is Zubsolv 1.4 mg / 0.36 mg or 2.9 mg / 0.71 mg a day.
Danish: Den anbefalede startdosis til voksne og unge over 15 år er en Zubsolv 1,4 mg/0,36 mg eller 2,9 mg/0,71 mg dagligt.
English: The primary study comparison was to assess the efficacy of buprenorphine and buprenorphine/naloxone individually against placebo.
Danish: Det primære formål med sammenligningsstudiet var at evaluere virkningen og sikkerheden af henholdsvist buprenorphin og buprenorphin/naloxon i forhold til placebo.
English: Bronchospasm Respiratory depression
Danish: Bronkospasme Respiratorisk depression
English: Cases of acute hepatic injury have been reported in opioid-dependent addicts both in clinical trials and in post marketing adverse reaction reports.
Danish: Der er modtaget indberetning om akut leverskade hos opioid-afhængige stofmisbrugere, både i kliniske studier og i bivirkningsrapporter efter markedsføring.
English: • protein in your urine, urinary tract infection, difficulty urinating, painful or difficult urination,
Danish: • protein i urinen, urinvejsinfektion, vandladningsbesvær, smertefuld eller vanskelig vandladning,
English: • CYP3A4 inducers: Concomitant use of CYP3A4 inducers with buprenorphine may decrease buprenorphine plasma concentrations, potentially resulting in sub-optimal treatment of opioid dependence with buprenorphine.
Danish: • CYP3A4-inducerende stoffer: Samtidig brug af CYP3A4-inducerende stoffer med buprenorphin kan nedsætte plasmabuprenorphin hvilket potentielt kan resultere i sub-optimal behandling af opioidafhængighed med buprenorphin.
English: Buprenorphine
Danish: Buprenorphin
English: The other ingredients are mannitol, citric acid anhydrous, sodium citrate, microcrystalline cellulose, croscarmellose sodium, sucralose, levomenthol, colloidal anhydrous silica and sodium stearyl fumarate.
Danish: Øvrige indholdsstoffer: mannitol, citronsyre vandfri, natriumcitrat, cellulose mikrokrystallinsk, croscarmellosenatrium, sucralose, levomenthol, silica kolloid vandfri og natriumstearylfumarat.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Danish: Tag ikke lægemidlet efter den udløbsdato, der står på kartonen og blisterpakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Buprenorphine is a partial agonist at the μ (mu)-opiate receptor and chronic administration produces dependence of the opioid type.
Danish: Buprenorphin er en partiel agonist på μ (my)-opioid-receptoren, og kronisk administration fremkalder opioidafhængighed.
English: Long-term administration of buprenorphine during the last three months of pregnancy may cause withdrawal syndrome in the neonate (e.g. hypertonia, neonatal tremor, neonatal agitation, myoclonus or convulsions).
Danish: Længerevarende behandling med buprenorphin i de sidste tre måneder af graviditeten kan medføre abstinenssyndrom hos det nyfødte barn (f.eks. hypertoni, neonatal tremor, neonatal agitation, myoclonus eller kramper).
English: • pain and sores in mouth, tongue discolouration
Danish: • smerter og sår i munden, misfarvning af tungen
English: The long half-life of methadone should be considered when starting buprenorphine/naloxone.
Danish: Metadons lange halveringstid skal tages i betragtning, når behandlingen med buprenorphin/naloxon påbegyndes.
English: To avoid precipitating withdrawal, induction with buprenorphine/naloxone only should be undertaken when objective and clear signs of withdrawal are evident (demonstrated e.g. by a score indicating mild to moderate withdrawal on the validated Clinical Opioid Withdrawal Scale, COWS).
Danish: For at undgå udvikling af abstinenser bør buprenorphin/naloxon først administreres, når der optræder objektive og tydelige tegn på abstinenser (påvises f.eks. ved en score, der indikerer milde til moderate abstinenser på den validerede COWS (Clinical Opioid Withdrawal Scale).
English: Treatment must be under the supervision of a physician experienced in the management of opioid dependence/addiction.
Danish: Behandlingen skal ske under overvågning af en læge, der har erfaring med behandling af opioidafhængighed/misbrug.
English: Orthostatic hypotension
Danish: Ortostatisk hypotension
English: Intravenous or intranasal misuse of Zubsolv is expected to be less likely than buprenorphine alone since the naloxone in Zubsolv can precipitate withdrawal in individuals dependent on heroin, methadone, or other opioid agonists.
Danish: Intravenøst eller intranasalt misbrug af Zubsolv forventes at være mindre sandsynligt end af buprenorphin alene, da naloxonen i Zubsolv kan udløse abstinenssymptomer hos personer, der er afhængige af heroin, metadon eller andre opioidagonister.
English: Hallucination
Danish: Hallucinationer
English: Modification of the buprenorphine/naloxone dose is not required in patients with renal impairment.
Danish: Dosisjustering af buprenorphin/naloxon er ikke nødvendig hos patienter med nedsat nyrefunktion.
English: Patients should be monitored for signs and symptoms of opioid withdrawal, toxicity or overdose caused by increased levels of naloxone and/or buprenorphine.
Danish: Patienterne bør monitoreres for tegn og symptomer på opioidabstinenser, toksicitet eller overdosering forårsaget af forhøjede niveauer af naloxon og/eller buprenorphin.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen, hvis du tager anden medicin eller har gjort det for nylig.
English: The effect of hepatic impairment on the pharmacokinetics of buprenorphine and naloxone were evaluated in a post-marketing study.
Danish: Effekten af nedsat leverfunktion på farmakokinetikken for buprenorphin og naloxon blev evalueret i et studie efter markedsføring.
English: Overall, buprenorphine plasma exposure increased approximately 3-fold in patients with severely impaired hepatic function, while naloxone plasma exposure increased 14-fold with severely impaired hepatic function.
Danish: Overordnet set var plasmaeksponeringen for buprenorphin cirka 3 gange højere hos patienter med svært nedsat leverfunktion og plasmaeksponeringen for naloxon cirka 14 gange højere hos patienter med svært nedsat leverfunktion.
English: Misusing this medicine by injecting it can cause withdrawal symptoms, infections, other skin reactions and potentially serious liver problems (see section 2, Warnings and precautions).
Danish: Misbrug af lægemidlet ved indsprøjtning kan forårsage abstinenser, infektioner, andre hudreaktioner og potentielt alvorlige leverproblemer (jf. punkt 2, Advarsler og forsigtighedsregler).
English: Regular monitoring of liver function is recommended (see section 4.4).
Danish: Regelmæssig overvågning af leverfunktionen anbefales (se pkt.
English: If you are dependent upon heroin or a short acting opioid, your first dose of Zubsolv should be taken when signs of withdrawal appear, but not less than 6 hours after you last used opioids
Danish: Hvis du er afhængig af heroin eller en kortvirkende opioid, skal din første dosis Zubsolv tages, når der ses tegn på abstinenser, dog mindst 6 timer efter, at du sidst brugte opioider
English: • anxiety, depression, decreased sexual drive, nervousness, abnormal thinking
Danish: • angst, depression, nedsat seksualdrift, nervøsitet, unormal tankegang
English: However, when administered intravenously to opioid-dependent patients the presence of naloxone in Zubsolv produces marked opioid antagonist effects, thereby deterring intravenous abuse.
Danish: Administreres det derimod intravenøst til opioidafhængige patienter, fremkalder indholdet af naloxon i Zubsolv en udtalt opioid-antagonistvirkning, hvilket modvirker intravenøst misbrug.
English: Co-administration during buprenorphine/naloxone treatment is contraindicated due to the potentially dangerous interaction that may precipitate a sudden onset of prolonged and intense opioid withdrawal symptoms (see section 4.3)
Danish: Samtidig administration under buprenorphin-/naloxonbehandling er kontraindiceret på grund af den potentielt farlige interaktion, der kan udløse pludseligt indsættende, langvarige og intense opioidabstinenser (se pkt.
English: In many cases the presence of pre-existing mitochondrial impairment (genetic disease, liver enzyme abnormalities, infection with hepatitis B or hepatitis C virus, alcohol abuse, anorexia, concomitant use of other potentially hepatotoxic medicines) and ongoing injecting drug use may have a causative or contributory role.
Danish: I mange tilfælde kan eksisterende nedsat mitokondriefunktion (arvelig sygdom, leverenzymabnormaliteter, infektion med hepatitis B- eller hepatitis C-virus, alkoholmisbrug, anoreksi, samtidig behandling med andre potentielt hepatotoksiske lægemidler) og samtidigt intravenøst stofmisbrug, spille en kausal eller medvirkende rolle.
English: Tear following the direction of the arrow.
Danish: Riv i pilens retning.
English: N-dealkylbuprenorphine is a μ-opioid agonist with weak intrinsic activity.
Danish: N-dealkylbuprenorphin er en μ-opioidagonist med svag egenvirkning.
English: • Blood pressure
Danish: • Blodtryk
English: Some risks to opioid misusers and abusers include overdose, spread of blood borne viral or localised and systemic infections, respiratory depression and hepatic injury.
Danish: Nogle af farerne ved forkert brug er misbrug og overdosis, spredning af blodbårne virusinfektioner eller lokaliserede og systemiske infektioner, respirationsdepression og leverskader.
English: A carcinogenicity study with buprenorphine/naloxone was conducted in rats at doses of 7, 30 and 120 mg/kg/day, with estimated dose multiples of 3 to75 times, based on a Zubsolv equivalent human daily sublingual dose of 11.4 mg of buprenorphine calculated on a mg/m² basis.
Danish: Et karcinogenicitetsstudie med buprenorphin/naloxon blev udført med rotter i doser på 7, 30 og 120 mg/kg/dag, med estimeret eksponeringsfaktor på 3 til 75 gange, baseret på en Zubsolv-ækvivalent human daglig sublingual dosis på 11,4 mg buprenorphin beregnet ud fra mg/m².
English: • have kidney problems • have recently suffered a head injury or brain disease
Danish: • for nyligt har slået hovedet eller har haft en hjernesygdom
English: The tablet is to be placed under the tongue until completely dissolved.
Danish: Resoribletten skal anbringes under tungen, indtil den er helt opløst.
English: Patients should not swallow or consume food or drink until the tablet is completely dissolved.
Danish: Patienten må ikke synke eller indtage mad eller drikkevarer, før resoribletten er helt opløst.
English: Concomitant administration of opioid antagonists (naltrexone, nalmefene) for the treatment of alcohol or opioid dependence.
Danish: Samtidig administration af opioidantagonister (naltrexon, nalmefen) til behandling af alkohol- eller opioidafhængighed.
English: Medical withdrawal
Danish: Medicinsk afvænning
English: The dose in mg can differ between buprenorphine products and products are not directly interchangeable.
Danish: Skift mellem produkter indeholdende buprenorphin Dosis i mg kan variere mellem buprenorphinprodukter, og produkterne kan ikke umiddelbart udskiftes.
English: Erectile dysfunction
Danish: Erektil dysfunktion
English: • inflammation of joints
Danish: • inflammation i leddene
English: “11.4” on one side
Danish: ”11.4” på den ene side
English: Appearance
Danish: Udseende
English: There are other strengths that are available to be used by your doctor who will decide what is the best treatment for you.
Danish: Din læge vil, ud fra de tilgængelige styrker, beslutte, hvad der er den bedste behandling til dig.
English: Do not breast-feed whilst taking this medicine, since Zubsolv passes into breast milk.
Danish: Du må ikke amme, når du er i behandling med dette lægemiddel, da Zubsolv udskilles i modermælken.
English: Clear signs of withdrawal should be evident before taking your first dose of Zubsolv.
Danish: Du skal have tydelige tegn på abstinenser, før du tager din første dosis Zubsolv.
English: After a period of successful treatment, you may agree with your doctor to reduce the dose gradually to a lower maintenance dose.
Danish: Når behandling har været vellykket i et stykke tid kan du i samråd med din læge beslutte at reducere din dosis gradvist til en lavere vedligeholdelsesdosis.
English: Buprenorphine is metabolised by 14-N-dealkylation and glucuroconjugation of the parent molecule and the dealkylated metabolite.
Danish: Buprenorphin metaboliseres ved 14-N-dealkylering og glukuronidkonjugering af modersubstansen og de dealkylerede metabolitter.
English: The safety and efficacy of buprenorphine/naloxone in children below the age of 15 years have not been established.
Danish: Der er ingen erfaring med sikkerheden og virkningen af buprenorphin/naloxon hos børn under 15 år.
English: If a patient is changed between buprenorphine or buprenorphine and naloxone containing products, dose adjustments may be necessary due to the potential differences in bioavailability (see sections 4.4 and 5.2).
Danish: Hvis en patient skifter mellem buprenorphin- eller buprenorphin- og naloxon-indeholdende produkter, kan det være nødvendigt at justere dosis på grund af de potentielle forskelle i biotilgængelighed (se pkt.
English: Pack-size of 28 (4 x 7) tablets.
Danish: Pakningsstørrelse: 28 (4 x 7) resoribletter.
English: Opioids have been shown to increase intracholedochal pressure, and should be used with caution in patients with dysfunction of the biliary tract.
Danish: Opioider har vist sig at øge trykket i choledochus, og bør anvendes med forsigtighed til patienter med dysfunktion i galdevejene.
English: The spectrum of abnormalities ranges from transient asymptomatic elevations in hepatic transaminases to hepatic failure, hepatic necrosis, hepatorenal syndrome, hepatic encephalopathy and death.
Danish: Spektret af abnormiteter spænder fra forbigående asymptomatisk forhøjede levertransaminaser til leversvigt, levernekrose, hepatorenalt syndrom, hepatisk encefalopati og død.
English: Opioids should be used with caution in patients with hypotension, prostatic hypertrophy or urethral stenosis.
Danish: Opioider bør anvendes med forsigtighed til patienter med hypotension, prostatahypertrofi eller uretrastenose.
English: “8.6” on one side
Danish: ”8.6” på den ene side
English: Keep the tablet under your tongue until it dissolves.
Danish: Hold resoribletten under tungen til den opløses.