FrancophonIA/ELRC3.0 huggingface dataset:
English: The frequency of possible side effects listed below is defined using the following convention: Very common (1/10), Common (1/100 to <1/10), Uncommon (1/1,000 to <1/100), Not known (cannot be estimated from available data).
Danish: Hyppigheden af bivirkninger i nedenstående tabel er bestemt i henhold til følgende konvention: Meget almindelig (1/10), almindelig (1/100 til <1/10), ikke almindelig (1/1.000 til <1/100), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Liver damage has been reported after taking Suboxone, especially when the medicine is misused.
Danish: Der er rapporteret om leverskader efter indtagelse af Suboxone, særligt hvis lægemidlet bruges forkert.
English: If buprenorphine is administered to some non-opioid dependent individuals, who are not tolerant to the effects of opioids, potentially fatal respiratory depression may occur.
Danish: Hvis buprenorphin administreres til ikke-opioidafhængige personer, som ikke er tolerante over for virkningerne af opioider, kan det medføre potentielt dødelig respirationsdepression.
English: Both Cmax and AUC of buprenorphine increased with the increase in dose (in the range of 4-16 mg), although the increase was less than dose-proportional.
Danish: Både Cmax og AUC af buprenorphin steg i takt med dosisforhøjelsen (inden for intervallet 4-16 mg), selvom stigningen var mindre end proportional med dosis.
English: 28 sublingual tablets
Danish: 28 sublinguale resoribletter
English: Do not forget to advise your doctor if you take this medicine.
Danish: Husk at fortælle til din egen læge, at du tager dette lægemiddel.
English: Towards the end of pregnancy buprenorphine may induce respiratory depression in the newborn infant even after a short period of administration.
Danish: Mod slutningen af graviditeten kan buprenorphin fremkalde respirationsdepression hos det nyfødte barn, selv efter en kort behandlingsperiode.
English: Regular blood tests may be conducted by your doctor to monitor the condition of your liver.
Danish: Der skal tages blodprøver jævnligt hos lægen for at overvåge din levers tilstand.
English: Following oral administration, naloxone is barely detectable in plasma; following sublingual administration of buprenorphine/naloxone, plasma naloxone concentrations are low and decline rapidly.
Danish: Efter oral administration kan naloxon knapt detekteres i plasma; efter sublingual administration af buprenorphin/naloxon er naloxonplasmakoncentrationerne lave og falder hurtigt.
English: 2 - Remove just one section from the blister pack, tearing it along the perforated line.
Danish: 2 - Fjern kun én blisterlomme fra blisterkortet ved at trække langs den perforerede linje.
English: • Do not chew or swallow the tablets, as the medicine will not work and you may get withdrawal symptoms.
Danish: • Lad være med at tygge på eller sluge resoribletterne, da medicinen så ikke vil virke, og du kan få abstinenser.
English: The percentage of thrice-weekly urine samples that were negative for non-study opioids was statistically higher for both buprenorphine/naloxone versus placebo (p < 0.0001) and buprenorphine versus placebo (p < 0.0001).
Danish: Andelen af urinprøver, der blev afgivet tre gange om ugen, som var negative for ikke-studierelaterede opioider var statistisk højere for både buprenorphin/naloxon versus placebo (p < 0,0001) og buprenorphin versus placebo (p < 0,0001).
English: It is unknown whether naloxone is excreted in human breast milk.
Danish: Det vides ikke om naloxon udskilles i human mælk.
English: Therefore the potential to overdose with a full agonist exists, especially when attempting to overcome buprenorphine partial agonist effects, or when buprenorphine plasma levels are declining.
Danish: Derfor er der potentiel risiko for at overdosere med en fuld agonist, især ved forsøg på at afhjælpe virkningerne af en partiel buprenorphin-agonist, eller når plasma-buprenorphin er faldende.
English: General warnings relevant to the administration of opioids Opioids may produce orthostatic hypotension in ambulatory patients.
Danish: Generelle advarsler, der er relevante ved administration af opioider Opioider kan fremkalde ortostatisk hypotension hos ambulante patienter.
English: Tell your doctor if you have any liver problems before you start treatment with Suboxone.
Danish: Tal med lægen, hvis du har nogen form for leverproblemer, før du starter behandling med Suboxone.
English: However, the dose given on any one day should not exceed 24 mg buprenorphine.
Danish: Dog bør den dosis, der gives i løbet af en dag, ikke overskride 24 mg buprenorphin.
English: On Day 3, those randomized to receive buprenorphine/naloxone were switched to the combination tablet.
Danish: På Dag 3 blev de forsøgspersoner, der var randomiseret til at modtage buprenorphin/naloxon, omstillet til kombinationsresoribletten.
English: Treatment is intended for use in adults and adolescents over 15 years of age who have agreed to be treated for addiction.
Danish: Behandlingen retter sig mod voksne og unge over 15 år, som har indvilliget i at blive behandlet for deres afhængighed.
English: Influenza Infection Pharyngitis Rhinitis
Danish: Influenza Infektion Pharyngitis Rhinitis
English: The syndrome is generally delayed for several hours to several days after birth.
Danish: Syndromet er sædvanligvis forsinket i flere timer til flere dage efter fødslen.
English: Do not take any other medicines whilst taking Suboxone without first talking to your doctor especially:
Danish: Tag ikke nogen anden medicin, mens du er i behandling med Suboxone, uden først at fortælle det til din læge, især:
English: Conjunctivitis Miosis
Danish: Konjunctivitis Miosis
English: Talk to your doctor before taking Suboxone if you have:
Danish: Kontakt lægen, før du tager Suboxone, hvis du har:
English: • Starting treatment of Suboxone whilst dependent on heroin
Danish: • Påbegyndelse af behandling med Suboxone, mens du er afhængig af heroin
English: These underlying factors must be taken into consideration before prescribing buprenorphine/naloxone and during treatment.
Danish: Disse underliggende faktorer skal tages i betragtning, inden ordination af buprenorphin/naloxon og under behandlingen.
English: Like all medicines, Suboxone can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Buprenorphine and its metabolites are excreted in human breast milk.
Danish: Buprenorphin og dets metabolitter udskilles i human mælk.
English: Initiation therapy (induction)
Danish: Indledende behandling (induktion)
English: The risks of using Suboxone in pregnant women are not known.
Danish: Farerne ved at anvende Suboxone til gravide kvinder er ukendte.
English: • Starting treatment of Suboxone whilst dependent on methadone
Danish: • Påbegyndelse af behandling med Suboxone, mens du er afhængig af methadon
English: Respiratory depression as a result of central nervous system depression is the primary symptom requiring intervention in the case of overdose because it may lead to respiratory arrest and death.
Danish: Respirationsdepression som følge af depression af centralnervesystemet er det primære symptom, som kræver intervention i tilfælde af overdosering, da det kan forårsag respirationsstop og død.
English: Its activity in opioid maintenance treatment is attributed to its slowly reversible properties with the -opioid receptors which, over a prolonged period, might minimise the need of addicted patients for drugs.
Danish: Stoffets virkning i forbindelse med opioid-vedligeholdelsesbehandling tilskrives dets langsomme reversible binding til -opioidreceptorerne, som over en længere periode kan minimere behovet for stoffer hos afhængige patienter.
English: Content of the pack and other Information
Danish: Pakningsstørrelser og yderligere oplysninger
English: Your treatment is prescribed and monitored by doctors who are experienced in the treatment of drug dependence.
Danish: Din behandling ordineres og overvåges af læger, som har erfaring med at behandle opioidafhængighed.
English: • feeling sleepy and uncoordinated, have blurred vision, have slurred speech, cannot think well or clearly, or your breathing gets much slower than is normal for you.
Danish: • søvnighed og manglende koordinationsevne, sløret syn, har sløret tale, hvis du ikke kan tænke ordentligt eller klart, eller hvis du trækker vejret meget langsommere end normalt.
English: Undesirable effects were based on the known pharmacological activity of opioid agonistic and/or antagonistic substances.
Danish: Bivirkningerne kunne føres tilbage til den kendte farmakologiske aktivitet af opioid-agonistiske og/eller antagonistiske stoffer.
English: During your treatment, the doctor may adjust the dose, depending upon your response.
Danish: Under behandlingen kan lægen justere dosis afhængigt af din reaktion.
English: Sublingual use
Danish: Sublingual brug
English: Naloxone is an antagonist at -opioid receptors.
Danish: Naloxon er en -opioidreceptor-antagonist.
English: Some people have died from respiratory failure (inability to breathe) because they misused this medicine or took it in combination with other central nervous system depressants, such as alcohol, benzodiazepines (tranquilisers), or other opioids.
Danish: Enkelte personer er døde af respirationssvigt (manglende vejrtrækning), fordi de har misbrugt dette lægemiddel eller har taget det i kombination med andre hæmmere af centralnervesystemet, såsom alkohol, benzodiazepiner (beroligende midler) eller andre opioider.
English: • if you have serious liver problems
Danish: • hvis du har alvorlige leverproblemer
English: Animal studies have shown a reduction in female fertility at high doses (systemic exposure > 2.4 times the human exposure at the maximum recommended dose of 24 mg buprenorphine, based on AUC).
Danish: Dyrestudier har påvist nedsat fertilitet hos hunner ved høje doser (systemisk eksponering > 2,4 gange den humane eksponering ved den højeste anbefalede dosis på 24 mg buprenorphin, baseret på AUC).
English: Therefore, breastfeeding should be discontinued during treatment with Suboxone.
Danish: Derfor skal amning ophøre under behandling med Suboxone.
English: For patients who may require a lower buprenorphine dose, buprenorphine 0.4 mg may be used.
Danish: Hos patienter med behov for en lavere buprenorphindosis, kan der gives 0,4 mg buprenorphin.
English: Urine Abnormality
Danish: Urin abnormitet
English: Opioid-induced miosis, changes in the level of consciousness, or changes in the perception of pain as a symptom of disease may interfere with patient evaluation or obscure the diagnosis or clinical course of concomitant disease.
Danish: Opioidinduceret miosis, ændringer i bevidsthedsniveau eller ændringer i opfattelsen af smerte som et symptom på sygdom kan påvirke patientevalueringen eller sløre diagnosen eller det kliniske forløb af samtidig sygdom.
English: • Diagnosis of unrelated medical conditions This medicine may mask pain symptoms that could assist in the diagnosis of some diseases.
Danish: • Diagnosticering af ikke relaterede sygdomstilstande Dette lægemiddel kan gøre, at du ikke mærker de smerter, som nogle sygdomme fremkalder.
English: These include medicines used to treat epilepsy (such as carbamazepine and phenytoin), and medicines used to treat tuberculosis (rifampicin).
Danish: Disse lægemidler omfatter lægemidler til behandling af epilepsi (såsom carbamazepin og phenytoin) og lægemidler til behandling af tuberkulose (rifampicin).
English: If you or someone else takes too much of this medicine, you must go or be taken immediately to an emergency centre or hospital for treatment as overdose with Suboxone may cause serious and lifethreatening breathing problems.
Danish: Hvis du eller en anden person tager for meget af denne medicin skal du straks tage på skadestuen eller hospitalet for at blive behandlet, da en overdosis af Suboxone kan forårsage alvorlige og livsfarlige vejrtrækningsproblemer.
English: Buprenorphine was titrated to maintenance dose by Day 3; active control doses were titrated more gradually.
Danish: Buprenorphin blev titreret til vedligeholdelsesdosis på Dag 3 - dosis af den aktive kontrol blev titreret mere gradvist.
English: • a urinary disorder (especially linked to enlarged prostrate in men)
Danish: • vandladningsbesvær (særligt forbundet med forstørret blærehalskirtel (prostata) hos mænd)
English: If the blister is damaged, discard the tablet.
Danish: Hvis blisterlommen er beskadiget, skal resoribletten kasseres.
English: This medicine can be a target for people who abuse prescription medicines, and should be kept in a safe place to protect it from theft.
Danish: Dette lægemiddel kan være et mål for personer, som misbruger receptpligtige lægemidler, og det skal derfor opbevares et sikkert sted for at beskytte det mod tyveri.
English: sedative Hı receptor antagonists (used to treat allergic reactions) such as diphenhydramine and chlorphenamine.
Danish: - sederende H1-receptorantagonister (som bruges til behandling af allergiske reaktioner) for eksempel diphenhydramin og chlorphenamin.
English: To minimize the risk of misuse, abuse and diversion, physicians should take appropriate precautions when prescribing and dispensing buprenorphine, such as to avoid prescribing multiple refills early in treatment, and to conduct patient follow-up visits with clinical monitoring that is appropriate to the patient's needs.
Danish: For at minimere risikoen for forkert brug, misbrug og diversion skal lægen tage passende forholdsregler i forbindelse med ordinering og udlevering af buprenorphin, for eksempel ved at undlade at ordinere flere pakninger tidligt i behandlingsforløbet og ved at foretage klinisk monitorering i henhold til patientens behov i forbindelse med kontrolbesøgene.
English: 28 tablets in blister packs Paper/Aluminium/Nylon/Aluminium/PVC.
Danish: 28 resoribletter i blisterpakninger af papir/aluminium/nylon/aluminium/PVC.
English: Some risks of misuse and abuse include overdose, spread of blood borne viral or localised and systemic infections, respiratory depression and hepatic injury.
Danish: Nogle af farerne ved forkert brug og misbrug er overdosis, spredning af blodbårne virusinfektioner eller lokaliserede og systemiske infektioner, respirationsdepression og leverskader.
English: Suboxone may cause drowsiness.
Danish: Suboxone kan forårsage døsighed.
English: The availability of doses of 2 mg/0.5 mg and 8 mg/2 mg allows for a downward titration of dosage.
Danish: Tilgængeligheden af resoribletter med 2 mg/0,5 mg og 8 mg/2 mg giver mulighed for en nedjustering af doseringen.
English: Starting treatment
Danish: Start af behandlingen
English: Also tell your doctor immediately if you experience side effects such as:
Danish: Du skal også straks informere din læge, hvis du har bivirkninger såsom:
English: During the days after you start treatment, your doctor may increase the dose of Suboxone you take according to your needs.
Danish: I dagene efter du begynder behandlingen, kan din læge øge din dosis af Suboxone i henhold til dine behov.
English: Efficacy and safety data for buprenorphine/naloxone are primarily derived from a one-year clinical trial, comprising a 4-week randomised double blind comparison of buprenorphine/naloxone, buprenorphine and placebo followed by a 48 week safety study of buprenorphine/naloxone.
Danish: Dokumentation for virkning og sikkerhed af buprenorphin/naloxon stammer primært fra et et-årigt klinisk studie, der omfattede en 4-ugers randomiseret dobbeltblind sammenligning af buprenorphin/naloxon, buprenorphin og placebo, efterfulgt af et 48-ugers sikkerhedsstudie af buprenorphin/naloxon.
English: Withdrawal symptoms may also be associated with sub-optimal dosing.
Danish: Abstinenssymptomer kan også være relateret til suboptimal dosering.
English: The effect of hepatic impairment on the pharmacokinetics of buprenorphine and naloxone were evaluated in a post-marketing study.
Danish: Indvirkningen af nedsat leverfunktion på farmakokinetikken af buprenorphin og naloxon er blevet evalueret i et studie efter markedsføringen.
English: Plasma levels of buprenorphine increased with the sublingual dose of buprenorphine/naloxone.
Danish: Plasmabuprenorphinniveauet steg med den sublinguale dosis buprenorphin/naloxon.
English: o Furthermore, adequate analgesia may be difficult to achieve when administering a full opioid agonist in patients receiving buprenorphine/naloxone.
Danish: o Endvidere kan det være vanskeligt at opnå tilstrækkelig analgesi, når en fuld opioidagonist indgives hos patienter i behandling med buprenorphin/naloxon.
English: • Benzodiazepines (used to treat anxiety or sleep disorders) such as diazepam, temazepam, alprazolam.
Danish: • Benzodiazepiner (til behandling af angsttilstande eller søvnforstyrrelser) som diazepam, temazepam, alprazolam.
English: Buprenorphine is an opioid partial agonist/antagonist which binds to the  and  (kappa) opioid receptors of the brain.
Danish: Buprenorphin er en partiel opioidagonist/antagonist, som binder sig til  og  (kappa) opioidreceptorerne i hjernen.
English: The reduced level of alertness can make driving and using machines hazardous.
Danish: Den nedsatte årvågenhed kan gøre det farligt at føre motorkøretøj eller betjene maskiner.
English: The medicinal product is metabolized in the liver, primarily by glucuronide conjugation, and excreted in the urine.
Danish: Lægemidlet metaboliseres i leveren, primært ved glukuronidkonjugering, og udskilles i urinen.
English: In this trial, 326 heroin-addicted subjects were randomly assigned to either buprenorphine/naloxone 16 mg per day, 16 mg buprenorphine per day or placebo.
Danish: I dette studie blev 326 heroinafhængige forsøgspersoner randomiseret til enten 16 mg buprenorphin/naloxon dagligt, 16 mg buprenorphin dagligt eller placebo.
English: Combining buprenorphine with naloxone in Suboxone is intended to deter misuse and abuse of the buprenorphine.
Danish: Kombinationen af buprenorphin og naloxon i Suboxone har til hensigt at modvirke forkert brug og misbrug af buprenorphin.
English: Studies in animals, as well as clinical experience, have demonstrated that buprenorphine may produce dependence, but at a lower level than a full agonist e.g. morphine.
Danish: Undersøgelser på dyr og klinisk erfaring har påvist, at buprenorphin kan forårsage afhængighed, men i mindre grad end en ren agonist som morphin.
English: These types of medicines will reduce your alertness levels making it difficult for you to drive and use machines.
Danish: Disse typer lægemidler vil nedsætte din årvågenhed og gøre det svært for dig at føre motorkøretøj eller betjene maskiner.
English: Treatment must be under the supervision of a physician experienced in the management of opiate dependence/addiction.
Danish: Behandling skal ske under overvågning af en læge, der har erfaring med behandling af opioidafhængighed/misbrug.
English: Intravenous or intranasal misuse of Suboxone is expected to be less likely than buprenorphine alone since the naloxone in Suboxone can precipitate withdrawal in individuals dependent on heroin, methadone, or other opioid agonists.
Danish: Intravenøst eller intranasalt misbrug af Suboxone forventes at være mindre sandsynligt end af buprenorphin alene, idet naloxonen i Suboxone kan udløse abstinenssymptomer hos personer, der er afhængige af heroin, methadon eller andre opioidagonister.
English: • Breathing problems
Danish: • Vejrtrækningsproblemer
English: East Yorkshire HU8 7DS, United Kingdom.
Danish: East Yorkshire HU8 7DS, Storbritannien.
English: Patients should be warned that it is extremely dangerous to self-administer non-prescribed benzodiazepines while taking this product, and should also be cautioned to use benzodiazepines concurrently with this product only as directed by their physician (see section 4.4).
Danish: Patienterne skal advares om, at det er meget farligt egenhændigt at administrere benzodiazepiner, som ikke er ordineret af en læge, under behandlingen med dette lægemiddel, og de skal endvidere informeres om, at samtidig anvendelse af benzodiazepiner skal ske i henhold til lægens anvisninger (se pkt.
English: • if you have serious breathing problems
Danish: • hvis du har alvorlige vejrtrækningsproblemer
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 kortåndethed)).
English: A carcinogenicity study with buprenorphine/naloxone was conducted in rats at doses of 7, 30 and 120 mg/kg/day, with estimated exposure multiples of 3 to 75 times, based on a human daily sublingual dose of 16 mg 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 human daglig sublingual dosis på 16 mg beregnet ud fra mg/m2.
English: o CYP3A4 inhibitors: an interaction study of buprenorphine with ketoconazole (a potent inhibitor of CYP3A4) resulted in increased Cmax and AUC (area under the curve) of buprenorphine (approximately 50 % and 70 % respectively) and, to a lesser extent, of norbuprenorphine.
Danish: o CYP3A4-hæmmere: En interaktionsundersøgelse med buprenorphin og ketoconazol (en potent CYP3A4-hæmmer) resulterede i øget Cmax og AUC (areal under kurven) af buprenorphin (henholdsvist cirka 50 % og 70 %) og i mindre grad af norbuprenorphin.
English: This product may cause drowsiness, dizziness, or impaired thinking, especially during treatment induction and dose adjustment.
Danish: Dette lægemiddel kan fremkalde sløvhed, svimmelhed eller nedsat tankevirksomhed, særligt i forbindelse med indledende behandling og dosisjustering.
English: • if you are intoxicated due to alcohol or have trembling, sweating, anxiety, confusion, or hallucinations caused by alcohol.
Danish: • hvis du er beruset af alkohol eller oplever rysten, svedeture, angst, forvirring eller hallucinationer forårsaget af alkohol.
English: Symptoms of overdose may include feeling sleepy and uncoordinated with slowed reflexes, blurred vision, and/or slurred speech.
Danish: Symptomerne på en overdosis kan være en fornemmelse af søvnighed og manglende koordinationsevne med langsomme reflekser, sløret syn og/eller sløret tale.
English: Injury, poisoning and procedural complications
Danish: Traumer, forgiftninger og behandlingskom plikationer
English: Buprenorphine/naloxone may cause severe, possibly fatal, respiratory depression in children and nondependent persons in case of accidental or deliberate ingestion.
Danish: Buprenorphin/naloxon kan forårsage alvorlig, eventuelt dødelig, respirationsdepression hos børn og ikke-afhængige personer i tilfælde af utilsigtet eller forsætlig indtagelse.
English: After a satisfactory stabilisation has been achieved the frequency of dosing may be decreased to dosing every other day at twice the individually titrated daily dose.
Danish: Når der er opnået en tilfredsstillende stabilisering, kan doseringshyppigheden nedsættes til en dobbelt dosis hver anden dag af den individuelt titrerede daglige dosis.
English: During the initiation of treatment, daily supervision of dosing is recommended to ensure proper sublingual placement of the dose and to observe patient response to treatment as a guide to effective dose titration according to clinical effect.
Danish: I den indledende behandlingsperiode anbefales daglig overvågning af doseringen for at sikre korrekt sublingual placering af resoribletterne og for at overvåge, hvordan patienterne reagerer på behandlingen, som guide til effektiv dosistitrering i henhold til klinisk effekt.