FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinical data confirm that CYP3A4 is responsible for the N-dealkylation of buprenorphine.
Danish: Kliniske data bekræfter, at CYP3A4 er ansvarlig for N-dealkylering af buprenorphin.
English: If the blister is damaged, discard the tablet.
Danish: Hvis blisterpakken er beskadiget, skal resoribletten smides ud
English: Depending on your condition, the dose of Zubsolv may continue to be reduced under careful medical supervision, until eventually it may be stopped.
Danish: Alt afhængigt af din tilstand vil din dosis af Zubsolv enten fortsætte eller blive reduceret under nøje medicinsk overvågning for eventuelt helt at ophøre til sidst.
English: When administered orally or sublingually in usual doses to patients experiencing opioid withdrawal, naloxone exhibits little or no pharmacological effect because of its almost complete first pass metabolism.
Danish: Når stoffet administreres oralt eller sublingualt i sædvanlige doser til patienter, der lider af opioidabstinenser, har naloxon ringe eller ingen farmakologisk virkning, på grund af stoffets næsten fuldstændige first pass metabolisme.
English: Talk to your doctor before taking Zubsolv if you:
Danish: Kontakt lægen før du tager Zubsolv, hvis du:
English: Following intravenous administration, naloxone is rapidly distributed (distribution half-life ~ 4 minutes).
Danish: Efter intravenøs administration distribueres naloxon hurtigt (distributionshalveringstid ca. 4 minutter).
English: The dose of buprenorphine or the CYP3A4 inducer may need to be adjusted accordingly
Danish: Dosis af buprenorphin eller det CYP3A4-inducerende stof skal muligvis justeres i overensstemmelse hermed
English: • drop in blood pressure on changing position from sitting or lying down to standing
Danish: • blodtryksfald efter at have skiftet stilling fra at være siddende eller liggende til at stå op
English: • have low blood pressure, enlarged prostate gland or difficulties passing water because of narrowing of the urethra
Danish: • har lavt blodtryk, forstørret prostata eller svært ved at lade vandet på grund af forsnævring af urinrøret
English: • Full opioid agonist: adequate analgesia may be difficult to achieve when administering a full opioid agonist in patients receiving buprenorphine/naloxone.
Danish: • fuld opioidagonist: Det kan være vanskeligt at opnå tilstrækkelig smertelindring, når en fuld opioidagonist administreres til patienter i behandling med buprenorphin/naloxon.
English: These include local reactions, sometimes septic (abscess, cellulitis), potentially serious acute hepatitis, and other acute infections such as pneumonia, endocarditis (see section 4.4).
Danish: Disse omfatter lokale reaktioner, til tider septiske (abscesser, cellulitis), og potentielt alvorlig akut hepatitis og andre akutte infektioner som f.eks. pneumoni, endocarditis (se pkt.
English: • Dependence
Danish: • Afhængighed
English: In cases of intravenous drug misuse, some adverse reactions are attributed to the act of misuse rather than the medicinal product.
Danish: I tilfælde af intravenøst stofmisbrug er der rapporteret om visse uønskede hændelser, som snarere skyldes misbruget end lægemidlet.
English: Store the blister safely.
Danish: Opbevar blisterpakningen sikkert.
English: • low blood pressure
Danish: • lavt blodtryk
English: • constipation, nausea
Danish: • forstoppelse, kvalme
English: • Breathing problems (see also ‘Do not take Zubsolv' above ) 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: • Vejrtrækningsproblemer (se også "Tag ikke Zubsolv" ovenfor) Enkelte personer er døde af respirationssvigt (manglende evne til at trække vejret), fordi de misbrugte dette lægemiddel eller tog det sammen med andre midler som hæmmer centralnervesystemet, såsom alkohol, benzodiazepiner (beroligende midler) eller andre opioider.
English: Pharmacotherapeutic group: Other nervous system drugs, drugs used in addictive disorders, ATC code: N07BC51.
Danish: Farmakoterapeutisk klassifikation: Andre midler mod lidelser i nervesystemet, midler mod afhængighedslidelser, ATC-kode: N07BC51.
English: Sub-optimal treatment with buprenorphine/naloxone may prompt medicine misuse by the patient, leading to overdose or treatment dropout.
Danish: Suboptimal behandling med buprenorphin/naloxon kan forårsage stofmisbrug hos patienten, hvilket kan føre til overdosering eller behandlingsophør.
English: - are intoxicated due to alcohol or have trembling, sweating, anxiety, confusion, or hallucinations caused by alcohol - are taking naltrexone or nalmefene for the treatment of alcohol or opioid dependence
Danish: - er beruset af alkohol eller oplever rysten, svedeture, angst, forvirring eller hallucinationer forårsaget af alkohol - tager naltrexon eller nalmefen til behandling af alkohol- eller opioidafhængighed
English: Angina Pectoris Bradycardia Myocardial infarction Palpitations Tachycardia
Danish: Angina pectoris Bradykardi Myokardieinfarkt Palpitationer Takykardi
English: Liver damage has been reported after taking buprenorphine/naloxone, especially when the medicine is misused.
Danish: Der er blevet rapporteret leverskade efter indtagelse af buprenorphin/naloxon, især når lægemidlet misbruges.
English: The availability of six different tablet strengths supports individual dose titration and tapering.
Danish: Tilgængeligheden af seks forskellige resoribletstyrker giver mulighed for individuel dosistitrering og nedtrapning.
English: If you stop taking Zubsolv
Danish: Hvis du holder op med at tage Zubsolv
English: These types of medicines will reduce your alertness levels making it dangerous 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: A doctor's assessment of your readiness for treatment will guide the timing of your first Zubsolv dose.
Danish: En læge skal bedømme, hvorvidt du er parat til behandling og vil angive tidspunktet for din første dosis Zubsolv.
English: - are allergic to buprenorphine, naloxone or any of the other ingredients of this medicine (listed in section 6)
Danish: - er allergisk over for buprenorphin, naloxon eller et af de øvrige indholdsstoffer i Zubsolv (angivet i punkt 6)
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 opioidagonistiske og/eller antagonistiske stoffer.
English: Some reports of seizure, vomiting, diarrhoea, and elevated liver function tests were considered serious.
Danish: Enkelte rapporter om krampeanfald, opkastning, diarré og forhøjede levertal blev anset for at være alvorlige.
English: The reduced level of alertness can make driving and using machines hazardous
Danish: Den nedsatte årvågenhed kan gøre det farligt at føre motorkøretøj og betjene maskiner
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 med erfaring i behandlingen af opioidafhængighed.
English: Based on retention in treatment and the percentage of thrice-weekly urine samples negative for non-study opioids, buprenorphine was more effective than the low dose of the control, in keeping heroin addicts in treatment and in reducing their use of opioids while in treatment.
Danish: Baseret på behandlingsretention og andelen af urinprøver, som blev afgivet tre gange om ugen, der var negative for ikke-forsøgsrelaterede opioider, var buprenorphin mere effektivt end den lave dosis af kontrollen med hensyn til at holde heroinmisbrugere i behandlingen og nedsætte deres misbrug af opioider, mens de var i behandling.
English: Zubsolv should not be taken together with:
Danish: Zubsolv bør ikke indtages sammen med:
English: Zubsolv disintegrates usually within 40 seconds, however it may take 5 to 10 minutes for the patient to feel complete tablet disappearance from the mouth.
Danish: Zubsolv opløses normalt inden for 40 sekunder, men det kan vare 5 til 10 minutter, før patienten føler, at resoribletten er helt forsvundet fra munden.
English: Abnormal dreams Agitation Apathy
Danish: Unormale drømme Agitation
English: Combining buprenorphine with naloxone in Zubsolv is intended to deter misuse and abuse of the buprenorphine.
Danish: Kombinationen af buprenorphin og naloxon i Zubsolv har til hensigt at modvirke forkert brug og misbrug af buprenorphin.
English: Zubsolv can also cause withdrawal symptoms if you stop taking it abruptly.
Danish: Zubsolv kan også give abstinenssymptomer, hvis du pludseligt stopper med at tage det.
English: Buprenorphine is eliminated in the faeces by biliary excretion of the glucuroconjugated metabolites (70 %), the rest being eliminated in the urine.
Danish: Buprenorphin elimineres i fæces ved biliær udskillelse af de glukuronidkonjugerede metabolitter (70 %), resten elimineres i urinen.
English: The combination (4:1) of buprenorphine hydrochloride and naloxone hydrochloride was not mutagenic in a bacterial mutation assay (Ames test), and was not clastogenic in an in vitro cytogenetic assay in human lymphocytes or in an intravenous micronucleus test in the rat.
Danish: Kombinationen af buprenorphinhydrochlorid og naloxonhydrochlorid (4:1) var ikke mutagen i et bakterielt mutationsstudie (Ames test) og var ikke klastogen i et in vitro cytogenetisk studie af humane lymfocytter eller i en intravenøs mikronukleustest på rotter.
English: Patients should be monitored during dose titration.
Danish: Patienterne bør overvåges under dosistitrering.
English: Depending upon the findings, the medicinal product may be discontinued cautiously so as to prevent withdrawal symptoms and to prevent a return to illicit drug use.
Danish: Afhængigt af resultaterne kan lægemidlet langsomt seponeres for at forebygge abstinenssymptomer og for at modvirke, at patienten vender tilbage til illegalt stofmisbrug.
English: • are elderly
Danish: • er ældre
English: Zubsolv must not be taken together with:
Danish: Zubsolv må ikke indtages sammen med:
English: Alcohol may increase drowsiness and may increase the risk of respiratory failure if taken with Zubsolv.
Danish: Alkohol kan forstærke døsighed og risikoen for respirationssvigt, hvis det indtages sammen med Zubsolv.
English: A peri-postnatal study has not been conducted with buprenorphine/naloxone; however, maternal oral administration of buprenorphine at high doses during gestation and lactation resulted in difficult parturition (possible as a result of the sedative effect of buprenorphine), high neonatal mortality and a slight delay in the development of some neurological functions (surface righting reflex and startle response) in neonatal rats.
Danish: Der er ikke gennemført noget peri-postnatalt studie med buprenorphin/naloxon, men maternel oral administration af høje doser buprenorphin under drægtighed og diegivning resulterede i svær fødsel (muligvis på grund af buprenorphins sedative virkning), høj neonatal dødelighed og en mindre forsinkelse i udviklingen af visse neurologiske funktioner (opretterefleks (“surface rightingreflex”) og overreaktion på forskrækkelse (“startle response”) hos nyfødte rotter.
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 lægerne træffe relevante 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: Patients should be closely monitored during the switching period from buprenorphine or methadone to buprenorphine/naloxone since withdrawal symptoms have been reported.
Danish: Patienterne skal overvåges nøje i overgangsperioden fra buprenorphin eller metadon til buprenorphin/naloxon, da der er blevet rapporteret abstinenssymptomer.
English: Buprenorphine/naloxone may cause severe, possibly fatal, respiratory depression in children and non-dependent persons in case of accidental or deliberate ingestion.
Danish: Buprenorphin/naloxon kan forårsage alvorlig, eventuel dødelig, respirationsdepression hos børn og ikke-afhængige personer i tilfælde af utilsigtet eller forsætlig indtagelse.
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 dobbeltblindet sammenligning af buprenorphin/naloxon, buprenorphin og placebo, efterfulgt af et 48-ugers sikkerhedsstudie af buprenorphin/naloxon.
English: There are small deviations in buprenorphine dose proportionality exposure parameters as well as deviations from strict compositional proportionality for the three lower strengths (2.9/0.71, 1.4/0.36, and 0.7/0.18 mg) compared to the three higher dose presentations.
Danish: Der er små afvigelser i proportionalitetseksponeringsparametre for buprenorphindosis samt afvigelser fra stringent kompositionel proportionalitet for de tre lavere styrker (2,9/0,71, 1,4/0,36 og 0,7/0,18 mg) sammenlignet med de tre højere dosispræsentationer.
English: Use of an opioid antagonist (i.e., naloxone) is recommended, despite the modest effect it may have in reversing the respiratory symptoms of buprenorphine compared with its effects on full agonist opioid agents.
Danish: Det anbefales at bruge en opioidantagonist (dvs. naloxon) på trods af den beskedne virkning, det kan have på at modvirke respirationssymptomerne af buprenorphin i forhold til stoffets virkning på rene opioidagonister.
English: Buprenorphine and its metabolites are excreted in human milk.
Danish: Buprenorphin og dets metabolitter udskilles i human mælk.
English: Signs of overdose may also include somnolence, amblyopia, miosis, hypotension, nausea, vomiting and/or speech disorders.
Danish: Tegn på overdosis kan også inkludere døsighed, amblyopi, miosis, hypotension, kvalme, opkastning og/eller taleforstyrrelser.
English: It is recommended that patients receiving buprenorphine/naloxone should be closely monitored if inducers (e.g. phenobarbital, carbamazepine, phenytoin, rifampicin) are co-administered.
Danish: Det anbefales, at patienter, der får buprenorphin/naloxon, overvåges nøje, hvis inducerende stoffer (f.eks. phenobarbital, carbamazepin, phenytoin, rifampicin) administreres samtidig.
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 observere patientens reaktion på behandlingen, som guide til effektiv dosistitrering i henhold til klinisk effekt.
English: Use of multiples of the three lower dose presentations of Zubsolv to substitute for any of the three higher dose presentations (in for example cases where the higher dose presentations are temporarily not available) is not recommended (see section 5.2).
Danish: Flere gange af de tre laveste præsentationer af Zubsolv kan ikke anbefales i stedet for nogen af de tre højere dosispræsentationer af (f.eks. i tilfælde hvor de højere dosispræsentationer midlertidigt ikke er tilgængelige) (se pkt.
English: Withdrawal symptoms may also be associated with sub-optimal dosing.
Danish: Abstinenssymptomerne kan også være relateret til suboptimal dosering.
English: The tablet contains buprenorphine which is responsible for the treatment of opioid (narcotic) dependence.
Danish: Resoribletten indeholder buprenorphin, som har til opgave at behandle afhængigheden af opioider (narkotika).
English: Deaths have also been reported in association with concomitant administration of buprenorphine and other depressants such as alcohol or other opioids.
Danish: Der er også modtaget indberetning om dødsfald i forbindelse med samtidig administration af buprenorphin og andre beroligende midler, såsom alkohol eller andre opioider.
English: • some antifungal agents (used to treat fungal infections) such as ketoconazole, itraconazole and certain antibiotics, may extend the effects of this medicine
Danish: • visse svampelægemidler (som bruges til behandling af svampeinfektioner), såsom ketoconazol, itraconazol og visse antibiotika, kan forlænge virkningen af dette lægemiddel
English: During your treatment, the doctor may adjust the dose, depending upon your response.
Danish: Under din behandling kan lægen justere din dosis, alt afhængigt af, hvordan du reagerer på lægemidlet.
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 enten16 mg buprenorphin/naloxon dagligt, 16 mg buprenorphin dagligt eller placebo.
English: Warnings and precautions • Misuse, abuse and diversion
Danish: Advarsler og forsigtighedsregler • Forkert brug, misbrug og uhensigtsmæssig brug
English: The intention of the naloxone component is to deter intravenous misuse.
Danish: Formålet med naloxon-bestanddelen er at modvirke intravenøst misbrug.
English: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥/10,000
Danish: Hyppigheden af bivirkninger i oversigten herunder 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), sjælden (≥/10.000 til <1/1.000), meget sjælden (<1/10.000), Ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
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 behandling med dette lægemiddel, og de skal endvidere informeres om, at samtidig anvendelse af benzodiazepiner skal se i henhold til lægens anvisninger (se pkt.
English: A patient who is under-dosed with buprenorphine/naloxone may continue responding to uncontrolled withdrawal symptoms by self-medicating with opioids, alcohol or other sedative-hypnotics such as benzodiazepines.
Danish: En patient, der er underdoseret med buprenorphin/naloxon, kan fortsætte med at reagere på ukontrollerede abstinenssymptomer ved selvmedicinering med opioider, alkohol eller andre sedativa-hypnotika såsom benzodiazepiner.
English: • eye inflammation or infection, small pupil size
Danish: • inflammation eller infektion i øjnene, små pupiller
English: Baseline liver function tests and documentation of viral hepatitis status are recommended prior to commencing therapy.
Danish: Baseline leverfunktionstests og dokumentation for viral hepatitis status anbefales før påbegyndelse af behandling.
English: How to remove the tablet from the blister
Danish: Sådan tager du resoribletten ud af blisterpakken
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 17.2 mg buprenorphine, based on AUC) (see section 5.3).
Danish: Dyrestudier har påvist nedsat fertilitet hos hunner ved høje doser (systemisk eksponering > 2,4 gange den humane eksponering ved den maksimale anbefalede dosis på 17,2 mg buprenorphin, baseret på AUC) (se pkt.
English: The safety and efficacy of buprenorphine/naloxone in elderly patients over 65 years of age have not been established.
Danish: Der er ingen erfaringer med sikkerheden og virkningen af buprenorphin/naloxon hos ældre patienter over 65 år.
English: • naltrexone and nalmefene are opioid antagonists that can block the pharmacological effects of buprenorphine.
Danish: • naltrexon og nalmefen er opioidantagonister, der kan blokere de farmakologiske virkninger af buprenorphin.
English: It is unknown whether naloxone/metabolites are excreted in human milk.
Danish: Det vides ikke, om naloxon og dets metabolitter udskilles i human mælk.
English: Zubsolv is not interchangeable with other buprenorphine products, as different buprenorphine products have different bioavailability.
Danish: Zubsolv kan ikke udskiftes med andre buprenorphin-produkter, da forskellige buprenorphin-produkter har forskellig biotilgængelighed.
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 dobbelt dosis hver anden dag af den individuelt titrerede daglige dosis.
English: Plasma levels of buprenorphine increased with the sublingual dose of buprenorphine/naloxone.
Danish: Plasmaniveauet for buprenorphin steg med den sublinguale dosis buprenorphin/naloxon.
English: White, round tablet, 7 mm in diameter
Danish: Hvid, rund resoriblet, 7 mm i diameter
English: Very common side effects (may affect more than one in 10 people):
Danish: Meget almindelige bivirkninger (kan påvirke mere end 1 ud af 10 personer):
English: If more than one tablet is required, they may be taken all at the same time or in two divided portions; the second portion is to be taken directly after the first portion has dissolved.
Danish: Hvis der er behov for mere end én resoriblet, kan de indtages samtidigt eller fordelt på to særskilte portioner.
English: • anti-retrovirals (used to treat HIV) such as ritonavir, nelfinavir, indinavir may increase the effects of this medicine
Danish: • antiretrovirale midler (som bruges til behandling af HIV) såsom ritonavir, nelfinavir, indinavir kan forlænge virkningen af dette lægemiddel
English: • severe tiredness, itching with yellowing of skin or eyes.
Danish: • ekstrem træthed, kløe med gulfarvning af huden eller øjnene.
English: Depression Libido decreased Nervousness Thinking abnormal
Danish: Depression Nedsat libido Nervøsitet Unormale tanker
English: When initiating treatment with buprenorphine/naloxone, the physician must be aware of the partial agonist profile of buprenorphine and that it can precipitate withdrawal in opioid-dependent patients, particularly if administered less than 6 hours after the last use of heroin or other short-acting opioid, or if administered less than 24 hours after the last dose of methadone.
Danish: Når behandling med buprenorphin/naloxon påbegyndes, skal lægen være opmærksom på buprenorphins partielle agonistprofil, og at det kan fremkalde abstinenssymptomer hos opioidafhængige patienter, især hvis det administreres mindre end 6 timer efter sidste brug af heroin eller andre korttidsvirkende opioider, eller hvis det administreres mindre end 24 timer efter den sidste dosis metadon.
English: • Other medicines that may make you feel sleepy which are used to treat illnesses such as anxiety, sleeplessness, convulsions/seizures, pain and other mental disorders.
Danish: • Anden medicin, som kan gøre dig søvnig, som bruges til behandling af lidelser såsom angst, søvnløshed, kramper/krampeanfald, smerter og andre psykiske lidelser.