FrancophonIA/ELRC3.0 huggingface dataset:
English: Renal elimination may be prolonged since 30 % of the administered dose is eliminated by the renal route.
Danish: Den renale elimination kan være forlænget, idet 30 % af den administrerede dosis elimineres renalt.
English: The 0.7mg / 0.18mg strength is intended to be used to fine tune the dose for patients especially during tapering of treatment or in case of tolerability issues during titration.
Danish: 0,7 mg/0,18 mg styrken er beregnet til at blive brugt til at finindstille dosis for patienter, navnlig under nedtrapning af behandlingen, eller i tilfælde af tolerabilitetsproblemer under titrering.
English: Some medicines may increase the side effects of Zubsolv and may sometimes cause very serious reactions.
Danish: Nogle lægemidler kan øge bivirkningerne af Zubsolv og kan i visse tilfælde forårsage alvorlige reaktioner.
English: • deterioration of brain function that is a serious complication of liver disease
Danish: • nedsat hjernefunktion, som er en alvorlig komplikation af leversygdom
English: Tell your doctor as soon as possible if you miss a dose.
Danish: Fortæl hurtigst muligt din læge, hvis du glemmer at tage en dosis.
English: A patent airway and assisted or controlled ventilation must be assured.
Danish: Frie luftveje og assisteret eller kontrolleret vejrtrækning skal sikres.
English: Your doctor will prescribe the correct dose for you.
Danish: Din læge vil ordinere den korrekte dosis til dig.
English: Do not give this medicine to anyone else.
Danish: Giv ikke dette lægemiddel til andre.
English: Regular blood tests may be conducted by your doctor to monitor the condition of your liver.
Danish: Din læge kan tage regelmæssige blodprøver for at overvåge din levers tilstand.
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 er beregnet til brug til voksne og unge over 15 år, som har indvilliget i at blive behandlet for afhængighed.
English: Furthermore, the use of buprenorphine/naloxone during pregnancy should be assessed by the physician.
Danish: Desuden bør brugen af buprenorphin/naloxon under graviditet vurderes af lægen.
English: Do not forget to advise your doctor if you take this medicine.
Danish: Husk at fortælle din læge det, hvis du tager dette lægemiddel.
English: Fold the packet along the dotted line.
Danish: Fold pakken langs den stiplede linje.
English: • For patients receiving methadone, the dose of methadone should be reduced to a maximum of
Danish: • Hos patienter i metadonbehandling, skal metadondosen reduceres til maksimalt 30
English: Patients must be warned to store the blister safely, to never open the blister in advance, to keep them out of the sight and reach of children and other household members, and not to take this medicine in front of children.
Danish: Patienterne skal informeres om at opbevare blisterpakningen sikkert, aldrig at åbne blister på forhånd, at opbevare dem utilgængelige for børn og andre medlemmer af husstanden, og ikke at tage medicinen foran børn.
English: Patients requiring a titrated daily dose > 5.7 mg buprenorphine /day may not find this regimen adequate.
Danish: Patienter, der kræver en titreret daglig dosis på > 5,7 mg buprenorphin/dag, vil muligvis ikke finde denne dosering tilstrækkelig.
English: Naloxone has a mean half-life from plasma of 1.2 hours.
Danish: Naloxon har en gennemsnitlig plasmahalveringstid på 1,2 timer.
English: Your doctor may increase the dose of Zubsolv you take according to your needs.
Danish: Din læge vil eventuelt øge den dosis Zubsolv, du tager, alt afhængigt af dine behov.
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 samt klinisk erfaring har påvist, at buprenorphin kan forårsage afhængighed, men i mindre grad end en ren agonist som f.eks. morfin.
English: Statistically significant increases in the incidence of benign testicular interstitial (Leydig's) cell adenomas were observed in all dosage groups.
Danish: Der blev observeret en statistisk signifikant stigning i forekomsten af benigne testikulære interstitielle (Leydigs) celleadenomer i alle doseringsgrupper.
English: Therefore the dose in mg can differ between products.
Danish: Derfor kan dosis i mg variere mellem produkterne.
English: Do not change the treatment in any way or stop treatment without the agreement of the doctor who is treating you.
Danish: Du må på ingen måde ændre eller stoppe behandlingen uden at have aftalt det med lægen, som behandler dig.
English: Zubsolv sublingual tablets are available in six different strengths, differentiated by shape and debossing:
Danish: Zubsolv sublinguale resoribletter fås i seks forskellige styrker, differentieret ved form og prægning:
English: Whilst you may notice that most of the table disintegrates within 40 seconds, it may take 5 to 10 minutes for the entire table to disappear from your mouth
Danish: Selvom du måske bemærker, at det meste af resoribletten opløses inden for 40 sekunder, kan det tage 5 til 10 minutter før hele resoribletten er forsvundet fra din mund
English: This may involve taking a combination of different strengths, but your daily dose should not exceed 17.2mg of buprenorphine.
Danish: Dette kan involvere indtagelse af en kombination af forskellige styrker, men din daglige dosis bør ikke overstige 17,2 mg buprenorphin.
English: Taking the wrong dose of benzodiazepines may cause death due to respiratory failure (inability to breathe).
Danish: Hvis du tager den forkerte dosis benzodiazepiner, kan det medføre død på grund af respirationssvigt (manglende evne til at trække vejret).
English: Therefore, breastfeeding should be discontinued during treatment with Zubsolv.
Danish: Derfor skal amning ophøre under behandling med Zubsolv.
English: If you feel that the effect of Zubsolv is too strong or too weak, talk to your doctor or pharmacist.
Danish: Hvis du føler, at virkningen af Zubsolv er for kraftig eller svag, skal du tale med din læge eller apotekspersonalet.
English: Zubsolv is used in adults and adolescents over 15 years of age, who are also receiving medical, social and psychological support.
Danish: Zubsolv bruges til voksne og unge over 15 år, som får medicinsk, social og psykologisk støtte.
English: • alcoholic drinks or medicines containing alcohol, as alcohol increases the sedative effect of buprenorphine (see section 4.7)
Danish: • alkoholiske drikke eller lægemidler, der indeholder alkohol, da alkohol øger den sedative virkning af buprenorphin (se pkt.
English: Respiratory depression
Danish: Respirationsdepression
English: No recommendation on posology can be made.
Danish: Der kan ikke gives nogen anbefalinger vedrørende dosering.
English: The combination of buprenorphine and naloxone has been investigated in acute and repeated dose (up to 90 days in rats) toxicity studies in animals.
Danish: Kombinationen af buprenorphin og naloxon er blevet undersøgt i akutte og gentagne doser (op til 90 dage i rotter) i toksicitetsstudier hos dyr.
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: Opioid-indiceret miosis, ændringer i bevidsthedsniveau, eller ændringer i opfattelsen af smerter som et symptom på sygdom, kan påvirke patientevalueringen eller sløre diagnosen eller det kliniske forløb af samtidig sygdom.
English: Buprenorphine/naloxone should be used during pregnancy only if the potential benefit outweighs the potential risk to the foetus.
Danish: Buprenorphin/naloxon bør kun anvendes under graviditet, hvis den potentielle fordel opvejer den potentielle risiko for fosteret.
English: Symptomatic treatment of respiratory depression and standard intensive care measures should be implemented.
Danish: Der skal gives symptomatisk behandling af respirationsdepression, og der skal iværksættes standardprocedurer for intensiv behandling.
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 Zubsolv may cause serious and life-threatening breathing problems.
Danish: Hvis du eller nogen anden tager for meget af dette lægemiddel, skal du straks tage eller bringes til skadestuen eller hospitalet til behandling, idet en overdosis af Zubsolv kan forårsage alvorlige og livstruende vejrtrækningsproblemer.
English: Buprenorphine was titrated to maintenance dose by Day 3; active control doses were titrated more gradually.
Danish: Buprenorphin blev titreret til en vedligeholdelsesdosis på Dag 3 - dosis af den aktive kontrol blev titreret mere gradvist.
English: Never open in advance as the tablet is sensitive to moisture
Danish: Åbn aldrig på forhånd, da resoribletten er følsom over for fugt
English: However, the dose given on any one day should not exceed 17.2 mg buprenorphine.
Danish: Dog bør den dosis, der gives på en enkelt dag, ikke overskride 17,2 mg buprenorphin.
English: Physicians are encouraged to prescribe a single tablet once daily regimen where possible to minimise risk of diversion.
Danish: Læger opfordres til at ordinere en behandling med en enkelt resoriblet én gang dagligt, hvor det er muligt, for at minimere risikoen for fejlanvending.
English: It also contains naloxone which is used to deter intravenous abuse of the product.
Danish: Den indeholder ligeledes naloxon, som bruges til at hindre intravenøst misbrug af produktet.
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, der misbruger receptpligtig medicin, og det skal derfor opbevares på et sikkert sted for at hindre tyveri.
English: There are no adequate data from the use of buprenorphine/naloxone in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data fra anvendelse af buprenorphin/naloxon til gravide kvinder.
English: Misuse, abuse and diversion
Danish: Forkert brug, misbrug og diversion
English: Summary of the safety profile
Danish: Sammenfatning af lægemidlets sikkerhedsprofil
English: Both Cmax and AUC of buprenorphine increased with the increase in dose, although the increase was less than dose-proportional.
Danish: Både Cmax og AUC af buprenorphin steg i takt med dosisforhøjelsen, selvom stigningen var mindre end proportional med dosis.
English: Severe respiratory insufficiency.
Danish: Alvorlig respirationsinsufficiens.
English: Store in the original package below 25°C in order to protect from moisture.
Danish: Opbevares i den originale karton ved temperaturer under 25 °C for at beskytte mod fugt.
English: • Place the tablets under the tongue
Danish: • Læg resoribletterne under tungen
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 virkningen af opioider, kan der forekomme en potentiel fatal respirationsdepression.
English: Subjects were seen daily in the clinic (Monday through Friday) for dosing and efficacy assessments.
Danish: Forsøgspersonerne blev tilset dagligt på studiecentret (mandag til fredag) i forbindelse med dosering og virkningsevaluering.
English: Zubsolv can be a target for people who abuse prescription medicine.
Danish: Zubsolv kan være et mål for personer, der misbruger receptpligtig medicin.
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 buprenorphinagonist, eller når plasma-buprenorphin er faldende
English: These may be symptoms of liver damage
Danish: Dette kan være symptomer på leverskade
English: No developmental toxicity was observed in rabbits at maternally toxic doses.
Danish: Der blev ikke observeret udviklingstoksicitet hos kaniner ved maternelt toksiske doser.
English: • Benzodiazepines (used to treat anxiety or sleep disorders) such as diazepam, temazepam, alprazolam.
Danish: • Benzodiazepiner (som benyttes til behandling af angsttilstande eller søvnforstyrrelser) såsom diazepam, temazepam, alprazolam.
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: 7 sublingual tablets 28 sublingual tablets 30 sublingual tablets
Danish: 7 sublinguale resoribletter 28 sublinguale resoribletter 30 sublinguale resoribletter
English: The risks of using Zubsolv in pregnant women are not known.
Danish: Risikoen ved, at gravide kvinder tager Zubsolv kendes ikke.
English: Naloxone exposure was not higher from Zubsolv at any of the tested dose levels.
Danish: Eksponering af naloxon var ikke højere for Zubsolv på nogen af de testede dosisniveauer.
English: • have poor adrenal gland function (e.g. Addison's disease)
Danish: • har dårlig binyrefunktion (f.eks. Addisons sygdom)
English: Remove just one section from the blister pack, tearing it along the perforated line.
Danish: Fjern kun én blisterlomme frablisterkortet ved at trække langs den perforerede linje.
English: These include medicines used to treat epilepsy (such as carbamazepine and phenytoin), and medicines used to treat tuberculosis (rifampicin)
Danish: Disse omfatter medicin til behandling af epilepsi (såsom carbamazepin og phenytoin) samt medicin til behandling af tuberkulose (rifampicin)
English: • menstrual or vaginal problems, abnormal ejaculation
Danish: • menstruationsmæssige eller vaginale problemer, unormal ejakulation
English: Table 1 summarises adverse reactions reported from pivotal clinical trials in which, 342 of 472 patients (72.5 %) reported adverse reactions and adverse reactions reported during post-marketing surveillance.
Danish: Tabel 1 viser en samlet oversigt over de bivirkninger, der blev indberettet fra de centrale kliniske studier, hvor 342 ud af 472 patienter (72,5 %) rapporterede bivirkninger, og de bivirkninger, der er indberettet i forbindelse med overvågningen efter markedsføring.
English: Injury, poisoning and procedural complications
Danish: Traumer, forgiftninger og behandlingskomplikati oner
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 eller sluge resoribletterne, da lægemidlet ikke vil virke, og du kan udvikle abstinenser
English: Zubsolv is used to treat dependence on opioid (narcotic) drugs such as heroin or morphine in drug addicts who have agreed to be treated for their addiction.
Danish: Zubsolv bruges til at behandle afhængighed af opioider (narkotika), såsom heroin eller morfin hos stofmisbrugere, som har indvilliget i at blive behandlet for deres afhængighed.
English: Serious cases of infections with potential fatal outcome may occur if Zubsolv is misused, by taking it intravenously.
Danish: Alvorlige tilfælde af infektioner med potentiel dødelig udgang kan forekomme, hvis Zubsolv misbruges ved intravenøs indtagelse.
English: What you need to know before you take Zubsolv 3.
Danish: Det skal du vide, før du begynder at tage Zubsolv 3.
English: Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: If infusion is not possible, repeated dosing with naloxone may be required.
Danish: Hvis infusion ikke er mulig, kan gentagen dosering af naloxon være nødvendig.
English: This product can cause withdrawal symptoms if you take it less than six hours after you use a short-acting opioid (e.g. morphine, heroin) or less than 24 hours after you use a long-acting opioid such as methadone.
Danish: Dette produkt kan give abstinenser, hvis du tager det mindre end seks timer efter, at du bruger en korttidsvirkende opioid (f.eks. morfin eller heroin), eller mindre end 24 timer efter, at du bruger en langtidsvirkende opioid såsom metadon.
English: Patients should be cautioned about driving or operating hazardous machinery in case buprenorphine/naloxone may affect their ability to engage in such activities.
Danish: Patienterne skal advares mod at føre motorkøretøj eller betjene farlige maskiner, hvis der er fare for, at buprenorphin/naloxon kan påvirke deres evne til at udføre sådanne aktiviteter.
English: Ongoing intravenous infusion rates should be titrated to patient response.
Danish: Hastigheden af kontinuerlig intravenøs infusion bør titreres efter patient-respons.
English: Its activity in opioid maintenance treatment is attributed to its slowly reversible properties with the μ-opioid receptors which, over a prolonged period, might minimise the need of addicted patients for drugs.
Danish: Dets virkning i opioidvedligeholdelsesbehandling skyldes dets langsomme reversible binding til μ-opioidreceptorerne, som over en længere periode kan minimere behovet for stoffer hos afhængige patienter.
English: Towards the end of pregnancy buprenorphine may induce respiratory depression in the newborn infant even after a short period of administration.
Danish: I slutningen af graviditeten kan buprenorphin fremkalde respirationsdepression hos det nyfødte barn, selv efter en kort behandlingsperiode.
English: The product should be used with care in patients with pre-existing breathing problems
Danish: Produktet bør anvendes med forsigtighed til patienter med allerede eksisterende vejrtrækningsproblemer.
English: A reduction of the buprenorphine/naloxone dose may be needed.
Danish: En reduktion af buprenorphin/naloxon-dosis kan være nødvendig.
English: This could also be due to viral infections (chronic hepatitis C), alcohol abuse, anorexia or use of other medicines that can harm your liver.
Danish: Dette kan også skyldes virusinfektioner (kronisk hepatitis C), alkoholmisbrug, anoreksi eller brug af anden medicin, der kan skade din lever.
English: The use of this medicinal product by the oral route is therefore inappropriate.
Danish: Dette lægemiddel er derfor ikke egnet til oral administration.
English: Physicians must warn patients that the sublingual route is the only effective and safe route of administration for this medicinal product (see section 4.4).
Danish: Læger skal informere deres patienter om, at sublingual indtagelse er den eneste effektive og sikre indgivelsesmåde for dette lægemiddel (se pkt.
English: On Day 3, those randomised 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: They must not be taken at the same time as Zubsolv treatment because you may experience a sudden onset of prolonged and intense withdrawal.
Danish: De må ikke tages samtidig med Zubsolvbehandlingen, da du kan opleve pludselige, langvarige og intense abstinenser.
English: Elimination of buprenorphine is bi- or tri-exponential, and has a mean half-life from plasma of 32 hours.
Danish: Elimination af buprenorphin er bi- eller tri-eksponentiel med en gennemsnitlig plasmahalveringstid på 32 timer.
English: Patients should be monitored following medical withdrawal because of the potential for relapse.
Danish: Patienterne bør monitoreres i forbindelse med medicinsk afvænning på grund af faren for tilbagefald.
English: Conjunctivitis Miosis
Danish: Konjunktivit Miosis
English: • Starting treatment of Zubsolv whilst dependent on methadone: If you have been taking methadone or a long acting opioid, the dose of methadone should ideally be reduced to below 30 mg/day before beginning Zubsolv therapy.
Danish: • Påbegyndelse af behandling med Zubsolv mens du er afhængig af metadon: Hvis du tager metadon eller en langtidsvirkende opioid, skal metadondosen ideelt set reduceres til under 30 mg/dag, inden du påbegynder behandling med Zubsolv.
English: Influenza Infection Pharyngitis Rhinitis
Danish: Influenza Infektion Pharyngitis Rinit
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 ordineringen af buprenorphin/naloxon og under behandlingen.
English: Patients already treated with CYP3A4 inhibitors should have their dose of buprenorphine/naloxone titrated carefully since a reduced dose may be sufficient in these patients (see section 4.5).
Danish: Patienter, der allerede behandles med CYP3A4-hæmmere, bør omhyggeligt få titreret deres buprenorphin/naloxon dosis, da en mindre dosis kan være tilstrækkelig hos disse patienter (se pkt.
English: Zubsolv may cause drowsiness.
Danish: Zubsolv kan forårsage døsighed.
English: This medicine may cause severe, possibly fatal, respiratory depression (reduced ability to breathe) in children and non-opioid dependent people.
Danish: Dette lægemiddel kan forårsage alvorlig, eventuelt dødelig respiratorisk depression (nedsat evne til at trække vejret) hos børn og ikke-opioidafhængige mennesker.
English: Following treatment induction on day one, the patient should be stabilised to a maintenance dose during the next few days by progressively adjusting the dose according to the clinical effect on the individual patient.
Danish: Efter den indledende behandling på Dag 1 skal patienten stabiliseres på en vedligeholdelsesdosis over de næste par dage ved gradvist at justere dosis i henhold til den kliniske virkning hos den enkelte patient.
English: The effectiveness of buprenorphine, 8 mg per day was similar to that of the moderate active control dose, but equivalence was not demonstrated.
Danish: Virkningen af buprenorphin 8 mg dagligt svarede til virkningen af den moderate dosis aktivt kontrolmiddel, men der blev ikke påvist ækvivalens.
English: This leaflet was last revised in.
Danish: Denne indlægsseddel blev senest ændret den
English: If the patient vomits, care must be taken to prevent aspiration of the vomitus.
Danish: Hvis patienten kaster op, skal der tages forholdsregler for at forebygge aspiration.
English: Therefore, multiples of the three lower dose presentations of Zubsolv should not be used to substitute for any of the three higher dose Zubsolv presentations.
Danish: Flere gange af de tre laveste præsentationer af Zubsolv bør ikke bruges i stedet for nogen af de tre højere dosispræsentationer af Zubsolv.
English: Reproduction studies by oral administration of buprenorphine: naloxone (ratio 1:1) indicated that embryolethality occurred in rats in the presence of maternal toxicity at all doses.
Danish: Reproduktionsstudier med oral administration af buprenorphin/naloxon (i forholdet 1:1) indikerede at embryoletalitet forekom hos rotter ved tilstedeværelse af maternel toksicitet ved alle doser.
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: • fornemmelse af at være søvnig eller manglende koordinationsevne, sløret syn, sløret tale, ude af stand til at tænke klart eller din vejrtrækning bliver betydeligt langsommere, end hvad der er normalt for dig