FrancophonIA/ELRC3.0 huggingface dataset:
English: Closer monitoring of patients is recommended during the dosing period after the switch.
Danish: Nærmere monitorering af patienter anbefales i doseringsperioden efter skift af behandling.
English: Following switching, patients may need closer monitoring.
Danish: Efter behandlingsskift kan patienter kræve nøjere monitorering.
English: These may be signs of a life-threatening allergic reaction.
Danish: Dette kan være tegn på en livsfarlig allergisk reaktion.
English: Steady-state exposure is reached at the fourth monthly dose.
Danish: Steady-state eksponering opnås med den fjerde månedlige dosis.
English: Before administration Safety syringe parts:
Danish: Inden administration Sikkerhedsinjektionssprøjtens dele:
English: The dose of buprenorphine in mg can differ between sublingual products, which needs to be taken into consideration on a product-by-product basis.
Danish: Dosen af buprenorphin i mg kan være forskellig for sublinguale produkter, hvilket skal tages i betragtning for det enkelte produkt.
English: The recommended dose for the second treatment week is the total dose administered during the week of initiation.
Danish: Den anbefalede dosis for den anden behandlingsuge er den samlede dosis administreret i den første behandlingsuge.
English: Simulated buprenorphine exposure data in adolescents aged 16 years show lower Cmax and AUC compared to observed values in adults for weekly and monthly Buvidal.
Danish: Simulerede buprenorphin eksponeringsdata hos teenagere i 16-års alderen, viser lavere Cmax og AUC sammenlignet med observerede værdier hos voksne for ugentligt og månedligt Buvidal.
English: Injection sites should be rotated for both weekly and monthly injections.
Danish: Injektionssteder bør skiftes for både ugentlige og månedlige injektioner.
English: To avoid missed doses, the weekly dose may be administered up to 2 days before or after the weekly time point, and the monthly dose may be administered up to 1 week before or after the monthly time point.
Danish: For at undgå glemte doser kan den ugentlige dosis administreres op til 2 dage før eller efter det ugentlige tidspunkt, og den månedlige dosis kan administreres op til 1 uge før eller efter det månedlige tidspunkt.
English: The apparent volume of distribution for buprenorphine is approximately 1900 L. Buprenorphine is approximately 96% protein-bound, primarily to alpha and beta globulin.
Danish: Det tilsyneladende fordelingsvolumen for buprenorphin er cirka 1900 l. Buprenorphin er cirka 96 % proteinbundet, primært alfa- og beta-globulin.
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-induceret myosis, 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: A minimum of 8 weeks should be left before reinjecting a previously used injection site with the weekly dose.
Danish: Der skal gå mindst 8 uger inden en ny injektion på et tidligere anvendt injektionssted med den ugentlige dosis.
English: Total clearance of buprenorphine is approximately 68 L/h.
Danish: Fuldstændig clearance af buprenorphin er cirka 68 l/t.
English: Any attempts to remove the depot should be monitored throughout treatment.
Danish: Eventuelle forsøg på at fjerne depotlægemidlet skal monitoreres i hele behandlingsperioden.
English: - Put on gloves and clean the injection site with a circular motion using an alcohol wipe (not provided in the pack).
Danish: - Tag handsker på og rens injektionsstedet i en cirkelbevægelse med en alkoholserviet (ikke inkluderet i pakken).
English: Animal studies do not indicate reproductive toxicity (see section 5.3).
Danish: Dyreforsøg angiver ikke forplantningsgiftighed (se afsnit 5.3).
English: If you miss an appointment, ask your doctor when to schedule your next dose.
Danish: Hvis du glemmer et besøg, skal du spørge din læge, hvornår du skal aftale en tid til at få den næste dosis.
English: Chronic toxicity studies in rat and dog of the vehicle used for Buvidal revealed no special hazard for humans.
Danish: Studier af kronisk toksicitet hos rotter og hunde af vehiklen anvendt til Buvidal viste ingen særlige farer for mennesker.
English: Depending on the findings, Buvidal may be discontinued.
Danish: Afhængigt af resultaterne kan Buvidal seponeres.
English: • Administration should be made into the subcutaneous tissue
Danish: • Administration skal foretages i subkutant væv.
English: The decision to reinject at the same site should also be guided by the attending physicians´ clinical judgement.
Danish: Beslutningen om at lave en injektion på det samme sted bør også guides af den behandlende læges vurdering.
English: The effects on buprenorphine exposure in patients treated with Buvidal have not been studied.
Danish: Virkningen af eksponering for buprenorphin hos patienter, der behandles med Buvidal, er ikke blevet undersøgt.
English: Do not touch the cleaned area again before injecting.
Danish: Rør ikke det rensede område igen inden injektionen.
English: Alcohol can worsen the sedative effect of this medicine.
Danish: Alkohol kan forstærke lægemidlets sedative virkning.
English: Acute toxicity of buprenorphine was determined in mice and rats following oral and parenteral (intravenous, intraperitoneal) administration.
Danish: Akut toksicitet af buprenorphin blev bestemt hos mus og rotter efter oral og parenteral (intravenøs, intraperiotoneal) administration.
English: When initiating treatment with buprenorphine, it is important to be aware of the partial agonist profile of buprenorphine.
Danish: Når behandling med buprenorphin påbegyndes, er det vigtigt at være opmærksom på buprenorphins partielle agonist-profil.
English: Healthcare professionals should administer Buvidal directly to the patient.
Danish: Sundhedspersonale skal administrere Buvidal direkte til patienten.
English: Steadystate exposure is reached at the fourth weekly dose.
Danish: Steady-state eksponering opnås med den fjerde ugentlige dosis.
English: Monthly injection:
Danish: Månedlig injektion:
English: Elderly No pharmacokinetic data in elderly patients (> 65 years) are available.
Danish: Ældre Der er ingen farmakokinetiske data tilgængelige for ældre patienter (> 65 år).
English: A long-term, open-label, phase 3 safety study with flexible dosing of weekly and monthly Buvidal for 48 weeks was conducted.
Danish: Der blev udført et langsigtet, ikke-blindet, fase 3-sikkerhedsstudie med fleksibel dosering af ugentlig og månedlig Buvidal i 48 uger.
English: A maximum of one supplemental Buvidal 8 mg dose may be administered at an unscheduled visit between regular weekly and monthly doses, based on individual patient's temporary needs.
Danish: Højst én supplerende dosis af Buvidal 8 mg kan administreres under et ikke-planlagt besøg mellem regelmæssige ugentlige og månedlige doser baseret på den individuelle patients midlertidige behov.
English: To minimise the risk of misuse, abuse and diversion, appropriate precautions should be taken when prescribing and dispensing buprenorphine.
Danish: For at minimere risikoen for forkert brug, misbrug og diversion, skal lægerne træffe relevante forholdsregler i forbindelse med ordinering og udlevering af buprenorphin.
English: Teratology and reproduction toxicity studies in rats and rabbits by intramuscular administration concluded that buprenorphine is not embryotoxic or teratogenic and has no marked effects on weaning potential.
Danish: Teratologi og studier af reproduktionstoksicitet hos rotter og kaniner efter intramuskulær administration konkluderede, at buprenorphin ikke er embryotoksisk eller teratogen og ikke har nogen markant effekt på potentialet for fravænning.
English: Towards the end of pregnancy, buprenorphine may induce respiratory depression in the newborn infant even after a short period of administration.
Danish: Hen mod slutningen af graviditeten kan buprenorphin fremkalde respirationsdepression hos det nyfødte barn, selv efter en kort behandlingsperiode.
English: Respiratory depression, as a result of central nervous system depression, is the primary symptom requiring intervention in the case of buprenorphine overdose because it may lead to respiratory arrest and death.
Danish: Respirationsdepression som følge af depression i centralnervesystemet er det primære symptom, som kræver intervention i tilfælde af overdosering af buprenorphin, da det kan føre til respirationsstop og død.
English: Buvidal contains alcohol
Danish: Buvidal indeholder alkohol
English: Symptomatic treatment of respiratory depression, following standard intensive care measures, should be instituted.
Danish: Der skal gives symptomatisk behandling af respirationsdepression ifølge standardprocedurer for intensiv behandling.
English: If you stop using Buvidal
Danish: Hvis du holder op med at bruge Buvidal
English: Buprenorphine may cause severe, possibly fatal, respiratory depression in children and non-opioid dependent persons who accidentally or deliberately use it.
Danish: Buprenorphin kan forårsage alvorlig, eventuel dødelig, respirationsdepression hos børn og ikkeopioidafhængige personer, som bruger det utilsigtet eller forsætligt.
English: Doses may be increased or decreased and patients can be switched between weekly and monthly products according to individual patient's needs and treating physician's clinical judgement as per recommendations in Table 2.
Danish: Doser kan øges eller reduceres, og patienters behandling kan skiftes mellem ugentlige og månedlige produkter i henhold til den enkelte patients behov og den behandlende læges kliniske vurdering ifølge anbefalingerne i Tabel 2.
English: • alcoholic drinks or medicinal products 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: Patients attended 12 weekly visits during the first 12 weeks and 6 visits during the last 12 weeks (3 scheduled monthly visits and 3 random urine toxicology visits).
Danish: Patienter kom til 12 ugentlige besøg i de første 12 uger og 6 besøg i de sidste 12 uger (3 planlagte månedlige besøg og 3 randomiserede besøg til toksikologisk kontrol af urinprøver).
English: These may be symptoms of liver damage.
Danish: Dette kan være symptomer på leverskade.
English: Buvidal is not for use in children below 16 years of age.
Danish: Buvidal må ikke bruges til børn under 16 år.
English: No pharmacokinetic data in paediatrics (less than 18 years) are available.
Danish: Ingen farmakokinetiske data inden for pædiatri (under 18 år) er tilgængelige.
English: Weekly injection:
Danish: Ugentlig injektion:
English: - if you have serious breathing problems - if you have serious liver problems - if you are intoxicated with alcohol or have trembling, sweating, anxiety, confusion or hallucinations caused by alcohol
Danish: - hvis du har alvorlige vejrtrækningsproblemer - hvis du har alvorlige leverproblemer - hvis du er beruset af alkohol eller oplever rysten, svedeture, angst, forvirring eller hallucinationer forårsaget af alkohol
English: What you need to know before you receive Buvidal You must not receive Buvidal:
Danish: Det skal du vide, før du begynder at få Buvidal Du må ikke få Buvidal:
English: - if you are allergic to buprenorphine or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for buprenorphin eller et af de øvrige indholdsstoffer i Buvidal (angivet i punkt 6).
English: N 213 Median 26.7
Danish: N Gennemsnit 26,7
English: - Gently pull the needle out of the skin.
Danish: - Træk forsigtig kanylen ud af huden.
English: - Liver damage: Liver damage can occur with buprenorphine, especially when it is misused.
Danish: - Leverskade: Leverskade kan forekomme med buprenorphin, især når lægemidlet misbruges.
English: - Injection should be made into the subcutaneous tissue.
Danish: - Injektionen skal foretages i subkutant væv.
English: Undesirable effects were based on the known pharmacological activity of buprenorphine.
Danish: Bivirkninger var baseret på den kendte farmakologiske aktivitet af buprenorphin.
English: During continued treatment, you might receive one additional Buvidal 8 mg dose between your weekly or monthly treatments if your doctor thinks this is appropriate for you.
Danish: Ved fortsat behandling kan du få en Buvidal 8 mg dosis mere mellem dine ugentlige og månedlige behandlinger, hvis din læge mener, at det er det bedste for dig.
English: - gabapentinoids (gabapentin or pregabalin) (used to treat epilepsy or neuropathic pain).
Danish: - gabapentinoider (gabapentin eller pregabalin) (som bruges til behandling af epilepsi eller neuropatiske smerter).
English: Yellowish to yellow clear liquid.
Danish: Gullig til klar gul væske.
English: There are no or limited data on effects of buprenorphine on human fertility.
Danish: Der foreligger ingen eller begrænsede data om virkningen af buprenorphin på fertilitet.
English: Naloxone can be cleared more rapidly than buprenorphine, allowing for a return of previously controlled buprenorphine overdose symptoms.
Danish: Naloxon kan elimineres hurtigere end buprenorphin, hvilket giver risiko for tilbagevenden af tidligere kontrollerede symptomer på buprenorphin-overdosering.
English: If treatment is continued, hepatic function should be monitored closely.
Danish: Hvis behandling fortsættes, skal leverfunktionen monitoreres nøje.
English: The patient should be cautioned not to drive or operate hazardous machinery whilst taking this medicine until it is known how the patient is affected by the medicine.
Danish: Patienten skal advares om ikke at køre eller betjene farlige maskiner, når denne medicin tages, indtil der er vished for, hvordan patienten reagerer på medicinen.
English: - Pinch the skin at the injection site between the thumb and finger as shown (see Figure 5).
Danish: - Sammenklem huden på injektionsstedet med tommel- og pegefingeren som vist (se Figur 5).
English: • naltrexone and nalmefene: These are opioid antagonists that can block the pharmacological effects of buprenorphine.
Danish: • naltrexon og nalmefen: Disse er opioid-antagonister, der kan blokere de farmakologiske virkninger af buprenorphin.
English: However, because elderly patients may have diminished renal/hepatic function, dose adjustment may be necessary (see Hepatic impairment and Renal impairment below).
Danish: Da ældre patienter kan have nedsat nyre/leverfunktion, kan dosisjustering dog være nødvendig (se Nedsat leverfunktion og Nedsat nyrefunktion nedenfor).
English: CDF = cumulative distribution function, CI = confidence interval, LS = least squares; SE = standard error, SL BPN/NX = sublingual buprenorphine/naloxone a Difference = Buvidal - SL BPN/NX.
Danish: CDF = kumulativ fordelingsfunktion (cumulative distribution function), KI = konfidensinterval, LS = mindste kvadrater (least squares); SE = standardfejl (standard error), SL BPN/NX = sublingual buprenorphin/naloxon a Forskel = Buvidal - SL BPN/NX.
English: • antipsychotics (used to treat psychiatric disorders such as schizophrenia)
Danish: • antipsykotika (som bruges til at behandle psykiske forstyrrelser som f.eks. skizofreni)
English: Subcutaneous administration of Buvidal results in significantly lower plasma concentrations of norbuprenorphine metabolite compared to administration of sublingual buprenorphine, due to avoidance of first-pass metabolism.
Danish: Subkutan administration af Buvidal medfører signifikant lavere plasmakoncentrationer af norbuprenorphin-metabolit sammenlignet med administration af sublingual buprenorphin, da "firstpass" metabolisering undgås.
English: It can also occur because of viral infections (chronic hepatitis C), alcohol abuse, anorexia (eating disorder) or use of other medicines which harm your liver.
Danish: Dette kan også skyldes virusinfektioner (kronisk hepatitis C), alkoholmisbrug, anoreksi (spisevægring) eller brug af anden medicin, der skader din lever.
English: There are no or limited data from the use of buprenorphine in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af buprenorphin til gravide kvinder.
English: Pharmacotherapeutic group: Other nervous system drugs, drugs used in opioid dependence, ATC code: N07BC01
Danish: Farmakoterapeutisk klassifikation: Andre midler mod lidelser i nervesystemet, midler mod afhængighedslidelser, ATC-kode: N07BC01
English: The most common adverse reactions were injection site pain (8.9%), injection site pruritus (6.1%) and injection site erythema (4.7%).
Danish: De mest almindelige bivirkninger var smerter på injektionsstedet (8,9 %), kløe på injektionsstedet (6,1 %) og erytem på injektionsstedet (4,7 %).
English: • The liquid should be clear.
Danish: • Væsken skal være klar.
English: The study enrolled a total of 227 patients with moderate to severe opioid dependence, of which 190 patients were switched from sublingual buprenorphine (with or without naloxone), and 37 patients were new to buprenorphine treatment.
Danish: Studiet tilmeldte i alt 227 patienter med moderat til svær opioidafhængighed, hvoraf 190 patienter skiftede behandling fra sublingual buprenorphin (med eller uden naloxon) og 37 patienter ikke tidligere var blevet behandlet med buprenorphin.
English: Statistic Buvidal
Danish: Statistik Buvidal
English: Hallucinations Euphoric mood
Danish: Hallucinationer Eufori
English: Some medicines may increase the side effects of Buvidal and may cause very serious reactions.
Danish: Nogle lægemidler kan øge bivirkningerne af Buvidal og kan i visse tilfælde forårsage alvorlige reaktioner.
English: If you are already taking sublingual buprenorphine, you can start receiving Buvidal the day after your last treatment.
Danish: Hvis du allerede tager sublingual buprenorphin, kan du begynde at få Buvidal dagen efter din sidste behandling.
English: The first dose of Buvidal will be given to you when you show clear signs of withdrawal.
Danish: Du vil få den første dosis Buvidal, når du viser tydelige tegn på abstinenser.
English: Percentage of urine samples negative for illicit opioids
Danish: Procentdel af urinprøver, der var negative for ulovlige opioider
English: During the 12 weeks with monthly injections, patients in both groups could receive one additional 8 mg weekly Buvidal dose per month, if needed.
Danish: I de 12 uger med månedlige injektioner kunne patienterne i begge grupper få yderligere en 8 mg ugentlig dosis af Buvidal- per måned efter behov.
English: Precautions to be taken before initiation of treatment
Danish: Sikkerhedsforanstaltninger før start af behandling
English: • monoamine oxidase inhibitors (MAOI): Possible exacerbation of the opioids effects, based on experience with morphine.
Danish: • monoaminoxidasehæmmere (MAOI): Mulig øget virkning af opioiderne, baseret på erfaring med morfin.
English: Table 3 presents adverse reactions reported for buprenorphine, including Buvidal.
Danish: Tabel 3 viser bivirkninger indberettet for buprenorphin, inklusive Buvidal.
English: Buprenorphine is primarily eliminated in the faeces by biliary excretion of the glucuroconjugated metabolites (70%), the remainder being eliminated in the urine.
Danish: Buprenorphin elimineres primært i fæces ved biliær udskillelse af de glukuronidkonjugerede metabolitter (70 %), resten elimineres i urinen.
English: Due to the long half-life of buprenorphine, neonatal monitoring for several days after birth should be considered to prevent the risk of respiratory depression or withdrawal syndrome in neonates.
Danish: På grund af buprenorphins lange halveringstid bør det overvejes at monitorere det nyfødte barn i flere dage efter fødslen for at forebygge risikoen hos det nyfødte barn for respirationsdepression eller abstinenssymptomer.
English: Caution should be exercised when co-administering Buvidal with other medicinal products that prolong the QT interval and in patients with a history of long QT syndrome or other risk factors for QT prolongation.
Danish: Der skal udvises forsigtighed ved samtidig administration af Buvidal med andre lægemidler, som forlænger QT-intervallet, og hos patienter med en anamnese, der inkluderer langt QT-syndrom eller andre risikofaktorer for QT-forlængelse.
English: It is recommended that the plunger is kept fully depressed while the needle is carefully lifted straight out from the injection site (see Figure 7).
Danish: Det anbefales, at stemplet holdes trykket helt i bund, mens kanylen forsigtigt løftes lige op fra injektionsstedet (se Figur 7).
English: Lacrimal disorder Mydriasis Miosis
Danish: Ændret tåreflåd Mydriasis Miosis
English: - Withdrawal symptoms: This medicine can cause withdrawal symptoms if you take it less than 6 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: - Abstinenssymptomer: Dette lægemiddel 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: • other opioids such as methadone, certain painkillers and cough medicines.
Danish: • andre opioider, såsom metadon, visse smertestillende midler og hostedæmpende midler.
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 illicit opioids for patients with opioid dependence.
Danish: Stoffets virkning i forbindelse med opioid-vedligeholdelsesbehandling tilskrives dets langsomme reversible binding til μ-opioidreceptorerne, som over en længere periode kan minimere behovet for ulovlige opioider hos opioidafhængige patienter.
English: The risks of using Buvidal in pregnant women are not known.
Danish: Risikoen ved, at gravide kvinder får Buvidal, kendes ikke.
English: Of the 428 randomised patients, 69.0% (147/213) of the patients in the Buvidal treatment group and 72.6% (156/215) of the patients in the sublingual buprenorphine/naloxone treatment group completed the 24-week treatment period.
Danish: Af de 428 randomiserede patienter fuldførte 69,0 % (147/213) af patienterne i Buvidalbehandlingsgruppen, og 72,6 % (156/215) af patienterne i behandlingsgruppen, som fik sublingual buprenorphin/naloxon behandlingsperioden på 24 uger.
English: - a urinary disorder (especially linked to enlarged prostate in men) - thyroid problems - an adrenocortical disorder (e.g. Addison's disease) - gall bladder problems
Danish: - en urinvejslidelse (særligt forbundet med en forstørret prostata hos mænd) - thyroideaproblemer - en binyrebarksygdom (f.eks. Addisons sygdom) - problemer med galdeblæren
English: Symptoms of overdose may include breathing more slowly and weakly than usual, feeling more sleepy than normal, smaller pupils.
Danish: Symptomer på en overdosis kan inkludere mere end normalt langsom og svag vejtrækning, mere end normal søvnighed, mindre pupiller.
English: Do not re-use the safety syringe.
Danish: Genbrug ikke sikkerhedsinjektionssprøjten.
English: This means a target dose of 24 mg or 32 mg during the first treatment week.
Danish: Dette betyder en måldosis på 24 mg eller 32 mg i den første behandlingsuge.
English: - Inspect the safety syringe closely:
Danish: - Efterse nøje sikkerhedsinjektionssprøjten:
English: When switching from sublingual buprenorphine to Buvidal, patients may need to be monitored to ensure plasma buprenorphine levels are adequate.
Danish: Ved skift fra sublingual buprenorphin til Buvidal kræver patienter muligvis monitorering for at sikre tilstrækkelige koncentrationer af buprenorphin i plasma.
English: There is no clinical data supporting reinjection of the monthly dose into the same site.
Danish: Der er ingen kliniske data, der understøtter ny injektion af den månedlige dosis på et tidligere injektionssted.