FrancophonIA/ELRC3.0 huggingface dataset:
English: • if you are allergic (hypersensitive) to buprenorphine, naloxone or any of the other ingredients of this medicine (see section 6)
Danish: • hvis du er allergisk over for buprenorphin, naloxon eller et af de øvrige indholdsstoffer i
English: Dosage adjustment and maintenance therapy:
Danish: Dosisjustering og vedligeholdelsesbehandling:
English: Since both buprenorphine and naloxone are extensively metabolized, plasma levels were found to be higher for both buprenorphine and naloxone in patients with moderate and severe hepatic impairment after single-dose administration.
Danish: Da både buprenorphin og naloxon metaboliseres i udtalt grad, blev der fundet højere plasmaniveauer af både buprenorphin og naloxon hos patienter med moderat og svært nedsat leverfunktion efter administration af en enkeltdosis.
English: Side effects reported with Suboxone
Danish: Indberettede bivirkninger ved Suboxone
English: o other central nervous system depressants, other opioid derivatives (e.g. methadone, analgesics and antitussives), certain antidepressants, sedative H1-receptor antagonists, barbiturates, anxiolytics other than benzodiazepines, neuroleptics, clonidine and related substances: these combinations increase central nervous system depression.
Danish: o andre CNS-supprimerende midler, andre opioidderivater (for eksempel methadon, analgetika og antitussiva), visse antidepressiva, sederende H1-receptorantagonister, barbiturater, andre anxiolytika end benzodiazepiner, neuroleptika, clonidin og beslægtede stoffer: Disse kombinationer øger CNS-depressionen.
English: Prior to treatment initiation, consideration should be given to the type of opioid dependence (i.e. longor short-acting opioid), the time since last opioid use and the degree of opioid dependence.
Danish: Følgende forhold bør klarlægges og afvejes inden behandlingsstart: opioidafhængighed (dvs. langtids- eller korttidsvirkende opioid), varigheden siden sidste brug af opioid og graden af opioidafhængighed.
English: • anti-retrovirals (used to treat HIV) such as ritonavir, nelfinavir, indinavir may increase the effects of this medicine.
Danish: • anti-retrovirale midler (som bruges til behandling af hiv) for eksempel ritonavir, nelfinavir eller indinavir, kan forlænge virkningen af dette lægemiddel.
English: When taken during pregnancy, particularly late pregnancy, medicines like Suboxone may cause drug withdrawal symptoms including problems with breathing in your newborn baby.
Danish: Hvis lægemidler som Suboxone indtages under graviditet, især sidst i graviditeten, kan det medføre, at barnet fødes med abstinenssymptomer, inklusive vejrtrækningsproblemer.
English: Buprenorphine/naloxone may cause drowsiness, particularly when taken together with alcohol or central nervous system depressants (such as tranquilisers, sedatives or hypnotics) (see section 4.5).
Danish: Buprenorphin/naloxon kan forårsage sløvhed, særligt ved samtidig indtagelse af alkohol eller CNSsupprimerende midler (såsom beroligende midler, sedativa eller hypnotika) (se pkt.
English: Marketing Authorisation Holder Indivior Europe Limited 27 Windsor Place Dublin 2
Danish: Indehaver af markedsføringstilladelsen Indivior Europe Limited 27 Windsor Place
English: The dose is made up from multiple Suboxone tablets of different strengths, which may be taken all at the same time or in two divided portions; the second portion to be taken directly after the first portion has dissolved.
Danish: En dosis består af flere Suboxone-resoribletter i forskellige styrker, som kan indtages samtidigt eller delt i to særskilte portioner.
English: Table 1: Treatment-related adverse reactions reported in clinical trials and post-marketing surveillance of buprenorphine/naloxone
Danish: Tabel 1: Behandlingsrelaterede bivirkninger, der blev indberettet fra kliniske studier og via overvågningen efter markedsføring af buprenorphin/naloxon
English: In patients presenting with marked drug dependence, initial administration of buprenorphine can produce a drug withdrawal syndrome similar to that associated with naloxone (see sections 4.2 and
Danish: Hos patienter med udpræget stofafhængighed kan indledende administration af buprenorphin fremkalde et abstinenssyndrom svarende til det, der er forbundet med naloxon (se pkt.
English: Slow or difficult breathing, liver injury with or without jaundice, hallucinations, swelling of face and throat or life threatening allergic reactions, drop in blood pressure on changing position from sitting or lying down to standing.
Danish: Langsom eller vanskelig vejrtrækning, leverskade med eller uden gulsot, hallucinationer, hævelse af ansigt og svælg eller livstruende allergiske reaktioner, fald i blodtrykket når du rejser dig fra siddende eller liggende stilling.
English: 6.5 Nature and contents of container 7 tablets in blister packs Paper/Aluminium/Nylon/Aluminium/PVC.
Danish: 7 resoribletter i blisterpakninger af papir/aluminium/nylon/aluminium/PVC.
English: An emergency unit should be contacted immediately in case of accidental ingestion or suspicion of ingestion.
Danish: Skadestuen skal kontaktes øjeblikkelig i tilfælde utilsigtet indtagelse eller ved mistanke herom.
English: o the concomitant use of monoamine oxidase inhibitors (MAOI) might produce exaggeration of the effects of opioids, based on experience with morphine.
Danish: o Samtidig behandling med monoaminooxidasehæmmere (MAO-hæmmere) kan forårsage øget virkning af opioiderne, baseret på erfaring med morphin.
English: What you need to know before you take Suboxone
Danish: Det skal du vide, før du begynder at tage Suboxone
English: Lactose monohydrate Mannitol
Danish: Lactosemonohydrat Mannitol
English: Haematuria Nephrolithiasis Urinary retention
Danish: Hæmaturi Nephrolithiasis Urinretention
English: Severe Hepatic Impairment (Child-Pugh Class C) (n=8)
Danish: Svært nedsat leverfunktion (Child-Pugh-klasse C) (n=8)
English: If you stop taking Suboxone
Danish: Hvis du holder op med at bruge Suboxone
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 lægemiddel kan fremkalde abstinenssymptomer, hvis du tager det mindre end 6 timer efter, du har brugt en kortvirkende opioid (for eksempel morphin eller heroin).
English: Moderate Hepatic Impairment (Child-Pugh Class B) (n=8)
Danish: Moderat nedsat leverfunktion (Child-Pugh-klasse B) (n=8)
English: Abrupt discontinuation of treatment is not recommended as it may result in a withdrawal syndrome that may be delayed in onset.
Danish: Pludselig afbrydelse af behandlingen frarådes, da det kan forårsage forsinkede abstinenssymptomer.
English: Opioid agonist ceiling effects were observed during clinical pharmacology studies in opioid-dependent persons.
Danish: Der blev observeret et loft for den opioidagonistiske effekt hos opioidafhængige personer i klinisk farmakologiske studier.
English: Opioids have been shown to increase intracholedochal pressure, and should be used with caution in patients with dysfunction of the biliary tract.
Danish: Opioider er vist at øge trykket i choledochus og bør anvendes med forsigtighed til patienter med dysfunktion af galdevejen.
English: Opioids should be used with caution in patients with myxoedema, hypothyroidism, or adrenal cortical insufficiency (e.g., Addison's disease).
Danish: Opioider bør anvendes med forsigtighed til patienter med myksødem, hypothyreoidisme eller binyrebarkinsufficiens (f.eks. Addisons sygdom).
English: Buprenorphine/naloxone is contraindicated in patients with severe hepatic impairment.
Danish: Buprenorphin/naloxon er kontraindiceret hos patienter med svært nedsat leverfunktion.
English: The concomitant use of monoamine oxidase inhibitors (MAOI) might produce an exaggeration of the effects of opioids, based on experience with morphine (see section 4.5).
Danish: Samtidig behandling med monoaminooxidasehæmmere (MAO-hæmmere) kan forårsage øget virkning af opioider, baseret på erfaring med morphin (se pkt.
English: Long-term administration of buprenorphine during the last three months of pregnancy may cause a withdrawal syndrome in the neonate (e.g. hypertonia, neonatal tremor, neonatal agitation, myoclonus or convulsions).
Danish: Længerevarende behandling med buprenorphin i sidste trimester kan medføre abstinenssyndrom hos det nyfødte barn (f.eks. hypertoni, neonatal tremor, neonatal agitation, myoklonus eller kramper).
English: Metabolites of buprenorphine accumulate in patients with renal failure.
Danish: Buprenorphins metabolitter akkumuleres hos patienter med nedsat nyrefunktion.
English: If naloxone is used, the long duration of action of buprenorphine should be taken into consideration when determining the length of treatment and medical surveillance needed to reverse the effects of an overdose.
Danish: Hvis naloxon anvendes til behandling af en overdosis, skal der tages højde for den lange virkningsvarighed af buprenorphin, når varigheden af behandlingen og den medicinske monitorering fastlægges.
English: Pharmacokinetic Parameter Suboxone 4 mg Suboxone 8 mg Suboxone 16 mg
Danish: Farmakokinetisk parameter Suboxone 4 mg Suboxone 8 mg Suboxone 16 mg
English: Pharmacokinetic Parameter Suboxone4 mg Suboxone 8 mg Suboxone16 mg
Danish: Farmakokinetisk parameter Suboxone4 mg Suboxone 8 mg Suboxone16 mg
English: They should not be taken at the same time as Suboxone treatment because you may experience a sudden onset of prolonged and intense withdrawal.
Danish: Du må ikke tage disse lægemidler, mens du er i behandling med Suboxone, fordi du kan opleve, at du pludseligt får langvarige og intense abstinenssymptomer.
English: You may be more closely monitored by your doctor if you are below the age of 18 or over the age of 65.
Danish: Hvis du er under 18 år eller over 65 år, vil lægen eventuelt holde dig under tættere kontrol.
English: If you are dependent upon heroin or a short acting opioid, your first dose of Suboxone should be taken when signs of withdrawal appear, but not less than 6 hours after you last used opioids.
Danish: Hvis du er afhængig af heroin eller en kortvirkende opioid, bør du tage din første dosis Suboxone, når der ses tegn på abstinenser, dog mindst 6 timer efter du sidst brugte opioider.
English: Stopping treatment suddenly may cause withdrawal symptoms.
Danish: Pludseligt ophør med behandlingen kan medføre abstinenssymptomer.
English: Packed in packs of 7 and 28 tablets.
Danish: Pakninger med 7 og 28 resoribletter.
English: Do not breast-feed whilst taking this medicine, since Suboxone passes into breast milk.
Danish: Amning skal ophøre under behandling med dette lægemiddel, da Suboxone udskilles i human mælk.
English: In many cases the presence of pre-existing mitochondrial impairment (genetic disease, liver enzyme abnormalities, infection with hepatitis B or hepatitis C virus, alcohol abuse, anorexia, concomitant use of other potentially hepatotoxic medicines) and ongoing injecting drug use may have a causative or contributory role.
Danish: I mange tilfælde kan eksisterende nedsat mitokondriefunktion (arvelig sygdom, leverenzymanomalier, infektion med hepatitis B eller hepatitis C virus, alkoholmisbrug, anoreksi, samtidig behandling med andre potentielt hepatotoksiske lægemidler) og samtidigt intravenøst stofmisbrug spille en kausal eller medvirkende rolle.
English: Urinary tract infection Vaginal infection
Danish: Urinvejsinfektio Vaginal infektion
English: • naltrexone and nalmefene (drugs used to treat addiction disorders) may prevent the therapeutic effects of Suboxone.
Danish: • naltrexon og nalmefen (lægemidler til behandling af afhængighed) kan forhindre de terapeutiske virkninger af Suboxone.
English: Suboxone sublingual tablets should be used with caution in patients with moderate hepatic impairment (See section 4.3 and 5.2).
Danish: Suboxone sublinguale resoribletter bør anvendes med forsigtighed hos patienter med moderat nedsat leverfunktion (se pkt.
English: Mild Hepatic Impairment (Child-Pugh Class A) (n=9)
Danish: Let nedsat leverfunktion (Child-Pugh-klasse A) (n=9)
English: Alcohol may increase drowsiness and may increase the risk of respiratory failure if taken with Suboxone.
Danish: Brug af Suboxone sammen med mad, drikke og alkohol Alkohol kan muligvis forstærke døsighed og øge risikoen for respirationssvigt, hvis det indtages sammen med Suboxone.
English: Suboxone contains lactose
Danish: Suboxone indeholder lactose
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: Dosis af buprenorphin/naloxon skal titreres omhyggeligt hos patienter i behandling med CYP3A4-hæmmere, da en mindre dosis kan være tilstrækkelig hos disse patienter (se pkt.
English: The first dose of Suboxone should be taken when signs of withdrawal appear, but not less than 24 hours after you last used methadone.
Danish: Den første dosis Suboxone bør tages, når der ses tegn på abstinenser, dog mindst 24 timer efter, du sidst har brugt methadon.
English: Buprenorphine, when taken orally, undergoes first-pass metabolism with N-dealkylation and glucuroconjugation in the small intestine and the liver.
Danish: Når det indtages oralt, gennemgår buprenorphin first-pass metabolisme med N-dealkylering og glukuronidkonjugering i tyndtarmen og leveren.
English: In cases of intravenous drug misuse, some adverse experiences are attributed to the act of misuse rather than the medicinal product and include local reactions, sometimes septic (abscess, cellulitis), and potentially serious acute hepatitis and other acute infections such as pneumonia, endocarditis have been reported (see section 4.4).
Danish: I tilfælde af intravenøst stofmisbrug er der rapporteret om visse uønskede hændelser, som snarere skyldes misbruget end lægemidlet, herunder lokale reaktioner, til tider septisk (absces, cellulitis), og potentielt alvorlig akut hepatitis og andre akutte infektioner, såsom pneumoni, endocarditis (se pkt.
English: • Do not consume any food or drink until the tablets have completely dissolved.
Danish: • Lad være med at indtage mad eller drikkevarer, indtil resoribletterne er opløst helt.
English: The first dose of buprenorphine/naloxone should be taken only when signs of withdrawal appear, but not less than 24 hours after the patient last used methadone.
Danish: Den første dosis buprenorphin/naloxon skal først administreres, når der optræder tegn på abstinenser, dog mindst 24 timer efter, patienten sidst anvendte methadon.
English: o For patients dependent upon heroin or short-acting opioids, the first dose of buprenorphine/naloxone should be taken when signs of withdrawal appear, but not less than 6 hours after the patient last used opioids.
Danish: o Hos heroinafhængige patienter eller patienter, der er afhængige af korttidsvirkende opioider, skal den første dosis buprenorphin/naloxon administreres, når der optræder tegn på abstinenser, dog mindst 6 timer efter, patienten sidst brugte opioider.
English: Albuminuria Dysuria
Danish: Albuminuri Dysuri
English: • severe tiredness, itching with yellowing of skin or eyes.
Danish: • udpræget træthed, kløe, og din hud eller det hvide i øjnene bliver gult.
English: Buprenorphine may precipitate symptoms of withdrawal in patients dependent upon methadone.
Danish: Buprenorphin kan udløse abstinenssymptomer hos methadonafhængige patienter.
English: other opioid containing medicines such as methadone, certain pain killers and cough suppressants anti-depressants (used to treat depression) such as isocarboxazid, phenelzine, selegiline, tranylcypromine and valproate may increase the effects of this medicine.
Danish: - andre opioider, som indeholder lægemidler som f.eks. methadon, visse smertestillende midler og hostestillende medicin - antidepressiva, som bruges til behandling af depression, for eksempel isocarboxazid, phenelzin, selegilin, tranylcypromin og valproat, kan forstærke virkningen af dette lægemiddel.
English: Tell your doctor immediately or seek urgent medical attention if you experience side effects, such as:
Danish: Du skal også straks informere din læge, hvis du får bivirkninger såsom:
English: other opioid containing medicines such as methadone, certain pain killers and cough suppressants anti-depressants (used to treat depression) such as isocarboxazide, phenelzine, selegiline, tranylcypromine and valproate may increase the effects of this medicine.
Danish: - andre opioider, som indeholder lægemidler som f.eks. methadon, visse smertestillende midler og hostestillende medicin - antidepressiva, som bruges til behandling af depression, for eksempel isocarboxazid, phenelzin, selegilin, tranylcypromin og valproat kan forstærke virkningen af dette lægemiddel.
English: Buprenorphine/naloxone is contraindicated in patients with severe hepatic impairment (see section 4.3 and 5.2).
Danish: Buprenorphin/naloxon er kontraindiceret hos patienter med alvorligt nedsat leverfunktion (se pkt.
English: • some antifungal agents (used to treat fungal infections) such as ketoconazole, itraconazole, certain antibiotics, may extend the effects of this medicine.
Danish: • visse lægemidler (som bruges til behandling af svampeinfektioner) for eksempel ketoconazol og itraconazol, visse antibiotika, kan forstærke virkningen af dette lægemiddel.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/359/003 8 mg sublingual tablets 7
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/06/359/003 8 mg sublinguale resoribletter 7
English: EU/1/06/359/004 8 mg sublingual tablets 28
Danish: EU/1/06/359/004 8 mg sublinguale resoribletter 28
English: • any kidney disease
Danish: • en nyresygdom
English: • some antifungal agents (used to treat fungal infections) such as ketoconzaole, itraconazole, certain antibiotics may extend the effects of this medicine.
Danish: • visse lægemidler (som bruges til behandling af svampeinfektioner) for eksempel ketoconazol og itraconazol og visse antibiotika kan forstærke virkningen af dette lægemiddel.
English: If you get any side effects, talk to your doctor.
Danish: Hvis du får bivirkninger, skal du straks informere din læge eller omgående søge læge.
English: Diarrhoea Dyspepsia Flatulence Vomiting
Danish: Diarré Dyspepsi Flatulens Opkastning
English: Bronchospasm Respiratory depression
Danish: Bronkospasme Respirationsdepr ession
English: Patients who are positive for viral hepatitis, on concomitant medicinal products (see section 4.5) and/or have existing liver dysfunction are at risk of accelerated liver injury.
Danish: 4.5) og/eller patienter med eksisterende leverdysfunktion, har risiko for accelereret leverskade.
English: Buprenorphine misuse by someone other than the intended patient poses the additional risk of new drug dependent individuals using buprenorphine as the primary drug of abuse, and may occur if the medicine is distributed for illicit use directly by the intended patient or if the medicinal product is not safeguarded against theft.
Danish: Hvis andre end den tilsigtede patient misbruger buprenorphin, er der yderligere risiko for, at nye stofafhængige bruger buprenorphin som det primære stof til deres misbrug.
English: Urticaria
Danish: Hæmaturi
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to special and restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en særlig recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé, pkt.
English: Caution is recommended when dosing patients with severe renal impairment (creatinine clearance <30 ml/min) (see sections 4.2 and 5.2).
Danish: Forsigtighed tilrådes ved dosering til patienter med alvorligt nedsat nyrefunktion (kreatininclearance < 30 ml/min) (se pkt.
English: Citric acid anhydrous Sodium citrate
Danish: Vandfri citronsyre Natriumcitrat
English: Suboxone 16 mg/4 mg sublingual tablets are white round biconvex tablets of 10.5 mm with “N16” debossed on one side.
Danish: Suboxone 16 mg/4 mg sublinguale resoribletter er hvide, runde, bikonvekse resoribletter på 10,5 mm, præget med “N16” på den ene side.
English: This may happen more often in the first few weeks of treatment when your dose is being changed, but can also happen if you drink alcohol or take other sedative medicines when you take Suboxone.
Danish: Det kan forekomme hyppigere i de første uger af behandlingen, mens din dosis ændres.
English: Caution is recommended when dosing patients with severe renal impairment (creatinine clearance < 30 ml/min) (see section 4.4 and 5.2).
Danish: Forsigtighed tilrådes ved dosering til patienter med svært nedsat nyrefunktion (kreatininclearance < 30 ml/ min) (se pkt.
English: After a satisfactory stabilisation has been achieved, if the patient agrees, the dosage may be reduced gradually to a lower maintenance dose; in some favourable cases, treatment may be discontinued.
Danish: Når der er opnået en tilfredsstillende stabilisering, kan doseringen med patientens samtykke trinvist nedsættes til en lavere vedligeholdelsesdosis.
English: PK Parameter
Danish: Farmakokinetisk parameter
English: How to take Suboxone
Danish: Sådan skal du tage Suboxone
English: Constipation Nausea
Danish: Forstoppelse Kvalme
English: If you have the impression that the effect of Suboxone is too strong or too weak, talk to your doctor or pharmacist.
Danish: Tal med lægen eller apoteket, hvis du har indtryk af, at effekten af Suboxone er for stærk eller for svag.
English: To avoid precipitating withdrawal, induction with buprenorphine/naloxone should be undertaken when objective signs of withdrawal are evident (see section 4.2).
Danish: For at undgå fremkaldelse af abstinenssymptomer bør administration af buprenorphin/naloxon først indledes, når der ses objektive tegn på abstinenser (se pkt.
English: Magnesium stearate Acesulfame potassium Natural lemon and lime flavour
Danish: Magnesiumstearat Acesulfamkalium Naturlig citron- og limearoma.
English: If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Kontakt lægen, før du tager dette lægemiddel, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: Sublingual tablet White hexagonal biconvex tablets of 11 mm with “N8” debossed on one side.
Danish: Hvid, hexagonal, bikonveks resoriblet på 11 mm præget med “N8” på den ene side.
English: Sublingual tablet White hexagonal biconvex tablets of 6.5 mm with “N2” debossed on one side.
Danish: Hvid, hexagonal, bikonveks resoriblet på 6,5 mm præget med “N2” på den ene side.
English: Hull, East Yorkshire
Danish: Hull, East Yorkshire HU8 7DS
English: Suboxone 2 mg/0.5 mg sublingual tablets are white hexagonal biconvex tablets of 6.5 mm with “N2” debossed on one side.
Danish: Suboxone 2 mg/0,5 mg sublinguale resoribletter er hvide, sekskantede, hvælvede resoribletter på 6,5 mm, præget med “N2” på den ene side.
English: Suboxone 8 mg/2 mg sublingual tablets are white hexagonal biconvex tablets of 11 mm with “N8” debossed on one side.
Danish: Suboxone 8 mg/2 mg sublinguale resoribletter er hvide, sekskantede, hvælvede resoribletter på11 mm, præget med “N8” på den ene side.
English: Sublingual tablet White round biconvex tablets of 10.5 mm with “N16” debossed on one side.
Danish: Hvid, rund, bikonveks resoriblet på 10,5 mm præget med “N16” på den ene side.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 7 and 28 TABLETS 2 mg STRENGTH
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS PAKNING MED 7 og 28 RESORIBLETTER 2 mg STYRKE
English: Each sublingual tablet contains 156.64 mg lactose (as monohydrate) For the full list of excipients, see section 6.1.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Hver sublingual resoriblet indeholder 156,64 mg lactose (som monohydrat)
English: INFORMATION IN BRAILLE Suboxone 2 mg/0.5 mg sublingual tablets
Danish: INFORMATION I BRAILLE-SKRIFT Suboxone 2 mg/0,5 mg sublinguale resoribletter