natgillin/translations-raw huggingface dataset:
Mistanke om en leverpåvirkning kræver biologisk og ætiologisk udredning.
When a hepatic event is suspected, further biological and etiological evaluation is required.
Afhængigt af fundene kan præparatet seponeres forsigtigt for at forebygge abstinenssymptomer og for at forhindre tilbagevendende stofmisbrug.
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.
Hvis behandlingen fortsættes, bør leverfunktionen følges nøje.
If the treatment is continued, hepatic function should be monitored closely.
Da buprenorphin er et opioid, kan smerte som symptom på en sygdom dæmpes.
As buprenorphine is an opioid, pain as a symptom of a disease may be attenuated.
Sportsfolk skal gøres opmærksom på, at medicinen kan give positiv reaktion på anti- doping tests.
Athletes must be aware that this medicine may cause a positive reaction to ‘ anti-doping’ tests.
Som ved andre opioider skal der udvises forsigtighed ved brug af buprenorphin hos patienter med læsioner i hovedet, øget intrakranielt tryk, hypotension, prostata hypertrofi eller uretral stenose.
As with other opioids, caution is requested in patients using buprenorphine and having head injury, increased intracranial pressure, hypotension, prostatic hypertrophy or urethral stenosis.
4. 3).
This product should be used with care in patients with: asthma or respiratory insufficiency (cases of respiratory depression have been reported with buprenorphine); renal insufficiency (30% of the administered dose is eliminated by the renal route; thus, renal elimination may be prolonged); hepatic insufficiency (hepatic metabolism of buprenorphine may be altered) (see section 4.3).
Lægemidler, som hæmmer enzymet CYP3A4, kan forårsage øgede koncentrationer af buprenorphin.
Medicines that inhibit the enzyme CYP3A4 may give rise to increased concentrations of buprenorphine.
Det kan være nødvendigt at reducere Suboxone- dosis.
A reduction of the Suboxone dose may be needed.
4. 5).
Patients already treated with CYP3A4 inhibitors should have their dose of Suboxone titrated carefully since a reduced dose may be sufficient in these patients (see section 4.5).
Samtidig brug af monoaminooxydase- hæmmere (MAOI) kan give mulig forstærket opioidvirkning baseret på erfaringer med morfin.
The concomitant use of monoamine oxidase inhibitors (MAOI) might produce exaggeration of the effects of opioids, based on experience with morphine.
Patienter med sjælden arvelig galaktoseintolerans, Lapp Lactase deficiency eller glukose/ galaktose malabsorption bør ikke anvende dette lægemiddel.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take this medicine.
4. 7).
• alcoholic drinks or medications containing alcohol, as alcohol increases the sedative effect of buprenorphine (see section 4.7).
Suboxone bør anvendes med forsigtighed sammen med:
Suboxone should be used cautiously when co-administered with:
• benzodiazepiner:
5 • benzodiazepines:
CNS– hæmning af respirationen.
This combination may result in death due to respiratory depression of central origin.
4. 4).
Therefore, dosages must be limited and this combination must be avoided in cases where there is a risk of misuse (see section 4.4).
• andre hæmmere af det centrale nervesystem, andre opioidderivater (f. eks. metadon, analgetika og hostestillende midler), visse antidepressiva, sederende H1- receptor antagonister, barbiturater, anxiolytika udover benzodiazepiner, neuroleptika, klonidin og relaterede stoffer:
• 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.
En interaktionsundersøgelse med buprenorphin og ketoconazol (en potent hæmmer af CYP3A4) medførte øget Cmax og AUC (areal under kurven) af buprenorphin (hhv. ca. 70% og 50%) og, i mindre grad, af norbuprenorphin.
• CYP3A4 inhibitors: an interaction study of buprenorphine with ketoconazole (a potent inhibitor of CYP3A4) resulted in increased Cmax and AUC (area under the curve) of buprenorphine (approximately 70% and 50% respectively) and, to a lesser extent, of norbuprenorphine.
Patienter, der får Suboxone, bør følges nøje og kan få behov for dosisreduktion, hvis potente CYP3A4- hæmmere (såsom proteasehæmmere som ritonavir, nelfinavir eller indinavir eller azolsvampemidler som ketoconazol eller itraconazol) anvendes samtidigt.
Patients receiving Suboxone should be closely monitored, and may require dose-reduction if combined with potent CYP3A4 inhibitors (e. g. protease inhibitors like ritonavir, nelfinavir or indinavir or azole antifungals such as ketoconazole or itraconazole).
Interaktionen mellem buprenorphin og CYP3A4- inducerende stoffer er ikke blevet undersøgt.
• CYP3A4 inducers: the interaction of buprenorphine with CYP3A4 inducers has not been investigated.
Det anbefales derfor at følge patienter, der er i behandling med Suboxone, nøje, hvis der samtidigt anvendes enzyminducerende stoffer (f. eks. phenobarbital, carbamazepin, phenytoin, rifampicin).
Therefore it is recommended that patients receiving Suboxone should be closely monitored if inducers (e. g. phenobarbital, carbamazepine, phenytoin, rifampicin) are co- administered.
Hidtil er der ikke påvist interaktion med kokain, det stof der hyppigst anvendes af flerstofmisbrugere i forbindelse med opioider.
To date, no notable interaction has been observed with cocaine, the agent most frequently used by multi-drug abusers in association with opioids.
Der er meget begrænset erfaring med buprenorphin/ naloxon hos gravide.
There is very limited experience with buprenorphine/ naloxone in pregnant women.
I slutningen af graviditeten kan høje doser af buprenorphin inducere respiratorisk undertrykkelse hos fosteret selv efter en kort indtagelsesperiode.
Towards the end of pregnancy high doses of buprenorphine may induce respiratory depression in the neonate even after a short period of administration.
Langtidsindtagelse af buprenorphin under graviditetens sidste tre måneder kan forårsage abstinenser hos fosteret.
Long-term administration of buprenorphine during the last three months of pregnancy may cause a withdrawal syndrome in the neonate.
Suboxone bør ikke anvendes under graviditet.
Suboxone should not be used during pregnancy.
Såfremt behandling efter lægens mening er påkrævet, skal anvendelsen af buprenorphin tages i betragtning under hensyntagen til den lokale buprenorphin - mærkning.
If it is the prescriber’ s opinion that therapy in pregnancy is required, the use of buprenorphine may be considered according to the local buprenorphine labeling.
Hvis videre behandling er påkrævet, skal der skiftes til buprenorphin.
In case pregnancy occurs while on Suboxone treatment, the mother and the unborn child should be closely monitored and switched to buprenorphine if further treatment is required.
Det vides ikke, om naloxon udskilles i modermælken.
It is unknown whether naloxone is excreted in human breast milk.
Buprenorphin og dets metabolitter udskilles i modermælk.
Buprenorphine and its metabolites are excreted in human breast milk.
Hos rotter har buprenorphin vist sig at hæmme mælkeproduktionen.
In rats buprenorphine has been found to inhibit lactation.
Amning bør derfor afbrydes under behandling med Suboxone.
Therefore, breast-feeding should be discontinued during treatment with Suboxone.
Generelt påvirker Suboxone i mindre eller moderat grad evnen til at færdes sikkert i trafikken, betjene maskiner, eller udføre andre aktiviteter, der kan være forbundet med fare.
In general Suboxone has minor to moderate influence on the ability to move safely in traffic, use machines, or perform other hazardous activities.
Suboxone kan forårsage døsighed, svimmelhed eller nedsat tænkeevne, særligt ved indtagelse sammen med alkohol eller CNS - hæmmere.
Suboxone may cause drowsiness, dizziness, or impaired thinking, particularly when taken together with alcohol or central nervous system depressants.
4. 4 og 4. 5).
Therefore caution is advised when performing the above mentioned activities (see sections 4.4 and 4.5).
De mest almindelige behandlingsrelaterede bivirkninger rapporteret i kliniske undersøgelser med Suboxone var relateret til abstinenssymptomer (f. eks. mavesmerter, diarré, muskelsmerter, angst, svedeture).
6 The most common-treatment related undesirable effects reported during clinical trials with Suboxone were those related to withdrawal symptoms (e. g. abdominal pain, diarrhoea, muscle aches, anxiety, sweating).
I den centrale kliniske undersøgelse med Suboxone rapporterede 342 ud af 472 (72, 5%) af patienterne behandlingsrelaterede birvirkninger.
In the pivotal clinical study of Suboxone, 342 of 472 patients (72.5%) reported treatment related adverse reactions.
Disse bivirkninger er opstillet i tabel 1 i systemorganklasser i henhold til MedDRA- databasen og hyppighed (meget almindelig (> 1/ 10), almindelig (> 1/ 100, < 1/ 10), ikke almindelig (> 1/ 1. 000, ≤1/ 100).
These reactions are listed in Table 1 by system organ class and frequency (very common (> 1/ 10), common (> 1/ 100 ,< 1/10), uncommon (> 1/ 1,000 to ≤ 1/ 100)).
Behandlingsrelaterede bivirkninger rapporteret i den centrale kliniske undersøgelse af Suboxone (≥ 0, 1% af Suboxone- behandlede patienter)
Treatment-related undesirable effects reported in the pivotal clinical study of Suboxone (≥ 0.1% of Suboxone-treated patients)
Infektion Ikke almindelige:
Infection Uncommon:
Vaginit Blod - og lymfesystem
Vaginitis Blood and lymphatic system disorders
Anæmi, trombocytopeni, leukopeni, lymfadenopati, leukocytose Immunsystemet
Anaemia, thrombocytopenia, leucopenia, lymphadenopathy, leukocytosis Immune system disorders
Metabolisme og ernæring
Allergic reaction Metabolism and nutrition disorders
Perifert ødem, vægttab Ikke almindelige:
Peripheral oedema, weight decreased Uncommon:
Hyperglykæmi, hyperlipæmi, hypoglykæmi Psykiske forstyrrelser
Hyperglycaemia, hyperlipemia, hypoglycemia Psychiatric disorders
Angst, nervøsitet, depression, nedsat libido, unormale tanker Ikke almindelige:
Anxiety, nervousness, depression, libido decreased, thinking abnormal Uncommon:
Stofafhængighed, amnesi, fjendtlighed, taleforstyrrelser, ændret personlighed, unormale drømme, apati, eufori Nervesystemet
Drug dependence, amnesia, hostility, speech disorder, depersonalization, abnormal dream, apathy, euphoria Nervous system disorders
Søvnløshed Almindelige:
Insomnia Common:
Søvnighed, svimmelhed, paræstesi, hypertoni Ikke almindelige:
Somnolence, dizziness, paresthesia, hypertonia Uncommon:
Kramper, agitation, tremor, hyperkinesi Øjne
Convulsion, agitation, tremor, hyperkinesia
Ændret tåredannelse, amblyogi Ikke almindelige:
Lacrimation disorder, amblyopia Uncommon:
Miose, konjunktivitis Hjerte
Miosis, conjunctivitis Cardiac disorders
Myocardieinfarkt, angina pectoris, palpitationer, takykardi, bradykardi Vaskulære sygdomme
Myocardial infarction, angina pectoris, palpitation, tachycardia, bradycardia
7 Luftveje, thorax og mediastinum
7 Vascular disorders
Rinit, faryngit, øget hoste Ikke almindelige:
Vasodilation, hypertension, migraine Uncommon:
Dyspnø, astma, gab Mave- tarmkanalen
Rhinitis, pharyngitis, cough increased Uncommon:
Forstoppelse, kvalme Almindelige:
Constipation, nausea Common:
Opkastning, dyspepsi, diarré, anorexi, flatulens Ikke almindelige:
Vomiting, dyspepsia, diarrhoea, anorexia, flatulence Uncommon:
Ulcerativ stomatit, misfarvning af tungen Lever og galdeveje
Ulcerative stomatitis, tongue discolouration Hepatobiliary disorders
Unormal leverfunktion Hud og subkutane væv
Liver function abnormal Skin and subcutaneous tissue disorders
Svedtendens Almindelige:
Sweating Common:
Udslæt, pruritus, nældefeber Ikke almindelige:
Rash, pruritus, urticaria Uncommon:
Afskallende dermatitis, akne, knopper i huden, alopeci, tør hud Knogler, led, muskler og bindevæv
Exfoliative dermatitis, acne, skin nodule, alopecia, dry skin Musculoskeletal, connective tissue and bone disorders
Artralgi, myalgi, krampe i benene Ikke almindelige:
Arthralgia, myalgia, leg cramps Uncommon:
Artrit Nyrer og urinveje
Arthritis Renal and urinary disorders
Albuminuri, unormal urin Ikke almindelige:
Albuminuria, urine abnormality Uncommon:
Hæmaturi, nyresten, øget kreatinin, urinvejsinfektion, dysuri, urinretention Det reproduktive system og mammae
Haematuria, kidney calculus, increased creatinine, urinary tract infection, dysuria, urinary retention Reproductive system and breast disorders
Impotens, amenoré, unormal ejakulation, menoragi, metroragi Almene symptomer og reaktioner på administrationsstedet
Impotence, amenorrhoea, abnormal ejaculation, menorrhagia, metrorrhagia General disorders
Abstinenssymptomer, hovedpine Almindelige:
Withdrawal syndrome, headache Common:
Asteni, feber, influenzasyndrom, utilpashed, utilsigtet tilskadekomst, kuldegysninger, brystsmerte, abdominal smerte, rygsmerte, smerte Traumer, forgiftninger og behandlingskomplikationer
Asthenia, fever, flu syndrome, malaise, accidental injury, chills, chest pain, abdominal pain, back pain, pain Injury, poisoning and procedural complications
Forstoppelse, hovedpine, søvnløshed, asteni, døsighed, kvalme og opkastning, besvimelse og svimmelhed, ortostatisk hypotension og svedtendens.
Buprenorphine used alone for treatment of opioid dependency has been associated with the following symptoms (> 1%): constipation, headache, insomnia, asthenia, drowsiness, nausea and vomiting, fainting and dizziness, orthostatic hypotension, and sweating.
Der er rapporteret andre bivirkninger (< 0, 1%), når buprenorphin bliver brugt alene.
Other undesirable effects (< 0.1%) have been reported in association with buprenorphine alone.
Disse er: • respirationshæmning (se pkt.
These are: • respiratory depression (see sections 4.4 and 4.5), • hepatic necrosis and hepatitis (see section 4.4), • hallucinations,
4. 4), • hallucinationer, • tilfælde af bronkospasmer, angioneurotisk ødem og anafylaktisk shock.
8 • cases of bronchospasm, angioneurotic oedema and anaphylactic shock.
4. 4).
In cases of intravenous misuse, local reactions, sometimes septic, and potentially serious acute hepatitis have been reported (see section 4.4).
Hos patienter med udpræget stofafhængighed kan initial administration af buprenorphin forårsage abstinenser tilsvarende de, som er forbundet med naloxon.
In patients presenting with marked drug dependence, initial administration of buprenorphine can produce a withdrawal effect similar to that associated with naloxone.
8 Spontan abort har været rapporteret med både buprenorphin og buprenorphin- naloxon.
Spontaneous abortion has been reported with both buprenorphine and buprenorphine-naloxone.
4. 6).
It is not possible to establish a causal relationship, since cases typically involve other drug use or risk factors for spontaneous abortion (see section 4.6).
Et neonatalt abstinenssyndrom har været rapporteret blandt nyfødte af kvinder, der har fået buprenorphin under graviditet.
A neonatal abstinence syndrome has been reported among newborns of women who have received buprenorphine during pregnancy.
Syndromet kan være mildere og mere langvarigt end det fra kortvirkende fulde µ- opioid agonister.
The syndrome may be milder and more protracted than that from short acting full µ-opioid agonists.
4. 6).
The nature of the syndrome may vary depending upon the mother’ s drug use history (see section 4.6).
I tilfælde af overdosering skal der indledes generel symptomatisk behandling og patientens respiratoriske og kardielle tilstand skal overvåges nøje.
In the event of overdose, general supportive measures should be instituted, including close monitoring of respiratory and cardiac status of the patient.
Det alvorligste symptom, der kræver intervention er respirationshæmning, som kan føre til respirationsstop og dødsfald.
The major symptom requiring intervention is respiratory depression, which could lead to respiratory arrest and death.
Der skal gives symptomatisk behandling af respirationshæmning, og der skal iværksættes standardprocedurer for intensiv behandling.
Symptomatic treatment of respiratory depression, and standard intensive care measures, should be implemented.
Der skal sørges for frie luftveje og om nødvendigt indsættes assisteret eller kontrolleret vejrtrækning.
A patent airway and assisted or controlled ventilation must be assured.
Anvendelse af en opioidantagonist (f. eks. naloxon) anbefales på trods af den beskedne effekt, det kan have i forhold til at ophæve respirationssymptomerne af buprenorphin sammenlignet med dets virkning på fulde opioidagonister.
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.
Ved behandling af en overdosis skal Suboxones lange virkningvarighed tages i betragtning under fastlæggelsen af behandlingens og den medicinske overvågnings varighed.
The long duration of action of Suboxone should be taken into consideration when determining the length of treatment and medical surveillance needed to reverse the effects of an overdose.
Midler til opioidafhængighed, ATC- kode:
Drugs used in opioid dependence, ATC code:
Buprenorphin er en partiel opioid- agonist/ antagonist, som binder sig til µ - (my) og κ - (kappa) receptorer i hjernen.
Buprenorphine is an opioid partial agonist/ antagonist which binds to the μ (mu) and κ (kappa) receptors of the brain.
Dets virkning i opioid- vedligeholdelsesbehandling skyldes dets langsomme reversible forbindelse med µ- receptorerne, der over en længere periode kan minimere behovet for stoffer hos afhængige patienter.
Its activity in opioid maintenance treatment is attributed to its slowly reversible properties with the μ receptors, which over a prolonged period, might minimise the need of addicted patients for drugs.
Der blev observeret opioid agonist ceiling effects ved kliniske farmakologiundersøgelser hos opioidafhængige personer.
Opioid agonist ceiling effects were observed during clinical pharmacology studies in opioid-dependent persons.
Naloxon er en µ - (my) opioidreceptor- antagonist.
Naloxone is an antagonist at μ (mu)-opioid receptors.
På grund af dets næsten fuldstændige first pass - metabolisme udviser Naloxon ringe eller ingen farmakologisk virkning, når det administreres peroralt eller sublingualt i sædvanlige doser til patienter med opioidabstinenser.
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.
Gives det derimod intravenøst til opioidafhængige personer, giver naloxon i Suboxone en udtalt opioid antagonistvirkning og opioidabstinenser, hvilket forhindrer intravenøs misbrug.
However, when administered intravenously to opioid dependent persons, the presence of naloxone in Suboxone produces marked opioid antagonist effects and opioid withdrawal, thereby deterring intravenous abuse.
Klinisk effektivitet Effektivitets - og sikkerhedsdata for Suboxone stammer primært fra en 1- års klinisk undersøgelse, der omfattede en 4- ugers randomiseret dobbeltblind sammenligning af Suboxone, buprenorphin og placebo- tabletter, og som blev fulgt af en 48 ugers sikkerhedsundersøgelse med Suboxone.
Efficacy and safety data for Suboxone are primarily derived from a one-year clinical trial, comprising a 4-week randomised double blind comparison of Suboxone, buprenorphine and placebo tablets followed by a 48 week safety study of Suboxone.
I denne undersøgelse blev 326 heroinmisbrugere randomiseret til enten Suboxone 16 mg per dag, 16 mg buprenorphin per dag eller placebo- tabletter.
In this trial, 326 heroin-addicted subjects were randomly assigned to either Suboxone 16 mg per day, 16 mg buprenorphine per day or placebo tablets.
9 begyndte dosering med en 8 mg buprenorphin- tablet på dag 1, fulgt af 16 mg (to 8 mg tabletter) buprenorphin på dag 2.
For subjects randomized to either active treatment, dosing began with one 8 mg tablet of buprenorphine on Day 1, followed by 16 mg (two 8 mg tablets) of buprenorphine on Day 2.
På dag 3 blev de, der var randomiseret til Suboxone, skiftet til kombinationstabletten.
On Day 3, those randomized to receive Suboxone were switched to the combination tablet.
Forsøgspersonerne blev tilset dagligt på klinikken (mandag til fredag) til doserings - og effektivitetsvurdering.
Subjects were seen daily in the clinic (Monday through Friday) for dosing and efficacy assessments.
Den primære undersøgelsessammenligning gik ud på at vurdere effektiviteten af buprenorphin og Suboxone individuelt i forhold til placebo.
The primary study comparison was to assess the efficacy of buprenorphine and Suboxone individually against placebo.
Procentdelen af urinprøver, som blev taget 3 gange om ugen, og som var negative for non- undersøgelsesopioider var statistisk højere for både Suboxone versus placebo (p < 0, 0001) og buprenorphin versus placebo (p < 0, 0001).
The percentage of thrice-weekly urine samples that were negative for non-study opioids was statistically higher for both Suboxone versus placebo (p < 0.0001) and buprenorphine versus placebo (p < 0.0001).
Heraf er den ene lav nok til at fungere som alternativ til placebo i en 3- 10 dages induktionsfase, en 16 ugers vedligeholdelsesfase og en 7 ugers afgiftningsfase.
In a double-blind, double-dummy, parallel-group study comparing buprenorphine ethanolic solution to a full agonist active control, 162 subjects were randomized to receive the ethanolic sublingual solution of buprenorphine at 8 mg/ day (a dose which is roughly comparable to a dose of 12 mg/ day of Suboxone), or two relatively low doses of active control, one of which was low enough to serve as an alternative to placebo, during a 3 to10 day induction phase, a 16-week maintenance phase and a 7- week detoxification phase.
Buprenorphin blev justeret til vedligeholdelsesdosis på dag 3; aktive kontroldoser blev justeret mere gradvist.
Buprenorphine was titrated to maintenance dose by Day 3; active control doses were titrated more gradually.
Baseret på retention i behandling og procentdelen af urinprøver, som blev taget 3 gange om ugen, og som var negative for non- undersøgelsesopioider, var buprenorphin mere effektiv end den lave kontroldosis til at holde heroinafhængige i behandling og til at reducere deres brug af opioid under behandlingen.
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.
Effektiviteten af buprenorphin 8 mg dagligt var sammenlignelig med den moderate aktive kontroldosis, men der blev ikke vist bioækvivalens.
The effectiveness of buprenorphine, 8 mg per day was similar to that of the moderate active control dose, but equivalence was not demonstrated.
Buprenorphin gennemgår first- pass metabolisme med N- dealkylering og glukuronid- konjugering i tyndtarmen og leveren, når det tages peroralt.
Buprenorphine, when taken orally, undergoes first-pass metabolism with N-dealkylation and glucuroconjugation in the small intestine and the liver.
Dette præparat er derfor ikke egnet til peroral administration.
The use of this medicinal product by the oral route is therefore inappropriate.
Der opnås maksimale plasmaconcentrationer 90 minutter efter sublingual administration.
Peak plasma concentrations are achieved 90 minutes after sublingual administration.
Plasma - buprenorphinniveauet stiger med den sublinguale Suboxone- dosis.
Plasma levels of buprenorphine increased with the sublingual dose of Suboxone.
Både Cmax og AUC af buprenorphin stiger med stigende dosis (i intervallet 4- 16 mg), selvom stigningen var mindre end proportional med dosis.
Both Cmax and AUC of buprenorphine increased with the increase in dose (in the range of 4-16 mg), although the increase was less than dose proportional.
Farmakokinetisk Parameter
Pharmacokinetic Parameter