natgillin/translations-raw huggingface dataset:
Buprenorphin alene er blevet anvendt som sublinguale tabletter siden midten af 1990’ erne som substitutionsbehandling for opioidafhængighed.
Buprenorphine on its own, as sublingual tablets, has been used since the mid-1990’ s as a substitution treatment for opioid addiction.
Men tabletterne er blevet misbrugt: der har været tilfælde af, at stofmisbrugere har opløst tabletterne for efterfølgende at indsprøjte opløsningen.
But the tablets have been misused: addicts have been known to dissolve them to inject the resulting solution.
Suboxone indeholder buprenorphin og naloxon sammen, fordi naloxon hjælper med til at forhindre
Suboxone contains buprenorphine with naloxone, because naloxone helps prevent the misuse of the medicine.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged misbrug af lægemidlet.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Suboxone been studied?
Virkningerne af Suboxone blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Suboxone were first tested in experimental models before being studied in humans.
Den vigtigste undersøgelse, der undersøgte effekten af Suboxone, sammenlignede Suboxone med buprenorphin alene eller med placebo (en uvirksom behandling) hos 326 opioidafhængige (heroin) patienter.
The main study of the effectiveness of Suboxone compared Suboxone to buprenorphine on its own or to placebo (dummy treatment) in 326 opioid-dependent (heroin) patients.
Patienterne anvendte desuden et specielt udviklet spørgeskema til registrering af deres trang til stoffer.
The study lasted 4 weeks, and measured the percentage of patients who had no trace of opioids in their urine at the end of the study.
Endvidere blev ændringen i pointtal i spørgeskemaet registreret før og efter undersøgelsen.
Patients also used a specially designed questionnaire to record their cravings, and the change in the questionnaire score before and at the end of the study was also measured.
Suboxone var mere effektiv end placebo: urinprøven hos 17, 8% af de patienter, der fik medicinen, blev testet negativ ved afslutningen af undersøgelsen; hvorimod procentdelen var 5, 8% hos de patienter, der havde modtaget placebo.
17.8% of the patients who received the medicine had a urine sample that tested negative at the end of the study, whereas the percentage was 5.8% in patients receiving placebo.
Pointtallene vedrørende trang til stoffer, som lå mellem 62, 4 og 65, 6 inden behandlingen, var nede på 29, 8 med Suboxone (og 55, 1 med placebo).
The craving score, which was between 62.4 and 65.6 before treatment, was down to 29.8 with Suboxone (and 55.1 with placebo).
Undersøgelsen viste endvidere, at der ikke var forskel i effekten af Suboxone, når det blev sammenlignet med buprenorphin alene.
The study also showed that there is no difference in the effectiveness of Suboxone when compared to buprenorphine on its own.
De mest almindelige bivirkninger (observeret hos flere end 1 ud af 10 patienter) er insomni (søvnbesvær), forstoppelse, kvalme, svedudbrud, hovedpine samt abstinenssymptomer.
The most common side-effects (seen in more than 1 patient in 10) are insomnia (difficulty sleeping), constipation, nausea (feeling sick), sweating, headache, and withdrawal syndrome.
Den fuldstændige liste over de indberettede bivirkninger ved Suboxone fremgår af indlægssedlen.
For the full list of all side effects reported with Suboxone, see the Package Leaflet.
Suboxone bør ikke anvendes af mennesker, der kan være overfølsomme (allergiske) over for buprenorphin eller naloxon eller over for et eller flere af hjælpestofferne.
Suboxone should not be used in people who may be hypersensitive (allergic) to buprenorphine or naloxone, or to any of the other ingredients.
Det bør ikke anvendes af patienter med svært nedsat lungefunktion, svært nedsat leverfunktion eller akut alkoholforgiftning eller delirium tremens (en tilstand der skyldes alkoholafvænning).
It should not be used in patients with severe lung insufficiency, severe liver insufficiency, or acute alcohol intoxication or delirium tremens (a condition brought on by alcohol withdrawal).
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at kombinationen af en opioid analog og en opioidantagonist er en etableret strategi til reducering af risikoen for intravenøst misbrug.
The Committee for Medicinal products for Human Use (CHMP) concluded that the combination of an opioid analogue with an opioid antagonist is an established strategy for reducing the potential for intravenous misuse.
Udvalget besluttede, at fordelene ved Suboxone som substitutionsbehandling for opioidafhængighed er større end risiciene, og udvalget anbefalede, at Suboxone fik markedsføringstilladelse.
They decided that Suboxone’ s benefits as a substitution treatment for opioid drug dependency are greater than its risks and they recommended that Suboxone be given marketing authorisation.
Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Suboxone?
Which measures are being taken to ensure the safe use of Suboxone?
Virksomheden, der markedsfører Suboxone, vil udfærdige informationsplaner for læger og farmaceuter med henblik på at sikre, at de er opmærksomme på risikoen for misbrug, og at de indberetter specifikke sikkerhedsproblemer i forbindelse med lægemidlet såsom leversygdomme og virkningen på nyfødte.
The company who markets Suboxone will put together information plans for doctors and pharmacists, to ensure that they are aware of the risk of misuse, and that they report on specific safety issues with the medicine such as liver disorders and effect on newborns.
Andre oplysninger om Suboxone:
Other information about Suboxone:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Suboxone til SP Europe den 26 september 2006.
The European Commission granted a marketing authorisation valid throughout the European Union for Suboxone to SP Europe on 26 September 2006.
Den fuldstændige EPAR om X findes her.
The full EPAR for Suboxone can be found here.
2 mg / 0, 5mg
2 mg / 0.5mg
resoribletter, sublinguale
Sublingual tablet
Blister (nylon/ ALU/ PVC)
Blister (nylon/ ALU/ PVC)
8 mg / 2 mg
8 mg / 2 mg
Suboxone 2 mg/ 0, 5 mg resoribletter, sublinguale
Suboxone 2 mg/ 0.5 mg sublingual tablets
Hver resoriblet indeholder 2 mg buprenorphin (som buprenorphinhydrochlorid) og 0, 5 mg naloxon (som naloxonhydrochloriddihydrat).
Each tablet contains 2 mg buprenorphine (as buprenorphine hydrochloride) and 0.5 mg naloxone (as naloxone hydrochloride dihydrate).
Laktose 42 mg.
Excipients: lactose 42 mg
Hvid, hexagonal, bikonveks resoriblet trykt med et logo i form af et sværd på den ene side og ” N2 ” på den modsatte side.
White hexagonal biconvex tablets, embossed with a sword logo on one side and “ N2” on the reverse side.
Substitutionsbehandling af opioid- afhængighed som led i en medicinsk, social og psykologisk behandling.
Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment.
Formålet med nalaxon- bestanddelen er at undgå intravenøs misbrug.
The intention of the naloxone component is to deter intravenous misuse.
Behandlingen retter sig mod voksne og unge over 15 år, der er motiveret for behandling for afhængighed.
Treatment is intended for use in adults and adolescents over 15 years of age who have agreed to be treated for addiction.
Behandling skal ske under overvågning af en læge, der har erfaring med behandling af opioid afhængighed/ misbrug.
Treatment must be under the supervision of a physician experienced in the management of opiate dependence/ addiction.
Hver Suboxone- resoriblet, sublingual, indeholder buprenorphin og naloxon.
Each Suboxone sublingual tablet contains buprenorphine and naloxone.
De Suboxone- tabletter, der indeholder 2 mg buprenorphin og 0, 5 mg naloxon, omtales som ” 2 mg- tabletterne ”.
Suboxone containing 2 mg buprenorphine and 0.5 mg naloxone is referred to as the "2 mg" tablets.
4. 4).
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).
Suboxone- resoribletten, sublingual, skal lægges under tungen, indtil den er opløst, hvilket sædvanligvis varer 5- 10 minutter.
Suboxone sublingual tablets are to be placed under the tongue until dissolved, which usually requires 5 to 10 minutes.
Den anden portion tages umiddelbart efter, at den første er opløst.
The dose is made up from Suboxone 2 mg/ 0.5 mg and Suboxone 8 mg/ 2 mg sublingual tablets, 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.
Voksne Det anbefales at foretage baseline leverfunktionstests og dokumentation for viral hepatitis– status, før behandlingen igangsættes.
Baseline liver function tests and documentation of viral hepatitis status is recommended prior to commencing therapy.
Der er risiko for hurtigt forværrede leverskader hos følgende patientgrupper: patienter, som er positive for viral hepatitis, patienter, som er i samtidig behandling med andre lægemidler (se pkt.
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.
4. 4).
Regular monitoring of liver function is recommended (see section 4.4).
Induktionsbehandling:
2 Induction:
Følgende forhold bør klarlægges og afvejes inden behandlingsstart: opioidafhængidhed (f. eks. langtids - eller korttidsvirkende opioid), varigheden siden sidste brug af opioid og graden af opioidafhængighed.
Prior to treatment induction, consideration should be given to the type of opioid dependence (i. e. long- or short-acting opioid), the time since last opioid use and the degree of opioid dependence.
For at undgå for brat afvænning bør der foretages induktion med Suboxone - eller buprenorphintabletter, når der ses objektive og klare tegn på abstinenser.
To avoid precipitating withdrawal, induction with Suboxone or buprenorphine only tablets should be undertaken when objective and clear signs of withdrawal are evident.
2 Indledende behandling:
Initiation therapy:
Anbefalet startdosis er en til to resoribletter Suboxone 2 mg/ 0, 5 mg.
The recommended starting dose is one to two tablets of Suboxone 2 mg/ 0.5 mg sublingual tablets.
Yderligere en til to resoribletter Suboxone 2 mg/ 0, 5 mg kan gives første dag afhængigt af den enkelte patients behov.
An additional one to two tablets of the Suboxone 2 mg/ 0.5 mg may be administered on day one depending on the individual patient’ s requirement.
Ved behandlingsstart bør den første dosis Suboxone tages, når der opstår tegn på abstinenser.
Opioid-dependent drug addicts who have not undergone withdrawal:
Det må dog ikke være mindre end 6 timer siden, at patienten sidst brugte opioider (f. eks. heroin; korttidsvirkende opioider).
When treatment starts, the first dose of Suboxone should be taken when signs of withdrawal appear, but not less than 6 hours after the patient last used opioids (eg. heroin; short acting opioids).
Patienter i metadonbehandling:
Patients receiving methadone:
Før behandling med Suboxone indledes, skal metadondosis reduceres til højst 30 mg/ dag.
Before beginning Suboxone therapy, the dose of methadone must be reduced to a maximum of 30 mg/ day.
Det må dog ikke være mindre end 24 timer siden, at patienten sidst anvendte metadon.
The first dose of Suboxone should be taken when signs of withdrawal appear, but not less than 24 hours after the patient last used methadone.
Dosisjustering og vedligeholdelse:
Dosage adjustment and maintenance:
Dosis bør ikke overskride en maksimal enkeltdosis på 24 mg/ daglig.
The dose of Suboxone should be increased progressively according to the clinical effect of the individual patient and should not exceed a maximum single daily dose of 24 mg.
Justeringen bør foretages i trin af 2- 8 mg.
The dosage is titrated according to reassessment of the clinical and psychological status of the patient and should be made in steps of 2-8 mg.
Ved behandlingsstart anbefales det at udlevere buprenorphin dagligt Efter stabilisering kan patienter, der anses for at være pålidelige, forsynes med Suboxone til flere dages behandling.
After stabilisation, a reliable patient may be given a supply of Suboxone sufficient for several days of treatment.
Det anbefales at begrænse mængden af Suboxone til 7 dage eller til den mængde, der er fastsat af de lokale krav.
It is recommended that the amount of Suboxone be limited to 7 days or according to local requirements.
Mindre end daglig dosering:
Less than daily dosing:
Ved tilfredsstillende stabilisering kan frekvensen af Suboxone- dosering nedsættes til hver anden dag med den dobbelte individuelt justerede daglige dosis.
After a satisfactory stabilisation has been achieved the frequency of Suboxone dosing may be decreased to dosing every other day at twice the individually titrated daily dose.
For eksempel kan en patient, som er stabiliseret på en daglig dosis på 8 mg, tage 16 mg hver anden dag uden dosering i dagene imellem.
For example, a patient stabilised to receive a daily dose of 8 mg may be given 16 mg on alternate days, with no dose on the intervening days.
Dosis for en enkelt dag bør dog aldrig overskride 24 mg.
However, the dose given on any one day should not exceed 24 mg.
Hos nogle patienter, hvor tilfredsstillende stabilisering er opnået, kan frekvensen af Suboxone- dosering nedsættes til 3 gange om ugen (f. eks. mandag, onsdag og fredag).
In some patients, after a satisfactory stabilisation has been achieved, the frequency of Suboxone dosing may be decreased to 3 times a week (for example on Monday, Wednesday and Friday).
Dosis mandag og onsdag bør være dobbelt dosis af den individuelt justerede daglige dosis, og dosis fredag bør være 3 gange den individuelt justerede daglige dosis, uden dosering i dagene imellem.
The dose on Monday and Wednesday should be twice the individually titrated daily dose, and the dose on Friday should be three times the individually titrated daily dose, with no dose on the intervening days.
Patienter som behøver en daglig dosis > 8 mg/ dag finder muligvis ikke denne behandling tilfredsstillende.
Patients requiring a titrated daily dose > 8 mg/ day may not find this regimen adequate.
Dosisreduktion og behandlingsophør:
Dosage reduction and termination of treatment:
I visse favorable tilfælde kan behandling seponeres.
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.
Tilgængeligheden af resoribletter i 2 mg og 8 mg muliggør nedjustering af dosis.
The availability of the sublingual tablet in doses of 2 mg and 8 mg allows for a downward titration of dosage.
Til patienter som behøver en mindre buprenorphin dosis, kan buprenorphin 0, 4 mg resoribletter, sublinguale anvendes.
For patients who may require a lower buprenorphine dose, buprenorphine 0.4 mg sublingual tablets may be used.
Patienter skal følges efter seponering af behandlingen p. g. a. risiko for recidiv.
Patients should be monitored following termination of treatment because of the potential for relapse.
Der er ingen data tilgængelige for ældre patienter.
No data is available on elderly patients.
Suboxone bør ikke anvendes til børn under 15 år p. g. a. manglende dokumentation for sikkerhed og virkning.
Suboxone is not recommended for use in children below age 15 years due to lack of data on safety and efficacy.
Patienter med nedsat leverfunktion:
3 Patients with impaired hepatic function:
Virkningen af leversvækkelse på buprenorphins og nalaxones farmakokinetik er ukendt.
The effect of hepatic impairment on the pharmacokinetics of buprenorphine and naloxone is unknown.
Da begge aktive substanser metaboliseres i udbredt grad, forventes plasmaniveauet at være højere hos patienter med moderat til svært nedsat leverfunktion.
Since both active substances are extensively metabolized, the plasma levels will be expected to be higher in patients with moderate and severe hepatic impairment.
Det vides ikke, om begge aktive substanser påvirkes i samme grad.
It is not known whether both active substances are affected to the same extent.
5. 2).
As Suboxone pharmacokinetics may be altered in patients with hepatic insufficiency, lower initial doses and careful dose titration in patients with mild to moderate hepatic impairment are recommended (see section 5.2).
3 Patienter med nedsat nyrefunktion:
Patients with impaired renal function:
Justering af Suboxonedosis er ikke nødvendig hos patienter med nyreinsufficens.
Modification of the Suboxone dose is not required in patients with renal insufficiency.
5. 2).
Caution is recommended when dosing patients with severe renal impairment (CLcr < 30 ml/ min) (see section 5.2).
Suboxone er kontraindiceret i følgende tilfælde: • overfølsomhed over for buprenorphin, over for naloxon eller over for et eller flere af hjælpestofferne, • svær respirationsinsufficiens, • svær leverinsufficiens, • akut alkoholisme eller delirium tremens.
Suboxone is contraindicated in the following instances: • hypersensitivity to buprenorphine, to naloxone, or to any of the excipients, • severe respiratory insufficiency, • severe hepatic insufficiency, • acute alcoholism or delirium tremens.
Som følge af mangel på data hos unge (i alderen 15 - < 18), bør Suboxone kun anvendes med forsigtighed i denne aldersgruppe.
Due to the lack of data in adolescents (age 15- < 18), Suboxone should be used only with caution in this age group.
Patienter bør overvåges nøje i den periode, hvor der skiftes fra buprenorphin eller metadon til Suboxone, da der har været rapporteret abstinenssymptomer.
Patients should be closely monitored during the switching period from buprenorphine or methadone to Suboxone since withdrawal symptoms have been reported.
Diversion:
Diversion:
Diversion refererer til introduktionen af buprenorphin på det illegale marked enten af patienter eller af personer, som har skaffet lægemidlet ved tyveri fra patienter eller apoteker.
Diversion refers to the introduction of buprenorphine into the illicit market either by patients or by individuals who obtain the medicinal product through theft from patients or pharmacies.
Denne diversion kan medføre nye afhængige, som anvender buprenorphin som det primære misbrugsstof med risiko for overdosering, spredning af blodoverførte virusinfektioner, respirationssuppression og leverskader.
This diversion may lead to new addicts using buprenorphine as the primary drug of abuse, with the risks of overdose, spread of blood borne viral infections, respiratory depression and hepatic injury.
Da indholdet af naloxon i kombinationstabletten fremskynder abstinenser hos personer, som er afhængige af heroin, metadon eller andre fulde agonister, er det mindre sandsynligt at Suboxone vil finde vej til et illegalt marked for intravenøs brug.
Because the naloxone in the combination tablet precipitated withdrawal in individuals dependent on heroin, methadone, or other full agonists, Suboxone is expected to be less likely to be diverted for intravenous use.
Fremkaldelse af abstinenser:
Precipitated withdrawal:
Det er især tilfældet, hvis det administreres mindre end 6 timer efter sidste brug af heroin eller andre kortvirkende opioider, eller hvis det administreres mindre end 24 timer efter sidste dosis metadon (se pkt.
When initiating treatment with buprenorphine, the physician must be aware of the partial agonist profile of buprenorphine and that it can precipitate withdrawal in opioid-dependent patients particularly if administered less than 6 hours after the last use of heroin or other short acting opioid, or if administered less than 24 hours after the last dose of methadone (see section 4.2).
Modsat kan abstinenser også være forbundet med suboptimal dosering.
Conversely, withdrawal symptoms may also be associated with suboptimal dosing.
Risikoen for alvorlige bivirkninger som eksempelvis overdosering eller behandlingsfrafald er større, hvis en patient er underdoseret med Suboxone og fortsætter med at selvmedicinere abstinenssymptomer med opioider, alkohol eller andre sedativ- hypnotika, særligt benzodiazepiner.
The risk of serious undesirable effects such as overdose or treatment dropout is greater if a patient is under dosed with Suboxone and continues to self medicate withdrawal symptoms with opioids, alcohol or other sedative-hypnotics in particular benzodiazepines.
Afhængighed:
Dependence:
Buprenorphin er en partiel my- opioat- receptoragonist og kronisk administration medfører afhængighed af opioidtypen.
Buprenorphine is a partial agonist at the mu-opiate receptor and chronic administration produces dependence of the opioid type.
Seponering af behandling kan medføre et forsinket abstinenssyndrom.
Discontinuation of treatment may result in a withdrawal syndrome that may be delayed.
Suboxone kan forårsage døsighed, særligt ved samtidig indtag af alkohol eller CNS- hæmmere (såsom beroligende midler, sedativa eller hypnotika) (se pkt.
4 Suboxone may cause drowsiness, particularly when taken together with alcohol or central nervous system depressants (such as tranquilisers, sedatives or hypnotics) (see section 4.5).
Både dyreforsøg og kliniske undersøgelser har vist, at buprenorphin kan medføre afhængighed, men i en lettere grad end morfin.
Studies in animals, as well as clinical experience, have demonstrated that buprenorphine may produce dependence but at a lower level than morphine.
Respirationshæmning:
Respiratory depression:
Dødsfaldene forekom særligt i de tilfælde, hvor buprenorphin blev brugt i kombination med benzodiazepiner (se pkt 4. 5), eller hvor buprenorphin ikke blev taget som foreskrevet.
A number of cases of death due to respiratory depression have been reported, particularly when buprenorphine was used in combination with benzodiazepines (see section 4.5), or when buprenorphine was not used according to prescribing information.
4 Der er rapporteret om dødsfald i forbindelse med samtidig indtagelse af buprenorphin og andre hæmmende midler som alkohol eller andre opioider.
Deaths have been reported in association with concomitant administration of buprenorphine and other depressants such as alcohol or other opioids.
Hepatitis og leverlidelser:
Hepatitis and hepatic events:
Tilfælde af akut leverskade er rapporteret hos opioidafhængige misbrugere både i kliniske undersøgelser og i bivirkningsrapportering efter markedsføring.
Cases of acute hepatic injury have been reported in opioid-dependent addicts both in clinical trials and in post marketing adverse event reports.
Spektret af abnormaliteter varierer fra forbigående asymptomatiske forhøjelser i levertransaminaser til rapporter om leversvigt, levernekrose, hepatorenalt syndrom og hepatisk encephalopati.
The spectrum of abnormalities ranges from transient asymptomatic elevations in hepatic transaminases to case reports of hepatic failure, hepatic necrosis, hepatorenal syndrome and hepatic encephalopathy.
I mange tilfælde kan tidligere eksisterende leverenzym- abnormaliteter, infektion med hepatitis B eller C virus, samtidig brug af andre potentielt hepatotoksiske midler og løbende brug af injicerede stoffer have en fremkaldende eller medvirkende effekt.
In many cases the presence of pre-existing liver enzyme abnormalities, infection with hepatitis B or hepatitis C virus, concomitant use of other potentially hepatotoxic medicines, and ongoing injecting drug use may have a causative or contributory role.
Disse underliggende faktorer skal tages i betragtning før ordination af Suboxone samt under behandling.
These underlying factors must be taken into consideration before prescribing Suboxone and during treatment.