FrancophonIA/ELRC3.0 huggingface dataset:
English: • For patients using heroin or short-acting opioids, the initial dose of Buvidal must not be administered until at least 6 hours after the patient last used opioids.
Danish: • Hos patienter, som bruger heroin eller korttidsvirkende opioider, må den første dosis af Buvidal ikke administreres, før mindst 6 timer efter, at patienten sidst brugte opioider.
English: If the patient is switched to treatment with sublingual buprenorphine, this should be done one week after the last weekly dose or one month after the last monthly dose of Buvidal according to the recommendations in Table 1.
Danish: Hvis patientens behandling skiftes til sublingual buprenorphin, skal det gøres en uge efter den sidste ugentlige dosis eller en måned efter den sidste månedlige dosis af Buvidal ifølge anbefalingerne i Tabel 1.
English: Long-term administration 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 i de sidste tre måneder af graviditeten kan medføre abstinenssyndrom hos det nyfødte barn (f.eks. hypertoni, neonatal tremor, neonatal agitation, myoclonus eller kramper).
English: During the 48-week treatment period, patients could be transitioned between weekly and monthly injections with Buvidal and between doses (8 mg to 32 mg weekly Buvidal and 64 mg to 160 mg monthly Buvidal) according to the physician's clinical judgement.
Danish: I behandlingsperioden på 48 uger kunne patienters behandling skiftes mellem ugentlige og månedlige injektioner med Buvidal og mellem doser (8 mg til 32 mg Buvidal ugentligt og 64 mg til 160 mg Buvidal månedligt) ifølge lægens kliniske vurdering.
English: The following pack sizes are available:
Danish: Følgende pakningsstørrelser fås:
English: Elimination of buprenorphine from Buvidal is release-rate limited with a terminal half-life ranging from 19 to 25 days.
Danish: Elimination af buprenorphin fra Buvidal begrænses af frigørelseshastigheden med en afsluttende halveringstid mellem 19 og 25 dage.
English: Buprenorphine should be used with care in patients with respiratory insufficiency (e.g. chronic obstructive pulmonary disease, asthma, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, pre-existing respiratory depression or kyphoscoliosis).
Danish: Buprenorphin bør anvendes med forsigtighed hos patienter med respirationsinsufficiens (f.eks. kronisk obstruktiv lungesygdom, astma, cor pulmonale, nedsat respiratorisk reserve, hypoxi, hyperkapni, eksisterende respirationsdepression eller kyfoskoliose).
English: Buprenorphine products have caused precipitated withdrawal symptoms in opioiddependent patients when administered before the agonist effects resulting from recent opioid use or misuse have subsided.
Danish: Buprenorphin-indeholdende produkter har fremkaldt abstinenssymptomer hos opioidafhængige patienter ved administration inden agonist-effekter, der er forbundet med nylig brug af opioid eller misbrug, har foretaget sig.
English: If used together with alcohol or central nervous system depressants, the effect is likely to be more pronounced (see sections 4.4. and 4.5).
Danish: Hvis det bruges sammen med alkohol eller CNS-supprimerende midler, vil virkningen sandsynligvis være mere udtalt (se pkt.
English: Buvidal is intended for subcutaneous administration only.
Danish: Buvidal er kun beregnet til subkutan administration.
English: • sedative antihistamines (used to treat allergic reactions)
Danish: • sederende antihistaminer (som bruges til at behandle allergiske reaktioner)
English: • antidepressants (used to treat depression)
Danish: • antidepressiva (som bruges til at behandle depression)
English: Patients should be warned that it is extremely dangerous to self-administer non-prescribed benzodiazepines whilst taking this product, and should also be cautioned to use benzodiazepines concurrently with this product only as directed by their physician (see section 4.4).
Danish: Patienterne skal advares om, at det er meget farligt egenhændigt at administrere benzodiazepiner, som ikke er ordineret af en læge, under behandling med dette lægemiddel, og de skal endvidere informeres om, at samtidig anvendelse af benzodiazepiner skal ske i henhold til lægens anvisninger (se pkt.
English: Elimination of buprenorphine from Buvidal is release-rate limited with a terminal half-life ranging from 3 to 5 days.
Danish: Elimination af buprenorphin fra Buvidal begrænses af frigørelseshastigheden med en afsluttende halveringstid mellem 3 og 5 dage.
English: Administration of Buvidal is restricted to healthcare professionals.
Danish: Administration af Buvidal er begrænset til sundhedspersonale.
English: For management of acute pain during continued use of Buvidal, a combination of use of opioids with high mu-opioid receptor affinity (e.g. fentanyl), non-opioid analgesics and regional anaesthesia might be necessary.
Danish: Det kan under fortsat brug af Buvidal være nødvendigt at behandle akutte smerter med en kombination af opioider med høj affinitet for my-opioid-receptoren (f.eks. fentanyl), analgetika uden opioid, og lokalanalgesi.
English: Buvidal may trigger withdrawal symptoms in methadone-dependent patients.
Danish: Buvidal kan udløse abstinenssymptomer hos metadonafhængige patienter.
English: Dose-proportional increases in exposure are observed in the dose interval 8 mg to 32 mg.
Danish: Dosisproportionelle stigninger i eksponering ses i doseringsintervallet fra 8 mg til 32 mg.
English: Preliminary symptoms of overdose may also include excessive sweating, somnolence, amblyopia, miosis, hypotension, nausea, vomiting and / or speech disorders.
Danish: Præliminære symptomer på overdosis kan også inkludere stærkt forøget svedtendens, døsighed, amblyopi, miosis, hypotension, kvalme, opkastning og/eller taleforstyrrelser.
English: Ethanol anhydrous
Danish: Vandfri ethanol
English: Treatment with monthly Buvidal can be started after treatment initiation with weekly Buvidal, in accordance with the dose conversion in Table 2 and once patients have been stabilised on weekly treatment (four weeks or more, where practical).
Danish: Behandling med månedlig Buvidal kan påbegyndes efter start af behandling med ugentlig Buvidal i overensstemmelse med dosiskonverteringen i Tabel 2. og så snart patienterne er stabiliseret med en ugentlig behandling (fire uger eller mere, hvor det er praktisk).
English: Camurus AB Ideon Science Park SE-223 70 Lund, Sweden
Danish: Camurus AB Ideon Science Park SE-223 70 Lund, Sverige
English: Maintenance treatment and dose adjustments
Danish: Vedligeholdelsesbehandling og dosisjustering
English: - Do not uncap the safety syringe until you are ready to inject.
Danish: - Tag ikke hætten af sikkerhedsanordningen, før du er klar til injektionen.
English: In particular, patients with concomitant medicinal products and/or comorbidities, should be monitored for signs and symptoms of toxicity, overdose or withdrawal caused by increased or decreased levels of buprenorphine.
Danish: Patienter, som samtidig modtager andre lægemidler og/eller har komorbiditeter, bør især monitoreres for tegn og symptomer på toksicitet, overdosering eller abstinenser som følge af forhøjede eller reducerede niveauer af buprenorphin.
English: An effect of buprenorphine on fertility in animals has not been seen (see section 5.3).
Danish: Der er ikke blevet set en effekt af buprenorphin på fertilitet hos dyr (se pkt.
English: - Take the syringe out of the cardboard box: pick up the syringe by the syringe guard body.
Danish: - Tag injektionssprøjten ud af papæsken: Tag fat i injektionssprøjten ved at holde om kanylebeskytteren.
English: Modification of the buprenorphine dose is not required for patients with renal impairment.
Danish: Dosisjustering af buprenorphin er ikke nødvendig hos patienter med nedsat nyrefunktion.
English: Do not uncap the safety syringe until you are ready to inject.
Danish: Tag ikke hætten af sikkerhedsanordningen, før du er klar til injektionen.
English: • For patients receiving methadone, the methadone dose should be reduced to a maximum of 30 mg/day before starting treatment with Buvidal which should not be administered until at least 24 hours after the patient last received a methadone dose.
Danish: • Hos patienter i metadonbehandling, skal metadondosen reduceres til maksimalt 30 mg/dag, inden behandling med Buvidal påbegyndes, dog mindst 24 timer efter, at patienten sidst fik metadon.
English: Take-home use or self-administration of the product by patients is not allowed.
Danish: Produktet må ikke udleveres til patienter til hjemmebrug eller selvadministration.
English: - other medicines that may make you feel sleepy which are used to treat illnesses such as anxiety, sleeplessness, convulsions (fits) and pain.
Danish: - Anden medicin, som kan gøre dig søvnig, som bruges til behandling af lidelser såsom angst, søvnløshed, kramper/krampeanfald og smerter.
English: Buprenorphine is an opioid partial agonist/antagonist which binds to the μ (mu) and κ (kappa) opioid receptors of the brain.
Danish: Buprenorphin er en partiel opioidagonist/antagonist, som binder sig til μ (my-) og κ (kappa-)
English: - certain antiepileptic medicines (used to treat epilepsy) such as phenobarbital, carbamazepine and phenytoin as they may decrease the effect of Buvidal.
Danish: - visse antiepileptika (som bruges til at behandle epilepsi) som f.eks. phenobarbital, carbamazepin og phenytoin, da de kan reducere virkningen af Buvidal.
English: Patients in the sublingual buprenorphine/naloxone group (n = 215) received weekly placebo injections during the first 12 weeks and monthly placebo injections during the last 12 weeks, plus daily sublingual buprenorphine/naloxone tablets during the complete treatment period (8 mg to 24 mg during the first 12 weeks and 8 mg to 32 mg during the last 12 weeks).
Danish: Patienter i behandlingsgruppen sublingual buprenorphin/naloxon (n = 215) fik ugentlige injektioner af placebo i de første 12 uger og månedlige injektioner af placebo i de sidste 12 uger, plus daglige sublinguale tabletter med buprenorphin/naloxon i hele behandlingsperioden (8 mg til 24 mg i de første 12 uger og 8 mg til 32 mg i de sidste 12 uger).
English: Titration of oral or intravenous short-acting opioid pain medicinal products (immediaterelease morphine, oxycodone or fentanyl) to the desired analgesic effect in patients treated with Buvidal might require higher doses.
Danish: Titrering af orale eller intravenøse kortvirkende smertestillende lægemidler, som indeholder opioid (morfin, oxycodon eller fentanyl med øjeblikkelig udløsning) kan kræve højere doser for at opnå den ønskede smertestillende virkning.
English: Opioid agonist ceiling effects were observed during clinical pharmacology studies in opioid-dependent persons.
Danish: Der blev observeret et loft for den opioidagonistisk effekt hos opioidafhængige personer i kliniske farmakologiske studier.
English: - While holding the syringe as shown (see Figure 6), slowly depress the plunger until the plunger head latches between the syringe guard wings and all the solution is injected.
Danish: - Hold injektionssprøjten som vist (se Figur 6) og skub langsomt stemplet ned, indtil stempelhovedet låses fast mellem vingerne på injektionssprøjtens kanylebeskytter, og al opløsningen injiceres.
English: A 1 mL pre-filled syringe (glass, Type I) with plunger stopper (fluoropolymer-coated bromobutyl rubber) with needle (½-inch, 23 gauge, 12 mm) and needle shield (styrene butadiene rubber).
Danish: En 1 ml fyldt injektionssprøjte (glas, Type I) med stempelprop (fluoropolymer-belagt bromobutylgummi) med kanyle (½ tomme, 23 gauge, 12 mm) og kanylehætte (styrenbutadiengummi).
English: Continuing treatment and dose adjustment
Danish: Fortsættelse af behandling og dosisjustering
English: Patients should be cautioned to use gabapentinoids (such as pregabalin and gabapentin) concurrently with this product only as directed by their physician (see section 4.4).
Danish: Patienterne skal advares om kun at bruge gabapentinoider (som f.eks. pregabalin og gabapentin) under behandling med dette lægemiddel i henhold til lægens anvisninger (se pkt.
English: - As soon as the needle has been completely removed from the skin, slowly take the thumb off the plunger and allow the syringe guard to automatically cover the exposed needle (see Figure 8).
Danish: - Så snart kanylen er blevet fjernet helt fra huden, slip langsomt stemplet med tommelfingeren og lad kanylebeskytteren automatisk dække den eksponerede kanyle (se Figur 8).
English: Norbuprenorphine is a µ-opioid agonist with weak intrinsic activity.
Danish: Norbuprenorphin er en μ-opioidagonist med svag egenvirkning.
English: Taking too much of a gabapentinoid may lead to death because both medicines can cause very slow and shallow breathing (respiratory depression).
Danish: Hvis du tager for meget gabapentinoid, kan det medføre død, da begge lægemidler kan forårsage meget langsom og overfladisk vejrtrækning (respirationsdepression).
English: Effect of hepatic impairment (change relative to healthy subjects) on pharmacokinetic parameters of buprenorphine following sublingual buprenorphine/naloxone administration (2.0/0.5 mg) in healthy subjects, and in subjects with varied degrees of hepatic impairment Pharmacokinetic
Danish: Effekt af nedsat leverfunktion (ændring i forhold til raske forsøgspersoner) på farmakokinetiske parametre for buprenorphin efter administration af sublingual buprenorphin/naloxon (2,0/0,5 mg) hos raske forsøgspersoner og hos forsøgspersoner med forskellige grader af nedsat leverfunktion Farmakokinetisk parameter let nedsat leverfunktion
English: Switching from sublingual buprenorphine products to Buvidal Patients treated with sublingual buprenorphine may be switched directly to weekly or monthly Buvidal, starting on the day after the last daily buprenorphine sublingual treatment dose in accordance with the dosing recommendations in Table 1.
Danish: Skift fra sublinguale buprenorphin-indeholdende produkter til Buvidal Patienter behandlet med sublingual buprenorphin kan få skiftet behandling direkte til ugentlig eller månedlig Buvidal med start fra dagen efter den sidste daglige sublinguale behandlingsdosis af buprenorphin i henhold til anbefalingerne vedrørende dosering i Tabel 1.
English: In patients with severe hepatic impairment, the use of buprenorphine is contraindicated (see section 4.3).
Danish: Hos patienter med alvorlig nedsat leverfunktion er brugen af buprenorphin kontraindiceret (se pkt.
English: Very common side effects (may affect more than 1 in 10 people): - Insomnia (inability to sleep) - Headache - Nausea (feeling sick) - Sweating, drug withdrawal syndrome, pain
Danish: Meget almindelige bivirkninger (kan påvirke mere end 1 ud af 10 personer): - Søvnløshed (manglende evne til at sove) - Hovedpine - Opkastningsfornemmelser (kvalme) - Svedtendens, abstinenssyndrom, smerter
English: The spectrum of abnormalities ranges from transient asymptomatic elevations in hepatic transaminases to case reports of cytolytic hepatitis, hepatic failure, hepatic necrosis, hepatorenal syndrome, hepatic encephalopathy and death.
Danish: Spektret af abnormiteter spænder fra forbigående asymptomatiske forhøjelser i levertransaminase til cytolytisk hepatitis, leversvigt, levernekrose, hepatorenalt syndrom, hepatisk encefalopati og død.
English: Patients in the Buvidal group (n = 213) received weekly injections (16 mg to 32 mg) during the first 12 weeks followed by monthly injections (64 mg to 160 mg) during the last 12 weeks, plus daily doses of sublingual placebo tablets during the complete treatment period.
Danish: Patienter i Buvidal-behandlingsgruppen (n = 213) fik ugentlige injektioner (16 mg til 32 mg) i de første 12 uger efterfulgt af månedlige injektioner (64 mg til 160 mg) i de sidste 12 uger plus daglige doser af sublinguale placebotabletter i hele behandlingsperioden.
English: Efficacy variables in a pivotal phase 3, randomised, double-blind, doubledummy, active-controlled, flexible-dose study in patients with moderate to severe opioid dependence
Danish: Effektvariabler i et fase 3-, randomiseret, dobbeltblindet, dobbelt-dummy, aktivtkontrolleret, fleksibel-dosis hovedstudie hos patienter med moderat til svær opioidafhængighed
English: Taking too much of a benzodiazepine together with Buvidal may lead to death because both medicines can cause very slow and shallow breathing (respiratory depression).
Danish: Hvis du tager for meget benzodiazepin sammen med Buvidal, kan det medføre død, da begge lægemidler kan forårsage meget langsom og overfladisk vejrtrækning (respirationsdepression).
English: Deaths have also been reported in association with concomitant administration of buprenorphine and other depressants such as alcohol, gabapentinoids (such as pregabalin and gabapentin) (see section 4.5) or other opioids.
Danish: Der er også modtaget indberetning om dødsfald i forbindelse med samtidig administration af buprenorphin og andre beroligende midler, såsom alkohol, gabapentinoider (såsom pregabalin og gabapentin) (se pkt.
English: The dose must not be administered intravascularly (intravenously), intramuscularly or intradermally (into the skin) (see section 4.4).
Danish: Dosen må ikke administreres intravaskulært (intravenøst), intramuskulært eller intradermalt (i huden) (se pkt.
English: For the new-to-treatment patients, the percentage of patients with illicit opioid-negative urine samples was 0.0% at baseline and 63.0% at the end of the 48-week treatment period.
Danish: For patienter, som ikke tidligere var blevet behandlet med buprenorphin, var procentdelen af urinprøver, der er negative for ulovlig opioid 0,0 % ved baseline og 63,0 % ved slutningen af behandlingsperioden på 48 uger.
English: Patients with moderate hepatic impairment should be monitored for signs and symptoms of precipitated opioid withdrawal, toxicity or overdose caused by increased levels of buprenorphine.
Danish: Patienter med moderat nedsat leverfunktion bør monitoreres for tegn og symptomer på fremprovokerede opioid-abstinenser, toksicitet eller overdosering forårsaget af forhøjede niveauer af buprenorphin.
English: The pharmacokinetic properties of Buvidal are described in section 5.2.
Danish: De farmakokinetiske egenskaber af Buvidal er beskrevet i pkt.
English: Figure 8 Disposing of the syringe
Danish: Figur 8 Bortskaffelse af injektionssprøjten
English: Safety syringe parts
Danish: Sikkerhedsinjektionssprøjtens dele
English: Buvidal with alcohol
Danish: Brug af Buvidal sammen med alkohol
English: Dysmenorrhoea
Danish: Dysmenoré
English: If you use more buprenorphine than you should
Danish: Hvis du har brugt for meget buprenorphin
English: The efficacy and safety of Buvidal in the treatment of opioid dependence were established in a pivotal phase 3, randomised, double-blind, double-dummy, active-controlled, flexible-dose study in patients with moderate to severe opioid dependence.
Danish: Effekten og sikkerheden af Buvidal til behandling af opioidafhængighed blev dokumenteret i et fase 3, randomiseret, dobbeltblindet, dobbelt-dummy, aktivt-kontrolleret, fleksibel- dosis studie hos patienter med moderat til svær opioidafhængighed.
English: To avoid precipitating symptoms of withdrawal, treatment with Buvidal should be started when objective and clear signs of mild to moderate withdrawal are evident (see section 4.4).
Danish: For at undgå at fremprovokere abstinenssymptomer bør behandling med Buvidal først indledes, når der ses objektive og tydelige tegn på milde til moderate abstinenser (se pkt.
English: Hypertonia Speech disorders
Danish: Hypertoni Taleforstyrrelser
English: For patients currently receiving naltrexone treatment, the intended therapeutic effects of buprenorphine administration may be blocked by naltrexone.
Danish: Naltrexon kan hos patienter, som på nuværende tidspunkt behandles med naltrexon, blokere den tilsigtede terapeutiske virkning af buprenorphinadministration.
English: A number of cases of death due to respiratory depression have been reported for patients being treated with buprenorphine, particularly when used in combination with benzodiazepines (see section 4.5) or when buprenorphine was not used according to prescribing information.
Danish: Der er modtaget indberetning om en række dødsfald forårsaget af respirationsdepression hos patienter i behandling med buprenorphin, særligt når buprenorphin blev anvendt samtidigt med benzodiazepiner (se pkt.
English: Do not use if the safety syringe is broken or the packaging is damaged.
Danish: Må ikke bruges, hvis sikkerhedsinjektionssprøjten eller emballagen er beskadiget.
English: Camurus AB Ideon Science Park SE-223 70 Lund, Sweden Phone: +800 2577 2577
Danish: Camurus AB Ideon Science Park SE-223 70 Lund,Sverige Telefon: +800 2577 2577
English: Using this medicine during late pregnancy may cause drug withdrawal symptoms including breathing problems in your new-born baby.
Danish: Brug af dette lægemiddel sidst i graviditeten kan medføre, at barnet fødes med abstinenssymptomer, inklusive vejrtrækningsproblemer.
English: Buprenorphine is extensively metabolised in the liver.
Danish: Buprenorphin metaboliseres i udbredt grad i leveren.
English: Common side effects (may affect up to 1 in 10 people): - Infection, influenza, sore throat and painful swallowing, runny nose - Swollen glands (lymph nodes) - Hypersensitivity - Decreased appetite - Anxiety, agitation, depression, hostility, nervousness, abnormal thinking, paranoia - Sleepiness, feeling dizzy, migraine, burning or tingling in hands and feet, fainting, tremor,
Danish: Almindelige bivirkninger (kan påvirke op til 1 ud af 10 personer): - Infektion, influenza, ondt i halsen og smerter når du synker, snue - Hævede kirtler (lymfekirtler) - Overfølsomhed - Nedsat appetit - Angst, agitation, depression, fjendtlighed, nervøsitet, unormal tankegang, paranoia - Søvnighed, svimmelhed, migræne, brændende eller snurrende fornemmelse i hænder og fødder,
English: Hepatic function should be monitored regularly whilst on treatment.
Danish: Leverfunktionen skal monitoreres regelmæssigt under behandling.
English: - Drowsiness: This medicine may cause drowsiness especially when used with alcohol or other central nervous system depressants (substances that slow down some brain activity) such as benzodiazepines, other medicines that reduce anxiety or cause sleepiness, pregabalin or gabapentin.
Danish: - Døsighed: Dette lægemiddel kan forårsage døsighed, især når det tages sammen med alkohol eller andre midler, som hæmmer centralnervesystemet (stoffer der reducerer hjernens aktivitet), såsom benzodiazepiner, andre angstdæmpende lægemidler, lægemidler som forårsager søvnighed, pregabalin eller gabapentin.
English: • Handle the safety syringe carefully to avoid a needle stick.
Danish: • Vær forsigtig ved håndtering af sikkerhedsinjektionssprøjten for at undgå kanylestik.
English: Buvidal prolonged-release solution for injection (monthly) EU/1/18/1336/005 [64 mg buprenorphine/0.18 mL] EU/1/18/1336/006 [96 mg buprenorphine/0.27 mL] EU/1/18/1336/007 [128 mg buprenorphine/0.36 mL]
Danish: Buvidal depotinjektionsvæske, opløsning (månedlig) EU/1/18/1336/005 [64 mg buprenorphin/0,18 ml] EU/1/18/1336/006 [96 mg buprenorphin/0,27 ml] EU/1/18/1336/007 [128 mg buprenorphin/0,36 ml]
English: - monoamine oxidase inhibitors (used to treat depression) such as phenelzine, isocarboxazid, iponiazid and tranylcypromine as they may increase the effects of this medicine.
Danish: - monoaminooxidasehæmmere (som bruges til behandling af depression), såsom phenelzin, isocarboxazid, iponiazid og tranylcypromin, da de kan forstærke virkningen af dette lægemiddel.
English: Buvidal 8 mg, 16 mg, 24 mg and 32 mg are given weekly.
Danish: Buvidal 8 mg, 16 mg, 24 mg og 32 mg gives ugentligt.
English: - macrolide antibiotics (used to treat bacterial infections) such as clarithromycin and erythromycin as they may increase the effects of this medicine.
Danish: - makrolidantibiotika (som bruges til at behandle bakterieinfektioner) såsom clarithromycin og erythromycin, da de kan forstærke virkningen af dette lægemiddel.
English: Injection site inflammation Injection site bruising Injection site urticaria
Danish: Inflammation på injektionsstedet Suggilation på injektionsstedet Urticaria på injektionsstedet