FrancophonIA/ELRC3.0 huggingface dataset:
English: Caution should be exercised in patients with a history of substance abuse and the patient should be monitored for symptoms of pregabalin misuse, abuse or dependence (development of tolerance, dose escalation, drug-seeking behaviour have been reported).
Danish: Der skal udvises forsigtighed ved behandling af patienter, der tidligere har haft et misbrug, og patienten bør overvåges for symptomer på forkert brug, misbrug og afhængighed af pregabalin (der er rapporteret om toleransudvikling, dosisstigning og stofsøgende adfærd).
English: • Changes in the recording of electrical changes (ECG) in the heart which correspond to heart rhythm disturbances.
Danish: • Forandringer i elektrokardiogrammet (ekg, optagelse af hjertets elektriske aktivitet), der svarer til hjerterytmeforstyrrelser.
English: If you experience swollen face or tongue or if your skin turns red and starts to blister or peel, you should seek immediate medical advice.
Danish: Hvis dit ansigt eller tunge hæver eller, hvis huden bliver rød og begynder at danne blærer eller skalle af, skal du straks kontakte læge eller skadestue.
English: • There have been reports of convulsions when taking this medicine or shortly after stopping this medicine.
Danish: • Der er set kramper i forbindelse med behandling med dette lægemiddel og kort tid efter ophør af behandling med lægemidlet.
English: The safety and efficacy of Pregabalin Accord in children below the age of 12 years and in adolescents (12-17 years of age) have not been established.
Danish: Pregabalin Accords sikkerhed og virkning hos børn under 12 år og unge (12-17 år) er ikke klarlagt.
English: In table 2 below all adverse reactions, which occurred at an incidence greater than placebo and in more than one patient, are listed by class and frequency (very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: De er anført efter organklasse og hyppighed (meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til  1/1.000); meget sjældne (< 1/10.000)), hyppighed ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Talk to your doctor or pharmacist before taking Pregabalin Accord.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Pregabalin Accord
English: You may feel sleepy, confused, agitated, or restless as a result of taking more this medicine than you should.
Danish: Du kan føle dig søvnig, forvirret, oprevet eller rastløs, hvis du har taget for meget af dette lægemiddel.
English: Appetite increased
Danish: Øget appetit.
English: Peripheral and central neuropathic pain
Danish: Perifere og centrale neuropatiske smerter
English: The other ingredients are: starch pregelatinise, talc (E553b), gelatin, titanium dioxide (E171), sodium laurilsulfate, black ink, (which contains shellac, propylene glycol, iron oxide black (E172), and , potassium hydroxide).
Danish: • Øvrige indholdsstoffer: prægelatiniseret stivelse, talkum (E553b), gelatine, titandioxid (E171), natriumlaurilsulfat, sort blæk, (som indeholder shellac, propylenglycol, sort jernoxid (E172) og kaliumhydroxid).
English: Potassium hydroxide
Danish: Kaliumhydroxid
English: • This medicine has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in elderly patients.
Danish: • Dette lægemiddel er forbundet med svimmelhed og søvnighed, som kan øge risikoen for faldulykker hos ældre patienter.
English: Anorexia, hypoglycaemia
Danish: Anoreksi, hypoglykæmi.
English: Nervous system disorders Very Common
Danish: Nervesystemet Meget almindelig
English: Peripheral and central neuropathic pain, Epilepsy or Generalised Anxiety Disorder:
Danish: Perifere og centrale neuropatiske smerter, epilepsi eller generaliseret angst:
English: Reduced acoustic startle response was observed in juvenile rats 1-2 weeks after exposure at > 2 times the human therapeutic exposure.
Danish: Reduceret respons for akustisk forskrækkelse ses hos juvenile rotter 1-2 uger efter doser > 2 gange højere end terapeutisk dosis hos mennesker.
English: Pregabalin pharmacokinetics were evaluated in paediatric patients with epilepsy (age groups: 1 to 23 months, 2 to 6 years, 7 to 11 years and 12 to 16 years) at dose levels of 2.5, 5, 10 and 15 mg/kg/day in a pharmacokinetic and tolerability study.
Danish: Pregabalins farmakokinetik blev evalueret hos pædiatriske patienter med epilepsi (aldersgrupper: 123 måneder, 2-6 år, 7-11 år og 12-16 år) ved dosisniveauer på 2,5, 5, 10 og 15 mg/kg dagligt i et farmakokinetik- og tolerabilitetsstudie.
English: • This medicine may cause blurring or loss of vision, or other changes in eyesight, many of which are temporary.
Danish: • Dette lægemiddel kan forårsage sløret syn, synstab eller andre synsændringer, som kan være forbigående.
English: The estimated infant dose from breast milk (assuming mean milk consumption of 150 ml/kg/day) of women receiving 300 mg/day or the maximum dose of 600 mg/day would be 0.31 or 0.62 mg/kg/day, respectively.
Danish: Den estimerede dosis, som spædbarnet fik fra modermælken (forudsat at mælkeindtagelsen var på 150 ml/kg dagligt) fra kvinder, der fik 300 mg dagligt eller den maksimale dosis på 600 mg dagligt, ville være henholdsvis 0,31 eller 0,62 mg/kg dagligt.
English: Pregabalin Accord may have minor or moderate influence on the ability to drive and use machines.
Danish: Pregabalin Accord påvirker i mindre eller moderat grad evnen til at føre motorkøretøj og betjene maskiner .
English: Pregabalin steady-state pharmacokinetics are similar in healthy volunteers, patients with epilepsy receiving anti-epileptic medicinal products and patients with chronic pain.
Danish: Pregabalins steady state farmakokinetik er ens hos raske forsøgspersoner, hos patienter med epilepsi i anti-epileptisk behandling og hos patienter med kroniske smerter.
English: Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg per day after an additional 7-day interval.
Danish: Afhængigt af patientens respons og tolerabilitet kan dosis efter 3-7 dage øges til 300 mg dagligt, og hvis nødvendigt kan dosis øges til maksimalt 600 mg dagligt efter yderligere 7 dage.
English: 30 hard capsules 200 hard capsules
Danish: 30 hårde kapsler 200 hårde kapsler
English: For patients who experienced somnolence the responder rates were 48% on pregabalin and 16% on placebo.
Danish: Hos patienter, der oplevede søvnighed er responderraterne 48% på pregabalin og 16% på placebo.
English: Neuropathic pain Pregabalin Accord is indicated for the treatment of peripheral and central neuropathic pain in adults.
Danish: Neuropatiske smerter Pregabalin Accord er indiceret til behandling af perifere og centrale neuropatiske smerter hos voksne.
English: • Decrease in white blood cell count.
Danish: • Nedsat antal hvide blodlegemer.
English: • Feeling of elation, confusion, disorientation, decrease in sexual interest, irritability.
Danish: • Følelse af opstemthed, forvirring, desorientering, nedsat seksuel interesse, irritabilitet.
English: Misuse, abuse potential or dependence
Danish: Forkert brug, misbrug og afhængighed
English: • Sore throat.
Danish: • Ondt i halsen.
English: Central nervous system influencing medicinal products Pregabalin may potentiate the effects of ethanol and lorazepam.
Danish: Pregabalin kan potensere virkningerne af ethanol og lorazepam.
English: Take your box or bottle of this medicine with you.
Danish: Medbring pakningen med dette lægemiddel.
English: In prenatal/postnatal toxicity studies, pregabalin induced offspring developmental toxicity in rats at exposures > 2 times the maximum recommended human exposure.
Danish: I præ-natale /post-natale toksicitetsundersøgelser fremkalder pregabalin udviklingstoksicitet hos afkom af rotter ved doser > 2 gange den maksimale anbefalede humane dosis.
English: There are post-marketing reports of events related to reduced lower gastrointestinal tract function (e.g. intestinal obstruction, paralytic ileus, constipation) when pregabalin was co-administered with medications that have the potential to produce constipation, such as opioid analgesics.
Danish: Efter markedsføring er der rapporteret om bivirkninger relateret til nedsat funktion af mave-tarmkanalen (f.eks intestinal obstruktion, paralytisk ileus, obstipation), når pregabalin gives samtidig med lægemidler, der potentielt kan medføre obstipation, herunder opioide analgetika.
English: • Breast pain.
Danish: • Brystsmerter.
English: Generalised anxiety disorder Pregabalin Accord is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Danish: Generaliseret angst Pregabalin Accord er indiceret til behandling af generaliseret angst (GAD) hos voksne.
English: The active substance is pregabalin.
Danish: • Aktivt indholdsstof: pregabalin.
English: Since pregabalin is predominantly excreted unchanged in the urine, undergoes negligible metabolism in humans (< 2% of a dose recovered in urine as metabolites), does not inhibit drug metabolism in vitro, and is not bound to plasma proteins, it is unlikely to produce, or be subject to, pharmacokinetic interactions.
Danish: Pregabalin udskilles hovedsagligt uomdannet i urin, gennemgår ubetydelig metabolisme hos mennesker (< 2% af dosis genfindes i urin som metabolitter), hæmmer ikke lægemiddelmetabolisme in vitro, og bindes ikke til plasmaproteiner.
English: • Feeling drunk, abnormal style of walking.
Danish: • Følelse af at være beruset, unormal gangart.
English: When taken with certain other medicines, Pregabalin Accord may potentiate the side effects seen with these medicines, including respiratory failure and coma.
Danish: Når det bruges sammen med visse typer medicin, kan Pregabalin Accord forstærke de bivirkninger, der er set med denne type medicin, herunder åndedrætssvigt og dyb bevidstløshed.
English: This medicine may be taken with oral contraceptives.
Danish: Dette lægemiddel kan tages sammen med svangerskabsforebyggende medicin.
English: Population pharmacokinetic analysis indicated that oral antidiabetics, diuretics, insulin, phenobarbital, tiagabine and topiramate had no clinically significant effect on pregabalin clearance.
Danish: Farmakokinetiske befolkningsanalyser tyder på, at orale antidiabetika, diuretika, insulin, phenobarbital, tiagabin og topiramat, ikke har nogen klinisk betydende virkning på pregabalinclearance.
English: • Some patients with diabetes who gain weight while taking pregabalin may need an alteration in their diabetic medicines.
Danish: • Nogle diabetespatienter kan få vægtøgning, når de tager Pregabalin Accord, og kan derfor have behov for at ændre deres diabetes medicin.
English: The pregabalin safety profile observed in three paediatric studies in patients with partial seizures with or without secondary generalization (12-week efficacy and safety study in patients with partial onset seizures, n=295; pharmacokinetic and tolerability study, n=65; 1 and year open label follow on safety study, n=54) was similar to that observed in the adult studies of patients with epilepsy .
Danish: Den sikkerhedsprofil for pregabalin, der blev observeret i 3 pædiatriske studier hos patienter med partielle anfald med eller uden sekundær generalisering (effekt- og sikkerhedsstudie af 12 ugers varighed hos patienter med partielle anfald, n=295; farmakokinetik- og tolerabilitetsstudier, n=65; og 1 års åben opfølgning af sikkerhedsstudiet, n=54), var den samme som den, der blev observeret i studier med voksne patienter med epilepsi.
English: • Blurred vision, double vision.
Danish: • Sløret syn, dobbeltsyn.
English: Additionally Pregabalin Accord 75mg hard capsules are also available in PVC/Aluminium blisterin pack sizes of 70 hard capsules.
Danish: Derudover Pregabalin Accord 75mg hårde kapsler fås også i PVC / aluminiumblister i pakninger indeholdende 70 hårde kapsler.
English: Results of a 12-week placebo-controlled study of 295 paediatric patients aged 4 to 16 years performed to evaluate the efficacy and safety of pregabalin as adjunctive therapy for the treatment of partial onset seizures and a 1 year open label safety study in 54 paediatric patients from 3 months to 16 years of age with epilepsy indicate that the adverse events of pyrexia and upper respiratory infections were observed more frequently than in adult studies of patients with epilepsy (see sections 4.2, 4.8 and 5.2).
Danish: Resultaterne af et placebokontrolleret studie af 12 ugers varighed med 295 pædiatriske patienter i alderen 4-16 år, som blev udført for at vurdere effekten og sikkerheden af pregabalin som tillægsbehandling ved behandling af partielle anfald og et åbent sikkerhedsstudie af 1 års varighed med 54 pædiatriske epilepsipatienter i alderen fra 3 måneder til 16 år, indikerer, at bivirkningerne pyreksi og øvre luftvejsinfektioner blev observeret hyppigere end i studier med voksne epilepsipatienter (se pkt.
English: Metabolism and nutrition disorders
Danish: Metabolisme og ernæring Almindelig
English: Blood and lymphatic system disorders
Danish: Blod- og lymfesystem Ikke almindelig
English: • Fluid in the lungs.
Danish: • Væske i lungerne.
English: Treatment of central neuropathic pain due to spinal cord injury In the treatment of central neuropathic pain due to spinal cord injury the incidence of adverse reactions in general, central nervous system adverse reactions and especially somnolence was increased.
Danish: Behandling af centrale neuropatiske smerter, der skyldes rygmarvsskader Ved behandling af centrale neuropatiske smerter, der skyldes rygmarvsskader, ses generelt en øget forekomst af bivirkninger, som bivirkninger i centralnervesystemet og især søvnighed.
English: The adverse events observed in a pharmacokinetic and tolerability study that enrolled patients from 3 months to 16 years of age (n=65) with partial onset seizures were similar to those observed in adults.
Danish: De bivirkninger, der sås i et farmakokinetikstudie og et tolerabilitetsstudie omfattende patienter i alderen fra 3 måneder til 16 år (n=65), med partielle anfald var de samme som dem, der sås hos voksne.
English: • When Pregabalin Accord is taken with other medicines that may cause constipation (such as some types of pain medicines) it is possible that gastrointestinal problems may occur (e.g. constipation, blocked or paralysed bowel).
Danish: • Når Pregabalin Accord tages med andre lægemidler, som er kendt for at kunne give forstoppelse (som f.eks visse typer smertestillende medicin), kan det give maveproblemer (f.eks. forstoppelse, tarmslyng).
English: Call your doctor or go to the nearest hospital emergency unit immediately.
Danish: Kontakt omgående lægen eller skadestuen.
English: System organ class
Danish: Organklasse
English: An increased incidence of retinal atrophy commonly observed in aged albino rats was seen after long-term exposure to pregabalin at exposures ≥ 5 times the mean human exposure at the maximum recommended clinical dose.
Danish: En øget hyppighed af nethindeatrofi ses sædvanligvis hos ældre albinorotter efter langtidseksponering med pregabalin ved doser  5 gange den maksimale anbefalede gennemsnitlige humane dosis.
English: Ear and labyrinth disorders
Danish: Øre og labyrint Almindelig
English: • Muscle damage.
Danish: • Muskelsvækkelse.
English: Efficacy has been shown in trials in diabetic neuropathy, post herpetic neuralgia and spinal cord injury.
Danish: Studier har vist effekt over for diabetisk neuropati, post-herpetisk neuralgi og rygmarvskader.
English: • Vertigo, problems with balance, fall.
Danish: • Svimmelhed, balanceproblemer, faldtendens.
English: If you forget to take Pregabalin Accord
Danish: Hvis du har glemt at tage Pregabalin Accord
English: Pregabalin has been studied in 10 controlled clinical trials of up to 13 weeks with twice a day dosing (BID) and up to 8 weeks with three times a day (TID) dosing.
Danish: Pregabalin er undersøgt i 10 kontrollerede kliniske studier i op til 13 uger med dosering 2 gange dagligt, og i op til 8 uger med dosering 3 gange dagligt.
English: Pregabalin Accord belongs to a group of medicines used to treat epilepsy, neuropathic pain and Generalised Anxiety Disorder (GAD) in adults.
Danish: Pregabalin Accord tilhører den gruppe medicin, der anvendes til behandling af epilepsi, neuropatiske smerter og generaliseret angst hos voksne.
English: Urinary incontinence, dysuria
Danish: Urininkontinens, dysuri.
English: In accordance with current clinical practice, if pregabalin has to be discontinued it is recommended this should be done gradually over a minimum of 1 week independent of the indication (see sections 4.4 and 4.8).
Danish: Hvis pregabalin skal seponeres, anbefales det at lade seponeringen ske gradvist over mindst 1 uge uafhængigt af indikationen og i overensstemmelse med gældende klinisk praksis (se pkt.
English: Do not use this medicine after the expiry date which is stated on the carton or bottle.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Oral contraceptives, norethisterone and/or ethinyl oestradiol Co-administration of pregabalin with the oral contraceptives norethisterone and/or ethinyl oestradiol does not influence the steady-state pharmacokinetics of either substance.
Danish: Samtidig indgift af pregabalin og orale kontraceptiva norethisteron og/eller ethinyløstradiol påvirker ikke steady state farmakokinetikken af nogen af stofferne.
English: The 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules also contain iron oxide red (E172).
Danish: • 75 mg, 100 mg, 200 mg, 225 mg og 300 mg kapsler indeholder også rød jernoxid (E172).
English: mental impairment, difficulty with thinking, increase in sexual interest, problems with sexual functioning including inability to achieve a sexual climax, delayed ejaculation.
Danish: mental svækkelse, vanskelighed ved at tænke, seksuelle problemer herunder problemer med at få orgasme, forsinket udløsning .
English: Other medicines and Pregabalin Accord
Danish: Brug af anden medicin sammen med Pregabalin Accord
English: For patients not experiencing somnolence, such an improvement was observed in 33% of patients treated with pregabalin and 18% of patients on placebo.
Danish: Hos patienter, der ikke oplevede søvnighed, ses en sådan forbedring hos 33% af patienterne behandlet med pregabalin og hos 18% af patienterne behandlet med placebo.
English: • Muscle twitching, joint swelling, muscle stiffness, pain including muscle pain, neck pain.
Danish: • Muskeltrækninger, ledhævelser, muskelstivhed, smerter herunder muskelsmerter, smerter i nakken.
English: Convulsions, parosmia, hypokinesia, dysgraphia
Danish: Kramper, parosmi, hypokinesi, dysgrafi.
English: Dizziness, somnolence, loss of consciousness, confusion, and mental impairment Pregabalin treatment has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in the elderly population.
Danish: Svimmelhed, søvnighed, bevidsthedstab, konfusion og mental svækkelse Behandling med pregabalin er forbundet med svimmelhed og søvnighed, som kan øge risikoen for faldulykker hos ældre patienter.
English: The pregabalin clinical programme involved over 8,900 patients exposed to pregabalin, of whom over 5,600 were in double-blind placebocontrolled trials.
Danish: Det kliniske program med pregabalin omfatter over 8.900 patienter, som fik pregabalin.
English: • Changes in blood and liver test results (blood creatinine phosphokinase increased, alanine amino transferase increased, aspartate aminotransferase increased, platelet count decreased,
Danish: • Ændringer i levertal og blodprøveresultater (forhøjet kreatinkinase i blodet, forhøjet alanin aminotransferase, forhøjet aspartat-aminotransferase, nedsat trombocyttal, for få hvide blodlegemer (neutropeni), forhøjet kreatinin i blodet, nedsat kalium i blodet.
English: • Interrupted menstrual periods.
Danish: • Menstruationsforstyrrelser.
English: Reproductive system and breast disorders
Danish: Det reproduktive system og mammae Almindelig
English: Renal failure, oliguria, urinary retention
Danish: Nyresvigt, oliguri, urinretention.
English: Very common ( may affect more than 1 in 10 people) :
Danish: Meget almindelige (kan forekomme hos flere end 1 ud af 10 behandlede)
English: After stopping long and short-term Pregabalin Accord treatment, you need to know that you may experience certain side effects.
Danish: Når du stopper med at tage Pregabalin Accord efter langtidsbehandling eller korttidsbehandling, skal du vide, at du måske får visse bivirkninger.
English: HDPE bottle pack should be used within 30 days (for 30's count) and 100 days (for 200's count) after first opening.
Danish: Indholdet af HDPE-beholderpakning skal anvendes inden for 30 (HDPE-beholder med 30 hårde kapsler) og 100 dage (HDPE-beholder med 200 hårde kapsler) efter første åbning.
English: The incidence of adverse reactions in general, central nervous system adverse reactions and especially somnolence was increased in the treatment of central neuropathic pain due to spinal cord injury (see section 4.4).
Danish: Der ses generelt en øget forekomst af bivirkninger, bivirkninger i centralnervesystemet og især søvnighed, ved behandling af centrale neuropatiske smerter, der skyldes rygmarvsskader (se pkt.
English: Neuropathic pain
Danish: Neuropatiske smerter
English: • There have been reports of reduction in brain function (encephalopathy) in some patients taking this medicine when they have other conditions.
Danish: • Hos nogle patienter med andre sygdomme er der set nedsat hjernefunktion (encefalopati) i forbindelse med behandling med dette lægemiddel.
English: Each hard capsule contains either 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg of pregabalin.
Danish: 1 hård kapsel indeholder 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg eller 300 mg pregabalin.
English: Therefore, you should be careful until you are used to any effect the medicine might have.
Danish: Du bør derfor være forsigtig, indtil du ved, hvordan medicinen virker på dig.
English: • Kidney failure, reduced urine volume, urinary retention.
Danish: • Nyresvigt, nedsat urinmængde, besvær med at lade vandet.
English: Starch pregelatinised
Danish: Prægelatiniseret stivelse
English: Pregabalin Accord 25/50/75/100/150/200/225/300mg hard capsules are available in blister packs (PVC/Aluminium) containing 14, 21, 56, 60, 84, 90, 100 or 112 hard capsules.
Danish: Pregabalin Accord 25/50/75/100/150/200/225/300 mg hårde kapsler fås i PVC/aluminiumblister i pakninger indeholdende 14, 21, 56, 60, 84, 90, 100 eller 112 hårde kapsler.
English: • Increased saliva production, heartburn, numb around mouth.
Danish: • Øget spytproduktion, halsbrand, følelsesløshed omkring munden.
English: • Dry eyes, eye swelling, eye pain, weak eyes, watery eyes, eye irritation.
Danish: • Tørre øjne, hævede øjne, øjensmerter, trætte øjne, øjne, der løber i vand, øjenirritation.
English: - If you have any further questions, ask your doctor or pharmacist.
Danish: Er du I tvivl så spørg lægen eller på apoteket.
English: Elderly patients may require a dose reduction of pregabalin due to a decreased renal function (see section 5.2).
Danish: Ældre Dosisreduktion hos ældre kan være nødvendig på grund af nedsat nyrefunktion (se Patienter pkt.
English: Adverse reactionson fertility in male and female rats were only observed at exposures sufficiently in excess of therapeutic exposure.
Danish: Påvirkning af fertilitet hos han- og hunrotter blev kun observeret ved eksponeringer, der i væsentlig grad oversteg den terapeutiske eksponering.
English: • Breast discharge, abnormal breast growth, breast growth in males.
Danish: • Flåd fra brystvorter, unormal vækst af bryster, vækst af bryster hos mænd.
English: Iron oxide red (E172)
Danish: Jernoxid, rød (E172)