FrancophonIA/ELRC3.0 huggingface dataset:
English: These symptoms may occur more commonly or severely if you have been taking Pregabalin Mylan Pharma for a longer period of time.
Danish: Disse symptomer kan forekomme oftere eller i en alvorligere grad, hvis du har taget Pregabalin Mylan Pharma i længere tid.
English: • Difficulty with or painful urination, incontinence
Danish: • Vanskelighed ved eller smertefuld vandladning, inkontinens.
English: No specific pharmacokinetic studies were carried out in patients with impaired liver function.
Danish: Der er ikke gennemført specifikke farmakokinetiske studier på patienter med nedsat leverfunktion.
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: Adverse effects on male reproductive organs and sperm parameters were reversible and occurred only at exposures sufficiently in excess of therapeutic exposure or were associated with spontaneous degenerative processes in male reproductive organs in the rat.
Danish: Bivirkninger på de mandlige forplantningsorganer og spermparametre var reversible og opstod kun ved eksponeringer, der i væsentlig grad oversteg den terapeutiske eksponering, eller som var forbundet med spontane, degenerative processer i de mandlige forplantningsorganer hos rotten.
English: Pregabalin Cmax and AUC parameters increased in a linear manner with increasing dose within each age group.
Danish: Cmax- og AUC-parametrene for pregabalin steg lineært med stigende dosis inden for hver aldersgruppe.
English: INSTRUCTIONS ON USE <For multilayer label only> ‘Peel here'
Danish: INSTRUKTIONER VEDRØRENDE ANVENDELSEN <Kun for flerlagsetiket> “Træk her”
English: In conventional safety pharmacology studies in animals, pregabalin was well-tolerated at clinically relevant doses.
Danish: I konventionelle undersøgelser af sikkerhedsfarmakologi på dyr, tåles pregabalin godt i klinisk relevante doser.
English: The safety and efficacy of Pregabalin Mylan Pharma in children below the age of 12 years and in adolescents (12-17 years of age) have not been established.
Danish: Pregabalin Mylan Pharmas sikkerhed og virkning hos børn under 12 år og unge (12-17 år) er ikke klarlagt.
English: If at any time you have these thoughts, immediately contact your doctor.
Danish: Hvis du på noget tidspunkt får sådanne tanker, skal du straks kontakte din læge.
English: A decision must be made whether to discontinue breast-feeding or to discontinue pregabalin therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med pregabalin seponeres, idet der tages højde for fordelene ved amning af barnet i forhold til de terapeutiske fordele for moderen.
English: Ammonia solution, concentrated Potassium hydroxide
Danish: Ammoniakopløsning, koncentreret Kaliumhydroxid
English: In a clinical trial to assess the effect of pregabalin on sperm motility, healthy male subjects were exposed to pregabalin at a dose of 600 mg/day.
Danish: I et klinisk studie, udført for at vurdere pregabalins indvirkning på sperms motilitet, fik raske mandlige forsøgspersoner pregabalindoser på 600 mg/dag.
English: Pregabalin Mylan Pharma and certain other medicines may influence each other (interaction).
Danish: Pregabalin Mylan Pharma og anden medicin kan påvirke hinanden (interaktion).
English: • Loss of appetite, weight loss, low blood sugar, high blood sugar
Danish: • Manglende appetit, vægttab, lavt blodsukker, højt blodsukker.
English: The symptoms of GAD are prolonged excessive anxiety and worry that are difficult to control.
Danish: Symptomer på generaliseret angst er vedvarende og udtalt angst og bekymring, som er svær at kontrollere.
English: In controlled clinical trials (4-8 week duration) 52% of the pregabalin treated patients and 38% of the patients on placebo had at least a 50% improvement in HAM-A total score from baseline to endpoint.
Danish: I de kontrollerede kliniske studier (af 4-8 ugers varighed) opnåede 52% af patienterne behandlet med pregabalin og 38% af patienterne på placebo mindst en 50% forbedring i HAM-A totalscore fra baseline til endpoint.
English: Ophthalmologic testing (including visual acuity testing, formal visual field testing and dilated funduscopic examination) was conducted in over 3600 patients within controlled clinical trials.
Danish: Oftalmologisk undersøgelse (herunder synsskarphedstest, formel synsfelttest og udvidet fundoskopi) blev udført på over 3600 patienter i de kontrollerede kliniske undersøgelser.
English: Cases of encephalopathy have been reported, mostly in patients with underlying conditions that may precipitate encephalopathy.
Danish: Tilfælde af encefalopati er blevet rapporteret, især hos patienter med underliggende tilstande, der kan udløse encefalopati.
English: Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Danish: Patienter (og plejepersonale) bør tilrådes straks at søge læge, hvis der opstår tegn på selvmordstanker og -adfærd.
English: These reactions are mostly seen in elderly cardiovascular compromised patients during pregabalin treatment for a neuropathic indication.
Danish: Disse hændelser er overvejende set hos ældre kardiovaskulært, kompromiterede patienter, der er i behandling med pregabalin for en neuropatisk indikation.
English: There have also been post-marketing reports of loss of consciousness, confusion and mental impairment.
Danish: Efter markedsføring er der også set tilfælde af bevidsthedstab, konfusion og mental svækkelse.
English: Pregabalin Mylan Pharma is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment.
Danish: Pregabalin Mylan Pharma er ikke beregnet til at blive brugt alene, men skal altid anvendes i kombination med anden behandling mod epilepsi.
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 bør 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 udvikling af tolerans, dosisstigning og stofsøgende adfærd).
English: Relief of the symptoms of GAD as reflected by the Hamilton Anxiety Rating Scale (HAM-A) was observed by Week 1.
Danish: Der blev set lindring af symptomer på generaliseret angst, målt ved ”Hamilton Anxiety Rating Scale” (HAM-A), efter 1 uge.
English: The other ingredients are: hydroxylpropylcellulose, maize starch, talc, gelatin, titanium dioxide (E171), sodium laurilsulfate, black ink (which contains shellac, black iron oxide (E172), macrogol, potassium hydroxide and concentrated ammonia solution), yellow iron oxide (E172) and erythrosine (E127).
Danish: Øvrige indholdsstoffer: hydroxylpropylcellulose, majsstivelse, talcum, gelatine, titandioxid (E171), natriumlaurilsulfat, sort blæk (der indeholder shellac, sort jernoxid (E172), macrogol, kaliumhydroxid og koncentreret ammoniakopløsning), gul jernoxid (E172) og erythrosin (E127).
English: Nine weeks after exposure, this effect was no longer observable.
Danish: Denne effekt kan ikke ses 9 uger efter eksponering.
English: The efficacy and safety of pregabalin as adjunctive treatment for epilepsy in paediatric patients below the age of 12 and adolescents has not been established.
Danish: Pregabalins virkning og sikkerhed som tillægsbehandling ved epilepsi hos pædiatriske patienter under 12 år og hos unge er ikke fastlagt.
English: The pharmacokinetics of 150 mg pregabalin given every 12 hours (300 mg daily dose) was evaluated in 10 lactating women who were at least 12 weeks postpartum.
Danish: Farmakokinetikken for 150 mg pregabalin indgivet hver 12. time (daglig dosis på 300 mg) blev evalueret hos 10 ammende kvinder, som alle var mindst 12 uger postpartum.
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 din tunge hæver, eller hvis huden bliver rød og begynder at danne blærer eller skalle af, skal du straks kontakte læge eller skadestue.
English: Misuse, abuse potential or dependence
Danish: Forkert brug, misbrug eller afhængighed
English: No tumours were observed in rats at exposures up to 24 times the mean human exposure at the maximum recommended clinical dose of 600 mg/day.
Danish: Der blev ikke set tumorer hos rotter ved en eksponering op til 24 gange den maksimale anbefalede gennemsnitlige humane dosis på 600 mg/dag.
English: In vivo studies and population pharmacokinetic analysis Accordingly, in in vivo studies no clinically relevant pharmacokinetic interactions were observed between pregabalin and phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, lorazepam, oxycodone or ethanol.
Danish: In vivo studier og populationsfarmakokinetiske analyser Følgelig har in vivo studier ikke vist klinisk relevante farmakokinetiske interaktioner mellem pregabalin og phenytoin, carbamazepin, valproat, lamotrigin, gabapentin, lorazepam, oxycodon eller ethanol.
English: For three times a day take Pregabalin Mylan Pharma once in the morning, once in the afternoon and once in the evening, at about the same time each day.
Danish: For 3 gange dagligt skal Pregabalin Mylan Pharma tages én gang om morgenen, én gang om eftermiddagen og én gang om aftenen og på omtrent samme tid hver dag.
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: The maximum dose of 600 mg per day may be achieved after an additional week.
Danish: Den maksimale dosis på 600 mg dagligt kan nås efter yderligere 7 dage.
English: The active substance is pregabalin.
Danish: Aktivt stof: pregabalin.
English: Therefore, there is no need for routine monitoring of plasma concentrations of pregabalin.
Danish: Derfor er det ikke nødvendigt at monitorere pregabalins plasmakoncentrationer regelmæssigt.
English: The N-methylated derivative of pregabalin, the major metabolite of pregabalin found in urine, accounted for 0.9% of the dose.
Danish: Det N-methylerede derivat af pregabalin, der er pregabalins hovedmetabolit, genfindes i urin og svarer til 0,9% af dosis.
English: There have been reports in the post-marketing experience of hypersensitivity reactions, including cases of angioedema.
Danish: Efter markedsføring har der været rapporter om overfølsomhedsreaktioner, herunder tilfælde af angioødem.
English: Two-year carcinogenicity studies with pregabalin were conducted in rats and mice.
Danish: 2-års karcinogenicitetsforsøg er udført med pregabalin på rotter og mus.
English: Each hard capsule contains either 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 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: Additional reactions reported from post-marketing experience are included in italics in the list below.
Danish: Yderligere bivirkninger, der er rapporteret efter markedsføring, er anført i kursiv i tabellen nedenfor.
English: Multiple dose pharmacokinetics are predictable from single-dose data.
Danish: Farmakokinetikken for gentagne doser kan forudsiges ud fra enkeltdosis-data.
English: Population pharmacokinetic analysis showed that creatinine clearance was a significant covariate of pregabalin oral clearance, body weight was a significant covariate of pregabalin apparent oral volume of distribution, and these relationships were similar in paediatric and adult patients.
Danish: En farmakokinetisk populationsanalyse viste, at efter oral indgift var kreatininclearance en signifikant kovariat af pregabalin-clearance, at kropsvægt var en signifikant kovariat af pregabalins tilsyneladende fordelingsvolumen, og at disse forhold var ens hos pædiatriske og voksne patienter.
English: BID = Two divided doses * Total daily dose (mg/day) should be divided as indicated by dose regimen to provide mg/dose + Supplementary dose is a single additional dose
Danish: * Total døgndosis (mg/døgn) skal fordeles som anført under dosisinterval for at give mg/dosis Supplerende dosis er en enkelt tillægsdosis.
English: Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications.
Danish: Selvmordstanker og -adfærd er rapporteret hos patienter i behandling med antiepileptika ved flere forskellige indikationer.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Patients are advised not to drive, operate complex machinery or engage in other potentially hazardous activities until it is known whether this medicinal product affects their ability to perform these activities.
Danish: Patienter opfordres til ikke at køre bil, betjene indviklede maskiner eller udsætte sig for andre potentielt farlige aktiviteter før det vides, hvordan denne medicin påvirker deres evne til at udføre disse aktiviteter.
English: Your doctor will prescribe Pregabalin Mylan Pharma for you to help treat your epilepsy when your current treatment is not controlling your condition.
Danish: Din læge vil udskrive Pregabalin Mylan Pharma til behandling af din epilepsi, hvis din nuværende behandling ikke kan kontrollere din tilstand.
English: Pregabalin has been studied in 6 controlled trials of 4-6 week duration, an elderly study of 8 week duration and a long-term relapse prevention study with a double blind relapse prevention phase of 6 months duration.
Danish: Pregabalin er undersøgt i 6 kontrollerede studier af 4-6 ugers varighed, et studie med ældre af 8 ugers varighed og et langtids relaps-forebyggelsesstudie med en dobbelt-blind relaps-forebyggelsesfase af 6 måneders varighed.
English: McDermott Laboratories Limited trading as Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13 Ireland
Danish: McDermott Laboratories Limited under forretningsnavnet Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13 Irland
English: Fertility There are no clinical data on the effects of pregabalin on female fertility.
Danish: Fertilitet Der findes ingen kliniske data om virkningen af pregabalin på fertiliteten hos kvinder.
English: It is important to take your Pregabalin Mylan Pharma capsules regularly at the same time each day.
Danish: Det er vigtigt, at du tager dine Pregabalin Mylan Pharma-kapsler regelmæssigt og på samme tid hver dag.
English: Concerning discontinuation of long-term treatment of pregabalin, data suggest that the incidence and severity of withdrawal symptoms may be dose-related.
Danish: Ved seponering af langtidsbehandling med pregabalin tyder data på, at hyppighed og sværhedsgrad af seponeringssymptomer kan være dosisrelaterede.
English: Capsules shell Iron oxide yellow (E172) Titanium dioxide (E171) Erythrosine (E127) Gelatin
Danish: Kapselskal Gul jernoxid (E172) Titandioxid (E171) Erythrosin (E127) Gelatine
English: A reduction in seizure frequency was observed by Week 1.
Danish: En reduktion i anfaldshyppighed ses efter 1 uge.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu/
English: The degree of dizziness, sleepiness and decreased concentration may be increased if Pregabalin Mylan Pharma is taken together with medicinal products containing:
Danish: Graden af svimmelhed, søvnighed og nedsat koncentrationsevne kan øges, når Pregabalin Mylan Pharma tages sammen med medicin, der indeholder:
English: In addition, pregabalin is effectively removed from plasma by haemodialysis (following a 4 hour haemodialysis treatment plasma pregabalin concentrations are reduced by approximately 50%).
Danish: Derudover kan pregabalin effektivt fjernes fra plasma via hæmodialyse (efter 4 timers hæmodialysebehandling er plasmakoncentrationerne af pregabalin reduceret med ca. 50%).
English: Pregabalin pharmacokinetics are linear over the recommended daily dose range.
Danish: Pregabalins farmakokinetik er lineær i det anbefalede daglige dosisområde.
English: The percentage of subjects with at least a 50% reduction in partial onset seizures as compared to baseline was 40.6% of subjects treated with pregabalin 10 mg/kg/day (p=0.0068 versus placebo), 29.1% of subjects treated with pregabalin 2.5 mg/kg/day (p=0.2600 versus placebo) and 22.6% of those receiving placebo.
Danish: Procentdelen af forsøgsdeltagere med mindst 50% reduktion i antallet af partielle anfald sammenlignet med baseline var 40,6% af de forsøgsdeltagere, der blev behandlet med pregabalin 10 mg/kg/dag (p=0,0068 versus placebo), 29,1% af de forsøgsdeltagere, der blev behandlet med pregabalin 2,5 mg/kg/dag (p=0,2600 versus placebo) og 22,6% af dem, der fik placebo.
English: Pregabalin is removed effectively from plasma by haemodialysis (50% of drug in 4 hours).
Danish: Pregabalin fjernes effektivt fra plasma via hæmodialyse (50% af lægemiddelstoffet på 4 timer).
English: The non-genotoxic mechanism of pregabalin-induced tumour formation in mice involves platelet changes and associated endothelial cell proliferation.
Danish: Den ikke-genotoksiske mekanisme af pregabalin-induceret tumordannelse hos mus involverer trombocytændringer og er forbundet med endotelcelleproliferation.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og blister efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt 6.1.
English: In preclinical studies, pregabalin has been shown to cross the blood brain barrier in mice, rats, and monkeys.
Danish: Prækliniske studier har vist, at pregabalin krydser blod-hjernebarrieren hos mus, rotter og aber.
English: Adverse reactions were usually mild to moderate in intensity.
Danish: Bivirkningerne er som regel lette til moderate.
English: Maximum dose (mg/day)
Danish: Maksimal dosis (mg/døgn)
English: Pregabalin has been shown to cross the placenta in rats and is present in the milk of lactating rats.
Danish: Det er vist, at pregabalin passerer placenta hos rotter og findes i mælken hos diegivende rotter.
English: Tachycardia, atrioventricular block first degree, sinus bradycardia, congestive heart failure
Danish: Takykardi, atrioventrikulært blok af første grad, sinusbradykardi, kongestiv hjerteinsufficiens.
English: Blood and lymphatic system disorders Uncommon
Danish: Blod- og lymfesystem Ikke almindelig
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: 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: Orale kontraceptiva, norethisteron og/eller ethinylestradiol Samtidig indgift af pregabalin og orale kontraceptiva norethisteron og/eller ethinyløstradiol påvirker ikke steady state farmakokinetikken af nogen af stofferne.
English: Pregabalin treatment can be started with a dose of 150 mg per day.
Danish: Behandling med pregabalin kan startes med en dosis på 150 mg dagligt.
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 mælken (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: Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after 1 week.
Danish: Afhængigt af patientens respons og tolerabilitet kan dosis efter 7 dage øges til 300 mg dagligt.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 June 2015
Danish: Dato for første markedsføringstilladelse: 25. juni 2015 Dato for seneste fornyelse: DD måned ÅÅÅÅ
English: Epilepsy
Danish: Epilepsi
English: PHARMACEUTICAL FORM AND CONTENTS Hard capsule.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Hård kapsel.
English: Hepatic failure, hepatitis
Danish: Leversvigt, hepatitis.
English: Paediatric population 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: Tell your doctor if you experience constipation, especially if you are prone to this problem.
Danish: Fortæl lægen, hvis du får forstoppelse, især hvis du er tilbøjelig til at få forstoppelse.
English: In the post-marketing experience, there are reports of respiratory failure and coma in patients taking pregabalin and other central nervous system (CNS) depressant medicinal products.
Danish: Efter markedsføring er der rapporteret om respirationssvigt og koma hos patienter, der tager pregabalin og andre lægemidler, der supprimerer centralnervesystemet (CNS).
English: These symptoms include swelling of the face, lips, tongue, and throat, as well as diffuse skin rash.
Danish: Disse symptomer omfatter hævelse af ansigt, læber, tunge og hals samt hududslæt.
English: EXPIRY DATE
Danish: UDLØBSDATO EXP
English: Discontinuation of pregabalin may result in resolution or improvement of these visual symptoms.
Danish: Seponering af behandling med pregabalin kan føre til en normalisering eller forbedring af disse synssymptomer.
English: • A small number of people being treated with anti-epileptics such as Pregabalin Mylan Pharma have had thoughts of harming or killing themselves.
Danish: • En lille andel af de personer, der bliver behandlet med epilepsimedicin som for eksempel Pregabalin Mylan Pharma har haft selvmordstanker eller tanker om at gøre skade på sig selv.
English: Pregabalin clearance is directly proportional to creatinine clearance.
Danish: Pregabalin-clearance er direkte proportional med kreatininclearance.
English: Continue taking Pregabalin Mylan Pharma until your doctor tells you to stop.
Danish: Fortsæt med at tage Pregabalin Mylan Pharma, indtil din læge beder dig om at stoppe.