FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor if you have a history of any serious medical conditions, including liver or kidney disease.
Danish: Fortæl lægen, hvis du har eller tidligere har haft en alvorlig sygdom, herunder lever- eller nyresygdom.
English: The effect of pregabalin on newborns/infants is unknown.
Danish: Virkningen af pregabalin på det ammede barn er ukendt.
English: Since pregabalin does not undergo significant metabolism and is excreted predominantly as unchanged drug in the urine, impaired liver function would not be expected to significantly alter pregabalin plasma concentrations.
Danish: Da pregabalin ikke undergår signifikant metabolisme og hovedsageligt udskilles som uomdannet lægemiddelstof i urinen, anses det ikke for sandsynligt, at nedsat leverfunktion signifikant vil ændre pregabalins plasmakoncentrationer.
English: Clinical trials indicate that gender does not have a clinically significant influence on the plasma concentrations of pregabalin.
Danish: Kliniske studier tyder på, at køn ikke har nogen klinisk betydende indflydelse på plasmakoncentrationen af pregabalin.
English: Following an additional week the dose may be increased to 450 mg per day.
Danish: Efter yderligere 7 dage kan dosis øges til 450 mg dagligt.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Mylan S.A.S
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Mylan S.A.S
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: Pregabalin Mylan Pharma is for oral use only.
Danish: Pregabalin Mylan Pharma er kun til oral anvendelse.
English: Capsules content Hydroxylpropylcellulose Maize starch Talc
Danish: Kapselindhold Hydroxylpropylcellulose Majsstivelse Talcum
English: Starting dose (mg/day)
Danish: Startdosis (mg/døgn)
English: No specific pharmacodynamic interaction studies were conducted in elderly volunteers.
Danish: Der er ikke udført specifikke farmakodynamiske interaktionsstudier på ældre raske forsøgspersoner.
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-tarm-kanalen (f.eks intestinal obstruktion, paralytisk ileus, obstipation), når pregabalin gives samtidig med lægemidler, der potentielt kan medføre obstipation, herunder opioide analgetika.
English: Pregabalin steady-state pharmacokinetics are similar in healthy volunteers, patients with epilepsy receiving anti-epileptic drugs 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: Once Daily or BID Once Daily
Danish: 1 gang dagligt
English: Ear and labyrinth disorders Common
Danish: Øre og labyrint Almindelig
English: Adjunctive Treatment
Danish: Tillægsbehandling
English: Lactation had little to no influence on pregabalin pharmacokinetics.
Danish: Amning havde kun lille eller ingen indflydelse på pregabalins farmakokinetik.
English: In controlled clinical trials, multiple oral doses of pregabalin co-administered with oxycodone, lorazepam, or ethanol did not result in clinically important effects on respiration.
Danish: I kontrollerede kliniske studier blev flere orale doser af pregabalin givet samtidig med oxycodon, lorazepam eller ethanol, og det førte ikke til klinisk afgørende påvirkninger af respirationen.
English: In the 12-week placebo-controlled study, paediatric patients were assigned to pregabalin 2.5 mg/kg/day (maximum, 150 mg/day), pregabalin 10 mg/kg/day (maximum, 600 mg/day), or placebo.
Danish: I det placebokontrollerede studie af 12 ugers varighed blev pædiatriske patienter behandlet med enten pregabalin 2,5 mg/kg/dag (maksimum 150 mg/dag), pregabalin 10 mg/kg/dag (maksimum 600 mg/dag) eller placebo.
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: In the post-marketing experience, visual adverse reactions have also been reported, including loss of vision, visual blurring or other changes of visual acuity, many of which were transient.
Danish: Efter markedsføring er der set tilfælde af øjenbivirkninger, herunder synstab, sløring af synet eller andre forandringer i synsskarpheden, hvoraf mange var forbigående.
English: HDPE bottle pack containing 200 hard capsules.
Danish: HDPE-beholder, der indeholder 200 hårde kapsler.
English: • Feeling of elation, confusion, disorientation, decrease in sexual interest, irritability
Danish: • Følelse af opstemthed, forvirring, desorientering, nedsat seksuel interesse, irritabilitet.
English: Central nervous system influencing medical products Pregabalin may potentiate the effects of ethanol and lorazepam.
Danish: Pregabalin kan potensere virkningerne af ethanol og lorazepam.
English: • Decrease in white blood cell count
Danish: • Nedsat antal hvide blodlegemer.
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; and 1 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: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: Hypersensitivity Angioedema, allergic reaction
Danish: Angioødem, allergiske reaktioner.
English: In repeated dose toxicity studies in rats and monkeys CNS effects were observed, including hypoactivity, hyperactivity and ataxia.
Danish: I gentagne dosis-toksicitetsundersøgelser på rotter og aber ses påvirkning af centralnervesystemet, bl.a. ved hypoaktivitet, hyperaktivitet og ataksi.
English: • Hepatitis (inflammation of the liver).
Danish: • Leverbetændelse (hepatitis).
English: Pregabalin is eliminated from the systemic circulation primarily by renal excretion as unchanged drug.
Danish: Pregabalin udskilles fra det systemiske kredsløb primært via renal udskillelse som uomdannet lægemiddelstof.
English: For patients receiving haemodialysis, the pregabalin daily dose should be adjusted based on renal function.
Danish: Hos patienter, der er i hæmodialysebehandling, skal den daglige dosis af pregabalin justeres i forhold til nyrefunktionen.
English: You may feel sleepy, confused, agitated, or restless as a result of taking more Pregabalin Mylan Pharma than you should.
Danish: Du kan føle dig søvnig, forvirret, oprevet eller rastløs, hvis du har taget for mange Pregabalin Mylan Pharma.
English: • Changes in eyesight, unusual eye movement, changes in vision including tunnel vision,
Danish: • Synsforstyrrelser, usædvanlige øjenbevægelser, ændring i synet herunder tunnelsyn, lysglimt,
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
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: There have been post-marketing reports of congestive heart failure in some patients receiving pregabalin.
Danish: Efter markedsføring er der rapporteret om kronisk venstresidig hjerteinsufficiens hos nogle patienter i behandling med pregabalin.
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: Epilepsy: Pregabalin Mylan Pharma is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults.
Danish: Epilepsi: Pregabalin Mylan Pharma anvendes til behandling af visse former for epilepsi (partielle anfald med eller uden sekundær generalisering) hos voksne.
English: • Feeling drunk, abnormal style of walking
Danish: • Følelse af at være beruset, unormal gangart.
English: Pregabalin Mylan Pharma may be taken with or without food.
Danish: Pregabalin Mylan Pharma kan tages med eller uden mad.
English: Fertility studies in male rats have shown adverse reproductive and developmental effects.
Danish: Fertilitetsstudier på hanrotter har vist negative virkninger på reproduktion og udvikling.
English: You should take Pregabalin Mylan Pharma in addition to your current treatment.
Danish: Du skal tage Pregabalin Mylan Pharma sammen med din nuværende behandling.
English: Pregabalin Mylan Pharma may produce dizziness, sleepiness and decreased concentration.
Danish: Pregabalin Mylan Pharma kan give svimmelhed, søvnighed og nedsat koncentrationsevne.
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: When taken with certain other medicines, Pregabalin Mylan Pharma 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 Mylan Pharma forstærke de bivirkninger, der er set med denne type medicin, herunder åndedrætssvigt og dyb bevidstløshed.
English: The most common adverse reactions resulting in discontinuation from pregabalin treatment groups were dizziness and somnolence.
Danish: De hyppigste bivirkninger, som førte til seponering af behandlingen i pregabalingruppen, var svimmelhed og søvnighed.
English: Pregabalin is rapidly absorbed when administered in the fasted state, with peak plasma concentrations occurring within 1 hour following both single and multiple dose administration.
Danish: Pregabalin absorberes hurtigt, når det gives fastende, og maksimal plasmakoncentration nås indenfor 1 time efter indgift af både enkelte og gentagne doser.
English: • Muscle damage
Danish: • Muskelsvækkelse.
English: • Some patients taking Pregabalin Mylan Pharma have reported symptoms suggesting an allergic reaction.
Danish: • Hos nogle patienter, der tager Pregabalin Mylan Pharma, er der rapporteret om symptomer, der tyder på en overfølsomhedsreaktion.
English: • Pregabalin Mylan Pharma may cause blurring or loss of vision, or other changes in eyesight, many of which are temporary.
Danish: • Pregabalin Mylan Pharma kan forårsage sløret syn, synstab eller andre synsændringer, som kan være forbigående.
English: However, administration of pregabalin with food has no clinically significant effect on the extent of pregabalin absorption.
Danish: Indgift af pregabalin sammen med føde har dog ingen klinisk betydende effekt på absorptionen af pregabalin.
English: Pregabalin Mylan Pharma is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Danish: Pregabalin Mylan Pharma er indiceret som supplerende behandling til voksne med refraktære partielle anfald med eller uden sekundær generalisering.
English: • Breast pain
Danish: • Brystsmerter.
English: Treatment of pregabalin overdose should include general supportive measures and may include haemodialysis if necessary (see section 4.2 Table 1).
Danish: Behandling af overdosis er generelt understøttende og kan omfatte hæmodialyse om nødvendigt (se pkt.
English: After oral administration of pregabalin in paediatric patients in the fasted state, in general, time to reach peak plasma concentration was similar across the entire age group and occurred 0.5 hours to 2 hours postdose.
Danish: Efter oral indgift af pregabalin hos fastende pædiatriske patienter var tidsperioden, til den højeste plasmakoncentration blev nået, generelt ens på tværs af alle aldersgrupper, og den højeste plasmakoncentration indtraf 0,5-2 timer efter dosisindgift.
English: At therapeutic exposures, there was evidence of CNS clinical signs of hyperactivity and bruxism and some changes in growth (transient body weight gain suppression).
Danish: Ved terapeutiske doser er der kliniske tegn på påvirkning af centralnervesystemet så som hyperaktivitet og tænderskæren samt nogle ændringer på vækst (undertrykkelse af forbigående legemsvægtøgning).
English: • Fluid in the lungs
Danish: • Væske i lungerne.
English: • Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure,
Danish: • Hjerterytmeforstyrrelser, hurtigere hjerterytme (puls), lavt blodtryk, højt blodtryk, ændringer i hjerteslag, hjertesvigt.
English: • There have been reports of convulsions when taking Pregabalin Mylan Pharma or shortly after stopping Pregabalin Mylan Pharma.
Danish: • Der er set kramper i forbindelse med behandling med Pregabalin Mylan Pharma og kort tid efter ophør af behandling med Pregabalin Mylan Pharma.
English: After stopping long and short-term Pregabalin Mylan Pharma treatment, you need to know that you may experience certain side effects.
Danish: Når du stopper med at tage Pregabalin Mylan Pharma efter langtidsbehandling eller korttidsbehandling, skal du vide, at du måske får visse bivirkninger.
English: In these patients, visual acuity was reduced in 6.5% of patients treated with pregabalin, and 4.8% of placebo-treated patients.
Danish: Synsskarpheden blev nedsat hos 6,5% af disse patienter, der blev behandlet med pregabalin, og hos 4,8% af placebobehandlede patienter.
English: The most common adverse events observed in the 12-week study with pregabalin treatment were somnolence, pyrexia, upper respiratory tract infection, increased appetite, weight increased, and nasopharyngitis (see sections 4.2, 5.1 and 5.2).
Danish: Den mest almindelige bivirkning, der blev observeret i studiet af 12 ugers varighed med behandling med pregabalin, var døsighed, pyreksi, øvre luftvejsinfektioner, øget appetit, vægtøgning og nasopharyngitis (se pkt.
English: • When Pregabalin Mylan Pharma 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 Mylan Pharma 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: Pregabalin Mylan Pharma may have minor or moderate influence on the ability to drive and use machines.
Danish: Pregabalin Mylan Pharma påvirker i mindre eller moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: Seizures were also reported.
Danish: Der er også rapporteret krampeanfald.
English: Euphoric mood, confusion, irritability, disorientation, insomnia, libido decreased
Danish: Eufori, konfusion, irritabilitet, desorientering, søvnløshed, nedsat libido.
English: Pregabalin should be discontinued immediately if symptoms of angioedema, such as facial, perioral, or upper airway swelling occur.
Danish: Behandling med pregabalin skal straks seponeres i tilfælde af symptomer på angioødem, f.eks. hævelse af ansigtet, læberne eller de øvre luftveje.
English: Hypotension, hypertension, hot flushes, flushing, peripheral coldness
Danish: Hypotension, hypertension, hedeture, flushing, perifer kuldefølelse.
English: After discontinuation of short-term and long-term treatment with pregabalin, withdrawal symptoms have been observed in some patients.
Danish: Efter seponering af kortidsbehandling og langtidsbehandling med pregabalin, er der set seponeringssymptomer hos nogle patienter.
English: In rare occasions, cases of coma have been reported.
Danish: Koma er set i sjældne tilfælde.
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: • Pregabalin Mylan Pharma has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in elderly patients.
Danish: • Pregabalin Mylan Pharma er forbundet med svimmelhed og søvnighed, som kan øge risikoen for faldulykker hos ældre patienter.
English: Nervous system disorders Very common Common
Danish: Nervesystemet Meget almindelig
English: Pregabalin Mylan Pharma may cause dizziness and somnolence and therefore may influence the ability to drive or use machines.
Danish: Pregabalin Mylan Pharma kan forårsage svimmelhed og søvnighed, og derfor kan det påvirke evnen til at køre bil eller betjene maskiner.
English: In mice, no increased incidence of tumours was found at exposures similar to the mean human exposure, but an increased incidence of haemangiosarcoma was observed at higher exposures.
Danish: Der blev ikke set øget forekomst af tumorer hos mus ved en eksponering, der er den samme som den gennemsnitlige humane dosis, men en øget forekomst af hæmangiosarkom blev set ved højere doser.
English: • Vertigo, problems with balance, fall
Danish: • Svimmelhed, balanceproblemer, faldtendens.
English: Cases of renal failure have been reported and in some cases discontinuation of pregabalin did show reversibility of this adverse reaction.
Danish: Der er set tilfælde af nyresvigt, og denne bivirkning er i nogle tilfælde reversibel ved seponering af pregabalin.
English: Skin and subcutaneous tissue disorders Uncommon
Danish: Hud og subkutane væv Ikke almindelig
English: • Changes in blood and liver test results (blood creatinine phosphokinase increased, alanine aminotransferase 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: The most commonly reported adverse reactions were dizziness and somnolence.
Danish: De hyppigst rapporterede bivirkninger er svimmelhed og søvnighed.
English: Visual field changes were detected in 12.4% of pregabalin-treated, and 11.7% of placebo-treated patients.
Danish: Synsfeltforandringer blev set hos 12,4% af patienterne, der blev behandlet med pregabalin, og hos 11,7% af placebobehandlede patienter.
English: • Blurred vision, double vision
Danish: • Sløret syn, dobbeltsyn.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BLISTER AND BOTTLE
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON TIL BLISTER OG BEHOLDER
English: Convulsions, including status epilepticus and grand mal convulsions, may occur during pregabalin use or shortly after discontinuing pregabalin.
Danish: Der kan opstå kramper, herunder status epilepticus og tonisk-kloniske kramper under behandling med pregabalin eller kort tid efter behandlingsophør.
English: • Lorazepam - (used for treating anxiety)
Danish: Oxycodon - (smertestillende middel) Lorazepam - (anvendes til behandling af angst) Alkohol
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: White blood cell count decreased * Alanine aminotransferase increased (ALT) and aspartate aminotransferase increased (AST).
Danish: * Forhøjet alaninaminotransferase (ALAT) og forhøjet aspartataminotransferase (ASAT).
English: Reproductive system and breast disorders Common
Danish: Det reproduktive system og mammae Almindelig
English: • Muscle twitching, joint swelling, muscle stiffness, pain including muscle pain, neck pain
Danish: • Muskeltrækninger, ledhævelser, muskelstivhed, smerter herunder muskelsmerter, smerter i nakken.
English: You should immediately tell your doctor if you experience any changes in your vision.
Danish: Kontakt straks lægen, hvis du får synsforandringer.
English: Funduscopic changes were observed in 1.7% of pregabalin-treated and 2.1% of placebo-treated patients.
Danish: Forandringer af øjenbaggrunden blev observeret hos 1,7% af patienterne, der blev behandlet med pregabalin og 2,1% af placebobehandlede patienter.
English: Convulsion, parosmia, hypokinesia, dysgraphia
Danish: Kramper, parosmi, hypokinesi, dysgrafi.
English: Psychiatric disorders Common
Danish: Psykiske forstyrrelser Almindelig
English: If you experience a convulsion, contact your doctor immediately.
Danish: Hvis du får kramper, skal du straks kontakte lægen.
English: Effects on the oestrus cycle were observed at 5-fold the human therapeutic exposure.
Danish: Virkningerne på den oestrale periode ses ved doser 5 gange højere end terapeutisk dosis hos mennesker.
English: Neutropaenia
Danish: Neutropeni.
English: The incidence of adverse reactions in general, CNS adverse reactions and especially somnolence was increased in the treatment of central neuropathic pain due to spinal cord injury (see section
Danish: Forekomsten af bivirkninger generelt, bivirkninger i centralnervesystemet og især somnolens blev forøget ved behandling af central neuropatisk smerte på grund af rygmarvsskade (se pkt.
English: A fertility study in female rats has shown adverse reproductive effects.
Danish: Et fertilitetsstudie på hunrotter har vist negative virkninger på reproduktion.
English: Sexual dysfunction, ejaculation delayed, dysmenorrhoea, breast pain
Danish: Seksual dysfunktion, forsinket ejakulation, dysmenoré, brystsmerter.