natgillin/translations-raw huggingface dataset:
• Synsforstyrrelser, usædvanlige øjenbevægelser, ændring i synet herunder tunnelsyn, lysglimt, 
• Changes in eyesight, unusual eye movement, changes in vision including tunnel vision,
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. 
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
Efter markedsføring er der rapporteret om kronisk venstresidig hjerteinsufficiens hos nogle patienter i behandling med pregabalin. 
There have been post-marketing reports of congestive heart failure in some patients receiving pregabalin.
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. 
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.
Epilepsi: Pregabalin Mylan Pharma anvendes til behandling af visse former for epilepsi (partielle anfald med eller uden sekundær generalisering) hos voksne. 
Epilepsy: Pregabalin Mylan Pharma is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults.
• Følelse af at være beruset, unormal gangart. 
• Feeling drunk, abnormal style of walking
Pregabalin Mylan Pharma kan tages med eller uden mad. 
Pregabalin Mylan Pharma may be taken with or without food.
Fertilitetsstudier på hanrotter har vist negative virkninger på reproduktion og udvikling. 
Fertility studies in male rats have shown adverse reproductive and developmental effects.
Du skal tage Pregabalin Mylan Pharma sammen med din nuværende behandling. 
You should take Pregabalin Mylan Pharma in addition to your current treatment.
Pregabalin Mylan Pharma kan give svimmelhed, søvnighed og nedsat koncentrationsevne. 
Pregabalin Mylan Pharma may produce dizziness, sleepiness and decreased concentration.
En øget hyppighed af nethindeatrofi ses sædvanligvis hos ældre albinorotter efter langtidseksponering med pregabalin ved doser  5 gange den maksimale anbefalede gennemsnitlige humane dosis. 
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.
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. 
When taken with certain other medicines, Pregabalin Mylan Pharma may potentiate the side effects seen with these medicines, including respiratory failure and coma.
De hyppigste bivirkninger, som førte til seponering af behandlingen i pregabalingruppen, var svimmelhed og søvnighed. 
The most common adverse reactions resulting in discontinuation from pregabalin treatment groups were dizziness and somnolence.
Pregabalin absorberes hurtigt, når det gives fastende, og maksimal plasmakoncentration nås indenfor 1 time efter indgift af både enkelte og gentagne doser. 
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.
• Muskelsvækkelse. 
• Muscle damage
• Hos nogle patienter, der tager Pregabalin Mylan Pharma, er der rapporteret om symptomer, der tyder på en overfølsomhedsreaktion. 
• Some patients taking Pregabalin Mylan Pharma have reported symptoms suggesting an allergic reaction.
• Pregabalin Mylan Pharma kan forårsage sløret syn, synstab eller andre synsændringer, som kan være forbigående. 
• Pregabalin Mylan Pharma may cause blurring or loss of vision, or other changes in eyesight, many of which are temporary.
Indgift af pregabalin sammen med føde har dog ingen klinisk betydende effekt på absorptionen af pregabalin. 
However, administration of pregabalin with food has no clinically significant effect on the extent of pregabalin absorption.
Pregabalin Mylan Pharma er indiceret som supplerende behandling til voksne med refraktære partielle anfald med eller uden sekundær generalisering. 
Pregabalin Mylan Pharma is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
• Brystsmerter. 
• Breast pain
Behandling af overdosis er generelt understøttende og kan omfatte hæmodialyse om nødvendigt (se pkt. 
Treatment of pregabalin overdose should include general supportive measures and may include haemodialysis if necessary (see section 4.2 Table 1).
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. 
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.
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). 
At therapeutic exposures, there was evidence of CNS clinical signs of hyperactivity and bruxism and some changes in growth (transient body weight gain suppression).
• Væske i lungerne. 
• Fluid in the lungs
• Hjerterytmeforstyrrelser, hurtigere hjerterytme (puls), lavt blodtryk, højt blodtryk, ændringer i hjerteslag, hjertesvigt. 
• Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure,
• Der er set kramper i forbindelse med behandling med Pregabalin Mylan Pharma og kort tid efter ophør af behandling med Pregabalin Mylan Pharma. 
• There have been reports of convulsions when taking Pregabalin Mylan Pharma or shortly after stopping Pregabalin Mylan Pharma.
Når du stopper med at tage Pregabalin Mylan Pharma efter langtidsbehandling eller korttidsbehandling, skal du vide, at du måske får visse bivirkninger. 
After stopping long and short-term Pregabalin Mylan Pharma treatment, you need to know that you may experience certain side effects.
Synsskarpheden blev nedsat hos 6,5% af disse patienter, der blev behandlet med pregabalin, og hos 4,8% af placebobehandlede patienter. 
In these patients, visual acuity was reduced in 6.5% of patients treated with pregabalin, and 4.8% of placebo-treated patients.
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. 
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).
• 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). 
• 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).
Pregabalin Mylan Pharma påvirker i mindre eller moderat grad evnen til at føre motorkøretøj og betjene maskiner. 
Pregabalin Mylan Pharma may have minor or moderate influence on the ability to drive and use machines.
Der er også rapporteret krampeanfald. 
Seizures were also reported.
Eufori, konfusion, irritabilitet, desorientering, søvnløshed, nedsat libido. 
Euphoric mood, confusion, irritability, disorientation, insomnia, libido decreased
Behandling med pregabalin skal straks seponeres i tilfælde af symptomer på angioødem, f.eks. hævelse af ansigtet, læberne eller de øvre luftveje. 
Pregabalin should be discontinued immediately if symptoms of angioedema, such as facial, perioral, or upper airway swelling occur.
Hypotension, hypertension, hedeture, flushing, perifer kuldefølelse. 
Hypotension, hypertension, hot flushes, flushing, peripheral coldness
Efter seponering af kortidsbehandling og langtidsbehandling med pregabalin, er der set seponeringssymptomer hos nogle patienter. 
After discontinuation of short-term and long-term treatment with pregabalin, withdrawal symptoms have been observed in some patients.
Koma er set i sjældne tilfælde. 
In rare occasions, cases of coma have been reported.
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. 
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).
• Pregabalin Mylan Pharma er forbundet med svimmelhed og søvnighed, som kan øge risikoen for faldulykker hos ældre patienter. 
• Pregabalin Mylan Pharma has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in elderly patients.
Nervesystemet Meget almindelig 
Nervous system disorders Very common Common
Pregabalin Mylan Pharma kan forårsage svimmelhed og søvnighed, og derfor kan det påvirke evnen til at køre bil eller betjene maskiner. 
Pregabalin Mylan Pharma may cause dizziness and somnolence and therefore may influence the ability to drive or use machines.
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. 
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.
• Svimmelhed, balanceproblemer, faldtendens. 
• Vertigo, problems with balance, fall
Der er set tilfælde af nyresvigt, og denne bivirkning er i nogle tilfælde reversibel ved seponering af pregabalin. 
Cases of renal failure have been reported and in some cases discontinuation of pregabalin did show reversibility of this adverse reaction.
Hud og subkutane væv Ikke almindelig 
Skin and subcutaneous tissue disorders Uncommon
• 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. 
• Changes in blood and liver test results (blood creatinine phosphokinase increased, alanine aminotransferase increased, aspartate aminotransferase increased, platelet count decreased,
De hyppigst rapporterede bivirkninger er svimmelhed og søvnighed. 
The most commonly reported adverse reactions were dizziness and somnolence.
Synsfeltforandringer blev set hos 12,4% af patienterne, der blev behandlet med pregabalin, og hos 11,7% af placebobehandlede patienter. 
Visual field changes were detected in 12.4% of pregabalin-treated, and 11.7% of placebo-treated patients.
• Sløret syn, dobbeltsyn. 
• Blurred vision, double vision
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON TIL BLISTER OG BEHOLDER 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BLISTER AND BOTTLE
Der kan opstå kramper, herunder status epilepticus og tonisk-kloniske kramper under behandling med pregabalin eller kort tid efter behandlingsophør. 
Convulsions, including status epilepticus and grand mal convulsions, may occur during pregabalin use or shortly after discontinuing pregabalin.
Oxycodon - (smertestillende middel) Lorazepam - (anvendes til behandling af angst) Alkohol 
• Lorazepam - (used for treating anxiety)
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. 
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.
* Forhøjet alaninaminotransferase (ALAT) og forhøjet aspartataminotransferase (ASAT). 
White blood cell count decreased * Alanine aminotransferase increased (ALT) and aspartate aminotransferase increased (AST).
Det reproduktive system og mammae Almindelig 
Reproductive system and breast disorders Common
• Muskeltrækninger, ledhævelser, muskelstivhed, smerter herunder muskelsmerter, smerter i nakken. 
• Muscle twitching, joint swelling, muscle stiffness, pain including muscle pain, neck pain
Kontakt straks lægen, hvis du får synsforandringer. 
You should immediately tell your doctor if you experience any changes in your vision.
Forandringer af øjenbaggrunden blev observeret hos 1,7% af patienterne, der blev behandlet med pregabalin og 2,1% af placebobehandlede patienter. 
Funduscopic changes were observed in 1.7% of pregabalin-treated and 2.1% of placebo-treated patients.
Kramper, parosmi, hypokinesi, dysgrafi. 
Convulsion, parosmia, hypokinesia, dysgraphia
Psykiske forstyrrelser Almindelig 
Psychiatric disorders Common
Hvis du får kramper, skal du straks kontakte lægen. 
If you experience a convulsion, contact your doctor immediately.
Virkningerne på den oestrale periode ses ved doser 5 gange højere end terapeutisk dosis hos mennesker. 
Effects on the oestrus cycle were observed at 5-fold the human therapeutic exposure.
Neutropeni. 
Neutropaenia
Forekomsten af bivirkninger generelt, bivirkninger i centralnervesystemet og især somnolens blev forøget ved behandling af central neuropatisk smerte på grund af rygmarvsskade (se pkt. 
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
Et fertilitetsstudie på hunrotter har vist negative virkninger på reproduktion. 
A fertility study in female rats has shown adverse reproductive effects.
Seksual dysfunktion, forsinket ejakulation, dysmenoré, brystsmerter. 
Sexual dysfunction, ejaculation delayed, dysmenorrhoea, breast pain
Påvirkning af fertilitet hos han- og hunrotter blev kun observeret ved eksponeringer, der i væsentlig grad oversteg den terapeutiske eksponering. 
Adverse effects on fertility in male and female rats were only observed at exposures sufficiently in excess of therapeutic exposure.
manglende smagsevne, brændende fornemmelse, rysten ved bevægelse, nedsat bevidsthed, 
sensitive skin, loss of taste, burning sensation, tremor on movement, decreased consciousness,
Symptomerne er værre end de, der kan opleves i forbindelse med dagligdagens stress og anstrengelser. 
This is different to the stresses and strains of everyday life.
Du må ikke stoppe med at tage Pregabalin Mylan Pharma, medmindre din læge har bedt dig herom. 
Do not stop taking Pregabalin Mylan Pharma unless your doctor tells you to.
Ved tillægsbehandling med pregabalin, er der ikke tilstrækkelig dokumentation for at seponere samtidig brug af anden antiepileptika, selv om anfaldskontrol er opnået, for derved at monoterapibehandle med pregabalin. 
Withdrawal of concomitant anti-epileptic medicinal products There are insufficient data for the withdrawal of concomitant anti-epileptic medicinal products, once seizure control with pregabalin in the add-on situation has been reached, in order to reach monotherapy on pregabalin.
Pregabalin Mylan Pharma 25 mg hårde kapsler Pregabalin Mylan Pharma 50 mg hårde kapsler Pregabalin Mylan Pharma 75 mg hårde kapsler Pregabalin Mylan Pharma 100 mg hårde kapsler Pregabalin Mylan Pharma 150 mg hårde kapsler Pregabalin Mylan Pharma 200 mg hårde kapsler Pregabalin Mylan Pharma 225 mg hårde kapsler Pregabalin Mylan Pharma 300 mg hårde kapsler pregabalin 
Pregabalin Mylan Pharma 25 mg hard capsules Pregabalin Mylan Pharma 50 mg hard capsules Pregabalin Mylan Pharma 75 mg hard capsules Pregabalin Mylan Pharma 100 mg hard capsules Pregabalin Mylan Pharma 150 mg hard capsules Pregabalin Mylan Pharma 200 mg hard capsules Pregabalin Mylan Pharma 225 mg hard capsules Pregabalin Mylan Pharma 300 mg hard capsules
SÆRLIGE OPBEVARINGSBETINGELSER Hold beholderen tæt tillukket for at beskytte mod fugt. 
SPECIAL STORAGE CONDITIONS Keep the bottle tightly closed in order to protect from moisture.
Fordi renal udskillelse er hovedeliminationsvejen, er det nødvendigt med dosisreduktion hos patienter med nedsat nyrefunktion, og dosistilskud efter hæmodialyse (se pkt. 
Because renal elimination is the major elimination pathway, dose reduction in patients with renal impairment and dose supplementation following haemodialysis is necessary (see section 4.2 Table 1).
Pregabalin Mylan Pharma indeholder det aktive stof pregabalin, der tilhører en gruppe lægemidler, som anvendes til behandling af epilepsi og generaliseret angst hos voksne. 
What Pregabalin Mylan Pharma is and what it is used for Pregabalin Mylan Pharma contains the active substance pregabalin which belongs to a group of medicines used to treat epilepsy and Generalised Anxiety Disorder (GAD) in adults.
Ataksi, koordinationsforstyrrelser, tremor, dysartri, amnesi, hukommelsesproblemer, opmærksomhedsforstyrrelser, paræstesi, hypæstesi, sedation, balanceforstyrrelser, letargi. 
Ataxia, coordination abnormal, tremor, dysarthria, amnesia, memory impairment, disturbance in attention, paraesthesia, hypoaesthesia, sedation, balance disorder, lethargy
Du skal derfor være forsigtig, indtil du ved, hvordan medicinen virker på dig. 
Therefore, you should be careful until you are used to any effect the medicine might have.
For 2 gange dagligt skal Pregabalin Mylan Pharma tages én gang om morgenen og én gang om aftenen og på omtrent samme tid hver dag. 
For twice a day take Pregabalin Mylan Pharma once in the morning and once in the evening,
Det kliniske program med pregabalin omfatter over 8.900 patienter, som fik pregabalin. 
The pregabalin clinical programme involved over 8900 patients exposed to pregabalin, of whom over 5600 were in double-blind placebo controlled trials.
Blister: Opbevares i den originale yderpakning for at beskytte mod fugt. 
Blister: Store in the original package in order to protect from moisture.
• Nyresvigt, nedsat urinmængde, besvær med at lade vandet. 
• Kidney failure, reduced urine volume, urinary retention
Forhøjet blod-kreatinin-fosfokinase, forhøjet blodglucose, nedsat antal blodplader, forhøjet S-kreatinin, nedsat S-kalium, vægttab. 
Blood creatine phosphokinase increased, blood glucose increased, platelet count decreased, blood creatinine increased, blood potassium decreased, weight decreased
Synkope, stupor, myokloni, bevidsthedstab, psykomotorisk hyperaktivitet, dyskinesi, ortostatisk svimmelhed, intentionstremor, nystagmus, kognitiv forstyrrelse, mental svækkelse, taleproblemer, hyporefleksi, hyperæstesi, brændende fornemmelse, manglende smagsopfattelse, utilpashed. 
Syncope, stupor, myoclonus, loss of consciousness, psychomotor hyperactivity, dyskinesia, dizziness postural, intention tremor, nystagmus, cognitive disorder, mental impairment, speech disorder, hyporeflexia, hyperaesthesia, burning sensation, ageusia, malaise
• Unormal lugtesans, synsforstyrelser, ændret synsopfattelse af dybde, øget lysfølsomhed, 
• Abnormal sense of smell, swinging vision, altered perception of depth, visual brightness,
Pregabalin er undersøgt i 3 kontrollerede studier af 12 ugers varighed med dosering enten 2 eller 3 gange dagligt. 
Pregabalin has been studied in 3 controlled clinical trials of 12 week duration with either BID or TID dosing.
Behandling med pregabalin kan startes med en dosis på 150 mg dagligt fordelt på 2 eller 3 doser. 
Pregabalin treatment can be started with a dose of 150 mg per day given as two or three divided doses.
• Visse bivirkninger, såsom søvnighed, kan være hyppigere hos patienter med rygmarvsskader, som følge af samtidig brug af andre præparater med lignende bivirkningsprofil, f.eks. til behandling af smerter eller spasticitet. 
• Certain side effects may be more common, such as sleepiness, because patients with spinal cord injury may be taking other medicines to treat, for example, pain or spasticity, that have similar side effects to Pregabalin and the severity of these effects may be increased when taken together.
Beholder: Hold beholderen tæt tillukket for at beskytte mod fugt. 
Bottle: Keep the bottle tightly closed in order to protect from moisture.
• Nogle sukkersyge (diabetes)patienter kan få vægtøgning, når de tager Pregabalin Mylan Pharma, og kan derfor have behov for at ændre deres diabetesmedicin. 
• Some patients with diabetes who gain weight while taking pregabalin may need an alteration in their diabetic medicines.
Da den potentielle risiko for mennesker er ukendt, skal kvinder i den fertile alder anvende sikker antikonception. 
Women of childbearing potential/Contraception in males and females As the potential risk for humans is unknown, effective contraception must be used in women of child bearing potential.
Dosis er 150-600 mg dagligt fordelt på 2 eller 3 doser. 
The dose range is 150 to 600 mg per day given as two or three divided doses.
Plasmaclearance og renalclearance af pregabalin er direkte proportionalt med kreatininclearance (se pkt. 
Pregabalin plasma clearance and renal clearance are directly proportional to creatinine clearance (see section 5.2 Renal impairment).
SÆRLIGE OPBEVARINGSBETINGELSER Blister: Opbevares i den originale yderpakning for at beskytte mod fugt. 
SPECIAL STORAGE CONDITIONS Blister: Store in the original package in order to protect from moisture.
Halluciationer, panikanfald, rastløshed, agitation, depression, forsænket stemningsleje, hævet stemningsleje, aggression, humørsvingninger, depersonalisation, svært ved at finde ord, drømmeforstyrrelser, øget libido, anorgasme, apati. 
Hallucination, panic attack, restlessness, agitation, depression, depressed mood, elevated mood, aggression, mood swings, depersonalisation, word finding difficulty, abnormal dreams, libido increased, anorgasmia, apathy
bevidshedstab, besvimelse, øget følsomhed over for støj, utilpashed. 
loss of consciousness, fainting, increased sensitivity to noise, feeling unwell
Kontakt lægen eller apotekspersonalet, før du tager Pregabalin Mylan Pharma 
Warnings and precautions Talk to your doctor or pharmacist before taking Pregabalin Mylan Pharma.
I de kontrollerede studier udgik 12% af patienterne, der fik pregabalin, og 5% af patienterne, der fik placebo, på grund af bivirkninger. 
In all controlled studies, the discontinuation rate due to adverse reactions was 12% for patients receiving pregabalin and 5% for patients receiving placebo.
• Flåd fra brystvorter, unormal vækst af bryster, vækst af bryster hos mænd. 
• Breast discharge, abnormal breast growth, breast growth in males
• Øget spytproduktion, halsbrand, følelsesløshed omkring munden. 
• Increased saliva production, heartburn, numb around mouth
Pregabalin er undersøgt i et kontrolleret studie af 56 ugers varighed med dosering 2 gange dagligt. 
Pregabalin has been studied in 1 controlled clinical trial of 56 week duration with BID dosing.
Immunsystemet Ikke almindelig Sjælden 
Immune system disorders Uncommon