FrancophonIA/ELRC3.0 huggingface dataset:
English: Pregabalin should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the foetus).
Danish: Pregabalin bør ikke anvendes under graviditet, medmindre det er klart nødvendigt (hvis fordelene for moderen klart opvejer den mulige risiko for fosteret/det nyfødte barn).
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 February 2017.
Danish: Dato for første markedsføringstilladelse: 27. februar 2017
English: SPECIAL STORAGE CONDITIONS Do not store above 30 °C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer over 30°C.
English: Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
Danish: Derfor bør patienterne overvåges for tegn på selvmordstanker og -adfærd, og passende behandling bør overvejes.
English: hard capsules may be taken with or without food.
Danish: hårde kapsler kan tages både sammen med eller uden mad.
English: • alcohol.
Danish: • alkohol
English: Appetite increased
Danish: Øget appetit
English: is too strong or too weak, talk to your doctor or pharmacist.
Danish: er for stærk eller alt for svag, skal du tale med din læge eller apoteket.
English: is used to treat long lasting pain caused by damage to the nerves.
Danish: anvendes til behandling af langvarige smerter, som skyldes beskadigede nervebaner.
English: The active substance, pregabalin, is a gamma-aminobutyric acid analogue [(S)-3-(aminomethyl)-5methylhexanoic acid].
Danish: Det aktive indholdsstof, pregabalin, er en gamma-aminosmørsyre-analog [(S)-3-(aminomethyl)-5methylhexansyre].
English: Pregabalin oral bioavailability is estimated to be ≥ 90% and is independent of dose.
Danish: Biotilgængeligheden af oral pregabalin anslås at være 90% og er ikke dosisafhængig.
English: The AUC was lower by 30% in paediatric patients below a weight of 30 kg due to an increased body weight adjusted clearance of 43% for these patients in comparison to patients weighing ≥ 30 kg.
Danish: AUC var 30% lavere hos pædiatriske patienter med en vægt under 30 kg på grund af en øgning i kropsvægtjusteret clearance på 43% hos disse patienter sammenlignet med patienter, der vejede ≥30 kg.
English: 25 mg hard capsules are packed into alu/alu (OPA/alu/PVC/alu) blisters as primary packaging.
Danish: 25 mg hårde kapsler er pakket i alu/alu (OPA/alu/PVC/alu) blister som indre emballage.
English: Pregabalin binds to an auxiliary subunit (α2-δ protein) of voltage-gated calcium channels in the central nervous system.
Danish: Pregabalin bindes til en hjælpeundergruppe (α2-δ-protein) i de spændingsafhængige calciumkanaler i centralnervesystemet.
English: In addition to the daily dose, a supplementary dose should be given immediately following every 4 hour haemodialysis treatment (see table 1).
Danish: Udover den daglige dosis, skal supplerende dosis gives umiddelbart efter hver 4. times hæmodialysebehandling (se tabel 1).
English: once in the morning, once in the afternoon and once in the evening, at about the same time each day.
Danish: tages én gang om morgenen, én gang om eftermiddagen og én gang om aftenen og på omtrent samme tid hver dag.
English: You can also report any side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: The dose, which has been adjusted for you and your condition, will generally be between 150 mg and 600 mg each day.
Danish: Den dosis, som er blevet tilpasset til dig og din tilstand, vil normalt være 150-600 mg dagligt.
English: In juvenile rats the types of toxicity do not differ qualitatively from those observed in adult rats.
Danish: Toksicitetstyperne set hos juvenile rotter er ikke kvalitativ forskellige fra dem, der ses hos voksne rotter.
English: Pharmacotherapeutic group: Anti-epileptics, other anti-epileptics; ATC code: N03AX16.
Danish: Farmakoterapeutisk klassifikation: Antiepileptika, andre antiepileptika; ATC-kode: N03AX16.
English: The rate of pregabalin absorption is decreased when given with food resulting in a decrease in Cmax by approximately 25 - 30% and a delay in tmax to approximately 2.5 hours.
Danish: Absorptionshastigheden af pregabalin nedsættes ved samtidig indtagelse af føde, hvilket nedsætter Cmax med ca. 25-30% og en forsinkelse i tmax på ca. 2½ time.
English: Single dose +
Danish: Engangsdosis +
English: once in the morning and once in the evening, at about the same time each day.
Danish: tages én gang om morgenen og én gang om aftenen og på omtrent samme tid hver dag.
English: In clinical trials up to 12 weeks for both peripheral and central neuropathic pain, a reduction in pain was seen by week 1 and was maintained throughout the treatment period.
Danish: I kliniske studier op til 12 uger af både perifere og centrale neuropatiske smerter ses en reduktion af smerter efter 1 uge, og denne reduktion opretholdes gennem hele behandlingsperioden.
English: If you are an elderly patient (over 65 years of age), you should take Pregabalin Zentiva k.s.
Danish: Hvis du er ældre (over 65 år), skal du tage Pregabalin Zentiva k.s.
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 kompromitterede patienter, der er i behandling med pregabalin for en neuropatisk indikation.
English: • A small number of people being treated with anti-epileptics such as pregabalin have had thoughts of harming or killing themselves.
Danish: • En lille andel af de personer, der bliver behandlet med epilepsimedicin som for eksempel pregabalin, har haft selvmordstanker eller tanker om at gøre skade på sig selv.
English: • if you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section
Danish: : - hvis du er allergisk over for pregabalin eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Danish: er indiceret som supplerende behandling til voksne med refraktære partielle anfald med eller uden sekundær generalisering.
English: Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbance, fatigue (tiredness), and can have an impact on physical and social functioning and overall quality of life.
Danish: Perifere og centrale neuropatiske smerter kan også være forbundet med humørsvingninger, søvnforstyrrelser, træthed (udmattelse) og kan have indflydelse på det fysiske og sociale velvære og den samlede livskvalitet.
English: is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults.
Danish: anvendes til behandling af visse former for epilepsi (partielle anfald med eller uden sekundær generalisering) hos voksne.
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 3.600 patienter i de kontrollerede kliniske undersøgelser.
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 sjælden (< 1/10.000), hyppighed ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: is indicated for the treatment of peripheral and central neuropathic pain in adults.
Danish: er indiceret til behandling af perifere og centrale neuropatiske smerter hos voksne.
English: You may feel sleepy, confused, agitated, or restless as a result of taking more Pregabalin Zentiva k.s.
Danish: Du kan føle dig søvnig, forvirret, oprevet eller rastløs, hvis du har taget for mange Pregabalin Zentiva k.s.
English: Peripheral and central neuropathic pain, epilepsy or generalised anxiety disorder Take the number of hard capsules as instructed by your doctor.
Danish: Perifere og centrale neuropatiske smerter, epilepsi eller generaliseret angst Tag det antal hårde kapsler, som lægen har ordineret.
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 degree of dizziness, sleepiness and decreased concentration may be increased if pregabalin is taken together with medicinal products containing:
Danish: Graden af svimmelhed, søvnighed og nedsat koncentrationsevne kan øges, når pregabalin tages sammen med medicin, der indeholder:
English: Do not store above 30 °C.
Danish: Må ikke opbevares ved temperaturer over 30°C.
English: The safety and efficacy of pregabalin in children below the age of 12 years and in adolescents (12 - 17 years of age) have not been established.
Danish: Pregabalins sikkerhed og virkning hos børn under 12 år og unge (12 - 17 år) er ikke klarlagt.
English: The 50 mg capsules also contain propylene glycol, strong ammonia solution, potassium hydroxide.
Danish: 50 mg kapslerne indeholder også propylenglycol, koncentreret ammoniakopløsning, kaliumhydroxid.
English: Very common: may affect more than 1 in 10 people • Dizziness, drowsiness, headache.
Danish: Meget almindelige: Sker hos flere end 1 ud af 10 behandlede • Svimmelhed, døsighed, hovedpine.
English: There have also been postmarketing reports of loss of consciousness, confusion and mental impairment.
Danish: Efter markedsføring er der også set tilfælde af bevidsthedstab, konfusion og mental svækkelse.
English: 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.
Danish: Kvinder i den fertile alder/antikonception hos mænd og kvinder Da den potentielle risiko for mennesker er ukendt, skal kvinder i den fertile alder anvende sikker antikonception.
English: Anorexia, hypoglycaemia
Danish: Anoreksi, hypoglykæmi
English: There are no adequate data from the use of pregabalin in pregnant women.
Danish: Graviditet Der foreligger ikke tilstrækkelige data om brugen af pregabalin hos gravide.
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 pregabalinclearance, at kropsvægt var en signifikant kovariat af pregabalins tilsyneladende fordelingsvolumen, og at disse forhold var ens hos pædiatriske og voksne patienter.
English: Adjunctive treatment
Danish: Tillægsbehandling
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: NAME OF THE MARKETING AUTHORISATION HOLDER Zentiva logo
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Zentiva logo
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: The other ingredients are lactose monohydrate, pregelatinized maize starch, talc, titanium dioxide (E171), gelatin, shellac, black iron oxide (E172).
Danish: Øvrige indholdsstoffer: Lactosemonohydrat, prægelatineret majsstivelse, talcum, titandioxid (E171), gelatine, shellac, sort jernoxid (E172).
English: Nervous system disorders Very common
Danish: Nervesystemet Meget almindelig
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: Tachycardia, atrioventricular block first degree, sinus bradycardia, congestive heart failure
Danish: Takykardi, atrioventrikulært blok af første grad, sinusbradykardi, kongestiv hjerteinsufficiens
English: • Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure, changes in heartbeat, heart failure.
Danish: • Hjerterytmeforstyrrelser, hurtigere hjerterytme (puls), lavt blodtryk, højt blodtryk, ændringer i hjerteslag, hjertesvigt.
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 may cause dizziness and somnolence and therefore may influence the ability to drive or use machines.
Danish: Pregabalin kan forårsage svimmelhed og døsighed, og derfor kan det påvirke evnen til at køre bil eller betjene maskiner.
English: For patients who experienced somnolence the responder rates were 48% on pregabalin and 16% on placebo.
Danish: Hos patienter, der oplevede døsighed, er responderraterne 48% på pregabalin og 16% på placebo.
English: is indicated for the treatment of generalised anxiety disorder (GAD) in adults.
Danish: er indiceret til behandling af generaliseret angst (GAD) hos voksne.
English: with food, drink and alcohol Pregabalin Zentiva k.s.
Danish: sammen med mad, drikke og alkohol Pregabalin Zentiva k.s.
English: Pregabalin 14 mg/kg/day significantly reduced the log-transformed partial onset seizure frequency versus placebo (p=0.0223); pregabalin 7 mg/kg/day did not show improvement relative to placebo.
Danish: Pregabalin 14 mg/kg/dag reducerede væsentligt den log-transformerede hyppighed af partielle anfald versus placebo (p = 0,0223); pregabalin 7 mg/kg/dag viste ingen forbedring i forhold til placebo.
English: Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på blisterpakningen og æsken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: • Some patients taking pregabalin have reported symptoms suggesting an allergic reaction.
Danish: • Hos nogle patienter, der tager pregabalin, er der rapporteret om symptomer, der tyder på en overfølsomhedsreaktion.
English: Pregabalin may produce dizziness, sleepiness and decreased concentration.
Danish: Pregabalin kan give svimmelhed, søvnighed og nedsat koncentrationsevne.
English: Capsules content Lactose monohydrate Pregelatinized maize starch Talc
Danish: Kapselindhold Lactosemonohydrat Prægelatineret majsstivelse Talcum
English: • Pregabalin has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in elderly patients.
Danish: • Pregabalin er forbundet med svimmelhed og døsighed, som kan øge risikoen for faldulykker hos ældre patienter.
English: BATCH NUMBER Batch:
Danish: FREMSTILLERENS BATCHNUMMER Batch
English: Pregabalin may have minor or moderate influence on the ability to drive and use machines.
Danish: Pregabalin påvirker i mindre eller moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: Urinary incontinence, dysuria
Danish: Urininkontinens, dysuri
English: * Total daily dose (mg/day) should be divided as indicated by dose regimen to provide mg/dose.
Danish: * Total døgndosis (mg/døgn) skal fordeles som anført under dosisinterval for at give mg/dosis + Supplerende dosis er en enkelt tillægsdosis.
English: • There have been reports of convulsions when taking pregabalin or shortly after stopping pregabalin.
Danish: • Der er set kramper i forbindelse med behandling med pregabalin og kort tid efter ophør af behandling med pregabalin.
English: Median 24-hour seizure frequencies at baseline and at the final visit were 4.7 and 3.8 for pregabalin 7 mg/kg/day, 5.4 and 1.4 for pregabalin 14 mg/kg/day, and 2.9 and 2.3 for placebo, respectively.
Danish: Median 24 timers anfaldshyppighed ved baseline og ved sidste besøg var henholdsvis 4,7 og 3,8 for pregabalin 7 mg/kg/dag, 5,4 og 1,4 for pregabalin 14 mg/kg/dag og 2,9 og 2,3 for placebo.
English: may be taken with oral contraceptives.
Danish: kan tages sammen med svangerskabsforebyggende medicin.
English: • Pregabalin may cause blurring or loss of vision, or other changes in eyesight, many of which are temporary.
Danish: • Pregabalin kan forårsage sløret syn, synstab eller andre synsændringer, som kan være forbigående.
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: 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: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PAPER FOLDING BOX
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE FOLDET PAPKARTON
English: 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: 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: 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: 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: No specific pharmacodynamic interaction studies were conducted in elderly volunteers.
Danish: Der er ikke udført specifikke farmakodynamiske interaktionsstudier med ældre raske forsøgspersoner.
English: It is advised not to drink alcohol while taking Pregabalin Zentiva k.s..
Danish: Det tilrådes ikke at drikke alkohol, når du tager Pregabalin Zentiva k.s.
English: If you have the impression that the effect of Pregabalin Zentiva k.s.
Danish: Hvis du har indtryk af, at virkningen af Pregabalin Zentiva k.s.
English: • Some patients with diabetes who gain weight while taking pregabalin may need an alteration in their diabetic medicines.
Danish: • Nogle sukkersyge (diabetes)patienter kan få vægtøgning, når de tager pregabalin, og kan derfor have behov for at ændre deres diabetesmedicin.
English: contains lactose monohydrate If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Danish: indeholder lactosemonohydrat Kontakt lægen, før du tager dette lægemiddel, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: * Alanine aminotransferase increased (ALT) and aspartate aminotransferase increased (AST).
Danish: Nedsat antal hvide blodlegemer * Forhøjet alaninaminotransferase (ALAT) og forhøjet aspartataminotransferase (ASAT).
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 inden for 1 time efter indgift af både enkelte og gentagne doser.
English: belongs to a group of medicines used to treat epilepsy, neuropathic pain and generalised anxiety disorder (GAD) in adults.
Danish: tilhører den gruppe medicin, der anvendes til behandling af epilepsi, neuropatiske smerter og generaliseret angst hos voksne.
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.
Danish: De mest almndelige bivirkninger, der blev observeret i studiet af 12 ugers varighed med behandling med pregabalin var døsighed, pyreksi, øvre luftvejsinfektioner, øget appetit, vægtøgning og nasopharyngitis.
English: When taken with certain other medicines, pregabalin 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 forstærke de bivirkninger, der er set med denne type medicin, herunder åndedrætssvigt og dyb bevidstløshed.