FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 986 bleeding episodes were recorded, the majority of which resolved with one injection of Nuwiq.
Danish: Der blev i alt registreret 986 blødningsepisoder, hvoraf størstedelen svandt med en enkelt indsprøjtning af Nuwiq.
English: Nuwiq is used to correct the factor VIII deficiency by replacing the missing factor VIII, giving temporary control of the bleeding disorder.
Danish: Nuwiq anvendes til at korrigere manglen på faktor VIII ved at erstatte den manglende faktor VIII, hvorved der opnås midlertidig kontrol med blødersygdommen.
English: It is not intended to provide practical advice on how to use Nuwiq.
Danish: Det er ikke en praktisk vejledning i, hvordan Nuwiq bør anvendes.
English: The active substance in Nuwiq, simoctocog alfa (human coagulation factor VIII), is a substance that helps the blood to clot.
Danish: Det aktive stof i Nuwiq, simoctocog alfa (human koagulationsfaktor VIII), er et stof, der hjælper blodet med at størkne.
English: Why is Nuwiq approved?
Danish: Hvorfor blev Nuwiq godkendt?
English: What is Nuwiq and what is it used for?
Danish: Hvad er Nuwiq, og hvad anvendes det til?
English: For more information about treatment with Nuwiq, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Nuwiq, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: When used for treatment, bleeding episodes resolved in 81% of cases following one or two injections with Nuwiq.
Danish: Når det blev anvendt til behandling af blødning, svandt blødningerne i 81 % af tilfældene efter en eller to indsprøjtninger med Nuwiq.
English: The Agency concluded that Nuwiq has been shown to be effective at treating and preventing bleeding in patients with haemophilia A and has an acceptable safety profile.
Danish: Agenturet besluttede, at det er påvist, at Nuwiq er effektivt til at behandle og forebygge blødning hos patienter med hæmofili A og har en acceptabel sikkerhedsprofil.
English: Nuwiq is a medicine used for the treatment and prevention of bleeding in patients of all ages with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).
Danish: Nuwiq er et lægemiddel, der anvendes til behandling og forebyggelse af blødning hos patienter i alle aldre med hæmofili A (en arvelig blødersygdom, der skyldes mangel på faktor VIII).
English: Nuwiq can only be obtained with a prescription and treatment should be started under the supervision of a doctor experienced in the treatment of haemophilia.
Danish: Nuwiq udleveres kun efter recept, og behandlingen bør iværksættes under opsyn af en læge med erfaring i behandling af hæmofili.
English: There is a risk with factor VIII medicines that some patients will develop inhibitors (antibodies) against factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control.
Danish: Der er desuden den risiko ved faktor VIII-lægemidler, at visse patienter danner antistoffer (inhibitorer) mod faktor VIII, hvilket medfører, at lægemidlet ikke længere virker, og kontrollen med blødning svigter.
English: Patients with haemophilia A lack factor VIII, and this causes blood clotting problems, such as bleeding in the joints, muscles or internal organs.
Danish: Patienter med hæmofili A mangler faktor VIII, og dette medfører problemer med blodets størkning, såsom blødning i led, muskler eller indre organer.
English: When Nuwiq was used to prevent bleeding, an average of 0.34 bleeds per month was recorded for each child.
Danish: Når Nuwiq blev anvendt til forebyggelse af blødning, var der gennemsnitligt 0,34 blødning pr. måned for hvert barn.
English: For the full list of all side effects and restrictions with Nuwiq, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Nuwiq fremgår af indlægssedlen.
English: What are the risks associated with Nuwiq?
Danish: Hvilke risici er der forbundet med Nuwiq?
English: Nuwiq is available as a powder and solvent that are mixed together to make a solution for injection into a vein.
Danish: Nuwiq leveres som pulver og solvens, der blandes sammen til en opløsning, som gives ved injektion i en vene.
English: Nuwiq has been shown to be effective at preventing and treating bleeding episodes in three main studies involving 113 patients with haemophilia A.
Danish: Nuwiqs effektivitet til at behandle og forebygge blødningsepisoder er blevet påvist i tre hovedundersøgelser, som omfattede 113 patienter med hæmofili A.
English: For practical information about using Nuwiq, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Nuwiq, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: In the two surgeries that occurred during the study, Nuwiq was rated as excellent in preventing bleeding episodes.
Danish: Ved de to operationer, der blev udført i løbet af undersøgelsen, blev Nuwiq bedømt som udmærket til at forebygge blødningsepisoder.
English: When used for the treatment of bleeding episodes, Nuwiq was mainly rated as ‘excellent' or ‘good' at treating major bleeding episodes and most bleeding episodes resolved following one or more injections of Nuwiq.
Danish: Ved behandling af blødningsepisoder blev Nuwiq hovedsagelig bedømt som "udmærket" eller "godt" til behandling af større blødningsepisoder, og de fleste blødningsepisoder svandt efter en eller flere indsprøjtninger med Nuwiq.
English: In the five surgeries that occurred during the study, Nuwiq was rated as excellent in preventing bleeding episodes for four surgeries and as moderate to prevent bleeding during one surgical intervention.
Danish: Ved de fem operationer, der blev udført i løbet af undersøgelsen, blev Nuwiq bedømt som udmærket til at forebygge blødningsepisoder i fire operationer og som nogenlunde til at forebygge blødning i én operation.
English: The first study involved 22 patients aged 12 years and above, who were given Nuwiq for the treatment of bleeding episodes or to prevent bleeding during surgery.
Danish: I den første undersøgelse deltog der 22 patienter på 12 år og derover, som fik Nuwiq til behandling af blødningsepisoder eller til forebyggelse af blødning under operation.
English: How is Nuwiq used?
Danish: Hvordan anvendes Nuwiq?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nuwiq have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Nuwiq.
English: The second study involved 32 patients aged 12 years and above who were given Nuwiq to prevent and treat bleeding events as well as to prevent bleeding during surgery.
Danish: Den anden undersøgelse omfattede 32 patienter på 12 år og derover, som fik Nuwiq til forebyggelse og behandling af blødningsepisoder og til forebyggelse af blødning under operation.
English: When used to prevent bleeding, an average of 0.19 bleeds per month was recorded for each patient.
Danish: Når Nuwiq blev anvendt til forebyggelse af blødning, havde hver patient gennemsnitligt 0,19 blødning pr. måned.
English: How does Nuwiq work?
Danish: Hvordan virker Nuwiq?
English: What benefits of Nuwiq have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Nuwiq?
English: For full details, see the package leaflet.
Danish: De nærmere oplysninger fremgår af indlægssedlen.
English: However, juvenile rats are more sensitive.
Danish: Juvenile rotter er imidlertid mere følsomme.
English: The need for treatment should be reassessed regularly.
Danish: Behov for behandling bør regelmæssigt revurderes.
English: • Difficulty with writing properly
Danish: • Problemer med at skrive korrekt.
English: The patient should be informed about this at the start of the treatment.
Danish: Patienten bør informeres om dette ved behandlingens start.
English: Do not take more medicine than prescribed.
Danish: Du må ikke tage mere medicin end foreskrevet.
English: • Take the number of capsules as instructed by your doctor.
Danish: • Tag det antal kapsler, som lægen har ordineret.
English: Pregabalin should be used with caution in these patients.
Danish: Pregabalin bør anvendes med forsigtighed til disse patienter.
English: Your doctor will determine what dose is appropriate for you.
Danish: Din læge vil fastsætte den dosis, der passer til dig.
English: Pregabalin and lamotrigine were similarly safe and well tolerated.
Danish: Pregabalin og lamotrigin var lige sikre og veltolererede.
English: The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for pregabalin.
Danish: Mekanismen bag denne risiko er ikke kendt, og de forhåndenværende data udelukker ikke muligheden for en forøget risiko for pregabalin.
English: Monotherapy (newly diagnosed patients)
Danish: Monoterapi (nydiagnosticerede patienter)
English: Therefore the effects were considered of little or no clinical relevance.
Danish: Derfor blev denne virkning betragtet som værende af ringe eller ingen klinisk relevans.
English: Interactions and the elderly
Danish: Interaktioner og ældre
English: In that case, just carry on with the next dose as normal.
Danish: I så fald skal du fortsætte med at tage din næste dosis som normalt.
English: • Slow or reduced movement of the body
Danish: • Langsom eller nedsat kropsbevægelse.
English: • Inappropriate behaviour
Danish: • Upassende opførsel.
English: If your treatment is stopped it should be done gradually over a minimum of 1 week.
Danish: Ophør af behandlingen skal ske gradvist over mindst 1 uge.
English: • Increased appetite
Danish: • Øget appetit.
English: Following repeated administration, steady state is achieved within 24 to 48 hours.
Danish: Efter gentagne doser nås steady state indenfor 24-48 timer.
English: If you forget to take a dose, take it as soon as you remember unless it is time for your next dose.
Danish: Hvis du glemmer at tage en dosis, skal du tage den straks, du kommer i tanke herom, medmindre det er ved at være tid for din næste dosis.
English: The safety and efficacy in children and adolescents (under 18 years of age) has not been established and therefore, pregabalin should not be used in this age group.
Danish: Sikkerheden og virkningen hos børn og unge (under 18 år) er ikke undersøgt, og derfor bør pregabalin ikke anvendes til denne aldersgruppe.
English: These estimated doses are approximately 7% of the total daily maternal dose on a mg/kg basis.
Danish: Disse estimerede doser er ca. 7% af moderens samlede daglige dosis baseret på mg/kg.
English: Suicidal ideation and behaviour
Danish: Selvmordstanker og -adfærd
English: Total pregabalin daily dose *
Danish: Total daglig dosis pregabalin *
English: After 3 months of treatment, there were no effects on sperm motility.
Danish: Efter 3 måneders behandling sås der ingen påvirkning af motiliteten.
English: These platelet changes were not present in rats or in humans based on short term and limited long term clinical data.
Danish: Disse trombocytændringer er ikke til stede hos rotter eller hos mennesker baseret på kliniske korttids- eller begrænsede langtidsdata.
English: 200 hard capsules
Danish: 200 hårde kapsler
English: Mylan S.A.S 117 Allée des Parcs 69800 Saint-Priest France
Danish: Mylan S.A.S 117 Allée des Parcs 69800 Saint-Priest Frankrig
English: There is no evidence to suggest an associated risk to humans.
Danish: Der er intet bevis for, at der er en lignende risiko for mennesker.
English: Sodium laurilsulfate
Danish: Natriumlaurilsulfat
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: Pregabalin did not achieve non-inferiority to lamotrigine based on the 6-month seizure freedom endpoint.
Danish: Pregabalin opnåede ikke non-inferioritet over for lamotrigin baseret på 6 måneders anfaldsfrihed som endepunkt.
English: Cases of misuse, abuse and dependence have been reported.
Danish: Tilfælde af forkert brug, misbrug og afhængighed er blevet rapporteret.
English: Inter-subject pharmacokinetic variability for pregabalin is low (<20%).
Danish: Variabiliteten i farmakokinetikken for pregabalin hos forskellige forsøgspersoner er lav (< 20%).
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: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medicinal product.
Danish: Derfor bør patienter tilrådes at udvise forsigtighed, indtil de er bekendt med bivirkningerne af medicinen.
English: The active substance, pregabalin, is a gamma-aminobutyric acid analogue [(S)-3-(aminomethyl)5- methylhexanoic acid].
Danish: Det aktive indholdsstof, pregabalin, er en gamma-aminosmørsyre-analog [(S)-3-(aminomethyl)-5-methylhexansyre].
English: Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your kidneys.
Danish: Din læge kan have anvist en anden doseringsvejledning og/eller dosis, hvis du har nyreproblemer.
English: Pregabalin appears to be additive in the impairment of cognitive and gross motor function caused by oxycodone.
Danish: Pregabalin synes at være additiv ved den nedsættelse af kognitiv og grovmotorisk funktion, der forårsages af oxycodon.
English: Dieselweg 25, 3752 LB Bunschoten The Netherlands
Danish: Dieselweg 25, 3752 LB Bunschoten Holland
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apoteket til råds, før du tager dette lægemiddel.
English: Pregabalin undergoes negligible metabolism in humans.
Danish: Pregabalin undergår ubetydelig metabolisme hos mennesker.
English: The marketing authorisation holder (MAH) shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Indehaveren af markedsføringstilladelsen skal fremsende den første PSUR for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: Creatinine clearance (CLcr) (ml/min)
Danish: Kreatininclearance (ml/min)
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, om de får tegn på selvmordstanker og -adfærd, og passende behandling bør overvejes.
English: In humans, the apparent volume of distribution of pregabalin following oral administration is approximately 0.56 l/kg.
Danish: Hos mennesker er pregabalins tilsyneladende fordelingsvolumen efter oral indgift ca. 0,56 l/kg.
English: Currently available data are described in section 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Danish: 4.8, 5.1 og 5.2, men der kan ikke gives nogen anbefalinger vedrørende dosering.
English: Stevens Johnson syndrome, cold sweat
Danish: Stevens-Johnsons syndrom, koldsved.
English: • Jaundice (yellowing of the skin and eyes).
Danish: • Gulsot (gulfarvning af hud og øjne).
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: Pregabalin mean elimination half-life is 6.3 hours.
Danish: Pregabalins gennemsnitlige halveringstid er 6,3 timer.
English: In preclinical studies, there was no indication of racemisation of pregabalin S-enantiomer to the R-enantiomer.
Danish: I prækliniske studier ses ingen tegn på racemisering af pregabalins S-enantiomer til R-enantiomer.
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: If you have the impression that the effect of Pregabalin Mylan Pharma is too strong or too weak, talk to your doctor or pharmacist.
Danish: Hvis du har indtryk af, at virkningen af Pregabalin Mylan Pharma er for stærk eller alt for svag, skal du tale med din læge eller apoteket.
English: Epilepsy or Generalised Anxiety Disorder:
Danish: Epilepsi eller generaliseret angst:
English: • Before taking this medicine you should tell your doctor if you have a history of alcoholism or any drug abuse or dependence.
Danish: • Inden du tager denne medicin, skal du fortælle lægen, hvis du nogensinde har misbrugt eller været afhængig af alkohol, medicin eller stoffer.
English: Following a dose of radiolabelled pregabalin, approximately 98% of the radioactivity recovered in the urine was unchanged pregabalin.
Danish: Efter en dosis radiomærket pregabalin genfindes ca. 98% af radioaktiviteten i urinen som uomdannet pregabalin.
English: If you are an older patient (over 65 years of age), you should take Pregabalin Mylan Pharma normally except if you have problems with your kidneys.
Danish: Hvis du er ældre (over 65 år), skal du tage Pregabalin Mylan Pharma som normalt, medmindre du har nyreproblemer.
English: Pharmacotherapeutic group: Anti-epileptics, other anti-epileptics, ATC code: N03AX16.
Danish: Farmakoterapeutisk klassifikation: Antiepileptika, andre antiepileptika, ATC-kode: N03AX16
English: Pregabalin Mylan Pharma 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 Mylan Pharma 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: Pregabalin was not teratogenic in mice, rats or rabbits.
Danish: Pregabalin er ikke teratogent hos mus, rotter eller kaniner.
English: This may be attributed to an additive effect due to concomitant medicinal products (e.g. anti-spasticity agents) needed for this condition.
Danish: Dette kan tilskrives en additiv effekt på grund af samtidig medicin (f.eks. antispastisk medicin), som er nødvendig for behandling af denne tilstand.
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 forskellig fra dem, der ses hos voksne rotter.
English: Swallow the capsule whole with water.
Danish: Kapslerne skal sluges hele og indtages med vand.
English: Iron oxide black (E172) Macrogol
Danish: Sort jernoxid (E172) Macrogol
English: • Painful menstrual periods
Danish: • Smertefuld menstruation.
English: Pregabalin is not bound to plasma proteins.
Danish: Pregabalin bindes ikke til plasmaproteiner.
English: The adverse reactions listed may also be associated with the underlying disease and/or concomitant medicinal products.
Danish: De anførte bivirkninger kan også have forbindelse til den tilgrundliggende sygdom og/eller anden samtidig behandling.
English: The clinical relevance of these findings is unknown (see section 5.3).
Danish: Den kliniske betydning af disse fund kendes ikke (se pkt.
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: Pregnancy There are no adequate data from the use of pregabalin in pregnant women.
Danish: Graviditet Der foreligger ikke tilstrækkelig data om brugen af pregabalin hos gravide.
English: Single dose+
Danish: Engangsdosis+
English: Pregabalin terminal half-life averaged about 3 to 4 hours in paediatric patients up to 6 years of age, and 4 to 6 hours in those 7 years of age and older.
Danish: Pregabalins gennemsnitlige terminale halveringstid lå på omkring 3-4 timer hos pædiatriske patienter i alderen op til 6 år og på 4-6 timer hos patienter på 7 år og derover.
English: A meta-analysis of randomised placebo controlled studies of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour.
Danish: En metaanalyse af randomiserede, placebokontrollerede studier med antiepileptika har også vist en let forøget risiko for selvmordstanker og -adfærd.
English: Pregabalin was excreted into breast milk with average steady-state concentrations approximately 76% of those in maternal plasma.
Danish: Pregabalin blev udskilt i mælken med gennemsnitlige koncentrationer ved steady state på ca. 76% af de koncentrationer, der sås i moderens plasma.
English: When pregabalin and opioids will be used in combination, measures to prevent constipation may be considered (especially in female patients and elderly).
Danish: Når pregabalin og opioider gives i kombination, bør der tages forholdsregler for at undgå obstipation (især hos kvinder og ældre patienter).
English: Mylan Hungary Kft Mylan utca 1, Komárom, 2900, Hungary
Danish: Mylan Hungary Kft Mylan utca 1, Komárom, 2900, Ungarn
English: UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.>
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
English: GSP Proizvodi d.o.o.
Danish: SlovenijaGSP Proizvodi d.o.o.
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 (2- protein) i de spændingsafhængige calciumkanaler i centralnervesystemet.
English: Diabetic patients
Danish: Diabetespatienter
English: Supplementary dosage following haemodialysis (mg)
Danish: Supplerende dosis efter hæmodialyse (mg)
English: • Your doctor will tell you to take Pregabalin Mylan Pharma either twice or three times a day.
Danish: • Din læge vil fortælle, at du enten skal tage Pregabalin Mylan Pharma 2 gange eller 3 gange dagligt.
English: • Coldness of hands and feet
Danish: • Kolde hænder og fødder.
English: You should not drive, operate complex machinery or engage in other potentially hazardous activities until you know whether this medicine affects your ability to perform these activities.
Danish: Du må ikke køre bil, betjene indviklede maskiner eller udføre andre aktiviteter, der kan være farlige, før du ved, om denne medicin påvirker din evne til at udføre disse aktiviteter.
English: Discontinuation of pregabalin
Danish: Seponering af pregabalin