FrancophonIA/ELRC3.0 huggingface dataset:
English: Each NULOJIX vial provides 250 mg of belatacept.
Danish: Et NULOJIX-hætteglas indeholder 250 mg belatacept.
English: Uncommon gastrointestinal disorder, pancreatitis, large intestinal ulcer, melaena, gastroduodenal ulcer, rectal haemorrhage, small intestinal obstruction, cheilitis, gingival hyperplasia, salivary gland pain, faeces discoloured Hepatobiliary disorders
Danish: Almindelig dyspepsi, aphthøs stomatitis, abdominal hernie Ikke almindelig gastrointestinale lidelser, pancreatitis, tyktarmsulceration, melæna, gastroduodenalt ulcus, rektal blødning, tyndtarmsobstruktion, cheilitis, gingival hyperplasi, smerter i spytkirtler, misfarvet faeces
English: INFORMATION IN BRAILLE Justification for not including Braille accepted.
Danish: INFORMATION I BRAILLESKRIFT <Fritaget fra krav om blindeskrift>
English: The reconstituted solution should be transferred from the vial to the infusion bag or bottle immediately.
Danish: Indholdet af hætteglasset bør straks flyttes til infusionsposen eller infusionsflasken efter rekonstituering.
English: Common renal tubular necrosis, renal vein thrombosis*, renal artery stenosis, glycosuria, hydronephrosis, vesicoureteric reflux, urinary incontinence, urinary retention, nocturia
Danish: Almindelig renal tubulær nekrose, nyrevenetrombose*, nyrearteriestenose, glycosuri, hydronefrose, vesikoureteral refluks, urinkontinens, urinretention, nyktori Ikke almindelig arteriel nyretrombose*, nefritis, nefrosclerose, tubulær artrofi, hæmoragisk cystitis, nyrefibrose
English: NAME OF THE MEDICINAL PRODUCT NULOJIX 250 mg powder for concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN NULOJIX 250 mg pulver til koncentrat til infusionsvæske, opløsning.
English: Common vertigo, ear pain, tinnitus
Danish: Almindelig vertigo, ørepine, tinnitus Ikke almindelig hypoacusis Hjerte
English: Discard the solution if any particulate matter or discolouration is observed.
Danish: Hvis der observeres partikelholdigt materiale eller misfarvning, skal opløsningen smides ud.
English: deficiency
Danish: Væskemangel
English: Uncommon venous thrombosis, arterial thrombosis, thrombophlebitis, arterial stenosis, intermittent claudication, flushing
Danish: Almindelig shock, infarkt, hæmatom, lymfocele, angiopati, arteriel fibrose Ikke almindelig venetrombose, arteriel trombose, tromboflebitis, arteriestenose, claudicatio intermittens, rødmen
English: Reaction to an infusion, scare tissue, inflammation, return of disease, feeling hot, ulcer Not making enough urine
Danish: Reaktion over for infusionen, arvæv, betændelsestilstand, tilbagevendende sygdom, følelse af varme, sår
English: Uncommon monocytopenia, pure red cell aplasia, agranulocytosis, haemolysis, hypercoagulation Immune system disorders Common blood immunoglobulin G decreased, blood immunoglobulin M decreased,
Danish: Immunsystemet Almindelig nedsat immunoglobulin G i blodet, nedsat immunoglobulin M i blodet
English: If you have been given a therapy for treatment of acute rejection, such as antithymocyte globulin to reduce T-cells.
Danish: Patienter har en højere risiko for at få PTLD i følgende tilfælde: hvis du ikke har været smittet med EBV inden din transplantation hvis du er smittet med en virus kaldet cytomegalovirus (CMV) hvis du har været i behandling for akut afstødning, f.eks. med antithymocytglobulin for at nedsætte mængden af T-celler.
English: Respiratory, thoracic and mediastinal disorders Very Common dyspnoea, cough Common pulmonary oedema, wheezing, hypocapnea, orthopnoea, epistaxis, oropharyngeal pain
Danish: Almindelig pulmonalt ødem, hvæsende vejrtrækning, hypokapni, ortopnø, epistaxis, oropharyngeale smerter
English: Uncommon cholelithiasis, hepatic cyst, hepatic steatosis Skin and subcutaneous tissue disorders Common acne, pruritis, alopecia, skin lesion, rash, night sweats, hyperhidrosis
Danish: Almindelig akne, pruritus, alopeci, hudlæsion, udslæt, nattesved, hyperhidrose Ikke almindelig psoriasis, unormal hårvækst, onychoclasi, penilt sår, hævet ansigt, trikoreksi
English: Very Common diarrhoea, constipation, nausea, vomiting, abdominal pain Common dyspepsia, aphthous stomatitis, abdominal hernia
Danish: Mave-tarm-kanalen Meget almindelig diarre, forstoppelse, kvalme, opkastning, abdominalsmerter
English: Musculoskeletal and connective tissue disorders Very Common arthralgia, back pain, pain in extremity Common myalgia, muscular weakness, bone pain, joint swelling, intervertebral disc disorder, joint lock, muscle spasms, osteoarthritis
Danish: Almindelig myalgi, muskelsvaghed, knoglesmerter, hævede led, sygdom i intervertebral discus, fastlåsning af led, muskelkramper, osteoarthritis
English: General disorders and administration site conditions Very Common oedema peripheral, pyrexia Common chest pain, fatigue, malaise, impaired healing
Danish: Medfødte, familiære og genetiske sygdomme Meget almindelig perifert ødem, pyreksi
English: Depression, fatigue, feeling of tiredness, drowsiness, or lack of energy, general feeling of being unwell, difficulty breathing when laying down, nose bleeding Typical appearance of a person with high levels of steroids, such as moon face, hump back, upper body obesity
Danish: Akne, hårtab, unormale ændringer på huden, øget svedproduktion, nattesved Svaghed/kløft i mavemusklerne og udposning af huden over det helede indsnit, bugvægsbrok Depression, udmattelse, træthed, døsighed eller manglende energi, generel utilpashed, vejrtrækningsbesvær i liggende stilling, næseblod Typisk udseende som hos en person, der får store mængder steroider, såsom måneansigt, tyrenakke, fedme på overkroppen
English: NAME OF THE MEDICINAL PRODUCT NULOJIX 250 mg powder for concentrate for solution for infusion belatacept
Danish: NULOJIX 250 mg pulver til koncentrat til infusionsvæske, opløsning belatacept
English: The European Commission granted a marketing authorisation valid throughout the European Union for Exviera on 15 January 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Exviera den 15. januar 2015.
English: This is a summary of the European public assessment report (EPAR) for Exviera.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Exviera.
English: The full EPAR and risk management plan summary for Exviera can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Exviera findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Exviera
Danish: Andre oplysninger om Exviera
English: It must also not be used together with medicines that affect the activity of certain enzymes that can raise or lower the level of the active substance in the blood.
Danish: Det må heller ikke bruges sammen med lægemidler, der indvirker på aktiviteten af visse enzymer, som kan øge eller sænke mængden af det aktive stof i blodet.
English: Exviera is available as 250 mg tablets, and the recommended dose is two tablets a day, one in the morning and one in the evening for 8, 12 or 24 weeks.
Danish: Exviera fås som tabletter a 250 mg, og den anbefalede dosis er to tabletter dagligt, én om morgenen og én om aftenen i 8, 12 eller 24 uger.
English: The Agency therefore concluded that the benefits of Exviera outweigh its risks and recommended that it be approved for use in the EU.
Danish: Agenturet konkluderede derfor, at fordelene ved Exviera overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse i EU.
English: Almost all the patients in the studies had the virus cleared from their blood after 12 or 24 weeks.
Danish: Næsten alle patienterne i undersøgelserne fik elimineret virus fra blodet efter 12 eller 24 uger.
English: What measures are being taken to ensure the safe and effective use of Exviera?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Exviera?
English: Why is Exviera approved?
Danish: Hvorfor blev Exviera godkendt?
English: This stops the hepatitis C virus from multiplying and infecting new cells.
Danish: Dette forhindrer hepatitis C-virus i at formere sig og inficere nye celler.
English: The clearance rate was particularly high in patients infected with genotype 1b.
Danish: Eliminationen var særligt høj hos patienter smittet med genotype 1b.
English: What are the risks associated with Exviera?
Danish: Hvilke risici er der forbundet med Exviera?
English: What is Exviera and what is it used for?
Danish: Hvad er Exviera, og hvad anvendes det til?
English: It is not intended to provide practical advice on how to use Exviera.
Danish: Det er ikke en praktisk vejledning i, hvordan Exviera bør anvendes.
English: The active substance in Exviera, dasabuvir, works by blocking the action of an enzyme in the hepatitis C virus called ‘NS5B RNA-dependent polymerase', which the virus needs to multiply.
Danish: Det aktive stof i Exviera, dasabuvir, virker ved at blokere virkningen af et enzym i hepatitis C-virusset kaldet "NS5B RNA-afhængig polymerase", som virusset behøver for at kunne formere sig.
English: Exviera must not be used in women taking ethinylestradiol, an oestrogen found in hormonal contraceptives.
Danish: Exviera må ikke anvendes hos kvinder, der får ethinylestradiol, som er et østrogen, der findes i hormonale svangerskabsforebyggende midler.
English: For more information about treatment with Exviera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Exviera, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Exviera is always used in combination with another medicine, Viekirax, which contains the active substances ombitasvir, paritaprevir and ritonavir.
Danish: Exviera bruges altid i kombination med et andet lægemiddel, Viekirax, der indeholder de aktive stoffer ombitasvir, paritaprevir og ritonavir.
English: The combination of medicines used and the duration of treatment will depend on which genotype of hepatitis C virus the patient is infected with, the nature of the liver problems they have (for example, if they have liver cirrhosis (scarring) or their liver is not working properly) and whether they have received previous treatment.
Danish: Den anvendte kombination af lægemidler og behandlingens varighed afhænger af genotypen af det hepatitis C-virus, patienten er smittet med, af arten af patientens leverproblemer (f.eks. om patienten har skrumpelever, eller leveren ikke fungerer som den skal) og af, om patienten tidligere har modtaget behandling.
English: Exviera can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in managing patients with chronic hepatitis C.
Danish: Exviera udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af kronisk hepatitis C.
English: Several varieties (genotypes) of hepatitis C virus exist and Exviera is recommended for use in patients with virus of genotypes 1a and 1b.
Danish: Der findes flere forskellige anlægstyper (genotyper) af hepatitis C-virus, og Exviera anbefales hos patienter med virus af genotypen 1a og 1b.
English: The company that markets Exviera will carry out a study in patients who previously have had liver cancer to evaluate the risk of liver cancer returning after treatment with direct-acting antivirals such as
Danish: Virksomheden, der markedsfører Exviera, vil gennemføre en undersøgelse blandt patienter, der tidligere har haft leverkræft, for at evaluere risikoen for, at leverkræften vender tilbage efter behandling med direkte virkende antivirale lægemidler som Exviera.
English: The European Medicines Agency noted that Exviera used in combination with Viekirax is effective in clearing the hepatitis C virus genotypes 1a and 1b from the blood with and without ribavirin.
Danish: Det Europæiske Lægemiddelagentur bemærkede, at Exviera anvendt i kombination med Viekirax er effektivt til at eliminere hepatitis C-virus genotype 1a og 1b fra blodet med og uden ribavirin.
English: In a seventh study, patients with liver scarring but stable liver function (compensated cirrhosis) who had genotype 1b infection were treated with Exviera and Viekirax without ribavirin and 100% of patients (60 out of 60 patients) had their blood cleared of the virus.
Danish: I en syvende undersøgelse blev patienter med skrumpelever men stabil leverfunktion (kompenseret skrumpelever), som var smittet med genotype 1b, behandlet med Exviera og Viekirax uden ribavirin, og 100 % af patienterne (60 ud af 60 patienter) fik elimineret virus fra blodet.
English: Exviera is an antiviral medicine used in combination with other medicines to treat adults with chronic (long-term) hepatitis C, an infectious disease of the liver caused by the hepatitis C virus.
Danish: Exviera er et lægemiddel mod virus (et antiviralt lægemiddel), der bruges i kombination med andre lægemidler til behandling af voksne med langvarig (kronisk) hepatitis C, som er smitsom leverbetændelse forårsaget af hepatitis C-virus.
English: The most common side effects with Exviera when used with Viekirax and ribavirin (which may affect more than 1 in 10 people) are insomnia (difficulty sleeping), nausea, pruritus (itching), asthenia (weakness) and fatigue (tiredness).
Danish: De hyppigste bivirkninger ved Exviera anvendt sammen med Viekirax og ribavirin (som kan forekomme hos mere end 1 ud af 10 patienter) er søvnløshed, kvalme, kløe, kraftesløshed og træthed.
English: For practical information about using Exviera, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Exviera, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Regarding its safety, although there were some cases of raised liver enzymes in patients treated with Exviera in combination with Viekirax and ribavirin, side effects seen with this combination were generally well tolerated.
Danish: Med hensyn til sikkerheden sås tilfælde af forhøjede leverenzymer hos patienter, der blev behandlet med Exviera i kombination med Viekirax og ribavirin, men sædvanligvis tåltes de iagttagne bivirkninger med denne kombination godt.
English: How is Exviera used?
Danish: Hvordan anvendes Exviera?
English: Some patients taking Exviera are also treated with another antiviral medicine, ribavirin, in addition to Viekirax.
Danish: Nogle patienter, der får Exviera, behandles foruden Viekirax også med et andet antiviralt lægemiddel, ribavirin.
English: What benefits of Exviera have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Exviera?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Exviera have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Exviera.
English: In patients with liver scarring, Exviera treatment in combination with Viekirax and ribavirin resulted in a clearance rate of between 93% and 100% after 24 weeks of treatment.
Danish: Patienter med skrumpelever opnåede en elimination af virus på mellem 93 % og 100 % efter 24 ugers behandling med Exviera kombineret med Viekirax og ribavirin.
English: In 6 initial main studies involving around 2,300 patients infected with hepatitis C virus genotypes 1a or 1b, Exviera in combination with Viekirax was effective in clearing the virus from the blood.
Danish: I kombination med Viekirax var Exviera effektivt til at eliminere virus fra blodet i seks indledende hovedundersøgelser omfattende ca. 2 300 patienter med hepatitis C-virus af genotype 1a eller 1b. Mellem 96 % og 100 % af patienterne uden skrumpelever fik elimineret virus fra blodet efter 12 ugers behandling (med eller uden ribavirin).
English: How does Exviera work?
Danish: Hvordan virker Exviera?
English: It is generally given once a day, except in life-threatening situations.
Danish: Lægemidlet indgives normalt én gang dagligt, undtagen i livstruende situationer.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Nonafact on 3 July 2001.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Nonafact den 3. juli 2001.
English: Nonafact can be used in adults and children over the age of 6.
Danish: Nonafact kan anvendes til voksne og børn over 6 år.
English: This is a summary of the European public assessment report (EPAR) for Nonafact.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Nonafact.
English: A risk management plan has been developed to ensure that Nonafact is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Nonafact anvendes så sikkert som muligt.
English: Patients may sometimes be able to give the medicine themselves after suitable training.
Danish: Patienterne kan selv indgive lægemidlet, når de er blevet behørigt instrueret heri.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Nonafact.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Nonafact skal anvendes.
English: The full detail on how to calculate the doses is included in the package leaflet.
Danish: Nærmere oplysninger om, hvordan doserne beregnes, fremgår af indlægssedlen.
English: Most patients had severe haemophilia B. The studies assessed the number of major or life-threatening bleeding episodes that occurred during treatment, or during and after surgery.
Danish: De fleste patienter havde svær hæmofili B. Undersøgelserne omfattede en vurdering af antallet af alvorlige eller livstruende blødningsepisoder under behandlingen eller under og efter et kirurgisk indgreb.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Nonafact, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Nonafact, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The dose is also adjusted depending on the severity of the haemorrhage or the type of surgery.
Danish: Dosis tilpasses også efter sværhedsgraden af blødningen eller typen af kirurgi.
English: Nonafact has been studied in two clinical studies, including 26 patients who received Nonafact as a prevention treatment (for example before extensive exercise), and 8 patients who received Nonafact during 11 surgical interventions.
Danish: Nonafact er blevet undersøgt i to kliniske forsøg med 26 patienter, som fik Nonafact som forebyggende behandling (f.eks. inden omfattende fysisk aktivitet), og 8 patienter, som fik Nonafact under 11 kirurgiske indgreb.
English: If this happens Nonafact may not work effectively.
Danish: Hvis dette sker, vil Novafacts virkning ikke være effektiv.
English: Nonafact is given by infusion into a vein at a rate of no more than 2 ml per minute.
Danish: Nonafact indgives ved intravenøs infusion i en vene med en hastighed på højst 2 ml i minuttet.
English: What measures are being taken to ensure the safe and effective use of Nonafact?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Nonafact?
English: Nonafact is intended for either short-term or long-term use.
Danish: Nonafact er beregnet til enten korttids- eller langtidsbehandling.
English: Other information about Nonafact
Danish: Andre oplysninger om Nonafact
English: Patients with haemophilia B lack factor IX, and this causes bleeding problems, such as bleeding in the joints, muscle or internal organs.
Danish: Patienter med hæmofili B mangler faktor IX, og dette medfører blodkoaguleringsproblemer såsom blødninger i led, muskler eller indre organer.
English: Hypersensitivity (allergic reactions) has been sometimes seen in patients treated with factor IX-containing products.
Danish: Der er i nogle tilfælde indberettet overfølsomhedsreaktioner (allergiske reaktioner) hos patienter behandlet med lægemidler indeholdende faktor IX.
English: Nonafact human coagulation factor IX
Danish: Human koagulationsfaktor IX
English: Treatment should be started under the supervision of a doctor with experience in treating haemophilia.
Danish: Behandling med Nonafact bør indledes af en læge med erfaring i behandling af hæmofili.
English: Nonafact is used to replace the missing factor IX; it corrects the factor IX deficiency and gives temporary control of the bleeding disorder.
Danish: Nonafact anvendes til at erstatte den manglende faktor IX, korrigere faktor IX-manglen og opnå midlertidig kontrol med blødningsforstyrrelser.
English: Nonafact must not be used in people who are hypersensitive (allergic) to human coagulation factor IX or to any of the other ingredients, or to mouse proteins.
Danish: Nonafact bør ikke anvendes af personer, som kan være overfølsomme (allergiske) over for human koagulationsfaktor IX eller en eller flere af indholdsstofferne eller over for museproteiner.
English: Nonafact was rated as “good” or “excellent” in its ability to prevent bleeding in patients with haemophilia B.
Danish: Nonafact blev bedømt til at være ”godt” eller ”særdeles godt” til forebyggelse af blødning hos patienter med hæmofili B.
English: Nonafact is used for the treatment and prevention of bleeding in patients with haemophilia B (an inherited bleeding disorder caused by lack of factor IX).
Danish: Nonafact anvendes til behandling og forebyggelse af blødning hos patienter med hæmofili B (medfødte blødningsforstyrrelser forårsaget af faktor IX-mangel).
English: The CHMP decided that Nonafact's benefits are greater than its risks for the treatment and prevention of bleeding in patients with haemophilia B. They recommended that Nonafact be given marketing authorisation.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Nonafact er større end risiciene ved behandling og forebyggelse af blødning hos patienter med hæmofili B og anbefalede derfor udstedelse af en markedsføringstilladelse for Nonafact.
English: For the full list of all the side effects reported with Nonafact, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Nonafact fremgår af indlægssedlen.
English: In the body, factor IX is one of the substances (factors) needed for blood coagulation (clotting).
Danish: Faktor IX er et af de stoffer (faktorer) i kroppen, som medvirker ved blodets koagulation (størkning).
English: Nonafact is a powder and solvent that are mixed together to form a solution for infusion (drip) into a vein.
Danish: Nonafact består af et pulver og en solvens, der blandes og indgives ved infusion (drop) i en vene.
English: The doctor will calculate a suitable dose, depending on whether Nonafact is used to treat haemorrhage (bleeding) or to prevent bleeding during surgery.
Danish: Dosis er afhængig af, hvorvidt Nonafact anvendes til behandling af hæmorrhagi (blødning) eller til forebyggelse af blødning under operationer.
English: Haemophilia B patients may develop antibodies (inhibitors) to factor IX.
Danish: Patienter med hæmofili B kan udvikle antistoffer (hæmmere) over for faktor IX.
English: What is the risk associated with Nonafact?
Danish: Hvilken risiko er der forbundet med Nonafact?
English: Nonafact contains the active substance human coagulation factor IX, which helps blood to clot.
Danish: Nonafact indeholder det aktive indholdsstof human koagulationsfaktor IX, som medvirker ved blodets størkning.