FrancophonIA/ELRC3.0 huggingface dataset:
English: c.T610C or c.T610A
Danish: c.610T>C eller c.610T>A c.T610C eller c.T610A
English: BLISTER SLEEVE
Danish: Muskelspasmer Myalgi
English: c.C453G or c.C453A
Danish: c.453C>G eller c.453C>A c.C453G eller c.C453A
English: c.1065C>A or c.1065C>G c.C1065A or c.C1065G
Danish: c.456C>A eller c.456C>G c.C456A eller c.C456G
English: c.T894G or c.T894A
Danish: c.894T>G eller c.894T>A c.T894G eller c.T894A
English: c.T102G or c.T102A
Danish: c.102T>G eller c.102T>A c.T102G eller c.T102A
English: c.T676C or c.T676A
Danish: c.676T>C eller c.676T>A c.T676C eller c.T676A
English: g.6547_9783del
Danish: UKENDT (del Exon3 og g.6547_9783del
English: c.T402G or c.T402A
Danish: c.402T>G eller c.402T>A c.T402G eller c.T402A
English: • Tiredness
Danish: • Mavepine
English: c.T960G or c.T960A
Danish: c.960T>G eller c.960T>A c.T960G eller c.T960A
English: c.C233G or c.C233A
Danish: c.233C>G eller c.233C>A c.C233G eller c.C233A
English: c.153G>A or c.153G>T or c.153G>C
Danish: Ændring i proteinsekvens c.153G>A eller c.153G>T eller c.153G>C
English: c.G131A or c.G132A
Danish: c.131G>A eller c.132G>A c.G131A eller c.G132A
English: c.966C>A or c.966C>G
Danish: c.966C>A eller c.966C>G c.C966A eller c.C966G
English: c.T484C or c.T484A
Danish: c.484T>C eller c.484T>A c.T484C eller c.T484A
English: c.465T>A or c.465T>G
Danish: c.465T>A eller c.465T>G c.T465A eller c.T465G
English: c.1074G>T or c.1074G>C
Danish: c.1074G>T eller c.1074G>C c.G1074T eller c.G1074C
English: c.860G>A or c.861G>A
Danish: c.860G>A eller c.861G>A c.G860A eller c.G861A
English: After follow up in the OLE, the mean change from baseline in LVMi in patients with left ventricular hypertrophy at baseline at Month 36 was -30.0 (95%) CI: -57.9, -2.2; n=4) and at Month 48
Danish: Efter opfølgning i det åbne forlængelsesforsøg var gennemsnitsændringen fra baseline i LVMi ved måned 36 -30,0 (95 %) CI: -57,9; -2,2; n=4) og ved måned 48 -33,1 (CI: -60,9; -5,4; n=4) hos patienter med venstre ventrikel-hypertrofi ved baseline.
English: c.408T>A or c.408T>G
Danish: c.408T>A eller c.408T>G c.T408A eller c.T408G
English: c.648T>A or c.648T>G
Danish: c.648T>A eller c.648T>G c.T648A eller c.T648G
English: c.3G>A or c.3G>T or c.3G>C c.G3A or c.G3T or c.G3C
Danish: c.3G>A eller c.3G>T eller c.3G>C
English: c.T702G or c.T702A
Danish: c.702T>G eller c.702T>A c.T702G eller c.T702A
English: L177X c.547G>A (putative splicing site) c.G547A (putative splicing site) UNKNOWN (G183S) c.548G>T
Danish: c.547G>A (fellermodet splejsningssted)
English: c.242G>A or c.243G>A
Danish: c.242G>A eller c.243G>A c.G242A eller c.G243A
English: c.778G>C or c.778G>A
Danish: c.778G>C eller c.778G>A c.G778C eller c.G778A
English: c.[811G>A; 937G>T]
Danish: Ændring i proteinsekvens c.[811G>A; 937G>T]
English: c.T834G or c.T834A
Danish: c.834T>G eller c.834T>A c.T834G eller c.T834A
English: c.707G>A or c.708G>A
Danish: c.707G>A eller c.708G>A c.G707A eller c.G708A
English: c.T881G or c.T881A
Danish: c.881T>G eller c.881T>A c.T881G eller c.T881A
English: Dyspnoea Epistaxis
Danish: • Fordøjelsesbesvær
English: c.687T>A or c.687T>G
Danish: c.687T>A eller c.687T>G c.T687A eller c.T687G
English: c.789T>A or c.789T>G
Danish: c.789T>A eller c.789T>G c.T789A eller c.T789G
English: c.T369G or c.T369A
Danish: c.369T>G eller c.369T>A c.T369G eller c.T369A
English: c.798T>A or c.798T>G
Danish: c.798T>A eller c.798T>G c.T798A eller c.T798G
English: c.677G>A or c.678G>A
Danish: c.677G>A eller c.678G>A c.G677A eller c.G678A
English: c.C666A or c.C666G
Danish: c.666C>A eller c.666C>G c.C666A eller c.C666G
English: c.G734A or c.G735A
Danish: c.734G>A eller c.735G>A c.G734A eller c.G735A
English: • Sensation of spinning
Danish: Nyrer og urinveje
English: c.103G>C or c.103G>A
Danish: c.103G>C eller c.103G>A c.G103C eller c.G103A
English: c.772G>C or c.772G>A
Danish: c.772G>C eller c.772G>A c.G772C eller c.G772A
English: M267R c.801G>A (putative splicing site) c.G801A (putative splicing site) UNKNOWN (M267I) c.803T>C
Danish: c.801G>A (fellermodet splejsningssted)
English: c.936G>T or c.936G>C
Danish: Ændring i proteinsekvens c.936G>T eller c.936G>C
English: The proportion of patients who had at least a 75% reduction in symptoms after 16 weeks of treatment was 68% with Halimatoz and 63% with Humira.
Danish: Andelen af patienter, som havde en reduktion af symptomer på mindst 75 % efter 16 ugers behandling, var 68 % med Halimatoz og 63 % med Humira.
English: These packs will include information on the safety of the medicine.
Danish: Dette informationsmateriale skal indeholde information om lægemidlets sikkerhed.
English: Further information on Halimatoz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Halimatoz findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This means that Halimatoz is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Danish: Det betyder, at Halimatoz i høj grad svarer til et andet biologisk lægemiddel ("referencelægemidlet"), der allerede er godkendt i EU.
English: An alert card will also be given to patients.
Danish: Patienterne skal desuden have udleveret et patientkort.
English: The reference medicine for Halimatoz is Humira.
Danish: Referencelægemidlet for Halimatoz er Humira.
English: Other information about Halimatoz
Danish: Andre oplysninger om Halimatoz
English: In addition, Halimatoz was as effective as Humira in a study involving 465 patients with moderate or severe plaque psoriasis.
Danish: Desuden var Halimatoz lige så effektivt som Humira i et studie med deltagelse af 465 patienter med moderat eller svær plaquepsoriasis.
English: As for all medicines, data on the use of Halimatoz are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Halimatoz løbende overvåget.
English: What measures are being taken to ensure the safe and effective use of Halimatoz?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Halimatoz?
English: An overview of Halimatoz and why it is authorised in the EU
Danish: En oversigt over Halimatoz, og hvorfor det er godkendt i EU
English: By attaching to TNF, adalimumab blocks its activity, thereby reducing inflammation and other symptoms of the diseases.
Danish: Ved at binde til TNF blokerer adalimumab dets aktivitet og mindsker dermed betændelsen og de andre symptomer på sygdommen.
English: Like other medicines of its class, Halimatoz may affect the ability of the immune system to fight off infections and cancer, and there have been some cases of serious infections and blood cancers in patients using adalimumab.
Danish: Ligesom andre lægemidler i sin klasse kan Halimatoz påvirke immunsystemets evne til at bekæmpe infektioner og kræft, og der har været nogle tilfælde af alvorlige infektioner og blodkræft hos patienter, der får adalimumab.
English: Side effects reported with Halimatoz are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Halimatoz vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Halimatoz must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure (an inability of the heart to pump enough blood around the body).
Danish: Halimatoz må ikke anvendes til patienter med aktiv tuberkulose eller andre svære infektioner eller til patienter med moderat til svær hjerteinsufficiens (hjertets manglende evne til at pumpe tilstrækkeligt blod rundt i kroppen).
English: After training, patients or their carers may inject Halimatoz if their doctor considers it appropriate.
Danish: Efter oplæring kan patienten eller dennes omsorgsgiver selv foretage injektionen med Halimatoz, hvis lægen finder det hensigtsmæssigt.
English: Halimatoz contains the active substance adalimumab and is a ‘biosimilar medicine'.
Danish: Halimatoz indeholder det aktive stof adalimumab og er et "biosimilært lægemiddel".
English: Halimatoz is mostly used in adults when their conditions are severe, moderately severe or getting worse, or when patients cannot use other treatments.
Danish: Halimatoz bruges oftest til voksne, når deres tilstand er svær eller moderat svær, når tilstanden forværres, eller når de ikke kan få andre behandlinger.
English: Halimatoz is a medicine that acts on the immune system and is used to treat the following conditions:
Danish: Halimatoz er et lægemiddel, der virker på immunsystemet, og som anvendes til behandling for følgende sygdomme:
English: Because Halimatoz is a biosimilar medicine, the studies on effectiveness and safety of adalimumab carried out with Humira do not all need to be repeated for Halimatoz.
Danish: Da Halimatoz er et biosimilært lægemiddel, behøver de studier af virkningen og sikkerheden af adalimumab, der er udført for Humira, ikke at blive gentaget for Halimatoz.
English: Why is Halimatoz authorised in the EU?
Danish: Hvorfor blev Halimatoz godkendt i EU?
English: What is Halimatoz and what is it used for?
Danish: Hvad er Halimatoz, og hvad anvendes det til?
English: Other rare serious side effects (which may affect up to 1 in 1,000 people) include failure of bone marrow to produce blood cells, disorder of the nerves, lupus and lupus-like conditions (where the immune system attacks the patient's own tissues, causing inflammation and organ damage), and Stevens-Johnson syndrome (a serious skin condition).
Danish: Andre sjældne alvorlige bivirkninger (som kan forekomme hos op til 1 ud af 1 000 personer) omfatter knoglemarvens svigtende produktion af blodceller, nervelidelser, lupus og lupuslignende sygdomme (hvor immunsystemet angriber patientens eget væv og forårsager betændelse og organskader) og Stevens-Johnsons syndrom (en alvorlig hudsygdom).
English: In addition, a study in psoriasis has shown that the effects of the medicine are equivalent to those of Humira in this condition.
Danish: Derudover har et studie vedrørende psoriasis vist, at lægemidlets virkning svarer til virkningen af Humira ved denne sygdom.
English: The most common side effects with adalimumab (seen in more than 1 patient in 10) are infections (including in the nose, throat and sinuses), injection site reactions (redness, itching, bleeding, pain or swelling), headache and muscle and bone pain.
Danish: De hyppigste bivirkninger med adalimumab (der forekommer hos mere end 1 ud af 10 patienter) er infektioner (herunder i næsen, halsen og bihulerne), reaktioner på injektionsstedet (rødme, kløe, blødning, smerter eller hævelse), hovedpine og muskel- og knoglesmerter.
English: The company that markets Halimatoz must provide educational packs for doctors who prescribe the medicine.
Danish: Den virksomhed, der markedsfører Halimatoz, skal udlevere informationsmateriale til læger, som ordinerer lægemidlet.
English: The active substance in Halimatoz, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a substance in the body called tumour necrosis factor (TNF).
Danish: Det aktive stof i Halimatoz, adalimumab, er et monoklonalt antistof (en type protein), der er opbygget, så det genkender og binder til et kemisk stof i kroppen, der kaldes tumornekrosefaktor (TNF).
English: Therefore, the Agency's view was that, as for Humira, the benefits of Halimatoz outweigh the identified risks and it can be authorised.
Danish: Det var derfor agenturets opfattelse, at fordelene ved Halimatoz opvejer de identificerede risici, som for Humira, og kan godkendes.
English: All these data were considered sufficient to conclude that Halimatoz will behave in the same way as Humira in terms of effectiveness and safety in its approved uses.
Danish: Disse oplysninger blev anset for tilstrækkelige til at konkludere, at Halimatoz vil have de samme egenskaber som Humira, hvad angår sikkerhed og virkning ved de godkendte anvendelser.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Halimatoz has a highly similar structure, purity and biological activity to Humira and is distributed in the body in the same way.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Halimatoz har en struktur, renhed og biologisk aktivitet, som i høj grad minder om Humira, og at det fordeles i kroppen på samme måde.
English: What are the risks associated with Halimatoz?
Danish: Hvilke risici er der forbundet med Halimatoz?
English: • polyarticular juvenile idiopathic arthritis and active enthesitis-related arthritis (both rare diseases causing inflammation in the joints);
Danish: • polyartikulær juvenil idiopatisk artritis og aktiv enthesitis-relateret artritis (begge er sjældne sygdomme, der giver betændelse i leddene)
English: Eye specialists treating uveitis should also take advice from doctors who have experience of using Halimatoz.
Danish: Øjenlæger, der behandler uveitis, bør også rådføre sig med læger, der har erfaring i brug af Halimatoz.
English: For more information on the use of Halimatoz in all conditions, including when it can be used in children, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Halimatoz til alle sygdomme, herunder hvornår det kan anvendes til børn, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: TNF is involved in causing inflammation and is found at high levels in patients with the diseases that Halimatoz is used to treat.
Danish: TNF er en medvirkende årsag til betændelsestilstande og findes i høje koncentrationer hos patienter med de sygdomme, der behandles med Halimatoz.
English: Halimatoz can only be obtained by prescription and treatment must be started and supervised by a doctor who has experience in the treatment of the diseases for which Halimatoz is used.
Danish: Halimatoz udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af de sygdomme, som behandles med Halimatoz.
English: For more information about using Halimatoz, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Halimatoz, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: Halimatoz is available as a solution for injection under the skin in a pre-filled syringe or pen and is usually given every 2 weeks.
Danish: Halimatoz fås som injektionsvæske, opløsning, i fyldte sprøjter eller penne til injektion under huden og gives normalt hver anden uge.
English: For the full list of side effects and restrictions with Halimatoz, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Halimatoz fremgår af indlægssedlen.
English: Studies have also shown that giving Halimatoz produces similar levels of the active substance in the body to giving Humira.
Danish: Studier har også vist, at indgivelse af Halimatoz giver samme niveau af det aktive stof i kroppen som indgivelse af Humira.
English: Laboratory studies comparing Halimatoz with Humira have shown that the active substance in Halimatoz is highly similar to that in Humira in terms of structure, purity and biological activity.
Danish: Af laboratoriestudier, hvor Halimatoz er blevet sammenlignet med Humira, fremgår det, at det aktive stof i Halimatoz i vid udstrækning svarer til det aktive stof i Humira, hvad angår struktur, renhed og biologisk aktivitet.
English: • axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis and when X-ray does not show disease but there are clear signs of inflammation;
Danish: • aksial spondyloartritis (betændelse i rygsøjlen, som giver rygsmerter), herunder ankyloserende spondylitis, hvor der er tydelige tegn på betændelse, men ved røntgen ikke ses nogen skader
English: How is Halimatoz used?
Danish: Hvordan anvendes Halimatoz?
English: How does Halimatoz work?
Danish: Hvordan virker Halimatoz?
English: What benefits of Halimatoz have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Halimatoz?
English: The dose and frequency of injection depends on the condition to be treated and the dose for a child is usually calculated according to the child's weight; because Halimatoz is only available in doses of 40 mg, it is not suitable for children who need less than a 40-mg dose.
Danish: Dosen og hyppigheden af injektioner afhænger af den sygdom, der skal behandles, og dosen til et barn beregnes typisk ud fra barnets vægt.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Halimatoz 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 Halimatoz.
English: • rheumatoid arthritis (a disease causing inflammation of the joints);
Danish: • leddegigt (rheumatoid artritis - en sygdom, som forårsager betændelse i leddene)
English: • hidradenitis suppurativa (acne inversa), a long-term skin disease that causes lumps, abscesses
Danish: • hidradenitis suppurativa (en kronisk hudsygdom, der giver knuder, abscesser (bylder) og ardannelse på huden)
English: • psoriatic arthritis (a disease causing red, scaly patches on the skin with inflammation of the joints);
Danish: • psoriasisartritis (en sygdom, som giver røde, skællende hudområder og betændelse i leddene)
English: • plaque psoriasis (a disease causing red, scaly patches on the skin);
Danish: • plaquepsoriasis (en sygdom, der giver røde, skællende hudområder)
English: Package size blister (PVC/alu) perforated blister (PVC/alu) non perforated
Danish: Paknings-størrelse blister (PVC/alu) perforeret
English: The European Commission granted a marketing authorisation valid throughout the EU for Pantecta Control on 12 June 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Pantecta Control den 12. juni 2009.
English: The full EPAR for Pantecta Control can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Pantecta Control findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Pantecta Control.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Pantecta Control.
English: The recommended dose of Pantecta Control is one tablet once a day until symptoms have stopped.
Danish: Den anbefalede dosis Pantecta Control er én tablet én gang dagligt, indtil symptomerne forsvinder.
English: It is used for long-term treatments and is also used to treat a wider range of gastrointestinal diseases (conditions affecting the gut) than Pantecta Control.
Danish: Det anvendes til langtidsbehandling og anvendes desuden til behandling af et større felt af gastrointestinale sygdomme (lidelser i tarmene) end Pantecta Control.
English: For more information about treatment with Pantecta Control, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Pantecta Control, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
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 Pantecta Control.
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 anvendelsesbetingelserne for Pantecta Control.
English: The most common side effects with Pantecta Control (seen in around 1 patient in 100) are diarrhoea and headache.
Danish: De hyppigste bivirkninger ved Pantecta Control (som optræder hos omkring 1 ud af 100 patienter) er diarré og hovedpine.
English: Pantecta Control must not be used in people who are hypersensitive (allergic) to pantoprazole, soya or any of the other ingredients.
Danish: Pantecta Control må ikke anvendes af patienter, der er overfølsomme (allergiske) over for pantoprazol, soja eller andre af indholdsstofferne.
English: Pantecta Control pantoprazole
Danish: Pantecta Control pantoprazol
English: Pantecta Control is similar to a ‘reference medicine' already authorised in the European Union (EU) called Pantecta.
Danish: Pantecta Control svarer til et referencelægemiddel ved navn Pantecta, som allerede er godkendt i Den Europæiske Union (EU).
English: Pantecta Control is a medicine that contains the active substance pantoprazole.
Danish: Pantecta Control er et lægemiddel, der indeholder det aktive stof pantoprazol.
English: The CHMP therefore decided that Pantecta Control's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede derfor, at fordelene ved Pantecta Control er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Pantecta Control.
English: Pantecta Control is used for the short-term treatment of the symptoms of acid reflux in adults.
Danish: Pantecta Control anvendes til korttidsbehandling af symptomer på syrerefluks hos voksne.
English: The active substance in Pantecta Control, pantoprazole, is a proton pump inhibitor.
Danish: Det aktive stof i Pantecta Control, pantoprazol, er en protonpumpehæmmer.
English: The reference medicine, Pantecta, is only available with a prescription.
Danish: Referencelægemidlet Pantecta udleveres kun efter recept.
English: Other information about Pantecta Control
Danish: Andre oplysninger om Pantecta Control:
English: What is the risk associated with Pantecta Control?
Danish: Hvilken risiko er der forbundet med Pantecta Control?
English: Pantecta Control without medical supervision is appropriate.
Danish: CHMP var også af den opfattelse, at adgangen til Pantecta Control uden lægelig overvågning, baseret på erfaringerne med anvendelsen af pantoprazol, er passende.
English: Why has Pantecta Control been approved?
Danish: Hvorfor blev Pantecta Control godkendt?
English: How has Pantecta Control been studied?
Danish: Hvordan blev Pantecta Control undersøgt?
English: What benefit has Pantecta Control shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Pantecta Control?
English: What is Pantecta Control?
Danish: Hvad er Pantecta Control?
English: What is Pantecta Control used for?
Danish: Hvad anvendes Pantecta Control til?
English: How is Pantecta Control used?
Danish: Hvordan anvendes Pantecta Control?
English: These can be taken from you or from a donor.
Danish: Disse kan tages fra dig eller fra en donor.
English: It is therefore difficult to recommend an optimal method.
Danish: Det er derfor svært at anbefale en optimal metode.
English: Equipment that you need
Danish: Udstyr, du har brug for
English: The significance of these changes is unknown.
Danish: Signifikansen af disse ændringer er ukendt.
English: These symptoms generally develop in a rapid fashion.
Danish: Disse symptomer udvikler sig almindeligvis hurtigt.
English: Date of first authorisation: 18 October 2013 Date of latest renewal: 4 October 2018
Danish: Dato for første markedsføringstilladelse: 18. oktober 2013 Dato for seneste fornyelse: 4. oktober 2018
English: Although this interaction has not been formally investigated, there is no evidence that such an interaction is harmful.
Danish: Selvom denne interaktion ikke er formelt undersøgt, er der ingen evidens for, at en sådan interaktion er skadelig.
English: MedDRA system organ class
Danish: MedDRA systemorgan-klasse