FrancophonIA/ELRC3.0 huggingface dataset:
English: Adult ankylosing spondylitis
Danish: Ankyloserende spondylitis hos voksne
English: It is recommended that therapeutic infectious agents not be given concurrently with Remicade (see section 4.4).
Danish: Terapeutiske smitstoffer bør ikke gives samtidig med Remicade (se pkt.
English: 5 vials 100 mg
Danish: 5 hætteglas 100 mg
English: Adult ulcerative colitis
Danish: Colitis ulcerosa hos voksne
English: If a patient does not respond after 2 doses, no additional treatment with infliximab should be given.
Danish: Hvis patienten ikke responderer efter 2 doser, bør der ikke behandles yderligere med infliximab.
English: Common: Arthralgia, myalgia, back pain.
Danish: Almindelig: Artralgi, myalgi, rygsmerter.
English: Very common: Upper respiratory tract infection, sinusitis.
Danish: Luftveje, thorax og mediastinum Meget almindelig: Øvre luftvejsinfektion, sinuitis.
English: Ankylosing spondylitis is an inflammatory disease of the spine.
Danish: Ankyloserende spondylitis (Bekhterevs sygdom) Ankyloserende spondylitis er en betændelsessygdom i rygraden.
English: Patients should be tested for HBV infection before initiating treatment with Remicade.
Danish: Før behandlingen med Remicade påbegyndes, skal patienten testes for HBV-infektion.
English: Tell your doctor straight away if you develop symptoms of lupus during treatment with Remicade.
Danish: Fortæl det straks til lægen, hvis du får symptomer på lupus under behandlingen med Remicade.
English: • Chills, a build up of fluid under the skin causing swelling
Danish: • Kuldegysninger, hævelse på grund af ophobning af væske under huden
English: Subjects randomised
Danish: Randomiserede forsøgspersoner
English: Remicade is not likely to affect your ability to drive or use tools or machines.
Danish: Remicade påvirker sandsynligvis ikke arbejdssikkerheden eller evnen til at færdes sikkert i trafikken.
English: IV
Danish: c
English: After reconstitution one ml contains 10 mg of infliximab.
Danish: Efter rekonstitution indeholder 1 ml 10 mg infliximab.
English: All infliximab
Danish: infliximab
English: Percentage of subjects with mucosal healing Mucosal healing at week 8
Danish: Procent forsøgspersoner med slimhindeheling Slimhindeheling i uge 8
English: It is recommended that therapeutic infectious agents not be given concurrently with Remicade.
Danish: Terapeutiske smitstoffer bør ikke gives samtidig med Remicade.
English: 2 vials 100 mg
Danish: 2 hætteglas 100 mg
English: 10 mg/kg q 8 wks
Danish: 10 mg/kg hver 8. uge
English: 4 vials 100 mg
Danish: 4 hætteglas 100 mg
English: Tell your doctor straight away if you get symptoms of liver problems during treatment with Remicade.
Danish: Fortæl det straks til lægen, hvis du får symptomer på leverproblemer under behandlingen med Remicade.
English: • Wounds taking longer to heal
Danish: • Længere sårhelingstid
English: After in utero exposure to infliximab, infants may be at increased risk of infection, including serious disseminated infection that can become fatal.
Danish: Spædbørn, der har været eksponeret for infliximab i uterus, kan have en øget risiko for infektion,
English: 5 mg/kg given as an intravenous infusion followed by additional 5 mg/kg infusions at 2 and 6 weeks after the first infusion.
Danish: 5 mg/kg indgivet som en intravenøs infusion følges op med yderligere infusioner på 5 mg/kg 2 og 6 uger efter den første infusion.
English: After preparation each ml contains 10 mg of infliximab
Danish: Efter klargøring indeholder hver ml 10 mg infliximab.
English: Mucosal healing at week 30
Danish: Slimhindeheling i uge 30
English: Adult rheumatoid arthritis
Danish: Reumatoid arthritis hos voksne
English: Uncommon: Keratitis, periorbital oedema, hordeolum.
Danish: Ikke almindelig: Keratitis, periorbitalt ødem, bygkorn.
English: • Tell your doctor if you have any abnormal skin openings (fistulae) before you are given
Danish: Unormale hudåbninger • Fortæl din læge, hvis du har unormale hudåbninger (fistler), før du får Remicade.
English: Each vial contains 100 mg of infliximab.
Danish: Hvert hætteglas indeholder 100 mg infliximab.
English: 3 vials 100 mg
Danish: 3 hætteglas 100 mg
English: 3 mg/kg q 8 wks
Danish: 3 mg/kg hver 8. uge
English: • Fainting
Danish: • Besvimelse
English: Table 1 Undesirable effects in clinical studies and from post-marketing experience Infections and infestations Very Common: Viral infection (e.g. influenza, herpes virus infection).
Danish: Tabel 1 Bivirkninger i kliniske studier og efter markedsføring Infektioner og parasitære sygdomme
English: Each Remicade vial contains 100 mg infliximab.
Danish: Hvert Remicade-hætteglas indeholder 100 mg infliximab.
English: ACR 20 response* 5(10%) 34 (65%) 48 (62%) 16 (16%) 54 (54%) 53 (53%) ACR 50 response* 0(0%) 24 (46%) 35 (45%) 4 (4%) 41(41%) 33 (33%) ACR 70 response* 0(0%) 15 (29%) 27 (35%) 2 (2%) 27 (27%) 20 (20%) PASI response
Danish: ACR 20 respons* 5(10 %) ACR 50 respons* 0(0 %) ACR 70 respons* 0(0 %) PASI respons (% af patienter)
English: 10 mg/kg q 4 wks
Danish: 10 mg/kg hver 4. uge
English: nd dose
Danish: 3. dosis
English: 3 mg/kg given as an intravenous infusion followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
Danish: Intravenøs infusion med 3 mg/kg efterfulgt af yderligere infusionsdoser på 3 mg/kg 2 og 6 uger efter den første infusion, og herefter hver 8. uge.
English: • Infections of the vagina
Danish: • Infektioner i skeden
English: The safety and efficacy of re-administration, other than every 8 weeks, has not been established (see sections 4.4 and 4.8).
Danish: Fornyet indgift ved psoriasis arthritis Sikkerhed og effekt ved fornyet indgift, udover hver 8. uge, er ikke vist (se pkt.
English: 5 mg/kg given as an intravenous infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks.
Danish: 5 mg/kg givet som en intravenøs infusion efterfulgt af yderligere infusionsdoser på 5 mg/kg 2 og 6 uger efter den første infusion, herefter hver 6. til 8. uge.
English: 3 mg/kg q 4 wks
Danish: 3 mg/kg hver 4. uge
English: Patients treated with Remicade should be given the package leaflet and the patient reminder card.
Danish: Indlægssedlen og patientinformationskortet skal gives til patienter, som behandles med Remicade.
English: 5 mg/kg given as an intravenous infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
Danish: 5 mg/kg gives som en intravenøs infusion efterfulgt af yderligere 5 mg/kg infusionsdoser 2 og 6 uger efter den første infusion, derefter hver 8. uge.
English: • Infection of the skin due to a fungus
Danish: • Svampeinfektion i huden
English: Re-administration for ankylosing spondylitis
Danish: Ankyloserend e spondylitis
English: • Psoriatic arthritis
Danish: • Psoriasisarthritis
English: In addition, post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with Remicade with the vast majority of cases occurring in Crohn's disease and ulcerative colitis, and most of whom were adolescent or young adult males (see section 4.4).
Danish: Hos patienter, som fik Remicade, er langt de fleste tilfælde forekommet hos patienter med Crohns sygdom eller colitis ulcerosa, og de fleste blev rapporteret hos unge og unge voksne mænd.
English: 10 mg/kg Combined
Danish: Infliximab 5 mg/kg 10 mg/kg Kombineret
English: st dose
Danish: 2. dosis
English: ‘Re-administration' below and section 4.4).
Danish: 4.4 "Infusionsreaktioner og overfølsomhed").
English: • Liver failure
Danish: • Leversvigt
English: Week 50
Danish: Uge 24 Uge 50
English: • Swollen lymph nodes
Danish: • Hævede lymfeknuder
English: Renal and urinary disorders Common: Urinary tract infection.
Danish: Almindelig: Urinvejsinfektion.
English: When the body cannot remove iron effectively, the excess iron can cause damage.
Danish: Når kroppen ikke kan fjerne jern effektivt, kan det overskydende jern medføre skade.
English: Further information on Deferasirox Mylan can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/deferasirox-mylan.
Danish: Yderligere information vedrørende Deferasirox Mylan findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/deferasirox-mylan.
English: The company will also prepare a similar pack for patients.
Danish: Virksomheden skal desuden udarbejde tilsvarende informationsmateriale til patienterne.
English: Deferasirox Mylan is available as film-coated tablets (90 mg, 180 mg and 360 mg), to be taken once a day at around the same time.
Danish: Deferasirox Mylan fås som filmovertrukne tabletter (90 mg, 180 mg og 360 mg), som tages en gang daglig på cirka samme tidspunkt.
English: The dose is then adjusted as needed, every 3 to 6 months, according to the iron levels in the blood.
Danish: Derefter kan doseringen efter behov justeres hver tredje til sjette måned alt efter omfanget af jernophobning.
English: This helps to correct the iron overload and prevent damage to organs such as the heart or liver from excess iron.
Danish: Dette medvirker til at afhjælpe jernophobningen og forebygge skader på organer, som f.eks. hjertet eller leveren, på grund af overskud af jern.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Exjade, and do not need to be repeated for Deferasirox Mylan.
Danish: Der er allerede foretaget studier over det aktive stofs fordele og risici ved godkendt brug med referencelægemidlet, Exjade, og de behøver ikke at blive gentaget for Deferasirox Mylan.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Deferasirox Mylan has been shown to have comparable quality and to be bioequivalent to Exjade.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Deferasirox Mylan er af sammenlignelig kvalitet og er bioækvivalent med Exjade.
English: Because Deferasirox Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Deferasirox Mylan er et generisk lægemiddel og er bioækvivalent med referencelægemidlet, anses dets fordele og risici for at være de samme som for referencelægemidlet.
English: It attaches to excess iron in the body to form a compound called a ‘chelate' that can be removed by the body, mainly in the stool.
Danish: Den binder til det overskydende jern i kroppen og danner derved en forbindelse ved navn "kelat", som kroppen kan udskille, hovedsagelig gennem afføringen.
English: This means that Deferasirox Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Exjade.
Danish: Det betyder, at Deferasirox Mylan indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", som allerede er godkendt i EU, og som hedder Exjade.
English: Non-transfusion-dependent thalassaemia syndromes are blood disorders similar to beta thalassaemia major but which do not require blood transfusions.
Danish: Ikketransfusionskrævende thalassæmisyndromer er blodsygdomme, der ligner beta-thalassæmi major, men hvor der ikke er behov for blodtransfusioner.
English: As for every medicine, the company provided studies on the quality of Deferasirox Mylan.
Danish: Som for alle lægemidler har virksomheden leveret studier vedrørende kvaliteten af Deferasirox Mylan.
English: As for all medicines, data on the use of Deferasirox Mylan are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Deferasirox Mylan løbende overvåget.
English: Side effects reported with Deferasirox Mylan are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Deferasirox Mylan vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: Deferasirox Mylan can only be obtained with a prescription and treatment should be started and supervised by a doctor who is experienced in the treatment of chronic iron overload.
Danish: Deferasirox Mylan fås kun på recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af kronisk jernophobning.
English: For more information about using Deferasirox Mylan, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Deferasirox Mylan, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: Therefore, the Agency's view was that, as for Exjade, the benefits of Deferasirox Mylan outweigh the identified risks and it can be authorised for use in the EU.
Danish: Det var derfor agenturets opfattelse, at fordelene ved Deferasirox Mylan opvejer de identificerede risici som for Exjade, og at det kan godkendes til anvendelse i EU.
English: The starting dose of Deferasirox Mylan depends on the patient's body weight, what the medicine is used for, and on the level of iron overload.
Danish: Startdosen af Deferasirox Mylan afhænger af patientens kropsvægt, hvad lægemidlet tages for og omfanget af jernophobning.
English: What measures are being taken to ensure the safe and effective use of Deferasirox Mylan?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Deferasirox Mylan?
English: This pack aims to inform them about the treatment recommendations with Deferasirox Mylan, including choosing the right dose and the need to monitor the patient's health, especially kidney function.
Danish: Dette materiale skal informere dem om behandlingsanbefalingerne for Deferasirox Mylan, herunder korrekt dosering og behovet for at overvåge patientens tilstand, særlig nyrefunktionen.
English: The company that markets Deferasirox Mylan must issue an education pack to healthcare professionals.
Danish: Virksomheden, der markedsfører Deferasirox Mylan, skal udlevere informationsmateriale til sundhedspersoner.
English: An overview of Deferasirox Mylan and why it is authorised in the EU
Danish: En oversigt over Deferasirox Mylan, og hvorfor det er godkendt i EU
English: Deferasirox Mylan is a medicine used to treat chronic iron overload (an excess of iron in the body) in:
Danish: Deferasirox Mylan er et lægemiddel til behandling af kronisk jernophobning (overskud af jern i kroppen) hos:
English: • patients from 6 years of age who have beta thalassaemia major (an inherited blood disorder in which patients do not have enough normal haemoglobin - the protein that carries oxygen around the body - in the blood) and who receive frequent blood transfusions;
Danish: • patienter fra seksårsalderen, der har beta-thalassæmi major (en arvelig blodsygdom, hvor patienterne ikke har nok normal hæmoglobin - det protein, som transporterer ilten rundt i kroppen - i blodet), og som hyppigt får blodtransfusioner
English: Deferasirox Mylan contains the active substance deferasirox and is a ‘generic medicine'.
Danish: Deferasirox Mylan indeholder det aktive stof deferasirox og er et "generisk lægemiddel".
English: The active substance in Deferasirox Mylan, deferasirox, is an ‘iron chelator'.
Danish: Det aktive stof i Deferasirox Mylan, deferasirox, er en "jernkelator".
English: What are the benefits and risks of Deferasirox Mylan?
Danish: Hvilke fordele og risici er der forbundet med Deferasirox Mylan?
English: Other information about Deferasirox Mylan
Danish: Andre oplysninger om Deferasirox Mylan
English: In these patients iron overload is caused by excess absorption of iron from the gut.
Danish: Optagelsen af for store mængder jern fra tarmen er årsag til jernophobningen hos disse patienter.
English: What is Deferasirox Mylan and what is it used for?
Danish: Hvad er Deferasirox Mylan, og hvad anvendes det til?
English: Why is Deferasirox Mylan authorised in the EU?
Danish: Hvorfor er Deferasirox Mylan godkendt i EU?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Deferasirox Mylan 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 Deferasirox Mylan.
English: • patients from 10 years of age with non-transfusion-dependent thalassaemia syndromes, when deferoxamine cannot be used or is inadequate.
Danish: • patienter fra 10-årsalderen med ikketransfusionskrævende thalassæmisyndromer, når deferoxamin ikke kan anvendes eller ikke har tilstrækkelig virkning.
English: • patients from 2 years of age who suffer from other types of anaemia (low levels of haemoglobin in the blood) and who receive blood transfusions, when deferoxamine cannot be used or is inadequate;
Danish: • patienter fra toårsalderen, der lider af andre former for anæmi (lavt hæmoglobinindhold i blodet), og som får blodtransfusioner, når deferoxamin ikke kan anvendes eller ikke har tilstrækkelig virkning
English: • children aged 2 to 5 years with beta thalassaemia major who receive frequent blood transfusions, when deferoxamine (another medicine used to treat iron overload) cannot be used or is inadequate;
Danish: • børn i alderen to til fem år med beta-thalassæmi major, som hyppigt får blodtransfusioner, når deferoxamin (et andet lægemiddel til behandling af jernophobning) ikke kan anvendes eller ikke har tilstrækkelig virkning
English: How has Deferasirox Mylan been studied?
Danish: Hvordan er Deferasirox Mylan blevet undersøgt?
English: • patients from 2 years of age with beta thalassaemia major who receive infrequent blood transfusions, when deferoxamine cannot be used or is inadequate;
Danish: • patienter fra toårsalderen med beta-thalassæmi major, som sjældent får blodtransfusioner, når deferoxamin ikke kan anvendes eller ikke har tilstrækkelig virkning
English: How is Deferasirox Mylan used?
Danish: Hvordan anvendes Deferasirox Mylan?
English: How does Deferasirox Mylan work?
Danish: Hvordan virker Deferasirox Mylan?
English: Trydonis received a marketing authorisation valid throughout the EU on 26 April 2018.
Danish: Trydonis fik en markedsføringstilladelse med gyldighed i hele EU den 26. april 2018.
English: Other information about Trydonis
Danish: Andre oplysninger om Trydonis
English: As for all medicines, data on the use of Trydonis is continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Trydonis løbende overvåget.
English: Further information on Trydonis can be found on the Agency's website: https://www.ema.europa.eu/en/medicines/human/EPAR/trydonis.
Danish: Yderligere information om Trydonis findes på agenturets websted under: https://www.ema.europa.eu/en/medicines/human/EPAR/trydonis.
English: The company that makes Trimbow has agreed that its scientific data can be used for Trydonis (‘informed consent').
Danish: Virksomheden, som fremstiller Trimbow, har indvilget i, at dens videnskabelige oplysninger må anvendes for Trydonis ("informeret samtykke").
English: What measures are being taken to ensure the safe and effective use of Trydonis?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Trydonis?
English: For more information about using Trydonis, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Trydonis, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: The European Medicines Agency therefore decided that Trydonis's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Trydonis opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: An overview of Trydonis and why it is authorised in the EU
Danish: En oversigt over Trydonis, og hvorfor det er godkendt i EU
English: What is Trydonis and what is it used for?
Danish: Hvad er Trydonis, og hvad anvendes det til?
English: Trydonis (beclometasone / formoterol / glycopyrronium bromide)
Danish: Trydonis (beclometason/formoterol/glycopyrroniumbromid)
English: Why is Trydonis authorised in the EU?
Danish: Hvorfor blev Trydonis godkendt i EU?
English: Side effects reported with Trydonis are carefully evaluated and any necessary action taken to protect patients.
Danish: Indberettede bivirkninger ved Trydonis vurderes omhyggeligt, og der tages om nødvendigt relevante forholdsregler for at beskytte patienterne.
English: In this study, Trydonis was as effective as tiotropium plus a combination of beclometasone and formoterol at reducing the number of exacerbations.
Danish: I dette studie var Trydonis lige så effektivt som tiotropium plus en kombination af beclometason og formoterol til at reducere antallet af symptomforværringer.
English: No major safety concerns have been reported with Trydonis, with side effects being manageable and similar to other COPD medicines.
Danish: Der er ikke indberettet om væsentlige sikkerhedsproblemer ved Trydonis, idet bivirkningerne er håndterbare og ligner bivirkningerne ved andre KOL-lægemidler.
English: What are the risks associated with Trydonis?
Danish: Hvilke risici er der forbundet med Trydonis?
English: Side effects with Trydonis include oral candidiasis (a fungal infection of the mouth caused by a yeast called Candida), muscle spasms and dry mouth.
Danish: Bivirkningerne ved Trydonis omfatter oral candidiasis (en svampeinfektion i munden forårsaget af gærsvampen Candida), muskelspasmer og mundtørhed.
English: By comparison, the FEV1 increased by 1 and 145 ml before and after dosing in patients treated with a medicine containing only 2 of the active substances found in Trydonis (beclometasone plus formoterol).
Danish: Til sammenligning steg FEV1 med 1 ml og 145 ml før og efter en dosis hos patienter, der blev behandlet med et lægemiddel, som kun indeholdt to af de aktive stoffer, der er i Trydonis (beclometason plus formoterol).
English: Trydonis is a medicine used in adults to relieve the symptoms of moderate to severe chronic obstructive pulmonary disease (COPD).
Danish: Trydonis er et lægemiddel, der anvendes hos voksne til at lindre symptomerne på moderat til svær kronisk obstruktiv lungesygdom (KOL).
English: Beta-2 agonists and muscarinic receptor antagonists help to widen the airways; corticosteroids reduce inflammation in the airways and lungs..
Danish: Beta-2-agonister og muskarinreceptorantagonister bidrager til at udvide luftvejene, og kortikosteroider mindsker betændelse i luftvejene og lungerne.
English: Trydonis is available as a liquid in a portable inhaler device.
Danish: Trydonis fås som væske i en bærbar inhalator.
English: For the full list of side effects and restrictions with Trydonis, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Trydonis fremgår af indlægssedlen.
English: Trydonis contains the active substances beclometasone, formoterol and glycopyrronium bromide.
Danish: Trydonis indeholder de aktive stoffer beclometason, formoterol og glycopyrroniumbromid.
English: COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing.
Danish: KOL er en langvarig sygdom, hvor luftvejene og lungeblæresækkene bliver beskadigede eller blokerede, så vejrtrækningen vanskeliggøres.
English: In the first study lasting a year, after 26 weeks of treatment, Trydonis improved patients' FEV1 (the maximum volume of air a person can breathe out in one second) by 82 ml before a dose and 261 ml after a dose.
Danish: I det første studie, der varede et år, havde Trydonis efter 26 ugers behandling forbedret patienternes FEV1 (den maksimale luftvolumen, der kan udåndes på ét sekund) med 82 ml før en dosis og 261 ml efter en dosis.