FrancophonIA/ELRC3.0 huggingface dataset:
English: The effectiveness of Equilis Prequenza Te was initially studied in several trials under laboratory and field conditions.
Danish: Virkningen af Equilis Prequenza Te er blevet undersøgt i flere undersøgelser under laboratorie- og feltbetingelser.
English: Other information about Equilis Prequenza Te:
Danish: Andre oplysninger om Equilis Prequenza Te
English: The studies showed that Equilis Prequenza Te is an effective vaccine against equine influenza to reduce clinical signs and virus excretion after infection, and against tetanus to prevent mortality, in horses from 6 months of age.
Danish: Undersøgelserne viste, at Equilis Prequenza Te er en effektiv vaccine mod hesteinfluenza til heste fra seks måneder og opefter for at lindre kliniske symptomer og virusudskillelse efter infektion og mod stivkrampe for at forebygge dødelighed.
English: Equilis Prequenza Te is used to vaccinate horses from six months of age against equine influenza and tetanus.
Danish: Equilis Prequenza Te anvendes til vaccination af heste, fra de er seks måneder, mod hesteinfluenza og tetanus (stivkrampe).
English: How has Equilis Prequenza Te been studied?
Danish: Hvordan blev Equilis Prequenza Te undersøgt?
English: What is the risk associated with Equilis Prequenza Te?
Danish: Hvilken risiko er der forbundet med Equilis Prequenza Te?
English: Why has Equilis Prequenza Te been approved?
Danish: Hvorfor blev Equilis Prequenza Te godkendt?
English: In the future, the immune system will be able to produce antibodies more quickly when it is exposed to these virus strains or to the unmodified toxin.
Danish: Når immunsystemet efterfølgende udsættes for virusstammerne eller den ikke-modificerede toksin igen, vil det være i stand til hurtigere at danne antistoffer mod dem. Antistofferne er med til at beskytte mod hesteinfluenza og stivkrampe.
English: What benefit has Equilis Prequenza Te shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Equilis Prequenza Te?
English: What is Equilis Prequenza Te used for?
Danish: Hvad anvendes Equilis Prequenza Te til?
English: How does Equilis Prequenza Te work?
Danish: Hvordan virker Equilis Prequenza Te?
English: What is Equilis Prequenza Te?
Danish: Hvad er Equilis Prequenza Te?
English: Steady state was achieved by Day 15.
Danish: Steady state blev opnået på dag 15.
English: Your doctor needs to know if you:
Danish: Lægen skal vide, om du:
English: There is no specific treatment for overdose.
Danish: Der findes ingen specifik behandling mod overdosering.
English: October 26,
Danish: 26. oktober
English: You need to know about important symptoms to look out for.
Danish: Det er nødvendigt, at du kender til vigtige symptomer, som du skal holde øje med.
English: Then carry on taking your tablets at regular times as usual.
Danish: Fortsæt herefter med at tage dine tabletter på de sædvanlige tidspunkter, som du plejer.
English: Mekinist can harm the unborn baby.
Danish: Mekinist kan skade det ufødte barn.
English: At 1 year At 2 years At 3 years At 4 years At 5 years
Danish: Ved 1 år Ved 2 år Ved 3 år Ved 4 år Ved 5 år
English: Signs that your liver may not be working properly may include:
Danish: Tegn på, at din lever ikke fungerer ordentligt, kan være:
English: This means that:
Danish: Dette betyder, at:
English: You may also have blood tests.
Danish: Du vil muligvis også få taget blodprøver.
English: Descriptions of these effects can be found in other sections (see sections 2 and 4).
Danish: Beskrivelser af disse bivirkninger kan findes i andre afsnit (se punkt 2 og 4).
English: stop using the medicine and seek medical attention immediately
Danish: stop med at tage medicinen og søg lægehjælp med det samme.
English: Some people taking Mekinist develop other conditions which can be serious.
Danish: Nogle personer, der tager Mekinist, udvikler andre tilstande, der kan være alvorlige.
English: In the first-line population, 68% of patients had not progressed after 9 months.
Danish: I førstelinjepopulationen havde 68 % af patienterne ikke progredieret efter 9 måneder.
English: Take Mekinist at about the same time each day.
Danish: Tag Mekinist på omtrent samme tidspunkt hver dag.
English: Date of first authorisation: 30 June 2014 Date of latest renewal: 14 February 2019
Danish: Dato for første markedsføringstilladelse: 30. juni 2014 Dato for seneste fornyelse: 14. februar 2019
English: Binding of trametinib to human plasma proteins is 97.4%.
Danish: Bindingen af trametinib til humane plasmaproteiner er 97,4 %.
English: The median DoR and PFS were not yet estimable (Table 14).
Danish: Median DoR og PFS kunne endnu ikke estimeres (tabel 14).
English: Mekinist with food and drink
Danish: Brug af Mekinist sammen med mad og drikke
English: Inter-subject variability at steady state was low (<28%).
Danish: Den inter-individuelle variabilitet ved steady state var lav (< 28 %).
English: Mekinist is not recommended for children and adolescents since the effects of Mekinist in people younger than 18 years old are not known.
Danish: Mekinist anbefales ikke til børn og unge, da virkningerne af Mekinist hos personer, der er yngre end 18 år, ikke kendes.
English: Avoid driving or using machines if you feel tired or weak, if you have problems with your vision or if your energy levels are low.
Danish: Undgå at føre motorkøretøj og betjene maskiner, hvis du føler dig træt eller svag, hvis du har problemer med dit syn, eller hvis dit energiniveau er lavt.
English: Mekinist can affect how well your heart pumps blood.
Danish: Mekinist kan påvirke, hvor godt dit hjerte pumper blod.
English: Mild and moderate renal impairment had no effect on trametinib exposure (<6% for either group).
Danish: Let og moderat nedsat nyrefunktion havde ingen effekt på eksponeringen for trametinib (< 6 % for begge grupper).
English: Don't take more Mekinist than your doctor has recommended, since this may increase the risk of side effects.
Danish: Tag ikke mere Mekinist, end lægen har foreskrevet, da det kan øge risikoen for at få bivirkninger.
English: Table 12 Survival data from the primary and post-hoc analyses
Danish: Tabel 12 Overlevelsesdata fra den primære og post hoc-analysen
English: In some cases, patients were able to continue trametinib.
Danish: I nogle tilfælde var patienterne i stand til at fortsætte med trametinib.
English: It is important to take Mekinist on an empty stomach because food affects the way the medicine is absorbed into your body (see section 3).
Danish: Det er vigtigt at tage Mekinist på tom mave, da mad påvirker den måde, som medicinen optages i kroppen på (se punkt 3).
English: Do not take Mekinist:
Danish: Tag ikke Mekinist:
English: Your doctor may decide to lower the dose if you get side effects.
Danish: Lægen kan beslutte at nedsætte dosis, hvis du får bivirkninger.
English: Mean terminal half-life is 127 hours (5.3 days) after single dose administration.
Danish: Den gennemsnitlige terminale halveringstid er 127 timer (5,3 dage) efter administration af en enkelt dosis.
English: Follow your doctor's instructions for what to do to help prevent rash.
Danish: Følg lægens anvisninger for, hvad du kan gøre for at hjælpe med at undgå udslæt.
English: Read all the information in this leaflet for guidance.
Danish: Læs alle oplysninger i denne indlægsseddel for at få vejledning.
English: ITT = Intent to Treat; PFS = Progression-free survival; CI = confidence interval.
Danish: ITT = Intent to Treat, PFS = progressionsfri overlevelse, CI = konfidensinterval.
English: 30 days at no more than 30ºC.
Danish: 30 dage ved temperaturer ikke højere end 30 °C.
English: Results for the primary analysis of RFS are presented in Table 13.
Danish: Resultaterne for den primære analyse af RFS er vist i tabel 13.
English: Full recovery was observed when stopping treatment.
Danish: Der blev observeret fuld bedring ved seponering af behandlingen.
English: The deacetylation is mediated by the carboxyl-esterases 1b, 1c and 2, with possible contributions by other hydrolytic enzymes.
Danish: Deacetyleringen medieres af carboxylesteraserne 1b, 1c og 2 med mulig medvirken fra andre hydrolytiske enzymer.
English: In the ITT population, 54% of patients were male and all were Caucasian.
Danish: I ITT-populationen var 54 % af patienterne mænd, og alle var kaukasiske.
English: Less than 0.1% of the excreted dose was recovered as parent in urine.
Danish: Mindre end 0,1 % af den udskilte dosis blev genfundet uomdannet i urinen.
English: For trametinib monotherapy, more than 90% of these liver events occurred within the first 6 months of treatment.
Danish: Ved trametinib-monoterapi opstod mere end 90 % af disse leverpåvirkninger inden for de første 6 behandlingsmåneder.
English: There are no adequate and well-controlled studies of trametinib in pregnant women.
Danish: Der er ikke udført tilstrækkelige og velkontrollerede studier af anvendelse af trametinib hos gravide kvinder.
English: * The intensity of clinical adverse reactions graded by the Common Terminology Criteria for Adverse Events v4.0 (CTC-AE)
Danish: *Intensiteten af kliniske bivirkninger gradinddelt i henhold til Common Terminology Criteria for Adverse Events v4.0 (CTC-AE).
English: The increase in exposure (Cmax and AUC) was dose-proportional following repeat dosing.
Danish: Eksponeringen (Cmax og AUC) steg dosisproportionalt efter gentagen dosering.
English: Your doctor will also check your head, neck, mouth and lymph glands and you will have scans of your chest and stomach area (called CT scans) regularly.
Danish: Lægen vil også undersøge dit hoved, hals, mund og lymfekirtler, og du vil regelmæssigt få foretaget scanninger af bryst- og maveområdet (kaldet CT-scanninger).
English: Prior to starting treatment with dabrafenib, talk to your doctor about options to improve your chances to have children in the future.
Danish: Inden du påbegynder behandlingen med dabrafenib, så tal med lægen om dine muligheder for at forbedre dine chancer for at få børn i fremtiden.
English: It is recommended that patients continue treatment with trametinib until patients no longer derive benefit or the development of unacceptable toxicity (see Table 2).
Danish: Det anbefales, at patienterne fortsætter behandlingen med trametinib, indtil de ikke længere har fordel heraf, eller indtil der udvikles uacceptabel toksicitet (se tabel 2).
English: The potential for these events in patients with low platelet counts (<75,000) has not been established as such patients were excluded from clinical trials.
Danish: Sandsynligheden for, at disse hændelser opstår hos patienter med lavt antal blodplader (< 75.000), er ikke fastlagt, da disse patienter blev ekskluderet fra kliniske studier.
English: All of these effects were reversible following an off-treatment period and attributable to pharmacology.
Danish: Alle disse virkninger var reversible efter en behandlingsfri periode og kan tilskrives den farmakologiske virkning.
English: Mekinist is a medicine that contains the active substance trametinib.
Danish: Mekinist er et lægemiddel, der indeholder det aktive stof trametinib.
English: Changes in your skin which may indicate new skin cancer Your doctor will check your skin before you start taking this medicine and regularly while you are taking it. Tell your doctor immediately if you notice any changes to your skin while taking this medicine or after treatment (see also section 4).
Danish: Ændringer i din hud, som kan være tegn på ny hudkræft Lægen vil undersøge din hud, inden du begynder at tage dette lægemiddel, og derefter regelmæssigt, så længe du tager det. Fortæl det straks til lægen, hvis du bemærker nogen ændringer i din hud, mens du tager dette lægemiddel eller efter behandlingen (se også punkt 4).
English: Your medicine targets proteins made from this mutated gene and slows down or stops the development of your cancer.
Danish: Dit lægemiddel er rettet mod proteiner, der er lavet fra dette muterede gen, og hæmmer eller stopper udviklingen af din kræft.
English: The median time to first presentation of ILD or pneumonitis was 160 days (range: 60 to 172 days).
Danish: Mediantiden til første forekomst af ILD eller pneumonitis var 160 dage (interval: 60 til 172 dage).
English: Pregnancy, breast-feeding and fertility Mekinist is not recommended for use during pregnancy.
Danish: Graviditet, amning og frugtbarhed Mekinist anbefales ikke under graviditet.
English: Rare side effects (may affect up to 1 in 1000 people) • A hole (perforation) in the stomach or intestines
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 personer): • et hul (perforation) i maven eller tarmene
English: o If it is less than 6 hours to your next scheduled dose of dabrafenib, which is taken twice daily.
Danish: o Hvis der er mindre end 6 timer til din næste planlagte dosis af dabrafenib, som tages to gange dagligt.
English: Fertility - both men and women Mekinist may impair fertility in both men and women.
Danish: Frugtbarhed - både mænd og kvinder Mekinist kan nedsætte frugtbarheden hos både mænd og kvinder.
English: Once opened, the bottle may be stored for 30 days at not more than 30°C.
Danish: Når beholderen er anbrudt, kan den opbevares i 30 dage ved temperaturer ikke højere end 30 °C.
English: Liver events were detected in clinical trials with monitoring every four weeks.
Danish: Leverpåvirkning blev registreret i kliniske studier med monitorering hver 4. uge.
English: The safety and efficacy of trametinib in non-Caucasian patients have not been established.
Danish: Trametinibs sikkerhed og virkning hos ikke-kaukasiske patienter er ikke klarlagt.
English: The majority of bleeding events were mild.
Danish: Størstedelen af blødningerne var lette.
English: Oncogenic mutations in BRAF lead to constitutive activation of the RAS/RAF/MEK/ERK pathway.
Danish: Onkogene mutationer i BRAF fører til konstitutiv aktivering af RAS/RAF/MEK/ERK-signalvejen.
English: For October 2011, 47% of subjects had crossed over, while for May 2013, 65% of subjects had crossed over.
Danish: I oktober 2011 havde 47 % af patienterne skiftet over, mens 65 % af patienterne havde skiftet over i maj 2013.
English: 1/10,000 to <1/1,000
Danish:  1/10.000 til < 1/1.000
English: Treatment naïve patients
Danish: Behandlingsnaive patienter
English: • If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: • Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
English: • if you are allergic to trametinib or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for trametinib eller et af de øvrige indholdsstoffer i Mekinist (angivet i punkt 6).
English: Because many medicinal products are excreted in human milk, a risk to the breast-feeding infant cannot be excluded.
Danish: Da mange lægemidler udskilles i human mælk, kan en påvirkning af det ammede spædbarn ikke udelukkes.
English: The safety and efficacy of trametinib have not been established in children and adolescents (<18 years).
Danish: Trametinibs sikkerhed og virkning hos børn og unge (< 18 år) er ikke klarlagt.
English:  Read the information “Possible serious side effects” in section 4 of this leaflet.
Danish:  Læs oplysningerne under “Alvorlige bivirkninger” i punkt 4 i denne indlægsseddel.
English: • have or have ever had lung or breathing problems.
Danish: • har eller nogensinde har haft lunge- eller vejrtrækningsproblemer.
English: Although smaller female subjects are predicted to have higher exposure than heavier male subjects, these differences are unlikely to be clinically relevant and no dosage adjustment is warranted.
Danish: Selvom mindre kvinder forventes at blive eksponeret i højere grad end tungere mænd, er det ikke sandsynligt, at disse forskelle er klinisk relevante, og der er derfor ikke grund til dosisjustering.
English: In melanoma and other cancers, this pathway is often activated by mutated forms of BRAF which activates MEK.
Danish: Ved melanom og andre cancerformer er denne pathway ofte aktiveret af muterede former af BRAF, hvilket aktiverer MEK.
English: Treatment with trametinib should only be initiated and supervised by a physician experienced in the administration of anti-cancer medicinal products.
Danish: Behandlingen med trametinib skal indledes og kontrolleres af en læge med erfaring i administration af lægemidler mod cancer.
English: Your doctor will check your skin before you start taking dabrafenib, then check it again every month while you are taking this medicine and for 6 months after you stop taking it.
Danish: Lægen vil undersøge din hud, inden du begynder at tage dabrafenib, og derefter undersøge den igen en gang om måneden, så længe du tager dette lægemiddel, og i 6 måneder efter, at du er holdt op med at tage det.
English: The trametinib dose should not exceed 2 mg once daily.
Danish: Dosis af trametinib bør ikke overstige 2 mg en gang daglig.
English: Physicians should be alert to the possibility of myocarditis in patients who develop new or worsening cardiac signs or symptoms.
Danish: Lægen bør være opmærksom på risikoen for myokarditis hos patienter, der udvikler nye eller forværrede kardielle tegn eller symptomer.
English: 3rd dose reduction (combination only)
Danish: 3. dosisreduktion (kun i kombination)
English: Extremadura, 3, 09400, Aranda De Duero, Burgos, Spain Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom
Danish: Extremadura, 3, 09400, Aranda De Duero, Burgos, Spanien Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, Storbritannien
English: Survival estimates at 1 and 2 years from randomisation were 97% and 91% in the combination arm and 94% and 83% in the placebo arm, respectively.
Danish: Estimater for overlevelse ved 1 og 2 år fra randomisering var henholdsvis 97 % og 91 % i kombinationsarmen og 94 % og 83 % i placebo-armen.
English: Continue treatment and monitor as clinically indicated.
Danish: Fortsæt behandlingen og monitorér som klinisk indiceret.
English: The tablets should not be chewed or crushed and they should be taken without food, at least 1 hour before or 2 hours after a meal.
Danish: Tabletterne må ikke tygges eller knuses og de skal tages uden mad, mindst 1 time før eller 2 timer efter et måltid.
English: Drug-drug interactions via these hydrolytic enzymes cannot be ruled out and could influence the exposure to trametinib.
Danish: Interaktioner mellem lægemidler via disse hydrolytiske enzymer kan ikke udelukkes og kan have indflydelse på eksponeringen af trametinib.
English: Hazard ratio is obtained from the stratified Pike model.
Danish: Hazard ratio stammer fra den stratificerede Pike-model.
English: Treatment for all patients continued until disease progression, death or withdrawal.
Danish: Alle patienter fik fortsat behandling indtil sygdomsprogression, dødsfald eller seponering.
English: • have had a different type of cancer other than melanoma or NSCLC, as you may be at greater risk of developing non-skin cancers when taking Mekinist.
Danish: • har haft en anden kræftform end malignt melanom eller NSCLC, da du vil have en større risiko for at udvikle andre kræftformer end hudkræft, når du tager Mekinist.
English: Keep the bottle tightly closed with the dessicant inside (small cylinder shaped container).
Danish: Hold beholderen tæt tillukket med tørremidlet indeni (lille cylinderformet beholder).
English: Table 14 Summary of efficacy in the combination treatment cohorts based on investigator and independent radiology review
Danish: Tabel 14 Resumé af effekt hos kohorterne med kombinationsbehandling baseret på investigatorvurdering og uafhængig radiologisk vurdering
English: An additional OS analysis was undertaken based upon the 20 May 2013 data cut, see Table 12.
Danish: Der blev foretaget en yderligere analyse af OS på basis af de data, hvor skæringen for dataindsamling var 20. maj 2013 (se tabel 12).
English: If trametinib is used during pregnancy, or if the patient becomes pregnant while taking trametinib, the patient should be informed of the potential hazard to the foetus.
Danish: Hvis trametinib anvendes under graviditet, eller hvis patienten bliver gravid under behandlingen med trametinib, skal patienten informeres om den potentielle risiko for fosteret.
English: No initial dose adjustment is required in patients >65 years of age.
Danish: Det er ikke nødvendigt at justere startdosis hos patienter > 65 år.
English: Mekinist can cause eye problems.
Danish: Mekinist kan give øjenproblemer.
English: Dose modification exceptions (where only one of the two therapies is dose reduced) for selected adverse reactions
Danish: Undtagelser i forbindelse med dosisjustering (hvor kun dosis af én af de to behandlinger reduceres) for udvalgte bivirkninger.
English: Mekinist can cause new or worsening high blood pressure (hypertension).
Danish: Mekinist kan give eller forværre allerede eksisterende højt blodtryk (hypertension).
English: Grade 2-3 RPED that does not improve to at least Grade 1 within 3 weeks
Danish: RPED af grad 2-3, der ikke bedres til mindst grad 1 inden for 3 uger
English: These checks are to detect if any other cancer, including squamous cell carcinoma, develops inside your body.
Danish: Disse undersøgelser har til formål at kontrollere, om der udvikles andre former for kræft, herunder pladecellekarcinom, inde din krop.
English: Baseline characteristics were balanced between treatment groups in the primary efficacy population and the ITT population.
Danish: Baseline-karakteristika var velbalanceret mellem behandlingsgrupperne i den primære effekt-population og ITT-populationen.
English: The clinical status of the patient and the adverse reaction profile should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor and cognitive skills.
Danish: Der skal tages hensyn til patientens kliniske status og bivirkningsprofilen i vurderingen af patientens evne til at udføre opgaver, som kræver dømmekraft, motoriske eller kognitive færdigheder.
English: • If you get side effects your doctor may decide that you should take lower doses of Mekinist and dabrafenib.
Danish: • Hvis du får bivirkninger, kan lægen beslutte, at du skal tage en lavere dosis af Mekinist og dabrafenib.
English: • Take Mekinist once daily and take dabrafenib twice daily.
Danish: • Tag Mekinist en gang dagligt, og tag dabrafenib to gange dagligt.
English: and BRF115532 (n=1,076)
Danish: BRF115532 (n=1.076)
English: Keep a list of the medicines you take, so you can show it to your doctor, nurse or pharmacist when you get a new medicine.
Danish: Hav en liste over de lægemidler, du tager, med dig, så du kan vise den til lægen, sundhedspersonalet eller apotekspersonalet, når du får et nyt lægemiddel.
English: • If you are a woman who could become pregnant, you must use reliable birth control (contraception) while you are taking Mekinist and for at least 16 weeks after you stop taking it.
Danish: • Hvis du er kvinde og kan blive gravid, skal du bruge en sikker præventionsmetode (svangerskabsforebyggende middel), mens du tager Mekinist, og i mindst 16 uger efter at du er holdt op med at tage det.
English: Mekinist can cause serious bleeding problems, especially in your brain or stomach.
Danish: Mekinist kan give alvorlige blødningsproblemer, specielt i din hjerne eller mave.
English: Drug-related material was excreted predominantly in the faeces (>80% of recovered radioactivity) and to a minor extent in urine (≤19%).
Danish: Lægemiddelrelaterede komponenter blev hovedsageligt udskilt via fæces (> 80 % af genfunden radioaktivitet) og i mindre grad via urinen (≤ 19 %).
English: 09400, Aranda de Duero
Danish: Extremadura, 3 09400, Aranda de Duero Burgos
English: 7 tablets 30 tablets
Danish: 7 tabletter 30 tabletter
English: The deacetylated metabolite was further metabolised by glucuronidation.
Danish: Den deacetylerede metabolit blev endvidere metaboliseret ved glukuronidering.
English: Grade 2-3 RPED that improves to Grade 0-1 within 3 weeks
Danish: RPED af grad 2-3, der bedres til grad 0-1 inden for 3 uger
English: a, BRF113928,
Danish: a, BRF113928 og