natgillin/translations-raw huggingface dataset:
Udvalget har fundet, at fordelene ved Forcaltonin er større end risiciene ved anvendelse til forebyggelse af knogletab i forbindelse med pludselig ubevægelighed, f.eks. ved nyligt knoglebrud som følge af knogleskørhed, samt til behandling af Pagets sygdom og til behandling af hyperkalcæmi ved ondartede sygdomme.
They decided that Forcaltonin’s benefits are greater than its risks for prevention of bone loss due to sudden immobilisation, such as in patients with recent bone fractures caused by osteoporosis (a disease that makes bones fragile), for treatment of Paget’s disease, and treatment of hypercalcaemia of malignancy.
Udvalget konkluderede at, fordelene ved Truvada opvejer risiciene og anbefalede udstedelse af markedsføringstilladelse.
The Committee concluded that Truvada’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget konkluderede derfor, at fordelene ved Activyl Tick Plus overvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The CVMP therefore concluded that the benefits of Activyl Tick Plus exceed the risks and recommended that it be given a marketing authorisation.
Udvalget konkluderede derfor, at fordelene ved Ameluz overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The Committee therefore concluded that the benefits of Ameluz are greater than its risks and recommended that it be granted marketing authorisation.
Udvalget konkluderede derfor, at fordelene ved Cholib overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse til anvendelse i EU.
The Committee therefore concluded that Cholib’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Udvalget konkluderede derfor, at fordelene ved Daklinza opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Committee therefore concluded that the benefits of Daklinza outweigh its risks and recommended that it be approved for use in the EU.
Udvalget konkluderede derfor, at fordelene ved Dexdor opvejer risiciene, og udvalget anbefalede udstedelse af markedsføringstilladelse for Dexdor.
The Committee therefore concluded that the benefits of Dexdor are greater than its risks and recommended that it be granted marketing authorisation.
Udvalget konkluderede derfor, at fordelene ved Esbriet er større end risiciene, og udvalget anbefalede udstedelse af markedsføringstilladelse for Esbriet.
It therefore decided that Esbriet’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget konkluderede derfor, at fordelene ved Exviera overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse i EU.
The Committee therefore concluded that the benefits of Exviera outweigh its risks and recommended that it be approved for use in the EU.
Udvalget konkluderede derfor, at fordelene ved lægemidlet opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Committee therefore concluded that the medicine’s benefits are greater than its risk and recommended that it be approved for use in the EU.
Udvalget konkluderede derfor, at fordelene ved Truberzi opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Committee therefore decided that Truberzi’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Udvalget konkluderede derfor, at fordelene ved Viekirax overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse i EU.
The Committee therefore concluded that the benefits of Viekirax outweigh its risks and recommended that it be approved for use in the EU.
Udvalget konkluderede derfor, at fordelene ved Xeplion er større end risiciene, og udvalget anbefalede udstedelse af markedsføringstilladelse for Xeplion.
The Committee decided that Xeplion’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget konkluderede derfor, at fordelene ved Zydelig opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Committee therefore concluded that Zydelig’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Udvalget konkluderede desuden, at alle patienters hjertefrekvens bør kontrolleres nøje efter den første dosis.
In addition, the Committee concluded that all patients should have their heart closely monitored after the first dose.
Udvalget konkluderede desuden, at Ivabradine Anpharm var effektivt ved langvarigt hjertesvigt og havde en acceptabel sikkerhedsprofil.
It also concluded that Ivabradine Anpharm was effective in long-term heart failure with an acceptable safety profile.
Udvalget konkluderede desuden, at undersøgelserne ved KOL tilfredsstillende påviste, at Relvar Ellipta, 92 /22 µg, havde en klinisk relevant virkning i form af nedsættelse af anfald med forværring af KOL.
The Committee also concluded that the data derived from the COPD studies adequately demonstrated that Relvar Ellipta 92 /22 microgram had a clinically relevant effect on the reduction of COPD flare-ups.
Udvalget konkluderede desuden, at undersøgelserne vedrørende KOL tilfredsstillende påviste, at Revinty Ellipta 92/22 µg havde en klinisk relevant virkning i form af nedsættelse af anfald med forværring af KOL.
The Committee also concluded that the data derived from the COPD studies adequately demonstrated that Revinty Ellipta 92 /22 microgram had a clinically relevant effect on the reduction of COPD flare-ups.
Udvalget konkluderede først, at fordelene ved Rivastigmine 1 A Pharma ikke opvejer risiciene til behandling af demens ved Parkinsons sygdom.
The Committee initially concluded that for the treatment of dementia due to Parkinson’s disease, Rivastigmine 1 A Pharma’s benefits did not outweigh its risks.
Udvalget konkluderede først, at fordelene ved Rivastigmine Hexal ikke opvejer risiciene til behandling af demens ved Parkinsons sygdom.
The Committee initially concluded that for the treatment of dementia due to Parkinson’s disease, Rivastigmine Hexal’s benefits did not outweigh its risks.
Udvalget konkluderede først, at fordelene ved Rivastigmine Sandoz ikke opvejer risiciene til behandling af demens ved Parkinsons sygdom.
The Committee initially concluded that for the treatment of dementia due to Parkinson’s disease, Rivastigmine Sandoz’s benefits did not outweigh its risks.
Udvalget konkluderede imidlertid, at fordelene ved lægemidlet opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Victrelis.
However, the Committee decided that the medicine’s benefits outweighed its risk and recommended that it be granted marketing authorisation.
Udvalget konkluderede imidlertid, at lægemidlet kun bør overvejes anvendt som »sidstevalgsbehandling«, når ingen andre proteasehæmmere forventes at virke.
However, it concluded that the medicine should only be considered for use as ‘last line’ therapy, when no other protease inhibitors are predicted to work.
Udvalget konkluderede oprindelig, at fordelene ved Exelon ikke opvejer risiciene ved behandling af demens som følge af Parkinsons sygdom.
The Committee initially concluded that for the treatment of dementia due to Parkinson’s disease, Exelon’s benefits did not outweigh its risks.
Udvalget konkluderede oprindelig, at fordelene ved Prometax ikke opvejer risiciene ved behandling af demens som følge af Parkinsons sygdom.
The Committee initially concluded that for the treatment of dementia due to Parkinson’s disease, Prometax’s benefits did not outweigh its risks.
Udvalget konkluderede på baggrund af de tilgængelige data, at fordelene ved PecFent opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for PecFent.
Based on available data, the Committee concluded that PecFent’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget konkluderede således, at fordelene ved Pravafenix opvejer risiciene for denne patientgruppe og anbefalede udstedelse af markedsføringstilladelse for Pravafenix.
The Committee therefore decided that Pravafenix’s benefits are greater than its risks in this group of patients and recommended that it be given marketing authorisation.
Udvalget konkluderede, at det også er effektivt hos børn.
The Committee concluded that it also was effective in children.
Udvalget konkluderede, at fordelene ved Atripla er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The Committee decided that Atripla’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget konkluderede, at fordelene ved Avaglim er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Avaglim.
The CHMP concluded that Avaglim’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget konkluderede, at fordelene ved Cerezyme er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The Committee decided that Cerezyme’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget konkluderede, at fordelene ved Cystadane opvejer risiciene, når det anvendes i henhold til indikationen som tillægsbehandling ved homocystinuri.
The committee decided that Cystadane’s benefits outweighed its risks in the adjunctive treatment of homocystinuria, when it is used according to its indication.
Udvalget konkluderede, at fordelene ved Glubrava opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Glubrava.
The Committee decided that Glubrava’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget konkluderede, at fordelene ved Ivabradine Anpharm overstiger risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Ivabradine Anpharm.
The Committee decided that Ivabradine Anpharm’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget konkluderede, at fordelene ved lægemidlet opvejer risiciene og anbefalede udstedelse af markedsføringstilladelse.
The Committee decided that the medicine’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget konkluderede, at fordelene ved Onduarp er større end risiciene, og anbefalede, at der blev udstedt markedsføringstilladelse for Onduarp.
The Committee decided that Onduarp’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget konkluderede, at fordelene ved Tepadina på baggrund af de tilgængelige publicerede oplysninger opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Tepadina.
The Committee decided that, based on available published information, Tepadina’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget konkluderede, at Imnovid er effektivt til at forsinke udviklingen af multipelt myelom hos patienter, hvis sygdom ikke reagerer på eller vender tilbage efter tidligere behandling, og som har meget begrænsede behandlingsmuligheder.
The Committee concluded that Imnovid is effective at delaying the progression of multiple myeloma in patients whose disease does not respond to or comes back after previous treatment, who have very limited treatment options.
Udvalget konkluderede, at lægemidlets effektivitet var påvist hos både ubehandlede og tidligere behandlede patienter, herunder dem med resistens mod integrasehæmmere.
The Committee concluded that the medicine had demonstrated its effectiveness in both untreated and previously treated patients, including those with resistance to integrase inhibitors.
Udvalget konkluderede, at virkningen af Xadago på det daglige tidsrum, hvor patienterne var uden bevægelsessymptomer, havde klinisk betydning, også sammenholdt med beskrivelser i litteraturen af virkningen af andre lægemidler mod Parkinsons sygdom.
The Committee concluded that the effect of Xadago on the daily time that patients lived without motor symptoms was of clinical relevance, also taking into account the response reported in the literature for other Parkinson’s medicines.
Udvalget konstaterede, at Cystadane ikke erstatter andre midler mod sygdommen.
The committee noted that Cystadane is not a substitute for other treatments.
Udvalget konstaterede, at den dobbelte kombination med ribavirin var effektiv mod kronisk infektion med hepatitis C-virus hos voksne og børn.
The Committee noted that the dual combination with ribavirin was shown to be effective against long- term hepatitis C virus infection in adults and children.
Udvalget konstaterede, at lægemidler som MACI i forvejen er velkendte i klinisk praksis, og at resultaterne af hovedundersøgelsen var i overensstemmelse med resultaterne fra den videnskabelige litteratur.
The Committee noted that treatments such as MACI are already established in clinical practice and that the results from the main study were consistent with results in the scientific literature.
Udvalget konstaterede, at Stocrin ikke er blevet tilstrækkelig undersøgt hos patienter med fremskreden sygdom (CD4-celletal under 50 celler/mm3) eller patienter, hos hvem protease-hæmmere (en anden type antiviral medicin) ikke har virket.
The Committee noted that Stocrin has not been studied adequately in patients with advanced disease (CD4 cell counts below 50 cells/mm3) or after treatment with protease inhibitors (another type of antiviral medicine) that was not working.
Udvalget konstaterede, at Sustiva ikke er tilstrækkelig undersøgt hos patienter med fremskreden sygdom (CD4-celletal under 50 celler/mm3) eller patienter, hos hvem protease-hæmmere (en anden type antiviral medicin) ikke har virket.
The Committee noted that Sustiva has not been studied adequately in patients with advanced disease (CD4 cell counts below 50 cells/mm3) or after treatment with protease inhibitors (another type of antiviral medicine) that was not working.
Udvalget mente, at Xgeva havde vist sig effektivt til forebyggelse af knoglerelaterede hændelser og var mindre giftigt for nyrerne og lettere at indgive end eksisterende behandlingsmuligheder.
The Committee considered that Xgeva was shown to be effective in preventing bone-related events and was less toxic to the kidneys and easier to administer than existing treatments.
Udvalget noterede sig også, at behandling med Firmagon ikke udløser den midlertidige bratte stigning i testosteronkoncentrationerne, som man ser med "GnRH-agonister" (andre lægemidler mod prostatakræft, som stimulerer produktionen af GnRH).
The Committee also noted that treatment with Firmagon does not trigger the temporary sharp rise in testosterone levels seen with ‘GnRH agonists’ (other medicines for prostate cancer that stimulate the production of GnRH).
Udvalget noterede sig, at Nimenrix i forhold til konventionelle vacciner havde den fordel at være konjugeret, inklusive at fremkalde en kraftig immunreaktion hos små børn.
The Committee noted that Nimenrix offered the benefits of conjugated vaccines over conventional vaccines, including producing a strong immune response in young children.
Udvalget nævnte desuden, at der er et udækket behandlingsbehov hos disse patienter.
The Committee also acknowledged that there is an unmet medical need for these patients.
Udvalget var af den opfattelse, at skønt kun en lille andel af patienterne med Cushings sygdom reagerede på behandlingen og fik normalt kortisolindhold i urinen, kunne Signifor være til fordel for patienter, hos hvem operation ikke havde givet tilfredsstillende resultat eller ikke var mulig.
The Committee took the view that, although the proportion of patients with Cushing’s disease who responded and whose cortisol levels in the urine normalised was small, Signifor could be of benefit in patients who have failed surgery or where surgery is not an option.
Udvalget var derfor af den opfattelse, at fordelene ved Atriance opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
Therefore, the Committee decided that Atriance’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget var derfor af den opfattelse, at fordelene ved Exelon opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
Therefore, the Committee decided that Exelon’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget var derfor af den opfattelse, at fordelene ved HBVaxPro opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
Therefore, the Committee decided that HBVaxPro’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget var derfor af den opfattelse, at fordelene ved Myocet opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
Therefore, the Committee decided that Myocet’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget var derfor af den opfattelse, at fordelene ved Nimenrix opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
Therefore, the CHMP decided that the benefits of Nimenrix are greater than its risks and recommended that it be granted marketing authorisation.
Udvalget var derfor af den opfattelse, at fordelene ved Prometax opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
Therefore, the Committee decided that Prometax’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget var derfor af den opfattelse, at fordelene ved Rivastigmine 1 A Pharma opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
Therefore, the Committee decided that Rivastigmine 1 A Pharma’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget var derfor af den opfattelse, at fordelene ved Rivastigmine Hexal opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
Therefore, the Committee decided that Rivastigmine Hexal’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget var derfor af den opfattelse, at fordelene ved Rivastigmine Sandozopvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
Therefore, the Committee decided that Rivastigmine Sandoz’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Udvalget var også af den opfattelse, at fordelene ved Invega havde vist sig at opveje risiciene ved behandling af skizofreni hos unge fra 15 års alderen.
The Committee also considered that the benefits of Invega had been shown to be greater than its risks in the treatment of schizophrenia in adolescents from 15 years of age.
Udvalget var også af den opfattelse, at fordelene ved Truvada var påvist til profylakse før eksponering, men beskyttelsesniveauet afhænger af, hvor gode personerne er til at holde sig til den anbefalede dosisplan.
The Committee also considered that the benefit of Truvada has been shown for pre-exposure prophylaxis but the level of protection depends on how well individuals stick to the recommended dose schedule.
Udvalgte behandlingsrelaterede klinisk abnorme laboratorieværdier (af grad 3 eller 4), der blev betragtet som bivirkninger, og som blev rapporteret hos EDURANT-behandlede patienter, var forhøjede pankreas-amylaser (3,8 %), forhøjet ASAT (2,3 %), forhøjet ALAT (1,6 %), forhøjet LDL- kolesterol (fastende, 1,5 %), fald i leukocyttal (1,2 %), forhøjet lipase (0,9 %), forhøjet bilirubin (0,7 %), forhøjede triglycerider (fastende, 0,6 %), fald i hæmoglobin (0,1 %), fald i trombocyttal (0,1 %) og forhøjet totalkolesterol (fastende, 0,1 %).
Selected treatment emergent clinical laboratory abnormalities (grade 3 or grade 4), considered as ADRs, reported in EDURANT treated patients were increased pancreatic amylase (3.8%), increased AST (2.3%), increased ALT (1.6%), increased LDL cholesterol (fasted, 1.5%), decreased white blood cell count (1.2%), increased lipase (0.9%), increased bilirubin (0.7%), increased triglycerides (fasted, 0.6%), decreased haemoglobin (0.1%), decreased platelet count (0.1%), and increased total cholesterol (fasted, 0.1%).
Udvalgte bivirkninger
Selected adverse drug reactions
Udvalgte bivirkninger, der blev rapporteret ved den anbefalede startdosis på 140 mg 1 gang dagligt, er vist i Tabel 3b.
Selected adverse reactions that were reported in the recommended starting dose of 140 mg once daily are shown in Table 3b.
Udvalgte karakteristika for demografi og sygdom ved baseline er vist i tabel 4.
Selected demographic and baseline disease characteristics are displayed in Table 1.
Udvalgte unormale laboratorieværdier, der er opstået under behandlingen
Selected treatment emergent laboratory abnormalities
Udvaskning skal fortsættes indtil klart (lyserødt, gennemsigtigt) venøst udløb er opnået.
Wash-out should continue until a clear (pink, transparent) venous outflow is obtained.
Udvaskningsprocedure:
Washout procedure
Udvendig karton til 1 (eller 5) hætteglas med blue box
Outer carton 1 (or 5) vials including blue box
UDVENDIG ÆSKE TIL 12 MG PAKNING
OUTER CARTON FOR 12 MG PACK
UDVENDIG ÆSKE TIL 4 MG PAKNING
OUTER CARTON FOR 4 MG PACK
Udvendige genitale vorter
External genital warts:
Udvendige vorter ved kønsorganer og endetarmsåbning (Condyloma acuminata) hos voksne
External genital and perianal warts (condylomata acuminata) in adults.
Udvendigt materiale: karton
Cardboard Outer
udvidede pupiller
dilated pupil
udvidede pupiller misfarvet afføring.
dilated pupils discoloured stools.
Udvidede pupiller, skeløjethed .
Dilated pupils, cross eyes
Udvidede pupiller, skeløjethed .
Dilated pupils, cross eyes.
Udvidede pupiller, skeløjethed.
Dilated pupils, cross eyes.
Udvidelse af blodkar og hjertebanken
Dilatation of the blood vessels and palpitation
Udvidelse af blodkar, lavt blodtryk, når du rejser dig op fra siddende eller liggende stilling (postural hypotension)
Widening of blood vessels, low blood pressure when you stand up from sitting or lying down (postural hypotension)
udvidelse) (N=63)
Expansion) (N=63)
Udvidet leverfibrosepanel (ELF), Fibrometer, ASAT/ALAT-forhold, Fib-4-score, Fibrotest (leverfibrose)
Enhanced Liver Fibrosis (ELF) panel, Fibrometer, AST/ALT ratio, Fib-4 score, Fibrotest (liver fibrosis).
Udvidet og hyppig monitorering for vejrtræknings- depression og andre opioid- relaterede bivirkninger anbefales.
Extended and frequent monitoring for respiratory depression and other opiate-associated adverse reactions is recommended.
Udvikle en PCV-fri vaccine jf. implementeringsplanen aftalt med CHMP.
Develop a PCV-free vaccine according to the implementation plan agreed with CHMP.
udviklede alvorlig bivirkning (5,4% vs 0%), inklusive KOL-exacerbation (1 ud af 37 patienter [2,7%]) og bronkitis (1 ud af 37 patienter [2,7%]).
0%), including COPD exacerbation (1 of 37 patients [2.7%]) and bronchitis (1 of 37 patients [2.7%]).
udvikler alvorlig diarré eller kaster op, da disse forhold kan begrænse effektiviteten af dette lægemiddel. har en unormal hjerterytme (ved ekg) i form af et såkaldt langt QTc-interval.
develop severe diarrhoea or vomiting, as these conditions may limit the effectiveness of this medicine. have an abnormal heart rhythm tracing (ECG) that shows a problem called long QTc interval
Udvikler diffust hududslæt eller blistre i munden.
Develop a diffuse skin rash or blisters in your oral cavity.
udvikler en blodprop i en arterie
develop a blood clot in your arteries
udvikler et hul i tarmvæggen
develop a hole in the wall of your gut
udvikler forhøjet blodtryk, indtil det er bragt under kontrol med blodtrykssænkende medicin
develop high blood pressure, until it is controlled with anti-hypertensive medicine
udvikler problemer med sårheling, indtil såret er helet, eller inden en planlagt operation skal have en planlagt operation, 4 uger før operationen
develop wound healing problems, until the wound is healed will undergo planned surgery, four weeks prior to surgery
Udvikles tegn eller symptomer på lokal irritation, skal injektionen eller infusionen afbrydes og startes påny i en anden vene.
If signs or symptoms of local irritation occur, the injection or infusion should be terminated and restarted in another vein.