FrancophonIA/ELRC3.0 huggingface dataset:
English: CI = confidence interval, FOLFIRI = irinotecan plus infusional 5-FU/FA, ORR = objective response rate (patients with complete response or partial response), OS = overall survival time, PFS = progression-free survival time
Danish: CI = confidence interval, konfidensinterval, FOLFIRI irinotecan plus 5-FU/FA-infusion, ORR = objective response rate (patienter med komplet respons eller delvis respons), OS = overlevelsestid, PFS = progressionsfri overlevelsestid
English: • EMR 62 202-047: This randomised study in patients with metastatic colorectal cancer who had not received prior treatment for metastatic disease compared the combination of cetuximab and oxaliplatin plus continuous infusional 5-fluorouracil/folinic acid (FOLFOX4) (169 patients) to the same chemotherapy alone (168 patients).
Danish: • EMR 62 202-047: Dette randomiserede studie med patienter med metastatisk kolorektal cancer, som ikke tidligere havde fået behandling for metastatisk sygdom, sammenlignede kombinationen af cetuximab og oxaliplatin plus kontinuerlig 5-fluoruracil/folinsyre-infusion (FOLFOX4) (169 patienter) med den samme kemoterapibehandling uden cetuximab (168 patienter).
English: • nail disorders, for example inflammation of the nail bed
Danish: • neglesygdomme, f.eks.betændelse i negleroden
English: Each vial of 100 mL contains 500 mg cetuximab.
Danish: Hvert hætteglas med 100 ml indeholder 500 mg cetuximab.
English: OS months, median (95% CI) Hazard Ratio (95% CI) p-value PFS months, median (95% CI) Hazard Ratio (95% CI) p-value Best overall response rate
Danish: OS måneder, median (95% CI) Hazard ratio (95% CI) p-værdi PFS måneder, median (95% CI) Hazard ratio (95% CI) p-værdi Bedste samlede responsrate
English: OS months, median (95% CI) Hazard Ratio (95% CI) p-value PFS months, median (95% CI) Hazard Ratio (95% CI) p-value ORR
Danish: OS måneder, median (95% CI) Hazard ratio (95% CI) p-værdi PFS måneder, median (95% CI) Hazard ratio (95% CI) p-værdi ORR
English: How to store Erbitux
Danish: Sådan får du Erbitux
English: Handling instructions
Danish: Håndteringsinstruktioner
English: No non-clinical data on the effect of cetuximab on wound healing are available to date.
Danish: Der findes til dato ingen prækliniske data om af cetuximabs virkning på sårheling.
English: 1.5 to 6.2 L/m2).
Danish: 4.4 og 5.1).
English: • COIN: This was an open-label, 3-arm, randomised study in 2445 patients with inoperable metastatic or locoregional colorectal cancer who had not received prior treatment for metastatic disease and compared oxaliplatin plus fluoropyrimidines (infusional 5-fluorouracil/folinic acid [OxMdG] or capecitabine [XELOX]) in combination with cetuximab to the same chemotherapy regimen alone.
Danish: • COIN: Dette var et randomiseret, 3-armet, open-label studie med 2.445 patienter med inoperabel metastatisk eller locoregional kolorektal cancer, som ikke tidligere havde fået behandling for metastatisk sygdom.
English: • heart failure
Danish: • hjertestop
English: BSC
Danish: CTX
English: Therefore, if you experience general signs of infection such as fever and tiredness, please speak to a doctor immediately.
Danish: Derfor skal du omgående tale med lægen, hvis du får generelle tegn på infektion, som f.eks. feber og træthed.
English: Please read 'Infusion-related side effects' in section 4 for details, as they may have serious consequences for you, including life-threatening conditions.
Danish: 4 for at få yderligere oplysninger, da disse bivirkninger kan have alvorlige konsekvenser for dig og endda være livstruende.
English: Radiation therapy + cetuximab
Danish: Variabel/statistik Strålebehandling plus cetuximab
English: What Erbitux is and what it is used for What you need to know before you use Erbitux How to use Erbitux
Danish: Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du fårbrugeErbitux Sådan fårduErbitux
English: • chest pain
Danish: • skaldende hud
English: • inflammation of the lining of the intestine and mouth
Danish: • betændelse i tarmens og mundhulens slimhinder
English: CI = confidence interval, FOLFOX4 = oxaliplatin plus continuous infusional 5-FU/FA, ORR = objective response rate (patients with complete response or partial response), OS = overall survival time, PFS = progression-free survival time, NE = not estimable
Danish: (95% CI) Oddsrate (95% CI) p-værdi CI = confidence interval, konfidensinterval, FOLFOX4 = oxaliplatin plus kontinuerlig 5-FU/FA-infusion, ORR = objective response rate (patienter med komplet respons eller delvis respons), OS = overlevelsestid, PFS = progressionsfri overlevelsestid, NE = kan ikke estimeres
English: • chills
Danish: • kløe
English: They generally resolve, without sequelae, over time following cessation of treatment if the recommended adjustments in dose regimen are followed (see section 4.4).
Danish: 4.4), heler hudreaktionerne generelt uden mén efter nogen tid, når behandlingen ophører.
English: Skin reactions
Danish: Hudreaktioner
English: MA (EU) number (Invented) name
Danish: MA (EU)-nummer
English: 1 pre-filled pen + 7 NovoFine Plus needles
Danish: 1 fyldt pen + 7 NovoFine Plus nåle
English: 1 pre-filled pen + 7 NovoTwist needles
Danish: 1 fyldt pen + 7 NovoTwist nåle
English: 1 pre-filled pen + 7 NovoFine needles
Danish: 1 fyldt pen + 7 NovoFine nåle
English: These concerns were raised with the applicant during the procedure but were never adequately addressed.
Danish: Disse forbehold blev rejst over for ansøgeren under proceduren, men blev aldrig tilfredsstillende besvaret.
English: The applicant addressed specifically the CHMP´s four initial principal grounds for refusal:
Danish: Ansøgeren henviste specifikt til CHMP´s fire indledende hovedgrunde til afslag:
English: Overall summary of the scientific evaluation of Qsiva
Danish: Samlet resumé af den videnskabelige vurdering af Qsiva
English: However, no additional weight loss was seen in the second year, rather there was a mean weight gain in all groups.
Danish: I det andet år sås imidlertid ikke yderligere vægttab, snarere en gennemsnitlig vægtforøgelse i alle grupper.
English: The overall quality of the medicinal product was considered acceptable by the CHMP.
Danish: Lægemidlets samlede kvalitet blev anset for acceptabel af CHMP.
English: It is only being approved for short term periods of treatment (less than three months) and its long term cardiac toxicity is unknown.
Danish: Det er kun godkendt til kortvarig behandling (under 3 måneder), og dets langsigtede kardiale toksicitet er ukendt.
English: The CHMP considered the following:
Danish: The CHMP behandlede følgende punkter:
English: • Quality issues
Danish: • Kvalitetsspørgsmål
English: as the safety of the above mentioned medicinal product was not sufficiently demonstrated, the applicant submitted detailed grounds for the re-examination of the grounds for refusal.
Danish: og eftersom sikkerheden af ovennævnte lægemiddel ikke var tilfredsstillende godtgjort, forelagde ansøgeren en detaljeret begrundelse for fornyet overvejelse af begrundelsen for afslaget.
English: Therefore, the CHMP has recommended the refusal of the granting of the marketing authorisation for Qsiva.
Danish: CHMP anbefalede derfor afslag på ansøgning om udstedelse af markedsføringstilladelse for Qsiva.
English: Grounds for re-examination
Danish: Begrundelse for fornyet overvejelse
English: In addition, patient registry and drug utilization study was proposed to be conducted to repeatedly evaluate the effectiveness of these measures.
Danish: Derudover blev det foreslået at foretage en undersøgelse af patientregistrering og medicinforbrug med løbende evaluering af effektiviteten af disse foranstaltninger.
English: Although these showed no obvious increased frequency of events with treatment, the data are of limited value as the duration of follow-up was relatively short and the total number of events was small.
Danish: Skønt værdierne ikke viste, at behandlingen var forbundet med et klart øget antal hændelser, er dataene af begrænset værdi, da opfølgningsvarigheden var relativt kort og det samlede antal hændelser lille.
English: The proposed removal of the top dose for the use of Qsiva does not alleviate the concerns.
Danish: Den påtænkte udeladelse af den højeste dosis ved anvendelse af Qsiva afhjælper ikke betænkelighederne.
English: Treatment with Qsiva 7.5/46 mg and 15/92 mg for 28 and 56 weeks resulted in clinically relevant reductions of body weight, with a maximum effect after approx. 36-40 weeks of treatment.
Danish: Ved behandling med Qsiva, 7,5/46 mg og 15/92 mg i 28 og 56 uger opnåedes klinisk relevant reduktion af legemsvægten med maksimal virkning efter ca. 36-40 ugers behandling.
English: The specification of the finished product was to be revised based on the batch data results and a second identity test method included for each drug substance.
Danish: Specifikationerne for det færdige produkt skulle revideres på grundlag af batchresultaterne, og der skulle indføres en supplerende metode til identitetstest for hvert lægemiddelstof.
English: With regard to reported cases of suicidal ideation in patients treated with Qsiva during the clinical studies, regular assessments in this regard would be required.
Danish: For de indberettede tilfælde af selvmordstanker hos patienter behandlet med Qsiva under de kliniske undersøgelser ville dette kræve regelmæssige vurderinger.
English: However, due to the voluntary nature of the registry the expected participation was considered to be low and hence its capacity to minimise off-label use remained uncertain.
Danish: Som følge af registerets frivillige art blev den forventede tilslutning imidlertid anset for at være for lav, hvorfor der er usikkerhed om dets evne til at minimere ikke godkendt anvendelse.
English: A meta-analysis of cardiovascular events showed the population studied to be at a low risk of cardiovascular events.
Danish: En metaanalyse af kardiovaskulære hændelser viste, at den undersøgte population havde lav risiko for kardiovaskulære hændelser.
English: Outcomes using various accepted MACE composite endpoints in the Qsiva programme showed no increase in risk for any of these endpoints compared to placebo (hazard ratios <1.0).
Danish: Baseret på forskellige anerkendte sammensatte MACE-endepunkter i Qsiva-programmet viste udfaldene ingen øget risiko for nogen af disse endepunkter ved sammenligning med placebo (alle risikoforhold <1,0).
English: The CHMP is of the opinion that pursuant to Article 12 of Regulation (EC) No 726/2004, the safety of the above mentioned medicinal product is not properly or sufficiently demonstrated.
Danish: anser CHMP's ikke sikkerheden af ovennævnte lægemiddel dokumenteret på passende og tilstrækkelig vis i overensstemmelse med artikel 12 i forordning (EF) nr. 726/2004.
English: Topiramate is known as a teratogenic substance causing congenital malformations.
Danish: Topiramat er kendt som et teratogent stof, der forårsager medfødte misdannelser.
English: The proposed patient registry was considered a key component to gather long term data on the safety of Qsiva and on the effectiveness of the risk minimisation measures, especially in relation to off-label use.
Danish: Det foreslåede patientregister blev anset for en central komponent i indsamlingen af langtidsdata om sikkerheden af Qsiva og om effektiviteten af risikominimeringsforanstaltningerne, navnlig vedrørende ikke godkendt anvendelse.
English: The applicant presented in their submission the following grounds for re-examination:
Danish: Ansøgeren fremlagde følgende begrundelse for fornyet overvejelse:
English: The magnitude of the weight loss was larger compared to previously approved weight reducing agents.
Danish: Vægttabet var større end med tidligere godkendte vægtreducerende midler.
English: The frequency of adverse psychiatric effects and their consequences, in particular resulting from the topiramate component, is unknown in the setting of long term use of this product in a large population.
Danish: 2. hyppigheden af psykiatriske bivirkninger og konsekvenserne heraf, navnlig forårsaget af topiramatkomponenten, er ukendt ved langtidsanvendelse af produktet hos en stor population.
English: The probability of off-label use of this product outside the population covered by the claimed indication is expected to be high.
Danish: 4. der må forventes høj sandsynlighed for ikke-godkendt anvendelse af produktet uden for den population, der er omfattet af den ansøgte indikation.
English: Existing data from phentermine use has major limitations and cannot be extrapolated with regard to conclusions on the safety profile of Qsiva.
Danish: De foreliggende data om anvendelse af phentermin har væsentlige begrænsninger og kan ikke ekstrapoleres, så der kan drages konklusioner om Qsivas sikkerhedsprofil.
English: Importantly, there were no increases in major depression diagnoses (by PHQ-9 questionaire), emergent antidepressant use, or suicidality (by C-SSRS questionaire) in the programme.
Danish: Det bør tillægges vægt, at der ikke var stigning i antallet af diagnoser med svær depression (ved PHQ-9-spørgeskema), i initieret behandling med antidepressiva eller i suicidalitet (i henhold til C-SSRS-spørgeskema) i programmet.
English: With regard to the general safety profile, the applicant pointed out that Qsiva is a combination of two approved drugs with long histories of use at higher doses and well established safety profiles of both components.
Danish: Vedrørende den overordnede sikkerhedsprofil påpegede ansøgeren, at Qsiva er en kombination af to godkendte lægemidler med lang tids anvendelse i højere dosering og med en velkendt sikkerhedsprofil for begge komponenters vedkommende.
English: In the setting of long term use of this product in a large population, the frequency of adverse psychiatric effects and their consequences, as well as the cognitive effects, are unknown.
Danish: Ved langtidsanvendelse af produktet i en stor population er hyppigheden af psykiske bivirkninger og konsekvenserne heraf ukendt, hvilket ligeledes gælder de kognitive virkninger.
English: The effect was similar in examined subpopulations, but experience in older subjects and patients with cardiovascular disease was very limited.
Danish: Virkningen var ens hos de undersøgte underpopulationer, dog med meget begrænsede erfaringer hos ældre og patienter med kardiovaskulær sygdom.
English: Even though there was no overall signal of an increased risk of cardiovascular events in the studies, the consequences of an increased heart rate in subjects with history of, or with ongoing cardiovascular disease, are unknown.
Danish: Skønt der samlet ikke var signaler om øget risiko for kardiovaskulære hændelser i undersøgelserne, savnes der viden om konsekvenserne af øget hjertefrekvens hos personer med tidligere eller nuværende kardiovaskulær sygdom.
English: Many of these adverse events were also reported with Qsiva as a fixed-dose combination of phentermine/topiramate in four pivotal Phase III studies and two supportive Phase II studies.
Danish: Mange af disse bivirkninger blev også indberettet med phentermin/topiramat som fastdosiskombinationen Qsiva i fire fase III-hovedundersøgelser og to støttende fase II-undersøgelser.
English: In addition, the cognitive effects of such combination during long term treatment remain uncertain in absence of adequate studies;
Danish: Der er desuden fortsat usikkerhed om de kognitive bivirkninger ved langtidsbehandling med en sådan kombination, da der savnes fyldestgørende undersøgelser,
English: The CHMP further considered that restricting prescribing to clinical settings where prescribing decisions can be informed by a multi-disciplinary clinical team that can assess both the physical and mental health of the patients and the appropriateness of treatment with Qsiva could help minimise the risks but had concerns about the feasibility of this practice in all EU member states.
Danish: CHMP fandt endvidere, at begrænsning af ordinationen til kliniske omgivelser, hvor ordinationerne kan baseres på information fra et tværfagligt klinisk team, der både kan vurdere patienternes fysiske og psykiske helbred og egnethed til behandling med Qsiva, kunne medvirke til at minimere risiciene, men havde forbehold omkring den praktiske gennemførlighed heraf i alle EU's medlemsstater.
English: Teratogenic risk - CHMP agreed that the risk from the teratogenic potential of Qsiva might be mitigated through the implementation of appropriate risk minimisation measures, which include a Pregnancy Prevention Plan (PPP), the principles of which should be consistent with that agreed across the EU for isotretinoin in 2003.
Danish: Teratogen risiko - CHMP tilsluttede sig, at risikoen ved det teratogene potentiale af Qsiva kunne afbødes ved gennemførelse af passende risikominimeringsforanstaltninger, herunder en plan for svangerskabsforebyggelse (PPP), i princippet svarende til den, der i 2003 blev godkendt i hele EU for isotretinoin.
English: Reduction of weight can be assumed as surrogate parameter for a beneficial cardiovascular (CV) outcome and current EMA guidance on medicinal products used in weight control does not require demonstration of a positive effect on CV morbidity and mortality prior to approval.
Danish: Vægtreduktion kan betragtes som en surrogatparameter for gavnlige kardiovaskulære udfald, og den gældende EMAvejledning om lægemidler til vægtkontrol kræver ikke, at der påvises positiv virkning på kardiovaskulær morbiditet og mortalitet før godkendelse.
English: The proposed RMP was assessed at the request of the CHMP by the Pharmacovigilance Risk Assessment Committee (PRAC).
Danish: Den foreslåede risikostyringsplan blev på anmodning af CHMP vurderet af Det Rådgivende Udvalg for Risikovurdering inden for Lægemiddelovervågning.
English: Psychiatric safety - Although there was an increase in reports of psychiatric and cognitive symptoms with the top-dose of Qsiva, the majority of these events were of mild severity, occurred early in treatment, resolved spontaneously or with discontinuation of study drug.
Danish: Psykiatrisk sikkerhed - Skønt der var en stigning i indberetningerne om psykiske og kognitive symptomer ved den højeste dosis af Qsiva, var størstedelen af disse hændelser af let sværhedsgrad, forekom tidligt i behandlingsforløbet og svandt spontant eller ved seponering af forsøgslægemidlet.
English: Dropout rates for depression with Qsiva significantly outnumbered those with placebo; thus close surveillance in trials may have stopped progression to more severe symptoms.
Danish: Frafaldsprocenterne som følge af depression var væsentligt større med Qsiva end med placebo; derfor kan den tætte overvågning i undersøgelserne have standset progression til sværere symptomer.
English: Phentermine as amphetamine-like substance has a well known drug abuse potential.
Danish: Phentermin er et amfetaminlignende stof med velkendt misbrugspotentiale.
English: Psychiatric safety -Depression, anxiety and cognitive impairment were more commonly reported in patients treated with Qsiva than placebo.
Danish: Psykiatrisk sikkerhed - Der blev oftere indberettet depression, angst og kognitiv hæmning for patienter behandlet med Qsiva end med placebo.
English: In the view of the CHMP, any increase in heart rate can remain a concern with regard to CV risk.
Danish: Efter CHMP's opfattelse kan enhver forøgelse af hjertefrekvensen give anledning til fortsat betænkelighed vedrørende den kardiovaskulære risiko.
English: The applicant presented in writing and at an oral explanation their grounds that the adopted CHMP Opinion may not have considered the data fully and also provided further analyses to support the clinical safety of Qsiva in the proposed indication.
Danish: Ansøgeren forelagde skriftligt og ved en mundtlig fremlæggelse sin begrundelse for, at den vedtagne CHMP-udtalelse muligvis manglede at tage alle data i betragtning, og fremlagde derudover yderligere analyser til støtte for den kliniske sikkerhed af Qsiva til den ansøgte indikation.
English: Additionally, the Committee noted that the actual patient numbers treated with the recommended mid dose were limited.
Danish: Endvidere bemærkede udvalget, at den anbefalede mellemste dosis kun var anvendt til et begrænset antal patienter.
English: Reported rates for most CNS-related side effects were similar between the mid-dose and placebo.
Danish: Den indberettede hyppighed var for størstedelen af CNS-relaterede bivirkninger ens i grupperne på mellemste dosis og placebo.
English: Cardiovascular safety - According to the applicant, the only concern about a potential increase in CV risk arises from a small (1.6 bpm) dose-related increase in heart rate that differed significantly from placebo only with the top-dose, but not for the mid-dose, whereas blood pressure was consistently and significantly reduced by both the mid- and top-doses of Qsiva.
Danish: Kardiovaskulær sikkerhed - i henhold til ansøgeren beror den eneste betænkelighed ved en potentiel stigning i kardiovaskulær risiko på en lille dosisrelateret stigning i hjertefrekvens (1,6 slag/min), der kun afveg lidt fra placebo ved den højeste dosering, men ikke ved den mellemste, hvorimod blodtrykket vedholdende var væsentligt reduceret ved både den mellemste og højeste dosering af Qsiva.
English: While the CHMP acknowledged that this could improve the benefit/risk ratio, CHMP concluded that the proposed removal of the high dose from the application did not sufficiently alleviate the concerns of the CHMP both with regard to the psychiatric and cardiovascular safety profile (see points above), which remains for the lower doses.
Danish: Skønt CHMP tilsluttede sig, at dette kunne forbedre benefit/risk-forholdet, konkluderede udvalget, at den påtænkte udeladelse af den høje dosis fra ansøgningen ikke i fornøden grad ophævede de tilbagestående betænkeligheder vedrørende de lavere doser hverken for den psykiatriske eller den kardiovaskulære sikkerhedsprofil (se ovenstående punkter).
English: There was a dose-dependent increase in the incidence of depression (3.8% in the mid dose group vs. 7.7% in the highest dose group, with 3.4% in the placebo group), anxiety (4.8% vs. 7.9%, respectively, with 2.6% in the placebo group), insomnia (6.8% vs. 10.8%, respectively, with 5.7% in the placebo group), paraesthesia (11.8% vs. 17.3%, respectively, with 1.2% in the placebo group) and cognitive disorders (5.0% vs. 7.6%, respectively, with 1.5% in the placebo group; mainly attention disturbances, memory impairment and language disorders).
Danish: Der var en dosisafhængig stigning i forekomsten af depression (3,8 % i den midterste dosisgruppe og 7,7 % i den højeste dosisgruppe, mod 3,4 % i placebogruppen), angst (henholdsvis 4,8 % og 7,9 %, mod 2,6 % i placebogruppen), insomni (henholdsvis 6,8 % og 10,8 %, mod 5,7 % i placebogruppen), paræstesi (henholdsvis 11,8 % og 17,3 %, mod 1,2 % i placebogruppen) samt kognitive forstyrrelser (henholdsvis 5,0 % og 7,6 %, mod 1,5 % i placebogruppen, hovedsagelig bestående i opmærksomhedsforstyrrelser hukommelsesbesvær og sproglige forstyrrelser).
English: The applicant further cited supportive CV safety data from published results of clinical studies with other sympathomimetic agents in other indications and from historical data with phentermine.
Danish: Ansøgeren henholdt sig desuden til støttende kardiovaskulære sikkerhedsdata fra offentliggjorte resultater af kliniske undersøgelser med andre sympatomimetika til andre indikationer samt fra historiske data med phentermin.
English: The Applicant presented hazard ratios for major cardiovascular events in Qsiva-treated subjects.
Danish: Ansøgeren forelagde risikoforholdværdier for alvorlige kardiovaskulære hændelser hos personer behandlet med Qsiva.
English: Further stability studies on PHEN beads and TPM beads stored in bulk were necessary in order to support a start of the shelf-life at the time of capsule filling.
Danish: Der krævedes yderligere stabilitetsundersøgelser af pellets af PHEN og pellets af TPM ved opbevaring i bulk som forudsætning for, at holdbarhedstiden blev beregnet fra tidspunktet for ifyldning i kapslerne.