natgillin/translations-raw huggingface dataset:
Sikkerhedspopulationen for Gilenya stammer fra to fase-III placebokontrollerede kliniske studier og et fase-III aktivt kontrolleret studie hos patienter med recidiverende-remitterende multipel sklerose.
The safety population of Gilenya is derived from two Phase III placebo-controlled clinical studies and one Phase III active-controlled clinical study in patients with relapsing remitting multiple sclerosis.
Sikkerhedsprocedurerne i lufthavnene og flyselskabernes regler ændres fra tid til anden, så derfor er det bedst, at du forhører dig om særlige regler hos lufthavnsmyndighederne og flyselskabet.
Airport security procedures and airline policies change from time to time, so it’s best to check with airport authorities and the airline for any special rules.
Sikkerhedsprofilen af avanafil er baseret på 2.436 personer, der er blevet eksponeret for avanafil under det kliniske udviklingsprogram.
The safety profile of Spedra is based on 2436 subjects exposed to avanafil during the clinical development program.
Sikkerhedsprofilen af busulfan i kombination med fludarabin (FB) er blevet undersøgt via en gennemgang af bivirkninger indrapporteret i publicerede data fra kliniske studier med RIC-regimet.
The safety profile of busulfan combined with fludarabine (FB) has been examined through a review of adverse events reported in published data from clinical trials in RIC regimen.
Sikkerhedsprofilen af dronedaron 400 mg to gange daglig hos patienter med atrieflimren (AF) eller atrieflagren (AFL) er baseret på 5 placebokontrollerede studier, hvor 6285 patienter blev randomiseret (3282 patienter modtog 400 mg dronedaron to gange daglig, og 2875 modtog placebo).
The safety profile of dronedarone 400 mg twice daily in patients with atrial fibrillation (AF) or atrial flutter (AFL) is based on 5 placebo controlled studies, in which a total of 6,285 patients were randomised (3,282 patients received dronedarone 400 mg twice daily, and 2,875 received placebo).
Sikkerhedsprofilen af Feraccru anses for acceptabel med bivirkninger, der hovedsagelig er lette til moderate og svarer til bivirkningerne ved andre jernpræparater.
The safety profile of Feraccru is considered acceptable, with side effects which are mostly mild to moderate in intensity and in line with those of other iron preparations.
Sikkerhedsprofilen af Herceptin subkutan formulering (evalueret i 298 og 297 patienter behandlet med henholdsvis intravenøs og subkutan formulering) fra det pivotale studie BO22227 i tidlig brystkræft var overordnet sammenlignelig med den kendte sikkerhedsprofil af den intravenøse formulering.
The safety profile of Herceptin subcutaneous formulation (evaluated in 298 and 297 patients treated with the intravenous and subcutaneous formulations respectively) from the pivotal trial BO22227 in EBC was overall similar to the known safety profile of the intravenous formulation.
Sikkerhedsprofilen af Ilaris i en undergruppe af unge SJIA-patienter i alderen 16 til 20 år (n=31) var i overensstemmelse med sikkerhedsprofilen hos SJIA-patienter under 16 år.
In a subset of young adult SJIA patients aged 16 to 20 years (n=31), the safety profile of Ilaris was consistent with what was observed in SJIA patients less than 16 years of age.
Sikkerhedsprofilen af maraviroc er baseret på 1.374 hiv 1-inficerede patienter, som i kliniske fase 2b/3-studier er behandlet med mindst én dosis maraviroc.
The safety profile of maraviroc is based on 1,374 HIV-1 infected patients who has received at least one dose of maraviroc during Phase 2b/3 clinical studies.
Sikkerhedsprofilen af maraviroc er baseret på 1.374 hiv 1-inficerede patienter, som i kliniske fase 2b/3-studier er behandlet med mindst én dosis maraviroc.
The safety profile of maraviroc is based on 1,374 HIV-1 infected patients who received at least one dose of maraviroc during Phase 2b/3 clinical studies.
Sikkerhedsprofilen af NovoEight blev ligeledes anset for at svare til den, andre faktor VIII-produkter har.
The safety profile of NovoEight was also considered similar to other factor VIII products.
Sikkerhedsprofilen af simeprevir i kombination med sofosbuvir hos patienter med HCV-genotype 1- infektion med eller uden cirrose er baseret på puljede data fra fase 2-studiet HPC2002 og fase 3- studierne HPC3017 og HPC3018 med 472 patienter inkluderet, der fik simeprevir sammen med sofosbuvir uden ribavirin (155, 286 og 31 patienter fik henholdsvis 8, 12 eller 24 ugers behandling), og 108 patienter, der fik simeprevir sammen med sofosbuvir og ribavirin (54 patienter fik 12 og 54 fik 24 ugers behandling).
The safety profile of simeprevir in combination with sofosbuvir in patients with HCV genotype 1 infection with or without cirrhosis is based on pooled data from the phase 2 study HPC2002 and the phase 3 studies HPC3017 and HPC3018 which included 472 patients who received simeprevir with sofosbuvir without ribavirin (155, 286 and 31 patients received 8, 12 or 24 weeks of treatment, respectively) and 108 patients who received simeprevir with sofosbuvir and ribavirin (54 patients each received 12 or 24 weeks of treatment).
Sikkerhedsprofilen af Sivextro fandtes at være sammenlignelig med linezolid og blev anset for acceptabel.
Sivextro’s safety profile is comparable to that of linezolid and was considered acceptable.
Sikkerhedsprofilen blev fundet gunstig i forhold til andre lægemidler, herunder ipilimumab og kemoterapi, og bivirkningerne synes at kunne håndteres med de eksisterende anbefalinger.
The safety profile was considered favourable compared with other treatment, including ipilimumab and chemotherapy, and side effects appear manageable.
Sikkerhedsprofilen er baseret på puljede data fra 981 patienter, som blev behandlet med IMBRUVICA i tre kliniske fase 2-studier og fire randomiserede fase 3-studier og fra rapporter efter markedsføringen.
The safety profile is based on pooled data from 981 patients treated with IMBRUVICA in three phase 2 clinical studies and four randomised phase 3 studies and from post-marketing experience.
Sikkerhedsprofilen er baseret på sammenlagte data fra kliniske fase IIb- og fase III-studier hos 1222 tidligere ubehandlede patienter, 357 tidligere behandlede patienter, ikke eksponeret for integrasehæmmere og 264 patienter med tidligere behandlingssvigt, hvor integrasehæmmer var inkluderet (inklusiv integraseklasseresistens).
The safety profile is based on pooled data from Phase IIb and Phase III clinical studies in 1222 previously untreated patients, 357 previously treated patients unexposed to integrase inhibitors and 264 patients with prior treatment failure that included an integrase inhibitor (including integrase class resistance).
Sikkerhedsprofilen er desuden kendetegnet ved andre symptomer, relateret til antikolinerge virkninger, med en hyppighed ≥ 15 %, herunder urinretention, ansigtsrødme og tilstoppet næse.
The safety profile is further characterised by other symptoms, related to the anticholinergic effects at a rate of ≥15%, including urinary retention, flushing and nasal congestion.
Sikkerhedsprofilen for alogliptin og pioglitazon administreret samtidigt svarede til profilen for komponenterne hver for sig, som den fremstår på baggrund af kliniske studier af alogliptin og de omfattende data, der foreligger for pioglitazon.
The safety profile of co-administered alogliptin and pioglitazone was consistent with that of the individual components as demonstrated in clinical trials for alogliptin and from the comprehensive data available for pioglitazone.
Sikkerhedsprofilen for anidulafungin er baseret på 840 patienter med candidæmi/invasiv candidiasis, som fik den anbefalede daglige dosis på 100 mg i 9 kliniske studier.
The safety profile of anidulafungin is based on 840 patients with candidaemia/invasive candidiasis receiving the recommended daily dose of 100 mg in 9 studies.
Sikkerhedsprofilen for Anoro er baseret på sikkerhedserfaringer med umeclidinium/vilanterol og de to komponenter individuelt fra det kliniske udviklingsprogram, der omfattede 6.855 patienter med KOL, og fra spontan indrapportering.
The safety profile of ANORO is based on safety experience with umeclidinium/vilanterol and the individual components from the clinical development program comprising of 6,855 patients with COPD and from spontaneous reporting.
Sikkerhedsprofilen for Avastin er baseret på data fra kliniske studier med over 5.400 patienter med forskellige maligne sygdomme, som primært blev behandlet med Avastin i kombination med kemoterapi.
The overall safety profile of Avastin is based on data from over 5,400 patients with various malignancies, predominantly treated with Avastin in combination with chemotherapy in clinical trials.
Sikkerhedsprofilen for Coagadex anses for at være tilfredsstillende baseret på de tilgængelige data; bivirkningerne kan behandles og er milde eller moderate.
The safety profile of Coagadex was considered satisfactory based on available data, with side effects that were manageable and of mild or moderate intensity.
Sikkerhedsprofilen for Cyramza ligger på linje med den, der forventes for andre lægemidler, som blokerer for aktiviteten af VEGFR, og den blev anset for at være håndterbar.
The safety profile of Cyramza is in line with what is expected for other medicines blocking VEGFR activity and considered manageable.
Sikkerhedsprofilen for dabrafenib som monoterapi er baseret på data fra fem kliniske studier og omfattede 578 patienter med melanom.
The dabrafenib monotherapy safety profile is based on data from five clinical studies and included 578 patients with melanoma.
Sikkerhedsprofilen for Ilaris var den samme som hos patienterne på 2 år og derover.
The safety profile of Ilaris appeared similar to that in patients aged 2 years and above.
Sikkerhedsprofilen for ipilimumab 3 mg/kg hos kemoterapi-naive patienter fra puljede kliniske fase 2– og fase 3–forsøg (N= 75; behandlede) og hos behandlingsnaive patienter i to retrospektive observationsstudier (N= 273 og N= 157) svarede til sikkerhedsprofilen ved tidligere behandlet fremskredent melanom.
The safety profile of ipilimumab 3 mg/kg in chemotherapy-naive patients pooled across Phase 2 and 3 clinical trials (N= 75; treated) and in treatment-naive patients in two retrospective observational studies (N= 273 and N= 157) was similar to that in previously-treated advanced melanoma.
Sikkerhedsprofilen for Laventair er baseret på sikkerhedserfaringer med umeclidinium/vilanterol og de to komponenter individuelt fra det kliniske udviklingsprogram, der omfattede 6.855 patienter med KOL, og fra spontan indrapportering.
The safety profile of LAVENTAIR is based on safety experience with umeclidinium/vilanterol and the individual components from the clinical development program comprising of 6,855 patients with COPD and from spontaneous reporting.
Sikkerhedsprofilen for levetiracetam er generelt den samme p å tværs af aldersgrupper (voksne og pædiatriske patienter) og for alle godkendte ep ilepsi-indikationer.
The safety profile of levetiracetam is generally similar across age groups (adult and paediatric patients) and across the approved epilepsy indications.
Sikkerhedsprofilen for MabThera hos patienter med svær reumatoid artrit (RA) er sammenfattet i afsnittene nedenfor.
The safety profile of MabThera in patients with moderate to severe rheumatoid arthritis (RA) is summarized in the sections below.
Sikkerhedsprofilen for naltrexon/bupropion (NB), der præsenteres herunder, er baseret på kliniske forsøg udført med fastdosis-kombination (bivirkninger med en hyppighed på mindst 0,1 % og det dobbelte af placebo).
The safety profile of naltrexone / bupropion (NB) presented below is based on clinical studies performed with the fixed-dose combination (adverse reactions at an incidence of at least 0.1% and twice that of placebo).
Sikkerhedsprofilen for OLYSIO 150 mg i kombination med peginterferon alfa og ribavirin i et fase 3- studie, der blev gennemført med asiatiske patienter i Kina og Sydkorea, er sammenlignelig med sikkerhedsprofilen for ikke-asiatiske patienter fra en samlet fase 3-population fra globale studier, bortset fra de højere frekvenser for bivirkningen ‘forhøjet bilirubin i blodet’ (se tabel 8).
The safety profile of OLYSIO 150 mg in combination with peginterferon alfa and ribavirin in a phase 3 study conducted in Asian patients in China and South-Korea is comparable to non-Asian patients from a pooled phase 3 population from global studies, except for higher frequencies for ‘blood bilirubin increased’ events (see table 8).
Sikkerhedsprofilen for Parareg hos disse patientpopulationer stemmer generelt overens med det, der ses hos patienter med kroniske nyresygdomme.
The safety profile of Parareg in these patient populations is generally consistent with that seen in patients with Chronic Kidney Disease.
Sikkerhedsprofilen for pasireotid til intramuskulær anvendelse svarede til andre somatostatinanalogers bortset fra den højere grad og hyppighed af hyperglykæmi, der sås ved pasireotid til intramuskulær anvendelse.
The safety profile of pasireotide intramuscular use was consistent with the somatostatin analogue class, except for the higher degree and frequency of hyperglycaemia seen with pasireotide intramuscular use.
Sikkerhedsprofilen for Ratiograstim i disse kliniske studier svarede til profilen for det referenceprodukt, der blev anvendt i studierne.
The safety profile of Ratiograstim observed in these clinical studies was consistent with that reported with the reference product used in these studies.
Sikkerhedsprofilen for Resolor i dette 24-ugers studie stemte overens med det, der er observeret i de tidligere 12-ugers studier.
The safety profile of prucalopride in this 24 week study was consistent with that seen in the previous 12 week studies.
Sikkerhedsprofilen for samtidigt administreret alogliptin og metformin svarede til profilen for komponenterne hver for sig som påvist i kliniske studier med alogliptin og de omfattende tilgængelige data, der foreligger om metformin.
The safety profile of co-administered alogliptin and metformin was consistent with that of the individual components as demonstrated in clinical trials for alogliptin and from the comprehensive data available for metformin.
Sikkerhedsprofilen for SIMBRINZA svarede til den for de enkelte komponenter (brinzolamid 10 mg/ml og brimonidin mg/ml).
The safety profile of SIMBRINZA was similar to that of the individual components (brinzolamide 10 mg/mL and brimonidine 2 mg/mL).
Sikkerhedsprofilen for simeprevir i kombination med peginterferon alfa og ribavirin er sammenlignelig mellem patienter med HCV-genotype 1-infektion med og uden samtidig HIV-1- infektion.
The safety profile of simeprevir in combination with peginterferon alfa and ribavirin is comparable between HCV genotype 1 infected patients with and without HIV-1 co-infection.
Sikkerhedsprofilen for Stivarga plus BSC i CONCUR-studiet var sammenlignelig med sikkerhedsprofilen i CORRECT- studiet.
The safety profile of Stivarga plus BSC in the CONCUR study was consistent with the safety profile observed in the CORRECT study.
Sikkerhedsprofilen for Tevagrastim i disse kliniske studier svarede til profilen for det referenceprodukt, der blev anvendt i studierne.
The safety profile of Tevagrastim observed in these clinical studies was consistent with that reported with the reference product used in these studies.
Sikkerhedsprofilen hos børn og unge patienter med PNH (i alderen 11 år til under 18 år), som blev inkluderet i det pædiatriske PNH-studie M07-005, var sammenlignelig med den sikkerhedsprofil, som var observeret hos voksne PNH-patienter.
In children and adolescent PNH patients (aged 11 years to less than 18 years) included in the paediatric PNH Study M07-005, the safety profile appeared similar to that observed in adult PNH patients.
Sikkerhedsprofilen hos disse forsøgspersoner adskilte sig imidlertid ikke fra den almene population.
2 %) however the safety profile of these subjects was not different from that of the general population.
Sikkerhedsprofilen hos disse pædiatriske patienter svarer til profilen hos voksne patienter.
The safety profile in these paediatric patients is consistent with that in adult patients.
Sikkerhedsprofilen hos immunokompromitterede personer og patienter med kroniske sygdomme er den samme som sikkerhedsprofilen hos raske voksne og ældre personer.
The safety profile in immunocompromised subjects and patients with chronic disease conditions is similar to the safety profile in healthy adults and older subjects.
Sikkerhedsprofilen hos patienter i alderen 65 år eller derover lignede sikkerhedsprofilen hos patienter på under 65 år (se pkt.
The safety profile in patients aged 65 years or older was similar to that in patients less than
Sikkerhedsprofilen hos patienter med aksial spondyloartritis, som blev behandlet med Cimzia, svarede til sikkerhedsprofilen hos patienter med reumatoid artritis samt tidligere erfaringer med Cimzia.
The safety profile for axial spondyloarthritis patients treated with Cimzia was consistent with the safety profile in rheumatoid arthritis and previous experience with Cimzia.
Sikkerhedsprofilen i det første pædiatriske, ikke-kontrollerede studie udført med den filmovertrukne tablet (BREATHE-3; n=19, gennemsnits alder 10 år [interval 3-15 år], åben behandling med bosentan 2 mg/kg legemsvægt to gange dagligt; 12-ugers behandlingsvarighed) var sammenlignelig med den, der blev observeret i de pivotale studier med voksne patienter med PAH.
The safety profile in the first paediatric uncontrolled study performed with the film-coated tablet (BREATHE-3: n = 19, median age 10 years [range 3–15 years], open-label bosentan 2 mg/kg twice daily; treatment duration 12 weeks) was similar to that observed in the pivotal trials in adult patients with PAH.
Sikkerhedsprofilen i det første pædiatriske, ikke-kontrollerede studie udført med den filmovertrukne tablet (BREATHE-3; n=19, gennemsnitsalder 10 år [interval 3-15 år], åben behandling med bosentan 2 mg/kg legemsvægt to gange dagligt; 12-ugers behandlingsvarighed) var sammenlignelig med den, der blev observeret i de pivotale studier med voksne patienter med PAH.
The safety profile in the first paediatric uncontrolled study performed with the film-coated tablet (BREATHE-3: n = 19, median age 10 years [range 3–15 years], open-label bosentan 2 mg/kg twice daily; treatment duration 12 weeks) was similar to that observed in the pivotal trials in adult patients with PAH.
Sikkerhedsprofilen i det første pædiatriske, ikke-kontrollerede studie udført med den filmovertrukne tablet (BREATHE-3; n=19, gennemsnitsalder 10 år [interval 3-15 år], åben behandling med bosentan 2 mg/kg legemsvægt to gange dagligt; 12-ugers behandlingsvarighed)var sammenlignelig med den, der blev observeret i de pivotale studier med voksne patienter med PAH.
The safety profile in the first paediatric uncontrolled study performed with the film-coated tablet (BREATHE-3: n = 19, median age 10 years [range 3–15 years], open-label bosentan 2 mg/kg twice daily; treatment duration 12 weeks) was similar to that observed in the pivotal trials in adult patients with PAH.
Sikkerhedsprofilen i dette stadium er i overensstemmelse med de bivirkninger, der blev observeret hos patienter i behandling med FIRDAPSE.
The safety profile in this study is consistent with adverse reactions observed with patients on FIRDAPSE.
Sikkerhedsprofilen i et 26-ugers åbent, forlænget forsøg var den samme som den, der blev observeret i det korte, placebokontrollerede forsøg.
The safety profile in a 26-week open-label extension trial was similar to that observed in the short- term, placebo-controlled trial.
Sikkerhedsprofilen præsenteret nedenfor er baseret på en samlet analyse af 9.621 personer, der i kliniske studier er blevet vaccineret med én dosis Nimenrix.
The safety profile presented below is based on a pooled analysis on 9,621 subjects who have been vaccinated with one dose of Nimenrix in clinical studies.
Sikkerhedsprofilen stemmer generelt overens for børn og unge, og den stemmer også overens med den for voksne patienter.
The safety profile is generally consistent among children and adolescents and is also consistent with adult patients.
Sikkerhedsprofilen svarede alt i alt til sikkerhedsprofilen i det sekundære studie af bivirkninger i SPS.
The safety profile was generally similar to the Adverse Event Monitoring Substudy of the SPS.
Sikkerhedsprofilen var generelt den samme som for aprepitant, som fremgår af tabellen ovenfor.
The safety profile was generally similar to that seen in the aprepitant table above.
Sikkerhedsprofilen var lig profilen hos ikke-HIV-smittede forsøgspersoner i andre studier.
The safety profile was similar to non-HIV infected subjects in other studies.
Sikkerhedsprofilen var omtrent den samme på tværs af de forskellige behandlingspopulationer nævnt ovenfor.
The safety profile was similar across the different treatment populations mentioned above.
Sikkerhedsprofilen var sammenlignelig hos patienter, der fik monoterapi med Sivextro intravenøst, og patienter, der fik monoterapi med Sivextro oralt, bortset fra at der blev rapporteret om flere gastrointestinale forstyrrelser ved oral administration.
The safety profile was similar when comparing patients receiving intravenous Sivextro alone to patients who received oral administration alone, except for a higher reported rate of gastrointestinal disorders associated with oral administration.
Sikkerhedsprofilen var sammenlignelig hos patienter, der fik monoterapi med Sivextro intravenøst, og patienter, der fik monoterapi med Sivextro oralt, bortset fra, at der blev rapporteret om flere gastrointestinale forstyrrelser ved oral administration.
The safety profile was similar when comparing patients receiving intravenous Sivextro alone to patients who received oral administration alone, except for a higher reported rate of gastrointestinal disorders associated with oral administration.
Sikkerhedsprofilen var uændret fra hvad der var observeret i tidligere studier.
The safety profile was unchanged from that observed in previous studies.
Sikkerhedsprofilerne for vedligeholdelsesbehandlingen med ALIMTA var sammenlignelige i de to studier JMEN og PARAMOUNT.
The ALIMTA maintenance safety profiles from the two studies JMEN and PARAMOUNT were similar.
Sikkerhedsrapporten, som blev udarbejdet af indehaveren af markedsføringstilladelsen (innovator), indeholdt flere tilfælde, som i høj grad tydede på kausal sammenhæng mellem levetiracetam og encefalop ati.
The safety report prepared by the Innovator MAH contained several cases very suggestive of a causal association between levetiracetam and encephalopathy.
Sikkerhedsresultaterne for 29 pædiatriske patienter (≤ 17 år), der var inkluderet i PID-studierne, blev evalueret.
The safety results for 29 paediatric patients (those  17 years old) included in the PID studies were evaluated.
Sikkerhedsresultaterne for 4 pædiatriske patienter (≤ 17 år), der var inkluderet i PID-studiet, samt resultaterne for de 12 børn (i alderen 3 til 16 år), der var inkluderet i ITP-studiet, blev evalueret.
The safety results for 4 paediatric patients (those  17 years old) included in the PID study and the results for the 12 children (aged 3 to 16 years old) included in the ITP study were evaluated.
Sikkerhedsresultaterne for pædiatriske patienter, som deltog i de p lacebokontrollerede kliniske studier, var i overensstemmelse med levetiracetams sikkerhedsprofil hos voksne bortset fra adfærdsmæssige og p sykiatriske bivirkninger, som var hyppigere hos børn end hos voksne.
Safety results in paediatric patients in placebo-controlled clinical studies were consistent with the safety profile of levetiracetam in adults except for behavioural and psychiatric adverse reactions which were more common in children than in adults.
Sikkerhedsråd til mænd
Safety advice for men
Sikkerhedsråd til WCBP
Safety advice for WCBP
Sikkerhedsrådgivning til fertile kvinder
Safety advice for women of childbearing potential
Sikkerhedsrådgivning til mænd
Safety advice for men
Sikkerhedsrådgivning, der er relevant for alle patienter
Safety advice relevant to all patients
Sikkerhedssprøjtens forskellige dele:
Parts of the syringes: