natgillin/translations-raw huggingface dataset:
Under hensyntagen til PRAC’s vurderingsrapport om /PSUR’erne for clofarabin er CHMP nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSUR(s) for clofarabine, the scientific conclusions of CHMP are as follows:
Under hensyntagen til PRAC’s vurderingsrapport om PSUR’en for influenzavaccine (overfladeantigen, inaktiveret, fremstillet i cellekulturer) er CHMP nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSUR for influenza vaccine (surface antigen, inactivated, prepared in cell cultures), the scientific conclusions of CHMP are as follows:
Under hensyntagen til PRAC’s vurderingsrapport om PSUR’en for melatonin er CHMP nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSUR for melatonin, the scientific conclusions of the CHMP are as follows:
Under hensyntagen til PRAC’s vurderingsrapport om PSUR’en for thalidomid er CHMP nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSUR for thalidomide, the scientific conclusions of CHMP are as follows:
Under hensyntagen til PRAC’s vurderingsrapport om PSUR’en/PSUR'erne for trametinib er CHMP nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSUR(s) for trametinib, the scientific conclusions of CHMP are as follows:
Under hensyntagen til PRAC’s vurderingsrapport om PSUR’erne for agomelatin er CHMP nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSUR for agomelatine, the scientific conclusions of CHMP are as follows:
Under hensyntagen til PRAC’s vurderingsrapport om PSUR’erne for aripiprazol er CHMP nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSURs for aripiprazole, the scientific conclusions of the CHMP are as follows:
Under hensyntagen til PRAC’s vurderingsrapport om PSUR’erne for bimatoprost er CHMP nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSUR for bimatoprost, the scientific conclusions of CHMP are as follows:
Under hensyntagen til PRAC’s vurderingsrapport om PSUR’erne for brimonidin (kun det centralt godkendte lægemiddel) er CHMP nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSUR(s) for brimonidine (centrally authorised product only), the scientific conclusions of CHMP are as follows:
Under hensyntagen til PRAC’s vurderingsrapport om PSUR’erne for cargluminsyre er CHMP nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSUR for carglumic acid, the scientific conclusions of CHMP are as follows:
Under hensyntagen til PRAC’s vurderingsrapport om PSUR’erne for enfuvirtid er CHMP nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSUR for enfuvirtide, the scientific conclusions of CHMP are as follows:
Under hensyntagen til PRAC’s vurderingsrapport om PSUR’erne for Firmagon er CHMP nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSURs for Firmagon, the scientific conclusions of the CHMP are as follows:
Under hensyntagen til PRAC’s vurderingsrapport om PSUR’erne for florbetaben (18F) er CHMP nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSUR(s) for florbetaben (18F), the scientific conclusions of CHMP are as follows:
Under hensyntagen til PRAC’s vurderingsrapport om PSUR’erne for Focetria er PRAC nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSUR for Focetria, the scientific conclusions of PRAC are as follows:
Under hensyntagen til PRAC’s vurderingsrapport om PSUR’erne for gimeracil / oteracilmonokalium / tegafur er CHMP nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSUR(s) for gimeracil / oteracil monopotassium / tegafur, the scientific conclusions of CHMP are as follows:
Under hensyntagen til PRAC’s vurderingsrapport om PSUR’erne for glimepirid / pioglitazon hydrochlorid, metformin / pioglitazon, pioglitazon er CHMP nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSUR(s) for glimepiride / pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone, the scientific conclusions of CHMP are as follows:
Under hensyntagen til PRAC’s vurderingsrapport om PSUR’erne for Incresync er PRAC nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSUR for Incresync, the scientific conclusions of PRAC are as follows:
Under hensyntagen til PRAC’s vurderingsrapport om PSUR’erne for ingenolmebutat er CHMP nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSUR(s) for ingenol mebutate, the scientific conclusions of CHMP are as follows:
Under hensyntagen til PRAC’s vurderingsrapport om PSUR’erne for liraglutid er PRAC nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSUR for liraglutide, the scientific conclusions of CHMP are as follows:
Under hensyntagen til PRAC’s vurderingsrapport om PSUR’erne for METFORMIN, VILDAGLIPTIN er CHMP nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSUR for METFORMIN, VILDAGLIPTIN, the scientific conclusions of the CHMP are as follows:
Under hensyntagen til PRAC’s vurderingsrapport om PSUR’erne for mirabegron er CHMP nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSUR for mirabegron, the scientific conclusions of CHMP are as follows:
Under hensyntagen til PRAC’s vurderingsrapport om PSUR’erne for ocriplasmin er CHMP nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSUR for ocriplasmin, the scientific conclusions of CHMP are as follows:
Under hensyntagen til PRAC’s vurderingsrapport om PSUR’erne for orlistat er CHMP nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSUR for orlistat, the scientific conclusions of CHMP are as follows:
Under hensyntagen til PRAC’s vurderingsrapport om PSUR’erne for orlistat er CHMP nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSURs for orlistat, the scientific conclusions of the CHMP are as follows:
Under hensyntagen til PRAC’s vurderingsrapport om PSUR’erne for ranolazin er CHMP nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSUR for ranolazine, the scientific conclusions of CHMP are as follows:
Under hensyntagen til PRAC’s vurderingsrapport om PSUR’erne for rivastigmin er CHMP nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSUR for rivastigmine, the scientific conclusions of CHMP are as follows:
Under hensyntagen til PRAC’s vurderingsrapport om PSUR’erne for temozolomid er CHMP nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSUR for temozolomide, the scientific conclusions of CHMP are as follows:
Under hensyntagen til PRAC’s vurderingsrapport om PSUR’erne for TERIFLUNOMID, er CHMP nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSUR for TERIFLUNOMIDE, the scientific conclusions of CHMP are as follows:
Under hensyntagen til PRAC’s vurderingsrapport om PSUR’erne for Vipdomet, er PRAC nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSUR for Vipidomet, the scientific conclusions of PRAC are as follows:
Under hensyntagen til PRAC’s vurderingsrapport om PSUR’erne for Vipidia er PRAC nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSUR for Vipidia, the scientific conclusions of PRAC are as follows:
Under hensyntagen til PRAC’s vurderingsrapport om PSUR’erne for zoledronsyre (indiceret til cancer og frakturer) er CHMP nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSUR(s) for zoledronic acid (indicated for cancer and fractures), the scientific conclusions of CHMP are as follows:
Under hensyntagen til samtlige data konkluderede CHMP, at fordelene ved Imvanex opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
Taking into account all the data, the CHMP concluded that Imvanex’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Under hiv-behandling kan der forekomme en stigning i legemsvægt og et forhøjet indhold af lipider og glucose i blodet.
During treatment for HIV there may be an increase in weight and in levels of blood lipids and glucose.
Under hiv-behandling kan der forekomme vægtstigning samt forhøjede koncentratione af lipider og glukose i blodet.
During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose.
Under holdbarhedstiden kan patienten opbevare kapslerne i en enkelt periode på 2 måneder ved en temperatur på ikke over 25 °C, hvorefter produktet skal kasseres.
During the shelf life, the patient may store the capsules for a single period of 2 months at a temperature not above 25°C, after which the medicinal product must be discarded.
Under INCIVO-behandlingen rapporteredes der om hændelser med udslæt (af alle grader) hos 55% af de patienter, som fik INCIVO- kombinationsbehandling, og hos 33% af de patienter, som kun fik pegyleret interferon-alfa og ribavirin.
During INCIVO treatment, rash events (all grades) were reported in 55% of patients who received INCIVO combination treatment and in 33% of patients who received peginterferon alfa and ribavirin.
Under indsprøjtning kan De muligvis høre et eller flere klik – dette er normalt for pennen.
During injection, you may hear one or more clicks – this is a normal device operation.
Under induktionsbehandling skal det planlagte behandlingsinterval mellem de enkelte Gazyvaro-doser overholdes.
During induction, the planned treatment interval for Gazyvaro should be maintained between doses.
Under infusion af fosaprepitant har der været enkeltstående rapporter om umiddelbare overfølsomhedsreaktioner inklusive flushing, erytem og dyspnø.
Isolated reports of immediate hypersensitivity reactions including flushing, erythema, and dyspnoea have occurred during infusion of fosaprepitant.
Under infusion i en hæmofili patient binder faktor VIII endogent til von Willebrand faktor i patientens cirkulation.
When infused into a haemophilia patient, factor VIII binds to endogenous von Willebrand Factor in the patient’s circulation.
Under infusionen bør hastigheden øges hvert 30. minut til maksimalt 400 ml/time (se pkt.
During infusion, the rate should be increased every 30 minutes to a maximum of 400 ml/h (see section 6.6).
Under injektionen: Statuslyset blinker stiftevis grønt og orange.
During the injection: The status light alternately flashes green and orange.
Under injektionsprocessen (figur J):
During the injection process (Figure J):
Under interkurrent sygdom skal der udvises særlig opmærksomhed på risikoen for udvikling af akut binyrebarkinsufficiens.
During intercurrent illness, there should be high awareness of the risk of developing acute adrenal insufficiency.
Under intermitterende behandling med 30 mio enheder (300 mikrogram) filgrastim/dag kan der ses store udsving i patientens ANC.
During intermittent dosing with 30 MU (300 micrograms)/day of filgrastim, there can be wide fluctuations in the patient's ANC over time.
under kirurgiske indgreb til at stoppe blødninger og til at forsegle vævsoverflader på indre organer
during an operation, to stop bleeding and to seal the surfaces of internal organs;
Under klargøring eller administration af Imlygic skal der bruges beskyttelsesdragt eller laboratoriekittel, beskyttelsesbriller eller ansigtsskærm og handsker.
Wear protective gown or laboratory coat, safety glasses, or face shield and gloves while preparing or administering Imlygic.
Under klargøringsprocessen pumpes noget af lægemidlet ud.
During the priming process product will be expelled.
Under klinisk afprøvning af produktet var frekvensen af gastrointestinale bivirkninger (opkast/diarrè) 10%.
During clinical trial testing of the product, the incidence of gastrointestinal reactions (diarrhoea/vomiting) was 10%.
Under klinisk relevante omstændig- heder (steady state) påvirkes vismodegibs farmakokinetik ikke af føde.
Under clinically relevant conditions (steady state), the PK of vismodegib is not affected by food.
Under kliniske forsøg blev følgende bivirkninger observeret i meget sjælden grad (dvs. i mindre end 1 tilfælde ud af 10.000 indgivelser til patienter): feber (pyreksi), forøget C-reaktivt protein, striber (urticaria), kløe (pruritus), udslæt og svimmelhed.
The following side effects were very rarely observed during clinical studies (less than 1 case in 10 000 administrations given to patients): fever (pyrexia), increased C-reactive protein, wheals (urticaria), itching (pruritus), rash and dizziness.
Under kliniske forsøg fik 128 børn (98 børn med væksthormonmangel og 30 med Turner’s syndrom) Valtropin.
During clinical studies 128 children (98 children with growth hormone deficiency and 30 with Turner syndrome) were exposed to Valtropin.
Under kliniske forsøg med Suprelorin 4,7 mg, var den gennemsnitlige varighed af undertrykkelse af testosteron 1,5 gange længere hos små hunde(< 10 kg) sammenlignet med større hunde.
During clinical trials with Suprelorin 4.7 mg, the mean duration of testosterone suppression was 1.5 times longer among smaller size dogs (<10 kg) compared with all larger dogs.
Under kliniske forsøg rapporteres hyppigt om allergiske reaktioner associeret med indgivelse af Enbrel.
Allergic reactions associated with Enbrel administration have been reported commonly.
under kliniske forsøg† og ‡
during clinical trials† and
Under kliniske studier er der forekommet forhøjelser af leveraminotransferase på 3 eller flere gange den øvre normalgrænse (upper limit of normal, ULN) hos 8,0 % af de patienter, der blev behandlet med fingolimod 0,5 mg, sammenlignet med 1,9 % af placebopatienterne.
In clinical trials, elevations 3-fold the upper limit of normal (ULN) or greater in ALT occurred in 8.0% of patients treated with fingolimod 0.5 mg compared to 1.9% of placebo patients.
Under kliniske studier forekom dosisafhængige forhøjelser af serum-kreatinin hos omkring 36% af patienterne, selvom de fleste blev inden for normalområdet.
During clinical studies, dose-dependent increases in serum creatinine occurred in about 36% of patients, though most remained within the normal range.
Under kliniske studier har infektioner i de nedre luftveje (inklusive pneumoni) været rapporteret med en forekomst i MabThera-armene svarende til forekomsten i kontrolarmene.
Lower respiratory tract infections (including pneumonia) have been reported during clinical trials, at a similar incidence in the MabThera-arms compared to control arms.
Under kliniske studier med CEPROTIN blev der rapporteret 6 ikke-alvorlige bivirkninger (ADR’er) hos 3 ud af 225 inkluderede patienter.
During clinical studies with CEPROTIN, a total of 6 non-serious adverse drug reactions (ADRs) were reported in 3 of 225 patients enrolled.
Under kliniske studier med forekom dosisafhængige forhøjelser af serum-kreatinin hos omkring 36% af patienterne, selvom de fleste blev inden for normalområdet.
During clinical studies dose-dependent increases in serum creatinine occurred in about 36% of patients, though most remained within the normal range.
Under kliniske studier med infliximab over alle godkendte indikationer var forekomsten af lymfom hos infliximab-behandlede patienter højere end forventet i den generelle befolkningsgruppe, men forekomsten af lymfom var sjæ lden.
During clinical studies of infliximab across all approved indications the incidence of lymphoma in infliximab-treated patients was higher than expected in the general population, but the occurrence of lymphoma was rare.
Under kombinationsbehandling
The clinical significance
Under kombinationsbehandling i op til 48 uger med IntronA og ribavirin blev væksthæmning observeret, som medførte reduceret sluthøjde hos nogle patienter.
During combination therapy for up to 48 weeks with IntronA and ribavirin, growth inhibition was observed that resulted in reduced final adult height in some patients.
Under kombinationsbehandlingen i op til 48 uger med interferon alfa-2b og ribavirin, blev væksthæmning observeret, som medførte reduceret sluthøjde hos nogle patienter.
During combination therapy for up to 48 weeks with interferon alfa- 2b and ribavirin, growth inhibition was observed that resulted in reduced final adult height in some patients.
Under konkomitant-fasen vil Deres læge starte behandlingen med en dosis Temodal på 75 mg/m2 (sædvanlig dosis).
During the concomitant phase, your doctor will start Temodal at a dose of 75 mg/m2 (usual dose).
Under konkomitant-fasen vil din læge starte behandlingen med en dosis Temozolomide HEXAL på 75 mg/m2 (sædvanlig dosis).
During the concomitant phase, your doctor will start Temozolomide Hexal at a dose of 75 mg/m2 (usual dose).
Under laboratoriebetingelser viste Purevax RCP FeLV sig at beskytte mod de ovennævnte sygdomme.
In laboratory conditions Purevax RCP FeLV was demonstrated to provide protection against the diseases listed above.
Under laboratoriebetingelser viste Purevax RCPCh FeLV sig at beskytte mod de ovennævnte sygdomme.
In laboratory conditions, Purevax RCPCh FeLV was demonstrated to provide protection against the diseases listed above.
Under lange perioder med sengeleje på grund af sygdom
For long periods of bed rest due to an illness
Under langtidsbehandling med kombinationen af Pegasys og ribavirin kan mundtørhed endvidere have en skadelig effekt på tænder og de mukøse membraner i munden.
In addition, dry mouth could have a damaging effect on teeth and mucous membranes of the mouth during long-term treatment with the combination of Pegasys and ribavirin.
under langvarig samtidig
be observed during prolonged
Under markedsføring af Azomyr er tilfælde af alvorlige allergiske reaktioner (vejrtrækningsbesvær, hiven efter vejret, kløe, kløende udslæt og hævelse) blevet rapporteret meget sjældent.
During the marketing of Azomyr, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) have been reported very rarely.
Under micafunginbehandling skal patienterne overvåges for anafylaktiske/anafylaktoide reaktioner, forværring af leverfunktionen, forværring af nyrefunktionen, hæmolyse, eksfoliative hudreaktioner samt toksicitet af anden samtidig lægemiddelbehandling, og der skal træffes passende foranstaltninger (seponering eller vurdering af risiko/fordel ved fortsat micafunginbehandling samt behandling af bivirkninger), når sådanne tilstande opstår.
Patients should be monitored during micafungin treatment for anaphylactic/anaphylactoid reactions, worsening of liver function, worsening of renal function, haemolysis, exfoliative cutaneous reactions, and concomitant drug therapy toxicity and adequate measures (discontinuation or evaluation for the risk/benefit of continuing micafungin therapy and treatment of adverse reactions) should be undertaken when such conditions occur.
Under monoterapi-fasen vil dosis og måden, De tager Temodal på være anderledes..
During the monotherapy phase, the dose and way you receive Temodal in this phase will be different.
Under normal brug kan der forekomme hvide partikler udvendigt på spidsen af cylinderampullen.
White particles may appear on the outside tip of the cartridge during normal use.
Under normale omstændigheder kan der af og til forekomme apati og anoreksi samt hypertermi (der sædvanligvis varer 1 til 2 dage).
In normal condition of use, transient apathy and anorexia may occasionally occur, as well as hyperthermia (lasting usually for 1 or 2 days).
Under normale omstændigheder kan der af og til forekomme apati og anoreksi samt hypertermi (der sædvanligvis varer 1 til 2 dage).
In normal conditions of use, transient apathy and anorexia may occasionally occur, as well as hyperthermia (lasting usually for 1or 2 days).
Under normale omstændigheder kan der af og til forekomme apati og mistet ædelyst samt forhøjet temperatur (der sædvanligvis varer 1 til 2 dage).
In normal conditions of use, transient apathy and anorexia may occasionally occur, as well as hyperthermia (lasting usually for 1 or 2 days).
Under normale omstændigheder kan der af og til forekomme apati, nedstemthed og mistet ædelyst samt forhøjet temperatur (der sædvanligvis varer 1 til 2 dage).
In normal conditions of use, transient apathy and anorexia may occasionally occur, as well as hyperthermia (lasting usually for 1 or 2 days).
Under normale omstændigheder opnås lave plasmakoncentrationer af fluticasonpropionat efter inhalation på grund af udtalt first pass metabolisme og høj systemisk clearance medieret af CYP3A4 i tarm og lever.
Under normal circumstances, low plasma concentrations of fluticasone propionate are achieved after inhaled dosing, due to extensive first pass metabolism and high systemic clearance mediated by cytochrome P450 3A4 in the gut and liver.
Under normale omstændigheder opnås lave plasmakoncentrationer af fluticasonpropionat efter inhalation på grund af udtalt first pass-metabolisme og høj systemisk clearance medieret af CYP3A4 i tarm og lever.
Under normal circumstances, low plasma concentrations of fluticasone propionate are achieved after inhaled dosing, due to extensive first pass metabolism and high systemic clearance mediated by cytochrome P450 3A4 in the gut and liver.
Under og efter behandling med Simponi
During and after Simponi treatment
Under og efter behandling med Simponi
During and after Simponi treatment:
Under omdannelse af GSH-konjugater til N-acetylcystein- konjugater, dannes der GSH-, cysteinylglycin- og cystein-konjugater.
During conversion of GSH conjugates to N-acetylcysteine conjugates, GSH, cysteinylglycine, and cysteine conjugates are formed.
Under omstændigheder der kræver hurtig beskyttelse, er nødvendig, kan det derfor være nødvendigt med en tredje dosis for at sikre varigheden.
In circumstances when a fast onset of protection is needed, a third dose might therefore be necessary to ensure duration of protection.
Under opbevaring kan der observeres et hvidt bundfald og en klar supernatant.
During storage, a white deposit and clear supernatant may be observed.
Under opbevaring kan der ses et fint, hvidt bundfald med en klar, farveløs supernatant.
Upon storage, a fine white deposit with a clear colourless supernatant can be observed.
Under operation
In operations
Under operation for grå stær kan der forekomme en tilstand kaldet intraoperativt floppy iris syndrom (IFIS), hvis du bruger eller har brugt Xeplion.
During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) can happen if you take or have taken Xeplion.
Under operationen klippes enhederne til i form og størrelse og anvendes til at lukke det blødende område.
During surgery, the patches are cut to shape and size and used to seal off the bleeding area.
Under Orgalutran behandlingen var den gennemsnitlige forekomst af LH-stigning (>10 IE/I) med samtidig stigning i progesteron (>1 mg/ml) 0,3 - 1,2 % sammenlignet med 0,8 % under behandling med GnRH agonist.
During Orgalutran treatment the average incidence of LH rises (> 10 IU/l) with concomitant progesterone rise (> 1 ng/mL) was 0.3 - 1.2 % compared to 0.8 % during GnRH agonist treatment.
Under overførslen af solvens skal pulveret gennemvædes fuldstændigt ved forsigtigt at hælde hætteglasset med pulver.
During solvent transfer, wet the powder completely by gently tilting the powder vial.