natgillin/translations-raw huggingface dataset:
Patienter bør rådes til at udvise forsigtighed under aktiviteter, som kræver høj koncentration f.eks. at føre motorkøretøj eller betjene maskiner.
Patients must be advised to exercise caution during activities requiring a high degree of alertness, e.g., driving or operating machinery.
Patienter bør rådes til at være forsigtige ved kørsel og ved betjening af maskiner, hvis de oplever træthed eller hovedpine under behandling med Signifor.
Patients should be advised to be cautious when driving or using machines if they experience fatigue or headache during treatment with Signifor.
Patienter bør rådes til ikke at føre motorkøretøjer eller betjene maskiner, hvis de oplever træthed, svimmelhed, synsforstyrrelser eller andre uønskede bivirkninger, som kan påvirke deres evne til at føre motorkøretøjer eller betjene maskiner.
Patients should be advised not to drive or operate machinery if they experience somnolence, dizziness, visual disturbances or other adverse reaction which can impair their ability to drive and operate machinery.
Patienter bør tilrådes forsigtighed ved betjening af maskiner, herunder også bilkørsel eller motorcykelkørsel, indtil de er forholdsvis sikre på, at AZILECT ikke påvirker dem ugunstigt.
Patients should be cautioned about operating hazardous machines, including motor vehicles, until they are reasonably certain that AZILECT does not affect them adversely.
Patienter bør tilrådes forsigtighed ved betjening af maskiner, herunder også bilkørsel eller motorcykelkørsel, indtil de er forholdsvis sikre på, at Rasagilin ratiopharm ikke påvirker dem ugunstigt.
Patients should be cautioned about operating hazardous machines, including motor vehicles, until they are reasonably certain that Rasagiline ratiopharm does not affect them adversely.
Patienter bør titreres individuelt for at finde frem til den dosis, der giver tilstrækkelig analgesi med acceptable lægemiddelbivirkninger.
Patients should be individually titrated to the dose that provides adequate analgesia with tolerable adverse drug reactions.
Patienter bør undersøges for tegn og symptomer på underliggende kardiopulmonal sygdom før initiering af dasatinib-behandling.
Patients should be evaluated for signs and symptoms of underlying cardiopulmonary disease prior to initiating dasatinib therapy.
Patienter co-inficeret med hepatitis B- og/eller hepatitis C-virus
Patients co-infected with hepatitis B and/or hepatitis C virus
Patienter der er ældre end 75 år, bør ikke indlede behandlingen med clopidogrel med en mætningsdosis.
For patients over 75 years of age clopidogrel, should be initiated without a loading dose.
Patienter der er ældre end 75 år, bør ikke indlede behandlingen med clopidogrel med en stabiliseringsdosis.
For patients over 75 years of age clopidogrel, should be initiated without a loading dose.
Patienter der får immunsuppressiv behandling med kombinationer af lægemidler, inkluisve CellCept, har forhøjet risiko for at udvikle lymfomer og andre maligniteter, særligt i huden (se pkt.
Patients receiving immunosuppressive regimens involving combinations of medicinal products, including CellCept, are at increased risk of developing lymphomas and other malignancies, particularly of the skin (see section 4.4).
Patienter der gennemgår hofteoperation
In patients undergoing hip replacement surgery
Patienter der gennemgår knæoperation
In patients undergoing knee replacement surgery
Patienter der har behov for en dosisøgning til 100 mg, bør tage to 50 mg orodispergible tabletter lige efter hinanden.
For patients requiring a dose increase to 100 mg, two 50 mg orodispersible tablets should be administered sequentially.
Patienter der ikke tidligere er blevet behandlet
Previously untreated patients
Patienter der responderede blev fulgt i yderligere 24 uger efter seponering af behandling.
Patients in response were followed for an additional 24 weeks off- treatment.
Patienter der tidligere har fået
PI-experienced
Patienter der tidligere har fået antiretroviral behandling, PI-naive
ART-experienced, PI-naïve
Patienter efter allogen blodstamcelletransplantation (en kompleks procedure, hvor patienten modtager blodstamceller fra en matchende donor, hvilket skal medvirke til at genoprette knoglemarven).
Patients after allogeneic blood stem-cell transplantation (a complex procedure where the patient receives stem cells from a matched donor to help restore the bone marrow).
patienter efter omstilling fra animalsk insulin til human insulin,
after transfer from animal insulin to human insulin,
Patienter fik behandling i minimum 3 cyklusser og patienter med stabil sygdom eller respons efter 3 cyklusser fortsatte behandling i yderligere 3 cyklusser til maksimalt 6 cyklusser.
Patients received treatment for a minimum of 3 cycles and patients with stable disease or response after 3 cycles continued treatment for a further 3 cycles for a maximum of 6 cycles.
Patienter fik behandling i minimum 3 cyklusser, og patienter med stabil sygdom eller respons efter 3 cyklusser fortsatte behandling i yderligere 3 cyklusser til maksimalt 6 cyklusser.
Patients received treatment for a minimum of 3 cycles and patients with stable disease or response after 3 cycles continued treatment for a further 3 cycles for a maximum of 6 cycles.
Patienter fik testet serumprøver for autoantistoffer på forskellige tidspunkter i reumatoid artrit forsøgne I-V.
Patients had serum samples tested for autoantibodies at multiple time points in rheumatoid arthritis Studies I−V.
Patienter fortsatte på stabil samtidig anti-Parkinson- lægemiddel.
Patients continued on stable concomitant anti-Parkinson medicinal product.
Patienter fra 12 år og opefter indtager indholdet af 1 dosisbeholder med 75 mg som en engangsdosis.
Patients from the age of 12 must take the contents of 1 jar with 75 mg.
Patienter fra 4 år og derover som ikke er i stand til at synke kapsler: Dosis beregnes af lægen i forhold til din vægt.
Patients of 4 years of age and older unable to swallow capsules: The dose will be calculated according to your weight by your doctor.
Patienter fra det randomiserede studie blev skiftet til perampanel i løbet af 16 uger, efterfulgt af en langvarig vedligeholdelsesperiode (≥1 år).
Patients from the randomised trial were converted to perampanel over 16 weeks followed by a long term maintenance period (≥1 year).
patienter fra seksårsalderen, der har svær beta-thalassæmi (en arvelig blodsygdom, hvor patienterne ikke har nok hæmoglobin i blodet), og som hyppigt får blodtransfusioner
patients from 6 years of age who have beta thalassaemia major (an inherited blood disorder in which patients do not have enough normal haemoglobin in the blood) and who receive frequent blood transfusions;
Patienter fra studie UC-I og UC-II havde mulighed for at indgå i et åben-label langvarigt forlængelsesstudie(UC III).
Patients from studies UC-I and UC-II had the option to roll over into an open-label long-term extension study (UC III).
Patienter fra Østasien (såsom kinesere, japanere, taiwanesere, koreanere eller thaier) skal begynde med en nedsat dosis på 25 mg eltrombopag én gang daglig (se pkt.
For patients of East Asian ancestry (such as Chinese, Japanese, Taiwanese, Korean or Thai), eltrombopag should be initiated at a reduced dose of 25 mg once daily (see section 5.2).
Patienter får blå mærker eller bløder lettere end normalt.
Bruising or bleeding more easily than normal.
Patienter gives ét Ozurdex-implantat ad gangen via injektion direkte i glaslegemet.
Patients receive one Ozurdex implant at a time, injected directly into the vitreous humour.
Patienter i
studied.
Patienter i alderen 18 år og derover med histologisk verificeret mantelcellelymfom og CT-målbar sygdom indgik.
Patients who were at least 18 years of age with histologically-proven MCL and CT-measurable disease were enrolled.
Patienter i alderen 2 år og derover
Patients from the age of 2 years
Patienter i alderen 80 år eller derover bør behandles med en dagligt dosis på 220 mg som 1 kapsel a 110 mg 2 gange dagligt, grundet en øget risiko for blødning i denne population.
Patients aged 80 years or above should be treated with a daily dose of 220 mg taken as one 110 mg capsule twice daily due to the increased risk of bleeding in this population.
Patienter i alderen >2 måneder til 2 år
Patients aged >2 months to 2 years of age
Patienter i alderen fra fødsel til <2 måneder
Patients from birth to <2 months of age
Patienter i ambulant bør få udleveret recept på både antiemetika og lægemidler mod diarré.
Patients should be provided with outpatient prescriptions for anti-emetic and anti-diarrhoeal medicinal products.
Patienter i armen med GLP-1 receptor- agonister skulle fortsætte med den samme GLP-1-receptoragonist som før indtrædelse i studiet.
Patients in the GLP-1 receptor agonist arm were to continue pre-trial GLP-1 receptor agonist treatment.
Patienter i armen med Tresiba inkluderede 43 børn i alderen 1 til 5 år, 70 børn i alderen 6 til 11 år og 61 unge i alderen 12 til 17 år.
Patients in the Tresiba arm included 43 children aged 1–5 years, 70 children aged 6–11 years and 61 adolescents aged 12–17 years.
Patienter i autologt blodprædonationsprogram
Patients in an autologous blood predonation programme
Patienter i begge behandlingsgrupper fik tilladelse til at skifte til oral fluconazol efter mindst 10 dages intravenøs behandling på betingelse af, at de kunne tåle oral medicin, og at de var afebrile i mindst 24 timer, samt at den seneste bloddyrkning var negativ for Candida-arter.
Patients in both study arms were permitted to switch to oral fluconazole after at least 10 days of intravenous therapy, provided that they were able to tolerate oral medication and were afebrile for at least 24 hours, and that the most recent blood cultures were negative for Candida species.
Patienter i begge behandlingsgrupper tog 40 mg dexamethason oralt én gang dagligt på dag 1 til 4, 9 til 12 og 17 til 20 i hver 28-dages cyklus i de første 4 cyklusser af behandlingen.
Patients in both treatment groups took 40 mg of dexamethasone orally once daily on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy.
Patienter i begge studier blev randomiseret i forholdet 1:1 til enten at få 150 mg ivacaftor eller placebo hver 12. time sammen med fedtholdig mad i 48 uger i tillæg til deres ordinerede CF-behandlinger (f.eks. tobramycin, dornase alfa).
Patients in both studies were randomised 1:1 to receive either 150 mg of ivacaftor or placebo every 12 hours with food containing fat for 48 weeks in addition to their prescribed CF therapies (e.g., tobramycin, dornase alfa).
Patienter i behandling med Aclasta bør få udleveret indlægssedlen og patienthuskekortet.
Patients treated with Zoledronic acid Teva Pharma should be given the package leaflet and the patient reminder card.
Patienter i behandling med anti-arytmi-lægemidler til kontrol af arytmier og lægemidler mod krampeanfald til kontrol af krampelidelser blev ekskluderet fra de kliniske studier.
Patients taking anti-arrhythmic medicinal products for the control of arrhythmias and anti-seizure medicinal products for the control of seizure disorders were excluded from clinical trials.
Patienter i behandling med antiarytmika til kontrol af arytmier og antiepileptika mod krampeanfald blev ekskluderet fra de kliniske studier.
Patients taking anti-arrhythmic medicinal products for the control of arrhythmias and anti-seizure medicinal products for the control of seizure disorders were excluded from clinical trials.
Patienter i behandling med antivirale stoffer mod influenza bør ikke få Pandemisk influenzavaccine H5N1 MedImmune tidligere end 48 timer efter ophør af den antivirale behandling af influenza.
Vaccine recipients under treatment with influenza antiviral agents should not receive Pandemic influenza vaccine H5N1 MedImmune until 48 hours after the cessation of influenza antiviral therapy.
Patienter i behandling med Benepali bør få udleveret et eksemplar af 'Patientkort'.
Patients treated with Benepali should be given the Patient Alert Card.
Patienter i behandling med CellCept, der får tilbagevendende infektioner, skal have målt serum- immunglobuliner.
Patients on CellCept who develop recurrent infections should have their serum immunoglobulins measured.
Patienter i behandling med CellCept, der får tilbagevendende infektioner, skal have målt serum- immunoglobuliner.
Patients on CellCept who develop recurrent infections should have their serum immunoglobulins measured.
Patienter i behandling med Enbrel bør få udleveret et eksemplar af ’Patientkort’.
Patients treated with Enbrel should be given the Patient Alert Card.
Patienter i behandling med filgrastim, der fortæller om øvre venstre abdominale smerter og/eller smerter yderst i skulderen, skal undersøges for forstørret milt/miltruptur.
Individuals receiving filgrastim who report left upper abdominal and/ or shoulder tip pain should be evaluated for an enlarged spleen or splenic rupture.
Patienter i behandling med filgrastim, der fortæller om øvre venstre abdominale smerter og/eller smerter yderst på skulderen, skal undersøges for forstørret milt/miltruptur.
Individuals receiving filgrastim who report left upper abdominal and/ or shoulder tip pain should be evaluated for an enlarged spleen or splenic rupture.
Patienter i behandling med Lamivudin Teva bør undersøges regelmæssigt.
During treatment with Lamivudine Teva patients should be monitored regularly.
Patienter i behandling med lomitapid bør orienteres om den potentielle risiko for dehydrering i forbindelse med gastrointestinale bivirkninger og tage forholdsregler for at undgå væskemangel.
Patients treated with lomitapide should be advised of the potential risk of dehydration in relation to gastrointestinal side effects and take precautions to avoid fluid depletion.
Patienter i behandling med lumacaftor/ivacaftor i 24 uger i studie 1 eller studie 2 fortsatte med at vise forbedringer i BMI efter yderligere 24 uger.
Patients treated with lumacaftor/ivacaftor for 24 weeks in Trial 1 or Trial 2 continued to show improvements in BMI after an additional 24 weeks.
Patienter i behandling med orale antikoagulantia: Metalyse kan overvejes, når resterende virkning af antikoagulans er usandsynlig ud fra dosering eller tiden siden sidste administration, og hvis relevant(e) test for antikoagulerende aktivitet af det (de) pågældende præparat(er) ikke viser en klinisk relevant aktivitet på koagulationssystemet (f.eks.
Patients receiving oral anticoagulants: The use of Metalyse may be considered when dosing or time since the last intake of anticoagulant treatment makes residual efficacy unlikely and if appropriate test(s) of anticoagulant activity for the product(s) concerned show no clinically relevant activity on the coagulation system (e.g.
Patienter i behandling med pomalidomid i kombination med dexamethason har udviklet venøse trombotiske hændelser (hovedsageligt dyb venetrombose og lungeemboli) samt arterielle trombotiske hændelser (myokardieinfarkt og cerebrovaskulært anfald).
Patients receiving pomalidomide in combination with dexamethasone have developed venous thromboembolic events (predominantly deep vein thrombosis and pulmonary embolism) and arterial thrombotic events (myocardial infarction and cerebrovascular accident).
Patienter i behandling med potente OATP1B1-hæmmere (fx ciclosporin).
Patients on treatment with potent inhibitors of OATP1B1 (e.g. cyclosporine)
Patienter i behandling med SYLVANT, der har kendt nedsættelse af leverfunktionen, samt patienter med forhøjet aminotransferase eller forhøjet bilirubin, bør monitoreres.
SYLVANT-treated patients with known liver impairment as well as patients with elevated transaminase or elevated bilirubin should be monitored.
Patienter i behandling med systemisk steroidbehandling, clonidin og H2-blokkere.
Patients receiving systemic steroid therapy, clonidine and H2 blocking agents.
Patienter i behandling med Vargatef har en øget risiko for venøs tromboembolisme, herunder dyb venøs trombose.
Patients treated with Vargatef have an increased risk of venous thromboembolism including deep vein thrombosis.
Patienter i behandling med VFEND har udviklet eksfoliative kutanreaktioner, såsom Stevens-Johnsons syndrom.
Patients have developed exfoliative cutaneous reactions, such as Stevens-Johnson syndrome, during treatment with VFEND.
Patienter i behandling med Vipdomet bør undgå at indtage alkohol og alkoholholdige produkter.
Consumption of alcohol and medicinal products containing alcohol should be avoided.
Patienter i behandling med voriconazol har udviklet eksfoliative kutanreaktioner, såsom Stevens- Johnsons syndrom.
Patients have developed exfoliative cutaneous reactions, such as Stevens-Johnson syndrome, during treatment with voriconazole.
Patienter i behandling med Zoledronsyre Accord bør få udleveret indlægssedlen og patienthuskekortet.
Patients treated with Zoledronic Acid Accord should be given the package leaflet and the patient reminder card.
Patienter i behandlingsgruppe med 300 mg alirocumab hver 4. uge modtog skiftende placeboinjektioner for at bibeholde “blindheden” i forhold til injektionshyppigheden.
Patients in the alirocumab 300 mg every 4 weeks treatment group received alternating placebo injections to maintain blinding in regard to injection frequency.
Patienter i behandlingsgruppen med exenatid opløsning til injektion med HbA1c 8,0 % i slutningen af BIO-fasen reducerede deres insulin glargin-dosis med mindst 10 %.
Patients in the immediate-release exenatide-treated group with an HbA1c 8.0% at the end of the BIO phase decreased their insulin glargine dose by at least 10%.
Patienter i BzmbDx- gruppen fik fire 21-dages cyklusser, hver bestående af bortezomib (1,3 mg/m2 administreret intravenøst to gange om ugen på dag 1, 4, 8 og 11) og oralt dexamethason (40 mg/dag på dag 1 til 4 og dag 9 til 12 i cyklus 1 og 2 og på dag 1 til 4 i cyklus 3 og 4).
Patients in the BzmbTDx group received six 4-week cycles, each consisting of bortezmib (1.3 mg/m2 administered twice weekly days 1, 4, 8, and 11, followed by a 17-day rest period from day 12 to day 28), dexamethasone (40 mg administered orally on days 1 to 4 and days 8 to 11), and thalidomide (administered orally at 50 mg daily on days 1-14, increased to 100 mg on days 15-28 and thereafter to 200 mg daily).
Patienter i D3-vitamin 2.800 gruppen fik FOSAVANCE (70 mg/2.800 IE) (n=299), og patienter i D3-vitamin 5.600 gruppen fik FOSAVANCE (70 mg/2.800 IE) plus yderligere 2.800 IE D3-vitamin (n=309) én gang ugentligt; yderligere D-vitamintilskud var tilladt.
Patients in the Vitamin D3 2,800 group received FOSAVANCE (70 mg/2,800 IU) (n=299) and patients in the Vitamin D3 5,600 group received FOSAVANCE (70 mg/2,800 IU) plus an additional 2,800 IU vitamin D3 (n=309) once a week; additional vitamin D supplements were allowed.
Patienter i D3-vitamin 2.800 gruppen fik VANTAVO (70 mg/2.800 IE) (n=299), og patienter i D3-vitamin 5.600 gruppen fik VANTAVO (70 mg/2.800 IE) plus yderligere 2.800 IE D3-vitamin (n=309) én gang ugentligt; yderligere D-vitamintilskud var tilladt.
Patients in the Vitamin D3 2800 group received VANTAVO (70 mg/2800 IU) (n=299) and patients in the Vitamin D3 5600 group received VANTAVO (70 mg/2800 IU) plus an additional 2800 IU vitamin D3 (n=309) once a week; additional vitamin D supplements were allowed.
Patienter i del II (dobbelblindet) fik enten Ilaris 4 mg/kg eller placebo hver 4. uge, indtil 37 udbrud var forekommet.
Patients in part II (double-blind) received either Ilaris 4 mg/kg or placebo every 4 weeks until 37 flare events occurred.
patienter i den perioperative levertransplantationsperiode, samt til nyfødte under 4 uger.
patients in the perioperative liver transplantation period and in neonates up to 4 weeks of age.
Patienter i det pivotale studie BO21004/CLL11 blev på forskellige tidspunkter testet for anti-terapeutiske-antistoffer (ATA) mod Gazyvaro.
Patients in the pivotal study BO21004/CLL11 were tested at multiple time-points for anti-therapeutic antibodies (ATA) to Gazyvaro.
Patienter i det pivotale studie CLEOPATRA blev på flere tidspunkter testet for anti-terapeutiske antistoffer mod Perjeta.
Patients in the pivotal trial CLEOPATRA were tested at multiple time-points for anti-therapeutic antibodies (ATA) to Perjeta.
Patienter i dette studie har haft diagnosen PsA i mindst 6 måneder og har som minumum haft mild psoriasis sygdom.
Patients in this study had a diagnosis of PsA for at least 6 months and had at least mild psoriatic disease.
Patienter i disse studier havde haft diagnosen AS i en mediantid på 2,7 til 5,8 år.
Patients in these studies had a diagnosis of AS for a median of 2.7 to 5.8 years.
Patienter i disse studier havde haft diagnosen PsA i en mediantid på 3,9 til 5,3 år.
Patients in these studies had a diagnosis of PsA for a median of 3.9 to 5.3 years.
Patienter i docetaxel-armen fik 75 mg/m² docetaxel (T) efterfulgt af 75 mg/m² cisplatin (P) efterfulgt af
Patients on the docetaxel arm received docetaxel (T) 75 mg/m² followed by cisplatin (P) 75 mg/m² followed by
Patienter i docetaxel-armen modtog docetaxel (T) 75 mg/m2 efterfulgt af cisplatin (P) 75 mg/m2 efterfulgt af 5- fluoruracil (F) 750 mg/m2 daglig som en kontinuerlig infusion i 5 dage.
Patients on the docetaxel arm received docetaxel (T) 75 mg/m2 followed by cisplatin (P) 75 mg/m2 followed by fluorouracil (F) 750 mg/m2 per day as a continuous infusion for 5 days.
Patienter i enhver form for samtidig behandling, der indeholder bupropion eller naltrexon
Patients receiving any concomitant treatment containing bupropion or naltrexone
Patienter i enkeltcenterstudiet havde relaps efter 1-6 forudgående terapiregimer, og 2 patienter havde relaps efter stamcelletransplantation.
Patients in the single centre study had relapsed following 1-6 prior therapy regimens and 2 patients had relapsed following stem cell transplantation.
Patienter i henholdsvis VcTDx- og TDx-gruppen havde en gennemsnitsalder på 57 versus 56 år, 99 % versus 98 % af patienterne var kaukasere og 58 % versus 54 % var mænd.
Patients in the VcTDx and TDx groups respectively had a median age of 57 versus 56 years, 99% versus 98% patients were Caucasians, and 58% versus 54% were males.
Patienter i Humira- behandling bør få udleveret et særligt patientkort.
Patients treated with Humira should be given the special alert card.
Patienter i Humira-behandling bør få udleveret et særligt patientkort.
Patients treated with Humira should be given the special alert card.
Patienter i hæmodialyse:
Hemodialysis patients
Patienter i immunsuppressiv behandling har øget risiko for at udvikle maligne lidelser.
Patients receiving immunosuppressive therapy are at increased risk of developing malignancies.
Patienter i immunsupprimerende behandling, herunder med mercaptopurin, har en øget risiko for at udvikle lymfoproliferative sygdomme og andre maligniteter, især hudcancer (melanom og non- melanom), sarkomer (Kaposi og non-Kaposi) og cervixcancer in situ.
Patients receiving immunosuppressive therapy, including mercaptopurine, are at an increased risk of developing lymphoproliferative disorders and other malignancies, notably skin cancers (melanoma and non-melanoma), sarcomas (Kaposi's and non-Kaposi's) and uterine cervical cancer in situ.
Patienter i kemoterapi-armen kunne skifte over til trametinib-armen efter uafhængig bekræftelse af sygdomsprogression.
Patients in the chemotherapy arm were allowed to cross-over to the trametinib arm after independent confirmation of progression.
Patienter i kliniske forsøg som oplevede milde eller moderate infusionsrelaterede reaktioner under behandling med agalsidase beta fortsatte behandlingen efter en reduktion af infusionshastigheden (~0,15 mg/min; 10 mg/t) og/eller forbehandling med antihistaminer, paracetamol, ibuprofen og/eller kortikosteroider.
Patients experiencing mild or moderate infusion-associated reactions when treated with agalsidase beta during clinical trials have continued therapy after a reduction in the infusion rate (~0.15 mg/min; 10 mg/hr) and/or pre-treatment with antihistamines, paracetamol, ibuprofen and/or corticosteroids.