natgillin/translations-raw huggingface dataset:
Patienter (%), der opnåede HbA1c < 7 %
Patients (%) achieving HbA1c < 7
Patienter (%), der opnåede HbA1c <7 % med baseline- HbA1c ≥7 %2
Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7%2
Patienter (%), der opnåede HbA1c <7 % med baseline-HbA1c
Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7%2
Patienter (%), der opnåede HbA1c ≤ 7 %
Patients (%) achieving HbA1c ≤ 7
Patienter (børn), der ikke er i stand til at synke kapslerne, kan dispergere tabletterne i et glas almindeligt vand eller æblejuice.
For patients (children) unable to swallow the capsules, their content may be diluted in a glass of either still water or apple juice.
Patienter (n=1.822), der tidligere deltog i fase 2 eller 3 af vedolizumab-studierne, kunne deltage i et løbende open-label studie og fik vedolizumab 300 mg hver 4. uge.
Patients (n=1,822) previously enrolled in Phase 2 or 3 vedolizumab studies were eligible to enrol in an ongoing open-label study and received vedolizumab 300 mg every four weeks.
Patienter (n=368) blev randomiseret på en dobbeltblind måde (3:2) til at få 2 doser vedolizumab 300 mg eller placebo i uge 0 og uge 2.
Patients (n=368) were randomised in a double-blind fashion (3:2) to receive two doses of vedolizumab 300 mg or placebo at Week 0 and Week 2.
Patienter (og deres omsorgspersoner) skal informeres om nødvendigheden af overvågning for forekomst af en hvilken som helst klinisk forværring, selvmordsrelateret adfærd eller selvmordstanker samt unormal adfærd og om, at de straks skal søge læge, hvis disse symptomer opstår.
Patients (and caregivers of patients) should be alerted to the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Patienter (og plejepersonale) bør tilrådes straks at søge læge, hvis der opstår tegn på selvmordstanker og –adfærd (se pkt.
Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge (see section 4.8).
Patienter 40 kg og derover
Patients 40 kg and above
Patienter 40 kg og derover*
Patients 40 kg and above
Patienter 40 kg og derover**
Patients 40 kg and above
Patienter < 30 kg, som ikke får valproat:
Patients <30 kg not receiving valproate:
Patienter < 30 kg, som ligeledes behandles med valproat:
Patients <30 kg also receiving valproate medication:
Patienter < 30 kg, som ligeledes behandles med valproat:
Patients <30 kg also receiving valproate:
Patienter < 6 år kan have behov for højere doser til vedligeholdelse af hæmogloblinkoncentrationen end patienter over den alder.
Patients < 6 years of age may need higher doses for maintenance of haemoglobin than patients above that age.
Patienter < 60 kg
Patients < 60 kg
Patienter <12 år: Ifølge resultaterne fra et klinisk studie, der påviste, at pædiatriske patienter under 12 år har lavere eksponering for VWF, bør det overvejes at give en profylaktisk dosis i området 40-80 IE VWF:RCo/kg legemsvægt 1-3 gange om ugen (se pkt.
Patients aged <12 years old: Based on results from a clinical trial in which paediatric patients under 12 years of age were shown to have lower exposure of VWF, a prophylactic dose range of 40 – 80 IU VWF:RCo/kg body weight 1 to 3 times a week should be considered. (see Section 5.2).
Patienter <30 kg, som ikke får valproat:
Patients <30 kg not receiving valproate:
Patienter <30 kg, som også får valproat:
Patients <30 kg also receiving valproate:
Patienter > 70 år kan få flere gastrointestinale bivirkninger ved behandling med liraglutid.
Patients >70 years may experience more gastrointestinal effects when treated with liraglutide.
Patienter > 75 år fik en dosis dexamethason på 20 mg én gang dagligt på dag 1, 8, 15 og 22 i hver 28-dages cyklus.
Patients >75 years received a dexamethasone dose of 20 mg once daily on Days 1, 8, 15, and 22 of each 28-day cycle.
Patienter > 75 år har imidlertid en mulig risiko for en øget hyppighed af alvorlige bivirkninger.
However, patients with age >75 years are potentially at risk for a higher frequency of serious adverse reactions.
Patienter >100 kg: 30 ml BRINAVESS 20 mg/ml tilsættes til 120 ml infusionsvæske.
Patients > 100 kg: 30 ml of BRINAVESS 20 mg/ml is added to 120 ml of diluent.
Patienter >100 kg: 30 ml BRINAVESS 20 mg/ml tilsættes til 120 ml infusionsvæske.
Patients >100 kg: 30 ml of BRINAVESS 20 mg/ml is added to 120 ml of diluent.
Patienter af ikke-kaukasisk oprindelse har ikke været inkluderet i disse kliniske studier.
Patients of non- Caucasian origin have not been included in these clinical studies.
Patienter af sort afrikansk eller afrocaribisk oprindelse bør derfor informeres om, at de skal fortsætte behandlingen, men søge lægehjælp, hvis astmasymptomerne fortsat er ukontrollerede under behandling med Aerivio Spiromax, eller hvis de forværres.
Patients of black African or Afro-Caribbean ancestry should therefore be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen whilst using Aerivio Spiromax.
Patienter af sort afrikansk eller afrocaribisk oprindelse bør derfor informeres om, at de skal fortsætte behandlingen, men søge lægehjælp, hvis astmasymptomerne fortsat er ukontrollerede under behandling med Airexar Spiromax, eller hvis de forværres.
Patients of black African or Afro-Caribbean ancestry should therefore be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen whilst using Aerivio Spiromax.
Patienter af østasiatisk oprindelse skal starte med en nedsat dosis på 25 mg eltrombopag én gang daglig (se punkt 5.2).
For patients of East Asian ancestry, eltrombopag should be initiated at a reduced dose of 25 mg once daily (see section 5.2).
Patienter anbefales at undgå eller nedsætte eksponering for direkte sol (også solarier).
Patients are advised to avoid or reduce exposure to direct sunlight (including sunlamps).
Patienter behandlet med 150 mg Cosentyx udviste forbedringer i spinal mobilitet målt ved ændringer i BASMI i forhold til baseline i uge 16 for både AS-studie 1 (-0,40 og -0,12 for placebo); p=0,0114) og AS-studie 2 (-0,51 og -0,22 for placebo; p=0,0533).
Patients treated with Cosentyx 150 mg showed improvements in spinal mobility as measured by change from baseline in BASMI at Week 16 for both AS Study 1 (-0.40 versus -0.12 for placebo; p=0.0114) and AS Study 2 (-0.51 versus -0.22 for placebo; p=0.0533).
Patienter behandlet med acetylsalicylsyre & clopidogrel per protokolgruppe
Patients receiving acetylsalicylic acid & clopidogrel as per protocol
Patienter behandlet med Baraclude har indberettet følgende bivirkninger:
Patients treated with Baraclude have reported the following side effects:
Patienter behandlet med Cimzia havde også signifikant forbedring i ACR50- og 70-responsraterne.
Cimzia treated patients also had significant improvements in ACR 50 and 70 response rates.
Patienter behandlet med Cimzia rapporterede statistisk signifikante forbedringer i Work Productivity Survey sammenlignet med placebo.
Cimzia-treated patients reported statistically significant improvements in the Work Productivity Survey compared to placebo.
Patienter behandlet med Cosentyx 150 mg udviste også statisk signifikante forbedringer i eksplorative endepunkter for fysisk funktion, målt ved Bath Ankylosing Spondylitis Functional Index (BASFI), sammenlignet med placebo (-2,15 og -0,68), og for træthed, målt ved Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)-skalaen, sammenlignet med placebo (8,10 og 3,30).
Patients treated with Cosentyx 150 mg also showed statistically significant improvements on exploratory endpoints in physical function as assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI) compared to placebo (-2.15 versus -0.68), and in fatigue as assessed by the Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-Fatigue) scale compared to placebo (8.10 versus 3.30).
Patienter behandlet med Cosentyx rapporterede signifikante forbedringer i helbredsrelateret livskvalitet, målt ved Short Form-36 Health Survey Physical Component Summary (SF-36 PCS)-score (p<0,001).
Cosentyx-treated patients reported significant improvements in health-related quality of life as measured by the Short Form-36 Health Survey Physical Component Summary (SF-36 PCS) score (p<0.001).
Patienter behandlet med Lyxumia bør informeres om den potentielle risiko for dehydrering i forbindelse med gastrointestinale bivirkninger og træffe foranstaltninger for at undgå væskemangel.
Patients treated with Lyxumia should be advised of the potential risk of dehydration in relation to gastrointestinal adverse reactions and take precautions to avoid fluid depletion.
Patienter behandlet med olaratumab i fase 2-studiet
Olaratumab-treated patients from Phase 2 study
Patienter behandlet med perkutan koronar intervention (PCI): Hvis den sidste subkutane administration af enoxaparinnatrium blev givet mindre end 8 timer inden ballonudvidelsen, er det ikke nødvendigt at give yderligere doser.
For patients managed with percutaneous coronary intervention (PCI): If the last enoxaparin sodium subcutaneous administration was given less than 8 hours before balloon inflation, no additional dosing is needed.
Patienter behandlet med trastuzumabemtansin skal have HER2-positiv tumorstatus, defineret som en score på 3+ ved immunhistokemi (IHC) eller en ratio ≥2,0 ved in situ-hybridisering (ISH) vurderet ved CE-mærket in vitro-diagnostisk (IVD) medicinsk udstyr.
Patients treated with trastuzumab emtansine should have HER2 positive tumour status, defined as a score of 3 + by immunohistochemistry (IHC) or a ratio of ≥ 2.0 by in situ hybridization (ISH) assessed by a CE-marked In Vitro Diagnostic (IVD) medical device.
Patienter behandlet med ustekinumab fik 45 mg eller 90 mg ved uge 0 og 4 (baseret på vægt i henhold til den godkendte dosering)
Patients treated with ustekinumab received 45 mg or 90 mg at Weeks 0 and 4 (dosed by weight as per approved posology)
Patienter behandlet med XELIRI oplevede i langt højere grad gastrointestinal toksicitet sammenlignet med FOLFIRI (48 % og 14 % fik diarré ved henholdsvis XELIRI og FOLFIRI).
Patients treated with XELIRI experienced excessive gastrointestinal toxicity compared with FOLFIRI (diarrhoea 48% and 14% for XELIRI and FLFIRI respectively).
Patienter behandlet med Zinbryta skal informeres om at rapportere eventuelle symptomer på ny eller forværret depression og/eller selvmordstanker til den ordinerende læge.
Patients treated with Zinbryta should be advised to report any symptoms of new or worsening depression, and/or suicidal ideation to the prescribing physician.
Patienter blev betragtet som havende nedsat knoglemarvreserve, hvis de havde et eller flere af følgende: Tidligere myeloablativ terapi med stamcellestøtte; tidligere ekstern stråling til > 25% af den aktive marv; et blodpladetal <100.000 celler/mm3; eller neutrofiltal <1.500 celler/mm3.
Patients were considered to have impaired bone marrow reserve if they had any of the following: prior myeloablative therapy with stem cell support; prior external beam radiation to >25% of active marrow; a platelet count <100,000 cells/mm3; or neutrophil count <1,500 cells/mm3.
Patienter blev fastholdt på studiemedicin, indtil der var PSA-progression (bekræftet 25 % stigning over patientens baseline/nadir) sammen med protokoldefineret radiografisk progression og symptomatisk eller klinisk progression.
Patients were maintained on study treatments until there was PSA progression (confirmed 25% increase over the patient’s baseline/nadir) together with protocol-defined radiographic progression and symptomatic or clinical progression.
Patienter blev klassificeret som ”reagerende”, hvis de ikke havde nogen kræftceller i rygmarvsvæsken efter endt behandling, og hvis deres symptomer ikke var blevet forværret efter fire uger.
A patient was classified as a ‘responder’ if they had no cancer cells in the spinal fluid after treatment and if their symptoms had not got worse after four weeks.
Patienter blev også randomiseret til at få placebo i ugerne 0, 1, 2 og 3, fulgt af samme dosis hver måned med start i uge 4.
Patients were also randomised to receive placebo at Weeks 0, 1, 2, and 3, followed by the same dose every month starting at Week 4.
Patienter blev udelukket fra undersøgelsen, hvis der forekom invasiv øsofaguscancer, hvis de havde cancer i sygehistorien udover ikke-melanomisk hudcancer, eller hvis de tidligere havde fået PDT på øsofagus.
Patients were excluded from the study if there was a presence of invasive oesophageal cancer, if they had a history of cancer other than non- melanoma skin cancer or if they had received prior PDT to the oesophagus.
Patienter blev udvalgt forud af deres læge til 1 af de 3 CCR’er inden randomiseringen.
Patients were pre-selected by their physician to 1 of the 3 CCR prior to randomisation.
Patienter bør dog informeres om, at svimmelhed er blevet indberettet under behandling med Stribild.
However, patients should be informed that dizziness has been reported during treatment with Stribild.
Patienter bør dog underrettes om, at svimmelhed er blevet indberettet som en bivirkning under behandling med tenofovirdisoproxilfumarat.
However, patients should be informed that dizziness has been reported during treatment with tenofovir disoproxil fumarate.
Patienter bør frarådes at amme under behandling med aripiprazol.
Patients should be advised not to breast feed if they are taking aripiprazole.
Patienter bør frarådes at amme under behandling med Aripiprazole.
Patients should be advised not to breast feed if they are taking aripiprazole.
Patienter bør frarådes at drikke grapefrugtjuice under behandlingen med dronedaron.
Patients should be warned to avoid grapefruit juice beverages while taking dronedarone.
Patienter bør få deres serum-kreatinin niveau vurderet før hver dosis af Zoledronsyre Teva.
Patients should have their serum creatinine levels assessed prior to each dose of zoledronic acid.
Patienter bør følges nøje for eventuelle tegn eller symptomer på psykiatriske lidelser.
If psychiatric symptoms persist or worsen, or
Patienter bør henvises til en dermatolog i tilfælde af observation af mistænkelige hudlæsioner.
The patient should be referred to a dermatologist in case suspicious lesions are detected.
Patienter bør i 3 dage gives en dosis på 300 mg to gange daglig.
Patients should not remain on 300 mg twice daily for more than 3 days.
Patienter bør ikke genbehandles med efterfølgende cyklusser af docetaxel indtil neutrofil-antallet gendannes til et niveau > 1.500 celler/mm3 og blodplader gendannes til et niveau > 100.000 celler/mm3.
Patients should not be retreated with subsequent cycles of docetaxel until neutrophils recover to a level > 1,500 cells/mm3 and platelets recover to a level > 100,000 cells/mm3.
Patienter bør ikke givesen dosis på 300 mg to gange daglig i mere end 3 dage.
Patients should not remain on 300 mg twice daily for more than 3 days.
Patienter bør ikke modtage levende og svækkede levende vacciner mens de er i behandling med Raptiva. (Se afsnit 4.4).
Patients should not receive live and live-attenuated vaccines during Raptiva treatment. (See section 4.4).
Patienter bør ikke starte behandling DuoResp Spiromax under en eksacerbation eller ved signifikant eller akut forværring af astma.
Patients should not be initiated on DuoResp Spiromax during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma.
Patienter bør ikke starte behandling med BiResp Spiromax under en eksacerbation eller ved signifikant eller akut forværring af astma.
Patients should not be initiated on BiResp Spiromax during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma.
Patienter bør ikke starte behandling med Budesonid/Formoterol Teva Pharma B.V. under en eksacerbation eller ved signifikant eller akut forværring af astma.
Patients should not be initiated on Budesonide/Formoterol Teva Pharma B.V. during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma.
Patienter bør ikke testes for anti-JCV-antistoffer inden for 2 uger efter PLEX på grund af fjernelse af antistoffer fra serum eller inden for 6 måneder efter IVIg (dvs.
Patients should not be tested for anti-JCV antibodies within 2 weeks of PLEX due to removal of antibodies from the serum, or within 6 months of IVIg (i.e.
Patienter bør indføre en passende daglig rutine for medicinindtagelsen og fastholde en rutine i forhold til madindtagelse.
Patients should establish a convenient daily schedule of drug intake and maintain a steady temporal relationship with food intake.
Patienter bør informeres om symptomer på disse potentielle bivirkninger, og instrueres i, at informere deres læge, hvis de udvikler symptomer såsom øjensmerter eller øget utilpashed, forværring af røde øjne, sløret eller nedsat syn, et øget antal små partikler i deres synsfelt, eller øget lysfølsomhed.
Patients should be informed of symptoms of these potential adverse reactions and instructed to inform their physician if they develop signs such as eye pain or increased discomfort, worsening eye redness, blurred or decreased vision, an increased number of small particles in their vision, or increased sensitivity to light.
Patienter bør informeres om tidlige tegn på overfølsomhedsreaktioner, hvilke kan inkludere angioødem, forbrændinger og brænden på injektionsstedet, forkølelse, rødme, udslæt, generel urticaria, hovedpine, nældefeber, hypotension, letargi, kvalme, rastløshed, tachykardi, tæthed for brystkassen, prikkende fornemmelse, opkastning og hiven efter vejret.
Patients should be informed of the early signs of hypersensitivity reactions, which may include angioedema, burning and stinging at the injection site, chills, flushing, rash, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting and wheezing.
Patienter bør informeres om tidlige tegn på overfølsomhedsreaktioner, hvilke kan inkludere angioødem, forbrændinger og brænden på injektionsstedet, forkølelse, rødme, udslæt, generel urticaria, hovedpine, nældefeber, hypotension, letargi, kvalme, rastløshed, tachykardi, tæthed for brystkassen, prikkende fornemmelse, opkastning og hiven efter vejret.
Patients should be informed of the early signs of hypersensitivity reactions, which may include angioedema, burning and stinging at the injection site, chills, flushing, rash, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, and wheezing.
Patienter bør informeres om, at de, hvis de oplever svimmelhed, bør de undgå mulige farlige gøremål som at føre motorkøretøj eller betjene maskiner.
Patients should be instructed that if they experience dizziness they should avoid potentially hazardous tasks such as driving or operating machines.
Patienter bør informeres om, at depigmentering af hår eller hud også kan forekomme under behandling med sunitinib.
Patients should be advised that depigmentation of the hair or skin may also occur during treatment with sunitinib.
Patienter bør informes om, at de skal undgå potentielle farlige gøremål såsom kørsel eller maskinbetjening, hvis de oplever disse symptomer.
Patients should be instructed that if they experience these symptoms they should avoid potentially hazardous tasks such as driving or operating machinery.
Patienter bør instrueres i at søge læge, hvis der opstår sygdomstegn/symptomer, der tyder på tuberkulose (f.eks. vedvarende hoste, tæring/vægttab, lav feber, apati), under eller efter behandling med Humira.
Patients should be instructed to seek medical advice if signs/symptoms suggestive of a tuberculosis infection (e.g., persistent cough, wasting/weight loss, low grade fever, listlessness) occur during or after therapy with Humira.
Patienter bør modtage kemo-stråleterapi efter kemoterapi
Following chemotherapy, patients should receive chemoradiotherapy.
Patienter bør monitoreres for objektive tegn og for symptomer på blødning - især patienter, som har forudgående eller behandlingsrelateret trombocytopeni.
Patients should be monitored for signs and symptoms of bleeding, particularly those with pre-existing or treatment- related thrombocytopenia.
Patienter bør monitoreres for opiat-
Patients should be monitored for
Patienter bør monitoreres for symptomer på kongestive hjertesvigt under behandlingen og under follow-up-perioden.
Patients should be monitored for symptoms of congestive heart failure during therapy and during the follow up period.
Patienter bør monitoreres for symptomer på kongestivt hjertesvigt under behandlingen og i follow-up- perioden.
Patients should be monitored for symptoms of congestive heart failure during therapy and during the follow up period.
Patienter bør monitoreres for symptomer på kongestivt hjertesvigt under behandlingen og i followup- perioden.
Patients should be monitored for symptoms of congestive heart failure during therapy and during the follow up period.
Patienter bør monitoreres for tegn og symptomer på opioidabstinenser, -toksicitet eller -overdosering som følge af øgede niveauer af naloxon og/eller buprenorphin.
Patients should be monitored for signs and symptoms of precipitated opioid withdrawal, toxicity or overdose caused by increased levels of naloxone and/or buprenorphine.
Patienter bør monitoreres klinisk, hvor samtidig administration med trimethoprim/sulfamethoxazol er påkrævet.
When concomitant administration is warranted, patients should be monitored clinically.
Patienter bør nøje monitoreres for at sikre, at den lavest godkendte effektive dosis MIRCERA anvendes til at sikre tilstrækkelig kontrol af de anæmiske symptomer, mens hæmoglobin- koncentration holdes under eller på 12 g/dl (7,45 mmol/l).
Patients should be monitored closely to ensure that the lowest approved effective dose of MIRCERA is used to provide adequate control of the symptoms of anaemia whilst maintaining a haemoglobin concentration below or at 12 g/dl (7.45 mmol/l).
Patienter bør også modtage passende behandling til regulering af urinsyreniveauet i blodet.
Patients should also receive appropriate treatment to control uric acid levels in the blood.
Patienter bør orienteres om, at Kivexa eller anden antiretroviral kombinationsbehandling ikke helbreder hiv-infektion og at der fortsat kan udvikles opportunistiske infektioner og andre komplikationer af hiv- infektionen.
Patients should be advised that Kivexa or any other antiretroviral therapy does not cure HIV infection and that they may still develop opportunistic infections and other complications of HIV infection.
Patienter bør orienteres om, at Trizivir eller anden antiretroviral behandling ikke helbreder hiv- infektionen, og at de stadig kan få opportunistiske infektioner eller andre komplikationer af hiv- infektionen.
Patients should be advised that Trizivir or any other antiretroviral therapy does not cure HIV infection and that they may still develop opportunistic infections and other complications of HIV infection.
Patienter bør overvåges med henblik på udviklingen af faktor IX-inhibitorer.
Patients should be monitored for the development of factor IX inhibitors.
Patienter bør overvåges nøje under behandlingen.
Patients should be carefully monitored during treatment.
Patienter bør overvåges omhyggeligt for tegn og symptomer på overfølsomhedsreaktioner, herunder overvågning af blodtryk og puls, under og minimum 30 minutter efter hver infusion med Rienso.
Patients should be carefully monitored for signs and symptoms of hypersensitivity reactions including monitoring of blood pressure and pulse during and for at least 30 minutes following each infusion of Rienso.
Patienter bør regelmæssigt undersøges for antistoffer mod menneskeligt hepatitis B-immunglobulin.
Patients should be monitored for antibodies against human hepatitis B immunoglobulin regularly.
Patienter bør rådes til at opbevare kapslerne utilgængeligt og ude af syne for børn, helst i et aflåst skab.
Patients should be advised to keep capsules out of thesight and reach of children, preferably in a locked cupboard.