FrancophonIA/ELRC3.0 huggingface dataset:
English: Prophylaxis of PCP should be considered for patients who require concomitant use of corticosteroids or other immunosuppressive agents based upon current standard of care.
Danish: Standard PJP-profylakse bør overvejes til patienter, som samtidig behandles med kortikosteroider eller andre immunsupprimerende.
English: After first dilution of the concentrate with 1.8 ml of the supplied solvent, the concentration of temsirolimus is 10 mg/ml.
Danish: Efter første fortynding af koncentratet med 1,8 ml af den medfølgende solvens er koncentrationen af temsirolimus 10 mg/ml.
English: Based on the results of a Phase 3 study in MCL, elderly patients (65 years of age) may be more likely to experience certain adverse reactions, including pleural effusion, anxiety, depression, insomnia, dyspnoea, leukopenia, lymphopenia, myalgia, arthralgia, taste loss, dizziness, upper respiratory infection, mucositis, and rhinitis.
Danish: På basis af resultaterne fra et fase-3 studie vedrørende MCL kan ældre patienter (≥65 år) have større sandsynlighed for at få visse bivirkninger, herunder pleuraekssudat, angst, depression, søvnløshed, dyspnø, leukopeni, lymfopeni, myalgi, artralgi, tab af smagssans, svimmelhed, infektion i de øvre luftveje, mucositis og rhinitis.
English: Caution should be used when treating patients with hepatic impairment.
Danish: Der skal udvises forsigtighed ved behandling af patienter med nedsat leverfunktion.
English: One vial of Torisel concentrate contains 30 mg of temsirolimus: when the 1.2 ml concentrate is combined with 1.8 ml of the supplied solvent, a total volume of 3.0 ml is obtained, and the concentration of temsirolimus will be 10 mg/ml.
Danish: Et hætteglas Torisel-koncentrat indeholder 30 mg temsirolimus: Når 1,2 ml koncentrat blandes med 1,8 ml af den medfølgende solvens, fås et totalt volumen på 3,0 ml, og koncentrationen af temsirolimus vil være 10 mg/ml.
English: c Compared with inv choice based on log-rank test. d Compared with inv choice alone based on Fisher's exact test.
Danish: Sammenlignet med investigators valg baseret på en log rank-test.
English: The use of both an in-line and end-filter is not recommended (see sections 6.1 and 6.2).
Danish: Brug af både integeret filter og endefilter kan ikke anbefales (se pkt.
English: The concentrate also contains: anhydrous ethanol, all-rac-α-tocopherol (E 307), propylene glycol and citric acid (E 330).
Danish: Koncentratet indeholder også: Vandfri ethanol, helt rac--tocopherol (E 307), propylenglycol, citronsyre (E 330).
English: Based on the results of the phase 3 studies, elderly patients may be more likely to experience certain adverse reactions, including face oedema, pneumonia, pleural effusion, anxiety, depression, insomnia, dyspnoea, leukopenia, lymphopenia, myalgia, arthralgia, ageusia, dizziness, upper respiratory infection, mucositis, and rhinitis.
Danish: Baseret på resultater fra fase 3 studie er det mere sandsynligt, at ældre får visse bivirkninger herunder ansigtsødem, pneumoni, pleural effusion, angst, depression, søvnløshed, dyspnø, leukopeni, lymfopeni, myalgi, artralgi, ageusi, svimmelhed, infektion i øvre luftveje, mucositis og rhinitis.
English: A.
Danish: i.v.
English: • Administration of the final diluted solution should be completed within six hours from the time that the Torisel is first added to sodium chloride 9 mg/ml (0.9%) solution for injection.
Danish: • Indgivelse af den færdigfortyndede infusionsvæske skal fuldføres inden for seks timer fra det tidspunkt, hvor Torisel første gang sættes til natriumchlorid 9 mg/ml (0,9%) injektionsvæske, opløsning.
English: Pack size: 1 vial of concentrate and 1 vial of solvent
Danish: Pakningsstørrelse: 1 hætteglas med koncentrat og 1 hætteglas med solvens.
English: The concentrate-solvent mixture may only be administered in sodium chloride 9 mg/ml (0.9%) solution for injection.
Danish: Koncentrat-solvens-blandingen må kun indgives i natriumchlorid 9 mg/ml (0,9%) injektionsvæske.
English: Contains: polysorbate 80 (E 433), macrogol 400, anhydrous ethanol.
Danish: Indeholder: Polysorbat 80 (E 433), macrogol 400, vandfri ethanol.
English: Each vial of 1.2 ml of concentrate for solution for infusion contains 30 mg temsirolimus.
Danish: Hvert hætteglas på 1,2 ml koncentrat til infusionsvæske, opløsning, indeholder 30 mg temsirolimus.
English: The required amount of the temsirolimus-solvent mixture (10 mg/ml) must be withdrawn and then rapidly injected into sodium chloride 9 mg/ml (0.9%) solution for injection.
Danish: Den ønskede mængde af temsirolimus-solvensblandingen (10 mg/ml) skal trækkes op og injiceres hurtigt i natriumchlorid 9 mg/ml (0,9 %) injektionsvæske.
English: Renal cell carcinoma
Danish: Renalcellekarcinom
English: Temsirolimus dose modifications based on weekly ANC and platelet counts ANC
Danish: Dosisændringer for temsirolimus baseret på ugentlige absolutte neutrofiltal og ugentlige trombocyttal
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2.2 ml
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: For mantle cell lymphoma, the recommended dose is 175 mg infused (as a drip) over a 30- to 60-minute period once weekly for 3 weeks followed by single weekly doses of 75 mg infused (as a drip) over a 30- to 60-minute period.
Danish: Til mantlecellelymfom er den anbefalede dosis 175 mg tilført (som drop) over en 30- til 60-minutters periode en gang om ugen i 3 uger efterfulgt af doser på 75 mg om ugen tilført (som drop) over en 30til 60-minutters periode.
English: Based on the Phase 1 study, no dose adjustment of temsirolimus is recommended for RCC patients with baseline platelet counts 100 x 109/l and mild to moderate hepatic impairment (total bilirubin up to 3 times upper limit of normal [ULN] with any abnormality of AST, or as defined by Child-Pugh Class A or B).
Danish: 9/l og let til moderat leverinsufficiens (totalbilirubin op til 3 gange den øvre normalgrænse [ULN] med enhver ASAT-abnormalitet eller som defineret ved Child-Pugh klasse A eller B).
English: The adverse reactions (all grades) experienced by at least 20% of the patients in RCC and MCL registration studies include anaemia, nausea, rash (including rash, pruritic rash, maculopapular rash, pustular rash), decreased appetite, oedema asthenia, fatigue, thrombocytopenia, diarrhoea, pyrexia, epistaxis, mucosal inflammation, stomatitis, vomiting, hyperglycaemia, hypercholesterolemia, dysgeusia, pruritus, cough, infection, pneumonia, dyspnoea.
Danish: Hos mere end 20% af patienterne i RCC- og MCL-studierne sås bivirkninger (alle grader), der inkluderer anæmi, kvalme, udslæt (herunder udslæt, kløende udslæt, maculopapuløst udslæt, pustulært udslæt), nedsat appetit, ødem, asteni, udtalt træthed, trombocytopeni, diarre, pyrexi, epistaxis, mucosa inflammation, stomatitis,opkastning, hyperglykæmi, hyperkolesterolæmi, dysgeusi, kløe, hoste, infektion, pneumoni, dyspnø.
English: Reductions in testicular weights and/or histological lesions (e.g., tubular atrophy and tubular giant cells) were observed in mice, rats, and monkeys.
Danish: Hos mus, rotter og aber blev der observeret reduktion i testikelvægt og/eller histologiske læsioner (f.eks. tubulær atrofi og tubulære kæmpeceller).
English: It is recommended that patients be followed closely for occurrence of clinical respiratory symptoms and patients should be advised to report promptly any new or worsening respiratory symptoms.
Danish: Det anbefales, at patienterne følges nøje med henblik på, om der opstår kliniske luftvejssymptomer.
English: The solvent is a clear to slightly turbid, light-yellow to yellow solution, free from visible particulates.
Danish: Solvensen er en klar til let uklar, lysegul til gul opløsning, fri for synlige partikler.
English: The temsirolimus arm showed a 49% increase in median OS compared with the IFN-α arm. Temsirolimus also was associated with statistically significant advantages over IFN-α in the secondary endpoints of PFS, TTF, and clinical benefit rate.
Danish: temsirolimus var også forbundet med statistisk signifikante fordele frem for IFN- i de sekundære endemål for PFS, TTF og klinisk nyttegrad.
English: The solvent contains: polysorbate 80 (E 433), macrogol 400 and anhydrous ethanol.
Danish: Solvens indeholder: polysorbat 80 (E 433), macrogol 400, vandfri ethanol.
English: Parameter temsirolimus 175/75 mg n = 54
Danish: Resumé af effektresultater i temsirolimus intravenøs MCL-klinisk studier Parameter temsirolimus 175/75 mg n = 54
English: Amphiphilic agents
Danish: Amfifile stoffer
English: The administration materials must consist of nonDEHP, non-PVC tubing with appropriate filter.
Danish: • Hensigtsmæssige materialer til indgivelse skal anvendes for at undgå for kraftigt tab af lægemiddel og for at nedsætte ekstraktionsgraden af DEHP. Materialerne til indgivelse skal bestå af non-DEHP, non-PVC-slanger med et passende filter.
English: If you experience any of them, seek medical advice immediately.
Danish: Hvis du får disse bivirkninger, skal du straks kontakte lægen.
English: Keep this leaflet.
Danish: - Gem indlægssedlen.
English: After further dilution of the concentrate-solvent mixture with sodium chloride 9 mg/ml (0.9%) solution for injection
Danish: Efter yderligere fortynding af opløsningen af koncentratog solvens med natriumchlorid 9 mg/ml (0,9%) injektionsvæske:
English: Uncommon Pulmonary embolism a
Danish: Pleura-effusion a,b
English: For mantle cell lymphoma, multiple vials will be required for each dose over 25 mg.
Danish: Til mantelcellelymfom vil der være brug for flere hætteglas til hver dosis over 25 mg.
English: Hyperlipaemia
Danish: Hyperlipæmi
English: Bleeding in the brain
Danish: Blodprop i lungen
English: Temsirolimus should be used with caution in patients with severe renal impairment (see section 4.4).
Danish: Temsirolimus skal anvendes med forsigtighed til patienter med svær nyreinsufficiens (se pkt.
English: Somnolence
Danish: Søvnighed
English: The solvent is a clear to slightly turbid, light-yellow to yellow solution.
Danish: Solvensen er en klar til let uklar lysegul til gul opløsning.
English: Embolism of the lung, perforation of the gut, problems with wound healing after surgery, inflammation and swelling of the voice box.
Danish: Blodprop i lungen, hul i tarmen, problemer med sårheling efter operation, betændelseslignende tilstand og hævelse i strubehovedet
English: For MCL, multiple vials will be required for each dose over 25 mg.
Danish: Bemærk: Til MCL vil der være brug for flere hætteglas til hver dosis over 25 mg.
English: Other side effects with Torisel may include:
Danish: Andre bivirkninger er set hos patienter, der er blevet behandlet med Torisel:
English: The concentrate-solvent mixture should be inspected visually for particulate matter and discolouration.
Danish: Koncentrat-solvens-blandingen skal inspiceres visuelt for partikler og misfarvning inden administration.
English: You should seek medical advice immediately if you suffer from general swelling, shortness of breath, tiredness.
Danish: Kontakt straks læge, hvis du får omfattende hævelser, åndenød og træthed.
English: Gastrointestinal haemorrhage (including anal, rectal, haemorrhoidal, lip, and mouth haemorrhage, gingival bleeding)
Danish: Almindelig Gastroinstinal blødning (herunder rektal blødning, blødning fra hæmorider, læber og blødning fra mund og gummer
English: b Based on Cox proportional hazard model stratified by prior nephrectomy and region (95% CI are descriptive only).
Danish: Baseret på Cox proportional risikomodel stratificeret på tidligere nephrectomistatus og region.
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Danish: ETIKETTERING OG INDLÆGSSEDDEL
English: The required amount of concentrate-solvent mixture from each vial must be combined in one syringe for rapid injection into 250 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Danish: Den nødvendige mængde koncentrat-solvens-blanding fra hvert hætteglas skal samles i én sprøjte for hurtigt at kunne injiceres i 250 ml natriumchlorid 9 mg/ml (0,9%) injektionsvæske (se pkt.
English: Co-administration of temsirolimus 5 mg with ketoconazole, a potent CYP3A4 inhibitor, had no significant effect on temsirolimus Cmax or AUC; however, sirolimus AUC increased 3.1-fold, and AUCsum (temsirolimus + sirolimus) increased 2.3-fold compared to temsirolimus alone.
Danish: Samtidig indgift af temsirolimus og rifampicin, en potent CYP3A4/5-induktor, havde ingen signifikant virkning på den maksimale temsirolimus koncentration (Cmax) og arealet under koncentrationstidskurven (AUC) efter intravenøs indgift, men reducerede sirolimus Cmax med 65% og AUC med 56%, sammenlignet med temsirolimus-behandling alene.
English: For patients with RCC and severe hepatic impairment (total bilirubin >3 times ULN with any abnormality of AST, or as defined by Child-Pugh Class C), the recommended dose for patients who have baseline platelets 100 x 109/l is 10 mg intravenous once a week infused over a 30-60 minute period (see section 4.2).
Danish: Til patienter med RCC og svær leverinsufficiens (totalbilirubin >3 gange ULN med enhver ASAT-abnormalitet eller som defineret ved Child-Pugh klasse C) med baseline-trombocytter 100 x 10
English: Very common Rash (including rash, pruritic rash, maculo-papular rash, rash, generalised rash, macular rash, papular rash) Pruritus (including pruritus generalised)
Danish: Udslæt (herunder udslæt, kløende udslæt, maculopapuløst udslæt, udslæt, generelt udslæt, makuløst udslæt, papuløst udslæt) Pruritus (herunder generel kløe)
English: Torisel, when diluted, contains polysorbate 80 and therefore appropriate administration materials must be used (see sections 6.1 and 6.2).
Danish: Torisel indeholder, når det er fortyndet, polysorbat 80, og der skal derfor anvendes hensigtsmæssige materialer til indgivelse (se pkt.
English: OS was similar.
Danish: OS blev også evalueret.
English: Posology
Danish: KARTON
English: a Hazard ratio IFN-α n = 207 P-value (95% CI)
Danish: IFN- n = 207
English: The concentrate for solution for infusion must be diluted with the supplied solvent before administration in sodium chloride 9 mg/ml (0.9%) solution for injection.
Danish: Koncentratet til infusionsvæske, opløsning, skal fortyndes med den medfølgende solvens før injektion i natriumchlorid 9 mg/ml (0,9%) injektionsvæske.
English: How to store Torisel
Danish: Solvens til Torisel.
English: In 36 patients with MCL, including 4 poor metabolisers, the effect of CYP2D6 inhibition after administration of single doses of 175 mg and 75 mg temsirolimus was investigated.
Danish: Effekten af CYP2D6-hæmning efter administration af 175 mg og 75 mg temsirolimus som enkeltdoser er blevet undersøgt hos 36 patienter med mantlecellelymfom, heraf 4 patienter med nedsat metabolisme.
English: Torisel 30 mg concentrate and solvent for solution for infusion
Danish: Torisel 30 mg koncentrat og solvens til infusionsvæske, opløsning.
English: Intestinal puncture, tear or holes
Danish: Knogler, led, muskler og bindevæv
English: One-year survival rate % (97.5% CI) a Compared with inv choice based on Cox proportional hazard model.
Danish: Sammenlignet med investigators valg baseret på modellen med Cox-regression (proportional hazards).
English: Hypersensitivity reactions / drug hypersensitiviy
Danish: Immunsystemet Almindelig Allergiske reaktioner/ lægemiddeloverfølsomhedsreaktioner
English: Rhabdomyolysis
Danish: Hyperglykæmi
English: How Torisel is given
Danish: Sådan bliver du behandlet med Torisel
English: 1 vial of concentrate contains 474 mg of anhydrous ethanol 1.8 ml of the solvent provided contains 358 mg anhydrous ethanol For the full list of excipients, see section 6.1.
Danish: 1,8 ml af den medfølgende solvens indeholder 358 mg vandfri ethanol.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of concentrate for solution for infusion contains 30 mg temsirolimus.
Danish: Hvert hætteglas med koncentrat til infusionsvæske, opløsning, indeholder 30 mg temsirolimus.
English: Upper respiratory tract infection Pharyngitis
Danish: Urinvejsinfektion (herunder cystitis) Infektioner i øvre luftveje Faryngitis
English: STEP 2: ADMINISTRATION OF CONCENTRATE FOR SOLUTION FOR INFUSION SOLVENT MIXTURE IN SODIUM CHLORIDE 9 MG/ML (0.9%) SOLUTION FOR INJECTION
Danish: TRIN 2: TILSÆTNING AF BLANDINGEN AF KONCENTRAT TIL INFUSIONSVÆSKE, OPLØSNING OG SOLVENS TIL NATRIUMCHLORID 9 MG/ML (0,9%) INJEKTIONSVÆSKE, OPLØSNING
English: Very common Fatigue Oedema (including generalised oedema, facial oedema, peripheral oedema, scrotal oedema, genital oedema)
Danish: Ødemer (herunder ødem, generelt ødem, ansigtsødem, perifere ødemer, skrotalt ødem, genitalt ødem) Asteni
English: The use of temsirolimus has been associated with abnormal wound healing; therefore, caution should be exercised with the use of temsirolimus in the peri-surgical period.
Danish: Der skal derfor udvises forsigtighed ved brugen af temsirolimus i den perioperative periode.
English: Dizziness
Danish: Nyresvigt
English: Constipation
Danish: Træthed
English: Temsirolimus should be used with caution in patients with hepatic impairment (see section 4.4).
Danish: Leverinsufficiens Temsirolimus skal anvendes med forsigtighed til patienter med leverinsufficiens (se pkt.
English: IV use
Danish: anvendelse.
English: Holda a Upon recovery to ANC 1.0 x 109/l (1000 cells/mm3) and platelets to 50 x 109/l
Danish: Når der er opnået et absolut neutrofiltal på ≥ 1,0 x 10 9/l (1.000 celler/mm 3) og et trombocyttal på ≥ 50 x 10 9/l (50.000 celler/mm 3), skal dosis reduceres til det næstfølgende dosisniveau i henhold til tabellen ovenfor.
English: Uncommon side effects (may affect up to 1 in 100 people):
Danish: Almindelige bivirkninger (forekommer hos mellem 1 og 10 ud af 100 patienter):
English: This may increase the risk of bleeding/bruising and infection (see section “Possible side effects").
Danish: Det kan medføre risiko for blødning/blå mærker og infektion.
English: 1.0 x 109/l
Danish: < 1,0 x 10
English: Temsirolimus elimination by the kidneys is negligible; studies in patients with varying renal impairment have not been conducted (see sections 4.2 and 5.2).
Danish: Studier med patienter med varierende grad af nyreinsufficiens er ikke gennemført (se pkt.
English: Paresthaesia
Danish: Dyspnø
English: Very common Nausea Diarrhoea
Danish: Almindelig Dårlig sårheling
English: Dysphagia
Danish: Diaré
English: Diabetes mellitus Dehydration Hypocalcaemia Hypophosphataemia Hyperlipidaemia
Danish: Almindelig Diabetes mellitus Dehydrering
English: For patients receiving the higher dose of 175 mg intravenous of temsirolimus for the treatment of MCL, the amount of ethanol in this medicinal product may impair the ability to drive or use machines (see section 4.4).
Danish: Ethanolindholdet i Torisel kan påvirke evnen til at køre bil eller betjene maskiner hos patienter, der får den høje dosis på 175 mg intravenøs temsirolimus til behandling af MCL (se pkt.
English: For patients who require use of corticosteroids, prophylaxis of PCP should be considered based upon current standard of care.
Danish: Standard PJP-profylakse bør overvejes til patienter, som samtidig behandles med kortikosteroider.
English: Thrombophlebitis
Danish: Trombocyttal
English: Note: For mantle cell lymphoma, multiple vials will be required for each dose over 25 mg. Each vial of Torisel must be diluted according to the instructions below.
Danish: Bemærk: Til mantelcellelymfom vil der være brug for flere hætteglas til hver dosis over 25 mg.
English: Myalgia
Danish: Hypokaliæmi
English: c
Danish: I/R
English: Uncommon Impaired wound healing
Danish: Almindelig Svimmelhed Paræstesi
English: Very common Blood creatinine increased Common
Danish: Øget serumcreatinin
English: Astheniaa
Danish: Kvalme
English: For patients with RCC and severe hepatic impairment, the recommended dose for patients who have baseline platelets 100 x 109/l is 10 mg intravenous once a week infused over a 30-60 minute period (see section 5.2).
Danish: 9/l er den anbefalede dosis 10 mg intravenøst en gang om ugen infunderet i løbet af 30-60 minutter (se pkt.
English: Musculoskeletal and connective tissue disorders
Danish: Dermatitis Eksfoliativt udslæt Akne
English: Dilution
Danish: Obstipation
English: In order to address the uncertainties with regards to the efficacy and safety of Symbioflor 2 (Escherichia coli bacteria (cells and autolysate)) and associated names in the treatment of irritable bowel syndrome in adult patients, the MAH should conduct and submit the results of a well-designed and adequately powered multicentre double blind randomised placebo controlled post approval efficacy study allowing for relevant subpopulation analyses, in accordance with an agreed protocol to assess the efficacy of Symbioflor 2 in the treatment of IBS in general versus subtypes of the disease such as IBS C and IBS D, both gender, disease severity and address the sustainability of efficacy The final study report should be submitted to the relevant National Competent Authorities.
Danish: For at imødegå usikkerheden med hensyn til virkningen og sikkerheden af Symbioflor 2 (Escherichia coli-bakterier (celler og autolysat)) og relaterede navne i behandlingen af irritabel tyktarmssyndrom hos voksne patienter bør indehaveren af markedsføringstilladelsen foretage og fremsende resultaterne af en veltilrettelagt multicenter-, dobbeltblindet, randomiseret, placebokontrolleret virkningsundersøgelse med et tilstrækkeligt antal forsøgsdeltagere efter godkendelsen for at muliggøre relevante underpopulationsanalyser i henhold til en vedtagen protokol med henblik på at vurdere virkningen af Symbioflor 2 til behandling af IBS generelt i forhold til undertyper af sygdommen såsom IBS C og IBS D, køn og sygdommens sværhedsgrad og undersøge virkningens varighed.
English: Symbioflor 2 (Escherichia coli bacteria (cells and autolysate)) and associated names
Danish: Symbioflor 2 (Escherichia coli-bakterier (celler og autolysat)) og relaterede navne
English: Submission of the final study results by March
Danish: Indsendelse af de endelige resultater af undersøgelsen senest i marts 2022.
English: Annex IV Conditions to the marketing authorisation(s)
Danish: Bilag IV Betingelser for markedsføringstilladelsen/-tilladelserne
English: Conditions to the marketing authorisation(s)
Danish: Betingelser for markedsføringstilladelsen/-tilladelserne
English: 15 January 2015 EMA/35715/2015
Danish: Den 15. januar 2015 EMA/35715/2015
English: • If you have any questions or concerns, you should consult your doctor or another healthcare professional.
Danish: • Hvis du har spørgsmål eller betænkeligheder, bør du kontakte lægen eller en anden sundhedsperson.
English: The review of Procoralan/Corlentor was initiated on 8 May 2014 at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Danish: Gennemgangen af Procoralan/Corlentor blev indledt den 8. maj 2014 på anmodning af EuropaKommissionen i medfør af artikel 20 i forordning (EF) nr. 726/2004.
English: Available at: http://www.nejm.org/doi/full/10.1056/NEJMoa1406430 (accessed 14/11/14).
Danish: Tilgængelig på: http://www.nejm.org/doi/full/10.1056/NEJMoa1406430 (set 14.11.2014).
English: Corlentor/Procoralan received an EU-wide marketing authorisation on 25 October 2005.
Danish: Corlentor/Procoralan fik markedsføringstilladelse i hele EU den 25. oktober 2005.
English: Regular monitoring for the occurrence of atrial fibrillation is recommended.
Danish: Regelmæssig overvågning med henblik på atrieflimren anbefales.
English: Your doctor will regularly measure your heart rate particularly before starting treatment and when adjusting the dose.
Danish: Lægen vil regelmæssigt måle din puls, navnlig ved påbegyndelse af behandlingen og ved ændring af dosis.
English: The EMA considered that the higher dose used in the study did not fully explain the findings.
Danish: EMA fandt, at resultaterne ikke fuldstændig kan forklares af den højere dosis, der blev anvendt i undersøgelsen.
English: Healthcare professionals should follow these recommendations:
Danish: Følgende anbefalinger gælder for sundhedspersoner: