FrancophonIA/ELRC3.0 huggingface dataset:
English: With one hand hold the powder vial and vial adapter, and with the other hand firmly grasp the barrel of the pre-filled solvent syringe and in a counterclockwise motion unscrew the syringe from the vial adapter (Figure H).
Danish: Hold hætteglasset og hætteglas-adapteren med den ene hånd, tag med den anden hånden fat i tromlen på den fyldte injektionssprøjte med solvens, og skru mod urets retning sprøjten af hætteglas-adapteren (figur H).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Obizur water for injections.
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Solvens til OBIZUR
English: Diabetic ketoacidosis a,
Danish: Diabetisk ketoacidose a, b
English: Table 9: Treatment effect for the primary composite endpoint, its components and mortality
Danish: Tabel 9: Behandlingens virkning, hvad angår det primære sammensatte endepunkt, endepunktets komponenter og mortalitet
English: Very common Common Uncommon Rare
Danish: Almindelig Ikke almindelig Sjælden Meget sjælden
English: Possible signs of losing too much fluid from your body are listed in section 4 ‘Possible side effects'.
Danish: Mulige tegn på for stort væsketab fra kroppen er anført i afsnit4, “Bivirkninger”
English: However, temporary interruption of treatment should be considered in patients with complicated urinary tract infections.
Danish: Midlertidig afbrydelse af behandlingen skal dog overvejes hos patienter med komplicerede urinvejsinfektioner.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking this medicine, and during treatment:
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager dette lægemiddel og under behandlingen,
English: It is especially important to mention the following:
Danish: Det er især vigtigt, atdu nævner følgende:
English: Pruritus (generalised)
Danish: Kløe (generaliseret)
English: This medicine is not recommended for use in children and adolescents under 18 years, because it has not been studied in these patients.
Danish: Børn og unge Synjardy anbefales ikke til børn og unge under 18 år, da det ikke er undersøgt hos disse patienter.
English: • cimetidine, a medicine used to treat stomach problems.
Danish: • cimetidin, der er et lægemiddel mod problemer med maven
English: Cationic substances that are eliminated by renal tubular secretion (e.g. cimetidine) may interact with metformin by competing for common renal tubular transport systems.
Danish: Kationiske stoffer, der elimineres via renal tubulær sekretion (f.eks. cimetidin), kan interagere med metformin ved at konkurrere om fælles transportsystemer i nyretubuli.
English: Table 2 Adverse reactions reported in placebo-controlled studies System organ class
Danish: Tabel 2: Bivirkninger indberettet i placebokontrollerede studier Systemorganklasse
English: Metformin The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.
Danish: Metformin Det prospektive, randomiserede studie (UKPDS) har påvist en positiv langtidsvirkning af tæt blodglucosekontrol ved type 2-diabetes.
English: These symptoms could be a sign of “diabetic ketoacidosis”a problem you can get with diabetes because of increased levels of “ketone bodies” in your urine or blood, seen in tests.
Danish: Disse symptomer kan være tegn på diabetisk ketoacidose - en komplikation, du kan få ved diabetes som følge af forhøjet niveau af ketonstoffer i urinen eller blodet, målt ved laboratorieanalyser.
English: Drug-drug interactions involving the major CYP450 and UGT isoforms with empagliflozin and concomitantly administered substrates of these enzymes are therefore considered unlikely.
Danish: Lægemiddel-lægemiddelinteraktioner mellem på den ene side de vigtigste CYP450- og UGTisoformer og på den anden side empagliflozin og samtidigt administrerede substrater for disse enzymer anses derfor for usandsynlige.
English: Taking this medicine • Swallow the tablet whole with water.
Danish: • Synk tabletterne hele sammen med vand.
English: General Synjardy should not be used in patients with type 1 diabetes.
Danish: Synjardy må ikke bruges til patienter med type 1-diabetes.
English: Diabetic ketoacidosis, seen rarely (may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see section 2, ‘Warnings and precautions'): - increased levels of “ketone bodies” in your urine or blood - rapid weight loss - feeling sick or being sick - stomach pain - excessive thirst - fast and deep breathing - confusion - unusual sleepiness or tiredness - a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat.
Danish: Diabetisk ketoacidose, ses sjældent (kan forekomme hos op til 1 ud af 1.000 patienter) Følgende symptomer er tegn på diabetisk ketoacidose (se afsnit 2, 'Advarsler og forsigtighedsregler'): - forhøjet niveau af ketonstoffer i urinen eller blodet - hurtigt vægttab - kvalme eller opkastning - mavesmerter - udtalt tørst - hurtig og dyb vejrtrækning - forvirring - usædvanlig søvnighed eller træthed - din ånde lugter sødligt, en sød eller metallisk smag i munden eller en unormal lugt fra din urin eller sved.
English: Complicated urinary tract infections (including serious urinary infections, pyelonephritis or urosepsis) occurred at a similar frequency in patients treated with empagliflozin compared to placebo.
Danish: Komplicerede urinvejsinfektioner (herunder alvorlige urinvejsinfektioner, pyelonefritis og urosepsis) forekom med samme hyppighed hos patienter, der blev behandlet med empagliflozin, sammenlignet med placebo.
English: Studies characterising the pharmacokinetics of empagliflozin in paediatric patients have not been performed.
Danish: Der er ikke gennemført studier til karakterisering af empagliflozins farmakokinetik hos pædiatriske patienter.
English: Time to first event of CV death, non-fatal MI, or non-fatal stroke) N (%) Hazard ratio vs. placebo (95.02% CI) p−value for superiority CV Death N (%) Hazard ratio vs. placebo (95% CI) p-value Non-fatal MI N (%) Hazard ratio vs. placebo (95% CI) p−value Non-fatal stroke N (%) Hazard ratio vs. placebo (95% CI) p−value All-cause mortality N (%) Hazard ratio vs. placebo (95% CI) p-value Non-CV mortality N (%) Hazard ratio vs. placebo (95% CI) CV = cardiovascular, MI = myocardial infarction Treated set (TS), i.e. patients who had received at least one dose of study drug Pooled doses of empagliflozin 10 mg and 25 mg Since data from the trial were included in an interim analysis, a two-sided 95.02% confidence interval applied which corresponds to a p-value of less than 0.0498 for significance.
Danish: Tid til første hændelse af CV-død, ikkedødeligt MI eller ikke-dødelig apopleksi, N (%) Hazard ratio vs. placebo (95,02 % CI) p-værdi for superioritet CV-død, N (%) Hazard ratio vs. placebo (95 % CI) p-værdi Ikke-dødeligt MI, N (%) Hazard ratio vs. placebo (95 % CI) p-værdi Ikke-dødelig apopleksi, N (%) Hazard ratio vs. placebo (95 % CI) p-værdi Mortalitet uanset årsag, N (%) Hazard ratio vs. placebo (95 % CI) p-værdi Ikke-CV mortalitet, N (%) Hazard ratio vs. placebo (95 % CI) CV = kardiovaskulær, MI = myokardieinfarkt Behandlet sæt, dvs. patienter, der har fået mindst én dosis forsøgslægemiddel Puljede doser af empagliflozin 10 mg og 25 mg Da data fra studiet indgår i en interim-analyse, er der anvendt et to-sidet 95,02 %-konfidensinterval, hvilket svarer til p < 0,0498 for signifikans.
English: This results in high levels of glucose in your blood which can lead to medical problems like heart disease, kidney disease, blindness, and poor circulation in your limbs.
Danish: Det medfører, at blodsukkeret bliver for højt, og det kan give problemer med helbredet, som f.eks. som hjertesygdom, nyresygdom, blindhed og dårligt blodomløb i arme og ben.
English: Table 10 Efficacy results at 12 week in a placebo-controlled study of empagliflozin in patients with type 2 diabetes and uncontrolled blood pressure Placebo empagliflozin
Danish: Tabel 10:Effektresultater efter 12 uger i et placebokontrolleret studie med empagliflozin til patienter med type 2-diabetes og dårligt kontrolleret blodtryk Placebo
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.euhttp://www.ema.europa.eu/ og på Lægemiddelstyrelsens hjemmeside http://www.laegemiddelstyrelsen.dk.
English: Blood creatinine increased/ Glomerular filtration rate decreased Haematocrit increased
Danish: Øget serumkreatinin/ Nedsat glomerulær filtrationshastighed Forhøjet hæmatokrit
English: respectively, were total cholesterol 5.0% and 5.2% versus 3.7%; HDL-cholesterol 4.6% and 2.7% versus -0.5%; LDL-cholesterol 9.1% and 8.7% versus 7.8%; triglycerides 5.4% and 10.8% versus
Danish: baseline for henholdsvis empagliflozin 10 mg og 25 mg versus placebo var for total-kolesterol 5,0 % og 5,2 % versus 3,7 %; for HDL-kolesterol 4,6 % og 2,7 % versus -0,5 %; for LDL-kolesterol 9,1 % og 8,7 % versus 7,8 %; for triglycerider 5,4 % og 10,8 % versus 12,1 %.
English: derived from postmarketing experience see section 4.4
Danish: Baseret på rapporter efter markedsføring Se pkt 4.4 De gennemsnitlige stigninger ift.
English: The steady state mean plasma AUC and Cmax were 1870 nmol.h and 259 nmol/l with empagliflozin 10 mg and 4740 nmol.h and 687 nmol/l with empagliflozin 25 mg once daily.
Danish: Den gennemsnitlige plasma-AUC og Cmax ved steady state var henholdsvis 1.870 nmol x time og 259 nmol/l for empagliflozin 10 mg én gang daglig og henholdsvis 4.740 nmol x time og 687 nmol/l for empagliflozin 25 mg én gang daglig.
English: Rare cases of diabetic ketoacidosis (DKA), including life-threatening cases, have been reported in clinical trials and post marketing in patients treated with SGLT2 inhibitors, including empagliflozin.
Danish: I kliniske studier og efter markedsføringen er der rapporteret om sjældne tilfælde af diabetisk ketoacidose, herunder livstruende tilfælde, hos patienter, der har fået behandling med SGLT2-hæmmere, herunder empagliflozin.
English: Table 8 Efficacy results at 18 and 78 weeks in a placebo-controlled study of empagliflozin as add on to basal insulin with metformin
Danish: Tabel 8: Effektresultater efter 18 og 78 uger i et placebokontrolleret studie af empagliflozin som supplement til basal insulin med samtidig metforminbehandling Placebo
English: Your doctor will normally start Synjardy treatment by prescribing the strength of tablet that supplies the same dose of metformin you are already taking (850 mg or 1,000 mg twice a day), and the lowest dose of empagliflozin (5 mg twice a day).
Danish: Startdosis af Synjardy vil supplere den dosis metformin, du allerede tager (850 mg eller 1.000 mg to gange daglig), og laveste dosis empagliflozin (5 mg to gange daglig).
English: Erythema Urticaria
Danish: Erytem Urticaria
English: • a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034,
Danish: • Et signifikant fald i den absolutte risiko for enhver diabetesrelateret komplikation i metformingruppen (29,8 tilfælde/1.000 patientår) i forhold til diæt alene (43,3 tilfælde/1.000 patientår), p= 0,0023, og i forhold til de kombinerede grupper med sulfonylurinstof alene og insulin alene (40,1 tilfælde/1.000 patientår), p= 0,0034.
English: Table 3: Efficacy results of 24 week placebo-controlled studies Add-on to metformin therapy
Danish: Tabel 3: Effektresultater fra 24 uger varende placebokontrollerede studier Supplement til metforminbehandling
English: Table 7: Efficacy results at 18 and 52 weeks in a placebo-controlled study of empagliflozin as add-on to multiple daily doses of insulin with concomitant metformin therapy
Danish: Tabel 7: Effektresultater efter 18 og 52 uger i et placebokontrolleret studie med empagliflozin som supplement til flere daglige doser insulin med samtidig metforminbehandling Placebo
English: The most commonly reported adverse events in clinical trials were hypoglycaemia in combination with insulin and/or sulphonylurea, urinary tract infections, genital tract infections and increased urination (see description of selected side effects).
Danish: Hypoglykæmi ved en kombination med insulin og/eller sulfonylurinstof, urinvejsinfektioner, genitale infektioner og øget vandladning (se beskrivelse af udvalgte bivirkninger) var de hyppigst rapporterede bivirkninger.
English: • medicines which increase urine production (diuretic), as Synjardy may increase the risk of losing too much fluid.
Danish: •vanddrivende lægemidler (diuretika), da Synjardy kan øge risikoen for tab af kropsvæske.Din læge beder dig måske stoppe med at tage Synjardy.
English: Glycaemic efficacy and cardivascular outcomes have been assessed in a total of 10,366 patients with type 2 diabetes who were treated in 9 double-blind, placebo or active-controlled clinical studies of at least 24 weeks duration, of which 2950 patients received empagliflozin 10 mg and 3701 received empagliflozin 25 mg as add-on to metformin therapy.
Danish: Glykæmisk virkning og kardiovaskulære resultater er blevet vurderet hos i alt 10.366 patienter med type 2-diabetes, som blev behandlet i 9 dobbeltblinde placebokontrollerede eller aktivt kontrollerede kliniske studier af mindst 24 ugers varighed.
English: The pack sizes are 10 x 1, 14 x 1, 30 x 1, 56 x 1, 60 x 1, 90 x 1 and 100 x 1 film-coated tablets and multipacks containing 120 (2 packs of 60 x 1), 180 (2 packs of 90 x 1) and 200 (2 packs of 100 x 1) film-coated tablets.
Danish: Pakningsstørrelser er på 10x1, 14x1, 30x1, 56x1, 60x1, 90x1og 100x1filmovertruknetabletter og multipakninger med 120 (2 pakker à 60 x 1), 180 (2 pakker à 90 x 1) og 200 (2 pakker à 100 x 1) filmovertrukne tabletter.
English: See subsections below for additional information Identified adverse reactions of empagliflozin monotherapy Identified adverse reactions of metformin monotherapy Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption which may very rarely result in clinically significant vitamin B12 deficiency (e.g. megaloblastic anaemia) Gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite occur most frequently during initiation of therapy and resolve spontaneously in most cases.
Danish: Langtidsbehandling med metformin har været ledsaget af et fald i absorptionen af vitamin B12, og dette kan i meget sjældne tilfælde medføre klinisk betydende vitamin B12-mangel (f.eks. megaloblastær anæmi).
English: • redness of the skin (erythema) or an itchy rash (hives)
Danish: • Rødme af huden eller et kløende udslæt (nældefeber)
English: Of these, a total of 794 patients received empagliflozin as add-on to metformin plus insulin, of which 266 patients were treated with empagliflozin 10 mg and 264 with empagliflozin 25 mg.
Danish: Af disse blev henholdsvis 266 og 264 patienter behandlet med empagliflozin 10 mg eller 25 mg som supplement til metformin plus insulin.
English: You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dosage of Synjardy.
Danish: Fortæl det altid til lægen, hvis du tageranden medicin eller har gjort det for nylig.Du skal eventuelt have kontrolleretdit blodsukker eller din nyrefunktion hyppigere, eller lægen kan ændre din dosis af Synjardy.
English: Table 4: Efficacy results at 24 week comparing empagliflozin in combination with metformin to the individual components
Danish: Tabel 4: Effekten på HbA1c efter 24 uger ved sammenligning af empagliflozin og metformin i kombination og disse lægemidler givet som individuelle lægemidler Empagliflozin 10 mg
English: Annex IV
Danish: Bilag IV Videnskabelige konklusioner
English: Common
Danish: Generelt
English: HbA1c (%) Baseline (mean) Change from baseline
Danish: HbA1c (%) Baseline (middelværdi) Ændring fra baseline Forskel til glimepirid
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1003/016 120 (2 x 60 x 1) film-coated tablets EU/1/15/1003/017 180 (2 x 90 x 1) film-coated tablets EU/1/15/1003/018 200 (2 x 100 x 1) film-coated tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1003/016 120 (2 x 60 x 1) filmovertrukne tabletter EU/1/15/1003/017 180 (2 x 90 x 1) filmovertrukne tabletter EU/1/15/1003/018 200 (2 x 100 x 1) filmovertrukne tabletter
English: • vomiting
Danish: • Kløe
English: Patients 75 years and older
Danish: Patienter 75 år og ældre
English: After first reconstitution the suspension should be used immediately.
Danish: Efter den første rekonstitution bør suspensionen anvendes med det samme.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Danish: Hvis produktet ikke anvendes straks, er opbevaringstid og -betingelser under anvendelse brugerens ansvar.
English: Over 99% of patients had an ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.
Danish: Over 99 % af patienterne havde en ECOG(Eastern Cooperative Oncology Group) præstationsstatus på 0 eller 1.
English: First Second Third
Danish: Første Anden Tredje
English: Some settling of the reconstituted suspension may occur.
Danish: En vis bundfældning af den rekonstituerede suspension kan forekomme.
English: Scleroderma of the skin has been reported.
Danish: Sklerodermi i huden er blevet rapporteret.
English: Treat with same dose
Danish: Behandl med samme dosis
English: AND ≥ 75,000
Danish: OG ≥ 75.000
English: The reconstituted suspension should be milky and homogenous without visible precipitates.
Danish: Den rekonstituerede suspension skal være mælkeagtig og homogen uden synligt bundfald.
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000).
Danish: Hyppighederne er defineret som: meget almindelige (≥1/10), almindelige (≥1/100 til <1/10), ikke almindelige (≥1/1.000 til <1/100), sjældne (≥1/10.000 til <1/1.000), meget sjældne (<1/10.000).
English: Date of first authorisation: 11 January 2008 Date of latest renewal: 14 January 2013
Danish: Dato for seneste fornyelse: 14. januar 2013
English: When it happens, hair loss is pronounced (over 50%) in the majority of patients)
Danish: Når hårtab forekommer, er det omfattende (over 50 %) hos de fleste patienter)
English: 1 The frequency of hypersensitivity reactions is calculated based on one definitely related case in a population of 789 patients.
Danish: 1Hyppigheden af overfølsomhedsreaktioner er udregnet ud fra ét sikkert relateret tilfælde i en population på 789 patienter.
English: Your doctor or pharmacist is responsible for disposing of any unused Abraxane correctly.
Danish: Din læge eller apotekspersonalet har ansvaret for at bortskaffe al ubrugt Abraxane på korrekt vis.
English: Some people may feel tired or dizzy after being given Abraxane.
Danish: Nogle personer kan føle sig trætte eller svimle, efter de har fået Abraxane.
English: Each drug was administered on Day 1 of each 21-day cycle.
Danish: Hvert lægemiddel blev administreret på Dag 1 i hver 21-dages cyklus.
English: • Loss of hair (the majority of cases of hair loss happened less than one month after starting
Danish: • Hårtab (de fleste tilfælde af hårtab forekom inden for en måned efter behandlingsstart med
English: A non-inferiority analysis was conducted for PFS and OS, with a pre-specified non-inferiority margin of 15%.
Danish: Der blev udført en efterfølgende noninferioritetsanalyse for PFS og OS med en præspecificeret non-inferioritetsmargin på 15 %.
English: Day 1 < 1500
Danish: Dag 1 < 1.500
English: Seventy-seven percent of the patients had been previously exposed to anthracyclines.
Danish: 77 % af patienterne havde tidligere været eksponeret for antracykliner.
English: Pronounced hair loss ≥50% is expected for the majority of patients who experience alopecia.
Danish: Omfattende hårtab ≥ 50 % forventes hos de fleste patienter, der oplever alopeci.
English: OR < 100,000
Danish: ELLER < 100.000
English: Cycle Day
Danish: Cyklusdag
English: *This data is based on Clinical Study Report: CA012-0 Addendum dated Final (23 March-2005) a Chi-squared test b Log-rank test
Danish: *Disse data er baseret på den kliniske studierapport: CA012-0 Addendum dateret Endelig udgave (23. marts 2005) a Chi2-test b Log-rank test
English: Figure 1: Kaplan-Meier curve of overall survival (intent-to-treat population)
Danish: Figur 1: Kaplan-Meier-kurve af samlet overlevelse (intent-to-treat-population)
English: The symptoms were usually transient, typically occurred three days after Abraxane administration and resolved within a week.
Danish: Symptomerne var sædvanligvis forbigående, de opstod typisk tre dage efter administration af Abraxane og forsvandt inden for en uge.
English: Nausea occurred in 29% of the patients and diarrhoea in 25% of the patients.
Danish: Kvalme forekom hos 29 % af patienterne og diarré hos 25 % af patienterne.
English: Gloves, goggles and protective clothing should be used.
Danish: Handsker, beskyttelsesbriller og beskyttelsesbeklædning bør anvendes.
English: Lymphopenia was observed in 45% of the patients.
Danish: Lymfopeni blev observeret hos 45 % af patienterne.
English: In addition, elimination of paclitaxel shows an inverse correlation with total bilirubin and a positive correlation with serum albumin.
Danish: Desuden viser eliminationen af paclitaxel en invers korrelation med totalbilirubin og en positiv korrelation med serumalbumin.
English: Sensory neuropathy occurs frequently with Abraxane, although development of severe symptoms is less common.
Danish: Sensorisk neuropati forekommer hyppigt ved behandling med Abraxane, selvom udvikling af svære symptomer er mindre almindeligt.
English: Such side effects occur far less with Abraxane.
Danish: Sådanne bivirkninger forekommer meget mindre hyppigt med Abraxane.
English: Abraxane has minor or moderate influence on the ability to drive and use machines.
Danish: Abraxane påvirker i mindre eller moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: Neutropenia was the most notable important haematological toxicity (reported in 79% of patients), and was rapidly reversible and dose dependent; leukopenia was reported in 71% of patients.
Danish: Neutropeni var den hyppigste vigtige hæmatologiske toksicitet (rapporteret hos 79 % af patienterne), den var hurtigt reversibel og dosisafhængig; leukopeni blev rapporteret hos 71 % af patienterne.
English: Take care and speak to your doctor when taking Abraxane at the same time as any of the following:
Danish: Vær forsigtig og tal med din læge, hvis du får Abraxane samtidig med nogle af følgende:
English: The non-inferiority criterion was met for both PFS and OS with the upper bound of the 95% confidence interval for the associated hazard ratios being less than 1.176 (Table 13).
Danish: Noninferioritetskriteriet blev opfyldt for både PFS og OS med den øvre grænse af 95 % konfidensintervallet for de tilhørende hazard ratioer på under 1,176 (Tabel 13).
English: Following the analysis of case reports of scleroderma, published in literature during the reporting period, describing the temporal relationship with administration of the drug or reduction of the dose, a causal association for nab-paclitaxel is considered likely.
Danish: Efter analyse af sagsrapporter om sklerodermi i den publicerede litteratur under rapporteringsperioden, som beskriver det tidsmæssige forhold ved indgivelse af lægemidlet eller reduktion af dosis, betragtes en kausal forbindelse med nab-paclitaxel som værende sandsynlig.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for paclitaxel albumin, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for paclitaxel albumin er CHMP nået frem til følgende videnskabelige konklusioner: