FrancophonIA/ELRC3.0 huggingface dataset:
English: Elderly (≥ 65 years old) Renal function and risk of volume depletion should be taken into account (see section 4.4).
Danish: Der bør tages højde for nyrefunktionen og risikoen for volumendepletering (se pkt.
English: Invokana 300 mg film-coated tablets EU/1/13/884/005 (10 tablets)
Danish: Invokana 300 mg filmovertrukne tabletter EU/1/13/884/005 (10 tabletter)
English: Invokana 100 mg film-coated tablets EU/1/13/884/001 (10 tablets)
Danish: Invokana 100 mg filmovertrukne tabletter EU/1/13/884/001 (10 tabletter)
English: The most commonly reported adverse reactions during treatment were hypoglycaemia in combination with insulin or a sulphonylurea, vulvovaginal candidiasis, urinary tract infection, and polyuria or pollakiuria
Danish: Under behandlingen var de hyppigst indberettede bivirkninger hypoglykæmi i kombination med insulin eller et sulfonylurinstof, vulvovaginal candidiasis, urinvejsinfektion og polyuri eller pollakisuri (d.v.s. hyppig vandladning).
English: i Mean percent increases from baseline for canagliflozin 100 mg and 300 mg versus placebo, respectively, were total cholesterol 3.4% and 5.2% versus 0.9%; HDL-cholesterol 9.4% and 10.3% versus 4.0%; LDL-cholesterol 5.7% and
Danish: i Gennemsnitsstigningerne (%) fra baseline med henholdsvis canagliflozin 100 mg og 300 mg versus placebo var som følger: totalkolesterol 3,4 % og 5,2 % versus 0,9 %; HDL-kolesterol 9,4 % og 10,3 % versus 4,0 %; LDL-kolesterol
English: In patients tolerating canagliflozin whose eGFR falls persistently below 60 mL/min/1.73 m or CrCl 60 mL/min, the dose of canagliflozin should be adjusted to or maintained at 100 mg once daily.
Danish: Hos patienter, der tåler canagliflozin, men hos hvem eGFR falder vedholdende til under 60 ml/min/1,73 m eller CrCl til under 60 ml/min, bør doseringen af canagliflozin justeres til eller opretholdes på 100 mg en gang dagligt.
English: ** See section 4.4. a Safety data profiles from individual pivotal studies (including studies in moderately renally impaired patients; older patients [≥ 55 years of age to ≤ 80 years of age]; patients with increased CV-risk) were generally consistent with the adverse reactions identified in this table.
Danish: a Sikkerhedsdataprofiler fra individuelle pivotale studier (herunder studier af patienter med moderat nedsat nyrefunktion, ældre patienter [i alderen > 55 år til < 80 år], patienter med øget risiko for kardiovaskulær sygdom)
English: g
Danish: , k
English: • If your doctor has prescribed canagliflozin along with any bile acid sequestrant such as cholestyramine (medicines for lowering cholesterol) you should take canagliflozin at least
Danish: • Hvis din læge har foreskrevet canagliflozin sammen med en galdesyrebindende ionbytter såsom colestyramin (middel til sænkning af kolesteroltallet), skal du tage canagliflozin mindst 1 time før eller 4-6 timer efter ionbytteren.
English: 9.3% versus 1.3%; non-HDL-cholesterol 2.2% and 4.4% versus 0.7%; triglycerides 2.4% and 0.0% versus 7.6%.
Danish: 5,7 % og 9,3 % versus 1,3 %; non- HDL-kolesterol 2,2 % og 4,4 % versus 0,7 %; triglycerider 2,4 % og 0,0 % versus j Gennemsnitsændringerne fra baseline i hæmatokrit var henholdsvis 2,4 % og 2,5 % med canagliflozin 100 mg og 300
English: Renal impairment (eGFR < 60 mL/min/1.73 m2 or CrCl < 60 mL/min) Patients with a baseline eGFR < 60 mL/min/1.73 m2 or CrCl < 60 mL/min had a higher incidence of adverse reactions associated with volume depletion (e.g., postural dizziness, orthostatic hypotension, hypotension) with incidences of 4.7%, 8.1%, and 1.5% on canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively (see sections 4.2 and 4.4).
Danish: Nedsat nyrefunktion (eGFR < 60 ml/min/1,73 m2 eller CrCl < 60 ml/min) Patienter med eGFR < 60 ml/min/1,73 m2 eller CrCl < 60 ml/min ved baseline havde en større bivirkningsincidens associeret med volumendepletering (f.eks. postural svimmelhed, ortostatisk hypotension, hypotension), idet incidensen var 4,7 %, 8,1 % og 1,5 % for henholdsvis canagliflozin 100 mg, canagliflozin 300 mg og placebo (se pkt.
English: compared to 0.0% for placebo.
Danish: mg sammenlignet med 0,0 % med placebo.
English: Polyvinyl chloride/Aluminum (PVC/Alu) perforated unit dose blister.
Danish: 6.5 Emballagetype og pakningsstørrelser Polyvinylchlorid/aluminium (PVC/Alu) perforeret enkeltdosisblister.
English: Canagliflozin has not been studied in severe renal impairment (eGFR < 30 mL/min/1.73 m2 or CrCl < 30 mL/min) or ESRD.
Danish: Canagliflozin er ikke undersøgt hos patienter med svært nedsat nyrefunktion (eGFR < 30 ml/min/1,73 m2 eller CrCl < 30 ml/min) eller nyresygdom i terminalstadiet.
English: N/Ac Compared to sitagliptin as triple therapy with metformin and sulphonylurea (52 weeks)
Danish: Intet svarc Sammenlignet med sitagliptin som trippelbehandling med metformin og sulfonylurinstof (52 uger)
English: Invokana 300 mg film-coated tablets Polyvinyl alcohol
Danish: Invokana 300 mg filmovertrukne tabletter Polyvinylalkohol
English: k Mean percent changes from baseline in creatinine were 2.8% and 4.0% for canagliflozin 100 mg and 300 mg,
Danish: k Gennemsnitsændringerne (%) fra baseline in kreatinin var 2,8 % og 4,0 % med henholdsvis canagliflozin 100 mg og
English: Invokana 100 mg film-coated tablets Polyvinyl alcohol
Danish: Invokana 100 mg filmovertrukne tabletter Polyvinylalkohol
English: Steady-state was reached after 4 days to 5 days of once-daily dosing with canagliflozin 100 mg to 300 mg. Canagliflozin does not exhibit time-dependent pharmacokinetics, and accumulated in plasma up to 36% following multiple doses of 100 mg and 300 mg.
Danish: standardafvigelse) var 10,6 ± 2,13 timer og 13,1 ± 3,28 timer for doserne på henholdsvis 100 mg og 300 mg. Steady state blev nået efter 4 dage til 5 dage med en daglig administration af canagliflozin 100 mg til 300 mg. Canagliflozin udviser ikke tidsafhængig farmakokinetik, og op til 36 % akkumuleres i plasma efter gentagne doser på 100 mg eller 300 mg.
English: In this pooled analysis, patients on loop diuretics, patients with a baseline eGFR 30 mL/min/1.73 m2
Danish: I denne poolede analyse sås generelt en større incidens af disse bivirkninger hos patienter, der fik loopdiuretika, patienter med eGFR 30 ml/min/1,73 m2 til < 60 ml/min/1,73 m2 ved baseline og patienter
English: Diabetic ketoacidosis (rare, may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see also 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: forhøjet niveau af “ketonstoffer” i urinen eller blodet hurtigt vægttab kvalme eller opkastning mavesmerter voldsom tørst hurtig og dyb vejrtrækning forvirring usædvanlig søvnighed eller træthed dine ånde lugter sødligt, du har en sødlig eller metallisk smag i munden, eller din urin eller sved lugter anderledes
English: The increased UGE with SGLT2 inhibition also translates to an osmotic diuresis, with the diuretic effect leading to a reduction in systolic blood pressure; the increase in UGE results in a loss of calories and therefore a reduction in body weight, as has been demonstrated in studies of patients with type 2 diabetes.
Danish: Forhøjelsen af UGE pga. SGLT2-hæmning udmønter sig også i osmotisk diurese, og den diuretiske virkning fører til fald i systolisk blodtryk.
English: 300 mg, respectively, compared to 2.7% for placebo.
Danish: 300 mg sammenlignet med 0,6 % med placebo.
English: compared to 1.5% for placebo.
Danish: 300 mg sammenlignet med 1,5 % med placebo.
English: Invokana 300 mg film-coated tablets Each tablet contains canagliflozin hemihydrate, equivalent to 300 mg canagliflozin.
Danish: Invokana 300 mg filmovertrukne tabletter En tablet indeholder canagliflozinhemihydrat svarende til 300 mg canagliflozin.
English: Renal impairment For patients with an eGFR 60 mL/min/1.73 m2 to < 90 mL/min/1.73 m2 or CrCl 60 mL/min to
Danish: Det er ikke nødvendigt at justere dosis hos patienter med eGFR 60 ml/min/1,73 m2 til < 90 ml/min/1,73 m2 eller CrCl 60 ml/min til < 90 ml/min.
English: n Mean percent changes from baseline in serum phosphate were 3.6% and 5.1% for canagliflozin 100 mg and 300 mg,
Danish: n Gennemsnitsændringerne (%) fra baseline i serumphosphat var 3,6 % og 5,1 %med canagliflozin 100 mg og 300 mg sammenlignet med 1,5 % med placebo.
English: e Bone fracture was reported in 0.7% and 0.6% for canagliflozin 100 mg and 300 mg, respectively, compared to 0.3%
Danish: e Knoglebrud blev rapporteret hos hhv. 0,7 % og 0,6 % af patienterne med canagliflozin 100 mg og 300 mg sammenlignet med hos 0,3 % af patienterne med placebo.
English: EU/1/13/884/007 (90 tablets)
Danish: EU/1/13/884/007 (90 tabletter)
English: How to store Invokana Keep this medicine out of the sight and reach of children.
Danish: Opbevar lægemidlet utilgængeligt for børn.
English: m Mean percent changes from baseline in blood potassium were 0.5% and 1.0% for canagliflozin 100 mg and 300 mg,
Danish: m Gennemsnitsændringerne (%) fra baseline i serumkalium var henholdsvis 0,5 % 1,0 % med canagliflozin 100 mg og
English: Rashc, Urticaria rare
Danish: Udslætc, urticaria
English: EU/1/13/884/002 (30 tablets)
Danish: EU/1/13/884/002 (30 tabletter)
English: EU/1/13/884/006 (30 tablets)
Danish: EU/1/13/884/006 (30 tabletter)
English: EU/1/13/884/008 (100 tablets)
Danish: EU/1/13/884/008 (100 tabletter)
English: EU/1/13/884/003 (90 tablets)
Danish: EU/1/13/884/003 (90 tabletter)
English: EU/1/13/884/004 (100 tablets)
Danish: EU/1/13/884/004 (100 tabletter)
English: Invokana 100 mg film-coated tablets Each tablet contains canagliflozin hemihydrate, equivalent to 100 mg canagliflozin.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Invokana 100 mg filmovertrukne tabletter En tablet indeholder canagliflozinhemihydrat svarende til 100 mg canagliflozin.
English: l Mean percent changes from baseline in blood urea nitrogen were 17.1% and 18.0% for canagliflozin 100 mg and
Danish: l Gennemsnitsændringerne (%) fra baseline i P-karbamid var henholdsvis 17,1 % og 18,0 % med canagliflozin 100 mg og 300 mg sammenlignet med 2,7 % med placebo.
English: Change from baseline (adjusted mean) Difference from placebo (adjusted mean) (97.5% CI)
Danish: placebo (justeret gennemsnitstal) [95% CI] (97,5% CI)
English: Baseline (mean) in kg % change from baseline (adjusted mean) Difference from glimepiride (adjusted mean) (95% CI)
Danish: Baseline (gennemsnit) Ændring fra baseline (justeret gennemsnitsændring) Forskel ift.
English: < 60 mL/min taking canagliflozin 100 mg who are receiving concurrent therapy with a UGT enzyme inducer and who require additional glycaemic control, other glucose-lowering therapies should be considered (see sections 4.2 and 4.4).
Danish: Hos patienter med eGFR 45 ml/min/1,73 m2 til < 60 ml/min/1,73 m2 eller CrCl 45 ml/min til < 60 ml/min, der tager canagliflozin 100 mg, og som er i samtidig behandling med en UGT-enzyminduktor og har behov for supplerende glykæmisk kontrol, bør andre glucosesænkende midler overvejes (se pkt.
English: Content Pack size
Danish: Pakningsstørrelse
English: This summary was last updated in November 2014.
Danish: Dette sammendrag blev sidst ajourført i november 2014.
English: Coxevac was initially authorised under ‘exceptional circumstances'.
Danish: Coxevac blev oprindeligt godkendt under "særlige omstændigheder".
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Coxevac on 30 September 2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Coxevac den 30. september 2010.
English: The duration of protection was established to be 280 days in cattle and one year in goats.
Danish: Varigheden af beskyttelsen blev fastslået til at være 280 dage hos kvæg og et år hos geder.
English: The withdrawal period for Coxevac for meat and milk is zero days.
Danish: Tilbageholdelsestiden for Coxevac for kød og mælk er nul dage.
English: The disease it causes is known as Q-fever.
Danish: Den sygdom, den forårsager, kaldes Q-feber.
English: For goats, one injection should be given one year later.
Danish: Til geder skal der gives en injektion et år senere.
English: Inactivated Coxiella burnetii vaccine
Danish: Inaktiveret Coxiella burnetii-vaccine
English: The vaccine is given to cattle and goats from three months of age.
Danish: Vaccinen gives til kvæg og geder fra tremåneders alderen.
English: The reaction reduces and disappears without need for treatment.
Danish: Reaktionen aftager og forsvinder, uden at det er nødvendigt med behandling.
English: The withdrawal period is the time allowed after administration of the medicine before the animal can be slaughtered and the meat or the milk used for human consumption.
Danish: Tilbageholdelsestiden er den tid, der skal gå efter indgivelsen af lægemidlet, før dyret kan slagtes, og kødet eller mælken kan anvendes til menneskeligt konsum.
English: The reaction gradually reduces and disappears without need for treatment.
Danish: Reaktionen aftager gradvist og forsvinder, uden at det er nødvendigt med behandling.
English: The European Medicines Agency (EMA) reviewed additional information according to an agreed timetable on the efficacy of the vaccine.
Danish: Det Europæiske Lægemiddelagentur (EMA) gennemgik i henhold til en aftalt tidsplan supplerende oplysninger om vaccinens virkning.
English: In the case of accidental self-injection, medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
Danish: I tilfælde af utilsigtet selvinjektion skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: The effectiveness of Coxevac was investigated in both laboratory and field studies.
Danish: Virkningen af Coxevac blev undersøgt i både laboratorie- og feltundersøgelser.
English: Other information about Coxevac:
Danish: Andre oplysninger om Coxevac:
English: The vaccine is given as two injections under the skin, three weeks apart.
Danish: Vaccinen gives som to injektioner under huden med tre ugers mellemrum.
English: Nine months later, two additional injections should be given to cattle, again three weeks apart.
Danish: Ni måneder senere skal der igen med tre ugers mellemrum gives to yderligere injektioner til kvæg.
English: In goats it is also very common to observe a slight increase of rectal temperature for 4 days post-vaccination without other general signs.
Danish: Hos geder er det ligeledes meget almindeligt at observere en let stigning i den rektale temperatur i 4 dage efter vaccinationen, uden at der er andre generelle tegn.
English: Coxiella burnetii is a bacterium that affects animals, including cattle and goats, and man.
Danish: Coxiella burnetii er en bakterie, der rammer både dyr, herunder kvæg og geder, og mennesker.
English: In 2014 the CVMP considered that the submitted data were adequate for the authorisation of Coxevac to convert to a normal status.
Danish: I 2014 konkluderede CVMP, at de forelagte oplysninger var tilstrækkelige for at kunne ændre godkendelsen af Coxevac til en normal godkendelse.
English: In cattle and goats Q-fever can cause abortions, still births and pneumonia.
Danish: Hos kvæg og geder kan Q-feber forårsage aborter, dødsfødsler og lungebetændelse.
English: This means that it was not possible to obtain complete information about Coxevac at the time of the initial authorisation.
Danish: Det betyder, at det på tidspunktet for den oprindelige godkendelse ikke var muligt at indhente fyldestgørende oplysninger om Coxevac.
English: Coxevac is a bacterial vaccine.
Danish: Coxevac er en bakterievaccine.
English: Coxevac is available as a suspension for injection.
Danish: Coxevac fås som en suspension til injektion.
English: In the future, if the animals are exposed to Coxiella burnetii bacteria, the immune system will be able to respond more quickly.
Danish: Hvis dyrene efterfølgende udsættes for Coxiella burnetii-bakterier, vil immunsystemet hurtigere kunne danne antistoffer mod dem.
English: Coxevac is used in cattle to lower the risk of spreading Coxiella burnetii infection and in goats to reduce abortions caused by the infection as well as reduce spreading the infection.
Danish: Coxevac anvendes til kvæg for at mindske risikoen for at sprede Coxiella burnetii-infektion, og til geder anvendes det for at reducere aborter forårsaget af infektionen og mindske spredningen af infektionen.
English: Coxevac is a veterinary vaccine that contains inactivated (killed) Coxiella burnetii bacteria.
Danish: Coxevac er et lægemiddel til dyr, som indeholder inaktiverede (dræbte) Coxiella burnetti-bakterier.
English: The CVMP concluded that the benefits of Coxevac exceed the risks for the approved indication and recommended that Coxevac be given a marketing authorisation.
Danish: Udvalget for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Coxevac er større end risiciene, når det anvendes til den godkendte indikation, og anbefalede udstedelse af markedsføringstilladelse for Coxevac.
English: When Coxevac is given to cattle and goats, their immune system recognises the bacteria contained in the vaccine as ‘foreign' and makes antibodies to defend against them.
Danish: Når Coxevac gives til kvæg og geder, opfatter immunsystemet bakterierne, der er indeholdt i vaccinen, som "fremmede" og danner antistoffer mod dem.
English: The studies in goats also showed a lower proportion of abortions in the goats that were vaccinated compared with unvaccinated goats.
Danish: Undersøgelsen hos geder viste også en lavere forekomst af aborter hos vaccinerede geder i forhold til ikke-vaccinerede.
English: The studies conducted in cattle and goats showed that Coxevac reduces bacteria shedding (which is a major factor in spreading the disease) in vaginal discharge and milk, whilst in goats Coxevac reduced bacteria shedding in faeces and the placenta as well.
Danish: De undersøgelser, der blev foretaget af kvæg og geder, viste, at Coxevac mindsker bakterieudskillelsen (som er en vigtig faktor for sygdommens spredning) i vaginale sekreter og mælk, og at Coxevac hos geder desuden mindsker bakterieudskillelsen i afføringen og moderkagen.
English: What is the risk associated with Coxevac?
Danish: Hvilken risiko er der forbundet med Coxevac?
English: Why has Coxevac been approved?
Danish: Hvorfor blev Coxevac godkendt?
English: In cattle it is very common to see a swelling of maximum diameter of 9 to 10 cm at the injection site, which may last for 17 days.
Danish: Hos kvæg er det meget almindeligt at se en hævelse på injektionsstedet med en maksimal diameter på 9-10 cm.
English: The effectiveness of the vaccine in goats has been determined in two field studies with pregnant goats exposed to Coxiella burnettii.
Danish: Vaccinens virkning hos geder er påvist i to feltundersøgelser med drægtige geder, som blev eksponeret for Coxiella burnetii.
English: A field study determined the effectiveness of the vaccine in cattle that came from farms where Coxiella burnetii was present.
Danish: Vaccinens virkning er påvist i en feltundersøgelse hos kvæg fra gårde, hvor der var Coxiella burnetii tilstede.
English: What is Coxevac?
Danish: Hvad er Coxevac?
English: In goats it is very common to see a palpable reaction of 3 to 4 cm diameter at the injection site which may last for 6 days.
Danish: Hos geder er det meget almindeligt at se en tydelig reaktion på injektionsstedet med en maksimal diameter på 3-4 cm.
English: This is of particular importance because Coxiella burnetii can lead to a disease in humans called Qfever and decreasing the disease in animals will decrease the likelihood of transmitting the disease to humans.
Danish: Dette er af særlig vigtighed, fordi Coxiella burnetii kan føre til en sygdom hos mennesker, der kaldes Q-feber.
English: What is Coxevac used for?
Danish: Hvad anvendes Coxevac til?
English: How has Coxevac been studied?
Danish: Hvordan blev Coxevac undersøgt?
English: What benefit has Coxevac shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Coxevac?
English: How does Coxevac work?
Danish: Hvordan virker Coxevac?
English: 448 (4 x 112) capsules
Danish: 448 (4 x 112) kapsler
English: Capsule, hard bottle (HDPE)
Danish: Oral anvendelse Flaske (HDPE)
English: 1 Regulation (EC) No 1394/2007
Danish: 1 Forordning (EF) nr. 1394/2007
English: Some of the concerns were linked to the manufacturing process.
Danish: Nogle af betænkelighederne var knyttet til fremstillingsprocessen.
English: On 14 January 2013, Anika Therapeutics S.r.l.
Danish: Den 14. januar 2013 meddelte Anika Therapeutics S.r.l.
English: Further data on its benefits and safety were being awaited from the company.
Danish: Yderligere oplysninger om produktets fordele og sikkerhed afventedes fra virksomheden.
English: What consequences does this withdrawal have for patients?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienterne?
English: Patients who have any questions should speak to their doctor.
Danish: Patienter, der ønsker yderligere oplysninger, bør kontakte lægen.
English: There were also questions about the way the main studies were conducted, such as the failure to randomly select patients for each treatment group, which led to uncertainties about how the results should be interpreted.
Danish: Der var desuden spørgsmål til den måde, hvorpå hovedundersøgelserne var foretaget, idet patienterne ikke tilfældigt var tildelt til hver behandlingsgruppe, hvilket skabte usikkerhed om fortolkning af resultaterne.
English: Overall, the results from studies in patients did not justify the proposed use of the product and its safety could not be ascertained conclusively from the data that had so far been presented.
Danish: Samlet set gav resultaterne fra undersøgelserne med patienter ikke grundlag for den påtænkte anvendelse af produktet, og produktets sikkerhed kunne ikke afgørende fastlægges af de forelagte oplysninger.
English: Hyalograft C autograft has been used in the following EU countries: Austria, Bulgaria, Czech Republic, Germany, Greece, Hungary, Italy, Lithuania, Poland and Romania, before the introduction of the EU
Danish: Hyalograft C autograft har været anvendt i følgende EU-medlemslande: Østrig, Bulgarien, Tjekkiet, Tyskland, Grækenland, Ungarn, Italien, Litauen, Polen og Rumænien, før EU's forordning om avancerede terapier blev indført i 2009.1 I henhold til forordningen skal avancerede terapier, der i forvejen er tilgængelige i EU, vurderes af EMA for at opnå markedsføringstilladelse i hele EU.
English: 21 February 2013
Danish: Den 21. februar 2013 EMA/52320/2013
English: It was for use in adults experiencing symptoms caused by sudden or repetitive trauma to the cartilage.
Danish: Lægemidlet skulle anvendes til voksne med symptomer fremkaldt af pludselige eller gentagne skader på brusken.
English: Following this withdrawal, Hyalograft C autograft will no longer be available and healthcare professionals will need to consider other treatment options for patients with femoral cartilage defects.
Danish: Efter tilbagetrækningen vil Hyalograft C autograft ikke længere være på markedet, og behandlerne må overveje andre behandlingsmuligheder for patienter med defekter i lårbensbrusken.
English: The main measures of effectiveness were based on the evaluation of patients' cartilage and knee function after treatment.
Danish: Behandlingens virkning blev hovedsagelig målt på vurderingen af patientens brusk og knæfunktion efter behandlingen.
English: At the time of the withdrawal, the CAT had not issued its final recommendation but had some concerns about the data submitted in the application.
Danish: På tilbagetrækningstidspunktet havde Udvalget For Avancerede Terapier endnu ikke fremsat sin endelige anbefaling, men havde visse betænkeligheder ved oplysningerne i ansøgningen.