natgillin/translations-raw huggingface dataset:
CHMP konkluderede, at Relvar Ellipta (92 /22 µg og 184 /22 µg) var påvist at være effektivt til at forbedre FEV1 hos patienter med astma; det var desuden påvist effektivt at nedsætte antallet af anfald med forværring af astma, og selv om denne nedsættelse var lille, blev den anset for at være klinisk relevant og at svare til virkningerne af anden inhalationsmedicin med en kombination af binyrebarkhormoner og langtidsvirkende beta-2-stimulerende midler.
The CHMP concluded that Relvar Ellipta (92 /22 microgram and 184 /22 microgram) was shown to be effective at improving FEV1 in patients with asthma; it was also shown to effectively reduce the number of asthma flare-ups and, although this reduction was small, it was considered to be clinically relevant and similar to the effects of other inhalation medicines combining corticosteroids and long-acting beta-2 agonists.
CHMP konkluderede, at Sylvant er påvist at have gavnlig virkning, der viser sig som mindskelse af svulsterne og symptomerne hos patienter med multicentrisk Castlemans sygdom, og denne positive virkning ser ud til at vedvare.
The CHMP concluded that Sylvant has been shown to have a beneficial effect by reducing tumour size and symptoms in patients with multicentric Castleman’s disease, and that this positive effect seems to be maintained over time.
CHMP konkluderede, at Topotecan Hospira i overensstemmelse med EU’s krav har vist sig at være sammenligneligt med Hycamtin.
The CHMP concluded that, in accordance with EU requirements, Topotecan Hospira has been shown to be comparable to Hycamtin.
CHMP konkluderede, at under forudsætning af, at meget strenge forholdsregler følges for at undgå ufødte børns eksponering for thalidomid, er fordelene ved Thalidomide Celgene større end risiciene, og anbefalede udstedelse af en markedsføringstilladelse.
The CHMP concluded that, provided that very strict measures are put in place to avoid exposure of unborn children to thalidomide, Thalidomide Celgene’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP konkluderede, at Valtropin i overensstemmelse med EU’ krav har vist sig at have en kvalitet, sikkerhed og virkning, som er sammenlignelig med Humatrope.
The CHMP decided that, in accordance with EU requirements, Valtropin has been shown to have a comparable quality, safety and efficacy profile to Humatrope.
CHMP konkluderede, at virkningen af Pradaxa til forebyggelse af blodpropper hos patienter, der har fået udskiftet hoften eller et knæ, kan sammenlignes med virkningen af enoxaparin.
The CHMP noted that effect of Pradaxa in preventing the formation of blood clots patients who have undergone a hip or knee replacement is comparable to that of enoxaparin.
CHMP konkluderede, at Xagrid har vist sig effektivt til at sænke blodpladetallet hos patienter med essentiel trombocytæmi.
The CHMP concluded that Xagrid had shown its effectiveness in lowering platelet counts in patients with essential thrombocythaemia.
CHMP konkluderede, at Zarzio i overensstemmelse med EU’s krav har vist sig at have en kvalitet, sikkerhed og virkning, som er sammenlignelig med Neupogen.
The CHMP decided that, in accordance with EU requirements, Zarzio has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
CHMP konkluderede, at Zyclara, creme, 3,75 %, er påvist at være effektiv til at fjerne aktinisk kerato- se fra huden, og at dets anvendelse ikke giver anledning til betænkeligheder vedrørende sikkerheden.
The CHMP concluded that Zyclara 3.75% cream had been shown to be effective at clearing actinic keratosis from the skin and that its use did not raise significant safety concerns.
CHMP konstaterede desuden, at risiciene ved anvendelse af læge- midlet er velkendte.
The CHMP also noted that the risks of using the medicine are well known.
CHMP konstaterede, at der som følge af det beskedne antal patienter med disse sygdomme kun foreligger begrænsede oplysninger til støtte for godkendelse af Atriance, men fandt, at lægemidlet kan give nogle patienter mulighed for at gå videre til knoglemarvstransplantation, så deres overlevelsesmulighed øges.
The CHMP noted that, due to the small number of patients with these diseases, the information to support the approval of Atriance is limited, but it agreed that the medicine could allow some patients to go on to receive bone-marrow transplantion, increasing their chances of survival.
CHMP konstaterede, at Eylea var lige så effektivt som ranibizumab til at opretholde synsevnen efter det første års behandling hos patienter med den våde form for AMD.
The CHMP noted that for wet AMD Eylea was as effective as ranibizumab in maintaining patients’ vision after the first year of treatment.
CHMP konstaterede, at Zinforo var effektivt til behandling af komplicerede infektioner i hud og underliggende væv og samfundserhvervet lungebetændelse, og at det sædvanligvis tåltes godt hos både voksne og børn.
The CHMP noted that Zinforo was effective in treating complicated skin and soft tissue infections and community-acquired pneumonia and was generally well tolerated in both adults and children.
CHMP lagde til grund, at anvendelse af Ketoconazole HRA til behandling af Cushings syndrom var anerkendt i behandlingspraksis og dokumenteret i den videnskabelige litteratur.
The CHMP considered that the use of Ketoconazole HRA to treat Cushing’s syndrome was well established in medical practice and documented in the scientific literature.
CHMP mener, at Lonsurfs livsforlængende virkning hos patienter med metastatisk tyktarmskræft, der tidligere har fået anden behandling, er klinisk relevant.
The CHMP considered that the benefit of Lonsurf in prolonging survival in patients with metastatic colorectal cancer who have received previous treatment was clinically relevant.
CHMP noterede sig, at det overbevisende var blevet påvist, at Zelboraf forbedrede den samlede overlevelsestid og sinkede forværringen af det ‘BRAF V600-mutationspositive’ melanom, som havde spredt sig, eller som ikke kunne fjernes kirurgisk.
The CHMP noted that Zelboraf had been convincingly shown to improve overall survival and to delay the worsening of ‘BRAF V600 positive’ melanoma which has spread or cannot be surgically removed.
CHMP noterede sig, at Orfadin synes at være effektivt til behandling af HT-1, især hvis behandlingen indledes, inden patientens lever er alt for beskadiget.
The CHMP noted that Orfadin seems to be an effective treatment for HT-1, particularly if it is started early, before the patient’s liver is too damaged.
CHMP rapport fremsendes til fremstilleren af vaccinen på dag 55.
CHMP report is circulated to the vaccine manufacturer on Day 55.
CHMP tilslutter sig PRAC´s videnskablige konklusioner.
The CHMP agrees with the scientific conclusions made by the PRAC.
CHMP tilslutter sig PRAC’s videnskabelige konklusioner
The CHMP agrees with the scientific conclusions made by the PRAC.
CHMP tilslutter sig PRAC’s videnskabelige konklusioner.
The CHMP agrees with the scientific conclusions made by the PRAC.
CHMP tog også i betragtning, at selvom Firdapse markedsføres i de fleste EU-medlemsstater, er størrelsen af patientpopulationen begrænset, hvilket resulterer i begrænsninger i den samlede eksponering for produktet.
The CHMP also considered that although Firdapse is marketed in most EU member states, the size of the patient population is limited, resulting in limitations of the overall exposure to the product.
CHMP var af den opfattelse, at bivirkningerne kunne håndteres, og medtog i produktoplysningerne, at det anbefaledes, at lægerne medvirkede til at mindske disse risici.
The CHMP considered the side effects to be manageable and included in the product information recommendations for doctors to help reduce the risks.
CHMP var af den opfattelse, at det var blevet påvist, at Nimenrix var mindst lige så effektiv som sammenligningsvaccinerne til at fremkalde en immunreaktion på de fire grupper af N. meningitidis- bakterien hos personer fra forskellige aldersgrupper.
The CHMP considered that Nimenrix had been shown to be at least as effective as comparable vaccines at stimulating an immune response to the four groups of the N. meningitidis bacterium in people of different age groups.
CHMP var af den opfattelse, at Fampyra sandsynligvis kunne gavne ca. en tredjedel af patienter med MS, som lider af gangbesvær, og at patienter, der har gavn af behandlingen, kan identificeres på et tidligt stadie, så behandlingen kan stoppes hos de øvrige patienter.
The CHMP considered that Fampyra was likely to benefit approximately one third of patients with MS who have a walking disability, and that patients benefiting from the treatment can be identified at an early stage allowing treatment to be stopped in other patients.
CHMP var af den opfattelse, at fordelene ved Optimark opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Optimark.
The CHMP decided that Optimark’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP var af den opfattelse, at fordelene ved Orfadin opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Orfadin.
Therefore, the CHMP decided that Orfadin’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP var af den opfattelse, at fordelene ved Torisel opvejer risiciene og anbefalede udstedelse af markedsføringstilladelse for Torisel.
The CHMP decided that Torisel’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP var af den opfattelse, at fordelene ved Xeristar opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The CHMP decided that Xeristar’s benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP var af den opfattelse, at Jevtanas evne til at forlænge den samlede overlevelse for patienter med hormonrefraktær metastatisk prostatakræft var klinisk signifikant.
The CHMP considered that the ability of Jevtana to prolong overall survival in hormone refractory metastatic prostate cancer patients was clinically important.
CHMP var af den opfattelse, at virkningerne af Xtandi til behandling af kræft var blevet klart påvist, og at fordelen med hensyn til forøget levetid er vigtigt for patienterne.
The CHMP considered that the anticancer effects of Xtandi had been clearly demonstrated and that its benefit in prolonging life is important for patients.
CHMP var derfor af den opfattelse, at fordelene er større end de identificerede risici som for Combivir.
Therefore, the CHMP’s view was that, as for Combivir, the benefit outweighs the identified risk.
CHMP var derfor af den opfattelse, at fordelene er større end de identificerede risici, ligesom det er tilfældet med Actos.
Therefore, the CHMP’s view was that, as for Actos, the benefit outweighs the identified risk.
CHMP var derfor af den opfattelse, at fordelene er større end de identificerede risici, ligesom det er tilfældet med Arava.
Therefore, the CHMP’s view was that, as for Arava, the benefit outweighs the identified risk.
CHMP var derfor af den opfattelse, at fordelene er større end de identificerede risici, ligesom det er tilfældet med Cellcept.
Therefore, the CHMP’s view was that, as for Cellcept, the benefit outweighs the identified risk.
CHMP var derfor af den opfattelse, at fordelene er større end de identificerede risici, ligesom det er tilfældet med Plavix.
Therefore, the CHMP’s view was that, as for Plavix, the benefit outweighs the identified risk.
CHMP var derfor af den opfattelse, at fordelene er større end de identificerede risici, ligesom det er tilfældet med Taxotere.
Therefore, the CHMP’s view was that, as for Taxotere, the benefit outweighs the identified risk.
CHMP var derfor af den opfattelse, at fordelene opvejer de identificerede risici som for Ammonaps.
Therefore, the CHMP’s view was that, as for Ammonaps, the benefit outweighs the identified risk.
CHMP var derfor af den opfattelse, at fordelene opvejer de identificerede risici som for Aprovel.
Therefore, the CHMP’s view was that, as for Aprovel, the benefit outweighs the identified risk.
CHMP var derfor af den opfattelse, at fordelene opvejer de identificerede risici som for Epivir.
Therefore, the CHMP’s view was that, as for Epivir, the benefit outweighs the identified risk.
CHMP var derfor af den opfattelse, at fordelene opvejer de identificerede risici som for MicardisPlus.
Therefore, the CHMP’s view was that, as for MicardisPlus, the benefit outweighs the identified risk.
CHMP var derfor af den opfattelse, at fordelene opvejer de identificerede risici som for Neupogen, og anbefalede, at det godkendes til anvendelse i EU.
Therefore, the CHMP’s view was that, as for Neupogen, the benefit outweighs the identified risks and recommended that it be approved for use in the EU.
CHMP var derfor af den opfattelse, at fordelene opvejer de identificerede risici som for NovoNorm.
Therefore, the CHMP’s view was that, as for NovoNorm, the benefit outweighs the identified risk.
CHMP var derfor af den opfattelse, at fordelene opvejer de identificerede risici som for Plavix.
Therefore, the CHMP’s view was that, as for Plavix, the benefit outweighs the identified risk.
CHMP var derfor af den opfattelse, at fordelene opvejer de identificerede risici som for Tamiflu.
Therefore, the CHMP’s view was that, as for Tamiflu, the benefit outweighs the identified risks.
CHMP var derfor af den opfattelse, at fordelene opvejer de identificerede risici som for Tractocile.
Therefore, the CHMP’s view was that, as for Tractocile, the benefit outweighs the identified risk.
CHMP var derfor af den opfattelse, at fordelene opvejer de identificerede risici som for Vfend.
Therefore, the CHMP’s view was that, as for Vfend, the benefit outweighs the identified risks.
CHMP var derfor af den opfattelse, at fordelene opvejer de identificerede risici som for Viagra.
Therefore, the CHMP’s view was that, as for Viagra, the benefit outweighs the identified risk.
CHMP var derfor af den opfattelse, at fordelene opvejer de identificerede risici som for Zeffix.
Therefore, the CHMP’s view was that, as for Zeffix, the benefit outweighs the identified risk.
CHMP var tilfreds med undersøgelserne af patienter med MMN, hvor Kiovig viste sig at være effektivt.
The CHMP was satisfied with the studies in patients with MMN, where Kiovig was shown to be effective.
CHMP vurderede manglen på specifikke behandlingsmuligheder for faktor X-mangel og konkluderede, at Coagadex har en dokumenteret virkning ved behandling og forebyggelse af blødning hos patienter i alderen 12 år og opefter.
The CHMP considered the lack of specific therapies for factor X deficiency, and concluded that Coagadex has been shown to be effective at treating and preventing the occurrence of bleeding in patients above 12 years with the condition.
CHMP vurderede, at fordelene ved Kinzalkomb er større end risiciene til behandling af essentiel hypertension hos patienter, hvis blodtryk ikke er tilstrækkeligt under kontrol med telmisartan alene.
The CHMP decided that Kinzalkomb’s benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on telmisartan alone.
CHMP vurderede, at fordelene ved PritorPlus er større end risiciene til behandling af essentiel hypertension hos patienter, hvis blodtryk ikke er tilstrækkeligt under kontrol med telmisartan alene.
The CHMP decided that PritorPlus’s benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on telmisartan alone.
CHMP vurderede, at Mycamines gavnlige virkninger er større end de risici, der er forbundet med stoffet til behandling af invasiv candidiasis og candidiasis i spiserøret og til profylakse af infektion med Candida hos patienter, som gennemgår allogen hæmatopoietisk stamcelletransplantation, eller som forventes at få neutropeni i 10 dage eller mere.
The CHMP decided that Mycamine’s benefits are greater than its risks for the treatment of invasive candidiasis and of oesophageal candidiasis, and for the prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation or who are expected to have neutropenia for 10 or more days.
CHMP vurderer, at de trufne foranstaltninger er tilstrækkelige til at håndtere disse risici.
The CHMP considered that the measures put in place are adequate to manage these risks.
CHMP) bemærkede, at Myocet var forbundet med en lavere risiko for hjerteproblemer end traditionel doxorubicin, men begge lægemidler var lige effektive.
The CHMP noted that Myocet has a lower risk of heart problems than conventional doxorubicin, while both medicines have similar levels of effectiveness.
CHMP-rapporten cirkuleres til vaccinefremstilleren på dag 55.
CHMP report is circulated to the vaccine manufacturer on Day 55.
CHMP-rapporten sendes til fremstilleren af vaccinen på dag 55.
CHMP report is circulated to the vaccine manufacturer on Day 55.
CHMP’s anbefalinger er baseret på denne indledende vurdering i CAT.
The CHMP’s recommendation is based on an initial assessment by the CAT.
Cholecystitis (NB), leversygdom (N), forhøjet bilirubin i blodet (N), hepatitis (N)
Cholecystitis (NB), Liver disorder (N), Blood bilirubin increased (N), Hepatitis (N)
Cholecystitis Cholelithiasis
Cholecystitis
Cholecystitis Cholelithiasis
terminology)
Cholelithiasis
Johnson
Cholelithiasis, forhøjet bilirubin, unormal leverfunktionsprøve
Cholelithiasis, blood bilirubin increased, Liver function test abnormal,
cholelithiasis, levercyste, leversteatose
cholelithiasis, hepatic cyst, hepatic steatosis
Cholestagel 625 mg filmovertrukne tabletter
Cholestagel 625 mg film-coated tablets
Cholestagel anvendes til at sænke kolesteroltallet hos voksne med primær hyperkolesterolæmi (forhøjet koncentration af kolesterol i blodet). ‘Primær’ betyder, at det ikke er nogen sygdom, der forårsager de høje kolesteroltal.
Cholestagel is used to lower cholesterol levels in adults with primary hypercholesterolaemia (high blood cholesterol levels). ‘Primary’ means that there is no disease causing the high cholesterol levels.
Cholestagel kan fremkalde eller forværre eksisterende obstipation.
Cholestagel can induce or worsen present constipation.
Cholestagel kan også  med eller uden statin  anvendes sammen med ezetimib (et kolesterolsænkende lægemiddel, der virker ved at nedsætte optagelsen af kolesterol fra tarmen).
Cholestagel may also be used together with ezetimibe (a cholesterol-lowering medicine that works by reducing cholesterol absorption from the gut), with or without a statin.
Cholestagel kan ordineres alene sammen med en diæt, der er fedt- og kolesterolfattig, når behandling med et statin (en type kolesterolsænkende medicin, der virker i leveren) er uhensigtsmæssigt eller ikke tåles godt.
Cholestagel may be prescribed on its own in addition to a diet low in fat and cholesterol when treatment with a statin (a class of cholesterol-lowering medicines that work in the liver) is inappropriate or not well tolerated.
Cholestagel tabletter er offwhite, kapselformede, filmovertrukne tabletter med ‘C625’ påtrykt på den ene side.
Cholestagel tablets are off-white, capsule-shaped film-coated tablets and imprinted with ‘C625’ on one side.
cholestatisk
cholestatic
Cholesterol 125 mikrogram
Cholesterol 125 micrograms
Cholesterol 125 μg
Cholesterol 125 µg Phosphatidylcholine 62.5 µg
Cholesterol 83 mikrogram
Cholesterol 83 micrograms
Cholib er kontraindiceret til børn og unge under 18 år (se pkt.
Cholib is contraindicated in children and adolescents up to 18 years old. (see section 4.3).
Cholib er kontraindiceret til patienter med moderat til svær nyreinsufficiens, hvis estimerede glomerulære filtrationshastighed er < 60 ml/min/1,73 m2 (se pkt 4.3).
Cholib is contraindicated in patients with moderate to severe renal insufficiency whose estimated glomerular filtration rate is < 60 mL/min/1.73 m2 (see section 4.3).
Cholib er kontraindiceret ved moderat til svært nedsat nyrefunktion (se pkt.
Cholib is contraindicated in moderate to severe renal impairment (see section 4.3).
Cholib er til anvendelse hos voksne, der har høj risiko for hjertesygdom, og hvis niveau af “dårligt” kolesterol i forvejen er reguleret med den tilsvarende dosis simvastatin alene.
Cholib is to be used in adults at high risk of heart disease whose levels of ‘bad’ cholesterol (LDL cholesterol) are already being controlled with the corresponding dose of simvastatin alone.
Cholib indeholder fenofibrat og simvastatin, som har forskellige virkningsmekanismer som beskrevet ovenfor.
Cholib contains fenofibrate and simvastatin, which have different modes of action as described above.
Cholib indeholder to forskellige aktive stoffer: fenofibrat (som tilhører en lægemiddelgruppe, der hedder fibrater) og simvastatin (som tilhører en lægemiddelgruppe, der hedder statiner).
Cholib contains two different active substances: fenofibrate (belongs to the group called ‘fibrates’) and simvastatin (belongs to the group called ‘statins’).
Cholsyre er ikke mutagen, men koadministration af cholsyre med kendte karcinogener har vist større tumordannelse end med det pågældende karcinogen alene.
Cholic acid is not mutagenic, however co-administration of cholic acid with known carcinogens has shown increased tumour formation compared to the known carcinogen alone.
Cholsyre er ikke undersøgt for sikkerhed og virkning hos personer over 65 år.
Cholic acid has not been studied for safety and effectiveness in people over 65 years of age.
Cholsyre er ikke undersøgt for sikkerhed og virkning hos spædbørn under 1 måned.
Cholic acid has not been studied for safety and effectiveness in babies under one month of age.
Cholsyre i Kolbam erstatter patientens manglende cholsyre.
The cholic acid contained in Kolbam replaces the patient’s missing cholic acid.
Cholsyre i Orphacol erstatter patientens manglende cholsyre.
The cholic acid contained in Orphacol replaces the patient’s missing cholic acid.
Cholsyre påvirker ikke eller i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
Cholic acid has no or neglible influence on the ability to drive and use machines.
Cholsyre viste ingen signifikant mutagen aktivitet i en række standardgenotoksicitetstest in vitro.
Cholic acid showed non significant mutagenic activity in a battery of genotoxicity tests performed in vitro.
Cholsyredosis bør hos disse patienter fastsættes og justeres som beskrevet, men en forhøjet dosis, betydeligt højere end den daglige dosisgrænse for voksne patienter på 500 mg, kan være nødvendig.
The dose of cholic acid in such patients should be established and adjusted as described, but an elevated dose, notably higher than the 500 mg daily limit for adult patients, may be required”.
ChondroCelect 10.000 celler/mikroliter suspension til implantation
ChondroCelect 10,000 cells/microlitre implantation suspension
ChondroCelect anbefales ikke til reparation af bruskdefekter andre steder end i knæets femurkondyl.
ChondroCelect is not recommended for the repair of cartilage defects in other locations than the femoral condyle.
ChondroCelect bør ikke anvendes til børn og unge under 18 år.
The use of ChondroCelect is not recommended in children and adolescents below 18 years.
ChondroCelect bør implanteres i et knæ, der på andre områder er rask.
ChondroCelect should be implanted in an otherwise healthy knee.
ChondroCelect er en cellesuspension (en væske) til implantation.
ChondroCelect is a cell suspension (a fluid) for implantation.
ChondroCelect er et lægemiddel til avanceret terapi, som kaldes et »produkt fremstillet ved vævsteknik«.
ChondoCelect is a type of advanced therapy medicine called a ‘tissue engineered product’.
ChondroCelect er kun beregnet til autolog anvendelse og bør administreres i forbindelse med debridement, en fysisk forsegling af læsionen (anbringelse af en biologisk membran, helst en collagenmembran) og genoptræning.
ChondroCelect is solely intended for autologous use and should be administered in conjunction with debridement (preparation of the defect bed), a physical seal of the lesion (placement of a biological membrane, preferentially a collagen membrane) and rehabilitation.