natgillin/translations-raw huggingface dataset:
Det var derfor CHMP’s opfattelse, at fordelene opvejer de identificerede risici som for Axura.
Therefore, the CHMP’s view was that, as for Axura, the benefit outweighs the identified risk.
Det var derfor CHMP’s opfattelse, at fordelene opvejer de identificerede risici som for Genotropin.
Therefore, the CHMP’s view was that, as for Genotropin, the benefit outweighs the identified risk.
Det var derfor CHMP’s opfattelse, at fordelene opvejer de identificerede risici som for Keppra.
Therefore, the CHMP’s view was that, as for Keppra, the benefit outweighs the identified risk.
Det var derfor CHMP’s opfattelse, at fordelene opvejer de identificerede risici som for Symbicort Turbohaler.
Therefore, the CHMP’s view was that, as for Symbicort Turbohaler, the benefit outweighs the identified risk.
Det var derfor CHMP’s opfattelse, at fordelene opvejer de identificerede risici som for Temodal.
Therefore, the CHMP’s view was that, as for Temodal, the benefit outweighs the identified risk.
Det var derfor CHMP’s 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.
Det var derfor CHMP’s opfattelse, at fordelene opvejer de identificerede risici som for Zyprexa og Zyprexa Velotab.
Therefore, the CHMP’s view was that, as for Zyprexa and Zyprexa Velotab, the benefit outweighs the identified risk.
Det var derfor CHMP’s opfattelse, at fordelene opvejer risiciene som for Zyprexa og Zyprexa Velotab.
Therefore, the CHMP’s view was that, as for Zyprexa and Zyprexa Velotab, the benefit outweighs the identified risk.
Det var derfor CVMP's opfattelse, at fordelene opvejer de identificerede risici som for Dexdomitor.
Therefore, the CVMP’s view was that, as for Dexdomitor, the benefits outweigh the identified risks.
Det var derfor CVMP's opfattelse, at fordelene opvejer de identificerede risici som for Metacam.
Therefore the CVMP’s view was that, as for Metacam, the benefits outweigh the identified risks.
Det var derfor CVMP's opfattelse, at fordelene opvejer de identificerede risici som for Metacam.
Therefore, the CVMP’s view was that, as for Metacam, the benefits outweigh the identified risks.
Det var derfor CVMP's opfattelse, at fordelene opvejer de identificerede risici som for SevoFlo.
Therefore, the CVMP’s view was that, as for SevoFlo, the benefits outweigh the identified risks.
Det var dog kun et lille antal af patienterne, der vejede under 50 kg.
≥ 50 kg; however the number of patients with a body weight of less than 50 kg was small.
Det var enten nydiagnosticerede patienter med Ph+ CML i kronisk fase eller patienter med Ph+ CML i kronisk fase, accelereret fase eller blastfase eller med Ph+ akut lymfoblastisk leukæmi (ALL), som var resistente eller intolerante over for tidligere behandling.
These patients were either newly diagnosed, Ph+ chronic phase CML or were resistant or intolerant to prior therapy with Ph+ chronic, accelerated, or blast phase CML or Ph+ acute lymphoblastic leukaemia (ALL).
Det var et kontrolleret og randomiseret studie, der sammenlignede Oncaspar med et andet pegyleret asparaginasepræparat, som indgik i kombination med flere midler i kemoterapi som førstevalgsbehandling.
This was a controlled, randomized study comparing Oncaspar to another pegylated asparaginase product in combination with multi-agent chemotherapy in the first line treatment.
Det var et krav, at patienterne tidligere havde fået passende behandling med mindst et tidligere program med kemoterapi af kombinationstypen.
Patients were required to have received adequate previous treatment with at least one prior combination chemotherapy regimen.
Det var et krav, at virussen udviste følsomhed over for INTELENCE ved screeningen.
Sensitivity of the virus to INTELENCE at screening was required.
Det var forbigående, af lav titer, og forsvandt trods fortsat behandling (første og anden sæson) og kunne ikke spores hos 55 ud af 56 børn i løbet af anden sæson (inklusive 2 med titer- værdier i løbet af første sæson).
This was transient, low titre, resolved despite continued use (first and second season), and could not be detected in 55 of 56 infants during the second season (including 2 with titres during the first season).
Det var forbigående, af lav-titer, og forsvandt trods fortsat behandling (første og anden sæson) og kunne ikke spores hos 55 ud af 56 børn i løbet af anden sæson (inklusive 2 med titer- værdier i løbet af første sæson).
This was transient, low titre, resolved despite continued use (first and second season), and could not be detected in 55 of 56 infants during the second season (including 2 with titres during the first season).
Det var ikke clastogent i en in vitro test med humane lymfocytter (ingen induktion af strukturel kromosomaberration, men øgede antallet af polyploide celler) og inducerede en stigning i antallet af mikronuklei i in vivo test hos rotter.
It was not clastogenic in an in vitro test in human lymphocytes (no induction of structural chromosomal aberration but it increased number of polyploid cells) and induced an increase of micronuclei in the in vivo test in rats.
Det var ikke muligt at måle cerebrospinalvæske (CSF) niveauer af stavudin før efter mindst 2 timer efter oral administration.
It was not possible to detect stavudine in cerebrospinal fluid until at least 2 hours after oral administration.
Det var ikke muligt at måle cerebrospinalvæske niveauer af stavudin før efter mindst 2 timer efter oral administration.
It was not possible to detect stavudine in cerebrospinal fluid until at least 2 hours after oral administration.
Det var ikke muligt at påvise en stigning i antistoffer mod C. felis, fordi kattene havde høje antistofniveauer fra starten af undersøgelserne.
It was not possible to detect a rise in antibodies against C. felis because of high levels of antibodies in the cats at the beginning of the study.
Det var ikke muligt at undersøge indflydelsen af gastrektomi på de farmakokinetiske parametre i en farmakokinetisk populationsanalyse, fordi der var få patienter, som havde undergået gastrektomi (1% af den samlede polulation).
The influence of gastrectomy on PK parameters was not able to be examined in the population PK analysis because there were few patients who had undergone gastrectomy (1% of overall).
Det var ligeledes effektivt til børn, når det blev anvendt sammen med ribavirin, idet 46 % af børnene havde reageret positivt på behandlingen ved det 6-måneders kontrolbesøg, der fulgte efter 1 års behandling.
It was also effective in children when used with ribavirin, with 46% of the children having responded to treatment at the six-month follow up visit following a year’s treatment.
Det var mere effektivt end placebo til at forebygge dødsfald som følge af sygdom i hjerte eller blodkar, eller indlæggelse pga. forværret hjertesvigt: 24,5 % (793 ud af 3 241) af de patienter, der blev behandlet med Ivabradine Anpharm, døde eller blev indlagt for første gang som følge af forværret hjertesvigt, sammenholdt med 28,7 % (937 ud af 3 264) af dem, der blev behandlet med placebo.
It was more effective than placebo at preventing death due to disease of the heart or blood vessels or hospitalisation due to worsening heart failure: 24.5% (793 out of 3,241) of patients treated with Ivabradine Anpharm died or were hospitalised for the first time due to worsening heart failure, compared with 28.7% (937 out of 3,264) of patients treated with placebo.
Det var muligt at justere dosen i tilfælde af bivirkninger.
Dose adjustment was possible in the case of adverse events.
Det var også CHMP’s opfattelse, at de forelagte data understøttede brugen af Signifor hos patienter med akromegali, hos hvem operation ikke havde givet tilfredsstillende resultat eller ikke var mulig, og for hvem behandling med en anden somatostatin-analog ikke virkede.
The CHMP was also of the opinion that the data provided support the use of Signifor in patients with acromegaly when surgery has failed or was not an option and for whom treatment with another somatostatin analogue did not work.
Det varer som regel 3-6 sekunder, men det kan tage op til 15 sekunder, før De hører det andet ”klik”.
This usually takes about 3-6 seconds, but it may take up to 15 seconds for you to hear the second ‘click’ sound.
Det varmelabile toksin (LT) af enterotoksigen E. coli (ETEC ) ligner CTB strukturelt, funktionelt og immunologisk.
The heat-labile toxin (LT) of enterotoxigenic E. coli (ETEC ) is structurally, functionally and immunologically similar to CTB.
det ved en fejl har været frosset eller,
it may have been accidentally frozen, or
Det vedvarende respons ved slutningen af opfølgningen var signifikant forhøjet ved tilføjelsen af ribavirin til interferon alfa- 2b (41 % mod 16 %, p < 0,001).
The sustained response at the end of follow-up was significantly increased by the addition of ribavirin to interferon alfa-2b (41 % vs 16 %, p < 0.001).
Det vedvarende virologiske respons opnået efter 16 uger og 24 ugers behandling blev også undersøgt i en retrospektiv undergruppe-undersøgelse af patienter, som var HCV-RNA-negative ved uge 4, og som havde en lav virologisk belastning ved baseline (se tabel 16).
The sustained viral response achieved with 16 weeks of treatment and with 24 weeks of treatment was also examined in a retrospective subgroup analysis of patients who were HCV RNA negative by week 4 and had a LVL at baseline (see Table 16).
Det veldokumenterede insulin asparts hurtige absorptionsegenskaber opretholdes af Ryzodeg.
The rapid absorption characteristics of the well-established insulin aspart are maintained by Ryzodeg.
Det veterinære lægemiddel bør indgives 2 gange dagligt som subkutan injektion.
The veterinary medicinal product should be administered twice daily by subcutaneous injection.
Det veterinære lægemiddel er en hvid til råhvid suspension til brug i drikkevand indeholdende 200 mg/ml fenbendazol og 20 mg/ml benzylalkohol.
The veterinary medicinal product is a white to off-white suspension for use in drinking water containing 200 mg/ml of fenbendazole and 20 mg/ml of benzyl alcohol.
Det veterinære lægemiddel forbliver effektivt efter udsættelse for sollys og vandgang (svømning og badning).
The veterinary medicinal product remains effective when treated animals are exposed to sunlight or immersed in water (e.g. swimming, bathing).
Det veterinære lægemiddel forbliver effektivt, selvom det behandlede dyr udsættes for sollys eller vand (fx svømning og badning).
The veterinary medicinal product remains effective when treated animals are exposed to sunlight or immersed in water (e.g. swimming, bathing).
Det veterinære lægemiddel kan give katte kramper, som kan være livstruende grundet denne dyrearts specielle fysiologi, der gør dem ude af stand til at nedbryde en række stoffer, herunder permethrin.
The veterinary medicinal product can induce convulsions in cats that could be fatal, due to the unique physiology of this species which is unable to metabolise certain compounds, including permethrin.
Det veterinære lægemiddel kan give katte kramper, som kan være livstruende på grund af denne dyrearts specielle fysiologi, der gør dem ude af stand til at nedbryde en række stoffer, herunder permethrin.
The veterinary medicinal product can induce convulsions in cats that could be fatal, due to the unique physiology of this species which is unable to metabolise certain compounds, including permethrin.
Det veterinære lægemiddel kan indgå som del af behandlingsstrategien af loppebetinget allergisk dermatitis (FAD).
The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
Det veterinære lægemiddel må ikke udledes i overfladevand.
The veterinary product should not be allowed to enter surface waters.
Det veterinære lægemiddelssikkerhed ved anvendelse i avlsdyr, drægtige eller lakterende dyr er ikke undersøgt.
The safety of the veterinary medicinal product for use in breeding, pregnant or lactating horses has not been evaluated.
Det veterinære lægemidels virkning og sikkerhed er ikke testet på hunde, der vejer mindre end 5 kg eller hos hunde med mistanke om nyre-, lever-, hjerte-, eller anden sygdom.
The safety of the veterinary medicinal product has not been tested in dogs weighing less than 5 kg or in dogs with safety concerns such as renal, liver, cardiac, gastrointestinal or other disease.
Det veterinærmedicinske lægemiddel skal administreres i en dosis på 2,50–5,36 mg/kg afoxolaner og 0,50–1,07 mg/kg milbemycinoxim i henhold til følgende tabel:
The veterinary medicinal product should be administered at a dose of 2.50–5.36 mg/kg of afoxolaner and 0.50–1.07 mg/kg of milbemycin oxime in accordance with the following table:
Det veterinærmedicinske lægemiddels sikkerhed er ikke undersøgt hos hunde yngre end 16 uger for dosen 8 mg/kg (transportsyge), hos hunde yngre end 8 uger for dosen 2 mg/kg (opkastning) eller hos drægtige eller diegivende tæver.
The safety of the veterinary medicinal product has not been established in dogs less than 16 weeks of age for the 8 mg/kg dose (motion sickness), and in dogs less than 8 weeks of age for the 2 mg/kg dose (vomiting) as well as in pregnant or lactating bitches.
Det veterinærmedicinske produkts sikkerhed er ikke fastlagt for katte, der er under 4 måneder gamle, for hunde, der er under 2 måneder gamle, eller for katte eller hunde med en legemsvægt på under 2,5 kg.
The safety of the veterinary medicinal product has not been established in cats less than 4 months of age and in dogs less than 2 months of age, or in cats or dogs less than 2.5 kg body weight.
Det vides dog ikke om kombinationen af tipranavir med ritonavir kan forårsage en større forøgelse af trazodoneksponering.
However, it is unknown whether the combination of tipranavir with ritonavir might cause a larger
Det vides dog ikke, om carfilzomib er induktor af CYP1A2, 2C8, 2C9, 2C19 eller 2B6 i terapeutiske koncentrationer.
However, it is unknown whether carfilzomib is an inducer of CYP1A2, 2C8, 2C9, 2C19 and 2B6 at therapeutic concentrations.
Det vides dog, at behandling med eptifibatid er associeret med antistoffer, der genkender GP IIb/IIIa, der er optaget af eptifibatid, hvilket peger på en immun- medieret mekanisme.
However, treatment with eptifibatide was associated with antibodies that recognise GPIIb/IIIa occupied by eptifibatide, suggesting an immune-mediated mechanism.
Det vides endnu ikke nøjagtigt hvordan pregabalin virker, men det menes at påvirke indstrømningen af calcium i nervecellerne.
The exact way in which pregabalin works is not fully understood, but it is thought to affect the way that calcium enters nerve cells.
Det vides endnu ikke nøjagtigt hvordan pregabalin virker, men det menes at påvirke indstrømningen af calcium i nervecellerne.
The exact way that pregabalin works is not fully understood, but it is thought to affect the way that calcium enters nerve cells.
Det vides endnu ikke nøjagtigt, hvordan Betaferon virker ved dissemineret sklerose, men beta-interferon synes at dæmpe immunsystemets aktivitet (kroppens naturlige forsvar) og forhindrer attakker af dissemineret sklerose.
The exact way that Betaferon works in MS is not yet known but beta-interferon seems to reduce the activity of the immune system (the body’s natural defences) and prevents the relapses of MS.
Det vides endnu ikke nøjagtigt, hvordan brivaracetam virker, men det bindes til proteinet synaptisk vesikelprotein 2A, som medvirker ved udskillelsen af kemiske signalstoffer fra nervecellerne.
The exact way in which brivaracetam works is not clear but it attaches to a protein called synaptic vesicle protein 2A, which is involved in the release of chemical messengers from nerve cells.
Det vides endnu ikke nøjagtigt, hvordan lacosamid virker, men det menes at nedsætte natriumkanalernes (porer på nervecellernes overflade) aktivitet, hvilket gør det muligt at sende elektriske impulser mellem nerveceller.
The exact way in which lacosamide works is still unclear but it seems to reduce the activity of sodium channels (pores on the surface of nerve cells) that allow electrical impulses to be transmitted between nerve cells.
Det vides endnu ikke, hvor stor eller lille risikoen for en blodprop med IOA er sammenlignet med risikoen ved et kombineret hormonelt præventionsmiddel, som indeholder levonorgestrel.
It is not yet known how the risk of a blood clot with IOA compares to the risk with a combined hormonal contraceptive that contains levonorgestrel.
Det vides endnu ikke, hvor stor eller lille risikoen for en blodprop med Zoely er sammenlignet med risikoen ved et kombineret hormonelt præventionsmiddel, som indeholder levonorgestrel.
It is not yet known how the risk of a blood clot with Zoely compares to the risk with a combined hormonal contraceptive that contains levonorgestrel.
Det vides endnu ikke, hvordan risikoen for at udvikle VTE med kombinerede hormonelle præventionsmidler, som indeholder nomegestrolacetat i kombination med estradiol, er sammenlignet med risikoen ved lavdosis kombinerede hormonelle præventionsmidler, som indeholder levonorgestrel.
It is not yet known how the risk of VTE with CHCs that contain nomegestrol acetate in combination with estradiol compares with the risk with low dose levonorgestrel-containing CHCs.
Det vides endnu ikke, om kortikosteroid– behandling ophæver dysfynktionen i glandlen.
It is currently unknown if the corticosteroid treatment reverses the gland dysfunction.
Det vides endnu ikke, om tedizolidphosphat kan nedsætte virkningen af hormonelle kontraceptiva, og derfor skal kvinder, der bruger hormonelle kontraceptiva, også bruge en anden form for kontraception som supplement (se pkt.
It is currently unknown whether tedizolid phosphate may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives must use an additional method of contraception (see section 4.5).
Det vides ikke nøjagtigt, hvordan alfa-interferoner virker ved virussygdomme, men de menes at være immunmodulerende (dvs. de ændrer den måde, kroppens immunsystem virker på).
The exact way alfa interferons work in viral diseases in not fully understood, but it is thought that they act as immunomodulators (substances that modify how the immune system, the body’s defence system, works).
Det vides ikke nøjagtigt, hvordan dextromethorphan virker ved PBA, men stoffet bindes til forskellige nervecellereceptorer i hjernen såsom NMDA-receptorer og sigma-1-receptorer for neurotransmitteren
Although the exact way dextromethorphan works in PBA is unclear, it attaches to several different nerve cell receptors in the brain such as NMDA receptors and sigma-1 receptors for the neurotransmitter glutamate as well as receptors for the neurotransmitter serotonin.
Det vides ikke nøjagtigt, hvordan teriflunomid virker ved multipel sklerose, men det menes at nedsætte antallet af lymfocytter, der er en del af immunsystemet og
The exact way teriflunomide works in MS is not known but it is thought to reduce the number of lymphocytes which form part of the immune system and are involved in the inflammation process.
Det vides ikke om den aktive substans udskilles i human mælk, men enzymet fordøjes sandsynligvis i barnets gastrointestinale kanal.
It is not known whether this active substance is excreted in human milk, however, the enzyme is likely to be digested in the child’s gastrointestinal tract
Det vides ikke om dette lægemiddel udskilles i human mælk .
It is not known whether this medicine is excreted in human milk.
Det vides ikke om dette lægemiddel udskilles i human mælk.
It is not known whether this medicine is excreted in human milk.
Det vides ikke om dexmedetomidin er sikkert at anvende ved malignt hyperthermi-sensitive personer, hvorfor det frarådes.
It is not known whether dexmedetomidine is safe to use in malignant hyperthermia-sensitive individuals therefore it is not recommended.
Det vides ikke om eflornithin udskilles i modermælk.
It is not known if eflornithine is excreted in human milk.
Det vides ikke om indholdsstofferne i Zelboraf udskilles i modermælken.
It is not known whether the ingredients in Zelboraf pass into human milk.
Det vides ikke om insulin glargin udskilles i humant mælk.
It is unknown whether insulin glargine is excreted in human milk.
Det vides ikke om insulin glulisin udskilles i human mælk, men som hovedregel passerer insulin ikke over i modermælken og absorberes ikke efter oral administration.
It is unknown whether insulin glulisine is excreted in human milk, but in general insulin does not pass into breast milk and is not absorbed after oral administration.
Det vides ikke om MIRCERA har en anden virkning på patienter med hæmoglobinopatier (sygdomme, som ledsages af unormalt hæmoglobin), tidligere eller nuværende blødning, kramper eller højt trombocyttal.
It is not known if MIRCERA has a different effect in patients with haemoglobinopathies (disorders associated with abnormal haemoglobin), past or present bleeding, seizures or with a high blood platelet count.
Det vides ikke om vemurafenib udskilles human mælk.
It is not known whether vemurafenib is excreted in human milk.
Det vides ikke præcist hvordan Extavia fungerer i forbindelse med dissemineret sklerose, men beta-interferon synes at dulme immunsystemet (kroppens naturlige forsvar) og forhindre DS-recidiver.
The exact way that Extavia works in MS is not yet known but beta-interferon seems to calm down the immune system (the body’s natural defences) and prevents the relapses of MS.
Det vides ikke på nuværende tidspunkt om vemurafenib også er substrat for andre transportproteiner.
It is currently unknown whether vemurafenib is a substrate also to other transport proteins.
Det vides ikke, hvilken dosis det er bedst at anvende til patienter under 18 år.
The best dose to use in patients below 18 years of age is not known.
Det vides ikke, hvilken virkning langtidsbehandling med Humira har på udviklingen af autoimmune sygdomme.
The impact of long- term treatment with Humira on the development of autoimmune diseases is unknown.
Det vides ikke, hvilken virkning langtidsbehandling med Trudexa har på udviklingen af autoimmune sygdomme.
The impact of long- term treatment with Trudexa on the development of autoimmune diseases is unknown.
Det vides ikke, hvor ofte disse bivirkninger forekommer.
It is not known how frequently these effects may occur.
Det vides ikke, hvordan ellaOne påvirker dit barn i ugen efter, at du har taget ellaOne.
The effect of breastfeeding your baby in the week after taking ellaOne is not known.
Det vides ikke, hvorvidt CIALIS er effektiv hos patienter, som har gennemgået kirurgi i bækkenet eller radikal ikke-nervebevarende prostatektomi.
It is not known if CIALIS is effective in patients who have undergone pelvic surgery or radical non-nerve- sparing prostatectomy.
Det vides ikke, hvorvidt flutemetamol (18F) udskilles i brystmælken under amning.
It is not known whether flutemetamol (18F) is excreted in human milk during breast-feeding.
Det vides ikke, hvorvidt tadalafil er effektiv hos patienter, som har gennemgået kirurgi i bækkenet eller radikal ikke-nervebevarende prostatektomi.
It is not known if tadalafil is effective in patients who have undergone pelvic surgery or radical non-nervesparing prostatectomy.
Det vides ikke, hvorvidt ungernes reducerede vækst skyldes nedsat modermælkeindtag på grund af en direkte virkning af GLP-1 eller reduceret mælkeproduktion hos moderen på grund af nedsat kalorieindtag.
It is unknown whether the reduced pup growth is caused by reduced pup milk intake due to a direct GLP­1 effect or reduced maternal milk production due to decreased caloric intake.
Det vides ikke, hvorvidt Volibris udskilles i mælken.
It is not known if Volibris is transferred to breast milk.
Det vides ikke, hvorvidt Xigris udskilles i modermælken, eller om der er en potentiel effekt på børn, der ammes.
It is not known whether Xigris is excreted in human milk or if there is a potential effect on the breast- fed infant.
Det vides ikke, i hvilket omfang lomitapid- associeret leversteatose bidrager til forhøjelsen af aminotransferase-værdierne.
The extent to which lomitapide-associated hepatic steatosis promotes the elevations in aminotransferase is unknown.
Det vides ikke, om
It is unknown whether the