natgillin/translations-raw huggingface dataset:
Da hovedundersøgelsen imidlertid ikke sammenlignede Blincyto med andre standardbehandlinger, fandt CHMP, at der er behov for yderligere data.
However, since the main study did not compare Blincyto to other standard treatments, the CHMP considered that further data were needed.
Da HPA, hvad enten det er forårsaget af PKU eller af BH4-mangel, er en kronisk tilstand, er Kuvan beregnet til langtidsbehandling, når behandlingsrespons er påvist.
As HPA due to either PKU or BH4 deficiency is a chronic condition, once responsiveness is demonstrated, Kuvan is intended for long-term use.
Da human alfa- 1-proteinasehæmmer er et protein og en fysiologisk bestanddel i humant blod, forventes det ikke at have karcinogene, genotoksiske eller teratogene virkninger.
Since human alpha1-proteinase inhibitor is a protein and a physiological constituent of human blood, it is not expected to present carcinogenic, genotoxic, or teratogenic effects.
Da humane immunglobuliner udskilles i mæ lk, må kvinder ikke amme i mindst 6 måneder efter Flixabibehandling.
Because human immunoglobulins are excreted in milk, women must not breast-feed for at least 6 months after Flixabi treatment.
Da humane immunglobuliner udskilles i mælk, må kvinder ikke amme i mindst 6 måneder efter Remicadebehandling.
Because human immunoglobulins are excreted in milk, women must not breast feed for at least
Da humant immunglobulin G (IgG) udskilles i modermælk, og risiko for absorption og for at skade spædbarnet er ukendt, bør kvinder frarådes at amme under behandling med Gazyvaro og i 18 måneder efter behandlingen med Gazyvaro er afsluttet (se pkt.
Because human immunoglobulin G (IgG) is secreted in human milk and the potential for absorption and harm to the infant is unknown, women should be advised to discontinue breast-feeding during Gazyvaro therapy and for 18 months after the last dose of Gazyvaro.
Da humant normalt immunglobulin har været anvendt til behandling af de pågældende sygdomme i lang tid, var det i henhold til de gældende retningslinjer tilstrækkeligt med tre små undersøgelser til at fastslå virkningen og sikkerheden af Privigen hos patienterne.
As human normal immunoglobulin has been used to treat these diseases for a long time, and in accordance with current guidelines, only three small studies were needed to establish the effectiveness and safety of Privigen in patients.
Da humant normalt immunglobulin har været anvendt til behandling af de pågældende sygdomme i nogen tid, var det, i henhold til de gældende retningslinjer, tilstrækkeligt med fire små undersøgelser til at fastslå virkningen og sikkerheden af Kiovig hos patienterne.
As human normal immunoglobulin has been used to treat these diseases for some time, and in accordance with current guidelines, four small studies were needed to establish the effectiveness and safety of Kiovig in patients.
Da Humira injiceres under huden(subkutant), burde mad og drikke ikke have nogen effekt på Humira.
Since Humira is injected under the skin (subcutaneously), food and drink should not affect Humira.
Da hydroxocobalamin administreres i potentielt livstruende situationer, er amning ikke en kontraindikation.
Because hydroxocobalamin will be administered in potentially life-threatening situations, breast- feeding is not a contraindication to its use.
Da hydroxocobalamin har en dyb rød farve, kan det forårsage, at hæmodialysemaskiner lukker ned på grund af en fejlagtigt detekteret 'blodlækage'.
Because of its deep red color, hydroxocobalamin may cause haemodialysis machines to shut down due to an erroneous detection of a ‘blood leak’.
Da HyQvia indeholder spormængder af IgA, kan du muligvis få en allergisk reaktion. i en blodåre (intravenøst).
Since HyQvia contains trace amounts of IgA, you might have an allergic reaction. into a blood vessel (intravenously).
Da hæmmere af vaskulær endotelial vækstfaktor (VEGF) kan hæmme sårheling, skal behandlingen med pazopanib stoppes mindst 7 dage før en planlagt operation.
Since Vascular Endothelial Growth Factor (VEGF) inhibitors may impair wound healing, treatment with pazopanib should be stopped at least 7 days prior to scheduled surgery.
Da I-Neb AAD-nebulisatoren kan anvendes til Ventavis 10 microgram/ml og Ventavis 20 microgram/ml, giver tabellen nedenfor en oversigt over brugervejledningen til I-Neb i de to koncentrationer af Ventavis:
Since the I-Neb AAD nebuliser can be used for Ventavis 10 microgram/ ml and Ventavis 20 microgram/ ml, the table below provides a summary of the user instructions of the I-Neb for the 2 concentrations of Ventavis:
Da I-Neb AAD-systemer kan anvendes til Ventavis 10 mikrogram/ml og Ventavis 20 mikrogram/ml, giver den nedenstående tabel en oversigt over brugervejledningen for I-Neb for de 2 koncentrationer af Ventavis:
Since the I-Neb AAD system can be used for Ventavis 10 microgram/ ml and Ventavis 20 microgram/ ml, the table below provides a summary of the user instructions of the I-Neb for the 2 concentrations of Ventavis:
Da Ibandronsyre Sandoz er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
Because Ibandronic Acid Sandoz is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.
Da Ibandronsyre Teva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlerne, anses benefit/risk-forholdet for at være det samme som for referencelægemidlerne.
Because Ibandronic Acid Teva is a generic medicine and is bioequivalent to the reference medicines, its benefits and risks are taken as being the same as the reference medicines’s.
Da Icandra indeholder metformin, skal behandlingen seponeres 48 timer før elektiv operation med helbedøvelse og må normalt først genoptages tidligst 48 timer efter operationen.
As Icandra contains metformin, the treatment should be discontinued 48 hours before elective surgery with general anaesthesia and should not usually be resumed earlier than 48 hours afterwards.
Da Ifirmacombi er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
Because Ifirmacombi is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.
Da iloprost hæmmer trombocytternes funktion, kan dets anvendelse sammen medfølgende stoffer forstærke den iloprost-medierede hæmning af trombocytterne og dermed øge risikoen for blødning:
Since iloprost inhibits platelet function its use with the following substances may enhance iloprost- mediated platelet inhibition, thereby increasing the risk of bleeding:
Da Imatinib Accord er et generisk lægemiddel, har undersøgelserne hos patienter været begrænset til test for at fastslå, at det er bioækvivalent med referencelægemidlet Glivec.
Because Imatinib Accord is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Glivec.
Da Imatinib Accord er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
Because Imatinib Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.
Da Imatinib Actavis er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Glivec.
Because Imatinib Actavis is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Glivec.
Da Imatinib Actavis er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
Because Imatinib Actavis is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.
Da imatinib blev givet som ”salvage therapy” til patienter, som ikke responderede eller som responderede dårligt på kemoterapi, opnåedes komplet hæmatologisk respons hos 9 (81,8%) ud af 11 patienter.
When salvage therapy with imatinib was administered in patients who did not respond or who responded poorly to chemotherapy, it resulted in 9patients (81.8%) out of 11 achieving a complete haematological response.
Da Imatinib medac er bioækvivalent med referencelægemidlet, antages det at have de samme fordele og risici som referencelægemidlet.
Because Imatinib medac is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.
Da Imatinib Teva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
Because Imatinib Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.
Da immunglobuliner lige som mange andre lægemidler kan udskilles i human mælk skal der tages en beslutning om, hvorvidt amning skal ophøre, eller brugen af Enbrel skal ophøre under amning, idet fordelen ved amning for barnet og fordelen ved behandlingen af kvinden tages i betragtning.
Because immunoglobulins, in common with many medicinal products, can be excreted in human milk, a decision must be made whether to discontinue breast-feeding or to discontinue Enbrel therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Da immunglobuliner udskilles i human mælk, kan en risiko for det ammede barn ikke udelukkes.
Since immunoglobulins are excreted into human breast milk, a risk to the breastfeeding child cannot be excluded.
Da immunitetens varighed endnu ikke er endelig fastsat skal ethvert revaccinationsprogram godkendes af den ansvarlige myndighed eller ansvarlige dyrlæge, således at den lokale epidemiologiske situation kan tages i betragtning.
As the duration of immunity is not yet fully established, any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation.
Da immunitetens varighed endnu ikke er endeligt fastsat, skal ethvert revaccinationsprogram godkendes af den ansvarlige myndighed eller ansvarlige dyrlæge, således at den lokale epidemiologiske situation kan tages i betragtning.
As the duration of immunity is not yet fully established, any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation
Da immunresponset for pertussis-antigener efter administration af Infanrix hexa er ækvivalent med det, som ses efter Infanrix, anses den beskyttende effekt af de to vacciner imidlertid for at være ækvivalent.
However, as the immune response to pertussis antigens following Infanrix hexa administration is equivalent to that of Infanrix, the protective efficacy of the two vaccines is expected to be equivalent.
Da Imvanex er godkendt under særlige omstændigheder, skal virksomheden, der markedsfører Imvanex, fremlægge yderligere data fra undersøgelser af ændringer i antistofniveauerne over tid hos personer, der er blevet vaccineret.
Since Imvanex has been approved under exceptional circumstances, the company that markets Imvanex will provide further data from studies on the changes in antibody levels over time seen in people who have been vaccinated.
Da infektioner med Demodex er en multi-faktoriel sygdom anbefales det også at behandle eventuelle underliggende sygdomme på passende måde.
As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying disease appropriately.
Da Inflacam er et generisk lægemiddel, er der udført undersøgelser for at påvise, at det er bioækvivalent med referencelægemidlet Metacam.
Since Inflacam is a generic medicine, studies have been conducted to determine that it is bioequivalent to the reference medicine, Metacam.
Da Inflacam er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
Because Inflacam is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.
Da injektionssystemet indeholder elektromekaniske dele og en brugt nål, må det ikke smides i skraldespanden.
As the administration system contains electromechanical parts and a used needle, the administration system must not be disposed of in household waste.
Da injektionsvæskeen ikke indeholder konserveringsmidler, skal sundhedspersonalet infundere den, så hurtigt som muligt efter åbning af flasken.
Because the solution contains no preservative, your healthcare professional must infuse it immediately after opening the vial.
Da injektionsvæsken ikke indeholder konserveringsmiddel, bør Hizentra bruges/infunderes hurtigst muligt efter åbning af hætteglasset.
Because the solution contains no preservative, Hizentra should be used/infused as soon as possible after opening the vial.
Da injektionsvæsken ikke indeholder konserveringsmiddel, skal du bruge/infundere Hizentra hurtigst muligt efter åbning af hætteglasset.
Because the solution contains no preservative, you must use/infuse it as soon as possible after opening the vial.
Da insulin og pioglitazon er begge associeret med væskeretention, kan samtidig indgivelse af insulin og Glubrava øge risikoen for ødemer.
Since insulin and pioglitazone are both associated with fluid retention, concomitant administration of insulin and Competact may increase the risk of oedema.
Da interaktion med lægemidler, som gennemgår intracellulær fosforylering, som fx antivirale stoffer, eller med hæmmere af adenosinoptagelse kan forventes, tilrådes samtidig brug af disse og cladribine ikke.
Since interactions with medicinal products undergoing intracellular phosphorylation, such as antiviral agents, or with inhibitors of adenosine uptake may be expected, their concomitant use with cladribine is not recommended.
Da Irbesartan/Hydrochlorothiazide Teva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
Because Irbesartan/Hydrochlorothiazide Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.
Da Janumet indeholder metforminhydrochlorid, bør behandlingen seponeres 48 timer før elektiv operation med generel, spinal eller epidural anæstesi.
As Janumet contains metformin hydrochloride, the treatment should be discontinued 48 hours before elective surgery with general, spinal or epidural anaesthesia.
Da Jentadueto indeholder metformin, skal behandlingen seponeres 48 timer før elektiv operation med generel, spinal eller epidural anæstesi.
As Jentadueto contains metformin hydrochloride the treatment must be discontinued 48 hours before elective surgery with general, spinal or epidural anaesthesia.
Da Jentadueto indeholder metformin, skal en patient med type 2-diabetes, der tidligere har været velbehandlet på Jentadueto, men som udvikler unormale laboratorieværdier eller klinisk sygdom (især uklar og dårligt defineret sygdom), straks vurderes for tegn på ketoacidose eller laktacidose.
As Jentadueto contains metformin, a patient with previously well controlled type 2 diabetes on Jentadueto who develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness) should be evaluated promptly for evidence of ketoacidosis or lactic acidosis.
Da kapslen ikke absorberes lige så godt på tom mave, skal Pravafenix altid tages sammen med mad (se pkt.
Since it is less well absorbed from an empty stomach, Pravafenix should always be taken with food (see sections 4.5. and 5.2).
Da kendskabet til sammenhængen mellem maternel toksicitet og effekter på fosterudviklingen imidlertid er mangelfuldt, kan den sikkerhedsmæssige betydning for mennesker ikke vurderes.
However, in the absence of understanding the association between maternal toxicity and developmental effect, the relevance to human safety cannot be addressed.
Da Kentera kan medføre døsighed, søvnighed eller sløret syn, skal De udvise forsigtighed, når De fører motorkøretøj eller betjener maskiner.
Because Kentera may produce drowsiness, somnolence, or blurred vision, patients should be advised to exercise caution when driving or using machinery.
Da ketoconazol er et velkendt stof og er anerkendt til behandling af Cushings syndrom, fremlagde ansøgeren data fra den publicerede litteratur om mere end 800 patienter med Cushings syndrom, der var behandlet med ketoconazol enten alene eller i kombination med andre lægemidler.
Because ketoconazole is a well-known substance, and its use in Cushing’s syndrome is well established, the applicant presented data from the published literature on more than 800 patients with Cushing’s syndrome who were treated with ketoconazole either alone or in combination with other treatments.
Da klinisk erfaring med olanzapin hos patienter med samtidige sygdomme er begrænset, tilrådes forsigtighed ved ordination til patienter med prostatahypertrofi eller paralytisk ileus og beslægtede tilstande.
However, as clinical experience with olanzapine in patients with concomitant illness is limited, caution is advised when prescribing for patients with prostatic hypertrophy, or paralytic ileus and related conditions.
Da klinisk erfaring med olanzapin til patienter med samtidige sygdomme er begrænset, tilrådes forsigtighed ved ordination til patienter med prostatahypertrofi eller paralytisk ileus og beslægtede tilstande.
However, as clinical experience with olanzapine in patients with concomitant illness is limited, caution is advised when prescribing for patients with prostatic hypertrophy, or paralytic ileus and related conditions, e.g. at baseline, 12 weeks after starting olanzapine treatment and every 5 years thereafter.
Da kliniske undersøgelser var begrænset til 90 dage, bør længere varende behandling observeres nøje samt være under regelmæssig overvågning af en dyrlæge.
As field studies were limited to 90 days, longer-term treatment should be considered carefully and regular monitoring undertaken by the veterinarian.
Da komplians kan være af betydning for behandlingens udfald, bør den indtagne dosis være så tæt som muligt på den anbefalede standarddosis.
As adherence might be of importance for outcome of therapy, the dose should be kept as close as possible to the recommended standard dose.
Da koncentrationen af cobimetinib sandsynligvis vil være betydeligt reduceret ved samtidig administration af potente CYP3A-inducerer, kan patientens effekt være kompromitteret.
Given that cobimetinib concentrations are likely to be significantly reduced when co-administered with moderate to strong CYP3A inducers, patient’s efficacy may be compromised.
Da kroppen nedbryder protein, efter at man har indtaget det, vil kvælstof ophobes i form af ammoniak, fordi kroppen ikke kan udskille det.
As the body breaks down protein after eating waste nitrogen, in the form of ammonia, accumulates because the body cannot eliminate it.
Da kræften skal have tilført testosteron for at overleve og vokse, kan abirateronacetat forsinke prostatakræftens udvikling ved at reducere produktionen af testosteron.
Because the cancer needs a supply of testosterone to survive and grow, by reducing the production of testosterone, abiraterone acetate may slow the growth of the prostate cancer.
Da kun ganske få patienter bliver udsat for ekstravasation af antracykliner, betragtes lidelsen som værende ”sjælden”, og den 19. september 2001 blev Savene udpeget som ”lægemiddel til sjældne sygdomme”.
Because the number of patients who have extravasation of anthracyclines is low, the condition is considered ‘rare’, and Savene was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 19 September 2001.
Da kvalme og opkastning kan forekomme i dagene efter kemoterapibehandling er det vigtigt, at du tager EMEND i 2 fortløbende dage, som foreskrevet af lægen.
As nausea and vomiting may occur in the days following your chemotherapy, it is important that you take EMEND for 2 consecutive days as prescribed by your doctor.
Da kvalme og opkastning kan forekomme i dagene efter kemoterapibehandling er det vigtigt, at du tager EMEND i 3 fortløbende dage, som foreskrevet af lægen.
As nausea and vomiting may occur in the days following your chemotherapy, it is important that you take EMEND for 3 consecutive days as prescribed by your doctor.
Da Kyprolis gives i kombination med lenalidomid, skal du følge programmet for forebyggelse af graviditet (se lenalidomids indlægsseddel for information om graviditetsforebyggelse og tal med lægen, sundhedspersonalet eller apotekspersonalet om det).
As Kyprolis is given in combination with lenalidomide, you must follow the Pregnancy Prevention Programme (see package leaflet for lenalidomide for information on pregnancy prevention and discuss with your doctor, pharmacist or nurse).
Da lamivudin er dialysérbart, kan kontinuerlig hæmodialyse benyttes ved behandling af overdosering, selvom det ikke er undersøgt.
Since lamivudine is dialysable, continuous haemodialysis could be used in the treatment of overdose, although this has not been studied.
Da lamivudin kan fjernes ved dialyse, kan kontinuerlig hæmodialyse benyttes ved behandling af overdosering, selvom det ikke er undersøgt.
Since lamivudine is dialysable, continuous haemodialysis could be used in the treatment of overdose, although this has not been studied.
Da lamivudin og zidovudin har været tilgængelige i EU i en årrække, har virksomheden fremlagt oplysninger fra tidligere undersøgelser, hvor de to stoffer blev givet sammen.
Because lamivudine and zidovudine have been available in the EU for a number of years, the company presented information obtained in earlier studies of the two substances taken together.
Da Lamivudin Teva er en nukleosidanalog, kan risikoen for laktacidose ikke udelukkes.
As lamivudine is a nucleoside analogue, this risk cannot be excluded.
Da Lamivudin/Zidovudin Teva er et generisk lægemiddel, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
Because Lamivudine/Zidovudine Teva is a generic medicine, its benefits and risks are taken as being the same as the reference medicine’s.
Da Lamivudine Teva Pharma B.V. er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Epivir.
Because Lamivudine Teva Pharma B.V. is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Epivir.
Da Lamivudine Teva Pharma B.V. er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
Because Lamivudine Teva Pharma B.V. is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.
Da lamivudins mutagene aktivitet in vitro ikke bekræftes i in vivo-tests, kan det konkluderes, at der ikke skulle være risiko for genotoksicitet hos patienter i behandling med lamivudin.
As the in vitro mutagenic activity of lamivudine could not be confirmed by in vivo tests, it is concluded that lamivudine should not represent a genotoxic hazard to patients undergoing treatment.
Da Lantus har en langvarig effect, kan det vare lidt før hypoglykæmien forsvinder.
The recovery of hypoglycaemia may be delayed because Lantus has a long action.
Da Lantus har en langvarig effekt, kan det vare lidt før hypoglykæmien forsvinder.
The recovery of hypoglycaemia may be delayed because Lantus has a long action.
Da Lantus har en langvarig effekt, kan det vare lidt, før hypoglykæmien forsvinder.
The recovery of hypoglycaemia may be delayed because Lantus has a long action.