natgillin/translations-raw huggingface dataset:
Sikkerheden af tenofovirdisoproxilfumarat ved administration sammen med ledipasvir/sofosbuvir og en farmakokinetisk forstærker er ikke klarlagt.
The safety of tenofovir disoproxil fumarate when co-administered with ledipasvir/sofosbuvir and a pharmacokinetic enhancer has not been established.
Sikkerheden af vardenafil er ikke undersøgt i følgende patientundergrupper og dets anvendelse er derfor kontraindiceret indtil yderligere information er tilgængelig: alvorlig leverinsufficiens (Child-Pugh C),
The safety of vardenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated until further information is available: severe hepatic impairment (Child-Pugh C),
Sikkerheden af vardenafil er ikke undersøgt i følgende patientundergrupper, og dets anvendelse er derfor kontraindiceret, indtil yderligere information foreligger: alvorlig leverinsufficiens (Child-Pugh C),
The safety of vardenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated until further information is available: severe hepatic impairment (Child-Pugh C),
Sikkerheden af Veraflox er ikke fastlagt under drægtighed og laktation for hunde og katte.
The safety of Veraflox has not been established during pregnancy and lactation in cats and dogs.
Sikkerheden af Veraflox er ikke fastlagt under drægtighed og laktation for katte.
The safety of Veraflox has not been established in queens during pregnancy and lactation.
Sikkerheden af veterinærlægemidlet er ikke fastlagt for heste ved drægtighed og laktation.
The safety of the veterinary medicinal product during pregnancy has not been established in horses during pregnancy and the product should not be used during pregnancy.
Sikkerheden af veterinærlægemidlet er ikke fastlagt for heste ved drægtighed og laktation.
The safety of the veterinary medicinal product during pregnancy has not been established in horses.
Sikkerheden af veterinærlægemidlet er ikke fastlagt under drægtighed og laktation (se afsnit 4.3).
The safety of the veterinary medicinal product has not been established during pregnancy and lactation (See section 4.3).
Sikkerheden af VIRACEPT 250 mg tabletter blev undersøgt i kontrollerede kliniske studier, som omfattede mere end 1300 patienter.
The safety of the VIRACEPT 250 mg tablet was studied in controlled clinical trials with over
Sikkerheden af voriconazol er undersøgt hos 288 pædiatriske patienter i alderen 2 til < 12 år (169) og 12 til < 18 år (119), som fik voriconazol-profylakse (183) og til terapeutisk brug (105) i kliniske studier.
The safety of voriconazole was investigated in 288 paediatric patients aged 2 to <12 years (169) and 12 to<18 years (119) who received voriconazole for prophylaxis (183 ) and therapeutic use (105 ) in clinical trials.
Sikkerheden af XGEVA blev undersøgt på:
The safety of XGEVA was evaluated in:
Sikkerheden blev anset for acceptabel, forudsat at de vedtagne foranstaltninger overholdes.
Safety was considered acceptable, provided agreed measures were followed.
Sikkerheden blev evalueret i et observationsstudie, der omfattede 69.237 børn i alderen 12 måneder til 12 år, som blev vaccineret med ProQuad og 69.237 matchede børn i en historisk sammenligningsgruppe, som samtidigt blev vaccineret med mæslinge-, fåresyge- og rubellavaccinen fremstillet af Merck & Co., Inc., og den levende varicellavaccine (Oka/Merck).
Safety was evaluated in an observational study that included 69,237 children vaccinated with ProQuad 12 months to 12 years old and 69,237 matched children in a historical comparison group who were vaccinated concomitantly with the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., and the Varicella Vaccine live (Oka/Merck).
Sikkerheden blev også demonstreret i avlsdyr, drægtige og diegivende dyr, der blev behandlet fortløbende med 28 dages intervaller med flere doser på op til 3 gange den maksimale anbefalede dosis.
Safety was also demonstrated in breeding, pregnant and lactating animals treated at 28-day intervals with multiple consecutive doses of up to 3 times the maximum recommended dose.
Sikkerheden blev vurderet i et kontrolleret klinisk forsøg, hvor der var inkluderet nyretransplanterede patienter på under 18 år, som ansås for at have en høj immunologisk risiko, defineret som havende én eller flere akutte episoder med afstødning af homologt transplantat i anamnesen og/eller med tilstede- værelsen af kronisk afstødning af nyretransplantat bekræftet ved nyrebiopsi (se afsnit 5.1).
Safety was assessed in a controlled clinical study enrolling renal transplant patients below 18 years of age considered of high immunologic risk, defined as a history of one or more acute allograft rejection episodes and/or the presence of chronic allograft nephropathy on a renal biopsy (see section 5.1).
Sikkerheden efter mere end ét behandlingsforløb med Xiapex for Peyronies sygdom er ukendt.
The safety of more than one treatment course of Xiapex for Peyronie’s disease is not known.
Sikkerheden er demonstreret i avlsdyr, drægtige og diegivende dyr, der blev behandlet fortløbende med flere doser med 28 dages intervaller op til 3 gange den maksimale anbefalede dosis.
Safety was demonstrated in breeding, pregnant and lactating animals treated at 28-day intervals with multiple consecutive doses up to 3 times the maximum recommended dose.
Sikkerheden er desuden vurderet hos 584 kvindelige partnere til de pågældende.
Safety has also been evaluated in 584 female partners of these subjects.
Sikkerheden er ikke fastlagt hos hunde yngre end 8 uger.
The safety has not been established in dogs younger than 8 weeks of age.
Sikkerheden er ikke fastlagt hos hunde, der vejer mindre end 1,5 kg.
The safety has not been established in dogs weighing less than 1.5 kg.
Sikkerheden er ikke fastlagt hos katte yngre end 8 uger.
The safety has not been established in cats younger than 8 weeks of age.
Sikkerheden er ikke fastlagt hos katte, der vejer mindre end 0,6 kg.
The safety has not been established in cats weighing less than 0.6 kg.
Sikkerheden er ikke fastslået hos får, som vejer mindre end 10 kg eller er under 2 uger gamle.
The safety has not been established in sheep weighing less than 10 kg or under 2 weeks of age.
Sikkerheden er også undersøgt hos 435 ikke tidligere vaccinerede børn i alderen 2-5 år, hvoraf 285 fik 2 doser Synflorix.
Safety was also assessed in 435 previously unvaccinated children from 2 to 5 years old of which 285 subjects received 2 doses of Synflorix.
Sikkerheden hos pædiatriske patienter er ikke klarlagt.
The safety in paediatric patients has not been established.
Sikkerheden og den diagnostisk nøjagtighed hos personer under 21 år, er ikke blevet fastslået.
Safety and diagnostic accuracy in persons under 21 years of age have not been established.
Sikkerheden og effekten af ataluren hos patienter på 65 år og derover er endnu ikke klarlagt. (Se pkt.
The safety and efficacy of ataluren in patients aged 65 and older have not yet been established. (See Section 5.2)
Sikkerheden og effekten af Avastin hos børn under 18 år er ikke klarlagt.
The safety and efficacy of Avastin in children less than 18 years old have not been established.
Sikkerheden og effekten af Avastin, i kombination med platinbaseret kemoterapi, til 1.- linjebehandling af patienter med ikke-planocellulær ikke-småcellet lungekræft (NSCLC), blev undersøgt i studierne E4599 og BO17704.
The safety and efficacy of Avastin, in addition to platinum-based chemotherapy, in the first-line treatment of patients with non-squamous non-small cell lung cancer (NSCLC), was investigated in trials E4599 and BO17704.
Sikkerheden og effekten af clopidrogrel er blevet evalueret i 5 dobbeltblindede studier, der omfattede mere end 88.000 patienter, CAPRIE-studier, hvor clopidogrel sammenlignes med ASA, og CURE, CLARITY og COMMIT-studierne, hvor clopidogrel sammenlignes med placebo, og hvor begge lægemidler gives i kombination med ASA eller anden standardterapi.
The safety and efficacy of clopidogrel have been evaluated in 5 double-blind studies involving over 88,000 patients: the CAPRIE study, a comparison of clopidogrel to ASA, and the CURE, CLARITY, COMMIT and ACTIVE-A studies comparing clopidogrel to placebo, both medicinal products given in combination with ASA and other standard therapy.
Sikkerheden og effekten af de i pkt 4.2 anførte reducerede doser er baseret på farmakokinetiske data og modellering ved en enkelt dosis og er ikke blevet klinisk evalueret.
The safety and efficacy of the reduced doses provided in section 4.2 are based on single dose pharmacokinetic data and modelling and have not been clinically evaluated.
Sikkerheden og effekten af den anbefalede dosis af trametinib (2 mg én gang daglig) i kombination med dabrafenib (150 mg to gange dagligt) til behandling af voksne patienter med inoperabelt eller metastatisk melanom med en BRAF V600-mutation blev undersøgt i to fase III-studier og et understøttende fase I/II-studie.
The safety and efficacy of the recommended dose of trametinib (2 mg once daily) in combination with dabrafenib (150 mg twice daily) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation was studied in two Phase III studies and one supportive Phase I/II study.
Sikkerheden og effekten af docetaxel i den indledende behandling af patienter med lokalt fremskredent pladecellecarcinom i hoved og hals (SCCHN) blev evalueret i et randomiseret, multicenter, open-label fase III studie (TAX 324).
The safety and efficacy of docetaxel in the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a randomized, multicenter open-label, phase III study (TAX324).
Sikkerheden og effekten af docetaxel i den indledende behandling af patienter med lokalt fremskredent pladecellecarcinom i hoved og hals (SCCHN) blev evalueret i et randomiseret, multicenter, open-label fase III studie (TAX 324).
The safety and efficacy of docetaxel in the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a randomized, multicenter open-label, phase III, study (TAX324).
Sikkerheden og effekten af docetaxel i den indledende behandling af patienter med lokalt fremskredent pladecellecarcinom i hoved og hals (SCCHN) blev evalueret i et randomiseret, multicenter, open-label fase III-studie (TAX 324).
The safety and efficacy of docetaxel in the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a randomized, multicenter open-label, phase III study (TAX324).
Sikkerheden og effekten af docetaxel i den indledende behandling af patienter med lokalt fremskredent pladecellecarcinom i hoved og hals (SCCHN) blev evalueret i et randomiseret, multicenter, open-label fase III-studie (TAX 324).
The safety and efficacy of docetaxel in the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a randomized, multicenter open-label, phase III, study (TAX324).
Sikkerheden og effekten af docetaxel i den indledende behandling af patienter med pladecellecarcinom i hovedet og halsen (SCCHN) blev evalueret i en fase III, multicenter, åben, randomiseret undersøgelse (TAX323).
The safety and efficacy of docetaxel in the induction treatment of patients with squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a phase III, multicenter, open-label, randomized study (TAX323).
Sikkerheden og effekten af docetaxel i den indledende behandling af patienter med pladecellecarcinom i hovedet og halsen (SCCHN) blev evalueret i et fase III, multicenter, åbent, randomiseret studie (TAX323).
The safety and efficacy of docetaxel in the induction treatment of patients with squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a phase III, multicenter, open-label, randomized study (TAX323).
Sikkerheden og effekten af docetaxel i den indledende behandling af patienter med pladecellecarcinom i hovedet og halsen (SCCHN) blev evalueret i et fase III, multicenter, åbet, randomiseret studie (TAX323).
The safety and efficacy of docetaxel in the induction treatment of patients with squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a phase III, multicenter, open-label, randomized study (TAX323).
Sikkerheden og effekten af docetaxel i kombination med prednison eller prednisolon hos patienter med hormonrefraktær metastatisk prostatakræft blev undersøgt i et randomiseret multicenter fase III- studie.
The safety and efficacy of docetaxel in combination with prednisone or prednisolone in patients with hormone refractory metastatic prostate cancer were evaluated in a randomized multicenter Phase III study.
Sikkerheden og effekten af docetaxel i kombination med prednison eller prednisolon hos patienter med hormonrefraktær metastatisk prostatakræft blev undersøgt i et randomiseret multicenter fase III- studium.
The safety and efficacy of docetaxel in combination with prednisone or prednisolone in patients with hormone refractory metastatic prostate cancer were evaluated in a randomized multicenter Phase III study.
Sikkerheden og effekten af docetaxel i kombination med prednison eller prednisolon hos patienter med hormonrefraktær prostatakræft blev undersøgt i et randomiseret multicenter fase III-studium.
The safety and efficacy of docetaxel in combination with prednisone or prednisolone in patients with hormone refractory metastatic prostate cancer were evaluated in a randomized multicenter phase III
Sikkerheden og effekten af docetaxel i kombination med prednison eller prednisolon hos patienter med hormonrefraktær prostatakræft blev undersøgt i et randomiseret multicenter fase III-studium.
The safety and efficacy of docetaxel in combination with prednisone or prednisolone in patients with hormone refractory metastatic prostate cancer were evaluated in a randomized multicenter phase III study.
Sikkerheden og effekten af Enbrel blev vurderet i et to-delt studie med 69 patienter med et polyartikulært forløb af juvenil idiopatisk artrit, som havde forskellige begyndelsestyper af juvenil idiopatisk artrit (polyartrit, pauciartrit, systemisk frembrud).
The safety and efficacy of Enbrel were assessed in a two-part study in 69 children with polyarticular- course juvenile idiopathic arthritis who had a variety of juvenile idiopathic arthritis onset types (polyarthritis, pauciarthritis, systemic onset) .
Sikkerheden og effekten af Enbrel blev vurderet i et to-delt studie med 69 patienter med et polyartikulært forløb af juvenil idiopatisk artrit, som havde forskellige begyndelsestyper af juvenil idiopatisk artrit (polyartrit, pauciartrit, systemisk frembrud).
The safety and efficacy of Enbrel were assessed in a two-part study in 69 children with polyarticular- course juvenile idiopathic arthritis who had a variety of juvenile idiopathic arthritis onset types (polyarthritis, pauciarthritis, systemic onset).
Sikkerheden og effekten af Enbrel er i stedet for blevet evalueret i tre randomiserede, dobbeltblinde, placebo-kontrollerede studier.
Instead, the safety and efficacy of Enbrel were assessed in four randomised, double-blind, placebo-controlled studies.
Sikkerheden og effekten af etanercept er i stedet for blevet evalueret i fire randomiserede, dobbeltblinde, placebo- kontrollerede studier.
Instead, the safety and efficacy of etanercept were assessed in four randomised, double-blind, placebo-controlled studies.
Sikkerheden og effekten af GRANUPAS til nyfødte er ikke blevet påvist.
The safety and efficacy of GRANUPAS in neonates have not been established.
Sikkerheden og effekten af kombinationen dabrafenib og trametinib er ikke blevet evalueret hos patienter med et mutationspositivt BRAF V600-melanom med metastaser til hjernen.
The safety and efficacy of the combination of dabrafenib and trametinib has not been evaluated in patients with a BRAF V600 mutation-positive melanoma which has metastasised to the brain.
Sikkerheden og effekten af kombinationen trametinib og dabrafenib er ikke blevet evalueret hos patienter med et mutationspositivt BRAF V600-melanom med metastaser til hjernen.
The safety and efficacy of the combination of trametinib and dabrafenib have not been evaluated in patients with a BRAF V600 mutation-positive melanoma which has metastasised to the brain.
Sikkerheden og effekten af Myozyme blev undersøgt i et randomiseret, dobbeltblindet, placebokontrolleret studie med 90 patienter med sent debuterende Pompes sygdom i alderen 10-70 år ved start af behandlingen.
The safety and efficacy of Myozyme was assessed in a randomized, double-blind, placebo-controlled study in 90 patients with late-onset Pompe disease who ranged in age from 10 to 70 years at initiation of treatment and were all naive to enzyme replacement therapy.
Sikkerheden og effekten af Naglazyme blev undersøgt i et randomiseret, dobbeltblind, placebo- kontrolleret fase 3 studie med 39 MPS VI patienter i alderen fra 5 til 29 år.
The safety and efficacy of Naglazyme was assessed in a randomised, double blind, placebo controlled, Phase 3 study of 39 MPS VI patients, ranging in age from 5 to 29 years.
Sikkerheden og effekten af NovoEight hos patienter der ikke tidligere er blevet behandlet, er endnu ikke etableret.
The safety and efficacy of NovoEight in previously untreated patients have not yet been established.
Sikkerheden og effekten af Oxyglobin er ikke blevet undersøgt hos hunde med thrombocytopenia med aktiv blødning, oliguria eller anuria, eller fremskredet hjertelidelse.
The safety and efficacy of Oxyglobin have not been evaluated in dogs with, thrombocytopenia with active bleeding, oliguria or anuria, or advanced cardiac disease.
Sikkerheden og effekten af PegIntron alene eller i kombination med ribavirin ved behandling af hepatitis C hos lever- eller andre organtransplantaterede patienter er ikke blevet undersøgt.
The safety and efficacy of PegIntron alone or in combination with ribavirin for the treatment of hepatitis C in liver or other organ transplant recipients have not been studied.
Sikkerheden og effekten af PegIntron alene eller i kombination med ribavirin ved behandling af hepatitis C hos lever- eller andre organtransplanterede patienter er ikke blevet undersøgt.
The safety and efficacy of PegIntron alone or in combination with ribavirin for the treatment of hepatitis C in liver or other organ transplant recipients have not been studied.
Sikkerheden og effekten af Rebif er blevet evalueret hos patienter med recidiverende-remitterende multipel sklerose ved dosering fra 11 til 44 mikrogram (3-12 millioner IE), administreret subkutant 3 gange ugentligt.
The safety and efficacy of Rebif has been evaluated in patients with relapsing-remitting multiple sclerosis at doses ranging from 11 to 44 micrograms (3-12 million IU), administered subcutaneously three times per week.
Sikkerheden og effekten af samtidigt administreret strålebehandling og Avastin er ikke fastlagt.
The safety and efficacy of concomitant administration of radiotherapy and Avastin has not been established.
Sikkerheden og effekten af Truvada som PrEP hos patienter med HBV- eller HCV-infektion er ikke fastlagt.
The safety and efficacy of Truvada for PrEP in patients with HBV or HCV infection has not been established.
Sikkerheden og effekten af Ziagen i et antal forskellige multistof kombinationsregimer er stadig ikke fuldstændigt vurderet (specielt i kombination med NNRTI’er).
The safety and efficacy of Ziagen in a number of different multidrug combination regimens is still not completely assessed (particularly in combination with NNRTIs).
Sikkerheden og effekten hos børn er ikke klarlagt.
The safety and efficacy in children have not been established.
Sikkerheden og effekten ved bortezomib (som intravenøs injektion) blev undersøgt i 2 forsøg med den anbefalede dosis på 1,3 mg/m2: et randomiseret, komparativt fase III-forsøg (APEX), vs. dexamethason (Dex) med 669 patienter med recidiverende eller refraktær myelomatose, som havde fået 1-3 tidligere behandlinger, og et fase II-forsøg med en enkelt gruppe med 202 patienter med recidiverende eller refraktær myelomatose, som havde fået mindst 2 tidligere behandlinger, og som i deres seneste behandlingsregime havde oplevet progression.
The safety and efficacy of bortezomib (injected intravenously) were evaluated in 2 studies at the recommended dose of 1.3 mg/m2: a Phase III randomised, comparative study (APEX), versus dexamethasone (Dex), of 669 patients with relapsed or refractory multiple myeloma who had received 1-3 prior lines of therapy, and a Phase II single-arm study of 202 patients with relapsed and refractory multiple myeloma, who had received at least 2 prior lines of treatment and who were progressing on their most recent treatment.
Sikkerheden og effekten ved bortezomib (som intravenøs injektion) blev vurderet i to studier med den anbefalede dosis på 1,3 mg/m2: et randomiseret, komparativt fase III-studie (APEX) versus dexametason (Dex) med 669 patienter med recidiverende eller refraktær myelomatose, som havde fået 1-3 tidligere behandlinger, og et fase II-studie med en enkelt gruppe med 202 patienter med recidiverende eller refraktær myelomatose, som havde fået mindst 2 tidligere behandlinger, og som i deres seneste behandlingsregime havde oplevet progression.
The safety and efficacy of bortezomib (injected intravenously) were evaluated in 2 studies at the recommended dose of 1.3 mg/m2: a Phase III randomised, comparative study (APEX), versus dexamethasone (Dex), of 669 patients with relapsed or refractory multiple myeloma who had received 1-3 prior lines of therapy, and a Phase II single-arm study of 202 patients with relapsed and refractory multiple myeloma, who had received at least 2 prior lines of treatment and who were progressing on their most recent treatment.
Sikkerheden og effekten ved VELCADE (som intravenøs injektion) blev vurderet i to studier med den anbefalede dosis på 1,3 mg/m2: et randomiseret, komparativt fase III-studie (APEX) versus dexametason (Dex) med 669 patienter med recidiverende eller refraktær myelomatose, som havde fået 1-3 tidligere behandlinger, og et fase II-studie med en enkelt gruppe med 202 patienter med recidiverende eller refraktær myelomatose, som havde fået mindst 2 tidligere behandlinger, og som i deres seneste behandlingsregime havde oplevet progression.
The safety and efficacy of VELCADE (injected intravenously) were evaluated in 2 studies at the recommended dose of 1.3 mg/m2: a Phase III randomised, comparative study (APEX), versus dexamethasone (Dex), of 669 patients with relapsed or refractory multiple myeloma who had received 1-3 prior lines of therapy, and a Phase II single-arm study of 202 patients with relapsed and refractory multiple myeloma, who had received at least 2 prior lines of treatment and who were progressing on their most recent treatment.
Sikkerheden og effektiviteten af docetaxel i induktionsbehandling af patienter med lokalt fremskreden pladecellekarcinom i hoved og hals (SCCHN) blev evalueret i et randomiseret, multicenter, open- label, fase III-studie (TAX 324).
The safety and efficacy of docetaxel in the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a randomized, multicenter open-label, phase III study (TAX324).
Sikkerheden og effektiviteten af docetaxel ved induktionsbehandling af patienter med pladecellekarcinom i hoved og hals (SCCHN) blev evalueret i et fase III, multicenter, open-label, randomiseret studie (TAX 323).
The safety and efficacy of docetaxel in the induction treatment of patients with squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a phase III, multicenter, open-label, randomized study (TAX323).
Sikkerheden og effektiviteten af Zinbryta i denne aldersgruppe er ikke kendt.
The safety and effectiveness of Zinbryta in this age group are not known.