natgillin/translations-raw huggingface dataset:
Sikkerhed til dyr under drægtighed og diegivning er ikke blevet fastlagt.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Sikkerhed ved immunisering med levende eller svækkede virale vacciner efter behandling med Gazyvaro er ikke undersøgt, og vaccination med levende virusvacciner frarådes under behandling og indtil B-celleniveauet er normaliseret.
The safety of immunisation with live or attenuated viral vaccines following Gazyvaro therapy has not been studied and vaccination with live virus vaccines is not recommended during treatment and until B cell recovery.
Sikkerhed ved og virkning af GANFORT enkeltdosis hos børn under 18 år er ikke klarlagt.
The safety and efficacy of GANFORT single-dose in children aged less than 18 years has not been established.
Sikkerhed ved vaccination med levende, virale vacciner efter MabThera-behandling er ikke undersøgt hos patienter med non-Hodgkin lymfom og kronisk lymfatisk leukæmi, og vaccination med levende, virale vacciner frarådes.
The safety of immunisation with live viral vaccines, following MabThera therapy has not been studied for NHL and CLL patients and vaccination with live virus vaccines is not recommended.
Sikkerhed ved vaccination og tidspunkt herfor, skal diskuteres med barnets læge (se pkt.
The safety and timing of vaccination should be discussed with the infant’s physician (see section 4.6).
Sikkerhed, effekt og livskvalitet med pazopanib blev målt over for sunitinib i et randomiseret, ublindet, parallelgruppe fase III non-inferioritets studie (VEG108844).
The safety, efficacy and quality of life of pazopanib versus sunitinib has been evaluated in a randomised, open-label, parallel group Phase III non-inferiority study (VEG108844).
Sikkerhed, herunder potentielt immunrespons og virkning efter gentagen administration er ikke vurderet hos hunde.
The safety, including potential immune responses and effectiveness of repeat TruScient administration have not been evaluated in dogs.
Sikkerhed, virkning og farmakokinetik ved brug af Pergoveris hos patienter med nedsat nyre- eller leverfunktion er ikke klarlagt.
Safety, efficacy, and pharmacokinetics of Pergoveris in patients with renal or hepatic impairment have not been established.
Sikkerheden af Activyl er ikke fastlagt hos hunde og katte yngre end 8 uger.
The safety of Activyl has not been established in dogs and cats younger than 8 weeks of age.
Sikkerheden af Activyl er ikke fastlagt hos hunde, der vejer mindre end 1,5 kg og hos katte, der vejer mindre end 0,6 kg.
The safety of Activyl has not been established in dogs weighing less than 1.5 kg and in cats weighing less than 0.6 kg.
Sikkerheden af Activyl Tick Plus er ikke fastlagt hos hunde yngre end 8 uger.
The safety of Activyl Tick Plus has not been established in dogs younger than 8 weeks of age.
Sikkerheden af Activyl Tick Plus er ikke fastlagt hos hunde, der vejer mindre end 1,2 kg.
The safety of Activyl Tick Plus has not been established in dogs weighing less than 1.2 kg.
Sikkerheden af Advocate er ikke undersøgt ved påføring samme dag som et adulticid.
The safety of Advocate has not been evaluated when administered on the same day as an adulticide.
Sikkerheden af apremilast blev ikke evalueret hos patienter med PsA eller PSOR med nedsat leverfunktion.
The safety of apremilast was not evaluated in PsA or PSOR patients with hepatic impairment.
Sikkerheden af begge behandlinger blev evalueret i det fulde analysedatasæt ( eller sikkerhedsdatasæt, dvs.
The safety of both treatments was evaluated in the full analysis data set (or safety data set, i.e.
Sikkerheden af BRINAVESS er blevet vurderet i kliniske studier med 1148 forsøgspersoner (patienter og raske frivillige), som er blevet behandlet med BRINAVESS.
The safety of BRINAVESS has been evaluated in clinical studies involving 1148 subjects (patients and healthy volunteers) who received treatment with BRINAVESS.
Sikkerheden af BROADLINE er ikke blevet undersøgt ved behandlingsintervaller kortere end 2 uger eller hos killinger som vejer under 0,6 kg og/eller er under 7 uger gamle.
The safety of BROADLINE has not been tested at intervals of less than 2 weeks or in kittens weighing less than 0.6 kg and/or under 7 weeks of age.
Sikkerheden af Convenia er ikke undersøgt med hensyn til dyr, der lider af svær nyreinsufficiens.
The safety of Convenia has not been assessed in animals suffering from severe renal dysfunction.
Sikkerheden af Convenia til hunde og katte under drægtighed og diegivning er ikke fastlagt.
The safety of Convenia in dogs and cats has not been established during pregnancy and lactation.
Sikkerheden af den anbefalede dosis er påvist hos hvalpe behandlet hver anden uge op til 5 gange.
The safety of the recommended dose has been demonstrated in puppies treated every two weeks, on up to five occasions.
Sikkerheden af det veterinærmedicinske lægemiddel er ikke undersøgt i 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 Cerenia 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.
Sikkerheden af dette veterinære lægemiddel er ikke fastlagt under drægtighed og laktation.
The safety of the veterinary medicinal product has not been established during pregnancy or lactation.
Sikkerheden af edoxaban er blevet evalueret i to fase III-studier, der inkluderede 21.105 patienter med NVAF (ENGAGE AF-TIMI 48-studiet) og 8.292 patienter med VTE (DVT og PE) (Hokusai-VTE- studiet).
The safety of edoxaban has been evaluated in two Phase 3 studies including 21,105 patients with NVAF (ENGAGE AF-TIMI 48 study), and 8,292 patients with VTE (DVT and PE) (Hokusai-VTE study).
Sikkerheden af emtricitabin og tenofoviralafenamid blev evalueret til og med 48 uger i et ublindet klinisk studie (GS-US-292-0106), hvor hiv 1-inficerede, behandlingsnaive pædiatriske patienter i alderen 12 til < 18 år fik emtricitabin og tenofoviralafenamid i kombination med elvitegravir og cobicistat som en fastdosis kombinationstablet.
The safety of emtricitabine and tenofovir alafenamide was evaluated through 48 weeks in an open- label clinical study (GS-US-292-0106) in which HIV-1 infected, treatment-naïve paediatric patients aged 12 to < 18 years received emtricitabine and tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet.
Sikkerheden af emtricitabin og tenofoviralafenamid blev evalueret til og med 96 uger i et ublindet klinisk studie (GS-US-292-0112), hvor 248 hiv 1-inficerede patienter, der enten var behandlingsnaive (n = 6) eller virologisk supprimerede (n = 242) med let til moderat nedsat nyrefunktion (estimeret glomerulær filtrationshastighed via Cockcroft-Gault-metoden [eGFRCG]: 30-69 ml/min) fik emtricitabin og tenofoviralafenamid i kombination med elvitegravir og cobicistat som en fastdosis kombinationstablet.
The safety of emtricitabine and tenofovir alafenamide was evaluated through 96 weeks in an open- label clinical study (GS-US-292-0112) in which 248 HIV-1 infected patients who were either treatment-naïve (n = 6) or virologically suppressed (n = 242) with mild to moderate renal impairment (estimated glomerular filtration rate by Cockcroft-Gault method [eGFRCG]: 30-69 mL/min) received emtricitabine and tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet.
Sikkerheden af emtricitabin+tenofoviralafenamid blev evalueret til og med 48 uger i et ublindet klinisk studie (GS-US-292-0106), hvor 50 hiv 1-inficerede, behandlingsnaive pædiatriske patienter i alderen 12 til < 18 år fik emtricitabin+tenofoviralafenamid i kombination med elvitegravir+cobicistat som en fastdosis kombinationstablet.
The safety of emtricitabine+tenofovir alafenamide was evaluated through 48 weeks in an open-label clinical study (GS-US-292-0106) in which 50 HIV-1 infected, treatment-naïve paediatric patients aged 12 to < 18 years received emtricitabine+tenofovir alafenamide in combination with elvitegravir+cobicistat as a fixed-dose combination tablet.
Sikkerheden af emtricitabin+tenofoviralafenamid blev evalueret til og med 96 uger i et ublindet klinisk studie (GS-US-292-0112), hvor 248 hiv 1-inficerede patienter, der enten var behandlingsnaive (n = 6) eller virologisk supprimerede (n = 242) med let til moderat nedsat nyrefunktion (estimeret glomerulær filtrationshastighed via Cockcroft-Gault-metoden [eGFRCG]: 30-69 ml/min) fik emtricitabin+tenofoviralafenamid i kombination med elvitegravir+cobicistat som en fastdosis kombinationstablet.
The safety of emtricitabine+tenofovir alafenamide was evaluated through 96 weeks in an open-label clinical study (GS-US-292-0112), in which 248 HIV-1 infected patients who were either treatment-naïve (n = 6) or virologically suppressed (n = 242) with mild to moderate renal impairment (estimated glomerular filtration rate by Cockcroft-Gault method [eGFRCG]: 30-69 mL/min) received emtricitabine+tenofovir alafenamide in combination with elvitegravir+cobicistat as a fixed-dose combination tablet.
Sikkerheden af Entresto hos patienter med kronisk hjertesvigt blev undersøgt i det pivotale fase 3- studie PARADIGM-HF, hvor man sammenlignede patienter behandlet 2 gange daglig med enten 97 mg/103 mg Entresto (n=4203) eller 10 mg enalapril (n=4229).
The safety of Entresto in patients with chronic heart failure was evaluated in the pivotal phase 3 study PARADIGM-HF, which compared patients treated twice daily with Entresto 97 mg/103 mg (n=4,203) or enalapril 10 mg (n=4,229).
Sikkerheden af EXUBERA-behandling alene eller i kombination med subkutan insulin eller orale lægemidler er evalueret i kliniske forsøg på mere end 2700 patienter med type 1 eller type 2 diabetes, inklusiv mere end 1975 voksne, der var i behandling i mere end 6 måneder, og mere end 745 voksne i mere end 2 år.
The safety of EXUBERA alone, or in combination with subcutaneous insulin or oral agents has been evaluated in clinical studies of more than 2700 patients with type 1 or type 2 diabetes, including more than 1975 adults exposed for greater than 6 months and more than 745 adults for greater than 2 years.
Sikkerheden af EXUBERA-behandling alene eller i kombination med subkutant insulin eller orale lægemidler er evalueret i kliniske forsøg på mere end 2700 patienter med type 1 eller type 2 diabetes, inklusiv mere end 1975 voksne, der var i behandling i mere end 6 måneder, og mere end 745 voksne i mere end 2 år.
The safety of EXUBERA alone, or in combination with subcutaneous insulin or oral agents has been evaluated in clinical studies of more than 2700 patients with type 1 or type 2 diabetes, including more than 1975 adults exposed for greater than 6 months and more than 745 adults for greater than 2 years.
Sikkerheden af fesoterodin blev vurderet i placebokontrollerede kliniske forsøg med i alt 2.859 pati- enter med overaktiv blære, hvoraf 780 fik placebo.
The safety of fesoterodine was evaluated in placebo-controlled clinical studies in a total of 2859 patients with overactive bladder, of which 780 received placebo.
Sikkerheden af Fortacin er vurderet på grundlag af 596 mandlige patienter, der anvendte det i kliniske undersøgelser.
The safety of Fortacin was evaluated based on 596 male patients who applied it during clinical trials.
Sikkerheden af FORTEKOR PLUS ikke blevet fastlagt i avlsdyr, drægtige eller diegivende hunde.
The safety of FORTEKOR PLUS has not been tested in breeding, pregnant or lactating dogs.
Sikkerheden af Genvoya hos 248 hiv 1-inficerede patienter, der enten var behandlingsnaive (n = 6) eller virologisk supprimerede (n = 242) med let til moderat nedsat nyrefunktion (estimeret glomerulær filtrationshastighed via Cockcroft-Gault-metoden [eGFRCG]: 30-69 ml/min) blev evalueret til og med 96 uger i et ublindet klinisk studie (GS-US-292-0112).
The safety of Genvoya in 248 HIV-1 infected patients who were either treatment-naïve (n = 6) or virologically suppressed (n = 242) with mild to moderate renal impairment (estimated glomerular filtration rate by Cockcroft-Gault method [eGFRCG]: 30-69 mL/min) was evaluated through 96 weeks in an open-label clinical study (GS-US-292-0112).
Sikkerheden af Harvoni er ikke blevet undersøgt hos patienter med svært nedsat nyrefunktion (estimeret glomulær filtrationshastighed [eGFR] <30 ml/min/1,73 m2) eller nyresygdom i slutstadiet (ESRD), der kræver hæmodialyse.
The safety of Harvoni has not been assessed in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2) or end stage renaldisease (ESRD) requiring haemodialysis.
Sikkerheden af Improvac blev undersøgt i laboratorie- og feltsikkerhedsundersøgelser.
The safety of Improvac was studied in laboratory and field safety studies.
Sikkerheden af Jakavi er vurderet hos 110 patienter i et åbent, randomiseret, kontrolleret fase 3-studie, RESPONSE.
The safety of Jakavi was assessed in 110 patients with PV in an open-label, randomised, controlled phase 3 RESPONSE study.
Sikkerheden af konjugerede østrogener/bazedoxifen blev vurderet hos 4.868 post-menopausale kvinder, der deltog i 5 fase III studier.
The safety of CE/bazedoxifene was evaluated in 4,868 post-menopausal women who participated in 5 Phase 3 trials.
Sikkerheden af Neparvis hos patienter med kronisk hjertesvigt blev undersøgt i det pivotale fase 3- studie PARADIGM-HF, hvor man sammenlignede patienter behandlet 2 gange daglig med enten 97 mg/103 mg Neparvis (n=4203) eller 10 mg enalapril (n=4229).
The safety of Neparvis in patients with chronic heart failure was evaluated in the pivotal phase 3 study PARADIGM-HF, which compared patients treated twice daily with Neparvis 97 mg/103 mg (n=4,203) or enalapril 10 mg (n=4,229).
Sikkerheden af NeuroBloc uden for den godkendte indikation er ikke klarlagt, og risici (herunder dysfagi og vejrtrækningsbesvær) kan opveje fordelene.
The safety of NeuroBloc outside the approved indication has not been established and the risks (including dysphagia and respiratory difficulties) may outweigh the benefits.
Sikkerheden af oral behandling med ibandronsyre 2,5 mg daglig er undersøgt hos 1251 patienter, som indgik i 4 placebokontrollerede kliniske studier; hovedparten af disse patienter var fra det pivotale treårs frakturstudie (MF 4411).
The safety of oral treatment with ibandronic acid 2.5 mg daily was evaluated in 1251 patients treated in 4 placebo-controlled clinical studies, with the large majority of patients coming from the pivotal three year fracture study (MF 4411).
Sikkerheden af ospemifen blev vurderet blandt 1.892 VVA-patienter med doser i området 5-90 mg pr. dag.
The safety of ospemifene has been assessed in 1,892 VVA patients with doses ranging from 5 – 90 mg per day.
Sikkerheden af Panretin gel er blevet vurderet i kliniske undersøgelser af mere end 469 patienter med AIDS-relateret KS, hvoraf 439 blev behandlet med en alitretinoin-koncentration på 0,1%.
The safety of Panretin gel has been assessed in clinical studies of more than 469 patients with AIDS- related KS, 439 of whom were treated with an alitretinoin concentration of 0.1%.
Sikkerheden af Perjeta administreret i flere end 6 serier i neoadjuverende behandling er ikke undersøgt.
The safety of Perjeta administered for more than 6 cycles in the neoadjuvant setting has not been established.
Sikkerheden af posaconazol koncentrat til infusionsvæske, opløsning
Posaconazole concentrate for solution for infusion safety
Sikkerheden af posaconazol tabletter og posaconazol oral suspension
Posaconazole tablet and oral suspension safety
Sikkerheden af Reconcile er ikke blevet fastlagt hos hunde, der er under 6 måneder gamle eller vejer under 4 kg.
The safety of Reconcile has not been established in dogs less than 6 months of age or weighing less than 4 kg.
Sikkerheden af ReFacto AF blev evalueret hos tidligere behandlede børn og unge (i alderen 12-16 år i en undersøgelse (n=18), og i alderen 7-16 år i en understøttende undersøgelse (n=49)).
Safety of ReFacto AF was evaluated in previously treated children and adolescents (n=18, age 12-16 years in a study and n=49, age 7-16 years in a supporting study).
Sikkerheden af rivaroxaban er blevet undersøgt i 11 fase III-studier omfattende 32.625 patienter, der fik rivaroxaban (se tabel 1).
The safety of rivaroxaban has been evaluated in eleven phase III studies including 32,625 patients exposed to rivaroxaban (see Table 1).
Sikkerheden af rivaroxaban er blevet undersøgt i elleve fase III-studier omfattende 32.625 patienter, der fik rivaroxaban (se tabel 1).
The safety of rivaroxaban has been evaluated in eleven phase III studies including 32,625 patients exposed to rivaroxaban (see Table 1).
Sikkerheden af sevelamer (som enten carbonat eller hydrochloridsalte) er blevet undersøgt i adskillige kliniske studier, der har involveret i alt 969 hæmodialysepatienter med behandlingsvarigheder på 4 til 50 uger (724 patienter behandlet med sevelamerhydrochlorid og 245 med sevelamercarbonat), 97 patienter i peritonealdialyse med behandlingsvarighed på 12 uger (alle behandlet med sevelamerhydrochlorid) og 128 patienter med kronisk nyresygdom, der ikke var i dialyse, med behandlingsvarigheder på 8 til 12 uger (79 patienter behandlet med sevelamerhydrochlorid og 49 med sevelamercarbonat).
The safety of sevelamer (as either carbonate and hydrochloride salts) has been investigated in numerous clinical trials involving a total of 969 haemodialysis patients with treatment duration of 4 to 50 weeks (724 patients treated with sevelamer hydrochloride and 245 with sevelamer carbonate), 97 peritoneal dialysis patients with treatment duration of 12 weeks (all treated with sevelamer hydrochloride) and 128 patients with CKD not on dialysis with treatment duration of 8 to 12 weeks (79 patients treatment with sevelamer hydrochloride and 49 with sevelamer carbonate).
Sikkerheden af sevelamer (som enten carbonat eller hydrochloridsalte) er blevet undersøgt i adskillige kliniske studier, der har involveret i alt 969 hæmodialysepatienter med behandlingsvarigheder på 4 til 50 uger(724 patienter behandlet med sevelamerhydrochlorid og 245 med sevelamercarbonat), 97 patienter i peritonealdialyse med behandlingsvarighed på 12 uger (alle behandlet med sevelamerhydrochlorid) og 128 patienter med kronisk nyresygdom, der ikke var i dialyse, med behandlingsvarigheder på 8 til 12 uger (79 patienter behandlet med sevelamerhydrochlorid og 49 med sevelamercarbonat).
The safety of sevelamer (as either carbonate and hydrochloride salts) has been investigated in numerous clinical trials involving a total of 969 haemodialysis patients with treatment duration of 4 to 50 weeks (724 patients treated with sevelamer hydrochloride and 245 with sevelamer carbonate), 97 peritoneal dialysis patients with treatment duration of 12 weeks (all treated with sevelamer hydrochloride) and 128 patients with CKD not on dialysis with treatment duration of 8 to 12 weeks (79 patients treatment with sevelamer hydrochloride and 49 with sevelamer carbonate).
Sikkerheden af sevelamer (som enten carbonat eller hydrochloridsalte) er blevet undersøgt i adskillige kliniske studier, har involveret i alt 969 hæmodialysepatienter med behandlingsvarigheder på 4 til 50 uger (724 patienter behandlet med sevelamerhydrochlorid og 245 med sevelamercarbonat), 97 patienter i peritonealdialyse med behandlingsvarighed på 12 uger (alle behandlet med sevelamerhydrochlorid) og 128 patienter med kronisk nyresygdom, der ikke var i dialyse, med behandlingsvarigheder på 8 til 12 uger (79 patienter behandlet med sevelamerhydrochlorid og 49 med sevelamercarbonat).
The safety of sevelamer (as either carbonate and hydrochloride salts) has been investigated in numerous clinical trials involving a total of 969 haemodialysis patients with treatment duration of 4 to 50 weeks (724 patients treated with sevelamer hydrochloride and 245 with sevelamer carbonate), 97 peritoneal dialysis patients with treatment duration of 12 weeks (all treated with sevelamer hydrochloride) and 128 patients with CKD not on dialysis with treatment duration of 8 to 12 weeks (79 patients treatment with sevelamer hydrochloride and 49 with sevelamer carbonate).
Sikkerheden af sevelamer (som enten carbonat- eller hydrochloridsalte) er blevet undersøgt i adskillige kliniske studier, der har involveret i alt 969 hæmodialysepatienter med behandlingsvarigheder på 4 til 50 uger (724 patienter behandlet med sevelamerhydrochlorid og 245 med sevelamercarbonat), 97 patienter i peritonealdialyse med behandlingsvarighed på 12 uger (alle behandlet med sevelamerhydrochlorid) og 128 patienter med CKD, der ikke var i dialyse, med behandlingsvarigheder på 8 til 12 uger (79 patienter behandlet med sevelamerhydrochlorid og 49 med sevelamercarbonat).
The safety of sevelamer (as either carbonate and hydrochloride salts) has been investigated in numerous clinical trials involving a total of 969 haemodialysis patients with treatment duration of 4 to 50 weeks (724 patients treated with sevelamer hydrochloride and 245 with sevelamer carbonate), 97 peritoneal dialysis patients with treatment duration of 12 weeks (all treated with sevelamer hydrochloride) and 128 patients with CKD not on dialysis with treatment duration of 8 to 12 weeks (79 patients treatment with sevelamer hydrochloride and 49 with sevelamer carbonate).
Sikkerheden af sevelamer (som enten carbonat- eller hydrochloridsalte) er blevet undersøgt i adskillige kliniske studier, der har involveret i alt 969 hæmodialysepatienter med behandlingsvarigheder på 4 til 50 uger(724 patienter behandlet med sevelamerhydrochlorid og 245 med sevelamercarbonat), 97 patienter i peritonealdialyse med behandlingsvarighed på 12 uger (alle behandlet med sevelamerhydrochlorid) og 128 patienter med CKD, der ikke var i dialyse, med behandlingsvarigheder på 8 til 12 uger (79 patienter behandlet med sevelamerhydrochlorid og 49 med sevelamercarbonat).
The safety of sevelamer (as either carbonate and hydrochloride salts) has been investigated in numerous clinical trials involving a total of 969 haemodialysis patients with treatment duration of 4 to 50 weeks (724 patients treated with sevelamer hydrochloride and 245 with sevelamer carbonate), 97 peritoneal dialysis patients with treatment duration of 12 weeks (all treated with sevelamer hydrochloride) and 128 patients with CKD not on dialysis with treatment duration of 8 to 12 weeks (79 patients treatment with sevelamer hydrochloride and 49 with sevelamer carbonate).
Sikkerheden af Sovaldi er ikke blevet vurderet hos personer med svært nedsat nyrefunktion (eGFR
The safety of Sovaldi has not been assessed in subjects with severe renal impairment (eGFR
Sikkerheden af Taltz i kombination med andre immunmodulerende midler eller lysbehandling er ikke blevet evalueret.
The safety of Taltz in combination with other immunomodulatory agents or phototherapy has not been evaluated.
Sikkerheden af tenofovirdisoproxil ved administration sammen med ledipasvir/sofosbuvir og en farmakokinetisk forstærker er ikke klarlagt.
The safety of tenofovir disoproxil when co-administered with ledipasvir/sofosbuvir and a pharmacokinetic enhancer has not been established.
Sikkerheden af tenofovirdisoproxilfumarat sammen med ledipasvir/sofosbuvir og en farmakokinetisk booster (f.eks. cobicistat) er ikke klarlagt.
The safety of tenofovir disoproxil fumarate when used with ledipasvir/sofosbuvir and a pharmacokinetic enhancer (e.g. cobicistat) has not been established.
Sikkerheden af tenofovirdisoproxilfumarat sammen med ledipasvir/sofosbuvir og en farmakokinetisk booster (f.eks. ritonavir eller cobicistat) er ikke klarlagt.
The safety of tenofovir disoproxil fumarate when used with ledipasvir/sofosbuvir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Sikkerheden af tenofovirdisoproxilfumarat sammen med ledipasvir/sofosbuvir og en farmakokinetisk booster er ikke klarlagt.
The safety of tenofovir disoproxil fumarate in the setting of ledipasvir/sofosbuvir and a pharmacokinetic enhancer has not been established.