natgillin/translations-raw huggingface dataset:
Forekomsten af laktacidose kan og skal nedsættes ved samtidig vurdering af andre tilknyttede risikofaktorer såsom dårligt reguleret diabetes, ketose, længerevarende faste, overdreven alkoholindtag, nedsat leverfunktion og tilstande, der er forbundet med hypoksi.
The incidence of lactic acidosis can and should be reduced by also assessing other associated risk factors such as poorly controlled diabetes, ketosis, prolonged fasting, excessive alcohol intake, hepatic impairment and any conditions associated with hypoxia.
Forekomsten af lymfomer (B-celle og T-celle) var højere i kliniske studier i forhold til, hvad der forventes i den generelle population.
The incidence of lymphoma (B-cell and T-cell) cases was higher in clinical trials than expected in the general population.
Forekomsten af lysfølsomhedsreaktioner var højere i Cotellic-plus-vemurafenib-armen end i placebo- plus-vemurafenib-armen (47% versus 35%).
Photosensitivity has been observed with a higher frequency in the Cotellic plus vemurafenib arm vs placebo plus vemurafenib arm (47% vs 35%).
Forekomsten af makulaødem stiger hos patienter med multipel sklerose, som har haft uveitis (17 % ved tidligere uveitis mod 0,5 % uden tidligere uveitis).
Macular oedema incidence is increased in multiple sclerosis patients with a history of uveitis (17% with a history of uveitis vs.
Forekomsten af medfødte misdannelser efter medicinsk assisteret reproduktionsbehandling med Orgalutran adskiller sig ikke fra den ved brug af andre GnRH- præparater til brug i medicinsk assisteret reproduktionsbehandling.
The incidence of congenital malformations after assisted reproduction techniques using Orgalutran is not different from that after using other GnRH analogues in the course of assisted reproduction techniques.
Forekomsten af mulige bivirkninger er anført nedenfor og er defineret på følgende måde: Meget almindelig (påvirker mere end 1 af 10 brugere)
The frequency of possible side effects listed below is defined using the following convention: Very common (affects more than 1 user in 10)
Forekomsten af nethindeløsning før vitrektomi var henholdsvis 0,4 % i Jetrea-gruppen og ingen i placebogruppen, mens forekomsten af nethinderifter (uden nethindeløsning) var 0,2 % i Jetra-gruppen og 0,5 % i placebogruppen).
The incidence of retinal detachment that occurred pre-vitrectomy was 0.4% in the JETREA group and none in the placebo group, while the incidence of retinal tears (without detachment) that occurred pre-vitrectomy was 0.2% in the JETREA group and 0.5% in the placebo group.
Forekomsten af neutraliserende antistoffer (inhibitorer) mod faktor VIII er velkendt ved behandlingen af patienter med hæmofili A. Som ved alle koagulationsfaktor VIII-produkter overvåges patienterne i forbindelse med udviklingen af inhibitorer, der skal titreres i Bethesda-enheder (BE) ved hjælp af Nijmegen-modifikationen af Bethesda-testen.
The occurrence of neutralising antibodies (inhibitors) to factor VIII is well known in the treatment of patients with haemophilia A. As with all coagulation factor VIII products, patients are to be monitored for the development of inhibitors that are to be titrated in Bethesda Units (BUs) using the Nijmegen modification of the Bethesda assay.
Forekomsten af ortostatisk hypotension i placebo-kontrollerede kliniske studier var 1,2 % ved behandling med silodosin og 1,0 % med placebo.
The incidence of orthostatic hypotension in placebo-controlled clinical studies was 1.2 % with silodosin and 1.0 % with placebo.
Forekomsten af overfølsomhedsreaktioner var 1,1 % hos både Onglyza behandlede patienter og placebo-patienter.
The incidence of hypersensitivity reactions was 1.1% in both Onglyza-treated patients and placebo- treated patients.
Forekomsten af overfølsomhedsreaktioner var 1,1 % hos både saxagliptinbehandlede patienter og placebobehandlede patienter.
The incidence of hypersensitivity reactions was 1.1% in both saxagliptin-treated patients and placebo-treated patients.
Forekomsten af patienter med triglycerid-stigning >5x øvre normalgrænse (ULN) var 2,4 % med Ilaris og 0,7 % med triamcinolonacetonid.
The incidence of patients with triglyceride elevations > 5 x upper limit of normal (ULN) was 2.4% with Ilaris and 0.7% with triamcinolone acetonide.
Forekomsten af perifert ødem, når vildagliptin 100 mg daglig blev anvendt i tillæg til maksimal dosis af baggrunds-pioglitazon (45 mg én gang daglig), var 7,0 %, sammenlignet med 2,5 % for baggrunds- pioglitazon alene.
The incidence of peripheral oedema when vildagliptin 100 mg daily was added to a maximum dose of background pioglitazone (45 mg once daily) was 7.0%, compared to 2.5% for background pioglitazone alone.
Forekomsten af pleuraeffusion og kongestivt hjertesvigt/hjerteinsufficiens var lavere blandt de patienter, der blev behandlet med SPRYCEL 100 mg 1 gang dagligt, end blandt de patienter, der blev behandlet med SPRYCEL 70 mg 2 gange dagligt i fase III-studiet vedrørende dosisoptimering hos patienter med CML i kronisk fase og med resistens eller intolerans over for tidligere behandling med imatinib (median behandlingsvarighed var 30 måneder).
In the Phase III dose-optimisation study in patients with chronic phase CML with resistance or intolerance to prior imatinib therapy (median duration of treatment of 30 months), the incidence of pleural effusion and congestive heart failure/cardiac dysfunction was lower in patients treated with SPRYCEL 100 mg once daily than in those treated with SPRYCEL 70 mg twice daily.
Forekomsten af præeksisterende antistoffer mod romiplostim og TPO var henholdsvis 8,0 % og 5,4 %.
The incidence of pre- existing antibodies to romiplostim and TPO was 8.0% and 5.4%, respectively.
Forekomsten af Q80K ved baseline var forbundet med lavere SVR-rater hos patienter med HCV- genotype 1a, der blev behandlet med simeprevir i kombination med peginterferon alfa og ribavirin (tabel 19, 21, 22).
The presence of Q80K at baseline was associated with lower SVR rates in HCV genotype 1a patients treated with simeprevir in combination with peginterferon alfa and ribavirin (tables 19, 21, 22).
Forekomsten af rifter i huden (29,1 %) var større for personer i behandling med to samtidige injektioner af Xiapex i det historisk kontrollerede kliniske studie AUX-CC-867, sammenlignet med personer i behandling med op til tre enkelte injektioner i fase III placebokontrollerede pivotale studier af Dupuytrens kontraktur (CORD I og CORD II) (8,8 %).
The incidence of skin laceration (29.1%) was higher for subjects treated with two concurrent injections of Xiapex in historically-controlled clinical study AUX-CC-867 compared with subjects treated with up to three single injections in the Phase 3 placebo-controlled pivotal studies in Dupuytren’s contracture (CORD I and CORD II) (8.8%).
Forekomsten af seponering på grund af bivirkninger var 7,8 % for patienter behandlet med liraglutid og 3,4 % for komparatorbehandlede patienter i de langvarige, kontrollerede studier (26 uger eller længere).
The incidence of withdrawal due to adverse reactions was 7.8% for liraglutide­treated patients and 3.4% for comparator­treated patients in the long­term controlled trials (26 weeks or longer).
Forekomsten af sløret syn eller svimmelhed kan påvirke evnen til at føre motorkøretøj eller betjene maskiner.
The occurrence of blurred vision or dizziness may influence the ability to drive or to use machines.
Forekomsten af større blødninger var ensartet i de to grupper (1.3 % versus 1.1 % for hhv. clopidogrel+ASA- og placebo+ASA-gruppen.) Dette var ensartet blandt undergrupperne af patienter, defineret ved baseline karakterisktika og typen af fibrinolytika eller heparinbehandling.
This was consistent across subgroups of patients defined by baseline characteristics, and type of fibrinolytic or heparin therapy.
Forekomsten af svære astma-eksacerbationer pr. patient pr. år var 0,19 i FF 92 mikrogram-gruppen (ca.
The rate of severe asthma exacerbations per patient per year was
Forekomsten af svære tilfælde var sammenlignelig for clopidogrel og ASA.
The incidence of severe cases was similar for clopidogrel and ASA.
Forekomsten af symptomatisk DVT var den samme i de behandlede grupper, nemlig 6 patienter (0,4 %) i fondaparinuxgruppen over for 5 patienter (0,3 %) i dalteparingruppen.
treatment groups: 6 patients (0.4%) in the fondaparinux group vs 5 patients (0.3%) in the dalteparin group.
Forekomsten af symptomatiske tromboemboliske komplika- tioner inklusive lungeemboli var ikke signifikant forskellig i behandlingsgrupperne.
The incidence of symptomatic VTE, including PE was not significantly different between treatment groups.
Forekomsten af sådan erhvervet resistens kan variere geografisk og tidsmæssigt for de enkelte arter, og der bør fremskaffes lokale oplysninger om resistens over for svampemidler/azoler, især ved behandling af svære infektioner.
The prevalence of such acquired resistance may vary geographically and over time for specific species, and therefore local information on antifungal/azole resistance is desirable, particularly when treating severe infections.
Forekomsten af takykardi for cabaziataxel var 1,6 %, hvoraf ingen var grad 3.
The incidence of tachycardia on cabazitaxel was 1.6%, none of which were Grade ≥3.
Forekomsten af tilbagefald i år ti var reduceret hos patienter, som fik TAC sammenlignet med dem, som fik FAC (hhv.
Incidence of relapses at 10 years was reduced in patients receiving TAC compared to those who received FAC
Forekomsten af tilbagefald ved 10 år var reduceret hos de patienter som fik TAC, sammenlignet med dem, som fik FAC (henholdsvis 39 % versus 45 %).
Incidence of relapses at 10 years was reduced in patients receiving TAC compared to those who received FAC
Forekomsten af trombose, vurderet som værende kateterrelateret, var for patienter, der fik foretaget PCI, hhv.
In subjects undergoing PCI the incidence of adjudicated guiding catheter thrombus was 1.0% vs.
Forekomsten af visse blødninger (MBE/CRBE; enhver blødning) var signifikant lavere ved et nominelt alfa-niveau på 5 % hos patienter, som fik dabigatranetexilat, sammenlignet med patienter behandet med warfarin.
Some bleeding events (MBEs/CRBEs; any bleeding) were significantly lower at a nominal alpha level of 5% in patients receiving dabigatran etexilate as compared with those receiving warfarin.
forekomsten af væsentlige negative kardiovaskulære hændelser (MACE) hos
events (MACE) in overweight and obese subjects.
Forekomsten af YMDD-mutation- HBV var ens med den, der blev observeret hos voksne, fra 19 % ved uge 52 op til 45 % hos patienter i vedvarende behandling i 24 måneder.
The incidence of YMDD mutant HBV was similar to that observed in adults, ranging from 19 % at week 52 up to 45 % in patients treated continuously for 24 months.
Forekomsten er betydeligt højere hos patienter af japansk afstamning i forhold til p atienter af ikke-japansk afstamning.
Prevalence is significantly higher in Japanese patients when compared to non- Japanese patients.
Forekomsten og typen af symptomer efter første og anden vaccination svarer til dem, der blev observeret hos voksne og ældre, der tager Celvapan.
The incidence and nature of symptoms after the first and second vaccination were similar to that observed in the adult and older population using Celvapan.
Forekomsten var dog sjælden, og opfølgningstiden for placebopatienter var kortere end for patienter, der fik TNF- antagonistbehandling.
However, the occurrence was rare, and the follow-up period of placebo patients was shorter than for patients receiving TNF-antagonist therapy.
Forekomsten var højere hos patienter med tidligere tilfælde thyreoidea-lidelser, både i LEMTRADA- gruppen og i interferon beta 1a (IFNB-1a)-gruppen.
The incidence of thyroid events was higher in patients with a medical history of thyroid disorders both in the LEMTRADA and interferon beta 1a (IFNB-1a) treatment groups.
Forekomster af laktatacidose (med fravær af hypoxæmi), undertiden fatal, og i reglen i forbindelse med svær hepatomegali med steatose, er blevet indberettet ved brug af nukleosid-/nukleotidanaloger.
Occurrences of lactic acidosis (in the absence of hypoxaemia) sometimes fatal, and usually associated with severe hepatomegaly with steatosis have been reported with the use of nucleoside/nucleotide analogues.
Foreliggende data fra pædiatriske populationer
Available data in paediatric populations
Foreliggende data tyder på en øget risiko for forsinket overfølsomhed ved længerevarende Inflectra-fri periode.
Available data suggest an increased risk for delayed hypersensitivity with increasing Inflectra-free interval.
Foreliggende data tyder på en øget risiko for forsinket overfølsomhed ved længerevarende Remsima-fri periode.
Available data suggest an increased risk for delayed hypersensitivity with increasing Remsima-free interval.
Foreliggende ikke-kliniske data viser ingen tegn på, at fertiliteten påvirkes under behandling med tocilizumab.
Available non-clinical data do not suggest an effect on fertility under tocilizumab treatment.
Foreløbige data fra børn under 12 år er konsistente med de data, der er indsamlet hos unge op til 17 år.
Preliminary data in children below 12 are consistent with those obtained in adolescents up to 17 years of age.
Foreløbige data fra England og Wales, som blev rapporteret mindre end 1 år efter indførelsen af standardimmunisering af børn i alderen 2, 4 og 13 måneder med et catch-up-program med en enkeltdosis til børn i alderen 13 til 23 måneder, indikerer, at effektiviteten af denne plan muligvis er lavere mod serotype 6B end mod de øvrige serotyper i vaccinen.
Preliminary data from England and Wales reported less than 1 year following introduction of routine immunisation at 2, 4 and 13 months with a single dose catch-up programme for children 13 to 23 months of age have suggested that effectiveness of this schedule might be lower against serotype 6B than against the other serotypes in the vaccine.
Foreløbige rapporter indsendes årligt inden for rammerne af den årlige revurdering
Interim reports submitted yearly in the frame of the Annual Re-assessment
forende hætte
front part cap
Foreslået handling:
Proposed action:
Forest Laboratories UK Ltd Whiddon Valley
Forest Laboratories UK Ltd Whiddon Valley Barnstaple
Forest Laboratories UK Ltd Whiddon Valley Barnstaple
Forest Laboratories UK Ltd., Whiddon Valley
Foretag blodtryksmåling før den første dosis af Gilenya.
Perform blood pressure measurement prior to the first dose of GILENYA.
Foretag en lang, jævn, dyb indånding.
Take one long, steady, deep breath in.
Foretag en visuel kontrol af den rekonstituerede opløsning for partikler og/eller misfarvning.
Do visually inspect the reconstituted solution for particulate matter and/or discoloration.
Foretag et cirka 5 mm langt snit langs den hævede ende af implantatet.
Make a stab incision, approximately 5 mm long, along the elevated near end of the implant.
Foretag grundig håndvask straks efter brug.
Wash hands thoroughly and immediately after use.
Foretag ikke en genberegning af dosis.
Do not make any dose re-calculation.
Foretag ikke selv indsprøjtninger, medmindre De er blevet undervist i det af Deres læge eller sygeplejerske.
Do not attempt to inject yourself unless you have been trained to do so by your doctor or nurse.
Foretag indsprøjtningen på omtrent samme tid hver dag
Try to self-inject at approximately the same time every day.
Foretag injektionen
Giving your injection
Foretag injektionen
Make the injection
Foretag injektionen på samme tidspunkt hver dag.
Perform the injection every day at the same time.
Foretag injektionen straks efter at have fjernet nålebeskyttelseshætten.
Inject the dose promptly after removing the needle cover.
Foretag klinisk overvågning ved samtidig behandling med stoffer, der har indvirkning på den renale gennemstrømning (diuretika).
Concomitant treatment with molecules displaying action on renal flow (e.g. diuretics) should be subject to clinical monitoring.
Foretag leverfunktionstest inden behandlingsstart.
Perform a liver function test prior to treatment initiation.
Foretag visuel inspektion af opløsningen for at sikre, at der ikke er misfarvninger eller uopløste partikler, før den indgives.
Visually inspect the solution for discolouration and particulate matter before administration.
foretages med forsigtighed.
lopinavir/ritonavir must be done
foretages med forsigtighed.
with caution.
foretages ud fra klinisk
CARDIOVASCULAR AGENTS
Foretrukken MedDRA-term
Injection site induration
Foretrukken term
Preferred MedDRA term
Foretrukken term i MedDRA (version 16).
MedDRA preferred term (Version 16).
Foretrukket injektionsvolumen pr. kg fisk (afhængig af fiskenes størrelse)*
Preferred injection volume per kg fish (depending on fish size)
Foretrukket injektionsvolumen pr. kg fisk (afhængigt af fiskenes størrelse)*
Preferred injection volume per kg fish (depending on fish size)
Foretrukket sted er
Preferred site is front of
Foretrukket sted er forrest på låret.
Preferred site is front of the thigh
Forfaldsdag
Due date
Forfra Bagfra
Front Back
FORFYLDT INJEKTIONSSPRØJTE MED SOLVENS
SYRINGE OF SOLVENT
Forfyldt pen
Pre-filled pen
Forfyldt pen (glas) (OptiSet)
pre-filled pen (glass) (OptiSet)
Forfyldt pen (glas) (SoloStar)
pre-filled pen (glass) (SoloStar)
FORFYLDT SPRØJTE MED SOLVENS
PRE-FILLED SYRINGE OF SOLVENT
Forfyldt sprøjte
pre-filled syringe
Forfyldt sprøjte (glas)
Pre-filled syringe (glass)
Forfyldt sprøjte med 2 nåle, pakke med 1, 10
Pre-filled syringe with 2 needles, pack of 1, 10
Forfyldte polypropylen-sprøjter til oralt brug, med en polyethylen-hætte, en gummitop og et polypropylen-stempel.
Pre-filled oral syringes made of polypropylene, with a polyethylene cap, a rubber rod tip, and a polypropylene plunger rod.
Forføjet niveau af nogle enzymer (aminotransferaser) i blodet.
feeling sick increased blood levels of some enzymes of the liver (transaminases).
Forgelatineret majsstivelse,
Pre-gelatinised maize starch
Forgelatineret stivelse (majsstivelse) Mikrokrystallinsk cellulose
Pre-gelatinised starch (maize) Microcrystalline cellulose Povidone
forgiftninger og behandlingskomp likationer
and procedural complications
Forhalet seponering af ISENTRESS eller andre mistænkte lægemidler efter optræden af alvorligt udslæt kan resultere i en livstruende reaktion.
Delay in stopping ISENTRESS treatment or other suspect agents after the onset of severe rash may result in a life-threatening reaction.
Forhaling af progression til klinisk proteinuri var tydelig allerede efter 3 måneder og den varede ved gennemhele 2-års perioden.
The slowing in the progression to clinical proteinuria was evident as early as three months and continued over the 2 year period.
forhindre, at der dannes blodpropper i blodet i følgende situationer:
top blood clots forming in your blood in the following situations:
Forhold
Ratio
FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Forhold, der kan øge din risiko for en blodprop i en pulsåre
Factors that increase your risk of a blood clot in an artery
forhold, der muliggør klinisk
which ensures clinical monitoring and
Forhold, som øger din risiko for en blodprop i en vene
Factors that increase your risk of a blood clot in a vein
forholdet er >32, nedsættes dosis af Zycortal uden at ændre doseringsintervallet.
If the polyuria/polydipsia persists and the Na⁺/K⁺ ratio is >32, then decrease the dose of Zycortal without changing the dosing interval.
Forholdet mellem den laveste og den maksimale effekt af CoAprovel
When measured by ambulatory blood pressure monitoring, the trough to peak effects of
Forholdet mellem den laveste og den maksimale effekt af CoAprovel 150 mg
When measured by ambulatory blood pressure monitoring, the trough to peak effects of
Forholdet mellem den laveste og den maksimale effekt af Ifirmacombi
When measured by ambulatory blood pressure monitoring, the trough to peak effects of Ifirmacombi
Forholdet mellem den laveste og den maksimale effekt af Irbesartan Hydrochlorothiazide BMS 150 mg /12,5 mg var 100%, når blodtrykket blev monitoreret ambulant.
When measured by ambulatory blood pressure monitoring, the trough to peak effects of Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg were 100%.
Forholdet mellem den laveste og den maksimale effekt af Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg var 100%, når blodtrykket blev monitoreret ambulant.
When measured by ambulatory blood pressure monitoring, the trough to peak effects of Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg were 100%.
Forholdet mellem den laveste og den maksimale effekt af Karvezide
When measured by ambulatory blood pressure monitoring, the trough to peak effects of
Forholdet mellem den laveste og den maksimale effekt af Karvezide 150 mg
When measured by ambulatory blood pressure monitoring, the trough to peak effects of
Forholdet mellem fordel/risiko for TAC-patienter med 4+ lymfeknuder blev ikke fuldt defineret i interimanalysen. (se pkt.
The benefit/risk ratio for TAC in patients with 4+ nodes was not defined fully at the interim analysis (see section 5.1).
Forholdet mellem forekomsten af eksacerbationer med fluticasonfuroat/vilanterol 92/22 mikrogram versus FF 92 mikrogram var 0,755 (95 % konfidensinterval 0,603; 0,945).
The ratio of the exacerbation rate for fluticasone furoate/vilanterol 92/22 micrograms versus FF 92 was 0.755 (95% CI 0.603, 0.945).
Forholdet mellem fuldblod og plasma- ribavirinkoncentrationer er cirka 60:1; det overskydende ribavirin i blodet er til stede som ribavirinnukleotider afsondret i erytrocytter.
The ratio of whole blood:plasma ribavirin concentrations is approximately 60:1; the excess of ribavirin in whole blood exists as ribavirin nucleotides sequestered in erythrocytes.
Forholdet mellem in vitro-følsomheden af hiv over for lamivudin og det kliniske respons af behandling hvor lamivudin er indeholdt undersøges forsat.
The relationship between in vitro susceptibility of HIV to lamivudine and clinical response to lamivudine-containing therapy remains under investigation.
Forholdet mellem koncentration og virkning
Relationship between concentration and effect
Forholdet mellem koncentrationen af 5-FU i tumor og plasma var 21,4 (spændvidde: 3,9 – 59,9, n=8), mens forholdet mellem normalt væv og plasma var 8,9 (spændvidde: 3,0 – 25,8, n=8).
The ratio of 5-FU concentration in tumour to plasma was 21.4 (ranged from 3.9 to 59.9, n=8) whereas the ratio in healthy tissues to plasma was 8.9 (ranged from 3.0 to 25.8, n=8).
Forholdet mellem koncentrationen af hovedmetabolitten M1 (des-(Orn8, Gly-NH2 9) -29)-[Mpa1, D-Tyr(Et)2, Thr4]- oxytocin) og atosiban i plasma var 1,4 og 2,8 ved henholdsvis den anden time og ved infusionens afslutning.
The ratios of the main metabolite M1 (des-(Orn8, Gly-NH2 9) -29)-[Mpa1, D-Tyr(Et)2, Thr4]-oxytocin) to atosiban concentrations in plasma were 1.4 and 2.8 at the second hour and at the end of the infusion respectively.
Forholdet mellem koncentrationen af hovedmetabolliten M1 (des-(Orn8, Gly-NH 9)-[Mpa1, D-Tyr(Et)2, Thr4]-oxytocin) og atosiban i plasma var 1,4 og 2,8 ved henholdsvis den anden time og ved infusionens afslutning.
The ratios of the main metabolite M1 (des-(Orn8, Gly-NH 9)-[Mpa1, D-Tyr(Et)2, Thr4]-oxytocin) to atosiban concentrations in plasma were 1.4 and 2.8 at the second hour and at the end of the infusion respectively.
Forholdet mellem koncentrationen af rivaroxaban og faktor Xa-aktiviteten blev bedst beskrevet af en Emax-model.
The relationship between rivaroxaban concentration and factor-Xa activity was best described by an Emax model.
Forholdet mellem plasmakoncentrationen af apixaban og anti- Faktor Xa-aktiviteten blev bedst beskrevet ved en lineær model.
The relationship between apixaban plasma concentration and anti-Factor Xa activity was best described by a linear model.
Forholdet mellem randomiserede patienter i remission ved 12 måneder og ved 18 måneder  (6 måneders komplet lægemiddelseponering)
Proportion of Randomized Patients in Remission at 12 Months and at 18 Months  (6 Months of Complete Drug Withdrawal)
Forholdet mellem risici og fordele ved behandling af trombocytopeni uden for den registrerede indikation er ikke afklaret.
The risk-benefit for the treatment of thrombocytopenia outside of the registered indication has not been established.