FrancophonIA/ELRC3.0 huggingface dataset:
English: The rate of atrial fibrillation serious adverse events was increased in patients receiving zoledronic acid (1.3%) (51 out of 3,862) compared with patients receiving placebo (0.6%) (22 out of 3,852).
Danish: Frekvensen af atrieflimren som alvorlig utilsigtigt hændelse var øget hos patienter i behandling med zoledronsyre (1,3%) (51 ud af 3.862) sammenlignet med patienter som modtog placebo (0,6%) (22 ud af 3.852).
English: Zoledronic Acid Hospira contains sodium
Danish: Zoledronsyre Hospira indeholder natrium
English: - Severe renal impairment with creatinine clearance < 35 ml/min (see section 4.4).
Danish: - Svært nedsat nyrefunktion med kreatinin clearance < 35 ml/min (se pkt.
English: Uncommon: Dizziness, paraesthesia, dysgeusia, hypoaesthesia, hyperaesthesia, tremor, somnolence
Danish: Svimmelhed, paræstesier, dysgeusi, hypæstesi, hyperæstesi, tremor, somnolens
English: Adequate calcium and vitamin D intake are recommended in association with zoledronic acid administration.
Danish: Det anbefales at indtage tilstrækkeligt med calcium og D-vitamin i forbindelse med administration af zoledronsyre.
English: Adequate calcium and vitamin D intake are recommended in association with Zoledronic Acid Hospira administration.
Danish: Det anbefales at indtage tilstrækkeligt med calcium og D-vitamin i forbindelse med administration af Zoledronsyre Hospira.
English: Concentrate for solution for infusion 4 mg/5 ml
Danish: Koncentrat til infusionsvæske, opløsning 4 mg/5 ml
English: Caution is advised when Zoledronic acid is administered with medicinal products known to cause hypocalcaemia, as they may have a synergistic effect resulting in severe hypocalcaemia (see section 4.5).
Danish: Der skal udvises forsigtighed, når zoledronsyre gives sammen med lægemidler, der vides at forårsage hypokalcæmi, da de kan have en synergistisk effekt, resulterende i svær hypokalcæmi (se pkt 4.5).
English: Uncommon Blood creatinine increased, pollakiuria, proteinuria
Danish: Serumkreatinin øget, pollakisuri, proteinuri
English: Caution is advised when Zoledronic Acid Hospira is administered with anti-angiogenic medicinal products, as an increase in the incidence of ONJ has been observed in patients treated concomitantly with these medicinal products.
Danish: Der tilrådes forsigtighed, når Zoledronsyre Hospira indgives sammen med anti-angiogene lægemidler, da der er set en øget hyppighed af osteonekrose af kæberne hos patienter i samtidig behandling med disse lægemidler.
English: If you are under dental treatment or are due to undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with Zoledronic Acid Hospira.
Danish: Hvis du er i gang med tandbehandling eller skal gennemgå kæbekirurgi (fx en tandudtrækning), skal du fortælle din læge om din tandbehandling, og fortælle din tandlæge, at du er i behandling med Zoledronsyre Hospira.
English: − The solution containing zoledronic acid is given as a single 15-minute intravenous infusion in a separate infusion line.
Danish: - Opløsningen indeholdende zoledronsyre indgives ved en enkelt intravenøs infusion over 15 minutter i en separat infusionsslange.
English: Only clear solution free from particles and discoloration should be used.
Danish: Kun en klar opløsning fri for partikler og misfarvning må benyttes.
English: Uncommon: Blurred vision, scleritis and orbital inflammation Rare
Danish: Sløret syn, sklerit og orbital inflammation
English: somnolence
Danish: Søvnløshed
English: Prior to administration, 5.0 ml concentrate from one vial or the volume of the concentrate withdrawn as required must be further diluted with 100 ml of calcium-free infusion solution (sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution).
Danish: Før administration skal 5,0 ml koncentrat fra et hætteglas, eller det påkrævede udtagende volumen af koncentratet fortyndes yderligere med 100 ml calciumfri infusionsvæske (natriumklorid 9 mg/ml (0,9% ) opløsning til injektion eller 5% w/v glukoseopløsning).
English: Uncommon (may affect up to 1 in 100 people):− Pain in the mouth, teeth and/or jaw, swelling or non-healing sores inside the mouth or jaw discharge, numbness or a feeling of heaviness in the jaw or loosening of a tooth.
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 patienter): - Smerter i munden, tænder og/eller kæberne, hævelse eller ikke helende sår inde i munden eller kæben, udflåd af gullig betændelse, følelsesløshed eller følelsen af tyngde i kæberne eller løsnen af en tand.
English: Zoledronic acid is eliminated by renal excretion.
Danish: Zoledronsyre elimineres via nyrerne.
English: Studies in animals with zoledronic acid have shown reproductive toxicological effects including malformations (see section 5.3).
Danish: Dyreforsøg har påvist reproduktionstoksicitet inklusive malformationer (se pkt.
English: The recommended dose in hypercalcaemia (albumin-corrected serum calcium 12.0 mg/dl or 3.0 mmol/l) is a single dose of 4 mg zoledronic acid.
Danish: Den anbefalede dosis ved hyperkalcæmi (albuminkorrigeret serumcalcium 12,0 mg/dl eller 3,0 mmol/l)eren enkeltdosis på4 mgzoledronsyre.Nyreinsufficiens
English: Cardiac disorders Uncommon: Hypertension, hypotension, atrial fibrillation, hypotension leading to syncope or circulatory collapse
Danish: Hypertension, hypotension, atrieflimren, hypotension førende til synkope eller kredsløbssvigt
English: Prevention of skeletal related events in patients with advanced malignancies involving bone:
Danish: Forebyggelse af skeletrelaterede hændelser hos patienter med fremskreden malign sygdom og knoglemetastaser:
English: Zoledronic Acid Hospira 4 mg/5 ml sterile concentrate IV
Danish: Zoledronsyre Hospira 4 mg/5 ml sterilt koncentrat I.V.
English: − Difficulty in breathing with wheezing or coughing.
Danish: - Vejrtrækningsbesvær med hiven efter vejret eller hosten.
English: Caution is advised when bisphosphonates are administered with aminoglycosides, calcitonin or loop diuretics, since these agents may have an additive effect, resulting in a lower serum calcium level for longer periods than required (see section 4.4).
Danish: Der tilrådes forsigtighed, når bisfosfonater indgives sammen med aminoglykosider, calcitonin eller loop-diuretika, da disse stoffer kan have en additiv effekt og give et lavere serumcalciumniveau i længere perioder end påkrævet (se pkt.4.4).
English: − Skin reactions (redness and swelling) at the infusion site, rash, itching.
Danish: - Hudreaktioner (rødme og hævelse) på infusionsstedet, udslæt, kløe.
English: In patients with bone metastases presenting with mild to moderate renal impairment prior to initiation of therapy, which is defined for this population as CLcr 30-60 ml/min, reduced Zoledronic Acid Hospira doses are recommended (see also section 4.4).
Danish: Til patienter med knoglemetastaser, der før behandlingen initieres, har mild til moderat nyreinsufficiens, som i denne population er defineret som CLcr 30-60 ml/min, anbefales nedsatte doser af Zoledronsyre Hospira (se også pkt.
English: Renal impairment has been observed in patients after a single administration, renal failure requiring dialysis or with a fatal outcome has rarely occurred in patients with underlying renal impairment or with any of the risk factors described above.
Danish: Dialysekrævende nyresvigt eller letale tilfælde er i sjældne tilfælde opstået hos patienter med underliggende nyresygdom eller med en af risikofaktorerne beskrevet ovenfor.
English: Adjusted dose (mg zoledronic acid)
Danish: Tilpasset dosis (mg zoledronsyre)
English: − From a microbiological point of view, the diluted solution for infusion should be used immediately.
Danish: - Ud fra et mikrobiologisk synspunkt skal den rekonstituerede opløsning til infusion anvendes straks.
English: − Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving zoledronic acid for postmenopausal osteoporosis.
Danish: - Uregelmæssig hjerterytme (atrieflimren) er set hos patienter, der fik zoledronsyre for postmenopausal osteoporose.
English: The MAH shall ensure that a patient reminder card regarding osteonecrosis of the jaw is implemented.
Danish: Indehaveren af markedsføringstilladelsen skal sikre at der implementeres patienthuskekort vedrørende osteonekrose af kæberne.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 100 ml dose of Zoledronic Acid Hospira, i.e. essentially “sodium free”.
Danish: Denne medicin indeholder mindre end 1 mmol (23 mg) natrium pr. 100 ml Zoledronsyre Hospira, dvs. den er i det væsentlige natriumfri.
English: • Creatinine clearance should be calculated based on actual body weight using the Cockcroft-Gault formula before each Zoledronic Acid Hospira dose.
Danish: • Før hver dosis Zoledronsyre Hospira bør kreatinin clearance beregnes på bais af den faktiske legemsvægt ved at bruge Cockcroft-Gault formlen.
English: If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of Zoledronic Acid Hospira.
Danish: Hvis du har hypokalcæmi, skal den korrigeres, inden du får den første dosis af Zoledronsyre Hospira.
English: Zoledronic Acid Hospira is contraindicated during breast-feeding (see section 4.3).
Danish: Zoledronsyre Hospira er kontraindiceret under gravididitet (se pkt.4.3).
English: Uncommon Neck pain, musculoskeletal stiffness, joint swelling, muscle spasms, shoulder pain, musculoskeletal chest pain, musculoskeletal pain, joint stiffness, arthritis, muscular weakness
Danish: Nakkesmerter, stivhed i bevægeapparatet, hævelse af led, muskelkramper, skuldersmerter, muskuloskeletale smerter i brystregionen, muskuloskeletale smerter, ledstivhed, artrit, muskelsvækkelse
English: In patients with mild to moderate renal impairment, reduced zoledronic acid doses are recommended (see section “Posology” above and section 4.4).
Danish: Hos patienter med let til moderat nedsat nyrefunktion, anbefales nedsatte doser af zoledronsyre (se afsnittet ”Dosering”ovenfor samt pkt.
English: − The bag does not require any specific storage conditions.
Danish: -Posen kræver ikke særlige opbevaringsbetingelser.
English: Table 1: Preparation of reduced doses of Zoledronic Acid Hospira 4 mg/100 ml solution for infusion
Danish: Tabel 1: Tilberedning af nedsatte doser af Zoledronsyre Hospira 4 mg/100 ml, infusionsvæske, opløsning
English: In patients with mild to moderate renal impairment, reduced Zoledronic Acid Hospira doses are recommended (see section “Posology” above and section 4.4).
Danish: Hos patienter med let til moderat nedsat nyrefunktion, anbefales nedsatte doser af Zoledronsyre Hospira (se afsnittet ”Dosering” ovenfor samt pkt.
English: Tell your doctor or dentist immediately if you experience such symptoms while being treated with Zoledronic Acid Hospira or after stopping treatment.
Danish: Fortæl det straks til din læge eller tandlæge, hvis du får sådanne symptomer, mens du er i behandling med Zoledronsyre Hospira eller efter behandlingsophør.
English: Common Hypocalcaemia* Uncommon Decreased appetite Rare
Danish: Almindelig Hypokalcæmi* Ikke almindelig
English: Tell your doctor and dentist immediately if you experience such symptoms while being treated with Zoledronic Acid Hospira or after stopping treatment.
Danish: Kontakt straks din læge og tandlæge, hvis du oplever sådanne symptomer, men du er i behandling med Zoledronsyre Hospira, eller efter at behandlingen er stoppet.
English: If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of Zoledronic acid.
Danish: Hvis du har hypokalcæmi, skal den korrigeres, inden du får den første dosis af zoledronsyre.
English: Animal reproduction studies with zoledronic acid have shown reproductive toxicity (see section 5.3).
Danish: Dyreforsøg har påvist reproduktionstoksicitet (se pkt.
English: - Patients with hypocalcaemia (see section 4.4).
Danish: - Patienter med hypokalcæmi (se pkt.
English: It also contains mannitol, sodium citrate, water for injections and sodium chloride.
Danish: Indeholder også mannitol, natriumcitrat, vand til injektionsvæsker og natriumchlorid.
English: In patients with bone metastases presenting with mild to moderate renal impairment prior to initiation of therapy, which is defined for this population as CLcr 30-60 ml/min, the following zoledronic acid dose is recommended (see also section 4.4):
Danish: Til patienter med knoglemetastaser, der før behandlingen initieres, har mild til moderat nyreinsufficiens, som i denne population er defineret som CLcr 30-60 ml/min, anbefales følgende dosis zoledronsyre (se også pkt.
English: Patients treated with Zoledronic Acid Hospira should be given the package leaflet and the patient reminder card
Danish: Patienter i behandling med Zoledronsyre Hospira bør få udleveret indlægssedlen og patienthuskekortet.
English: - if you are having dental treatment or are due to undergo dental surgery, tell your dentist that you are being treated with Zoledronic Acid Hospira and inform your doctor about your dental treatment.
Danish: - hvis du er under tandlægebehandling eller skal have en tandoperation, bør du fortælle tandlægen, atdu eribehandlingmed ZoledronsyreHospiraog informere din læge om tandlægebehandlingen.
English: Make sure you drink enough fluids (at least one or two glasses) before and after the treatment with Zoledronic Acid Hospira, as directed by your doctor.
Danish: Brug af Zoledronsyre Hospira sammen med mad og drikke Sørg for at drikke tilstrækkelig væske (mindst 1 eller 2 glas) før og efter behandling med Zoledronsyre Hospira, som din læge har fortalt dig.
English: Uncommon Cough, dyspnoea
Danish: Hoste, dyspnø
English: It is given as a single 15-minute intravenous infusion in a separate infusion line.
Danish: Det skal indgives ved en enkelt intravenøs infusion over 15 minutter i en separat infusionsslange.
English: Very rare Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) and other anatomical sites including femur and hip
Danish: Osteonekrose af øregangen (klasse-bivirkning for bisfosfonater) og andre anatomiske steder, inklusive femur og hofte
English: Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, or non-healing of sores or discharge, as these could be signs of osteonecrosis of the jaw.
Danish: Kontakt straks din læge eller tandlæge, hvis du får nogle problemer med din mund eller tænder, som fx tab af tænder, smerte eller hævelse, eller manglende sårheling eller pus fra såret, da dette kan være tegn på osteonekrose i kæben.
English: •Hypersensitivity to the active substance, to other bisphosphonates or to any of the excipients listed in section 6.1.
Danish: • Overfølsomhed over for det aktive stof, andre bisfosfonater eller over for et eller flere af hjælpestofferne angivet i pkt.
English: Patients treated with zoledronic acid should be given the package leaflet and the patient reminder card.
Danish: Patienter i behandling med zoledronsyre bør få udleveret indlægssedlen og patienthuskekortet.
English: Uveitis, episcleritis, iritis
Danish: Udslæt, hyperhidrose, pruritus, erytem
English: Rare cases of renal failure requiring dialysis and rare cases with a fatal outcome have been reported in patients with pre-existing renal dysfunction or other risk factors such as advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, or dehydration in the post infusion period (see sections 4.4 and 4.8 Class effects)
Danish: Sjældne tilfælde af dialysekrævende nyresvigt og sjældne tilfælde med letal udgang er rapporteret hos patienter med forudeksisterende nedsat nyrefunktion eller andre risikofaktorer som fremskreden alder, samtidig anvendelse af nefrotoksiske lægemidler, samtidig anvendelse af diuretika eller dehydrering efter behandlingen med zoledronsyre (se pkt.
English: - Do not use this medicine after the expiry date which is stated on the carton.
Danish: - Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og flasken efter udløbsdatoen.
English: Common Influenza-like illness, chills, fatigue, asthenia, pain, malaise, infusion site reaction
Danish: Almindelig Influenzalignende sygdom, kulderystelser, træthed, asteni, smerter, utilpashed, reaktioner på infusionsstedet
English: In clinical trials with zoledronic acid, patients with serum creatinine > 265 µmol/l or > 3.0 mg/dl were excluded.
Danish: I kliniske forsøg med zoledronsyre blev patienter med serum-kreatinin >265 μmol/l eller >3,0 mg/dl ekskluderet.
English: - For patients with abnormal baseline creatinine (> 1.4 mg/dl or > 124 µmol/l), an increase of 1.0 mg/dl or 88 µmol/l.
Danish: - Øgning på 1,0 mg/dl eller 88 μmol/l hos patienter med abnorm kreatinin ved baseline (>1,4 mg/dl eller >124 μmol/l).
English: Do not mix Zoledronic Acid Hospira concentrate with calcium-containing or other divalent cation containing solutions such as lactated Ringer's solution.
Danish: Zoledronsyre Hospira opløsning må ikke blandes med calciumholdige eller andre divalente kationholdige opløsninger som Ringer's laktatopløsning.
English: The rate of atrial fibrillation serious adverse events was 1.3% (51 out of 3,862) and 0.6% (22 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
Danish: Frekvensen af atrieflimren som alvorlig utilsigtet hændelse var 1,3% (51 ud af 3.862) og 0,6% (22 ud af 3.852) hos patienter som fik henholdsvis zoledronsyre 5 mg og placebo.
English: No dose adjustment is necessary in TIH patients with serum creatinine < 400 µmol/l or < 4.5 mg/dl (see section 4.4).
Danish: Det er ikke nødvendigt at dosisjustere patienter med TIH og serum-kreatinin <400 μmol/l eller <4,5 mg/dl (se pkt.
English: Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, such as zoledronic acid (see section 4.4).
Danish: Tilfælde af osteonekrose i kæberne er blevet rapporteret, overvejende hos cancerpatienter i behandling med lægemidler, der hæmmer knogleresorption, såsom zoledronsyre (se pkt.
English: − Urticaria.
Danish: Nældefeber.
English: Solution for infusion 4 mg/100 ml
Danish: Infusionsvæske, opløsning 4 mg/100 ml
English: Multiple event analysis showed 30.7% risk reduction in developing SREs in the zoledronic acid 4 mg group compared with placebo.
Danish: Analyser af gentagne hændelser viste risikoreduktion på 30,7% i udviklingen af skeletrelaterede hændelser i zoledronsyre 4 mg-gruppen sammenlignet med placebo.
English: Tachycardia Respiratory, thoracic and mediastinal disorders Common:
Danish: Takykardi Luftveje, thorax og mediastinum Almindelig:
English: What you need to know before you are given Zoledronic Acid Hospira
Danish: Det skal du vide, før du får Zoledronsyre Hospira
English: Efficacy results are provided in Table 5.
Danish: Effektresultaterne kan ses i tabel 5.
English: Osteonecrosis Osteonecrosis of the jaw
Danish: Osteonekrose Osteonekrose af kæberne
English: Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: Very common ( 1/10), common ( 1/100 to <1/10), uncommon ( 1/1,000 to <1/100), rare ( 1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Bivirkningerne er ordnet under overskrifter om hyppighed, den hyppigste først, ved brug af de følgende konventionelle regler: Meget almindelig (1/10), almindelig (1/100 til <1/10), ikke almindelig (1/1.000 til <1/100), sjælden (1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Osteonecrosis of the jaw has been reported uncommonly in clinical trials and in the post-marketing setting in patients receiving zoledronic acid.
Danish: Osteonekrose af kæberne er blevet rapporteret med frekvensen ”ikke almindelig” i kliniske forsøg og efter markedsføring hos patienter behandlet med zoledronsyre.
English: Zoledronic Acid Hospira is supplied as packs containing 1 bag.
Danish: Zoledronsyre Hospira leveres i pakninger indeholdende 1 pose.
English: This medicinal product must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer's solution, and should be administered as a single intravenous solution in a separate infusion line.
Danish: Dette lægemiddel må ikke blandes med infusionsopløsninger indeholdende calcium eller andre divalente kationer så som Ringer's laktatopløsning og bør administreres som en enkelt intravenøs infusion i en separat infusionsslange.
English: Zoledronic acid is contraindicated in patients with creatinine clearance < 35 ml/min (see sections 4.3 and 4.4).
Danish: Zoledronsyre er kontraindiceret til patienter med kreatinin clearance < 35 ml/min (se pkt.
English: The renal clearance of zoledronic acid was correlated with creatinine clearance, renal clearance representing 75 ± 33% of the creatinine clearance, which showed a mean of 84 ± 29 ml/min (range 22 to 143 ml/min) in the 64 patients studied.
Danish: Den renale clearance af zoledronsyre korrelerer tydeligt med kreatinin clearance, idet den renale clearance udgjorde 75 ± 33 % af kreatinin clearance, hvilket viste en median på 84 ± 29 ml/min (varierende fra 22 til 143 ml/min) hos de 64 undersøgte patienter.
English: − High blood pressure, shortness of breath, dizziness, anxiety, sleep disturbances, taste disturbances, trembling, tingling or numbness of the hands or feet, diarrhea, constipation, abdominal pain, dry mouth.
Danish: - Forhøjet blodtryk, åndenød, svimmelhed, angst, søvnforstyrrelser, smagsforstyrrelser, rysten, følelsesløshed eller prikkende fornemmelse i hænder eller fødder, diarré, forstoppelse, mavesmerter, mundtørhed.
English: The withdrawn amount of concentrate must be further diluted in 100 ml of sterile sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution.
Danish: Den udtagne mængde af koncentratet skal fortyndes yderligere i 100 ml sterilt natriumchlorid 9 mg/ml (0,9%) opløsning til injektion eller 5% w/v glukoseopløsning.
English: − Hypersensitivity reactions.
Danish: Overfølsomhedsreaktioner
English: Cases of osteonecrosis of the jaw have been reported; predominantly in cancer patients treated with medicinal products that inhibit bone resorption, including zoledronic acid (see section 4.4).
Danish: Tilfælde af osteonekrose afkæberne er blevet rapporteret overvejende hos cancerpatienter, der er i behandling med lægemidler, der hæmmer knogleresorption, herunder zoledronsyre(se pkt.
English: Remove the following amount of Zoledronic Acid Hospira 4 mg/100 ml solution for infusion (ml)
Danish: Fjern følgende mængde af Zoledronsyre Hospira 4 mg/100 ml infusionsvæske, opløsning (ml)
English: Headache, dizziness, sickness, vomiting, diarrhoea, pain in the muscles, pain in the bones and/or joints, pain in the back, arms or legs, flu-like symptoms (e.g. tiredness, chills, joint and muscle pain), chills, feeling of tiredness and lack of interest, weakness, pain, feeling unwell, swelling and/or pain at the infusion site.
Danish: Almindelige (kan forekomme hos op til 1 ud af 10 patienter) Hovedpine, svimmelhed, kvalme, opkastninger, diarré, muskelsmerter, knogle- og/eller ledsmerter, smerter i ryg, arme eller ben, influenzalignende symptomer (f.eks. træthed, kuldegysninger, led- og muskelsmerter), kuldegysninger, følelse af træthed og manglende interesse, svækkelse, smerter, sygdomsfølelse, hævelse og/eller smerte ved infusionsstedet.
English: Cases of ONJ have been reported in the postmarketing setting for zoledronic acid.
Danish: Tilfælde af osteonekrose af kæberne er blevet rapporteret efter markedsføring for zoledronsyre.
English: - The unopened bag does not require any special storage conditions.
Danish: - Den uåbnede pose kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: Placebo zoledronic acid
Danish: Placebo Zoledronsyre 4 mg
English: - For patients with normal baseline serum creatinine (< 1.4 mg/dl or < 124 µmol/l), an increase of 0.5 mg/dl or 44 µmol/l;
Danish: - Øgning på 0,5 mg/dl eller 44 μmol/l hos patienter med normal serum-kreatinin ved baseline (<1,4 mg/dl eller <124 μmol/l);