FrancophonIA/ELRC3.0 huggingface dataset:
English: Due to potentially severe clinical outcomes for the cutaneous vasculitic ulcers reported in patients with myeloproliferative disease, hydroxycarbamide should be discontinued and/or its dose reduced if cutaneous vasculitic ulcerations develop.
Danish: På grund af de potentielt alvorlige kliniske udfald af de kutane vaskulære ulcerationer, der blev indberettet for patienter med myeloproliferativ sygdom, skal hydroxycarbamid seponeres og/eller dosis reduceres, hvis der opstår kutane vaskulære ulcerationer.
English: In adults with Sickle Cell Syndrome, mean cumulative urinary hydroxycarbamide excretion was 62% of the administered dose at 8 hours, and thus higher than in cancer patients (35-40%).
Danish: Hos voksne med seglcellesygdom var den gennemsnitlige kumulative udskillelse af hydroxycarbamid i urin 62 % af den indgivne dosis efter 8 timer og dermed højere end hos cancerpatienter (35 - 40 %).
English: Recently, hydroxycarbamide has shown to be associated with the generation of nitric oxide suggesting that nitric oxide stimulates cyclic guanosine monophosphatase (cGMP) production, which then activates a protein kinase and increases the production of HbF.
Danish: Hydroxycarbamid har for nylig vist sig at være forbundet med dannelsen af nitrogenoxid, hvilket indikerer, at nitrogenoxid stimulerer produktionen af cyklisk guanosin monophosphat (cGMP), som igen aktiverer en proteinkinase og øger produktionen af HbF.
English: In a repeated dose study in adult patients with Sickle Cell Syndrome approximately 60% of the hydroxycarbamide dose was detected in urine at steady state.
Danish: I en undersøgelse med gentagne doser på voksne patienter med seglcellesygdom blev cirka 60 % af hydroxycarbamid-dosis konstateret i urin ved steady state.
English: Always take Siklos exactly as your doctor has told you.
Danish: Tag altid Siklos nøjagtigt efter lægens anvisning.
English: Siklos therapy can then be re-initiated at a lower dose (see section 4.2).
Danish: Behandlingen med Siklos kan derefter startes igen ved en lavere dosis (se pkt.
English: Other medicines and Siklos
Danish: Brug af anden medicin sammen med Siklos
English: - if you are allergic to hydroxycarbamide or any of the other ingredients of this medicine (listed in section 6), - if you suffer from severe liver disease, - if you suffer from severe kidney disease, - if you are myelosuppressed (if you have decreased production of red, white, or coagulating blood cells) as described in section 3 “How to take Siklos, Treatment follow-up”, - if you are breast-feeding (see section “Pregnancy,breast-feeding and fertility”).
Danish: - hvis De er overfølsom over for hydroxycarbamid eller et af de øvrige indholdsstoffer i denne lægemiddel (se pkt 6), - hvis De lider af alvorlig leversygdom, - hvis De lider af alvorlig nyresygdom, - hvis De har nedsat produktion af røde, hvide eller koagulerende blodlegemer som beskrevet i afsnittet 3 “Sådan skal De tage Siklos”, Behandlingsopfølgning”, - hvis De ammer (se afsnittet “Graviditet, amning og frugtbarhed”).
English: In patients with Sickle Cell Syndrome hydroxycarbamide was eliminated with a half-life of approximately six to seven hours, which is longer than reported in other indications.
Danish: Hos patienter med seglcellesygdom blev hydroxycarbamid elimineret med en halveringstid på cirka 67 timer, hvilket er længere, end det, der er indberettet for andre indikationer.
English: In patients, whose CrCl was below 60 ml/min or patients with end-stage renal disease the mean exposure to hydroxycarbamide was approximately 64% higher than in patients with normal renal function.
Danish: Hos patienter, hvis CrCl var under 60 ml/min, eller patienter med nyresygdom i sidste stadie var den gennemsnitlige eksponering for hydroxycarbamid cirka 64 % højere end hos patienter med normal nyrefunktion.
English: Gastrointestinal disorders: Uncommon:
Danish: Gastrointestinale sygdomme: Usædvanlig:
English: 2 The macrocytosis caused by hydroxycarbamide is not vitamin B12 or folic acid dependent.
Danish: 2 Macrocytose forårsaget af hydroxycarbamid er ikke afhængigt af vitamin B12 eller folinsyre.
English: There are no data that support specific guidance for dose adjustment in patients with hepatic impairment, but, due to safety considerations, Siklos is contraindicated in patients with severe hepatic impairment (see section 4.3).
Danish: Der findes ingen data, som understøtter en speciel vejledning til dosisjustering for patienter med nedsat leverfunktion, men af sikkerhedsmæssige årsager er Siklos kontraindiceret til patienter med kraftigt nedsat leverfunktion (se pkt.
English: Siklos is a cytotoxic medicine that must be handled with care.
Danish: Siklos er et cytotoksisk lægemiddel, som skal håndteres med forsigtighed.
English: Siklos is a medicinal product that must be handled with care.
Danish: Siklos er et lægemiddel, som skal håndteres med forsigtighed.
English: Since there is no available data in patients with mild to moderate liver impairment, Siklos should be used with caution (see section 4.2).
Danish: Da der ikke foreligger data vedrørende patienter med mild til moderat leverinsufficiens, bør Siklos anvendes med forsigtighed (se pkt.
English: Patients with normal (creatinine clearance CrCl>80 ml/min), mild (CrCl 60-80 ml/min), moderate (CrCl 30 - 60 ml/min), or severe (<30 ml/min) renal impairment received hydroxycarbamide as a single dose of 15 mg/kg b.w.
Danish: Patienter med normal (kreatininclearance CrCl > 80 ml/min), mild (CrCl 60 - 80 ml/min), moderat (CrCl 30 - < 60 ml/min) eller svær (<30 ml/min) nyresvækkelse fik hydroxycarbamid som en enkeltdosis på 15 mg/kg legemsvægt med anvendelse af kapslerne på 200 mg, 300 mg eller 400 mg.
English: Severe renal impairment (creatinine clearance < 30 ml/min).
Danish: Svær nyreinsufficiens (kreatininclearance < 30ml/min).
English: - A severe infection, - Tiredness and/or looking pale, - Unexplained bruising (accumulation of blood under the skin) or bleeding, - Unusual headache, - Difficulties in breathing.
Danish: - En alvorlig infektion, - Træthed og/eller bleghed, - Uforklarlige blå mærker (samling af blod under huden) eller blødning, - Usædvanlig hovedpine, - Problemer med at trække vejret.
English: Bone marrow depression is the dose-limiting toxic effect of hydroxycarbamide.
Danish: Knoglemarvshæmning er den dosisbegrænsende toksiske effekt af hydroxycarbamid.
English: In Sickle Cell disease, hydroxycarbamide helps also to prevent red blood cells from taking abnormal shape.
Danish: Ved seglcellesygdom er hydroxycarbamid med til at forhindre, at de røde blodlegemer får en unormal form.
English: Low blood cell counts (myelosuppression), enlargement of red blood cells, decreased resistance to infections.
Danish: Lave blodlegemetællinger, forstørrelse af røde blodlegemer, nedsat modstand over for infektioner.
English: Specific interaction studies have not been performed with hydroxycarbamide.
Danish: Der er ikke udført specifikke interaktionsundersøgelser med hydroxycarbamid.
English: One of the mechanisms by which hydroxycarbamide acts is the elevation of foetal haemoglobin (HbF) concentrations in sickle cell patients.
Danish: En af virkningsmekanismerne bag hydroxycarbamid er forhøjelsen af koncentrationen af føtal hæmoglobin (HbF) hos seglcellepatienter.
English: The clinical data obtained in patients with Sickle Cell Syndrome have not shown evidence of adverse reactions of hydroxycarbamide on hepatic and renal function.
Danish: De kliniske data, der er indsamlet fra patienter med seglcellesygdom, har ikke vist tegn på bivirkninger af hydroxycarbamid på lever- og nyrefunktionen.
English: These effects lead to a reduction of circulating red, white and coagulation blood cells (myelosuppressive effect).
Danish: Disse virkninger fører til en reduktion af cirkulerende røde og hvide blodlegemer samt blodplader (en hæmning af knoglemarven).
English: Weight gain5
Danish: Vægtøging5
English: Isolated cases of malignant disease of blood cells (leukaemia), skin cancer in elderly patients, viral infection with Parvovirus B19, bleeding, gastrointestinal disturbances, vomiting, skin dryness, fever, absence of menstrual cycles (amenorrhoea), and weight gain.
Danish: Enkelte tilfælde af ondartet sygdom i blodlegemerne (leukæmi), hudkræft hos ældre patienter, virusinfektion med parvovirus B19, blødning, forstyrrelser i mave-tarm-kanalen, opkastning, hudtørhed, feber, udeblevne menstruationscyklusser (amenorré) samt vægtøgning.
English: The volume of distribution at steady state adjusted for bioavailability is 0.57 L/kg in patients with Sickle Cell Syndrome (amounting to approximately 72 and 90 L in children and adults, respectively).
Danish: Distributionsvolumen ved steady state justeret for biotilgængelighed er 0,57 L/kg for patienter med seglcellesygdom (i alt cirka 72 L og 90 L for henholdsvis børn og voksne).
English: Siklos should be used with caution in patients with mild to moderate renal impairment (see section
Danish: Siklos skal anvendes med forsigtighed til patienter med mild til moderat nyreinsufficiens (se pkt.
English: Conventional long-term studies to evaluate the carcinogenic potential of hydroxycarbamide have not been performed.
Danish: Der er ikke gennemført konventionelle langsigtede undersøgelser til evaluering af hydroxycarbamids karcinogenicitet.
English: Generally, the patient's antibody response to vaccines may be decreased.
Danish: Patientens antistofreaktion kan generelt være nedsat.
English: Cutaneous vasculitic toxicities, including vasculitic ulcerations and gangrene, have occurred in patients with myeloproliferative disorders during therapy with hydroxycarbamide.
Danish: Kutane vaskulære toksiciteter, herunder vaskulær ulceration og gangræn, er opstået hos patienter med myeloproliferative sygdomme under behandling med hydroxycarbamid.
English: These adverse reactions are expected based on the pharmacology of hydroxycarbamide.
Danish: Disse bivirkninger er forventede på baggrund af farmakologien for hydroxycarbamid.
English: As long as the patient responds to therapy either clinically or haematologically (e.g. increase of haemoglobin F (HbF), Mean Corpuscular Volume (MCV), neutrophil count) the dose of Siklos should be maintained.
Danish: Dosis af Siklos bør opretholdes, så længe patienten reagerer på behandlingen - enten klinisk eller hæmatologisk (fx stigning i hæmoglobin F (HbF), Mean Corpuscular Volume (MCV), neutrofiltælling).
English: Acute mucocutaneous toxicity has been reported in patients receiving hydroxycarbamide at doses several times above the therapeutic dose.
Danish: Akut mucokutan toksicitet er blevet indberettet for patienter, der fik hydroxycarbamid i doseringer, som var flere gange højere end den terapeutiske dosis.
English: - The other ingredients are sodium stearyl fumarate, silicified microcrystalline cellulose and basic butylated methacrylate copolymer.
Danish: - Øvrige indholdsstoffer: Natriumstearylfumarat, silicificeret mikrokrystallinsk cellulose og grundbutyleret methacrylatcopolymer.
English: The most common symptoms of overdose with Siklos are: - Redness of the skin, - Soreness (touch is painful) and swelling of the palms of hands and soles of feet followed by the hands and feet becoming scaly, - Skin becoming strongly pigmented (locally changes of colour), - Soreness or swelling in the mouth.
Danish: De mest almindelige symptomer på overdosering med Siklos er: - Rødmen af huden, - Ømhed (berøring gør ondt) og hævelse i håndfladerne og på fodsålerne, hvorefter der kommer skæl på hænder og fødder, - Huden bliver kraftigt farvet (lokale pigmenteret), - Ømhed eller hævelse i munden.
English: Hydroxycarbamide causes macrocytosis, which may mask the incidental development of folic acid and vitamin B12 deficiency.
Danish: Hydroxycarbamid forårsager makrocytose, som kan skjule den medfølgende udvikling af folinsyre- og vitamin B12-mangel.
English: Treatment with Siklos should be initiated by a physician experienced in the management of Sickle Cell Syndrome.
Danish: Behandlingen med Siklos skal forestås af en læge med erfaring inden for behandling af seglcellesygdom.
English: Soreness, violet erythema, oedema on palms and soles followed by scaling of hand and feet, severe generalised hyperpigmentation of the skin and stomatitis have been observed.
Danish: Ømhed, blåviolet erythem, ødem på håndflader og fodsåler efterfulgt af skældannelse på hænder og fødder, svær generaliseret hyperpigmentering af huden samt stomatitis er blevet observeret.
English: Urea is one metabolite of hydroxycarbamide.
Danish: Urea er en af hydroxycarbamids metabolitter.
English: As renal excretion is a pathway of elimination, consideration should be given to decreasing the dose of Siklos in patients with renal impairment.
Danish: Da udskillelse via nyren er en elimineringsvej, skal det overvejes at reducere doseringen af Siklos for patienter med nedsat nyrefunktion.
English: Cytotoxic: handle tablets with care.
Danish: Cytotoksisk: tabletterne skal håndteres med forsigtighed.
English: Siklos 1000 mg film-coated tablets EU/1/07/397/001
Danish: Siklos 1000 mg filmovertrukne tabletter EU/1/07/397/001
English: Haemodialysis reduced the exposure to hydroxycarbamide by 33% (see sections 4.2 and 4.4).
Danish: Hæmodialyse reducerede eksponeringen for hydroxycarbamid med 33 % (se pkt.
English: Siklos 100 mg film-coated tablets EU/1/07/397/002
Danish: Siklos 100 mg filmovertrukne tabletter EU/1/07/397/002
English: Inflammation of the skin causing red scaly patches and possibly occurring together with pain in the joints.
Danish: Hudbetændelse, der giver røde afskallende pletter, evt. sammen med ledsmerter.
English: Leg ulcers are a common complication of Sickle Cell Syndrome, but have also been reported in patients treated with hydroxycarbamide.
Danish: Bensår er en almindelig komplikation ved seglcellesygdom, men er også blevet indberettet for patienter, der blev behandlet med hydroxycarbamid.
English: Reduced number of red blood cells (anaemia), low platelet count, headache, skin reactions, inflammation or ulceration of the mouth (oral mucositis).
Danish: Reduceret antal røde blodlegemer (anæmi), lave blodpladetællinger, hovedpine, hudreaktioner, betændelse eller sårdannelse i munden (oral mucositis).
English: In adults, the total clearance adjusted for bioavailability was 9.89 L/h (0.16 L/h/kg) thereof 5.64 and 4.25 L/h by renal and non-renal clearance, respectively.
Danish: Den samlede clearance justeret for biotilgængelighed var hos voksne 9,89 L/t (0,16 L/t/kg), heraf 5,64 og 4,25 L/t ved henholdsvis renal og ikke-renal clearance.
English: Store below 30 °C
Danish: Opbevares under 30 °C
English: Siklos is indicated for the prevention of recurrent painful vaso-occlusive crises including acute chest syndrome in adults, adolescents and children older than 2 years suffering from symptomatic Sickle Cell Syndrome (see section 5.1).
Danish: Siklos er indiceret til forebyggelse af recidiverende smertefulde vasookklusive kriser og akut lungesvigt (acute chest syndrome) hos voksne og unge patienter samt børn over to år, der lider af symptomatisk seglcellesygdom (se pkt.
English: Sickle Cell disease is an inherited blood disorder that affects the disc shaped red cells of the blood.
Danish: Seglcellesygdom er en arvelig blodlidelse, der påvirker de runde, røde blodlegemer i blodet.
English: Siklos 1000 mg is supplied in plastic bottles containing 30 tablets.
Danish: Siklos 1000 mg leveres i flasker med 30 tabletter.
English: The extent of protein binding of hydroxycarbamide is unknown.
Danish: Udstrækningen af hydroxycarbamids proteinbinding kendes ikke.
English: Skin cancer has also been reported in patients receiving long-term hydroxycarbamide.
Danish: Hudcancer er også blevet indberettet for patienter, der var i langtidsbehandling med hydroxycarbamid.
English: Thrombocytopenia (< 80 x 109/L), anaemia (haemoglobin < 4.5 g/dl)3
Danish: Thrombocytopeni (< 80 x 109/L), anæmi (hæmoglobin < 4,5 g/dl)3 Sygdomme i nervesystemet:
English: The respective value for total clearance in children was 7.25 L/h (0.20 L/h/kg) with 2.91 and 4.34 L/h by renal and non-renal pathways.
Danish: Den tilsvarende værdi for den samlede clearance for børn var 7,25 L/t (0,20 L/t/kg) med 2,91 og 4,34 L/t ved renal og ikke-renal clearance.
English: - if you have a liver disease, - if you have a kidney disease, - if you have leg ulcers, - if you are taking other myelosuppressive medicines (decrease production of red, white, or coagulating blood cells) or receiving radiation therapy, - if you have a known lack of vitamin B12 or folate.
Danish: - hvis De har en leversygdom, - hvis De har en nyresygdom, - hvis De har bensår, - hvis De tager anden medicin, som nedsætter produktionen af røde, hvide eller koagulerende blodlegemer, eller hvis De får strålebehandling, - hvis De ved, at De lider af vitamin B12-mangel eller folinsyremangel.
English: The specific mechanism of action of hydroxycarbamide is not fully understood.
Danish: Den specifikke virkningsmekanisme ved hydroxycarbamid kendes ikke helt.
English: Powder spilled from the broken tablet should be wiped up with a damp disposable towel which must be thrown out.
Danish: Pulver, der spildes fra den brudte tablet, skal tørres op med en fugtig engangsklud, som efterfølgende kasseres.
English: - The active substance is hydroxycarbamide.
Danish: - Aktivt stof: hydroxycarbamid.
English: Contents of the pack and other information What Siklos contains
Danish: Pakningsstørrelser og yderligere oplysninger Siklos indeholder
English: Concurrent use of hydroxycarbamide and other myelosuppressive medicinal products or radiation therapy may increase bone marrow depression, gastro-intestinal disturbances or mucositis.
Danish: Samtidig anvendelse af hydroxycarbamid og andre myelosuppressive præparater eller strålebehandling kan forværre en allerede eksisterende myelosuppression (knoglemarvshæmning), gastrointestinale forstyrrelser eller mucositis.
English: Powder eventually spilled from the broken tablet should be wiped up with a damp disposable towel, which must be discarded.
Danish: Pulver, der eventuelt spildes fra den brudte tablet, skal tørres op med en fugtig engangsklud, som efterfølgende kasseres.
English: Dizziness, nausea, itching red eruption of the skin (rash), black nails (melanonychia), and hair loss.
Danish: Svimmelhed, kvalme, kløende røde udbrud i huden (udslæt), sortfarvning af neglene (melanonychia), og hårtab.
English: Infections and infestations: Not known:
Danish: Infektioner og parasitære sygdomme: Ikke kendt:
English: The adverse reactions are listed below by system organ class and absolute frequency.
Danish: De bivirkninger, der anses for som et minimum at kunne være forbundet med behandlingen, er angivet på nedenstående liste, inddelt efter systemorganklasse og absolut hyppighed.
English: Siklos 100 mg film-coated tablets Pack sizes of 60, 90 or 120 tablets.
Danish: Siklos 100 mg filmovertrukne tabletter Pakningsstørrelser på 60,90 eller 120 tabletter.
English: Sodium stearyl fumarate Silicified microcrystalline cellulose Basic butylated methacrylate copolymer
Danish: Natriumstearylfumarat Silicificeret mikrokrystallinsk cellulose Grundbutyleret methacrylatcopolymer
English: In the event a patient does still not respond when treated with the maximum dose of hydroxycarbamide (35 mg/kg b.w./day) over three to six months, permanent discontinuation of Siklos should be considered.
Danish: Permanent seponering af Siklos bør overvejes, hvis en patient stadig ikke reagerer efter behandling med maksimumdosis af hydroxycarbamid (35 mg/kg legemsvægt/dag) i et tidsrum på tre til seks måneder.
English: An effective method of contraception is strongly recommended in women of childbearing potential.
Danish: Fødedygtige kvinder tilrådes på det kraftigste at anvende en effektiv antikonceptionsmetode.
English: Off-white, capsule-shaped, film-coated tablet with triple scoring on both sides.
Danish: Råhvid, kapselformet, filmovertrukken tablet med tredobbelt delekærv på begge sider.
English: Siklos must not be administered to patients with severe renal impairment (creatinine clearance < 30 ml/min) (see sections 4.3, 4.4 and 5.2).
Danish: Siklos må ikke indgives til patienter med svær nyreinsufficiens (kreatininclearance < 30 ml/min) (se pkt.
English: However, hydroxycarbamide is presumed to be a transspecies carcinogen.
Danish: Hydroxycarbamid formodes dog at være et tværartsligt karcinogen.
English: Vascular disorders: Not known:
Danish: Vaskulære sygdomme: Ikke kendt:
English: DETAILS OF SIDE EFFECTS Very common side effects (may affect more than 1 in 10 people):
Danish: ANGIVELSE AF BIVIRKNINGER Meget almindelige bivirkninger (kan påvirke flere end 1 ud af 10 brugere):
English: - Fever or chills, - Feeling sick, or a general feeling of being unwell, - Rash (itching red eruption of the skin), - Ulcers or wounds on your legs, - Sore (open skin infection) on your skin, - Disorientation (confusion) and dizziness.
Danish: - Feber eller kulderystelser, - De har kvalme eller en generel følelse af utilpashed, - Kløende røde udbrud i huden (udslæt), - Sår på benene, - Ømhed i huden (åben hudinfektion), - Desorientering (forvirring) og svimmelhed.
English: Siklos 1000 mg film-coated tablets are off-white, capsule-shaped tablets marked with three score lines on both sides.
Danish: Siklos 1000 mg filmovertrukne tabletter er råhvide, kapselformede tabletter med tre delekærve på begge sider.
English: Hydroxycarbamide is presumed to be a transspecies carcinogen.
Danish: Hydroxycarbamid formodes at være et tværartsligt karcinogen.
English: Elevated liver enzymes Skin and subcutaneous tissue disorders: Common Skin reactions (for example oral, ungual and cutaneous pigmentation) and oral mucositis.
Danish: Hudreaktioner (for eksempel oral, negle- og kutan pigmentering) samt oral mucositis.
English: Siklos 1000 mg film-coated tablets Pack size of 30 tablets.
Danish: Siklos 1000 mg filmovertrukne tabletter Pakningsstørrelse på 30 tabletter.
English: Siklos 100 mg film-coated tablets are off-white, oblong-shaped tablets with a break line on both sides.
Danish: Siklos 100 mg filmovertrukne tabletter er råhvide, aflange tabletter med en delekærv på begge sider.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER TABLETBEHOLDER
English: In preclinical toxicity studies the most common effects noted included bone marrow depression, lymphoid atrophy and degenerative changes in the epithelium of the small and large intestines.
Danish: I prækliniske undersøgelser af toksiciteten var knoglemarvshæmning, lymfoid atrofi og degenerative ændringer i tyndtarmens og tyktarmens epitel de mest almindelige virkninger, der blev observeret.
English: Siklos 100 mg tablets hydroxycarbamide Oral use
Danish: Siklos 100 mg tabletter hydroxycarbamid Oral anvendelse
English: Based on the limited amount of available information, in case of an exposure to hydroxycarbamide of pregnant female patients or pregnant partners of male patients, treated by hydroxycarbamide, a careful follow-up with adequate clinical, biological and ultrasonographic examinations should be considered.
Danish: Som følge af den begrænsede mængde information, der er til rådighed, skal en nøje opfølgning med fyldestgørende kliniske og biologiske undersøgelser og ultralydsundersøgelser overvejes i tilfælde af, at gravide kvindelige patienter eller gravide partnere i behandling medbydroxycarbamid eksponeres for hydroxycarbamid under graviditet.
English: Package leaflet: information for the user Siklos 100 mg film-coated tablets Siklos 1000 mg film-coated tablets hydroxycarbamide
Danish: Indlægsseddel: Information til brugeren Siklos 100 mg filmovertrukne tabletter Siklos 1000 mg filmovertrukne tabletter
English: Rare side effects (may affect up to 1 in 1,000 people):
Danish: Sjældne bivirkninger (kan påvirke op til 1 ud af 1.000 brugere):
English: Renal impairment As renal excretion is a main pathway of elimination, dose reduction of Siklos should be considered in patients with renal impairment.
Danish: Nyreinsufficiens Da eliminering hovedsageligt sker via nyrerne, bør en reduktion af dosis af Siklos overvejes for patienter med nedsat nyrefunktion.