FrancophonIA/ELRC3.0 huggingface dataset:
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Danish: A. FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG
English: Pharmathen International S.A. Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300,
Danish: Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300,
English: A lower starting dose (75 mg) should be considered for patients undergoing haemodialysis (see section
Danish: En lavere startdosis (75 mg) bør overvejes hos patienter i hæmodialyse (se pkt.
English: Terms marked with a star (*) refer to the adverse reactions that were additionally reported in > 2% of diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria and in excess of placebo.
Danish: Termer mærket med stjerne (*) henviser til bivirkninger, som yderligere er indberettet hos >2% af diabetiske, hypertensive patienter med kronisk nyreinsufficiens og udtalt proteinuri og i højere grad end med placebo.
English: • if you suffer from kidney problems
Danish: • hvis du lider af nyreproblemer
English: In the female and black subgroups which represented 32% and 26% of the overall study population respectively, a renal benefit was not evident, although the confidence intervals do not exclude it. As for the secondary endpoint of fatal and non-fatal cardiovascular events, there was no difference among the three groups in the overall population, although an increased incidence of non-fatal MI was seen for women and a decreased incidence of non-fatal MI was seen in males in the irbesartan group versus the placebobased regimen.
Danish: I subgrupper bestående af kvinder og sorte patienter, henholdsvis 32% og 26% af den samlede forsøgspopulation, sås der ingen evidens for nyrefordel, selvom sikkerhedsintervallerne ikke udelukker det. Der sås forøget hyppighed af ikke-fatalt MI hos kvinder og en reduceret hyppighed af ikke-faltalt MI hos mænd i irbesartangruppen versus det placebo-baserede regime.
English: 28 film-coated tablets 56 film-coated tablets 90 film-coated tablets 98 film-coated tablets
Danish: 28 filmovertrukne tabletter 56 filmovertrukne tabletter 90 filmovertrukne tabletter 98 filmovertrukne tabletter
English: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare
Danish: Hyppigheden af bivirkninger anført nedenfor defineres i henhold til følgende konventioner: 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).
English: Tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, silica colloidal anhydrous, hypromellose, magnesium stearate, Film-coating: hypromellose, titanium dioxide (E171), macrogol 400
Danish: • Øvrige indholdsstoffer: Tabletkerne: lactosemonohydrat, mikrokrystallinsk cellulose, croscarmellosenatrium, silica kolloid vandfri, hypromellose, magnesiumstearat, Filmovertræk: hypromellose, titandioxid (E171), macrogol 400.
English: The study examined the long-term effects (2 years) of irbesartan on the progression to clinical (overt) proteinuria (urinary albumin excretion rate (UAER) > 300 mg/day, and an increase in UAER of at least 30% from baseline).
Danish: Studiet undersøgte langtidsvirkningerne (2 år) af irbesartan med henblik på progression til klinisk proteinuri (urinalbumin udskillelsesrate (UAER) > 300 mg/dag, og en stigning i UAER på mindst 30% i forhold til baseline).
English: Immune system disorders: Not known:
Danish: Immunsystemet: Ikke kendt:
English: If you get any of these symptoms or get short of breath, stop taking Sabervel and contact your doctor imme diate ly.
Danish: Hvis du får et eller flere af disse symptomer eller får åndenød, skal du holde op med at tage Sabervel og straks søge lægehjælp.
English: Side effects reported in clinical studies for patients treated with Irbesartan were:
Danish: Følgende bivirkninger blev indberettet i kliniske forsøg med patienter, der fik irbesartan:
English: • if you are going to have an operation (surgery) or be given anaesthetics.
Danish: • hvis du skal opereres eller bedøves.
English: As observed for angiotensin converting enzyme inhibitors, irbesartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population (see section 5.1).
Danish: Som det også er observeret for angiotensin-konverterende enzymhæmmere er irbesartan og de andre angiotensin antagonister mindre effektive til at nedsætte blodtrykket hos sorte patienter end hos hvide, muligvis fordi reninniveauet ofte er lavere hos den sorte, hypertensive befolkning (se pkt.
English: hypersensitivity reactions such as angioedema, rash, urticaria
Danish: Overfølsomhedsreaktioner, fx angioødem, udslæt, urticaria
English: irbesartan induced hyperplasia/hypertrophy of the juxtaglomerular cells (in rats at ≥ 90 mg/kg/day, in macaques at ≥ 10 mg/kg/day).
Danish: Herudover inducerede irbesartan hyperplasi/hypertrofi af de juxtaglomerulære celler (hos rotte ved ≥ 90 mg/kg/dag, hos marekatte ved ≥ 10 mg/kg/dag).
English: Hypersensitivity to the active substance, or to any of the excipients (see section 6.1).
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne (se pkt.
English: Sabervel is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Danish: Du bør ikke tage Sabervel i begyndelsen af graviditeten, og du må ikke tage det, hvis du er længere end 3 måneder henne i din graviditet, da det kan skade dit barn alvorligt, hvis du tager det efter tredje måned af graviditeten.
English: General: in patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure.
Danish: Generelt: Hos patienter, hvis vaskulære tonus og nyrefunktion hovedsageligt afhænger af reninangiotensin-aldosteronsystemets aktivitet, (fx patienter med alvorlig hjerteinsufficiens eller underliggende nyresygdom, inklusive nyrearteriestenose), er behandling med angiotensinkonverterende enzymhæmmere eller angiotensin-II receptorantagonister, der påvirker dette system, blevet forbundet med akut hypotension, azotæmi, oliguri og i sjældne tilfælde med akut nyresvigt.
English: • Very common : if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.
Danish: • Meget almindeligt: hvis du har højt blodtryk og type 2 diabetes med nyresygdom, kan blodprøver vise, at du har for meget kalium i blodet.
English: Skin and subcutaneous tissue disorders: Not known:
Danish: Hud og subkutane væv: Ikke kendt:
English: Intravascular volume depletion: symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Danish: Nedsat intravaskulært volumen: Specielt efter første dosis kan derforekomme symptomatisk hypotension hos patientermed hypovolæmi og/eller hyponatriæmi forårsaget af kraftig diuretisk behandling, nedsat saltindtag gennem kosten, diarré eller opkastning.
English: In hypertensive type 2 diabetic patients, therapy should be initiated at 150 mg irbesartan once daily and titrated up to 300 mg once daily as the preferred maintenance dose for treatment of renal disease.
Danish: Hos hypertensive type-2 diabetikere bør behandling starte ved 150 mg irbesartan 1 gang dagligt, og titreres op til 300 mg 1 gang dagligt, som den foretrukne vedligeholdelsesdosering til behandling af nyresygdom.
English: M anufacture r:
Danish: Fre ms tille r:
English: If you experience these, talk to your doctor before attempting to drive or use machines.
Danish: Hvis du oplever svimmelhed eller træthed, bør du kontakte lægen, inden du kører bil eller betjener maskiner.
English: Hyperkalaemia: as with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Sabervel, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/or heart failure.
Danish: Hyperkaliæmi: Som med andre lægemidler, der påvirker renin-angiotensin-aldosteronsystemet, kan der opstå hyperkaliæmi under behandling med Sabervel, specielt i tilfælde af nyrefunktionsnedsættelse, klinisk proteinuri på grund af diabetisk nyresygdom og/eller hjertefejl.
English: 6, Dervenakion str., 15351 Pallini Attiki, Greece Tel.: +30 210 66 65 067
Danish: 6, Dervenakion str., 153 51 Pallini Attiki, Grækenland Tel.: +30 210 66 65 067
English: A limited accumulation of irbesartan (18%) in plasma was observed upon repeated once daily dosing.
Danish: Der er set en begrænset akkumulering af irbesartan (< 20%) i plasma efter gentagne doseringer, en gang dagligt.
English: HOW TO TAKE SABERVEL
Danish: SÅDAN SKAL DU TAGE SABERVEL
English: • Uncommon : heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.
Danish: • Ikke almindeligt: hurtig hjerterytme, rødme, hoste, diarré, fordøjelsesbesvær/halsbrand, seksuelle problemer, brystsmerter.
English: Respiratory, thoracic and mediastinal disorders: Uncommon:
Danish: Luftveje, thorax og mediastinum: Ikke almindelig:
English: However, initiation of therapy with 75 mg could be considered, particularly in haemodialysed patients and in the elderly over 75 years.
Danish: Dog bør en initialdosis på 75 mg overvejes, specielt til patienter i hæmodialyse og hos ældre patienter >75 år.
English: • Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease.
Danish: • Patienter med højt blodtryk og type 2-diabetes med nyresygom Hos patienter med højt blodtryk og type 2 diabetes er 300 mg 1 gang dagligt den foretrukne vedligeholdelsesdosis til behandling af ledsagende nyresygdom.
English: Additional antihypertensive agents (excluding
Danish: Yderligere antihypertensive præparater
English: The concomitant use of Sabervel with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Danish: Samtidig brug af Sabervel og lægemidler indeholdende aliskiren er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR < 60 ml/min/1,73 m2) (se pkt.
English: ACE inhibitors, angiotensin II receptor antagonists and dihydropyridine calcium blockers) were added as needed to help achieve the blood pressure goal.
Danish: (eksklusiv ACE-hæmmere, angiotensin II-receptor antagonister og dihydropyridin-calciumblokkere) blev tilføjet efter behov for at nå blodtryksmålet.
English: Exposure to AIIRA therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Danish: Det er kendt, at eksponering for behandling med AIIRA under andet og tredje trimester kan inducere human føtotoksicitet (nedsat nyrefunktion, oligohydramnios, hæmning af kraniets ossifikation) og neonatal toksicitet (nyresvigt, hypotension, hyperkaliæmi) (se pkt.
English: Reproductive system and breast disorders: Uncommon:
Danish: Det reproduktive system og mammae: Ikke almindelig:
English: In diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria, hyperkalaemia (≥ 5.5 mEq/L) occurred in 46.3% of the patients in the irbesartan group and 26.3% of the patients in the placebo
Danish: Blandt diabetiske, hypertensive patienter med kronisk nyreinsufficiens og udtalt proteinuri sås hyperkaliæmi (≥5,5 mEq/l) hos 46,3% af patienterne i irbesartangruppen og 26,3% af patienterne i placebogruppen.
English: Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter.
Danish: Det bør overvejes at monitorere nyrefunktionen, eftersamtidig behandling er initieret og periodisk derefter.
English: Pharmathen S.A. 6 Dervenakion str. 15351 Pallini Attiki Greece
Danish: Pharmathen S.A. 6 Dervenakion str. 15351 Pallini Attiki Grækenland
English: • salt substitutes containing potassium
Danish: • salterstatninger, der indeholder kalium
English: It is also indicated for the treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen (see sections 4.3, 4.4, 4.5 and 5.1).
Danish: Det er også indiceret til behandling af nyresygdom hos voksne patienter med hypertension og type 2-diabetes mellitus, som del af et antihypertensivt lægemiddelregime (se pkt.
English: Tell your doctor or pharmacist if you are taking , have recently taken or might take any other medicines.
Danish: Fortæl altid det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: In non-clinical safety studies, high doses of irbesartan (≥ 250 mg/kg/day in rats and ≥ 100 mg/kg/day in macaques) caused a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit).
Danish: I ikke-kliniske sikkerhedsstudier forårsagede høje doser af irbesartan (≥ 250 mg/kg/dag hos rotter og ≥100 mg/kg/dag hos marekatte) en reduktion af røde blodlegeme-parametre (erytrocytter, hæmoglobin, hæmatokrit).
English: Some side effects have been reported since marketing of Irbesartan Side effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, abnormal liver function, increased blood potassium levels, impaired kidney function, and inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis).
Danish: Bivirkninger, hvor hyppigheden ikke er kendt, er: følelse af, at omgivelserne kører rundt, hovedpine, smagsforstyrrelser, ringen for ørerne, muskelkramper, led- og muskelsmerter, unormal leverfunktion, gulsot (hvor huden og/eller det hvide i øjnene bliver gulfarvet), forhøjet mængde af kalium i blodet, nedsat nyrefunktion samt betændelseslignende tilstand i de små blodkar, der primært påvirker huden (en tilstand der kaldes leukocytoklastisk vaskulitis).
English: Diabetes Mellitus (IRMA 2)” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
Danish: IRMA 2-studiet (Effects of Irbesartan on Microalbuminuria in Hypertensive Patients with type 2diabetes Mellitus) viste, at irbesartan 300 mg forsinker progression til klinisk proteinuri hos patienter med mikroalbuminuri.
English: 15351 Pallini, Attiki, Greece
Danish: 15351 Pallini, Attiki, Grækenland
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS) There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).
Danish: Dobbelthæmning af renin-angiotensin-aldosteronsystemet (RAAS) Der er tegn på, at samtidig brug af ACE-hæmmere og angiotensin II-receptorantagonister eller aliskiren øger risikoen for hypotension, hyperkaliæmi og nedsat nyrefunktion (inklusive akut nyresvigt).
English: 08184 - Palau-solità i Plegamans, Barcelona, Spain Pharmathen S.A,
Danish: ES-08184 - Palau-solità i Plegamans, Barcelona, Spanien Pharmathen S.A.
English: IRMA 2 was a placebo-controlled double blind morbidity study in 590 patients with type 2 diabetes, microalbuminuria (30-300 mg/day) and normal renal function (serum creatinine ≤ 1.5 mg/dl in males and < 1.1 mg/dl in females).
Danish: IRMA 2 var et placebo-kontrolleret dobbeltblindt morbiditetsstudie med 590 patienter med type 2-diabetes, mikroalbuminuri (30-300 mg/dag) og normal nyrefunktion (serum kreatinin ≤ 1,5 mg/dl hos mænd og < 1,1 mg/dl hos kvinder).
English: In diabetic hypertensive patients with microalbuminuria and normal renal function, hyperkalaemia (≥
Danish: Hos diabetiske, hypertensive patienter med mikroalbuminuri og normal nyrefunktion sås hyperkaliæmi
English: 08184 - Palau-solità i Plegamans, Barcelona, Spain
Danish: ES-08184 - Palau-solità i Plegamans, Barcelona, Spanien
English: Because no information is available regarding the use of Sabervel during breast-feeding, Sabervel is not recommended and alternative treatments with better established safety profiles during breastfeeding are preferable, especially while nursing a newborn or preterm infant.
Danish: Da der ikke foreligger oplysninger om anvendelse af Sabervel under amning, frarådes brugen af Sabervel, og andre behandlingsregimer med en mere veletableret sikkerhedsprofil for anvendelse under amning bør foretrækkes.
English: Renal and urinary disorders: Not known:
Danish: Nyrer og urinveje: Ikke kendt:
English: In patients insufficiently controlled with 150 mg once daily, the dose of Sabervel can be increased to 300 mg, or other antihypertensive agents can be added (see sections 4.3, 4.4, 4.5 and 5.1).
Danish: Hos patienter som ikke er tilstrækkeligt kontrolleret på 150 mg, 1 gang daglig, kan dosis af Sabervel øges til 300 mg, eller andre antihypertensiva kan tilføjes (se pkt.
English: hypertensive patients with type 2 diabetes, proteinuria ≥ 900 mg/day and serum creatinine ranging from 1.0-3.0 mg/dl, the long-term effects (mean 2.6 years) of irbesartan on the progression of renal disease and all-cause mortality were examined.
Danish: Hos 1.715 hypertensive patienter med type 2-diabetes, proteinuri ≥ 900 mg/dag og serumkreatininværdier i intervallet 1,0-3,0 mg/dl, evalueredes langtidseffekterne (median 2,6 år) ved irbesartan med henblik på progression af nyresygdom og totalmortalitet.
English: Important information about some of the ingredients of Sabervel Sabervel contains lactose.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Sabervel
English: While similar blood pressure was achieved in all treatment groups, fewer subjects in the irbesartan 300 mg group (5.2%) than in the placebo (14.9%) or in the irbesartan 150 mg group (9.7%) reached the endpoint of overt proteinuria, demonstrating a 70% relative risk reduction versus placebo (p = 0.0004) for the higher dose.
Danish: Der var dog færre patienter i irbesartan-gruppen der fik 300 mg (5,2%) som nåede endepunktet, klinisk proteinuri, sammenlignet med placebo-gruppen (14,9%) og irbesartangruppen der fik 150 mg (9,7%), hvilket viste en relativ risikoreduktion på 70% versus placebo (p= 0,0004) ved den højere dosis.
English: INFORMATION IN BRAILLE Sabervel 75 mg
Danish: INFORMATION I BRAILLESKRIFT Sabervel 75 mg
English: Renal impairment and kidney transplantation: when Sabervel is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.
Danish: Nyrefunktionsnedsættelse og nyretransplantation: Der anbefales periodisk kontrol af serum-kalium- og serum-kreatinin, hvis Sabervel anvendes til patienter med nedsat nyrefunktion.
English: Each tablet of Sabervel 75 mg contains 75 mg irbesartan.
Danish: Hver filmovertrukken Sabervel-tablet 75 mg indeholder 75 mg irbesartan
English: The dose may later be increased to 300 mg once daily
Danish: Dosis kan senere øges til 300 mg 1 gang dagligt afhængig af blodtryksmålingerne.
English: INFORMATION IN BRAILLE Sabervel 300 mg
Danish: INFORMATION I BRAILLESKRIFT Sabervel 300 mg
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Danish: Hvis du vil have yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant
English: Hypertension and type 2 diabetes with renal disease The “Irbesartan Diabetic Nephropathy Trial (IDNT)” shows that irbesartan decreases the progression of renal disease in patients with chronic renal insufficiency and overt proteinuria.
Danish: Hypertensive patienter med type 2-diabetisk nyresygdom IDNT studiet (Irbesartan Diabetic Nephropathy Trial) har vist, at irbesartan nedsætter progression af nyresygdom hos patienter med kronisk nyre insufficiens og klinisk proteinuri.
English: Excipients: also contains lactose monohydrate.
Danish: LISTE OVER HJÆLPESTOFFER Indholdsstoffer: indeholder også lactosemonohydrat.
English: The demonstration of renal benefit of Sabervel in hypertensive type 2 diabetic patients is based on studies where irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure (see sections 4.3, 4.4, 4.5 and 5.1).
Danish: Dokumentationen for forbedring af nyresygdom ved brug af Sabervel hos hypertensive type 2-diabetikere er baseret på studier, hvor irbesartan blev brugt efter behov med tillæg af andre antihypertensive lægemidler, for at nå det ønskede blodtryk (se pkt.
English: Marketing Authorisation Holder: Pharmathen S.A,
Danish: Inde have ren af marke ds føringstilladelsen: Pharmathen S.A,
English: INFORMATION IN BRAILLE Sabervel 150 mg
Danish: INFORMATION I BRAILLESKRIFT Sabervel 150 mg
English: vertigo, headache Ear and labyrinth disorder: Not known:
Danish: Øre og labyrint: Ikke kendt:
English: Each tablet of Sabervel 300 mg contains 300 mg irbesartan.
Danish: Hver filmovertrukken Sabervel-tablet 300 mg indeholder 300 mg irbesartan
English: Medicines should not be disposed of via wastewater or household waste.
Danish: Af hensyn til miljøet må du må ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: Pharmacotherapeutic group: Angiotensin-II antagonists, plain.
Danish: 5.1 Farmakodynamiske egenskaber Farmakoterapeutisk klassifikation: angiotensin II-antagonister, almindelige.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 75 mg irbesartan
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 75 mg irbesartan
English: Each tablet of Sabervel 150 mg contains 150 mg irbesartan.
Danish: Hver filmovertrukken Sabervel-tablet 150 mg indeholder 150 mg irbesartan
English: • This medicine has been prescribed for you.
Danish: • Lægen har ordineret Sabervel til dig personligt.
English: IRMA 2 was a placebo-controlled double blind morbidity study in 590 patients with type 2 diabetes, microalbuminuria (30-300 mg/day) and normal renal function
Danish: IRMA 2 var et placebo-kontrolleret dobbeltblindt morbiditetsstudie med 590 patienter med type 2-diabetes, mikroalbuminuri (30-300 mg/dag) og normal nyrefunktion (serumkreatinin ≤ 1,5 mg/dl hos mænd og < 1,1 mg/dl hos kvinder).
English: Renal impairment: no dosage adjustment is necessary in patients with impaired renal function.
Danish: Nyrefunktionsnedsættelse: Det er ikke nødvendigt, at dosisjustere patienter med nedsat nyrefunktion.