FrancophonIA/ELRC3.0 huggingface dataset:
English: In such patients the risk of treatment should be considered in relation to possible benefit and clinical monitoring is recommended.
Danish: Hos disse patienter bør behandlingsrisikoen vægtes overfor mulige fordele og klinisk monitorering anbefales.
English: Round, yellow coloured, intagliated with 'ZD4522' and '5' on one side and plain on the reverse.
Danish: Rund, gul, mærket med ”ZD4522” og ”5” på den ene side og jævn på den anden side.
English: All doses showed a beneficial effect on lipid parameters and treatment to target goals.
Danish: Samtlige doser viste en gavnlig virkning på lipidparametre og behandlingsmål.
English: Uncommon (>1/1,000, <1/100); Rare (>1/10,000, <1/1000);
Danish: Hyppigheden af bivirkningerne opdeles på følgende måde: Almindelig (>1/100, <1/10); Usædvanlig (>1/1000, <1/100) Sjælden (>1/10 000, <1/1000).
English: Crestor is contraindicated in pregnancy and lactation.
Danish: Crestor er kontraindikeret under graviditet og amning.
English: Linearity: Systemic exposure of rosuvastatin increases in proportion to dose.
Danish: Linearitet: Rosuvastatin's systemiske eksponering stiger proportionelt med dosis.
English: Use in the elderly
Danish: Anvendelse hos ældre
English: Rosuvastatin (Crestor) 10 mg is currently authorised in the majority of MS as a start and maintenance dose with acceptable risk/benefit ratio.
Danish: Rosuvastatin (Crestor) 10 mg er i øjeblikket godkendt i flertallet af medlemsstaterne som start- og vedligeholdelsesdosis med et acceptabelt risk/benefit forhold.
English: GR-151 25 Maroussi Athens
Danish: GR-151 25 Maroussi
English: It is recommended that liver function tests be carried out prior to, and 3 months following, the initiation of treatment.
Danish: Der anbefales leverfunktionsmålinger før og 3 måneder efter behandlingsstart.
English: Metabolism: Rosuvastatin undergoes limited metabolism (approximately 10%).
Danish: Metabolisme: Rosuvastatin undergår begrænset metabolisering (ca. 10 %).
English: In addition, rosuvastatin is a poor substrate for these isoenzymes.
Danish: Desuden fungerer rosuvastatin kun i ringe grad som substrat for disse isoenzymer.
English: Before treatment initiation the patient should be placed on a standard cholesterol-lowering diet that should continue during treatment.
Danish: Inden behandling bør patienten sættes på en standard kolesterolsænkende diæt, som bør fortsættes under behandlingen.
English: <[See Annex I- to be completed nationally]>
Danish: <Se bilag I - Udfyldes nationalt>
English: The recommended start dose is 5 mg for patients of Japanese and Chinese ancestry.
Danish: Anbefalet startdosis er 5 mg for patienter af Japansk og Kinesisk oprindelse.
English: It also lowers ApoB, nonHDL-C, VLDL-C, VLDL-TG and increases ApoA-I (see Table 1).
Danish: Det sænker også ApoB, nonHDL-C, VLDL-C, VLDL-TG og øger ApoA-I (se tabel 1).
English: Postfach 153, A-1037 Vienna
Danish: Postfach 153, A-1037 Wien Østrig
English: Other medicinal products: Based on data from specific interaction studies no clinically relevant interaction with digoxin is expected.
Danish: Andre lægemidler: På baggrund af data fra specifikke interaktionsstudier forventes der ingen klinisk relevante interaktioner med digoxin.
English: Rosuvastatin has not been proven to prevent the associated complications of lipid abnormalities, such as coronary heart disease as mortality and morbidity studies with Crestor have not yet been completed.
Danish: Det er ikke påvist, at rosuvastatin forebygger følgekomplikationer forbundet med lipidabnormaliteter såsom koronar hjertesygdomme, da mortalites- og morbiditets undersøgelser med Crestor endnu ikke er færdiggjort.
English: These effects were observed at maternotoxic doses at systemic exposures several times above the therapeutic exposure level.
Danish: Dette sås ved maternel toksiske doser ved systemiske eksponeringer adskillige gange højere end det terapeutiske eksponeringsniveau.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [To be completed nationally]
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN
English: In the event of overdose, the patient should be treated symptomatically and supportive measures instituted as required.
Danish: I tilfælde af overdosering bør patienten behandles symptomatisk og de nødvendige understøttende forholdsregler institueres.
English: CYP3A4).
Danish: CYP2A6 og CYP3A4).
English: Concomitant administration did not affect plasma concentrations of cyclosporin.
Danish: Samtidig administration påvirkede ikke ciclosporin's plasmakoncentration.
English: Therefore, Crestor is not recommended for paediatric use at this time.
Danish: Derfor anbefales Crestor ikke til børn på nuværende tidspunkt.
English: An assessment of renal function should be considered during routine follow-up of patients treated with a dose of 40 mg.
Danish: Evaluering af nyrefunktion bør overvejes ved rutine opfølgning af patienter behandlet med 40 mg.
English: Special warnings and special precautions for use).
Danish: Særlige advarsler og forsigtighedsregler vedrørende brugen).
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenicity potential.
Danish: Prækliniske data viser ingen særlig fare for mennesker på basis af konventionelle undersøgelser af sikkerhedsfarmakologi, gentagen dosistoksicitet, genotoksicitet og karcinogenicitets potentiale.
English: In patients with secondary hypercholesterolaemia caused by hypothyroidism or nephrotic syndrome, the underlying disease should be treated prior to initiating therapy with Crestor.
Danish: Hos patienter med sekundær hyperkolesterolæmi forårsaget af hypothyreoidisme eller nefrotisk syndrom, bør den underliggende sygdom behandles før behandling med Crestor startes.
English: These increased plasma levels should be considered when selecting oral contraceptive doses.
Danish: Disse øgede plasmaniveauer bør tages i betragtning, når dosis af peroral antikonceptiva fastsættes.
English: A population pharmacokinetic analysis revealed no clinically relevant differences in pharmacokinetics between Caucasian and Black groups.
Danish: En farmakokinetisk populationsanalyse viste ikke nogen klinisk relevant farmakokinetisk forskel blandt kaukasiere og sorte grupper.
English: Paediatric experience is limited to a small number of children (aged 8 years or above) with homozygous familial hypercholesterolaemia.
Danish: Erfaring hos børn er begrænset til et lille antal patienter (8 år og opefter) med homozygot familiær hyperkolesterolæmi.
English: Women of child bearing potential should use appropriate contraceptive measures.
Danish: Kvinder i den fødedygtige alder bør anvende passende antikonception.
English: If CK levels are significantly elevated at baseline (>5xULN) a confirmatory test should be carried out within 5 - 7 days.
Danish: Hvis CK niveauerne er markant forhøjede ved baselinie (>5xULN) bør en bekræftende test udføres indenfor 5-7 dage.
English: B-1180 Brussels
Danish: B-1180 Bruxelles Belgien
English: Table 1 Dose response in patients with primary hypercholesterolaemia (type IIa and IIb)
Danish: Tabel 1: Dosisrespons hos patienter med primær hyperkolesterolæmi (type IIa og IIb)
English: Rare: myopathy and rhabdomyolysis
Danish: Sjælden: Myopati og rhabdomyolyse.
English: HDPE bottles: Do not store above 30°C.
Danish: HDPE beholder: Må ikke opbevares over 30°C.
English: Luomanportti 3 FIN-02200 Espoo Finland
Danish: FIN-02200 Espoo Finland
English: - in patients with myopathy.
Danish: - i patienter med myopati.
English: Invented Name
Danish: Særnavn
English: It is not considered necessary to request a generally higher ratio between start dose and maximum dose for rosuvastatin (20 mg in the general target population, 40 mg in selected patients) than has been requested for other statins assessed by CHMP (simvastatin, pravastatin).
Danish: Det anses ikke for nødvendigt med et generelt krav om et højere forhold mellem startdosis og maksimaldosis for rosuvastatin (20 mg i den almindelige målpopulation, 40 mg i udvalgte patienter) end det, der er blevet krævet for andre statiner, som er vurderet af CHMP (simvastatin, pravastatin).
English: Excretion: Approximately 90% of the rosuvastatin dose is excreted unchanged in the faeces (consisting of absorbed and non-absorbed active substance) and the remaining part is excreted in urine.
Danish: Elimination: Ca. 90 % af rosuvastatin dosis udskilles uomdannet i fæces (bestående af absorberet og uabsorberet stof) og den resterende del i urinen.
English: CYP2C9 was the principal isoenzyme involved, with 2C19, 3A4 and 2D6 involved to a lesser extent.
Danish: Det var fortrinsvis CYP2C9 som var involveret og 2C19, 3A4 og 2D6 i mindre grad.
English: Crestor should be discontinued or the dose reduced if the level of serum transaminases is greater than 3 times the upper limit of normal.
Danish: Crestor bør seponeres eller dosis reduceres ved vedvarende serum transaminaser større end 3 gange den øvre normale grænseværdi.
English: 33% of patients reached EAS guidelines for LDL-C levels (<3 mmol/l).
Danish: 33 % af patienterne nåede EAS guideline målene for LDL-C niveauer (<3
English: Race: Pharmacokinetic studies show an approximate 2-fold elevation in median AUC compared with western Caucasians in both Japanese subjects residing in Japan, and Chinese subjects living in
Danish: Race: Farmakokinetiske studier viser en ca. fordoblet stigning i gennemsnits AUC sammenlignet med vestlige kaukasiere hos både Japanske patienter bosiddende i Japan og Kinesiske patienter bosiddende i
English: In controlled clinical trials, less than 4% of Crestor-treated patients were withdrawn due to adverse events.
Danish: I kontrollerede kliniske undersøgelser måtte færre end 4 % af de patienter som fik Crestor udgå af undersøgelserne på grund af bivirkninger.
English: If a patient becomes pregnant during use of this product, treatment should be discontinued immediately.
Danish: Hvis en patient bliver gravid under anvendelse af Crestor, skal behandlingen seponeres med det samme.
English: There are no pharmacokinetic data available in subjects taking concomitant Crestor and HRT and therefore a similar effect cannot be excluded.
Danish: Der foreligger ingen farmakokinetiske data fra personer som har taget Crestor og hormonsubstitutionsbehandling samtidig og derfor kan en lignende effekt ikke udelukkes.
English: - concomitant use of fibrates.
Danish: - samtidig anvendelse af fibrater
English: Crestor reduces elevated LDL-cholesterol, total cholesterol and triglycerides and increases HDLcholesterol.
Danish: Crestor reducerer forhøjet LDL-kolesterol, total kolesterol og triglycerider og øger HDL kolesterol.
English: Crestor 5 mg film-coated tablets.
Danish: Crestor 5 mg filmovertrukne tabletter
English: The dose should be individualised according to the goal of therapy and patient response, using current consensus guidelines.
Danish: Dosis bør individualiseres efter behandlingsmål og patientrespons, i henhold til gældende guidelines.
English: Concomitant administration of itraconazole (an inhibitor of CYP3A4) and rosuvastatin resulted in a 28% increase in AUC of rosuvastatin.
Danish: Samtidig administration af itraconazol (en hæmmer af CYP3A4) og rosuvastatin medførte en stigning på 28 % i AUC for rosuvastatin.
English: Creatine Kinase (CK) should not be measured following strenuous exercise or in the presence of a plausible alternative cause of CK increase which may confound interpretation of the result.
Danish: Måling af creatinin kinase (CK) bør ikke foretages efter anstrengende motion eller ved tilstedeværelsen af en anden mulig grund til CK øgning, som kan påvirke resultatet.
English: - in patients with active liver disease including unexplained, persistent elevations of serum transaminases and any serum transaminase elevation exceeding 3 x the upper limit of normal
Danish: - i patienter med aktiv leversygdom inklusiv uforklarlige, vedvarende stigninger i serum transaminaser og enhver transaminase stigning som overstiger 3 gange den øvre normale grænseværdi (ULN).
English: Rosuvastatin accounts for greater than 90% of the circulating HMG-CoA reductase inhibitor activity.
Danish: Rosuvastatin tegner sig for mere end 90 % af den cirkulerende HMG-CoA reduktase aktivitet.
English: Crestor also lowers the LDL-C/HDL-C, total C/HDL-C and nonHDL-C/HDL-C and the ApoB/ApoA-I
Danish: Crestor sænker også forholdene LDL-C/HDL-C, total C/HDL-C og nonHDL-C/HDL-C samt ApoB/ApoA-I.
English: The adverse events seen with Crestor are generally mild and transient.
Danish: Crestor‘s bivirkninger er generelt milde og forbigående.
English: Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor for cholesterol.
Danish: Rosuvastatin er en selektiv og kompetitiv inhibitor af HMG-CoA reduktase, det hastighedsbegrænsende enzym som omdanner 3-hydroxy-3-methylglutaryl coenzym A til mevalonat, et forstadie til kolesterol.
English: - during pregnancy and lactation and in women of childbearing potential not using appropriate contraceptive measures.
Danish: - under graviditet og amning samt hos kvinder i den fødedygtige alder som ikke benytter sikker antikonception.
English: Following titration to a daily dose of 40 mg (12 weeks of treatment), LDL-C
Danish: Efter titrering til en daglig dosis på 40 mg (12 ugers behandling) var
English: If the repeat test confirms a baseline CK >5xULN, treatment should not be started.
Danish: Hvis denne test bekræfter en baselinie CK >5xULN bør behandling ikke startes.
English: Such factors include: - moderate renal impairment (creatinine clearence < 60 ml/min)
Danish: Disse faktorer kan være: - moderat nedsat nyrefunktion (kreatinin clearence <60 ml/min)
English: Age and sex: There was no clinically relevant effect of age or sex on the pharmacokinetics of rosuvastatin.
Danish: Alder og køn: Alder og køn har ingen klinisk relevant effekt på rosuvastatin's farmakokinetik.
English: AstraZeneca A/SRoskildevej 22 DK-2620 Albertslund Denmark
Danish: AstraZeneca A/SRoskildevej 22 DK-2620 Albertslund
English: The Ndesmethyl metabolite is approximately 50% less active than rosuvastatin whereas the lactone form is considered clinically inactive.
Danish: N-desmethyl metabolitten er ca. halvt så aktiv som rosuvastatin hvorimod laktonformen betragtes som klinisk inaktiv.
English: The main metabolites identified are the N-desmethyl and lactone metabolites.
Danish: De identificerede hovedmetabolitter er N-desmethyl og lakton metabolitterne.
English: Glycerol triacetate
Danish: Glyceroltriacetat
English: Therapy should be discontinued if CK levels are markedly elevated (>5xULN) or if muscular symptoms are severe and cause daily discomfort (even if CK levels are ≤ 5x ULN).
Danish: Behandling bør seponeres, hvis CK værdierne er markant forhøjede (>5xULN) eller ved svære muskelsymptomer med dagligt ubehag (også hvis CK niveauer er ≤5xULN).
English: Based on data from specific interaction studies no pharmacokinetic relevant interaction with fenofibrate is expected, however a pharmacodynamic interaction may occur.
Danish: På baggrund af data fra specifikke interaktionsstudier forventes der ingen farmakokinetisk relevante interaktioner med fenofibrat, mens der kan indtræffe en farmakodynamisk interaktion.
English: Dose N LDLC
Danish: Antal LDLC
English: Cyclosporin: During concomitant treatment with Crestor and cyclosporin, rosuvastatin AUC values were on average 7 times higher than those observed in healthy volunteers (see Section 4.3 Contraindications).
Danish: Ciclosporin: Ved samtidig behandling med Crestor og ciclosporin var rosuvastatin's AUC værdier i gennemsnit 7 gange højere end hos raske frivillige (se afsnit 4.3 Kontraindikationer).
English: Crestor should not be used in any patient with an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g. sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders; or uncontrolled seizures).
Danish: Crestor bør ikke anvendes hos patienter med en akut, alvorlig tilstand som tyder på myopati eller ved prædisponering for udvikling af nyresvigt sekundært til rhabdomyolyse (f.eks. sepsis, hypotension, større kirurgiske indgreb, traume, alvorlige metaboliske, endokrine eller elektrolyt forstyrrelser; eller ukontrollerede kramper).
English: The choice of start dose should take into account the individual patient's cholesterol level and future cardiovascular risk as well as the potential risk for adverse reactions (see below).
Danish: Valg af startdosis bør indeholde overvejelser omkring den enkelte patients individuelle kolesterolværdi og fremtidige risiko for hjertekarsygdom såvel som den mulige risiko for bivirkninger (se nedenfor).
English: Subjects with severe impairment (CrCl <30 ml/min) had a 3-fold increase in plasma concentration and a 9-fold increase in the N-desmethyl metabolite concentration compared to healthy volunteers.
Danish: Hos individer med svær nyreinsufficiens (CrCl < 30 ml/min) sås en 3-foldig stigning i plasmakoncentration og en 9-foldig stigning i koncentrationen af N-desmethyl metabolitten sammenlignet med raske frivillige.
English: However, two subjects with Child-Pugh scores of 8 and 9 showed an increase in systemic exposure of at least 2-fold compared to subjects with lower Child-Pugh scores.
Danish: Dog viste to individer med Child-Pugh score på 8 og 9 en stigning i systemisk eksponering som var mindst fordoblet sammenlignet med individer med lavere Child-Pugh score.
English: Common: constipation, nausea, abdominal pain
Danish: Almindelig: Obstipation, kvalme, abdominale smerter.
English: This transporter is important in the hepatic elimination of rosuvastatin.
Danish: Denne transporter er vigtig for rosuvastatins' leverelimination.
English: In a large study, 435 patients with heterozygous familial hypercholesterolaemia were given Crestor from 20 mg to 80 mg in a force-titration design.
Danish: I en stor undersøgelse af patienter med heterozygot familiær hyperkolesterolæmi fik 435 individer Crestor fra 20 mg til 80 mg i et force-titrerings design.
English: No clinically relevant interactions have been observed between rosuvastatin and either fluconazole (an inhibitor of CYP2C9 and CYP3A4) or ketoconazole (an inhibitor of CYP2A6 and
Danish: Der er ikke observeret klinisk relevante interaktioner mellem rosuvastatin og enten fluconazol (en hæmmer af CYP2C9 og CYP3A4) eller ketoconazol (en hæmmer af
English: In a force-titration, open label trial, 42 patients with homozygous familial hypercholesterolaemia were evaluated for their response to Crestor 20 - 40 mg.
Danish: I et force-titrerings open label studie blev 42 patienter med homozygot familiær hyperkolesterolæmi evalueret for deres respons på 20-40 mg Crestor.
English: Proteinuria has not been shown to be predictive of acute or progressive renal disease (see Section 4.8 Undesirable effects).
Danish: Proteinuri har ikke vist sig at være tegn på akut eller progressiv nyresygdom (se afsnit 4.8 Bivirkninger).
English: - in patients receiving concomitant cyclosporin.
Danish: - i patienter med samtidig administration af ciclosporin.
English: Antacid: The simultaneous dosing of Crestor with an antacid suspension containing aluminium and magnesium hydroxide resulted in a decrease in rosuvastatin plasma concentration of approximately 50%.
Danish: Antacida: Samtidig dosering af Crestor med en syreneutraliserende suspension af aluminium og magnesiumhydroxid medførte et fald i rosuvastatin's plasmakoncentration med ca. 50 %.
English: - hypothyroidism
Danish: - hypothyreoidisme
English: - in patients with severe renal impairment (creatinine clearance <30 ml/min).
Danish: - i patienter med svær nyreinsufficiens (creatinin clearence <30 ml/min).
English: Cytochrome P450 enzymes: Results from in vitro and in vivo studies show that rosuvastatin is neither an inhibitor nor an inducer of cytochrome P450 isoenzymes.
Danish: Cytochrom P450 enzymer: Resultater fra in vitro og in vivo studier viser, at rosuvastatin hverken inhiberer eller inducerer cytochrom P450 isoenzymer.
English: Rather, the choice of start dose should take into account potential safety concerns in the individual patient based e.g. on sensitivity to adverse reactions and pharmacokinetic considerations.
Danish: Ved valg af startdosis bør der snarere tages hensyn til mulige sikkerhedsmæssige betænkeligheder vedrørende den enkelte patient, f.eks. baseret på følsomhed for bivirkninger og farmakokinetiske overvejelser.
English: Distribution: Rosuvastatin is taken up extensively by the liver which is the primary site of cholesterol synthesis and LDL-C clearance.
Danish: Distribution: Rosuvastatin optages hovedsagelig af leveren, det primære organ for kolesterolsyntese og LDL-C clearence.
English: Lactose monohydrate
Danish: Lactose monohydrat
English: The assessment of relevance of this incremental reduction is complex, and must take into account the body of evidence available from outcome trials for this class of agents.
Danish: At vurdere relevansen af en sådan trinvis reduktion er en kompliceret opgave, som må inddrage den foreliggende dokumentation for behandlingsresultater i kliniske undersøgelser med denne kategori af lægemidler.
English: Steady-state plasma concentrations of rosuvastatin in subjects undergoing haemodialysis were approximately 50% greater compared to healthy volunteers.
Danish: Rosuvastatin's steady state plasmakoncentrationer hos patienter i hæmodialyse var ca. 50 % større sammenlignet med raske frivillige.
English: Rosuvastatin increases the number of hepatic LDL receptors on the cell-surface, enhancing uptake and catabolism of LDL and it inhibits the hepatic synthesis of VLDL, thereby reducing the total number of VLDL and LDL particles.
Danish: Rosuvastatin øger antallet af lever-LDL receptorer på celleoverfladen og fremmer dermed optagelse og katabolisering af LDL og det hæmmer syntesen af VLDL i leveren, hvorved det totale antal af VLDL og LDL partikler reduceres.
English: Therefore, drug interactions resulting from cytochrome P450-mediated metabolism are not expected.
Danish: Der forventes derfor ingen interaktioner stammende fra cytochrom P450 medieret metabolisme.
English: (See sections 4.4 Special warnings and special precautions for use, 4.5 Interaction with other medicinal products and other forms of interaction and 5.2 Pharmacokinetic properties).
Danish: (se afsnit 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen, 4.5 Interaktion med andre lægemidler og andre former for interaktion og 5.2 Farmakokinetiske egenskaber)
English: The overall experience with rosuvastatin 5 mg is more limited than that with 10 mg but available clinical trials information and post-marketing data do not support relevant safety benefit at group level of the 5 mg dose, in comparison with the 10 mg dose.
Danish: De samlede erfaringer med rosuvastatin 5 mg er mere begrænsede end med 10 mg, men de foreliggende oplysninger fra kliniske undersøgelser og post-marketing oplysninger giver ikke holdepunkt for, at 5 mg doseringen på gruppeniveau skulle have nogen relevant sikkerhedsmæssig fordel frem for 10 mg doseringen.
English: P O Box 599 NL-2700 An Zoetermeer
Danish: NL-2700 An Zoetermeer
English: (ULN).
Danish: (feks.
English: No dose adjustment is necessary in patients with mild to moderate renal impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med mild til moderat nyreinsufficiens.
English: The elimination half-life does not increase at higher doses.
Danish: Plasmaudskillelseshalveringstiden stiger ikke ved højere doser.
English: There is no experience in subjects with Child-Pugh scores above 9.
Danish: Der er ingen erfaring hos individer med Child-Pugh score over 9.
English: Crestor is contraindicated in patients with active liver disease (see Section 4.3 Contraindications).
Danish: Crestor er kontraindikeret hos patienter med aktiv leversygdom (se afsnit 4.3 Kontraindikationer).