FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical trials there was no evidence of increased skeletal muscle effects in the small number of patients dosed with Crestor and concomitant therapy.
Danish: I kliniske undersøgelser var der ikke tegn på øget påvirkning af skeletmuskulaturen hos det lille antal patienter, der fik Crestor og anden samtidig behandling.
English: A dose adjustment to the next dose level can be made after 4 weeks, if necessary (see Section 5.1 Pharmacodynamic properties).
Danish: Om nødvendigt, kan dosisjustering til næste dosis niveau foretages efter 4 uger (se afsnit 5.1
English: A dose-related increase in CK levels has been observed in patients taking rosuvastatin; the majority of cases were mild, asymptomatic and transient.
Danish: Hos patienter behandlet med rosuvastatin er der set en dosisafhængig øgning i CK niveauer; de fleste tilfælde var milde, asymptomatiske og forbigående.
English: The plasma elimination half-life is approximately 19
Danish: Plasmaudskillelseshalveringstiden er ca. 19 timer.
English: Absorption: Maximum rosuvastatin plasma concentrations are achieved approximately 5 hours after oral administration.
Danish: 5.2 Farmakokinetiske egenskaber Absorption: Maksimale plasmakoncentrationer af rosuvastatin opnås ca. 5 timer efter peroral administration.
English: Gemfibrozil increases the risk of myopathy when given concomitantly with some HMG-CoA reductase inhibitors.
Danish: Gemfibrozil øger risikoen for myopati når det gives sammen med nogle HMG-CoA reduktasehæmmere.
English: was reduced by 53%.
Danish: LDL-C reduceret med 53 %.
English: The primary site of action of rosuvastatin is the liver, the target organ for cholesterol lowering.
Danish: Rosuvastatins primære virkningsted er leveren, målorganet for kolesterolsænkning.
English: In vitro metabolism studies using human hepatocytes indicate that rosuvastatin is a poor substrate for cytochrome P450
Danish: In vitro metabolisme undersøgelser med humane hepatocytter indikerer at rosuvastatin er et ringe substrat for cytochrom P450 baseret metabolisme.
English: (see Section 4.3 Contraindications).
Danish: (se afsnit 4.3 Kontraindikationer og
English: The recommended start dose is 5 mg in patients with predisposing factors to myopathy (see Section 4.4
Danish: Anbefalet startdosis er 5 mg hos patienter med prædisponeringsfaktorer for myopati (se afsnit 4.4
English: If CK levels are significantly elevated at baseline (>5xULN) treatment should not be started.
Danish: Hvis CK niveauerne er markant forhøjede ved baselinie (>5xULN) bør behandling ikke startes.
English: The 40 mg dose is contraindicated in patients with pre-disposing factors for myopathy/rhabdomyolysis.
Danish: Doser på 40 mg er kontraindiceret hos patienter med prædisponeringsfaktorer for myopati/rhabdomyolyse.
English: The recommended start dose is 5 or 10 mg orally once daily in both statin naïve or patients switched from another HMG CoA reductase inhibitor.
Danish: Anbefalet startdosis er 5 eller 10 mg peroralt én gang daglig hos patenter som ikke tidligere har været i behandling med statin og patienter som skifter fra andre HMG-CoA reduktase inhibitorer.
English: As with other HMG-CoA reductase inhibitors, the hepatic uptake of rosuvastatin involves the membrane transporter OATP-C.
Danish: Som med andre HMG-CoA reduktasehæmmere involverer rosuvastain's leveroptagelse membrantransporteren OATP-C.
English: Marketing Authorisation Holders/Applicants
Danish: Indehavere af markedsføringstilladelse/ansøge re
English: Renal insufficiency: In a study in subjects with varying degrees of renal impairment, mild to moderate renal disease had no influence on plasma concentration of rosuvastatin or the N-desmethyl metabolite.
Danish: Nyreinsufficiens: I en undersøgelse hos individer med varierende grad af nyresinsufficiens, havde mild til moderat nyresygdom ingen indflydelse på rosuvastatin's eller N-desmethyl metabolittens plasmakoncentration.
English: The volume of distribution of rosuvastatin is approximately 134 L. Approximately 90% of rosuvastatin is bound to plasma proteins, mainly to albumin.
Danish: Rosuvastatin er bundet ca. 90 % til plasmaproteiner, hovedsagelig til albumin.
English: Dosage in patients with pre-disposing factors to myopathy
Danish: Doser hos patienter med prædisponeringsfaktorer for myopati
English: The conclusion is that the benefit/risk ratio is favourable for Crestor 5 mg or Crestor 10 mg as alternative start doses.
Danish: konkluderes det, at benefit/risk forholdet er gunstigt for Crestor 5 mg og Crestor 10 mg som alternative startdoser.
English: In conclusion, the benefit/risk ratio is favourable for Crestor 5 or Crestor 10 mg as alternative start doses.
Danish: Det kan konkluderes, at benefit/risk-forholdet er gunstigt for Crestor 5 og Crestor 10 mg som alternative startdoser.
English: However, an increase in the incidence of myositis and myopathy has been seen in patients receiving other HMG-CoA reductase inhibitors together with fibric acid derivatives including gemfibrozil, cyclosporin, nicotinic acid, azole antifungals, protease inhibitors and macrolide antibiotics.
Danish: Dog er der set en stigning i incidensen af myositis og myopati hos patienter behandlet med andre HMG-CoA reduktasehæmmere sammen med fibrinsyrederivater inklusiv gemfibrozil, ciclosporin, nikotinsyre, azol antifungalmidler,
English: Animal studies provide limited evidence of reproductive toxicity (see Section 5.3
Danish: Dyrestudier giver begrænset bevis på reproduktionstoksicitet (se afsnit 5.3 Prækliniske sikkerhedsdata).
English: Liver Effects: As with other HMG-CoA reductase inhibitors, a dose-related increase in transaminases has been observed in a small number of patients taking rosuvastatin; the majority of cases were mild,
Danish: Leverpåvirkning: Som med andre HMG-CoA reduktasehæmmere er der hos et lille antal patienter behandlet med rosuvastatin, set en dosis relateret stigning i transaminaser ; de fleste tilfælde var milde,
English: Gemfibrozil and other lipid-lowering products: Concomitant use of Crestor and gemfibrozil resulted in a 2-fold increase in rosuvastatin C max and AUC (see Section 4.4 Special warnings and special precautions for use).
Danish: Gemfibrozil og andre lipidsænkende produkter: Samtidig behandling med Crestor og gemfibrozil medførte en 2-foldig stigning i rosuvastatin's Cmax og AUC (se afsnit 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen).
English: As with other HMG-CoA reductase inhibitors, Crestor should be used with caution in patients who consume excessive quantities of alcohol and/or have a history of liver disease.
Danish: Som med andre HMG-CoA reduktasehæmmere bør Crestor anvendes med forsigtighed hos patienter som indtager store mængder alkohol og/eller tidligere har haft leversygdom.
English: Proteinuria, detected by dipstick testing and mostly tubular in origin, has been observed in patients treated with higher doses of Crestor, in particular 40 mg, where it was transient or intermittent in most cases.
Danish: Der er observeret proteinuri (påvist ved sticktest og hovedsagelig tubulær af oprindelse) hos patienter behandlet med højere Crestor doser, specielt 40 mg hvor det i de fleste tilfælde var forbigående eller periodisk tilbagevendende.
English: Crestor, as with other HMG-CoA reductase inhibitors, should be prescribed with caution in patients with pre-disposing factors for myopathy/rhabdomyolysis.
Danish: Crestor bør, som andre HMG-CoA reduktasehæmmere, anvendes med forsigtighed hos patienter med prædisponeringsfaktorer for myopati/rhabdomyolyse.
English: Since cholesterol and other products of cholesterol biosynthesis are essential for the development of the foetus, the potential risk from inhibition of HMG-CoA reductase outweighs the advantage of treatment during pregnancy.
Danish: Da kolesterol og andre produkter fra kolesterolbiosyntesen er essentielle for fosterets udvikling er den potentielle risiko ved hæmning af
English: In a rat pre- and postnatal study, reproductive toxicity was evident from reduced litter sizes, litter weight and pup survival.
Danish: I en præ-og postnatal undersøgelse hos rotter sås reproduktionstoksicitet i form af reduktion i kuldstørrelser, kuldvægt og ungernes overlevelse.
English: Patients should be asked to report inexplicable muscle pain, weakness or cramps immediately,
Danish: Patienter bør instrueres i straks at melde tilbage ved uforklarlige muskelsmerter, muskelsvaghed eller kramper specielt ved samtidig ubehag eller feber.
English: The 40 mg dose is contraindicated in patients with moderate renal impairment.
Danish: Doser på 40 mg er kontraindiceret hos patienter med moderat nedsat nyrefunktion.
English: Crestor with fibrates or niacin should be carefully weighed against the potential risks of such combinations.
Danish: Fordelen ved yderligere sænkning af lipidniveauerne ved kombineret brug af Crestor og fibrater eller niacin bør vægtes nøje mod den potentielle risiko ved disse kombinationer.
English: DK-2620 Albertslund Denmark
Danish: Roskildevej 22 DK-2620 Albertslund
English: AstraZeneca UK Limited Horizon Place, 600 Capability
Danish: Horizon Place, 600 Capability
English: If CK levels are elevated (>5xULN), treatment should be discontinued (see Section 4.4 Special warnings and special precautions for use).
Danish: Hvis CK niveauer er forhøjede (>5xULN) bør behandlingen afbrydes (se afsnit 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen).
English: There are no data to support a steeper dose relationship for adverse reactions (myopathy, hepatotoxicity) for rosuvastatin, compared with other statins.
Danish: Ingen oplysninger underbygger, at dosis-bivirkningskurven (myopati, hepatotoksicitet) skulle være stejlere for rosuvastatin end for andre statiner.
English: A start dose of 5 mg is recommended in patients > 70 years (see section 4.4 Special warnings and precautions for use).
Danish: En startdosis på 5 mg anbefales til patienter > 70 år (se afsnit 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen).
English: In the overall population, the mean LDL-C reduction was 22%.
Danish: I den samlede population var middel LDL-C
English: The 40 mg dose is contraindicated in some of these patients (see Section 4.3 Contraindications).
Danish: Doser på 40 mg er kontraindiceret i disse patienter (se afsnit 4.3 Kontraindikationer).
English: Renal Effects: Proteinuria, detected by dipstick testing and mostly tubular in origin, has been observed in patients treated with Crestor.
Danish: Der er observeret proteinuri (påvist ved sticktest og hovedsagelig tubulær af oprindelse) hos patienter behandlet med Crestor.
English: GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS
Danish: BEGRUNDELSE FOR ÆNDRING AF PRODUKTRESUMÉET
English: Oral contraceptive/hormone replacement therapy (HRT): Concomitant use of Crestor and an oral contraceptive resulted in an increase in ethinyl oestradiol and norgestrel AUC of 26% and 34%, respectively.
Danish: Peroral antikonception/hormonsubstitutionsbehandling: Samtidig anvendelse af Crestor og et peroralt antikonceptivum medførte en stigning i ethinylestradiol's og norgestrel's AUC på henholdsvis
English: Increased systemic exposure has been seen in Japanese and Chinese subjects (see section 4.4 Special warnings and special precautions for use and section 5.2 Pharmacokinetic properties).
Danish: Øget systemisk eksponering hos Japanske og Kinesiske patienter er blevet observeret (se afsnit 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen og afsnit 5.2 Farmakokinetiske egenskaber).
English: Hepatic insufficiency: In a study with subjects with varying degrees of hepatic impairment there was no evidence of increased exposure to rosuvastatin in subjects with Child-Pugh scores of 7 or below.
Danish: Leverinsufficiens: I en undersøgelse hos individer med varierende grad af leverinsufficiens, sås intet tegn på en øget eksponering af rosuvastatin hos individer med Child-Pugh score på 7 eller derunder.
English: Titanium dioxide (E171) Ferric oxide, yellow (E172) 6.2 Incompatibilities Not applicable.
Danish: Titaniumdioxid (E 171) Gul jernoxid (E 172)
English: Studies to determine the effect of Crestor on the ability to drive and use machines have not been conducted .
Danish: 4.7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner Der er ikke foretaget undersøgelser af Crestor's indflydelse på evnen til at føre bil eller betjene maskiner.
English: The difference in lipid-lowering efficacy between rosuvastatin 5 mg and 10 mg is that anticipated with a statin, i.e. a doubling of the dose from 5 mg to 10 mg (either through start dose or through up-titration)
Danish: Forskellen i lipidsænkende virkning mellem rosuvastatin 5 mg og 10 mg svarer til, hvad man kan forvente af et statin, dvs. en fordobling af dosis fra 5 mg til 10 mg (uanset om det sker ved højere startdosis eller ved optitrering) giver en gennemsnitlig reduktion af LDL-C på 6 %, fra i gennemsnit 41
English: The use of Crestor in patients with severe renal impairment is contraindicated for all doses.
Danish: Crestor er kontraindikeret hos patienter med svær nyreinsufficiens i alle doser.
English: Skeletal muscle effects: Effects on skeletal muscle e.g. myalgia, myopathy and, rarely, rhabdomyolysis have been reported in Crestor-treated patients with all doses and in particular with doses > 20 mg.
Danish: Der er rapporteret om påvirkninger af skeletmuskulaturen, fx myalgi, myopati og sjældent rhabdomyolyse, hos individer behandlet med Crestor uafhængig af dosis, men specielt med doser > 20
English: Calcium phosphate Crospovidone
Danish: Mikrokrystallinsk cellulose Calciumphosphat Crospovidon
English: Erythromycin: Concomitant use of Crestor and erythromycin resulted in a 20% decrease in AUC (0-t) and a 30% decrease in Cmax of rosuvastatin.
Danish: Erythromycin: Samtidig anvendelse af Crestor og erythromycin medførte et fald på 20 % i AUC (0-t)
English: Pharmacokinetic studies show an increase in exposure in Japanese and Chinese subjects compared with Caucasians (see section 4.2 Posology and Method of administration and section 5.2 Pharmacokinetic properties)
Danish: Farmakokinetiske studier viser en øget eksponering hos Japanske og Kinesiske patienter sammenlignet med kaukasere (se afsnit 4.2 Dosering og indgivelsesmåde og afsnit 5.2 Farmakokinetiske egenskaber).
English: Immune system disorders Rare: hypersensitivity reactions including angioedema
Danish: Sjælden: Overfølsomhedsreaktioner som f.eks. angioødem.
English: Primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet and other nonpharmacological treatments (e.g. exercise, weight reduction) is inadequate.
Danish: Som supplement til diætbehandling ved primær hyperkolesterolæmi (type IIa inklusiv heterozygot familiær hyperkolesterolæmi) eller kombineret dyslipidæmi (type IIb), hvor diæt og andre ikke farmakologiske foranstaltninger (f.eks. motion og vægtreduktion) er utilstrækkelige.
English: The 40 mg dose is contraindicated with concomitant use of a fibrate (see Section 4.3 Contraindications and Section 4.4 Special warnings and special precautions for use).
Danish: Doser på 40 mg er kontraindiceret ved samtidig anvendelse af fibrater (se afsnit 4.3 Kontraindikationer og afsnit 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen).
English: Haemodialysis is unlikely to be of benefit.
Danish: Det er usandsynligt, at hæmodialyse har en gavnlig virkning.
English: When driving vehicles or operating machines, it should be taken into account that dizziness may occur during treatment.
Danish: Der bør tages hensyn til, at der kan forekomme svimmelhed under behandling.
English: 6.4 Special precautions for storage Blisters: Do not store above 30°C.
Danish: Blister: Må ikke opbevares over 30°C.
English: In light of the increased reporting rate of adverse reactions with the 40 mg dose compared to lower doses (see Section 4.8 Undesirable effects), a final titration to the maximum dose of 40 mg should only be considered in patients with severe hypercholesterolaemia at high cardiovascular risk (in particular those with familial hypercholesterolaemia), who do not achieve their treatment goal on 20 mg, and in whom routine follow up will be performed (see Section 4.4 Special warnings and precautions).
Danish: I lyset af den øgede rapportering af bivirkninger for en dosis på 40 mg sammenlignet med lavere doser (se afsnit 4.8 Bivirkninger), skal en endelig titrering til maksimum dosis på 40 mg kun overvejes hos patienter med svær hyperkolesterolæmi med høj risiko for hjertekarsygdom
English: In these patients an assessment of renal function should be considered (see Section 4.4 Special warnings and special precautions for use).
Danish: En evaluering af nyrefunktionen bør overvejes hos disse patienter (se afsnit 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen).
English: Vitamin K antagonists: As with other HMG-CoA reductase inhibitors, the initiation of treatment or dosage up-titration of Crestor in patients treated concomitantly with vitamin K antagonists (e.g.
Danish: Vitamin K antagonister: Som med andre HMG-CoA reduktasehæmmere kan initiering af behandling eller dosis optitrering med Crestor hos patienter som samtidig behandles med vitamin K antagonister (f.eks. warfarin) resultere i en stigning i International Normaliseret Ratio (INR).
English: The choice of start dose in the individual patient should take into account aspects of efficacy and safety, as detailed in the SPC.
Danish: Ved valg af startdosis til den enkelte patient bør aspekter vedrørende virkning og sikkerhed indgå i overvejelserne som nærmere beskrevet i produktresuméet.
English: MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)
English: As with other HMG-CoA reductase inhibitors, the incidence of adverse drug reactions tends to be dose dependent.
Danish: Som med andre HMG-CoA reduktase hæmmere er der tendens til at bivirkninghyppigheden er dosisafhængig.
English: In clinical studies with a limited number of patients, Crestor has been shown to have additive efficacy in lowering triglycerides when used in combination with fenofibrate and in increasing HDL-C levels when used in combination with niacin (see Section 4.4 Special warnings and special precautions for use).
Danish: I kliniske undersøgelser med et begænset antal patienter har Crestor vist en additiv effekt i sænkning af triglycerider ved kombination med fenofibrat og i øgning af HDL-C niveaer i kombination med niacin
English: B-1180 Brussels, Belgium
Danish: Egide Van Ophemstraat 110 B-1180 Bruxelles, Belgien
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Danish: 6.1 Fortegnelse over hjælpestoffer Tabletkerne
English: From pooled phase III data, Crestor has been shown to be effective at treating the majority of patients with type IIa and IIb hypercholesterolaemia (mean baseline LDL-C about 4.8 mmol/l) to recognised European Atherosclerosis Society (EAS; 1998) guideline targets; about 80% of patients treated with 10 mg reached the EAS targets for LDL-C levels (<3 mmol/l).
Danish: Poolet fase III data har vist, at Crestor er effektiv til behandling af størstedelen af patienter med type IIa og IIb hyperkolesterolæmi (gennemsnits baselinie LDL-C ca. 4,8 mmol/l) til anerkendte European
English: However, increased systemic exposure has been observed in subjects with Child-Pugh scores of 8 and 9 (see Section 5.2 Pharmacokinetic properties).
Danish: Hos individer med Child-Pugh score på 8 og 9 er der dog set en øget systemisk eksponering (se afsnit 5.2 Farmakokinetiske egenskaber).
English: Contraindications and Section 5.2 Pharmacokinetic properties).
Danish: 5.2 Farmakokinetiske egenskaber).
English: TG nonHDLC
Danish: TG nonHDL-C ApoB ApoAI
English: Whilst on Treatment
Danish: Under behandling
English: AstraZeneca Österreich GmbH
Danish: AstraZeneca Österreich GmbH Schwarzenbergplatz 7
English: Dosage in patients with renal insufficiency
Danish: Dosis hos patienter med nyreinsufficiens
English: Skeletal Muscle Effects
Danish: Skeletmuskulaturpåvirkninger
English: Nervous system disorders Common: headache, dizziness
Danish: Almindelig: Hovedpine, svimmelhed.
English: Pharmacotherapeutic group: HMG-CoA reductase inhibitors ATC code: C10A A07
Danish: ATC-kode: C10 A A07
English: CoA reductase inhibitor at the lowest dose with close monitoring.Routine monitoring of CK levels in asymptomatic patients is not warranted.
Danish: Rutine monitorering af CK niveauer hos asymptomatiske patienter er ikke påkrævet.
English: The recommended start dose is 5 mg in patients with moderate renal impairment (creatinine clearance
Danish: Anbefalet startdosis er 5 mg hos patienter med moderat nedsat nyrefunktion (creatinin clearence <60 ml/min).
English: regardless of race, sex, or age and in special populations such as diabetics, or patients with familial hypercholesterolaemia.
Danish: Crestor er effektiv hos voksne med hyperkolesterolæmi med eller uden hypertriglyceridæmi uafhængig af race, køn og alder samt i specielle grupper som f.eks diabetikere eller patienter med familiær hyperkolesterolæmi.
English: Liver Effects
Danish: Leverpåvirkninger
English: The 40 mg dose is contraindicated in Japanese and Chinese patients (see sections 4.3 Contraindications and 5.2 Pharmacokinetic properties).
Danish: Japanske og Kinesiske patienter (se afsnit 4.3 Kontraindikationer og 5.2 Farmakokinetiske egenskaber).
English: Based on the finding that ⇒ Crestor 10 mg daily dose leads to a higher reduction in LDL-C compared with 5 mg ⇒ No important safety or tolerability difference between rosuvastatin 5 mg and 10 mg is evident on the basis of post-marketing or clinical trial data
Danish: ⇒ at der ikke ses at være væsentlig forskel i sikkerheden eller tolerabiliteten af rosuvastatin 5 mg og 10 mg ud fra post-marketing oplysninger elleroplysninger fra kliniske undersøgelser,
English: Common: asthenia
Danish: Almindelig: Myalgi.
English: In most cases, proteinuria decreases or disappears spontaneously on continued therapy, and has not been shown to be predictive of acute or progressive renal disease.
Danish: mg. En mindre stigning i skift fra “ingen” eller “spor” til ”+” blev observeret med dosis på 20 mg. I de fleste tilfælde reduceres eller forsvinder proteinuri spontant ved fortsat behandling og der er ikke vist, at det er tegn på akut eller progressiv nyresygdom.
English: Renal Effects
Danish: Place Renault
English: The 40 mg dose is contraindicated with concomitant use of a fibrate.
Danish: Doser på 40 mg er kontraindiceret.
English: 5 mg oral use
Danish: Filmovertrukket tablet Oral anvendelse
English: Crestor-treated patients with all doses and in particular with doses > 20 mg.
Danish: myopati og sjældent rhabdomyolyse, hos individer behandlet med Crestor uafhængig af dosis, men specielt med doser > 20 mg.
English: <1% of patients at some time during treatment with 10 and 20 mg, and in approximately 3% of patients treated with 40 mg. A minor increase in shift from none or trace to + was observed with the 20 mg dose.
Danish: Skift i urinprotein fra “ingen” eller “spor” til “++” eller mere på et tidspunkt under behandling med 10 og 20 mg sås hos <1 % af patienterne og hos ca. 3 % af patienterne med 40
English: particularly if associated with malaise or fever.
Danish: Usædvanlig: udslæt, kløe og nældefeber.
English: If symptoms resolve and CK levels return to normal, then consideration should be given to re-introducing Crestor or an alternative HMG
Danish: niveauerne normaliseres bør det overvejes at genopstarte behandlingen med Crestor eller anden HMGCoA reduktasehæmmer ved laveste dosis med tæt monitorering.
English: Gemfibrozil, fenofibrate, other fibrates and lipid lowering doses (> or equal to 1g/day) of niacin (nicotinic acid) increase the risk of myopathy when given concomitantly with HMG-CoA reductase inhibitors, probably because they can produce myopathy when given alone.
Danish: fenofibrater, andre fibrater og lipid sænkende doser (> eller svarende til 1 g/dag) af niacin (nikotinsyre)
English: <60 ml/min).
Danish: mmol/l).