FrancophonIA/ELRC3.0 huggingface dataset:
English: In the pivotal European multicenter 64-week clinical trial including 12 week randomised, doubleblind, double-dummy, 2-arm, parallel study period, 248 high vascular risk patients with mixed dyslipidaemia were randomised to one of the two treatment groups: Pravafenix 40 mg/160 mg or pravastatin 40 mg. Only patients who had not met their NCEP ATP III target LDL-C and Triglyceride goals (LDL >100 mg/dl and TG >150 mg/dl) after 8 weeks on pravastatin 40 mg (1 tablet, once daily) were randomized.
Danish: I den europæiske 64-ugers pivotale kliniske multicenterundersøgelse, som omfattede en 12-ugers randomiseret, dobbeltblindet, dobbelt-dummy, to-armet, parallel undersøgelsesperiode, blev 248 patienter med høj vaskulær risiko og med blandet dyslipidæmi randomiseret til en af de to behandlingsgrupper: Pravafenix 40 mg/160 mg eller pravastatin 40 mg. Kun patienter, som ikke havde nået deres mål med hensyn til NCEP ATP III LDL-C og triglycerider (LDL >100 mg/dl og TG >150 mg/dl) efter 8 uger på pravastatin 40 mg (1 tablet én gang om dagen), blev randomiseret.
English: Also tell your doctor or pharmacist if you have a muscle weakness that is constant.
Danish: Fortæl det til lægen eller på apoteket, hvis du har vedvarende muskelsvaghed.
English: Sodium starch glycolate Magnesium stearate Talc
Danish: Natriumstivelsesglycolat Magnesiumstearat
English: Embryotoxic effects have been shown at doses in the range of maternal toxicity (see section 5.3).
Danish: Embryotoksiske virkninger er blevet påvist ved doser, der ligger inden for intervallet for maternel toksicitet (se pkt.
English: • Inflammation of the liver (hepatitis), symptoms of which may be mild yellowing of the skin and whites of the eyes (jaundice), abdominal pain and itching.
Danish: • Leverbetændelse (hepatitis), hvor symptomerne kan være en let gulfarvning af huden og det hvide i øjnene (gulsot), mavesmerter og kløe.
English: Routine monitoring of CK is systematically recommended every 3 months during the first 12 months of the combination therapy and let to the appreciation of the clinician beyond this initial period.
Danish: Rutinemæssig monitorering af CK anbefales systematisk hver 3. måned i de første 12 måneder af kombinationsbehandlingen og overlades til lægens vurdering efter denne startperiode.
English: If you are not sure, talk to your doctor or pharmacist before taking Pravafenix.
Danish: Er du i tvivl, så spørg lægen eller apoteket, inden du tager Pravafenix.
English: The lipid-lowering properties of fenofibrate seen in clinical practice have been explained in vivo in transgenic mice and in human hepatocyte cultures by activation of Peroxisome Proliferator Activated
Danish: De lipidsænkende egenskaber hos fenofibrat, der er set i klinisk praksis, er blevet klarlagt in vivo hos transgene mus og i humane hepatocytkulturer ved aktivering af peroxisom proliferator-aktiveret receptor af alfa-typen (PPARα).
English: Fenofibrate plus simvastatin therapy did not show any significant differences compared to simvastatin monotherapy in the composite primary outcome of non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death (hazard ratio [HR] 0.92, 95% CI 0.79-1.08, p = 0.32 ; absolute risk reduction: 0.74%).
Danish: Behandling med Fenofibrat samt simvastatin viste ingen signifikante forskelle i forhold til simvastatin monoterapi i det sammensatte primære udfald af ikke-fatal myokardieinfarkt, ikke-fatale slagtilfælde og kardiovaskulær død (Risikorate [HR] 0,92, 95% CI 0,79-1,08, p = 0,32, absolut risikoreduktion: 0,74%).
English: Toxicological findings in these co-administration studies were consistent with those seen with pravastatin and fenofibrate administered individually.
Danish: De toksikologiske resultater af disse undersøgelser af samtidig indgivelse var i overensstemmelse med resultaterne af individuelt indgivet pravastatin og fenofibrat.
English: Skeletal muscle: Marked and persistent increases of creatine phosphokinase (CK) have been reported infrequently.
Danish: Skeletmuskulatur: Lejlighedsvise indberetninger om markante og vedvarende stigninger i creatinkinase (CK).
English: Hard capsule.
Danish: Kapsel, hård.
English: Secondly, pravastatin inhibits LDL production by inhibiting the hepatic synthesis of VLDLcholesterol, the LDL-cholesterol precursor.
Danish: For det andet hæmmer pravastatin dannelsen af LDL ved at hæmme leversyntesen af VLDL-kolesterol, som et forstadie for LDL-kolesterol.
English: Interaction between pravastatin and fusidic acid can lead to an increased risk of rhabdomyolysis.
Danish: Lægemiddelinteraktion mellem pravastatin og fusidinsyre kan medføre en øget risiko for rabdomyolyse.
English: Interactions relevant to pravastatin
Danish: Interaktioner i forbindelse med pravastatin
English: Pruritus, urticaria
Danish: Nyrer og urinveje
English: Opaque white HDPE bottles containing 14, 30, 60 and 90 hard capsules.
Danish: Uigennemsigtige, hvide HDPE-beholdere med 14, 30, 60 og 90 hårde kapsler.
English: Myopathy must be considered in any patient presenting with unexplained muscle symptoms such as pain or tenderness, muscle weakness, or muscle cramps.
Danish: Myopati bør overvejes hos alle patienter, der har uforklarlige muskelsymptomer såsom smerter eller ømhed, muskelsvaghed eller muskelkramper.
English: Treatment initiation with Pravafenix should be decided after renal function has been evaluated (see section 4.4 Renal and urinary disorders).
Danish: Indledning af behandling med Pravafenix bør besluttes, efter at nyrefunktionen er blevet vurderet (se pkt.
English: - Severe hepatic impairment including biliary cirrhosis or active liver disease including unexplained persistent elevations in liver function tests (including serum transaminase elevation) exceeding 3
Danish: - Svært nedsat leverfunktion, herunder biliær cirrose eller aktiv leversygdom, bl.a. uforklarlige og vedvarende forhøjelser i leverfunktionstest (herunder forhøjelse af serumtransaminase), der er over 3 gange højere end den øvre grænse for normalområdet (ULN) (se pkt.
English: Pravafenix must be taken with food, as food enhances the bioavailability of fenofibrate (see sections 4.2 and 5.2).
Danish: Interaktioner med mad Pravafenix skal tages med mad, eftersom mad øger fenofibrats biotilgængelighed (se pkt.
English: Pharmacotherapeutic group: Lipid modifying agents, HMG CoA reductase inhibitors in combination with other lipid modifying agents, ATC code: C10BA03
Danish: Farmakoterapeutisk klassifikation: Lipidmodificerende midler, HMG-CoA-reduktasehæmmere i kombination med andre lipidmodificerende midler, ATC-kode: C10BA03 Farmakodynamisk virkning
English: Blood creatinine increased, creatinine renal clearance decreased, creatinine renal clearance increased, Renal failure
Danish: Forhøjet blodkreatinin, reduceret renal kreatininclearance, forøget renal kreatininclearance, nyreinsufficiens
English: Activation of PPARα also induces an increase in the synthesis of Apoproteins A-I,
Danish: Aktivering af PPARα medfører ligeledes en stigning i syntesen af apoprotein A-I og A-II og af HDL-kolesterol.
English: No modification of posology should be necessary in patients with mild renal impairment.
Danish: Ingen ændring af dosis bør være nødvendig hos patienter med let nedsat nyrefunktion.
English: The effects of Pravafenix 40 mg/160 mg were confirmed in a similar multicenter, 64-week trial including a 12 week randomized, double-blind phase in a study performed in the USA and comparing Pravafenix 40 mg/160 mg to Fenofibrate 160 mg monotherapy and Pravastatin 40 mg monotherapy in patients with mixed dyslipidaemia.
Danish: Virkningerne af Pravafenix 40 mg/160 mg blev bekræftet i en lignende 64-ugers multicenterundersøgelse, herunder en 12-ugers randomiseret, dobbeltblindet fase i en undersøgelse foretaget i USA, som sammenlignede Pravafenix 40 mg/160 mg med Fenofibrat 160 mg monoterapi og Pravastatin 40 mg monoterapi hos patienter med blandet dyslipidæmi.
English: It is recommended that transaminase levels be monitored every 3 months during the first 12 months of treatment and let to the appreciation of the clinician beyond this initial period.
Danish: Det anbefales, at transaminaseniveauerne monitoreres hver 3. måned i de første 12 måneder af behandlingen, og at de overlades til lægens vurdering efter denne startperiode.
English: Therefore, as far as pravastatin is contra indicated (see below), Pravafenix is contraindicated during pregnancy (see section 4.3).
Danish: Eftersom pravastatin er kontraindiceret (se nedenfor), er Pravafenix således kontraindiceret under graviditeten (se pkt.
English: This metabolite has one-tenth to one-fortieth the HMG-CoA reductase inhibitor activity of the parent compound.
Danish: Denne metabolit har 1/10 til 1/40 af HMG-CoA-reduktasehæmmerens aktivitet i udgangsstoffet.
English: There are no data from the combined use of pravastatin and fenofibrate in pregnant women.
Danish: Der er ingen data fra kombineret anvendelse af pravastatin og fenofibrat til gravide kvinder.
English: Rhabdomyolysis is an acute potentially fatal condition of skeletal muscle, which may develop at any time during treatment and is characterised by massive muscle destruction associated with major increase in CK (usually > 30 or 40 times the ULN) leading to myoglobinuria.
Danish: som kan opstå på et hvilket som helst tidspunkt under behandlingen, og som er kendetegnet ved massiv muskeldestruktion associeret med en større stigning i CK (sædvanligvis > 30 eller 40 x ULN), der fører til myoglobinuri.
English: Name and address of the manufacturer responsible for batch release:
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse
English: Rhabdomyolysis, which can be associated with acute renal failure secondary to myoglobinuria, myopathy (see section 4.4); myositis, polymyositis.
Danish: Rabdomyolyse, der kan associeres med akut nyreinsufficiens efter myoglobinuri, myopati (se pkt.
English: The capsules are hard gelatine capsule with olive cap and light green body containing a waxy white beige mass and a tablet.
Danish: Kapslerne er hårde gelatinekapsler med olivengrøn hætte og lysegrøn krop, som indeholder en voksagtig, beigehvid masse og en tablet.
English: Adverse reaction (fenofibrate)
Danish: Bivirkning (fenofibrat)
English: If treatment with fusidic acid is necessary, pravastatin treatment should be discontinued throughout the duration of the fusidic acid treatment.
Danish: Hvis behandling med fusidinsyre er nødvendig, skal pravastatinbehandlingen seponeres under hele behandlingsforløbet med fusidinsyre.
English: Blood cholesterol increased, blood triglycerides increased, lowdensity lipoprotein increased, weight increased.
Danish: Forhøjet kolesteroltal, forhøjede triglycerider i blodet, forhøjet lavdensitetslipoprotein, vægtstigning
English: Exceptional cases of interstitial lung disease have been reported with some statins, especially with long term therapy (see section 4.8).
Danish: Der er indberetninger om sjældne tilfælde af interstitiel lungesygdom med visse statiner, navnlig ved langvarig behandling (se pkt.
English: This is because, on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage, and very rarely deaths have occurred.
Danish: I sjældne tilfælde kan muskelproblemerne nemlig være alvorlige og omfatte en muskelnedbrydning, der resulterer i nyreskader, og i meget sjældne tilfælde er der set dødsfald.
English: • The active substances are fenofibrate and pravastatin.
Danish: • Aktive stoffer: fenofibrat og pravastatin.
English: Pancreatitis has been reported in patients taking fenofibrate or pravastatin (see sections 4.3).
Danish: Der er indberetninger om pancreatitis hos patienter, som tager fenofibrat eller pravastatin (se pkt.
English: Asthenia, fatigue, influenza like illness
Danish: Asteni, træthed, influenzalignende sygdom
English: Do not take Pravafenix if you are breast-feeding.
Danish: Du må ikke tage Pravafenix, hvis du ammer.
English: Pravafenix is bioequivalent to coadministered fenofibrate and pravastatin in a single dose study.
Danish: Pravafenix er bioækvivalent med samtidig indgivet fenofibrat og pravastatin i en enkeltdosisundersøgelse.
English: No studies in lactating animals have been conducted with Pravafenix.
Danish: Der er ikke foretaget undersøgelser af Pravafenix hos diegivende dyr.
English: Prolongation of the gestation period and difficulties during delivery were observed at high doses.
Danish: Ved høje doser blev der observeret forlængelse af drægtighedsperioden og vanskeligheder under fødslen.
English: Indigo carmine Black iron oxide Titanium dioxide Yellow iron oxide
Danish: Kapselskal Gelatine Indigotin Sort jernoxid Titaniumdioxid Gul jernoxid
English: It is important that you inform your doctor if you are already being treated with any of the following: - Bile acid resins such as colestyramine/colestipol (a medicine for lowering cholesterol), because it affects the way Pravafenix works.
Danish: Det er vigtigt, at du fortæller det til lægen, hvis du allerede bliver behandlet med et af følgende lægemidler: - Galdesyrebindende resin såsom kolestyramin/kolestipol (et kolesterolsænkende lægemiddel),
English: Pravafenix is not recommended in patients with moderate hepatic impairment and is contraindicated in patients with severe hepatic impairment (see section 4.3.).
Danish: Pravafenix anbefales ikke til patienter med moderat nedsat leverfunktion og er kontraindiceret til patienter med svært nedsat leverfunktion (se pkt.
English: In patients where the use of systemic fusidic acid is considered essential, statin treatment should be discontinued throughout the duration of fusidic acid treatment.
Danish: Hos patienter, hvor brug af systemisk fusidinsyre vurderes at være nødvendig, skal statinbehandlingen seponeres under hele behandlingsforløbet med fusidinsyre.
English: Rare * In the FIELD-study (fenofibrate study), a randomised placebo-controlled trial performed in 9,795 patients with type 2 diabetes mellitus, a statistically significant increase in pancreatitis cases was observed in patients receiving fenofibrate versus patients receiving placebo (0.8% versus 0.5%; p = 0.031).
Danish: * I FIELD-studiet (fenofibratundersøgelsen), som var en randomiseret, placebokontrolleret undersøgelse, der blev foretaget hos 9.795 patienter med type 2-diabetes mellitus, blev der observeret en statistisk signifikant stigning i pancreatitis-tilfældene hos patienter, der fik fenofibrat, sammenlignet med patienter, der fik placebo (0,8 % sammenlignet med 0,5 %; p = 0,031).
English: Fenofibrate
Danish: Fenofibrat
English: Arthralgia, back pain, blood creatine phosphokinase increased, muscle spasms, musculoskeletal pain, myalgia, pain in extremity.
Danish: Artralgi, rygsmerter, forhøjet creatinkinase, muskelspasmer, smerter i muskler og knogler, myalgi, smerter i ekstremiteterne
English: In mice, a 2-year carcinogenicity study with pravastatin demonstrates at doses of 250 and 500 mg/kg/day (> 310 times the maximum human mg/kg dose), statistically significant increases in the incidence of hepatocellular carcinomas in males and females, and lung adenomas in females only.
Danish: Hos mus viste en karcinogenicitetsundersøgelse af 2 års varighed med pravastatin, at der ved doser på 250 og 500 mg/kg/dag (> 310 gange den maksimale humane dosis i mg/kg) var statistisk signifikante stigninger i incidensen af hepatocellulære karcinomer hos hanner og hunner og af lungeadenomer hos hunner alene.
English: Abdominal distension, abdominal pain, abdominal pain upper, constipation, diarrhoea, dry mouth, dyspepsia, eructation, flatulence, nausea, abdominal discomfort, vomiting.
Danish: Mave-tarm-kanalen Abdominal distension, abdominale smerter, smerter i øvre del af abdomen, obstipation, diarré, mundtørhed, dyspepsi, opstød, flatulens, kvalme, abdominalt ubehag, opkastning
English: Venothromboembolic events
Danish: Venøse tromboemboliske hændelser
English: Pravafenix is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance < 60 ml/min) (see section 4.3.)
Danish: Pravafenix er kontraindiceret til patienter med moderat til svært nedsat nyrefunktion (defineret som kreatininclearance < 60 ml/min.)
English: Laboratoires SMB s.a. Rue de la Pastorale, 26-28 B-1080 Brussels Belgium
Danish: Laboratoires SMB s.a. Rue de la Pastorale, 26-28 B-1080 Bruxelles Belgien
English: Very rare side effects (may affect up to 1 in 10,000 people)
Danish: Meget sjældne bivirkninger (forekommer hos mindre end 1 ud af 10 000 patienter)
English: There have been no formal interaction studies for Pravafenix; however the concomitant use of the active substances in patients in clinical studies has not resulted in any unexpected interactions.
Danish: Samtidig brug af de aktive stoffer hos patienter i kliniske undersøgelser har dog ikke resulteret i nogen uventede interaktioner.
English: Side effects of unknown frequency (frequency cannot be estimated from the available data) • Muscle weakness that is constant
Danish: Bivirkninger med ukendt hyppighed: • Vedvarende muskelsvaghed.
English: Since it is less well absorbed from an empty stomach, Pravafenix should always be taken with food (see sections 4.5. and
Danish: Da kapslen ikke absorberes lige så godt på tom mave, skal Pravafenix altid tages sammen med mad (se pkt.
English: If you take more Pravafenix than you should Please contact your doctor or pharmacist
Danish: Hvis du har taget for meget Pravafenix Kontakt lægen eller apoteket.
English: The usual dose is one capsule taken daily during the evening meal.
Danish: Den sædvanlige dosis til voksne er én kapsel, som tages én gang om dagen i forbindelse med aftensmåltidet.
English: Possible side effects reported with some statins (same type of cholesterol-lowering medicines as pravastatin)
Danish: Bivirkninger, der er indberettet for visse statiner (samme type kolesterolsænkende lægemidler som pravastatin)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE FOR 14 AND 30 HARD CAPSULES
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE BEHOLDER TIL 14 OG 30 HÅRDE KAPSLER
English: There have been reports of rhabdomyolysis (including some fatalities) in patients receiving this combination (see section 4.5).
Danish: Der er rapporteret om rabdomyolyse (inklusive dødelige tilfælde) hos patienter, der fik denne kombination (se pkt.
English: Dizziness, headache, paraesthesia
Danish: Svimmelhed, hovedpine, paræstesi
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BOTTLES
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE TIL BLISTERPAKNINGER
English: The incremental benefit of Pravafenix 40 mg/160 mg on main lipid parameters versus Pravastatin 40 mg and Fenofibrate 160 mg monotherapy was also established.
Danish: Den yderligere fordel ved Pravafenix 40 mg/160 mg sammenlignet med Pravastatin 40 mg og Fenofibrat 160 mg monoterapi, når det gælder de vigtigste lipidparametre, blev ligeledes fastlagt.
English: Your doctor can measure your cholesterol with a simple blood test. Visit your doctor regularly to keep track of your cholesterol level.
Danish: Gå til læge regelmæssigt for at holde øje med dit kolesterolniveau.
English: The patient should be advised to seek medical advice immediately if they experience any symptoms of muscle weakness, pain or tenderness.
Danish: Patienterne skal informeres om omgående at søge læge, hvis de oplever symptomer som muskelsvaghed, -smerter eller -ømhed.
English: Pravafenix does not usually affect your ability to drive or use machines.
Danish: Trafik- og arbejdssikkerhed Pravafenix påvirker sædvanligvis ikke evnen til at føre motorkøretøj eller betjene maskiner.
English: Muscle disorder (e.g. myositis, muscular weakness)
Danish: Muskelsygdomme (f.eks. myositis, muskelsvaghed)
English: No effect on fertility in reproductive toxicity studies have been observed with both fenofibrate and pravastatin (see section 5.3)
Danish: I reproduktionstoksicitetsundersøgelser er der ikke observeret nogen virkninger på fertiliteten med hverken fenofibrat eller pravastatin (se pkt.
English: Fenofibrate cannot be eliminated by haemodialysis.
Danish: Fenofibrat kan ikke elimineres ved hæmodialyse.
English: Fenofibrate is excreted in milk of female rat.
Danish: Fenofibrat udskilles i mælken hos hunrotter.
English: • Obesity.
Danish: • Overvægt.
English: Blood and lymphatic system disorders
Danish: Blod og lymfesystem Anæmi, leukopeni
English: Therefore, taking into account the contra indication of pravastatin during lactation, Pravafenix is contraindicated during breastfeeding (see section 4.3).
Danish: I betragtning af kontraindikationen for pravastatin under amning er Pravafenix således kontraindiceret under amning (se pkt.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLES FOR 60 AND 90 HARD CAPSULES
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE BEHOLDER TIL 60 OG 90 HÅRDE KAPSLER
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapps lactasemangel) eller glucose/galactosemalabsorption.
English: - Tell your doctor if you drink large amounts of alcohol (if you drink more than the recommended daily amount; ask your doctor or pharmacist if you are unsure) or have ever had liver disease.
Danish: - Fortæl lægen, hvis du drikker store mængder alkohol (se punktet nedenfor om "Brug af Pravafenix sammen med mad og drikke"), eller hvis du nogensinde har haft en leversygdom.
English: It is recommended to systematically assess the estimated creatinine clearance at the initiation of the treatment and every 3 months during the first 12 months of the combination therapy then let to the appreciation of the clinician beyond this period.
Danish: Det anbefales at foretage en systematisk vurdering af den estimerede kreatininclearance ved behandlingens start og hver 3. måned i de første 12 måneder af kombinationsbehandlingen.
English: In the same study, a statistically significant increase was reported in the incidence of pulmonary embolism (0.7% in the placebo group versus 1.1% in the fenofibrate group; p = 0.022) and a statistically non-significant increase in deep vein thromboses (placebo: 1.0 % [48/4,900 patients] versus fenofibrate 1.4% [67/4,895 patients]; p = 0.074).
Danish: I samme undersøgelse blev der rapporteret en statistisk signifikant stigning i incidensen af lungeemboli (0,7 % i placebogruppen sammenlignet med 1,1 % i fenofibratgruppen; p=0,022) og en ikke statistisk signifikant stigning i incidensen af dyb venetrombose (placebo 1,0 % [48/4.900 patienter] sammenlignet med fenofibrat 1,4 % [67/4.895 patienter]; p = 0,074).
English: What Pravafenix contains
Danish: Pravafenix indeholder:
English: Pravafenix is contraindicated in moderate to severe renal impairment (section 4.3).
Danish: Pravafenix er kontraindiceret ved moderat til svær nyreinsufficiens (pkt.
English: Hepatic pain, gammaglutamyl transferase increased.
Danish: Leversmerter, forhøjet gammaglutamyltransferase
English: In the pre-specified subgroup of dyslipidaemic patients, defined as those in the lowest tertile of HDL-C (≤34 mg/dl or 0.88 mmol/L) and highest tertile of TG (≥204
Danish: I den præspecificerede undergruppe af dyslipidæmiske patienter, defineret som dem i den laveste tertil af HDL-C (≤34 mg/dl eller 0,88 mmol/l) og højest tertil af TG (≥204 mg/dl eller 2,3 mmol/l) ved baseline, viste behandling med fenofibrat samt simvastatin en relativ reduktion på 31% i forhold til simvastatin monoterapi ift.
English: No posology adjustment is required in patients with mild hepatic impairment.
Danish: Der kræves ingen dosisjusteringer for patienter med let nedsat leverfunktion.
English: PHARMACEUTICAL FORM AND CONTENTS 14 hard capsules
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 14 hårde kapsler
English: In clinical studies, the incidence of important elevations in creatine phosphokinase (CK ≥ 3 times the ULN, < 5 times the ULN) was 1.92% for patients treated with Pravafenix.
Danish: I kliniske undersøgelser var incidensen af væsentlige forhøjelser af creatinkinase (CK ≥ 3 gange ULN, < 5 gange ULN) 1,92 % for patienter, som blev behandlet med Pravafenix.