natgillin/translations-raw huggingface dataset:
6 msek. ved 1. 000 mg to gange dagligt), reduktion af T- takkens amplitude og i 7 nogle tilfælde difasiske T- takker hos patienter i behandling med Ranexa.
Dose and plasma concentration-related increases in the QTc interval (about 6 msec at 1000 mg twice daily), reductions in T wave amplitude, and in some cases notched T waves, have been observed in patients treated with Ranexa.
Disse virkninger af ranolazin på overflade- EKG' et formodes at være fremkaldt af hæmningen af den hurtigt korrigerende kaliumstrøm, hvilket forlænger det ventrikulære aktionspotentiale, og af hæmningen af den sene natriumstrøm, der forkorter det ventrikulære aktionspotentiale.
These effects of ranolazine on the surface electrocardiogram are believed to result from inhibition of the fast-rectifying potassium current, which prolongs the ventricular action potential, and from inhibition of the late sodium current, which shortens the ventricular action potential.
I en populationsanalyse af kombinerede data fra 1. 308 patienter og raske frivillige forsøgspersoner påvistes en gennemsnitlig stigning i QTc fra baseline på 2, 4 msek. pr.
A population analysis of combined data from
1. 000 ng/ ml plasmakoncentration af ranolazin.
7 1,308 patients and healthy volunteers demonstrated a mean increase in QTc from baseline of 2.4 msec per 1000 ng/ ml ranolazine plasma concentration.
Denne værdi stemmer overens med data fra afgørende kliniske forsøg, hvor der sås en gennemsnitlig ændring fra baseline af QTcF (Fridericias korrektion) efter doser på 500 og 750 mg to gange dagligt på henholdsvis 1, 9 og 4, 9 msek.
This value is consistent with data from pivotal clinical studies, where mean changes from baseline in QTcF (Fridericia’ s correction) after doses of 500 and 750 mg twice daily were 1.9 and 4.9 msec, respectively.
I et stort forsøg (MERLIN- TIMI 36), hvori 6. 560 patienter med ustabil angina pectoris/ NSTEMI- AKS deltog, var der ingen forskel mellem Ranexa og placebo med hensyn til mortalitetsrisiko uanset årsag (relativ risiko ranolazin: placebo 0, 99), pludselig hjertedød (relativ risiko ranolazin: placebo 0, 87) eller hyppigheden af symptomatiske dokumenterede arytmier (3, 0% mod 3, 1%).
In a large outcome study (MERLIN-TIMI 36) in 6,560 patients with UA/ NSTEMI ACS, there was no difference between Ranexa and placebo in the risk of all-cause mortality (relative risk ranolazine: placebo 0.99), sudden cardiac death (relative risk ranolazine: placebo 0.87), or the frequency of symptomatic documented arrhythmias (3.0% versus 3.1%).
Der blev ikke observeret nogen pro- arytmisk virkning hos 3. 162 patienter, der blev behandlet med Ranexa, baseret på 7- dages- Holter- monitorering i MERLIN- TIMI 36- forsøget.
No proarrhythmic effects were observed in 3,162 patients treated with Ranexa based on 7-day Holter monitoring in the MERLIN-TIMI 36 study.
Der var en signifikant lavere forekomst af arytmier hos patienter i behandling med Ranexa (74%) sammenlignet med placebo (83%), herunder ventrikulær takykardi ≥ 8 slag (5% mod 8%).
There was a significantly lower incidence of arrhythmias in patients treated with Ranexa (74%) versus placebo (83%), including ventricular tachycardia ≥ 8 beats (5% versus 8%).
Det er i kliniske forsøg påvist, at Ranexa er effektivt og sikkert til behandling af patienter med kronisk angina pectoris enten som monoterapi, eller når behandling med andre lægemidler mod angina pectoris ikke har været helt optimal.
Clinical studies have demonstrated the efficacy and safety of Ranexa in the treatment of patients with chronic angina, either alone or when the benefit from other antianginal medicinal products was sub-optimal.
I det afgørende CARISA- forsøg blev Ranexa givet sammen med atenolol 50 mg én gang dagligt, amlodipin 5 mg én gang dagligt eller diltiazem 180 mg én gang dagligt.
In the pivotal study, CARISA, Ranexa was added to treatment with atenolol 50 mg once daily, amlodipine 5 mg once daily, or diltiazem 180 mg once daily.
823 patienter (heraf 23% kvinder) blev randomiseret til 12 ugers behandling med Ranexa 750 mg to gange dagligt, 1. 000 mg to gange dagligt eller placebo.
Eight-hundred and twenty-three patients (23% women) were randomised to receive 12 weeks of treatment with Ranexa 750 mg twice daily, 1000 mg twice daily, or placebo.
Der var imidlertid ingen forskel i arbejdsvarighed mellem de to doser (24 sekunder sammenlignet med placebo; p ≤ 0, 03).
However, there was no difference in exercise duration between the two doses (24 seconds compared to placebo; p ≤ 0.03).
Ranexa medførte signifikante fald i antallet af angina- anfald pr. uge og i forbruget af korttidsvirkende nitroglycerin sammenlignet med placebo.
Ranexa resulted in significant decreases in the number of angina attacks per week and consumption of short-acting nitroglycerin compared to placebo.
Forsøgspersonerne udviklede ikke tolerance over for ranolazin i løbet af behandlingen, og der blev ikke observeret nogen rebound- stigning i angina- anfald efter pludselig seponering.
Tolerance to ranolazine did not develop during treatment and a rebound increase in angina attacks was not observed following abrupt discontinuation.
33% af forbedringen for mænds vedkommende ved en dosis på 1. 000 mg to gange dagligt.
The improvement in exercise duration in women was about 33% of the improvement in men at the 1000 mg twice-daily dose level.
Reduktionen i hyppigheden af angina- anfald og nitroglycerin- forbruget var dog ens for både kvinder og mænd.
However, men and women had similar reductions in frequency of angina attacks and nitroglycerin consumption.
I betragtning af de dosisafhængige bivirkninger og samme virkning ved 750 mg og 1. 000 mg administreret to gange dagligt anbefales en maksimal dosis på 750 mg to gange dagligt.
Given the dose-dependent side effects and similar efficacy at 750 and 1000 mg twice daily, a maximum dose of 750 mg twice daily is recommended.
565 patienter blev randomiseret til behandling med en startdosis Ranexa 500 mg to gange dagligt eller placebo i 1 uge efterfulgt af 6 uger med Ranexa 1. 000 mg to gange dagligt eller placebo i tillæg til samtidig behandling med amlodipin 10 mg én gang dagligt.
Five-hundred and sixty-five patients were randomised to receive an initial dose of Ranexa 500 mg twice daily or placebo for 1 week, followed by 6 weeks of treatment with Ranexa 1000 mg twice daily or placebo, in addition to concomitant treatment with amlodipine 10 mg once daily.
Derudover behandledes 45% af forsøgspopulationen med langtidsvirkende nitrater.
Additionally, 45% of the study population also received long-acting nitrates.
Ranexa medførte signifikante fald i antallet af angina- anfald pr. uge (p = 0, 028) og i forbruget af korttidsvirkende nitroglycerin (p = 0, 014) sammenlignet med placebo.
Ranexa resulted in significant decreases in the number of angina attacks per week (p = 0.028) and consumption of short-acting nitroglycerin (p = 0.014) compared to placebo.
Såvel det gennemsnitlige antal angina- anfald som forbruget af nitroglycerin- tabletter faldt med ca. ét anfald/ én tablet pr. uge.
Both the average number of angina attacks and nitroglycerin tablets consumed decreased by approximately one per week.
191 patienter blev randomiseret til behandling med Ranexa 500 mg to gange dagligt, 1. 000 mg to gange dagligt, 1. 500 mg to gange dagligt og matchende placebo, alle i 1 uge i et overkrydsningsdesign.
One-hundred and ninety-one patients were randomised to treatment with Ranexa 500 mg twice daily, 1000 mg twice daily, 1500 mg twice daily, and matching placebo, each for 1 week in a crossover design.
Ranexa var signifikant bedre end placebo til at forlænge arbejdsvarigheden, tid til angina- anfald og tid til 1 mm - ST- segment- depression ved alle undersøgte doser med et observeret dosis- respons- forhold.
Ranexa was significantly superior to placebo in prolonging exercise time, time to angina, and time to 1 mm ST segment depression at all doses studied with an observed dose-response relationship.
Forbedringen i arbejdsvarighed var statistisk signifikant sammenlignet med placebo ved alle tre doser ranolazin fra 24 sekunder ved 500 mg administreret to gange dagligt til 46 sekunder ved 1. 500 mg 8 administreret to gange dagligt, og der blev dermed påvist et dosisrelateret respons.
Improvement of exercise duration was statistically significant compared to placebo for all three doses of ranolazine from 24 seconds at 500 mg twice daily to 46 seconds at 1500 mg twice daily, showing a dose-related response.
I dette forsøg var arbejdsvarigheden længst hos 1. 500 mg- gruppen, men der blev konstateret en uforholdsmæssig stigning i bivirkninger, og 1. 500 mg- dosen blev derfor ikke undersøgt yderligere.
In this study, exercise duration was longest in the 1500 mg group; however, there was a disproportional increase in side effects, and the 1500 mg dose was not studied further.
I et stort forsøg (MERLIN- TIMI 36) med 6. 560 patienter med UA/ NSTEMI- AKS var der ingen forskel i mortalitetsrisikoen uanset årsag (relativ risiko ranolazin: placebo 0, 99), pludselig hjertedød (relativ risiko ranolazin: placebo 0, 87) eller hyppigheden af symptomatiske dokumenterede arytmier (3, 0% mod 3, 1%) mellem Ranexa og placebo, når de blev føjet til den medicinske standardbehandling, herunder betablokkere, calciumkanalblokkere, nitrater, trombocytfunktionshæmmere, lipidsænkende lægemidler og ACE- hæmmere.
In a large outcome study (MERLIN-TIMI 36) in 6,560 patients with UA/ NSTEMI ACS, there was no difference in the risk of all-cause mortality (relative risk ranolazine: placebo 0.99), sudden cardiac
Ca. halvdelen af patienterne i MERLIN- TIMI 36 havde en anamnese med angina.
Approximately one-half of the patients in MERLIN-TIMI 36 had a history of angina.
Resultaterne viste, at arbejdsvarigheden var 31 sekunder længere hos ranolazin- patienterne sammenlignet med placebo - patienterne (p = 0, 002).
The results showed that exercise duration was 31 seconds longer in ranolazine patients versus placebo patients (p = 0.002).
I spørgeskemaet Seattle Angina Questionnaire sås signifikant virkning på flere niveauer, herunder hyppigheden af angina (p < 0, 001) sammenlignet med placebobehandlede patienter.
The Seattle Angina Questionnaire showed significant effects on several dimensions, including angina frequency (p < 0.001), compared to placebo-treated patients.
Kun en mindre del ikke- kaukasiere var inkluderet i de kontrollerede kliniske forsøg, og der kan derfor ikke drages nogen konklusion om virkningen og sikkerheden hos ikke- kaukasiere.
A small proportion of non-Caucasians was included in the controlled clinical studies; therefore, no conclusions can be drawn regarding the effect and safety in non-Caucasians.
Steady state opnås generelt inden for 3 dage ved en dosis to gange dagligt.
Steady state is generally achieved within 3 days of twice-daily dosing.
Ranolazins gennemsnitlige absolutte biotilgængelighed efter oral administration af ranolazin- tabletter med øjeblikkelig frigivelse var 35– 50% med store interindividuelle forskelle.
The mean absolute bioavailability of ranolazine after oral administration of immediate- release ranolazine tablets ranged from 35− 50%, with large inter-individual variability.
Steady state- AUC steg 2, 5– 3 gange, da dosis blev øget fra 500 mg til 1. 000 mg to gange dagligt.
There was a 2.5- to 3-fold increase in steady-state AUC as the dose was increased from 500 mg to 1000 mg twice daily.
1. 770 ng/ ml (SD 1. 040), og steady state AUC0- 12 var i gennemsnit 13. 700 ng x t/ ml (SD 8. 290) efter en dosis på 500 mg to gange dagligt.
In a pharmacokinetic study in healthy volunteers, steady-state Cmax was, on average, approximately 1770 (SD 1040) ng/ ml, and steady-state AUC0-12 was, on average, 13,700 (SD 8290) ng x h/ ml following a dose of 500 mg twice daily.
Ca.
Distribution:
62% af ranolazin er bundet til plasmaproteiner, især til alfa- 1- syre- glykoprotein og svagt til albumin.
Approximately 62% of ranolazine is bound to plasma proteins, mainly alpha-1 acid glycoprotein and weakly to albumin.
180 l.
The mean steady-state volume of distribution (Vss) is about 180 l.
Ranolazin elimineres primært ved metabolisme.
Ranolazine is eliminated primarily by metabolism.
Mindre end 5% af dosis udskilles uforandret i urin og fæces.
Less than 5% of the dose is excreted unchanged in the urine and faeces.
Efter oral administration af en enkeltdosis 500 mg [14C] - ranolazin til raske forsøgspersoner blev 73% af radioaktiviteten udskilt i urin og 25% i fæces.
Following oral administration of a single 500 mg dose of [14C]-ranolazine to healthy subjects, 73% of the radioactivity was recovered in urine and 25% in faeces.
2– 3 timer efter intravenøs administration.
The elimination half-life is about 2− 3 hours after intravenous administration.
7 timer, da eliminationen begrænses af absorptionshastigheden.
The terminal half-life at steady state after oral administration of ranolazine is about 7 hours, due to the absorption rate-limited elimination.
Ranolazin gennemgår en hurtig og omfattende metabolisme.
Ranolazine undergoes rapid and extensive metabolism.
13% af radioaktiviteten i plasma efter en enkelt, oral dosis 500 mg [14C] - ranolazin.
In healthy young adults, ranolazine accounts for approximately 13% of the radioactivity in plasma following a single oral 500 mg dose of [14C]-ranolazine.
Der er identificeret 14 primære reaktionsmekanismer, hvoraf O- demethylering og N- dealkylering er de vigtigste.
Fourteen primary pathways have been identified of which O-demethylation and N-dealkylation are the most important.
In vitro- forsøg med humane levermikrosomer tyder på, at ranolazin primært metaboliseres gennem CYP3A4, men også gennem CYP2D6.
In vitro studies using human liver microsomes indicate that ranolazine is metabolised primarily by CYP3A4, but also by CYP2D6.
Ved en dosis på 500 mg to gange dagligt havde forsøgspersoner med manglende CYP2D6- aktivitet (de såkaldte poor metabolisers) 62% højere AUC end forsøgspersoner med CYP2D6- metaboliseringskapacitet (de såkaldte extensive metabolisers).
At 500 mg twice daily, subjects lacking CYP2D6 activity (poor metabolisers, PM) had 62% higher AUC than subjects with CYP2D6 metabolising capacity (extensive metabolisers, EM).
Den tilsvarende forskel ved en dosis på 1. 000 mg to gange dagligt var 25%.
The corresponding difference at the 1000 mg twice-daily dose was 25%.
9 Særlige populationer
Special populations
Køn:
Gender effects:
Kønnet havde ingen klinisk relevant indvirkning på de farmakokinetiske parametre.
Gender had no clinically relevant effect on pharmacokinetic parameters.
Alder alene havde ingen klinisk relevant indvirkning på de farmakokinetiske parametre.
Age alone had no clinically relevant effect on pharmacokinetic parameters.
Kropsvægt:
9 Body weight:
1, 4 gange højere end hos forsøgspersoner med en kropsvægt på 70 kg.
Compared to subjects weighing 70 kg, exposure was estimated to be about 1.4-fold higher in subjects weighing 40 kg.
Kronisk hjerteinsufficiens:
CHF:
Patienter med kronisk hjerteinsufficiens (NYHA- klasse III og IV) vurderedes at have en 1, 3 gange højere plasmakoncentration.
CHF NYHA Class III and IV were estimated to have about 1.3-fold higher plasma concentrations.
I en undersøgelse af nyrefunktionens indvirkning på ranolazins farmakokinetik, var ranolazins AUC gennemsnitligt 1, 7 til 2 gange højere hos forsøgspersoner med let, moderat og svært nedsat nyrefunktion sammenlignet med forsøgspersoner med normal nyrefunktion.
In a study evaluating the influence of renal function on ranolazine pharmacokinetics, ranolazine AUC was on average 1.7- to 2-fold higher in subjects with mild, moderate, and severe renal impairment compared with subjects with normal renal function.
AUC for én farmakologisk aktiv ranolazin- metabolit var 5 gange højere hos patienter med svært nedsat nyrefunktion.
The AUC of one pharmacologically active ranolazine metabolite was 5-fold increased in patients with severe renal impairment.
I den farmakokinetiske populationsanalyse blev det skønnet, at ranolazineksponering hos forsøgspersoner med moderat nedsat nyrefunktion (kreatininclearance 40 ml/ min) steg 1, 2 gange.
In the population pharmacokinetic analysis, a 1.2-fold increase in ranolazine exposure was estimated in subjects with moderate impairment (creatinine clearance 40 ml/ min).
Hos forsøgspersoner med svært nedsat nyrefunktion (kreatininclearance 10– 30 ml/ min) skønnedes det, at ranolazineksponeringen steg 1, 3– 1, 8 gange.
In subjects with severe renal impairment (creatinine clearance 10– 30 ml/ min), a 1.3- to 1.8-fold increase in ranolazine exposure was estimated.
Ranolazins farmakokinetik er blevet evalueret hos patienter med let til moderat nedsat leverfunktion.
The pharmacokinetics of ranolazine have been evaluated in patients with mild or moderate hepatic impairment.
AUC for ranolazin var uforandret hos patienter med let nedsat leverfunktion, men steg 1, 8 gange hos patienter med moderat nedsat leverfunktion.
Ranolazine AUC was unaffected in patients with mild hepatic impairment but increased 1.8-fold in patients with moderate impairment.
QT- forlængelse var mere udtalt hos disse patienter.
QT prolongation was more pronounced in these patients.
Ranolazins farmakokinetik er ikke blevet undersøgt i den pædiatriske population (< 18 år).
The pharmacokinetic parameters of ranolazine have not been studied in the paediatric population (< 18 years).
Bivirkninger, der ikke blev set i de kliniske forsøg, men i dyreforsøg ved doser svarende til den kliniske eksponering, var som følger:
Adverse reactions not observed in clinical studies, but seen in animals at levels similar to clinical exposure, were as follows:
3 gange højere end ved den foreslåede maksimale kliniske dosis.
Ranolazine was associated with convulsions and increased mortality in rats and dogs at plasma concentrations approximately 3-fold higher than at the proposed maximum clinical dose.
Der blev ikke konstateret nogen virkning på binyrebark - aksen for menneskers vedkommende.
No effect on the adreno-cortical axis was noted in humans.
I karcinogenicitetsforsøg over lang tid med ranolazindoser på op til 50 mg/ kg/ dag (150 mg/ m2/ dag) hos mus og 150 mg/ kg/ dag (900 mg/ m2/ dag) hos rotter sås der ingen relevant stigning i forekomsten af tumor uanset type.
In long-term carcinogenicity studies at doses of ranolazine up to 50 mg/ kg/ day (150 mg/ m2/ day) in mice and 150 mg/ kg/ day (900 mg/ m2/ day) in rats, no relevant increases in the incidence of any tumour types were seen.
0, 1 og 0, 8 gange den maksimale anbefalede humane dosis på 2 g baseret på mg/ m2 og er den maksimalt tolererede dosis hos disse arter.
These doses are equivalent to 0.1 and 0.8 times, respectively, the maximum recommended human dose of 2 grams on a mg/ m2 basis, and represent the maximum tolerated doses in these species.
10 Der sås tegn på embryo - og modertoksicitet, men ikke teratogenicitet, ved doser af ranolazin på op til 400 mg/ kg/ dag (2. 400 mg/ m2/ dag) hos rotter og 150 mg/ kg/ dag (1. 275 mg/ m2/ dag) hos kaniner.
Signs of embryonal and maternal toxicity, but not teratogenicity, were seen at doses of ranolazine up to 400 mg/ kg/ day (2400 mg/ m2/ day) in rats and 150 mg/ kg/ day (1275 mg/ m2/ day) in rabbits.
2 og 1 gange den maksimale anbefalede humane dosis.
These doses represent 2 and 1 times, respectively, the maximum recommended human dose.
Hjælpestoffer for alle ranolazin- depottabletter:
Excipients for all ranolazine prolonged-release tablets:
Carnaubavoks Hypromellose Magnesiumstearat Methacrylsyre- ethylacrylatcopolymer (1: 1) Mikrokrystallinsk cellulose Natriumhydroxid Titaniumdioxid
Carnauba wax Hypromellose Magnesium stearate Methacrylic acid-ethyl acrylate copolymer (1:1) Microcrystalline cellulose Sodium hydroxide Titanium dioxide
Øvrige hjælpestoffer for 375 mg- tabletter:
Additional excipients for 375 mg tablet:
Polyethylenglykol Polysorbat 80 Blå 2/ Indigocarmin aluminium lake (E 132)
Polyethylene glycol Polysorbate 80 Blue #2/ Indigo Carmine Aluminium Lake (E132)
PVC/ PVDC/ aluminium- blister med 10 tabletter pr. blisterkort.
PVC/ PVDC/ Aluminium blisters of 10 tablets per blister card.
Hver æske indeholder 3, 6 eller 10 blisterkort (30, 60 eller 100 tabletter) eller en HDPE- flaske med 60 tabletter.
Each carton contains 3, 6, or 10 blister cards (30, 60, or 100 tablets) or one HDPE bottle containing 60 tablets.
1, Avenue de la Gare, L- 1611 Luxembourg Luxembourg
1, Avenue de la Gare, L-1611 Luxembourg Luxembourg
60 tabletter i blisterpakning 60 tabletter i flaske 30 tabletter i blisterpakning 100 tabletter i blisterpakning
60 tablets in blister pack 60 tablets in bottle 30 tablets in blister pack 100 tablets in blister pack
9. juli 2008
09 July 2008
Ranexa 500 mg- depottabletter
Ranexa 500 mg prolonged-release tablets
Hver tablet indeholder 0, 12 mg azofarvestoffet E 110.
Each tablet contains 0.12 mg azo colouring agent E110.
Depottablet Lys orange, oval tablet præget med CVT500 på den ene side.
Prolonged-release tablet Light orange oval-shaped tablet engraved with CVT500 on one side.
13 Ældre:
13 Elderly:
4. 8).
The incidence of adverse events was higher in the elderly (see section 4.8).
Patienter med lav kropsvægt:
Low weight:
En populationsanalyse af kombinerede data fra patienter og raske frivillige forsøgspersoner påviste, at hældningskoefficienten for plasmakoncentration/ QTc- forholdet vurderedes at være 2, 4 millisekund pr.
A population-based analysis of combined data from patients and healthy volunteers demonstrated that the slope of the plasma concentration-QTc relationship was estimated to be 2.4 msec per 1000 ng/ ml, which is approximately equal to a 2- to 7-msec increase over the plasma concentration range for ranolazine 500 to 1000 mg twice daily.
1. 000 ng/ ml, hvilket ca. svarer til en stigning på 2 til 7 millisekunder i 14 plasmakoncentrationsområdet for ranolazin 500 til 1. 000 mg administreret to gange dagligt.
Therefore, caution should be observed
4. 5).
14 when treating patients with a history of congenital or a family history of long QT syndrome, in patients with known acquired QT interval prolongation, and in patients treated with drugs affecting the QTc interval (see section 4.5 also).
Azo farvestof E110:
Azo colouring agent E110:
Dette lægemiddel indeholder azo farvestoffet E110, som kan medføre allergiske reaktioner.
This medicinal product contains the azo colouring agent E110 which may cause allergic reactions.
15 Ranolazins indvirkning på andre lægemidler
Effects of ranolazine on other medicinal products
Det antydes i de tilgængelige data, at ranolazin er en mild CYP2D6- hæmmer.
15 Available data suggest that ranolazine is a mild inhibitor of CYP2D6.
16 Psykiske forstyrrelser Ikke almindelig: angst, søvnløshed.
Psychiatric disorders Uncommon: anxiety, insomnia.
Nervesystemet Almindelig: svimmelhed, hovedpine.
16 Nervous system disorders Common: dizziness, headache.
Øjne Ikke almindelig: sløret syn, synsforstyrrelse.
Eye disorders Uncommon: blurred vision, visual disturbance.
17 Ældre og patienter med nedsat nyrefunktion eller lav vægt:
In general, adverse events occurred more frequently among elderly patients and patients with renal impairment; however, the types of events in these subgroups were similar to those observed in the general population.
Generelt optrådte bivirkningerne hyppigere blandt ældre patienter og patienter med nedsat nyrefunktion, men bivirkningerne var de samme i disse undergrupper som dem, der ses i den almindelige befolkning.
Of the most commonly reported, the following events occurred more often with Ranexa (placebo-corrected frequencies) in elderly
Blandt de hyppigst forekommende bivirkninger (korrigeret for placebo) optrådte følgende hyppigere ved behandling med Ranexa hos ældre (≥ 75 år) end hos yngre patienter (< 75 år): forstoppelse (8% mod 5%), kvalme (6% mod 3%), hypotension (5% mod 1%) og opkastning (4% mod 1%).
17 (≥ 75 years of age) than younger patients (< 75 years of age): constipation (8% versus 5%), nausea (6% versus 3%), hypotension (5% versus 1%), and vomiting (4% versus 1%).