natgillin/translations-raw huggingface dataset:
Hvis en patient oplever behandlingsrelaterede bivirkninger, f. eks. svimmelhed, kvalme eller opkastning, kan en nedtitrering af Ranexa til 500 mg eller 375 mg to gange dagligt være nødvendig.
If a patient experiences treatment-related adverse events (e. g. dizziness, nausea, or vomiting), down- titration of Ranexa to 500 mg or 375 mg twice daily may be required.
Samtidig behandling med CYP3A4 - og P- glykoproteinhæmmere:
Concomitant treatment with CYP3A4 and P-glycoprotein (P-gp) inhibitors:
4. 4 og 4. 5).
Careful dose titration is recommended in patients treated with moderate CYP3A4 inhibitors (e. g. diltiazem, fluconazole, erythromycin) or P-gp inhibitors (e. g. verapamil, ciclosporin) (see sections 4.4 and 4.5).
4. 3 og 4. 5).
Concomitant administration of potent CYP3A4 inhibitors is contraindicated (see sections 4.3 and 4.5).
4. 4, 4. 8 og 5. 2).
Careful dose titration is recommended in patients with mild to moderate renal impairment (creatinine clearance 30– 80 ml/ min) (see sections 4.4, 4.8, and 5.2).
4. 3 og 5. 2).
Ranexa is contraindicated in patients with severe renal impairment (creatinine clearance < 30 ml/ min) (see sections 4.3 and 5.2).
4. 4 og 5. 2).
Careful dose titration is recommended in patients with mild hepatic impairment (see sections 4.4 and 5.2).
4. 3 og 5. 2).
Ranexa is contraindicated in patients with moderate or severe hepatic impairment (see sections 4.3 and 5.2).
Ældre:
2 Elderly:
4. 4).
Dose titration in elderly patients should be exercised with caution (see section 4.4).
4. 8).
Low weight:
Bivirkningsincidensen var højere hos patienter med en lav kropsvægt (≤ 60 kg).
The incidence of adverse events was higher in patients with low weight (≤ 60 kg).
4. 4, 4. 8 og 5. 2).
Dose titration in patients with low weight should be exercised with caution (see sections 4.4, 4.8, and 5.2).
Patienter med kronisk hjerteinsufficiens (CHF):
Congestive heart failure (CHF):
4. 4 og 5. 2).
Dose titration in patients with moderate to severe CHF (NYHA Class III– IV) should be exercised with caution (see sections 4.4 and 5.2).
Ranexa bør ikke anvendes til børn under 18 år på grund af manglende dokumentation for sikkerhed og virkning.
Ranexa is not recommended for use in children below the age of 18 years due to a lack of data on safety and efficacy.
Ranexa- tabletter bør synkes hele og bør ikke knuses, brækkes eller tygges.
Ranexa tablets should be swallowed whole and not crushed, broken, or chewed.
Svært nedsat nyrefunktion defineret som en kreatininclearance på < 30 ml/ min (se pkt.
Severe renal impairment (creatinine clearance < 30 ml/ min) (see sections 4.2 and 5.2).
4. 2 og 4. 5).
Concomitant administration of potent CYP3A4 inhibitors (e. g. itraconazole, ketoconazole, voriconazol, posaconazol, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone) (see sections 4.2 and 4.5).
Samtidig administration af antiarytmika af klasse Ia, f. eks. quinidin, eller klasse III, f. eks. dofetilid og sotalol, bortset fra amiodaron.
Concomitant administration of Class Ia (e. g. quinidine) or Class III (e. g. dofetilide, sotalol) antiarrhythmics other than amiodarone.
4. 2 og 5. 2).
Caution should be exercised when prescribing or uptitrating ranolazine to patients in whom an increased exposure is expected: • Concomitant administration of moderate CYP3A4 inhibitors (see sections 4.2 and 4.5). • Concomitant administration of P-gp inhibitors (see sections 4.2 and 4.5). • Mild hepatic impairment (see sections 4.2 and 5.2). • Mild to moderate renal impairment (creatinine clearance 30– 80 ml/ min) (see sections 4.2, 4.8, and 5.2). • Elderly (see sections 4.2, 4.8, and 5.2). • Patients with low weight (≤ 60 kg) (see sections 4.2, 4.8, and 5.2). • Patients with moderate to severe CHF (NYHA Class III– IV) (see sections 4.2 and 5.2).
5. 2).
The risk for increased exposure leading to adverse events in these different subgroups is higher in patients lacking CYP2D6 activity (poor metabolisers, PM) than subjects with CYP2D6 metabolising capacity (extensive metabolisers, EM) (see section 5.2).
De ovennævnte forholdsregler er baseret på en CYP2D6 PM- patient og skal følges, når CYP2D6- status ikke kendes.
The above precautions are based on the risk in a CYP2D6 PM patient, and are needed when the CYP2D6 status is unknown.
Behovet for at følge forholdsreglerne er mindre hos patienter med CYP2D6 EM- status.
There is a lower need for precautions in patients with CYP2D6 EM status.
Hvis patientens CYP2D6- status er blevet bestemt, f. eks. ved genotypning, eller hvis det vides fra tidligere, at patienten er EM, kan Ranexa anvendes med forsigtighed hos sådanne patienter, hos hvem en kombination af flere af ovennævnte risikofaktorer gør sig gældende.
If the CYP2D6 status of the patient has been determined (e. g. by genotyping) or is previously known to be EM, Ranexa can be used with caution in these patients when they have a combination of several of the above risk factors.
QT- forlængelse:
QT prolongation:
1. 000 ng/ ml, hvilket ca. svarer til en stigning på 2 til 7 millisekunder i plasmakoncentrationsområdet for ranolazin 500 til 1. 000 mg administreret to gange dagligt.
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.
Der skal derfor udvises forsigtighed ved behandling af patienter med anamnestisk langt QT- syndrom (medfødt
Therefore, caution should be observed
4. 5).
3 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).
Interaktion med andre lægemidler:
Drug-drug interactions:
Samtidig administration af CYP3A4- induktorer forventes ikke at have nogen virkning.
Co-administration with CYP3A4 inducers is expected to lead to lack of efficacy.
Ranexa bør ikke anvendes hos patienter, der er i behandling med CYP3A4 - induktorer, f. eks. rifampicin, phenytoin, phenobarbital, carbamazepin og prikbladet perikon (se pkt.
Ranexa should not be used in patients treated with CYP3A4 inducers (e. g. rifampicin, phenytoin, phenobarbital, carbamazepine, St.
4. 5).
John’ s Wort) (see section 4.5).
4. 2, 4. 3, 4. 8 og 5. 2).
Renal function decreases with age and it is therefore important to check renal function at regular intervals during treatment with ranolazine (see sections 4.2, 4.3, 4.8, and 5.2).
CYP3A4 - eller P- glykoproteinhæmmere:
CYP3A4 or P-gp inhibitors:
Ranolazin er et substrat for cytokrom CYP3A4.
Ranolazine is a substrate of cytochrome CYP3A4.
CYP3A4 - hæmmere øger plasmakoncentrationen af ranolazin.
Inhibitors of CYP3A4 increase plasma concentrations of ranolazine.
Incidensen af dosisrelaterede bivirkninger, f. eks. kvalme og svimmelhed, kan også stige med øget plasmakoncentration.
The potential for dose-related adverse events (e. g. nausea, dizziness) may also increase with increased plasma concentrations.
Samtidig behandling med ketoconazol 200 mg to gange dagligt fik ranolazins AUC til at stige 3, 0- 3, 9 gange under ranolazinbehandlingen.
Concomitant treatment with ketoconazole 200 mg twice daily increased the AUC of ranolazine by 3.0- to 3.9-fold during ranolazine treatment.
4. 3).
Combining ranolazine with potent CYP3A4 inhibitors (e. g. itraconazole, ketoconazole, voriconazole, posaconazole, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone) is contraindicated (see section 4.3).
Grapefrugtjuice er også en potent CYP3A4- hæmmer.
Grapefruit juice is also a potent CYP3A4 inhibitor.
Diltiazem (180 til 360 mg én gang dagligt), der er en moderat potent CYP3A4- hæmmer, fremkalder dosisafhængige stigninger i de gennemsnitlige steady state- koncentrationer af ranolazin på 1, 5 til 2, 4 gange.
Diltiazem (180 to 360 mg once daily), a moderately potent CYP3A4 inhibitor, causes dose-dependent increases in average ranolazine steady-state concentrations of 1.5- to 2.4-fold.
Der anbefales at udvise forsigtighed ved dosistitrering af Ranexa hos patienter, der er i behandling med diltiazem og andre moderat potente CYP3A4- hæmmere, f. eks. erythromycin og fluconazol.
Careful dose titration of Ranexa is recommended in patients treated with diltiazem and other moderately potent CYP3A4 inhibitors (e. g. erythromycin, fluconazole).
4. 2 og 4. 4).
Down-titration of Ranexa may be required (see sections 4.2 and 4.4).
Ranolazin er et substrat for P- glykoprotein.
Ranolazine is a substrate for P-gp.
P- glykoproteinhæmmere, f. eks. ciclosporin, quinidin og verapamil, øger plasmaniveauet af ranolazin.
Inhibitors of P-gp (e. g. ciclosporin, quinidine, verapamil) increase plasma levels of ranolazine.
Verapamil (120 mg tre gange dagligt) øger steady state - koncentrationen af ranolazin 2, 2 gange.
Verapamil (120 mg three times daily) increases ranolazine steady-state concentrations 2.2-fold.
Der anbefales at udvise forsigtighed ved dosistitrering af Ranexa hos patienter, der er i behandling med P- glykoproteinhæmmere.
Careful dose titration of Ranexa is recommended in patients treated with P-gp inhibitors.
CYP3A4- induktorer:
CYP3A4 inducers:
95%.
Rifampicin (600 mg once daily) decreases ranolazine steady-state concentrations by approximately 95%.
Behandling med Ranexa bør ikke initieres ved samtidig administration af CYP3A4- induktorer, f. eks. rifampicin, phenytoin, phenobarbital, carbamazepin og prikbladet perikon (se pkt.
Initiation of treatment with Ranexa should be avoided during administration of inducers of CYP3A4 (e. g. rifampicin, phenytoin, phenobarbital, carbamazepine, St.
4. 4).
John’ s Wort) (see section 4.4).
CYP2D6- hæmmere:
CYP2D6 inhibitors:
Derfor kan hæmmere af dette enzym få plasmakoncentrationen af ranolazin til at stige.
Ranolazine is partially metabolised by CYP2D6; therefore, inhibitors of this enzyme may increase plasma concentrations of ranolazine.
Ved en dosis på 20 mg én gang dagligt fik den potente CYP2D6- hæmmer, paroxetin, steady state- plasmakoncentrationen af ranolazin 1. 000 mg administreret to gange dagligt til gennemsnitligt at stige 1, 2 gange.
The potent CYP2D6 inhibitor paroxetine, at a dose of 20 mg once daily, increased steady-state plasma concentrations of ranolazine 1000 mg twice daily by an average of 1.2-fold.
62%.
At the dose level 500 mg twice daily, co-administration of a potent inhibitor of CYP2D6 could result in an increase in ranolazine AUC of about 62%.
Ranolazin er en moderat til potent P- glykoproteinhæmmer og en mild CYP3A4- hæmmer, og stoffet kan øge plasmakoncentrationen af P- glykoprotein eller CYP3A4- substrater.
Ranolazine is a moderate to potent inhibitor of P-gp and a mild inhibitor of CYP3A4, and may increase plasma concentrations of P-gp or CYP3A4 substrates.
Fordelingen af lægemidler, der transporteres af P- glykoprotein, til væv kan øges.
Tissue distribution of drugs which are transported by P-gp may be increased.
Det antydes i de tilgængelige data, at ranolazin er en mild CYP2D6- hæmmer.
Available data suggest that ranolazine is a mild inhibitor of CYP2D6.
Eksponeringen for CYP2D6- substrater, f. eks. tricykliske antidepressiva og antipsykotika, kan øges ved samtidig administration af Ranexa, og det kan blive nødvendigt at nedjustere dosis af disse lægemidler.
The exposure of CYP2D6 substrates (e. g. tricyclic antidepressants and antipsychotics) may be increased during co-administration of Ranexa, and lower doses of these medicinal products may be required.
4 Potentialet for hæmning af CYP2B6 er ikke blevet evalueret.
4 The potential for inhibition of CYP2B6 has not been evaluated.
Det tilrådes at udvise forsigtighed ved samtidig administration af CYP2B6- substrater, f. eks. bupropion, efavirenz og cyclophosphamid.
Caution is advised during co-administration with CYP2B6 substrates (e. g. bupropion, efavirenz, cyclophosphamide).
Der er rapporteret om en stigning i plasmakoncentrationen af digoxin på gennemsnitligt 1, 5 gange, når Ranexa og digoxin er blevet administreret samtidigt.
An increase in plasma digoxin concentrations by an average of 1.5-fold has been reported when Ranexa and digoxin are co-administered.
Digoxin- niveauet bør derfor følges nøje efter opstart og afslutning af behandling med Ranexa.
Therefore, digoxin levels should be monitored following initiation and termination of Ranexa therapy.
Metabolismen og simvastatinclearance afhænger i høj grad af CYP3A4.
Simvastatin metabolism and clearance are highly dependent on CYP3A4.
Ranexa 1. 000 mg to gange dagligt fik plasmakoncentrationen af simvastatinlakton, simvastatinsyre og HMG - CoA- reduktase- hæmmerens aktivitet til at stige 1, 4- 1, 6 gange.
Ranexa 1000 mg twice daily increased plasma concentrations of simvastatin lactone, simvastatin acid, and the HMG-CoA reductase inhibitor activity by 1.4- to 1.6-fold.
Der er en teoretisk risiko for, at behandling med ranolazin samtidig med andre lægemidler, der vides at forlænge QTc- intervallet, kan medføre en farmakodynamisk interaktion og øge risikoen for ventrikulære arytmier.
There is a theoretical risk that concomitant treatment of ranolazine with other drugs known to prolong the QTc interval may give rise to a pharmacodynamic interaction and increase the possible risk of ventricular arrhythmias.
Eksempler på sådanne lægemidler omfatter visse antihistaminer (f. eks. terfenadin, astemizol og mizolastin), visse antiarytmika (f. eks. quinidin, disopyramid og procainamid), erythromycin og tricykliske antidepressiva (f. eks. imipramin, doxepin og amitriptylin).
Examples of such drugs include certain antihistamines (e. g. terfenadine, astemizole, mizolastine), certain antiarrhythmics (e. g. quinidine, disopyramide, procainamide), erythromycin, and tricyclic antidepressants (e. g. imipramine, doxepin, amitriptyline).
Der foreligger ikke tilstrækkelige data om brugen af ranolazin hos gravide.
There are no adequate data from the use of ranolazine in pregnant women.
5. 3).
Animal studies are insufficient with respect to effects on pregnancy and embryofoetal development (see section 5.3).
Det vides ikke, om ranolazin udskilles i human brystmælk.
It is unknown whether ranolazine is excreted in human breast milk.
4. 8), og det kan påvirke evnen til at føre motorkøretøj og betjene maskiner.
Ranexa may cause dizziness and blurred vision (see section 4.8), which may affect the ability to drive and use machines.
4. 8 Bivirkninger
Undesirable effects in patients receiving Ranexa are generally mild to moderate in severity and often develop within the first 2 weeks of treatment.
De blev indberettet i løbet af det kliniske fase 3 - udviklingsprogram, der omfattede 1. 030 patienter med kronisk angina pectoris, der blev behandlet med Ranexa.
These were reported during the Phase 3 clinical development programme, which included a total of 1,030 chronic angina patients treated with Ranexa.
De bivirkninger, der blev vurderet til i det mindste muligvis at være relateret til behandlingen, er kategoriseret nedenfor efter kropssystem, organklasse og absolut hyppighed.
The adverse events, considered to be at least possibly related to treatment, are listed below by body system, organ class, and absolute frequency.
Hyppigheden defineres som meget almindelig (≥ 1/ 10), almindelig (≥ 1/ 100 til < 1/ 10), ikke almindelig (≥ 1/ 1. 000 til < 1/ 100), sjælden (≥ 1/ 10. 000 til < 1/ 1. 000) og meget sjælden (< 1/ 10. 000).
Frequencies are defined as very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100), rare (≥ 1/ 10,000 to < 1/ 1,000), and very rare (< 1/ 10,000).
Metabolisme og ernæring Ikke almindelig: anoreksi, nedsat appetit, dehydrering.
Metabolism and nutrition disorders Uncommon: anorexia, decreased appetite, dehydration.
Psykiske forstyrrelser Ikke almindelig: angst, søvnløshed.
Psychiatric disorders Uncommon: anxiety, insomnia.
Nervesystemet Almindelig: svimmelhed, hovedpine.
Nervous system disorders Common: dizziness, headache.
Ikke almindelig: letargi, synkope, hypoæstesi, somnolens, tremor, postural svimmelhed.
Uncommon: lethargy, syncope, hypoaesthesia, somnolence, tremor, postural dizziness.
Sjælden: amnesi, nedsat bevidsthedsniveau, bevidsthedstab, parosmi.
Rare: amnesia, depressed level of consciousness, loss of consciousness, parosmia.
5 Øjne Ikke almindelig: sløret syn, synsforstyrrelse.
5 Eye disorders Uncommon: blurred vision, visual disturbance.
Øre og labyrint Ikke almindelig: vertigo, tinnitus.
Ear and labyrinth disorders Uncommon: vertigo, tinnitus.
Vaskulære sygdomme Ikke almindelig: hedetur, hypotension.
Vascular disorders Uncommon: hot flush, hypotension.
Mave- tarmkanalen Almindelig: forstoppelse, opkastning, kvalme.
Gastrointestinal disorders Common: constipation, vomiting, nausea.
Hud og subkutane væv Ikke almindelig: pruritus, hyperhidrosis.
Skin and subcutaneous tissue disorders Uncommon: pruritus, hyperhydrosis.
Sjælden: allergisk dermatitis, urticaria, koldsved, udslæt.
Rare: allergic dermatitis, urticaria, cold sweat, rash.
Knogler, led, muskler og bindevæv Ikke almindelig: smerter i ekstremiteterne, muskelkramper, ledhævelse.
Musculoskeletal and connective tissue disorders Uncommon: pain in extremity, muscle cramp, joint swelling.
Nyrer og urinveje Ikke almindelig: dysuri, hæmaturi, kromaturi.
Renal and urinary disorders Uncommon: dysuria, haematuria, chromaturia.
Ikke almindelig: fatigue, perifere ødemer.
Uncommon: fatigue, peripheral oedema.
Undersøgelser Ikke almindelig: forhøjet kreatinin, forhøjet carbamid, forlænget QT- korrigeret interval, forhøjet trombocyt - eller leukocyttal, vægttab.
Investigations Uncommon: increased blood creatinine, increased blood urea, prolonged QT corrected interval, increased platelet or white blood cell count, decreased weight.
Bivirkningsprofilen var overvejende den samme i MERLIN- TIMI 36- forsøget.
The adverse event profile was generally similar in the MERLIN-TIMI 36 study.
Det blev bekræftet gennem evalueringer af patienter, der formodes at have en større risiko for bivirkninger, hvis de behandles med andre lægemidler mod angina pectoris, f. eks. patienter med diabetes, klasse I - og II - hjertesvigt eller obstruktive luftvejslidelser, at disse lidelser ikke var forbundet med klinisk relevante stigninger i bivirkningsincidensen.
Evaluations in patients who may be considered at higher risk of adverse events when treated with other antianginal medicinal products, e. g. patients with diabetes, Class I and II heart failure, or obstructive airway disease, confirmed that these conditions were not associated with clinically meaningful increases in the incidence of adverse events.
Ældre og patienter med nedsat nyrefunktion eller lav vægt:
Elderly, renal impairment, and low weight:
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.
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.
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%).
Of the most commonly reported, the following events occurred more often with Ranexa (placebo-corrected frequencies) in elderly (≥ 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%).
6 Hos patienter med let til moderat nedsat nyrefunktion (kreatininclearance på ≥ 30– 80 ml/ min) sammenlignet med dem, der havde en normal nyrefunktion (kreatininclearance > 80 ml/ min), var de hyppigst indberettede bivirkninger korrigeret for placebo: forstoppelse (8% mod 4%), svimmelhed (7% mod 5%) og kvalme (4% mod 2%).
In patients with mild or moderate renal impairment (creatinine clearance ≥ 30– 80 ml/ min) compared to those with normal renal function (creatinine clearance > 80 ml/ min), the most commonly reported
Generelt var typen og hyppigheden af bivirkninger rapporteret hos patienter med en lav kropsvægt (≤ 60 kg) de samme som hos dem med en højere (> 60 kg), men korrigeret for placebo var hyppigheden af følgende almindelige bivirkninger højere i gruppen af patienter med lav kropsvægt end hos de øvrige patienter: kvalme (14% mod 2%), opkastning (6% mod 1%) og hypotension (4% mod 2%).
In general, the type and frequency of adverse events reported in patients with low body weight (≤ 60 kg) were similar to those of patients with higher weight (> 60 kg); however, the placebo- corrected frequencies of the following common adverse events were higher in low body weight than heavier patients: nausea (14% versus 2%), vomiting (6% versus 1%), and hypotension (4% versus 2%).
Laboratoriefund:
Laboratory findings:
Små, klinisk ubetydelige, reversible forhøjelser i serumkreatininniveauet er observeret hos raske forsøgspersoner og patienter, der er behandlet med Ranexa.
Small, clinically insignificant, reversible elevations in serum creatinine levels have been observed in healthy subjects and patients treated with Ranexa.
62% af ranolazin bindes til plasmaproteiner, og derfor er det sandsynligvis ikke muligt at opnå fuldstændig clearance ved hæmodialyse.
Approximately 62% of ranolazine is bound to plasma proteins, and therefore, complete clearance by haemodialysis is unlikely.
Andre hjertemidler, ATC- kode:
Other cardiac preparations, ATC code:
Ranolazins virkningsmekanisme er overvejende ukendt.
The mechanism of action of ranolazine is largely unknown.
Dermed reduceres den intracellulære natriumakkumulation og som følge heraf falder det intracellulære calcium- overload.
This reduces intracellular sodium accumulation and consequently decreases intracellular calcium overload.
Ranolazin menes at reducere disse intracellulære ion- ubalancer ved iskæmi qua dets evne til at reducere den sene natriumstrøm.
Ranolazine, via its action to decrease the late sodium current, is considered to reduce these intracellular ionic imbalances during ischaemia.
Reduktionen i cellulært calcium- overload forventes at forbedre den myokardielle relaxation og derigennem mindske den venstre ventrikels diastoliske dysfunktion.
This reduction in cellular calcium overload is expected to improve myocardial relaxation and thereby decrease left ventricular diastolic stiffness.
Den kliniske påvisning af ranolazins hæmning af den sene natriumstrøm er fundet ved en signifikant forkortelse af QTc- intervallet og en forbedring af den diastoliske relaxation i et åbent forsøg med 5 patienter med langt QT- syndrom (LQT3 med SCN5A ∆KPQ- genmutationen).
Clinical evidence of inhibition of the late sodium current by ranolazine is provided by a significant shortening of the QTc interval and an improvement in diastolic relaxation in an open-label study of 5 patients with a long QT syndrome (LQT3 having the SCN5A ∆ KPQ gene mutation).
Denne virkning afhænger ikke af ændringer i hjerterytme, blodtryk eller vasodilatation.
These effects do not depend upon changes in heart rate, blood pressure, or vasodilation.
Hæmodynamisk virkning:
Haemodynamic effects:
Der blev i kontrollerede forsøg observeret minimale fald i den gennemsnitlige hjertefrekvens (< 2 slag pr. minut) og det gennemsnitlige systoliske blodtryk (< 3 mm Hg) hos patienter, der blev behandlet med ranolazin enten alene eller i kombination med andre antianginøse lægemidler.
Minimal decreases in mean heart rate (< 2 beats per minute) and mean systolic blood pressure (< 3 mm Hg) were observed in patients treated with ranolazine either alone or in combination with other antianginal medicinal products in controlled studies.
Elektrokardiografisk virkning:
Electrocardiographic effects: