FrancophonIA/ELRC3.0 huggingface dataset:
English: Glycerol triacetate
Danish: Glycerolacetat
English: The Seattle Angina Questionnaire showed significant effects on several dimensions, including angina frequency (p < 0.001), compared to placebo-treated patients.
Danish: I spørgeskemaet Seattle Angina Questionnaire sås signifikant virkning på flere niveauer, herunder hyppigheden af angina (p < 0,001) sammenlignet med placebobehandlede patienter.
English: The improvement in exercise duration in women was about 33% of the improvement in men at the 1000 mg twice-daily dose level.
Danish: Forbedringen i arbejdsvarighed hos kvinder var ca. 33 % af forbedringen for mænds vedkommende ved en dosis på 1.000 mg to gange dagligt.
English: What you need to know before you take Ranexa 3.
Danish: Det skal du vide, før du begynder at tage Ranexa 3.
English: The influence of dialysis on the pharmacokinetics of ranolazine has not been evaluated.
Danish: Indvirkningen af dialyse på ranolazins farmakokinetik er ikke blevet evalueret.
English: Excessive sweating, itching
Danish: Overdreven sveden, kløe
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PVC/PVDC/Aluminium blisters
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS PVC/PVDC/aluminium-blister
English: Excipients: Each tablet contains 0.04 mg azo colouring agent E102 and 12.0 mg lactose monohydrate.
Danish: Hjælpestoffer: Hver tablet indeholder 0,04 mg azofarvestoffet E 102 og 12,0 mg lactosemonohydrat.
English: Approximately 62% of ranolazine is bound to plasma proteins, and therefore, complete clearance by haemodialysis is unlikely.
Danish: Ca. 62 % af ranolazin bindes til plasmaproteiner, og derfor er det sandsynligvis ikke muligt at opnå fuldstændig clearance ved hæmodialyse.
English: This reduces intracellular sodium accumulation and consequently decreases intracellular calcium overload.
Danish: Dermed reduceres den intracellulære natriumakkumulation og som følge heraf falder det intracellulære calcium-overload.
English: When the submission of a PSUR and the update of a RMP coincide, they should be submitted at the same time.
Danish: Hvis tidsfristen for en periodisk, opdateret sikkerhedsindberetning (PSUR) og for opdatering af en RMP er sammenfaldende, kan de fremsendes samtidig.
English: Absorption: The mean absolute bioavailability of ranolazine after oral administration of immediaterelease ranolazine tablets ranged from 35−50%, with large inter-individual variability.
Danish: Absorption: Ranolazins gennemsnitlige absolutte biotilgængelighed efter oral administration af ranolazin-tabletter med øjeblikkelig frigivelse var 35-50 % med store interindividuelle forskelle.
English: Grapefruit juice is also a potent CYP3A4 inhibitor.
Danish: Grapefrugtjuice er også en potent CYP3A4-hæmmer.
English: In this long term study, acute renal failure was also reported with an incidence less than 1% in placebo and ranolazine patients.
Danish: Under dette langtidsforsøg blev der også indberettet akut nyresvigt med en incidens på mindre end 1 % hos patienter, der fik placebo eller ranolazin.
English: QT prolongation: Ranolazine blocks IKr and prolongs the QTc interval in a dose-related manner.
Danish: QT-forlængelse: Ranolazin blokerer IKr og forlænger QTc-intervallet på en dosisrelateret måde.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Danish: Ranexa kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Post-natal mortality of pups was not recorded when the exposure of nursing mothers was 1.3 fold higher than in expected humans, whereas at 3-fold higher exposure post-natal mortality was recorded, concomitant with evidence of milk excretion of ranolazine in rats.
Danish: Ungernes postnatale mortalitet blev ikke registreret, når eksponeringen for diegivende mødre var 1,3 gange højere end forventet hos mennesker, hvorimod der ved en 3 gange så stor eksponering blev registreret postnatal mortalitet samtidigt med bevis på udskillelse af ranolazin i mælken hos rotter.
English: Breast-feeding: It is unknown whether ranolazine is excreted in human breast milk.
Danish: Amning: Det vides ikke, om ranolazin udskilles i human brystmælk.
English: Ranexa is a medicine used in combination with other medicines to treat angina pectoris, which is a chest pain or discomfort that you feel anywhere along the upper part of your body between your neck and upper abdomen, often brought on by exercise or too much activity.
Danish: Ranexa er en medicin, der bruges i kombination med anden medicin til behandling af angina pectoris, som er brystsmerter eller ubehag et hvilket som helst sted i den øverste del af kroppen mellem halsen og maven, og som ofte udløses af træning eller for megen aktivitet.
English: Adverse reactions not observed in clinical studies, but seen in animals at levels similar to clinical exposure, were as follows: 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.
Danish: Bivirkninger, der ikke blev set i de kliniske forsøg, men i dyreforsøg ved doser svarende til den kliniske eksponering, var som følger: Ranolazin blev forbundet med kramper og øget mortalitet hos rotter og hunde ved plasmakoncentrationer, der var ca. 3 gange højere end ved den foreslåede maksimale kliniske dosis.
English: Ranexa is supplied in cartons containing 30, 60, or 100 tablets in blister strips or 60 tablets in plastic bottles.
Danish: Ranexa fås i æsker med 30, 60 eller 100 tabletter i blisterstrips eller 60 tabletter i plasticflasker.
English: In a second study, ERICA, Ranexa was added to treatment with amlodipine 10 mg once daily (the maximum labelled dose).
Danish: I et andet forsøg, ERICA, blev Ranexa givet sammen med amlodipin 10 mg én gang dagligt (den maksimale godkendte dosis).
English: This colouring agent- may cause allergic reactions.
Danish: Dette farvestof kan give overfølsomhedsreaktioner.
English: LIST OF EXCIPIENTS Contains colouring agent E102 and lactose; see package leaflet for further information.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder farvestof E 102 og lactose: Se indlægssedlen for yderligere oplysninger.
English: България “Берлин-Хеми/А.
Danish: “Берлин-Хеми/А.
English: Digoxin: An increase in plasma digoxin concentrations by an average of 1.5-fold has been reported when Ranexa and digoxin are co-administered.
Danish: Digoxin: Der er rapporteret om en stigning i plasmakoncentrationen af digoxin på gennemsnitligt 1,5 gange, når Ranexa og digoxin er blevet administreret samtidigt.
English: Tolerance to ranolazine did not develop during treatment and a rebound increase in angina attacks was not observed following abrupt discontinuation.
Danish: 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.
English: If you get any any side effects talk to your doctor or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge eller apoteket.
English: Effects of other medicinal products on ranolazine
Danish: Andre lægemidlers indvirkning på ranolazin
English: Embryofetal toxicity studies were conducted in rats and rabbits: no effect were noted in rabbit fetuses when mothers were exposed at levels (AUC) of plasma ranolazine similar to expected human levels.
Danish: Der er gennemført embryo-/føtotoksicitetsstudier med rotter og kaniner: Der blev ikke bemærket nogen effekt hos kaninfostre, hvis mødre havde været eksponeret for niveauer (AUC) af plasmakoncentrationer for ranolazin svarende til de forventede niveauer for mennesker.
English: Both the average number of angina attacks and nitroglycerin tablets consumed decreased by approximately one per week.
Danish: Såvel det gennemsnitlige antal angina-anfald som forbruget af nitroglycerin-tabletter faldt med ca. ét anfald/én tablet pr. uge.
English: C]-ranolazine to healthy subjects, 73% of the radioactivity was recovered in urine and 25% in faeces.
Danish: C]-ranolazin til raske forsøgspersoner blev 73 % af radioaktiviteten udskilt i urin og 25 % i fæces.
English: Chronic toxicity studies in rats indicated that treatment was associated with adrenal changes at exposures slightly greater than those seen in clinical patients.
Danish: Forsøg med kronisk toksicitet hos rotter tydede på, at behandlingen var forbundet med binyreforandringer ved en eksponering, der var en lille smule højere end den, der fandtes hos patienterne.
English: The above precautions are based on the risk in a CYP2D6 PM patient, and are needed when the CYP2D6 status is unknown.
Danish: De ovennævnte forholdsregler er baseret på en CYP2D6 PM-patient og skal følges, når CYP2D6-status ikke kendes.
English: 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 ΔKPQ gene mutation).
Danish: 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 relaksation i et åbent forsøg med 5 patienter med langt QT-syndrom (LQT3 med SCN5A ΔKPQ-genmutationen).
English: A large number of metabolites has been identified in human plasma (47 metabolites), urine (> 100 metabolites), and faeces (25 metabolites).
Danish: Et stort antal metabolitter er blevet identificeret i humant plasma (47 metabolitter), urin (> 100 metabolitter) og fæces (25 metabolitter).
English: These doses are equivalent to 0.1 and 0.8 times, respectively, the maximum recommended human dose of 2 grams on a mg/m basis, and represent the maximum tolerated doses in these species.
Danish: Disse doser svarer til hhv. 0,1 og 0,8 gange den maksimale anbefalede humane dosis på 2 g baseret på mg/m og er den maksimalt tolererede dosis hos disse arter.
English: • swollen face, tongue, or throat
Danish: • hævelser i ansigt, tunge eller svælg
English: Body weight: Compared to subjects weighing 70 kg, exposure was estimated to be about 1.4-fold higher in subjects weighing 40 kg.
Danish: Kropsvægt: Eksponeringen hos forsøgspersoner med en kropsvægt på 40 kg vurderedes at være ca. 1,4 gange højere end hos forsøgspersoner med en kropsvægt på 70 kg.
English: This reduction in cellular calcium overload is expected to improve myocardial relaxation and thereby decrease left ventricular diastolic stiffness.
Danish: Reduktionen i cellulært calcium-overload forventes at forbedre den myokardielle relaksation og derigennem mindske den venstre ventrikels diastoliske dysfunktion.
English: Laboratory findings: Small, clinically insignificant, reversible elevations in serum creatinine levels have been observed in healthy subjects and patients treated with Ranexa.
Danish: Laboratoriefund: Små, klinisk ubetydelige, reversible forhøjelser i serumkreatininniveauet er observeret hos raske forsøgspersoner og patienter, der er behandlet med Ranexa.
English: In rats, no effects in fetuses was noted when mothers were exposed to 2-fold greater levels (AUC) than expected in humans, whereas decreased fetal weight and reduced ossification were observed when the exposure of mothers was 7.5-fold than those obtained in humans.
Danish: Hos rotter blev der ikke bemærket nogen effekt hos fostre, når mødrene blev eksponeret for dobbelt så store niveauer (AUC) som forventet for mennesker, hvorimod der blev observeret lavere føtal vægt og nedsat ossificering, hvis mødrenes eksponering var 7,5 gange så stor som den, der blev opnået hos mennesker.
English: The results showed that exercise duration was 31 seconds longer in ranolazine patients versus placebo patients (p = 0.002).
Danish: Resultaterne viste, at arbejdsvarigheden var 31 sekunder længere hos ranolazin-patienterne sammenlignet med placebopatienterne (p = 0,002).
English: Ranolazine may have some antianginal effects by inhibition of the late sodium current in cardiac cells.
Danish: Ranolazin kan have nogen antianginøs virkning gennem hæmning af den sene natriumstrøm i hjerteceller.
English: Following oral administration of a single 500 mg dose of
Danish: Efter oral administration af en enkeltdosis på 500 mg [
English: The starting dose for adults is one 375 mg tablet twice a day.
Danish: Startdosis for voksne er én 375 mg tablet to gange dagligt.
English: Concomitant treatment with ketoconazole 200 mg twice daily increased the AUC of ranolazine by 3.0- to 3.9-fold during ranolazine treatment.
Danish: Samtidig behandling med ketoconazol 200 mg to gange dagligt fik ranolazins AUC til at stige 3,0-3,9 gange under ranolazinbehandlingen.
English: After 2-4 weeks, the dose should be titrated to 500 mg twice daily and, according to the patient's response, further titrated to a recommended maximum dose of 750 mg twice daily (see section 5.1).
Danish: Efter 2-4 uger bør dosis titreres til 500 mg to gange dagligt, og afhængigt af patientens respons kan der titreres op til en anbefalet maksimal dosis på 750 mg to gange dagligt (se pkt.
English: These medicines may cause an increase in the number of side effects, such as dizziness, nausea, or vomiting, which are possible side effects of Ranexa (see section 4).
Danish: Disse midler vil kunne medføre, at du får flere bivirkninger såsom svimmelhed, kvalme eller opkastning, som er mulige bivirkninger ved Ranexa (se pkt.
English: In vitro studies using human liver microsomes indicate that ranolazine is metabolised primarily by CYP3A4, but also by CYP2D6.
Danish: In vitro-forsøg med humane levermikrosomer tyder på, at ranolazin primært metaboliseres gennem CYP3A4, men også gennem CYP2D6.
English: Methacrylic acid-ethyl acrylate copolymer (1:1) Microcrystalline cellulose
Danish: Methacrylsyre-ethylacrylatcopolymer (1:1) Mikrokrystallinsk cellulose Natriumhydroxid
English: Low level of sodium in the blood (hyponatremia) which can cause tiredness and confusion, muscle twitching, cramps, and coma.
Danish: Lavt natriumindhold i blodet (hyponatriæmi), hvilket kan medføre træthed og forvirring, muskeltrækinger, kramper og koma
English: Ranolazine is a substrate for P-gp.
Danish: Ranolazin er et substrat for P-glykoprotein.
English: Swallow whole.
Danish: Synkes hele.
English: Clearance of ranolazine is dose-dependent, decreasing with increased dose.
Danish: Ranolazinclearance er dosisafhængig og falder med stigende doser.
English: CYP3A4 inducers: Rifampicin (600 mg once daily) decreases ranolazine steady-state concentrations by approximately 95%.
Danish: CYP3A4-induktorer: Rifampicin (600 mg én gang dagligt) nedsætter steady state-koncentrationen af ranolazin med ca. 95 %.
English: The potential for dose-related adverse events (e.g. nausea, dizziness) may also increase with increased plasma concentrations.
Danish: Incidensen af dosisrelaterede bivirkninger, f.eks. kvalme og svimmelhed, kan også stige med øget plasmakoncentration.
English: 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.
Danish: 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.
English: There was a large inter-individual variability in AUC in subjects with renal impairment.
Danish: Der var en stor interindividuel forskel i AUC hos forsøgspersoner med nedsat nyrefunktion.
English: A renal function study in healthy volunteers demonstrated a reduction in creatinine clearance with no change in glomerular filtration rate consistent with inhibition of renal tubular secretion of creatinine.
Danish: I en undersøgelse af nyrefunktionen hos raske frivillige forsøgspersoner blev der konstateret en reduktion af kreatininclearance uden ændring af den glomerulære filtrationshastighed svarende til hæmningen af kreatininudskillelse gennem nyretubuli.
English: 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.
Danish: 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.
English: Low weight: The incidence of adverse events was higher in patients with low weight (≤ 60 kg).
Danish: Patienter med lav kropsvægt: Bivirkningsincidensen var højere hos patienter med en lav kropsvægt (≤ 60 kg).
English: This is also recommended for other CYP3A4 substrates with a narrow therapeutic range (e.g., ciclosporin, sirolimus, everolimus).
Danish: Dette anbefales ligeledes for andre CYP3A4-substrater med et snævert terapeutisk indeks (f.eks. ciclosporin, sirolimus, everolimus).
English: - certain medicines to treat high levels of cholesterol in the blood (e.g. simvastatin, lovastatin, atorvastatin).
Danish: - visse former for medicin mod forhøjet kolesterol i blodet (f.eks. simvastatin, lovastatin, atorvastatin).
English: Drug-drug interactions: Co-administration with CYP3A4 inducers is expected to lead to lack of efficacy.
Danish: Interaktion med andre lægemidler: Samtidig administration af CYP3A4-induktorer forventes at føre til manglende virkning.
English: In addition to these adverse events, diplopia, lethargy, and syncope were observed in an intravenous overdose study in healthy volunteers.
Danish: Ud over disse bivirkninger observeredes der diplopi, letargi og synkope i et forsøg med en intravenøs overdosis hos raske frivillige forsøgspersoner.
English: Your doctor may decide to change the dose of this medicine while you are taking Ranexa.
Danish: Lægen vil måske ændre dosis af dette lægemiddel, så længe du tager Ranexa.
English: Rare: pancreatitis, erosive duodenitis, oral hypoaesthesia.
Danish: Sjælden: pankreatitis, erosiv duodenitis, oral hypæstesi.
English: The AUC of metabolites increased with decreased renal function.
Danish: AUC for metabolitterne steg med nedsat nyrefunktion.
English: 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).
Danish: Risikoen for øget eksponering, der medfører bivirkninger i disse undergrupper, er højere hos patienter med manglende CYP2D6-aktivitet (de såkaldte poor metabolisers, PM) end hos patienter med kapacitet til at metabolisere CYP2D6 (de såkaldte extensive metabolisers, EM) (se pkt.
English: In healthy young adults, ranolazine accounts for approximately 13% of the radioactivity in plasma following a single oral 500 mg dose of [
Danish: Hos raske yngre voksne stod ranolazin for ca. 13 % af radioaktiviteten i plasma efter en enkelt, oral dosis på 500 mg
English: It is important that you tell your doctor if you get side effects such as dizziness or feeling or being sick.
Danish: Det er vigtigt, at du fortæller det til din læge, hvis du får bivirkninger såsom svimmelhed, kvalme eller opkastning.
English: Ask your doctor for advice about driving or using machines.
Danish: Spørg din læge til råds, før du kører bil eller motorcykel, cykler eller arbejder med værktøj eller maskiner.
English: 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.
Danish: I et farmakokinetisk forsøg med raske frivillige forsøgspersoner var steady state Cmax i gennemsnit ca. 1.770 ng/ml (SD 1.040), og steady state AUC0-12 var i gennemsnit 13.700 ng x timer/ml (SD 8.290) efter en dosis på 500 mg to gange dagligt.
English: However, the elderly may have increased ranolazine exposure due to age-related decrease in renal function.
Danish: Ældre kan imidlertid have en øget eksponering for ranolazin på grund af aldersrelateret nedsat nyrefunktion.
English: Rare: hyponatremia
Danish: Sjælden: hyponatriæmi.
English: Tell your doctor or pharmacist before you take Ranexa if you use: - certain medicines to treat a bacterial infection (erythromycin), or a fungal infection (fluconazole), a medicine used to prevent rejection of a transplanted organ (ciclosporin), or if you are taking some heart tablets such as diltiazem or verapamil.
Danish: Fortæl det til din læge eller på apoteket, før du tager Ranexa, hvis du tager: - visse former for medicin, der bruges til behandling af bakterielle infektioner (erythromycin) eller svampeinfektioner (fluconazol), medicin, der skal forebygge afstødning af et transplanteret organ (ciclosporin), eller hvis du tager visse hjertetabletter såsom diltiazem eller verapamil.
English: There was a significantly lower incidence of arrhythmias in patients treated with Ranexa (80%) versus placebo (87%), including ventricular tachycardia ≥ 8 beats (5% versus 8%).
Danish: Der var en signifikant lavere forekomst af arytmier hos patienter i behandling med Ranexa (80 %) sammenlignet med placebo (87 %), herunder ventrikulær takykardi ≥ 8 slag (5 % mod 8 %).
English: 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.
Danish: Ranexa medførte signifikante fald i antallet af angina-anfald pr. uge (p = 0,028) og i forbruget af hurtigvirkende nitroglycerin (p = 0,014) sammenlignet med placebo.
English: - certain medicines to treat depression (bupropion), psychosis, HIV infection (efavirenz), or cancer (cyclophosphamide).
Danish: - visse former for medicin, der bruges til behandling af depression (bupropion), psykose, hivinfektion (efavirenz) eller kræft (cyclophosphamid).
English: • hives or difficulty breathing
Danish: • nældefeber eller vejrtrækningsbesvær
English: 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.
Danish: 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.
English: Tell your doctor if you experience common side effects such as dizziness or feeling sick or vomiting.
Danish: Fortæl din læge, hvis du oplever almindelige bivirkninger såsom svimmelhed, kvalme eller opkastning.
English: There is a lower need for precautions in patients with CYP2D6 EM status.
Danish: Behovet for at følge forholdsreglerne er mindre hos patienter med CYP2D6 EM-status.
English: In a phase 3, double-blind, placebo-controlled, event-driven trial (RIVER-PCI) in 2604 patients aged ≥18 years with a history of chronic angina and incomplete revascularisation after percutaneous coronary intervention (PCI) patients were up-titrated to 1000 mg twice daily (dosage not approved in the current SmPC).
Danish: I et fase 3, dobbeltblindet, placebokontrolleret, hændelsesbaseret forsøg (RIVER-PCI) omfattende 2604 patienter i alderen ≥18 år med kronisk angina og ufuldstændig revaskularisering efter perkutan koronar intervention (PCI) blev patienterne optitreret til 1000 mg to gange dagligt (en dosis, der ikke er godkendt i det gældende produktresumé).
English: - certain medicines used to prevent transplanted organ rejection (e.g. tacrolimus, ciclosporin, sirolimus, everolimus) as your doctor may decide to change the dose of this medicine while you are taking Ranexa.
Danish: - visse former for medicin, der hindrer afstødning af et transplanteret organ (f.eks. tacrolimus, ciclosporin, sirolimus, everolimus), da lægen måske vil ændre dosis af dette middel, så længe du tager Ranexa.