FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 4.
Danish: Tabel 3.
English: Myopathy, back pain
Danish: Myopati, rygsmerter
English: EU/1/10/615/006
Danish: EU/1/10/615/005 EU/1/10/615/006
English: • tiredness
Danish: • forstoppelse
English: EU/1/10/615/034
Danish: EU/1/10/615/033 EU/1/10/615/034
English: Gastrointestinal disorders Very common:
Danish: Mave-tarmkanalen Meget almindelig:
English: PHARMACEUTICAL FORM AND CONTENTS
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING
English: EU/1/10/615/018
Danish: EU/1/10/615/017 EU/1/10/615/018
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 250 mg temozolomide.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hårde kapsel indeholder 250 mg temozolomid.
English: MA (EU) Number (Invented) name Strength Pharmaceutical Form Route of Administration
Danish: Handelsnavn Styrke Lægemiddel-form Indgivelsesvej Emballage
English: You may need to read it again.
Danish: Du kan få brug for at læse dem igen.
English: - if you are elderly.
Danish: - hvis du er ældre.
English: No similar changes have been identified in humans.
Danish: Der er ikke fundet lignende forandringer i mennesker.
English: After 2−4 weeks, your doctor may increase the dose to get the right effect.
Danish: Efter 2-4 uger kan din læge eventuelt sætte dosis op for at opnå den rette virkning.
English: QT prolongation was more pronounced in these patients.
Danish: QT-forlængelse var mere udtalt hos disse patienter.
English: Not all pack-sizes may be marketed.
Danish: Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: Do not chew.
Danish: Må ikke tygges.
English: Germany or
Danish: Tyskland eller
English: If you forget to take a dose, take it as soon as you remember unless it is nearly time (less than 6 hours) to take your next dose.
Danish: Hvis du har glemt at tage en dosis, skal du tage den, så snart du kommer i tanke om det, medmindre det er lige ved at være tid til den næste dosis (mindre end 6 timer).
English: An updated RMP shall be submitted every three years.
Danish: En opdateret RMP skal fremsendes hvert tredje år.
English: Other side effects you may experience include the following:
Danish: Andre bivirkninger, som du kan opleve, er:
English: No data are available
Danish: Der foreligger ingen data.
English: 24041 Brembate (BG) Italy or
Danish: 24041 Brembate (BG) Italien eller
English: In patients with a combination of these factors, additional exposure increases are expected.
Danish: Hos patienter med en kombination af disse faktorer forventes der yderligere stigninger i eksponering.
English: - if you have ever had an abnormal electrocardiogram (ECG).
Danish: - hvis du tidligere har haft et unormalt elektrokardiogram (EKG).
English: Use in children and adolescents Children and adolescents under 18 years old should not take Ranexa.
Danish: Brug til børn og unge Børn og unge under 18 år bør ikke tage Ranexa.
English: Dosedependent side effects are likely to occur.
Danish: Dosisafhængige bivirkninger vil sandsynligvis forekomme.
English: Blister pack: 5 years Bottle pack: 4 years
Danish: Blisterpakning: 5 år Flaske: 4 år
English: While being treated with Ranexa, you should not drink grapefruit juice.
Danish: Mens du bliver behandlet med Ranexa, bør du ikke drikke grapefrugtjuice.
English: Do not use this medicine after the expiry date which is stated on each blister strip of tablets and on the outside of the carton and bottle after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på hver blisterstrip og uden på æsken og flasken efter EXP.
English: 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.
Danish: 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.
English: Depending on the tablet strength, the tablet coatings also contain:
Danish: Afhængig af tablettens styrke indeholder overtrækket også:
English: Steady state is generally achieved within 3 days of twice-daily dosing.
Danish: Steady state opnås generelt inden for 3 dage ved to daglige doser.
English: Fourteen primary pathways have been identified of which O-demethylation and N-dealkylation are the most important.
Danish: Der er identificeret 14 primære reaktionsmekanismer, hvoraf O-demethylering og N-dealkylering er de vigtigste.
English: Decreased or loss of consciousness
Danish: Fald i eller tab af bevidsthed
English: Lactose: This medicinal product contains lactose.
Danish: Laktose: Dette lægemiddel indeholder laktose.
English: In the event of overdose, the patient should be closely monitored and the treatment should be symptomatic and supportive.
Danish: I tilfælde af overdosis bør patienten følges nøje, og behandlingen bør være symptomatisk og understøttende.
English: The elimination half-life is about 2−3 hours after intravenous administration.
Danish: Halveringstiden er ca. 2-3 timer efter intravenøs administration.
English: Less than 5% of the dose is excreted unchanged in the urine and faeces.
Danish: Mindre end 5 % af dosis udskilles uforandret i urin og fæces.
English: Feeling of coldness in hands and legs
Danish: Kuldefølelse i hænder og ben
English: These medicines may cause muscle pain and muscle injury.
Danish: Disse lægemidler kan give muskelsmerter og muskelskader.
English: If you accidentally take too many Ranexa tablets or take a higher dose than recommended by your doctor, it is important that you tell your doctor at once.
Danish: Hvis du kommer til at tage for mange Ranexa-tabletter, eller hvis du tager en højere dosis end den, din læge har ordineret, er det vigtigt, at du fortæller det til din læge med det samme.
English: If you cannot contact your doctor, go to the nearest accident and emergency department.
Danish: Hvis du ikke kan komme i kontakt med din læge, skal du tage til den nærmeste skadestue.
English: The adverse events, considered to be at least possibly related to treatment, are listed below by body system, organ class, and absolute frequency.
Danish: De bivirkninger, der blev vurderet til i hvert fald muligvis at være relateret til behandlingen, er kategoriseret nedenfor efter kropssystem, organklasse og absolut hyppighed.
English: Ranexa should not be used during pregnancy unless clearly necessary.
Danish: Ranexa bør ikke anvendes under graviditet, medmindre det er klart nødvendigt.
English: The potential for inhibition of CYP2B6 has not been evaluated.
Danish: Potentialet for hæmning af CYP2B6 er ikke blevet evalueret.
English: Always swallow the tablets whole with water.
Danish: Tabletterne skal synkes hele sammen med vand.
English: The mean steady-state volume of distribution (Vss) is about 180 l.
Danish: Det gennemsnitlige steady state-fordelingsvolumen (Vss) er ca. 180 l.
English: Ranexa tablets should be swallowed whole and not crushed, broken, or chewed.
Danish: Ranexa-tabletter bør synkes hele og må ikke knuses, brækkes eller tygges.
English: Hot flushes, low blood pressure
Danish: Hedeture, lavt blodtryk
English: This effect is associated with increased plasma cholesterol concentrations.
Danish: Denne virkning er forbundet med en øget koncentration af plasmakolesterol.
English: If symptoms do not resolve after dose reduction, treatment should be discontinued.
Danish: Hvis symptomerne ikke forsvinder efter dosisreduktion, bør behandlingen seponeres.
English: These effects do not depend upon changes in heart rate, blood pressure, or vasodilation.
Danish: Denne virkning afhænger ikke af ændringer i hjertefrekvens, blodtryk eller vasodilatation.
English: Additionally, 45% of the study population also received long-acting nitrates.
Danish: Derudover behandledes 45 % af forsøgspopulationen med langtidsvirkende nitrater.
English: 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).
Danish: 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).
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: You must talk to a doctor if you do not feel better or if you feel worse.
Danish: Kontakt lægen, hvis du får det værre, eller hvis du ikke får det bedre.
English: Titanium dioxide
Danish: Titaniumdioxid
English: Do not crush, suck, or chew the tablets or break them in half, as this might affect the way the medicine is released from the tablets into your body.
Danish: Du må ikke knuse, sutte på eller tygge tabletterne, og du må heller ikke halvere dem, da dette kan påvirke måden, hvorpå medicinen frigives i kroppen.
English: If you experience these symptoms, do not drive or operate machinery until they have resolved completely.
Danish: Hvis du får nogle af disse symptomer, skal du undlade at køre eller betjene maskiner, indtil du er helt symptomfri.
English: SpA Via R. Follereau 25 24027 Nembro (BG) Italy
Danish: SpA Via R. Follereau 25 24027 Nembro (BG) Italien
English: You should stop taking Ranexa and see your doctor immediately if you experience the following symptoms of angioedema, which is a rare condition but can be severe:
Danish: Du skal holde op med at tage Ranexa og kontakte din læge øjeblikkeligt, hvis du oplever følgende symptomer på angioødem, der er en sjælden bivirkning, men som kan være alvorlig:
English: - if you have low weight (60 kg or less).
Danish: - hvis din kropsvægt er lav (60 kg eller derunder).
English: Elimination: Ranolazine is eliminated primarily by metabolism.
Danish: Elimination: Ranolazin elimineres primært ved metabolisme.
English: Rare: disorientation.
Danish: Sjælden: desorientering.
English: C]-ranolazine.
Danish: [14C]-ranolazin.
English: Ranexa with food and drink
Danish: Brug af Ranexa sammen med mad og drikke
English: 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.
Danish: 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.
English: Take along any tablets that are left, including the container and the carton, so that the hospital staff can easily tell what you have taken.
Danish: Medbring alle de resterende tabletter, tabletbeholderen og æsken, så personalet på hospitalet nemt kan se, hvad du har taget.
English: The exposure of other OCT2 substrates, including but not limited to pindolol and varenicline, may be affected to a similar degree.
Danish: Eksponeringen for andre OCT2-substrater inklusive, men ikke begrænset til, pindolol og vareniclin, kan blive påvirket tilsvarende.
English: Approximately one-half of the patients in MERLIN-TIMI 36 had a history of angina.
Danish: Ca. halvdelen af patienterne i MERLIN-TIMI 36 havde en anamnese med angina.
English: Food does not affect the rate and extent of absorption of ranolazine.
Danish: Indtagelse af mad har ingen indvirkning på hastigheden og omfanget af absorptionen af ranolazin.
English: Ask your doctor for advice if you are breastfeeding.
Danish: Spørg din læge til råds, hvis du ammer.
English: However, there was no difference in exercise duration between the two doses (24 seconds compared to placebo; p ≤ 0.03).
Danish: Der var imidlertid ingen forskel i arbejdsvarighed mellem de to doser (24 sekunder sammenlignet med placebo; p ≤ 0,03).
English: Abnormal laboratory values for liver
Danish: Unormale laboratorieværdier for levertal
English: Ranexa exposure increases more than in proportion to dose.
Danish: Eksponering for Ranexa øges mere end proportionalt med dosis.
English: Менарини България” ЕООД тел.
Danish: Менарини България” ЕООД
English: Ranexa can be taken with or without food.
Danish: Ranexa kan tages sammen med eller uden mad.
English: There was no renal toxicity related to these findings.
Danish: Der blev ikke konstateret nogen renal toksicitet i forbindelse med disse fund.
English: Therefore, digoxin levels should be monitored following initiation and termination of Ranexa therapy.
Danish: Digoxin-niveauet bør derfor følges nøje efter opstart og afslutning af behandling med Ranexa.
English: Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany or
Danish: Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Tyskland eller
English: No adverse effects on newborn rats were observed at levels of exposures similar to those observed in humans.
Danish: Der blev ikke observeret bivirkninger hos nyfødte rotter ved eksponeringsniveauer svarende til dem, der er observeret hos mennesker.
English: Pregnancy: There are limited amount of data from the use of ranolazine in pregnant women.
Danish: Graviditet: Der er utilstrækkelige data fra anvendelse af ranolazin til gravide kvinder.
English: - if you have heart failure.
Danish: - hvis du lider af hjertesvigt.
English: Your doctor may decide to give you a lower dose.
Danish: Din læge kan beslutte at nedsætte din dosis.
English: Pregnancy You should not take Ranexa if you are pregnant unless your doctor has advised you to do so.
Danish: Graviditet Du bør ikke tage Ranexa, hvis du er gravid, medmindre din læge har anvist det.
English: Date of last renewal: 06 March 2013
Danish: Dato for første markedsføringstilladelse: 9. juli 2008 Dato for sidste fornyelse: 6. marts 2013
English: Always take this medicine exactly as your doctor has told you to.
Danish: Tag altid dette lægemiddel nøjagtigt efter lægens anvisning.
English: The terminal half-life at steady state after oral administration of ranolazine is about 7 hours, due to the absorption rate-limited elimination.
Danish: Den terminale halveringstid ved steady state efter oral administration af ranolazin er ca. 7 timer, da eliminationen begrænses af absorptionshastigheden.
English: Elderly patients: Age alone had no clinically relevant effect on pharmacokinetic parameters.
Danish: Ældre patienter: Alder alene havde ingen klinisk relevant indvirkning på de farmakokinetiske parametre.
English: Fertility: In animals, reproduction studies indicated no adverse effects on fertility (see section 5.3).
Danish: Fertilitet: Reproduktionsstudier hos dyr indikerede ikke skadelige virkninger på fertiliteten (se pkt.
English: Decrease in blood pressure upon standing
Danish: Fald i blodtrykket, når man rejser sig op
English: Azo colouring agent E102: This medicinal product contains the azo colouring agent E102 which may cause allergic reactions.
Danish: Azo farvestof E102: Dette lægemiddel indeholder azo farvestoffet E102, som kan medføre allergiske reaktioner.
English: Do not take Ranexa - if you are allergic to ranolazine or any of the other ingredients of this medicine listed in section 6 of this leaflet.
Danish: Tag ikke Ranexa - hvis du er allergisk over for ranolazin eller et af de øvrige indholdsstoffer i Ranexa angivet i punkt 6.
English: Mechanism of action: The mechanism of action of ranolazine is largely unknown.
Danish: Virkningsmekanisme: Ranolazins virkningsmekanisme er overvejende ukendt.
English: Package leaflet: Information for the patient
Danish: Indlægsseddel: information til brugeren
English: Loss of appetite and/or weight loss
Danish: Appetitløshed og/eller vægttab
English: If Ranexa is used in patients with a combination of several of these factors, monitoring of adverse events should be frequent, the dose reduced, and treatment discontinued, if needed.
Danish: Hvis Ranexa anvendes hos patienter med en kombination af flere af disse faktorer, bør monitoreringen af bivirkninger være hyppig, dosis bør reduceres, og behandlingen bør om nødvendigt seponeres.
English: Undesirable effects in patients receiving Ranexa are generally mild to moderate in severity and often develop within the first 2 weeks of treatment.
Danish: Bivirkninger hos patienter, der behandles med Ranexa, er normalt milde til moderate og optræder ofte i de første to uger af behandlingen.
English: Reproductive system and breast disorders Rare: erectile dysfunction.
Danish: Det reproduktive system og mammae Sjælden: erektil dysfunktion.
English: These were reported during the Phase 3 clinical development programme, which included a total of 1,030 chronic angina patients treated with Ranexa.
Danish: De blev indberettet i løbet af det kliniske fase 3udviklingsprogram, der omfattede 1.030 patienter med kronisk angina pectoris, der blev behandlet med Ranexa.
English: No studies on the effects of Ranexa on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget undersøgelser af virkningen af Ranexa på evnen til at føre motorkøretøj eller betjene maskiner.
English: Effects of ranolazine on other medicinal products
Danish: Ranolazins indvirkning på andre lægemidler
English: In the main dose-finding study, MARISA, ranolazine was used as monotherapy.
Danish: I det primære doseringsforsøg, MARISA, blev ranolazin anvendt som monoterapi.
English: The safety and efficacy of Ranexa in children below the age of 18 years have not been established.
Danish: Ranexas sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: Gender effects: Gender had no clinically relevant effect on pharmacokinetic parameters.
Danish: Køn: Kønnet havde ingen klinisk relevant indvirkning på de farmakokinetiske parametre.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For oral use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Indtagelse gennem munden.
English: It is recommended that tacrolimus blood levels are monitored when co-administering Ranexa and tacrolimus and that tacrolimus dosage is adjusted accordingly.
Danish: Det anbefales at monitorere tacrolimuskoncentrationen i blodet ved samtidig administration af Ranexa og tacrolimus og at justere tacrolimusdosis i henhold hertil.
English: Detailed information on this medicine is available on the European Medicines Agency web site http://www.ema.europa.eu.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: - heart medicines containing digoxin or metoprolol, as your doctor may want to change the dose of this medicine whilst you are taking Ranexa.
Danish: - hjertemedicin, der indeholder digoxin eller metoprolol, da din læge muligvis vil ønske at ændre doseringen af denne medicin, mens du tager Ranexa.
English: This include any possible side effects not listed in this leaflet.
Danish: Dette gælder også mulige bivirkninger, som ikke er medtaget i denne indlægsseddel.
English: Caution should be exercised when prescribing or uptitrating ranolazine to patients in whom an increased exposure is expected:
Danish: Det tilrådes at være forsigtig ved ordination eller optitrering af ranolazin til patienter, hos hvem der forventes en øget eksponering:
English: The adverse event profile was generally similar in the MERLIN-TIMI 36 study.
Danish: Bivirkningsprofilen var overvejende den samme i MERLIN-TIMI 36-forsøget.
English: Pharmacotherapeutic group: Other cardiac preparations, ATC code: C01EB18
Danish: Farmakoterapeutisk klassifikation: Andre hjertemidler, ATC-kode: C01EB18
English: Biotransformation: Ranolazine undergoes rapid and extensive metabolism.
Danish: Biotransformation: Ranolazin gennemgår en hurtig og omfattende metabolisme.
English: Carton containing blister strips or carton containing HDPE bottle and bottle label.
Danish: Æske indeholdende blisterstrips eller æske indeholdende en HDPE flaske samt etiket.
English: In male and female rats, oral administration of ranolazine that produced exposures (AUC) 3.6-fold or 6.6-fold higher than expected in humans, respectively, had no effect on fertility.
Danish: Hos han- og hunrotter havde oral administration af ranolazin, der resulterede i eksponeringer (AUC) henholdsvis 3,6 og 6,6 gange højere end forventet hos mennesker, ikke nogen effekt på fertiliteten.
English: No dose adjustment is required.
Danish: Det er ikke nødvendigt at justere dosis.
English: Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Paediatric population: The pharmacokinetic parameters of ranolazine have not been studied in the paediatric population (< 18 years).
Danish: Pædiatrisk population: Ranolazins farmakokinetik er ikke blevet undersøgt i den pædiatriske population (< 18 år).
English: If you forget to take Ranexa
Danish: Hvis du har glemt at tage Ranexa
English: If a patient experiences treatment-related adverse events (e.g. dizziness, nausea, or vomiting), downtitration of Ranexa to 500 mg or 375 mg twice daily may be required.
Danish: 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.
English: 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.
Danish: 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.
English: No proarrhythmic effects were observed in 3,162 patients treated with Ranexa based on 7-day Holter monitoring in the MERLIN-TIMI 36 study.
Danish: 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.
English: Elderly, renal impairment, and low weight: 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.
Danish: Ældre og patienter med nedsat nyrefunktion eller lav vægt: 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.
English: Distribution: Approximately 62% of ranolazine is bound to plasma proteins, mainly alpha-1 acid glycoprotein and weakly to albumin.
Danish: Fordeling: Ca. 62 % af ranolazin er bundet til plasmaproteiner, især til alfa-1-syre-glykoprotein og svagt til albumin.
English: In long-term carcinogenicity studies at doses of ranolazine up to 50 mg/kg/day (150 mg/m 2/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.
Danish: I karcinogenicitetsforsøg over lang tid med ranolazindoser på op til 50 mg/kg/dag (150 mg/m hos mus og 150 mg/kg/dag (900 mg/m2/dag) hos rotter sås der ingen relevant stigning i forekomsten af tumor uanset type.
English: 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.
Danish: 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.
English: Your doctor may lower your dose or, if this is not sufficient, stop treatment with Ranexa.
Danish: Din læge vil eventuelt sætte din dosis ned eller, hvis dette ikke er tilstrækkeligt, afbryde behandlingen med Ranexa.
English: There are no data in patients with severe hepatic impairment.
Danish: Der foreligger ingen data for patienter med svært nedsat leverfunktion.