FrancophonIA/ELRC3.0 huggingface dataset:
English: 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 death (relative risk ranolazine:placebo 0.87), or the frequency of symptomatic documented arrhythmias (3.0% versus 3.1%) between Ranexa and placebo when added to standard medical therapy (including beta-blockers, calcium channel blockers, nitrates, anti-platelet agents, lipid-lowering medicinal products, and ACE inhibitors).
Danish: 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.
English: General disorders and administration site conditions Common: asthenia.
Danish: Almene symptomer og reaktioner på administrationsstedet Almindelig: asteni.
English: Hepatic impairment: The pharmacokinetics of ranolazine have been evaluated in patients with mild or moderate hepatic impairment.
Danish: Nedsat leverfunktion: Ranolazins farmakokinetik er blevet evalueret hos patienter med let til moderat nedsat leverfunktion.
English: Rhabdomyolysis has been associated with high doses of simvastatin and cases of rhabdomyolysis have been observed in patients receiving Ranexa and simvastatin, in postmarketing experience.
Danish: Rabdomyolyse er sat i forbindelse med høje simvastatindoser, og efter markedsføring af Ranexa er der observeret tilfælde af rabdomyolyse hos patienter, der fik Ranexa og simvastatin.
English: Common: dizziness, headache.
Danish: Almindelig: svimmelhed, hovedpine.
English: Drugs transported by the Organic Cation Transporter-2 (OCT2): Plasma exposure of metformin (1000 mg twice daily) increased 1.4- and 1.8-fold in subjects with type 2 diabetes mellitus when coadministered with RANEXA 500 mg and 1000 mg twice daily respectively.
Danish: Lægemidler, der transporteres af organisk kationtransportør-2 (OCT2): Eksponeringen for metformin i plasma (1000 mg to gange dagligt) steg med henholdsvis faktor 1,4 og 1,8 hos forsøgspersoner med type 2-diabetes mellitus, når det blev administreret sammen med henholdsvis RANEXA 500 mg og 1000 mg to gange dagligt.
English: Ranexa 750 mg twice daily increased plasma concentrations of metoprolol by 1.8-fold.
Danish: Ranexa 750 mg to gange dagligt øgede plasmakoncentrationen af metoprolol med faktor 1,8.
English: 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 placebocorrected 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
Danish: Generelt var typen og hyppigheden af bivirkninger rapporteret hos patienter med en lav kropsvægt (≤ 60 kg) de samme som hos dem med en højere vægt (> 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 %).
English: - if you have severe kidney problems.
Danish: - hvis du har svære nyreproblemer.
English: Excipients for all ranolazine prolonged-release tablets: Carnauba wax
Danish: Hjælpestoffer for alle ranolazin-depottabletter: Carnaubavoks
English: Careful dose titration of Ranexa is recommended in patients treated with P-gp inhibitors.
Danish: Der anbefales at udvise forsigtighed ved dosistitrering af Ranexa hos patienter, der er i behandling med P-glykoproteinhæmmere.
English: 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).
Danish: I den farmakokinetiske populationsanalyse blev det skønnet, at ranolazineksponering hos forsøgspersoner med moderat nedsat nyrefunktion (kreatininclearance 40 ml/min) steg 1,2 gange.
English: Additional excipients for 750 mg tablet:
Danish: Øvrige hjælpestoffer i 750 mg-tabletter:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09 July 2008
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE / FORNYELSE AF TILLADELSEN
English: However, men and women had similar reductions in frequency of angina attacks and nitroglycerin consumption.
Danish: Reduktionen i hyppigheden af angina-anfald og nitroglycerin-forbruget var dog ens for både kvinder og mænd.
English: Renal impairment: 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).
Danish: Nedsat nyrefunktion: Nyrefunktionen mindskes med alderen, og det er derfor vigtigt at kontrollere nyrefunktionen regelmæssigt under behandling med ranolazin (se pkt.
English: Concomitant administration of potent CYP3A4 inhibitors is contraindicated (see sections 4.3 and 4.5).
Danish: Samtidig administration af potente CYP3A4-hæmmere er kontraindiceret (se pkt.
English: Metabolism and nutrition disorders Uncommon: anorexia, decreased appetite, dehydration.
Danish: Ikke almindelig: anoreksi, nedsat appetit, dehydrering.
English: Uncommon: dyspnoea, cough, epistaxis.
Danish: Ikke almindelig: dyspnø, hoste, epistaxis.
English: - medicines to treat epilepsy or another neurologic disorder (e.g. phenytoin, carbamazepine, or phenobarbital); are taking rifampicin for an infection (e.g. tuberculosis); or are taking the herbal remedy St. John's Wort, as these medicines may cause Ranexa to be less effective.
Danish: - medicin, der bruges til behandling af epilepsi eller andre neurologiske forstyrrelser (f.eks. phenytoin, carbamazepin eller phenobarbital), rifampicin til infektionsbehandling (f.eks. tuberkulose) eller naturlægemidlet prikbladet perikon, da disse former for medicin kan nedsætte virkningen af Ranexa.
English: Concomitant treatment with CYP3A4 and P-glycoprotein (P-gp) inhibitors: 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).
Danish: Samtidig behandling med CYP3A4- og P-glykoproteinhæmmere: Forsigtig dosistitrering anbefales hos patienter i behandling med moderate CYP3A4-hæmmere, f.eks. diltiazem, fluconazol og erythromycin, eller P-glykoproteinhæmmere, f.eks. verapamil og ciclosporin (se pkt.
English: Uncommon: lethargy, syncope, hypoaesthesia, somnolence, tremor, postural dizziness, paresthesia.
Danish: Ikke almindelig: letargi, synkope, hypæstesi, døsighed, tremor, postural svimmelhed, paræstesi.
English: The 375 mg tablets are pale blue and are engraved with 375 on one side.
Danish: 375 mg-tabletterne er lyseblå og præget med 375 på den ene side.
English: • Concomitant administration of moderate CYP3A4 inhibitors (see sections 4.2 and 4.5).
Danish: • Samtidig administration af moderate CYP3A4-hæmmere (se pkt.
English: • Mild to moderate renal impairment (creatinine clearance 30-80 ml/min) (see sections 4.2, 4.8,
Danish: • Let til moderat nedsat nyrefunktion (kreatininclearance 30-80 ml/min) (se pkt.
English: Ringing in the ears and/or feeling a spinning sensation Stomach pain or discomfort, indigestion, dry mouth, or wind
Danish: Ringen for ørerne og/eller følelse af at verden drejer rundt Mavepine eller ubehag i maven, let mave-tarm-ubehag efter måltiderne, tørhed i munden eller luft i maven.
English: Ranolazine, via its action to decrease the late sodium current, is considered to reduce these intracellular ionic imbalances during ischaemia.
Danish: Ranolazin menes at reducere disse intracellulære ion-ubalancer ved iskæmi qua dets evne til at reducere den sene natriumstrøm.
English: • Elderly (see sections 4.2, 4.8, and 5.2).
Danish: 4.2, 4.3, 4.8 og 5.2).
English: 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%).
Danish: 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 %).
English: Limit the dose of simvastatin to 20 mg once daily in patients taking any dose of Ranexa.
Danish: Simvastatindosis bør højst være 20 mg en gang dagligt hos disse patienter uanset Ranexadosis.
English: The influence of various factors on the pharmacokinetics of ranolazine was assessed in a population pharmacokinetic evaluation in 928 angina patients and healthy subjects.
Danish: I en farmakokinetisk populationsundersøgelse af 928 patienter med angina pectoris og raske forsøgspersoner vurderedes indflydelsen af forskellige faktorer på ranolazins farmakokinetik.
English: 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%).
Danish: 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 %).
English: Ranexa 375 mg prolonged-release tablets Ranexa 500 mg prolonged-release tablets Ranexa 750 mg prolonged-release tablets
Danish: Ranexa 375 mg depottabletter Ranexa 500 mg depottabletter Ranexa 750 mg depottabletter
English: Concomitant administration of Class Ia (e.g. quinidine) or Class III (e.g. dofetilide, sotalol) antiarrhythmics other than amiodarone.
Danish: Samtidig administration af antiarytmika af klasse Ia, f.eks. quinidin, eller klasse III, f.eks. dofetilid og sotalol, amiodaron dog undtaget.
English: Feeling swollen or bloated
Danish: Følelse af at være hævet eller oppustet
English: The 750 mg tablets are pale green and are engraved with 750 on one side.
Danish: 750 mg-tabletterne er lysegrønne og præget med 750 på den ene side.
English: Uncommon: anxiety, insomnia, confusional state, hallucination.
Danish: Ikke almindelig: angst, søvnløshed, konfusion, hallucinationer.
English: Talk to your doctor before taking Ranexa: - if you have mild or moderate kidney problems.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du tager Ranexa: - hvis du har lette til moderate nyreproblemer.
English: Renal impairment: 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).
Danish: Nedsat nyrefunktion: Forsigtig dosistitrering anbefales hos patienter med let til moderat nedsat nyrefunktion (kreatininclearance 30-80 ml/min) (se pkt.
English: 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,
Danish: 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.
English: 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).
Danish: 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).
English: Eye disorders Uncommon: blurred vision, visual disturbance, diplopia.
Danish: Øjne Ikke almindelig: sløret syn, synsforstyrrelse, diplopi.
English: - if you are using certain medicines to treat bacterial infections (clarithromycin, telithromycin), fungal infections (itraconazole, ketoconazole, voriconazol, posaconazol), HIV infection (protease inhibitors), depression (nefazodone) or heart rhythm disorders (e.g. quinidine, dofetilide, or sotalol).
Danish: - hvis du tager visse typer medicin mod bakterielle infektioner (clarithromycin, telithromycin), svampeinfektioner (itraconazol, ketoconazol, voriconazol, posaconazol), hiv-infektion (proteasehæmmere), depression (nefazodon) eller forstyrrelser i hjerterytmen (f.eks. quinidin, dofetilid eller sotalol).
English: Ranexa should not be used during breast-feeding.
Danish: Ranexa bør ikke anvendes af ammende kvinder.
English: PVC/PVDC/Aluminium blisters of 15 or 20 tablets per blister card. Each carton contains 2, 3, or 5 blister cards (30, 60, or 100 tablets) or one HDPE bottle containing 60 tablets.
Danish: Hver æske indeholder 2, 3 eller 5 blisterkort (30, 60 eller 100 tabletter) eller en HDPE-flaske med 60 tabletter.
English: 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 events and their placebo-corrected frequencies included: constipation (8% versus 4%), dizziness (7% versus 5%), and nausea (4% versus 2%).
Danish: Hos patienter med let til moderat nedsat nyrefunktion (kreatininclearance på ≥ 30-80 ml/min) sammenlignet med dem, der havde 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 %).
English: - certain medicines to treat allergies (e.g. terfenadine, astemizole, mizolastine), heart rhythm disorders (e.g. disopyramide, procainamide), and depression (e.g. imipramine, doxepin, amitriptyline), as these medicines may affect your ECG.
Danish: - visse former for medicin, der bruges til behandling af overfølsomhed (f.eks. terfenadin, astemizol, mizolastin), forstyrrelser i hjerterytmen (f.eks. disopyramid, procainamid) og depression (f.eks. imipramin, doxepin, amitriptylin), da disse former for medicin kan påvirke dit EKG.
English: • Patients with moderate to severe CHF (NYHA Class III-IV) (see sections 4.2 and 5.2).
Danish: • Patienter med moderat til svært hjertesvigt, dvs. NYHA-klasse III-IV (se pkt.
English: Common: constipation, vomiting, nausea.
Danish: Almindelig: forstoppelse, opkastning, kvalme.
English: Down-titration of Ranexa may be required (see sections 4.2 and 4.4).
Danish: Nedtitrering af Ranexa kan være nødvendigt (se pkt.
English: Ranexa should not be used in patients treated with CYP3A4 inducers (e.g. rifampicin, phenytoin, phenobarbital, carbamazepine, St. John's Wort) (see section 4.5).
Danish: Ranexa bør ikke anvendes hos patienter, der er i behandling med CYP3A4induktorer, f.eks. rifampicin, phenytoin, phenobarbital, carbamazepin og prikbladet perikon (se pkt.
English: Uncommon: increased blood creatinine, increased blood urea, prolonged QT corrected interval,
Danish: Ikke almindelig: forhøjet kreatinin, forhøjet carbamid, forlænget QT-korrigeret interval, forhøjet trombocyt- eller leukocyttal, vægttab.
English: 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.
Danish: 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.
English: Difficulty breathing, cough, nose bleed
Danish: Åndedrætsbesvær, hoste, næseblødning
English: 01097 Dresden Germany or
Danish: Leipziger Straβe 7-13 01097 Dresden Tyskland eller
English: 750 mg tablet: glycerol triacetate, lactose monohydrate, Blue #1/Brilliant Blue FCF Aluminium Lake
Danish: 750 mg tablet: glyceroltriacetat, lactosemonohydrat, Blå 1/Brilliant Blue FCF aluminium lake (E 133) og Gul 5/Tartrazin aluminium lake (E 102)
English: which is approximately equal to a 2- to 7-msec increase over the plasma concentration range for ranolazine 500 to 1000 mg twice daily.
Danish: 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.
English: Additional excipients for 375 mg tablet: Macrogol
Danish: Øvrige hjælpestoffer i 375 mg-tabletter: MakrogolPolysorbat 80
English: How to take Ranexa
Danish: Sådan skal du tage Ranexa
English: Uncommon: hot flush, hypotension.
Danish: Ikke almindelig: hedetur, hypotension.
English: Ranexa is contraindicated in patients with moderate or severe hepatic impairment (see sections 4.3 and 5.2).
Danish: Ranexa er kontraindiceret hos patienter med moderat eller svært nedsat leverfunktion (se pkt.
English: Ranexa may cause side effects such as dizziness (common), blurred vision (uncommon), confusional state (uncommon), hallucination (uncommon), double vision (uncommon), coordination problems
Danish: Ranexa kan have bivirkninger såsom svimmelhed (almindeligt), uklart syn (ikke almindeligt),
English: Also, transient ischemic attack occurred more frequently in patients treated with ranolazine 1000 mg twice daily compared with placebo (1.0% vs 0.2%, respectively); however, the incidence of stroke was similar between treatment groups (ranolazine 1.7% vs placebo 1.5%).
Danish: Transitorisk iskæmisk anfald forekom oftere hos patienter, der blev behandlet med 1000 mg ranolazin to gange dagligt sammenlignet med placebo (hhv. 1,0 % vs. 0,2 %).
English: A population analysis of combined data from 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.
Danish: 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.
English: AUTHORISATION
Danish: Κύπρος
English: Anxiety, difficulty sleeping, confusional state, hallucination Blurred vision, visual disturbance
Danish: Angst, søvnbesvær, forvirring, hallucinationer
English: Ranexa 750 mg prolonged-release tablets contain the azo colouring agent E102.
Danish: Ranexa 750 mg depottabletter indeholder azofarvestoffet E 102.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Danish: Kontakt din læge, før du tager dette lægemiddel, hvis din læge har fortalt dig, at du ikke kan tåle visse sukkerarter.
English: Uncommon: abdominal pain, dry mouth, dyspepsia, flatulence, stomach discomfort.
Danish: Ikke almindelig: mavesmerter, tør mund, dyspepsi, flatulens, mavekneb.
English: INFORMATION IN BRAILLE Ranexa 375 mg
Danish: INFORMATION I BRAILLE-SKRIFT Ranexa 375 mg
English: The incidence of adverse events was higher in the elderly (see section 4.8).
Danish: Bivirkningsincidensen var højere hos ældre patienter (se pkt.
English: Light orange oval-shaped tablet engraved with 500 on one side.
Danish: Depottablet Lys orange, oval tablet præget med 500 på den ene side.
English: Rare side effects (occur in 1 to 10 users in 10,000) are:
Danish: Sjældne bivirkninger (forekommer hos 1 til 10 brugere ud af 10.000) er: Vandladningsbesvær
English: Initiation of treatment with Ranexa should be avoided during administration of inducers of CYP3A4 (e.g. rifampicin, phenytoin, phenobarbital, carbamazepine, St. John's Wort) (see section 4.4).
Danish: Behandling med Ranexa bør ikke initieres ved samtidig administration af CYP3A4-induktorer, f.eks. rifampicin, phenytoin, phenobarbital, carbamazepin og prikbladet perikon (se pkt.
English: Dose limitation of atorvastatin and appropriate clinical monitoring may be considered when taking Ranexa.
Danish: Hos patienter, der får Ranexa, bør det overvejes at begrænse atorvastatindosis og iværksætte passende klinisk monitorering.
English: Uncommon side effects (occur in 1 to 10 users in 1,000) are:
Danish: Ikke almindelige bivirkninger (forekommer hos 1 til 10 brugere ud af 1.000) er: Føleforstyrrelser
English: No effect on the adreno-cortical axis was noted in humans.
Danish: Der blev ikke konstateret nogen virkning på binyrebarkaksen for menneskers vedkommende.
English: MARKETING AUTHORISATION HOLDER Menarini International Operations Luxembourg S.A.
Danish: Norge Menarini International Operations Luxembourg S.A.
English: INFORMATION IN BRAILLE Ranexa 750 mg
Danish: INFORMATION I BRAILLE-SKRIFT Ranexa 750 mg
English: Uncommon: fatigue, peripheral oedema.
Danish: Ikke almindelig: udmattelse, perifere ødemer.
English: Pale blue oval-shaped tablet engraved with 375 on one side.
Danish: Depottablet Lyseblå, oval tablet præget med 375 på den ene side.
English: • Patients with low weight (≤ 60 kg) (see sections 4.2, 4.8, and 5.2).
Danish: • Patienter med lav kropsvægt, dvs. ≤ 60 kg (se pkt.
English: Marketing Authorisation Holder Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg
Danish: Indehaveren af markedsføringstilladelsen Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg
English: Changes in sensation (touch or taste), tremor, feeling tired or sluggish, sleepiness or drowsiness,
Danish: Ændringer i føle- eller smagssansen, rystelser, træthed, følelse af ugidelighed, søvnighed eller døsighed, besvimelsesfornemmelse eller besvimelse, svimmelhed, når man rejser sig op Mørk urin, blod i urinen, vandladningsbesvær
English: MARKETING AUTHORISATION HOLDER Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg Luxembourg
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg Luxembourg
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse
English: 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).
Danish: Samtidig administration af potente CYP3A4-hæmmere, f.eks. itraconazol, ketoconazol, voriconazol, posaconazol, hiv-proteasehæmmere, clarithromycin, telithromycin og nefazodon (se pkt.
English: Hives, allergic skin reaction
Danish: Nældefeber, overfølsomhedsreaktion i huden Impotens
English: Combining ranolazine with potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazole, posaconazole, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone) is contraindicated (see section 4.3).
Danish: Samtidig administration af ranolazin og potente CYP3A4-hæmmere, f.eks. itraconazol, ketoconazol, voriconazol, posaconazol, hiv-proteasehæmmere, clarithromycin, telithromycin og nefazodon, er kontraindiceret (se pkt.
English: Feeling weak
Danish: Kraftløshed og svaghed
English: Rare: throat tightness.
Danish: Sjælden: sammensnøring af strube.
English: INFORMATION IN BRAILLE Ranexa 500 mg
Danish: INFORMATION I BRAILLE-SKRIFT Ranexa 500 mg
English: Dizziness
Danish: Svimmelhed
English: PHARMACEUTICAL FORM AND CONTENTS 30 prolonged-release tablets 60 prolonged-release tablets 100 prolonged-release tablets
Danish: LÆGEMIDDELFORM OG ANTAL (PAKNINGSSTØRRELSE) 30 depottabletter