FrancophonIA/ELRC3.0 huggingface dataset:
English: No significant difference occurred in the composite primary endpoint (time to first occurrence of ischaemia-driven revascularisation or ischaemia-driven hospitalisation without revascularisation) in the ranolazine group (26.2%) versus the placebo group (28.3%), hazard ratio 0.95, 95% CI 0.82-1.10 p= 0.48.
Danish: Der forekom ingen signifikant forskel i det sammensatte primære endepunkt (tid til første forekomst af iskæmirelateret revaskularisering eller iskæmirelateret indlæggelse uden revaskularisering) i den gruppe, der fik ranolazin (26,2 %), sammenlignet med placebogruppen (28,3 %), hazard ratio 0,95, 95 % CI 0,82-1,10 p= 0,48.
English: Available pharmacodynamic/toxicological data in rats have shown excretion of ranolazine in milk (for details see Section 5.3).
Danish: De tilgængelige farmakodynamiske/toksikologiske data fra rotter viser, at ranolazin udskilles i mælk (se pkt.
English: Tissue distribution of drugs which are transported by P-gp may be increased.
Danish: Fordelingen af lægemidler, der transporteres af P-glykoprotein, til væv kan øges.
English: The AUC of one pharmacologically active ranolazine metabolite was 5-fold increased in patients with severe renal impairment.
Danish: AUC for én farmakologisk aktiv ranolazin-metabolit var 5 gange højere hos patienter med svært nedsat nyrefunktion.
English: Therefore, caution should be observed 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).
Danish: Der skal derfor udvises forsigtighed ved behandling af patienter med anamnestisk langt QT-syndrom (medfødt eller i familien), patienter med kendt erhvervet forlængelse af QT-intervallet og patienter i behandling med lægemidler, der påvirker QTc-intervallet (se også pkt.
English: Rare: impaired hearing.
Danish: Sjælden: nedsat hørelse.
English: Ranexa was significantly superior to placebo in prolonging exercise time, time to angina, and time to 1 mm ST segment depression at all doses studied with an observed dose-response relationship.
Danish: Ranexa var signifikant bedre end placebo til at forlænge arbejdsvarigheden, tid til angina-anfald og tid til 1 mmST-segment-depression ved alle undersøgte doser med et observeret dosis-respons-forhold.
English: Clinical efficacy and safety: Clinical studies have demonstrated the efficacy and safety of Ranexa in the treatment of patients with chronic angina, either alone or when the benefit from other antianginal medicinal products was sub-optimal.
Danish: Klinisk virkning og sikkerhed: Det er i kliniske forsøg påvist, at Ranexa er effektivt og sikkert til behandling af patienter med kronisk angina pectoris enten som monoterapi, eller når behandling med andre lægemidler mod angina pectoris ikke har været helt optimal.
English: This medicine contains less than 1 mmol sodium (23 mg) per prolonged-release tablet, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. depottablet, dvs. den er i det væsentlige natriumfrit.
English: 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%.
Danish: Ved en dosis på 500 mg to gange dagligt kan samtidig administration af en potent CYP2D6hæmmer medføre en øgning af ranolazins AUC på ca. 62 %.
English: 1, Avenue de la Gare, L-1611 Luxembourg Luxembourg
Danish: 1, Avenue de la Gare, L-1611 Luxembourg
English: In the pivotal study, CARISA, Ranexa was added to treatment with atenolol 50 mg once daily, amlodipine 5 mg once daily, or diltiazem 180 mg once daily.
Danish: I det afgørende CARISA-forsøg blev Ranexa givet sammen med atenolol 50 mg én gang dagligt, amlodipin 5 mg én gang dagligt eller diltiazem 180 mg én gang dagligt.
English: A large number of metabolites has been identified in human plasma
Danish: Et stort antal metabolitter er blevet identificeret i humant plasma (47 metabolitter),
English: Your doctor may lower your dose or stop treatment with Ranexa.
Danish: Din læge vil eventuelt sætte din dosis ned eller afbryde behandlingen med Ranexa.
English: Blue #2/Indigo Carmine Aluminium Lake (E132)
Danish: Blå 2/Indigocarmin aluminium lake (E 132)
English: Improvement of exercise duration was statistically significant compared to placebo for all three doses of ranolazine from 24 seconds at 500 mg twice daily to 46 seconds at 1500 mg twice daily, showing a dose-related response.
Danish: Forbedringen i arbejdsvarighed var statistisk signifikant sammenlignet med placebo ved alle tre doser ranolazin fra 24 sekunder ved 500 mg administreret to gange dagligt til 46 sekunder ved 1.500 mg administreret to gange dagligt, og der blev dermed påvist et dosisrelateret respons.
English: Inhibitors of CYP3A4 increase plasma concentrations of ranolazine.
Danish: CYP3A4hæmmere øger plasmakoncentrationen af ranolazin.
English: Haemodynamic effects: 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.
Danish: Hæmodynamisk virkning: 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.
English: Ranexa demonstrated greater efficacy than placebo in prolonging exercise time at trough at 12 weeks for both doses studied when used as an add-on therapy.
Danish: Ranexa havde en større virkning end placebo med hensyn til at forlænge arbejdsvarighed ved dalværdi efter 12 uger ved begge undersøgte doser, når stoffet blev anvendt som tillægsbehandling.
English: Adults: The recommended initial dose of Ranexa is 375 mg twice daily.
Danish: Voksne: Den anbefalede startdosis Ranexa er 375 mg to gange dagligt.
English: Studies in animals showed embryo toxicity (see Section 5.3).
Danish: Dyreforsøg viser embryotoksicitet (se pkt.
English: The other ingredients are: hypromellose, magnesium stearate, methacrylic acid-ethyl acrylate copolymer, microcrystalline cellulose, sodium hydroxide, titanium dioxide and carnauba wax.
Danish: Øvrige indholdsstoffer: hypromellose, magnesiumstearat, methacrylsyre-ethylacrylatcopolymer, mikrokrystallinsk cellulose, natriumhydroxid, titaniumdioxid og carnaubavoks.
English: Available data suggest that ranolazine is a mild inhibitor of CYP2D6.
Danish: De tilgængelige data tyder på, at ranolazin er en mild CYP2D6-hæmmer.
English: Renal impairment: In a study evaluating the influence of renal function on ranolazine pharmacokinetics, ranolazine AUC was on average 1.7- to 2-fold higher in subjects with mild, moderate, and severe renal impairment compared with subjects with normal renal function.
Danish: Nedsat nyrefunktion: I en undersøgelse af nyrefunktionens indvirkning på ranolazins farmakokinetik, var ranolazins AUC gennemsnitligt 1,7 til 2 gange højere hos forsøgspersoner med let, moderat og svært nedsat nyrefunktion sammenlignet med forsøgspersoner med normal nyrefunktion.
English: 375 mg tablet: macrogol, polysorbate 80, Blue #2/Indigo Carmine Aluminium Lake (E132) 500 mg tablet: macrogol, talc, polyvinyl alcohol-part hydrolyzed, iron oxide yellow (E172), iron oxide red (E172)
Danish: 375 mg tablet: makrogol, polysorbat 80, Blå 2/Indigocarmin aluminium lake (E 132) 500 mg tablet: makrogoltalcum, polyvinylalkohol, delvist hydrolyseret, jernoxid, gul (E172), jernoxid, rød (E172)
English: Ranexa resulted in significant decreases in the number of angina attacks per week and consumption of short-acting nitroglycerin compared to placebo.
Danish: Ranexa medførte signifikante fald i antallet af angina-anfald pr. uge og i forbruget af korttidsvirkende nitroglycerin sammenlignet med placebo.
English: Therefore the exposure to metoprolol or other CYP2D6 substrates (e.g. propafenone and flecainide or, to a lesser extent, tricyclic antidepressants and antipsychotics) may be increased during co-administration with Ranexa, and lower doses of these medicinal products may be required.
Danish: Derfor kan eksponeringen for metoprolol eller andre CYP2D6-substrater (f.eks. propafenon og flecainid eller i et mindre omfang tricykliske antidepressiva og antipsykotika) blive forøget ved samtidig administration af Ranexa, og det kan blive nødvendigt at nedjustere dosis af disse lægemidler.
English: The slope is higher in patients with clinically significant hepatic impairment.
Danish: Hældningskoefficienten er højere hos patienter med klinisk signifikant nedsat leverfunktion.
English: Double vision
Danish: Dobbeltsyn
English: Eight-hundred and twenty-three patients (23% women) were randomised to receive 12 weeks of treatment with Ranexa 750 mg twice daily, 1000 mg twice daily, or placebo.
Danish: 823 patienter (heraf 23 % kvinder) blev randomiseret til 12 ugers behandling med Ranexa 750 mg to gange dagligt, 1.000 mg to gange dagligt eller placebo.
English: Ranolazine AUC was unaffected in patients with mild hepatic impairment but increased 1.8-fold in patients with moderate impairment.
Danish: AUC for ranolazin var uforandret hos patienter med let nedsat leverfunktion, men steg 1,8 gange hos patienter med moderat nedsat leverfunktion.
English: This leaflet was last revised in
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}.
English: 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.
Danish: 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.
English: There was a 2.5- to 3-fold increase in steady-state AUC as the dose was increased from 500 mg to 1000 mg twice daily.
Danish: Steady state-AUC steg 2,5-3 gange, da dosis blev øget fra 500 mg til 1.000 mg to gange dagligt.
English: 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.
Danish: 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.
English: Verapamil (120 mg three times daily) increases ranolazine steady-state concentrations 2.2-fold.
Danish: Verapamil (120 mg tre gange dagligt) øger steady statekoncentrationen af ranolazin 2,2 gange.
English: In this study, there was a higher reporting rate for congestive heart failure in the ranolazine group (2.2% vs 1.0% in placebo).
Danish: Der blev i dette studie indberettet flere tilfælde af kronisk hjerteinsufficiens i den gruppe, der fik ranolazin (2,2 % dvs. 1,0 % for placebo).
English: Simvastatin: Simvastatin metabolism and clearance are highly dependent on CYP3A4.
Danish: Simvastatin: Metabolismen og simvastatinclearance er i høj grad afhængig af CYP3A4.
English: Coordination problems
Danish: Koordinationsforstyrrelser
English: What you need to know before you take RANEXA
Danish: Det skal du vide, før du begynder at tage Ranexa
English: After oral administration of Ranexa, peak plasma concentrations (Cmax) are typically observed between 2 and 6 hours.
Danish: Den maksimale plasmakoncentration (Cmax) efter oral administration af Ranexa ses som regel efter 2 til 6 timer.
English: Rare: acute renal failure, urinary retention.
Danish: Sjælden: akut nyresvigt, urinretention.
English: What Ranexa looks like and contents of the pack Ranexa prolonged-release tablets are oval shaped tablets.
Danish: Ranexas udseende og pakningsstørrelse Ranexa depottabletter er ovale.
English: Congestive heart failure (CHF): 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).
Danish: Patienter med kronisk hjerteinsufficiens (CHF): Dosistitrering hos patienter med moderat til svær CHF (NYHA-klasse III-IV) skal gennemføres med forsigtighed (se pkt.
English: The maximum dose of Ranexa is 750 mg twice a day.
Danish: Den højeste dosis Ranexa er 750 mg to gange dagligt.
English: In subjects with severe renal impairment (creatinine clearance 10-30 ml/min), a 1.3- to 1.8-fold increase in ranolazine exposure was estimated.
Danish: Hos forsøgspersoner med svært nedsat nyrefunktion (kreatininclearance 10-30 ml/min) skønnedes det, at ranolazineksponeringen steg 1,3-1,8 gange.
English: Elderly: Dose titration in elderly patients should be exercised with caution (see section 4.4).
Danish: Ældre: Dosistitrering hos ældre patienter skal gennemføres med forsigtighed (se pkt.
English: Sodium: This medicine contains less than 1 mmol sodium (23 mg) per prolonged-release tablet, that is to say essentially ‘sodium-free'.
Danish: Natrium: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. depottablet, dvs. det er i det væsentlige natriumfrit.
English: Tacrolimus, ciclosporin, sirolimus, everolimus: Increased plasma concentrations of tacrolimus, a CYP3A4 substrate, have been observed in patients after ranolazine administration.
Danish: Tacrolimus, ciclosporin, sirolimus, everolimus: Efter administration af ranolazin er der observeret øget plasmakoncentration af tacrolimus, som er et CYP3A4-substrat.
English: Acute kidney failure
Danish: Akut nyresvigt
English: Ελλάδα MENARINI HELLAS AE Τηλ: +30 210 8316111-13
Danish: MENARINI HELLAS AE Τηλ: +30 210 8316111-13
English: Five-hundred and sixty-five patients were randomised to receive an initial dose of Ranexa 500 mg twice daily or placebo for 1 week, followed by 6 weeks of treatment with Ranexa 1000 mg twice daily or placebo, in addition to concomitant treatment with amlodipine 10 mg once daily.
Danish: 565 patienter blev randomiseret til behandling med en startdosis Ranexa 500 mg to gange dagligt eller placebo i 1 uge efterfulgt af 6 uger med Ranexa 1.000 mg to gange dagligt eller placebo i tillæg til samtidig behandling med amlodipin 10 mg én gang dagligt.
English: 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.
Danish: Ranolazin er en moderat til potent P-glykoproteinhæmmer og en mild CYP3A4-hæmmer, og stoffet kan øge plasmakoncentrationen af P-glykoprotein eller CYP3A4-substrater.
English: Rare: amnesia, depressed level of consciousness, loss of consciousness, coordination abnormal, gait disturbance, parosmia.
Danish: Sjælden: amnesi, nedsat bevidsthedsniveau, bevidsthedstab, koordinationsforstyrrelser, gangforstyrrelser, parosmi.
English: The corresponding difference at the 1000 mg twice-daily dose was 25%.
Danish: Den tilsvarende forskel ved en dosis på 1.000 mg to gange dagligt var 25 %.
English: Dose adjustment of sensitive CYP3A4 substrates (e.g. simvastatin, lovastatin) and CYP3A4 substrates with a narrow therapeutic range (e.g. ciclosporin, tacrolimus, sirolimus, everolimus) may be required as RANEXA may increase plasma concentrations of these drugs.
Danish: Dosisjustering af følsomme CYP3A4-substrater (f.eks. simvastatin, lovastatin) og CYP3A4-substrater med et snævert terapeutisk indeks (f.eks. ciclosporin, tacrolimus, sirolimus, everolimus) kan være nødvendig, eftersom Ranexa kan øge plasmakoncentrationen af disse lægemidler.
English: Ranexa is indicated in adults as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies (such as beta-blockers and/or calcium antagonists).
Danish: Ranexa er indiceret som supplement til symptomatisk behandling af stabil angina pectoris hos voksne patienter, der ikke er tilstrækkeligt kontrolleret, eller som ikke tåler førstevalgsbehandling af angina pectoris (såsom betablokkere og/eller calciumantagonister).
English: The effect of ranolazine on human fertility is unknown.
Danish: Det er ukendt, om ranolazin påvirker human fertilitet.
English: Elderly may have increased ranolazine exposure due to age-related decrease in renal function (see section 5.2).
Danish: Ældre kan have øget eksponering for ranolazin på grund af aldersrelateret nedsat nyrefunktionen (se pkt.
English: Change in sense of smell, numbness in mouth or lips, impaired hearing Cold sweat, rash
Danish: Ændringer i lugtesansen, følelsesløshed i munden eller læberne, nedsat hørelse Koldsved, udslæt
English: Atorvastatin: Ranexa 1000 mg twice daily increased Cmax and AUC of atorvastatin 80 mg once daily by 1.4- and 1.3 -fold, respectively and changed the Cmax and AUC of atorvastatin metabolites less than 35%.
Danish: Atorvastatin: Ranexa 1000 mg to gange dagligt øgede Cmax og AUC for atorvastatin 80 mg en gang dagligt med henholdsvis faktor 1,4 og 1,3 og ændrede Cmax og AUC for atorvastatins metabolitter med mindre end 35 %.
English: The active substance in Ranexa is ranolazine.
Danish: Ranexa indeholder: Aktivt stof: ranolazin.
English: In an oral high-dose tolerability study in angina patients, the incidence of dizziness, nausea, and vomiting increased in a dose-dependent manner.
Danish: I et tolerabilitetsforsøg med en høj oral dosis hos patienter med angina pectoris sås der en dosisafhængig stigning i hyppigheden af svimmelhed, kvalme og opkastning.
English: (47 metabolites), urine (> 100 metabolites), and faeces (25 metabolites).
Danish: urin (> 100 metabolitter) og fæces (25 metabolitter).
English: Ear and labyrinth disorders Uncommon: vertigo, tinnitus.
Danish: Ikke almindelig: vertigo, tinnitus.
English: Rare: peripheral coldness, orthostatic hypotension.
Danish: Sjælden: perifer kuldefølelse, ortostatisk hypotension.
English: At 500 mg twice daily, subjects lacking CYP2D6 activity (poor metabolisers, PM) had 62% higher AUC than subjects with CYP2D6 metabolising capacity (extensive metabolisers, EM).
Danish: Ved en dosis på 500 mg to gange dagligt havde forsøgspersoner med manglende CYP2D6-aktivitet (de såkaldte poor metabolisers) 62 % højere AUC end forsøgspersoner med CYP2D6-metaboliseringskapacitet (de såkaldte extensive metabolisers).
English: Careful dose titration of Ranexa is recommended in patients treated with diltiazem and other moderately potent CYP3A4 inhibitors (e.g. erythromycin, fluconazole).
Danish: 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.
English: Caution is advised during co-administration with CYP2B6 substrates (e.g. bupropion, efavirenz, cyclophosphamide).
Danish: Det tilrådes at udvise forsigtighed ved samtidig administration af CYP2B6-substrater, f.eks. bupropion, efavirenz og cyclophosphamid.
English: CYP3A4 or P-gp inhibitors: Ranolazine is a substrate of cytochrome CYP3A4.
Danish: CYP3A4- eller P-glykoproteinhæmmere: Ranolazin er et substrat for cytokrom CYP3A4.
English: Each tablet contains 375 mg, 500 mg, or 750 mg ranolazine.
Danish: Hver tablet indeholder 375 mg, 500 mg eller 750 mg ranolazin.
English: (rare), that may affect your ability to drive or use machines.
Danish: 4.8), og det kan påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Common side effects (occur in 1 to 10 users in 100) are: Constipation
Danish: Almindelige bivirkninger (forekommer hos 1 til 10 brugere ud af 100) er: Forstoppelse
English: Blue #1/Brilliant Blue FCF Aluminium Lake (E133) and Yellow #5/Tartrazine Aluminium Lake (E102)
Danish: Blå 1/Brilliant Blue FCF aluminium lake (E 133) og Gul 5/Tartrazin aluminium lake (E 102)
English: Rare: angioedema, allergic dermatitis, urticaria, cold sweat, rash.
Danish: Sjælden: angioødem, allergisk dermatitis, urticaria, koldsved, udslæt.
English: - if you have moderate or severe liver problems.
Danish: - hvis du har moderate til svære leverproblemer.
English: The 500 mg tablets are light orange and are engraved with 500 on one side.
Danish: 500 mg-tabletterne er lys orange og præget med 500 på den ene side.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Menarini International O. L. S.A.
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Menarini International O. L. S.A.
English: Musculoskeletal and connective tissue disorders Uncommon: pain in extremity, muscle cramp, joint swelling, muscular weakness.
Danish: Knogler, led, muskler og bindevæv Ikke almindelig: smerter i ekstremiteterne, muskelkramper, ledhævelse, muskelsvaghed.
English: Ranexa 750 mg prolonged-release tablets contain lactose monohydrate.
Danish: Ranexa 750 mg depottabletter indeholder lactosemonohydrat.
English: - if you have mild liver problems.
Danish: - hvis du har lette leverproblemer.
English: One-hundred and ninety-one patients were randomised to treatment with Ranexa 500 mg twice daily, 1000 mg twice daily, 1500 mg twice daily, and matching placebo, each for 1 week in a crossover design.
Danish: 191 patienter blev randomiseret til behandling med Ranexa 500 mg to gange dagligt, 1.000 mg to gange dagligt, 1.500 mg to gange dagligt og matchende placebo, alle i 1 uge i et overkrydsningsdesign.
English: Ranexa is contraindicated in patients with severe renal impairment (creatinine clearance < 30 ml/min) (see sections 4.3 and 5.2).
Danish: Ranexa er kontraindiceret hos patienter med svært nedsat nyrefunktion (kreatininclearance < 30 ml/min) (se pkt.
English: Increases in a substance called creatinine or increases in urea in your blood, increase in blood platelets or white blood cells, changes in ECG heart tracing Joint swelling, pain in extremity
Danish: Forhøjet kreatinin- eller urinstofindhold i blodet, forhøjet antal blodplader eller hvide blodlegemer, ændringer i ekg-kurve
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, 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: 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. 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: Inhibitors of P-gp (e.g. ciclosporin, verapamil) increase plasma levels of ranolazine.
Danish: P-glykoproteinhæmmere, f.eks. ciclosporin og verapamil, øger plasmaniveauet af ranolazin.
English: Respiratory, thoracic, and mediastinal disorders Uncommon: dyspnoea, cough, epistaxis.
Danish: Luftveje, thorax og mediastinum Ikke almindelig: dyspnø, hoste, epistaxis.