FrancophonIA/ELRC3.0 huggingface dataset:
English: In controlled phase 3 clinical studies with background DMARDs, the rates of infections over 0-3 months in the 5 mg twice daily (total 973 patients) and 10 mg twice daily (total 969 patients) tofacitinib plus DMARD group were 21.3% (207 patients) and 21.8% (211 patients), respectively, compared to 18.4% (103 patients) in the placebo plus DMARD group (total 559 patients).
Danish: I kontrollerede fase 3-studier med tofacitinib og baggrunds-DMARD var infektionsraten over 0-3 måneder 21,3 % (207 patienter) i gruppen med 5 mg 2 gange dagligt (i alt 973 patienter), 21,8 % (211 patienter) i gruppen med 10 mg 2 gange dagligt (i alt 969 patienter) og 18,4 % (103 patienter) i placebogruppen (i alt 559 patienter).
English: What XELJANZ is and what it is used for What you need to know before you take XELJANZ How to take XELJANZ
Danish: Det skal du vide, før du begynder at tage XELJANZ Sådan skal du tage XELJANZ Bivirkninger
English: XELJANZ 5 mg film-coated tablets
Danish: XELJANZ 5 mg filmovertrukne tabletter
English: Dose should be reduced to 5 mg twice daily when the indicated dose in the presence of normal renal function is 10 mg twice daily.
Danish: Dosis skal reduceres til 5 mg to gange dagligt, når den indicerede dosis ved tilstedeværelsen af normal nyrefunktion er 10 mg to gange dagligt.
English: XELJANZ 11 mg prolonged-release tablets tofacitinib
Danish: XELJANZ 11 mg depottabletter tofacitinib
English: Tofacitinib 10 mg twice daily + MTX Mean difference from placebob
Danish: Tofacitinib 10 mg 2 gange dagligt + MTX Gennemsnitlig forskel fra placebo (CI)
English: Month 3 NA
Danish: Måned 3: HAQ-DI
English: Tofacitinib 5 mg twice daily monotherapy N=370
Danish: Tofacitinib som monoterapi 5 mg 2 gange dagligt N= 370
English: In the clinical studies in UC, changes in ALC observed with tofacitinib treatment were similar to the changes observed in clinical studies in RA.
Danish: I de kliniske studier med UC lignede de observerede ændringer i ALC under tofacitinib-behandlingen de ændringer, der blev observeret i kliniske studier med RA.
English: Each prolonged-release tablet contains 11 mg of tofacitinib (as tofacitinib citrate).
Danish: Hver depottablet indeholder 11 mg tofacitinib (som tofacitinibcitrat).
English: In the controlled RA clinical studies, confirmed decreases in ANC below 1,000 cells/mm3 occurred in 0.08% of patients for the 5 mg twice daily and 10 mg twice daily doses combined.
Danish: I de kontrollerede kliniske RA-studier sås i de puljede grupper af patienter, der fik 5 eller 10 mg 2 gange dagligt, et bekræftet fald i ANC til under 1,0 x10
English: BLISTER FOR 5 MG TABLETS
Danish: BLISTERKORT TIL 5 MG FILMOVERTRUKNE TABLETTER
English: Musculoskeletal pain
Danish: Blødende tyktarmsbetændelse
English: • rheumatoid arthritis
Danish: • Tyktarmsbetændelse
English: Tofacitinib 10 mg twice daily monotherapy N=394
Danish: Tofacitinib som monoterapi 10 mg 2 gange dagligt N= 394
English: In the controlled RA clinical studies, confirmed decreases in ALC below 500 cells/mm3 occurred in 0.3% of patients and for ALC between 500 and 750 cells/mm3 in 1.9% of patients for the 5 mg twice daily and 10 mg twice daily doses combined.
Danish: 9 celler/l hos 0,3 % af patienterne og et bekræftet fald i ALC til mellem 0,50 og 0,75 x10 9 celler/l hos 1,9 % af patienterne.
English: Table 6: Adverse drug reactions
Danish: Tabel 6: Bivirkninger Systemorgankla sse
English: Tofacitinib dose should be reduced to 5 mg twice daily in patients receiving 10 mg twice daily.
Danish: PK: Farmakokinetik Tofacitinibs dosis skal reduceres til 5 mg to gange dagligt hos patienter, der får 10 mg to gange dagligt.
English: XELJANZ 10 mg film-coated tablets tofacitinib
Danish: XELJANZ 10 mg filmovertrukne tabletter tofacitinib
English: In the RA long-term safety population, confirmed decreases in ALC below 500 cells/mm3 occurred in 1.3% of patients and for ALC between 500 and 750 cells/mm in 8.4% of patients for the 5 mg twice daily and 10 mg twice daily doses combined.
Danish: I RA-langtidssikkerhedspopulationen sås i de puljede grupper af patienter, der fik 5 eller 10 mg 2 gange dagligt, et bekræftet fald i ALC til under 0,50 x10
English: In the clinical studies in UC, changes in lipids observed with tofacitinib treatment were similar to the changes observed in clinical studies in RA.
Danish: I de kliniske studier med UC lignede de observerede ændringer i lipider under tofacitinibbehandlingen de ændringer, der blev observeret i kliniske studier med RA.
English: Study I (O RAL
Danish: Studie I (ORAL Solo)
English: Tofacitinib 5 mg twice daily Mean difference from MTXd (CI)
Danish: Tofacitinib 5 mg 2 gange dagligt Gennemsnitlig forskel fra MTX
English: XELJANZ 5 mg film-coated tablets tofacitinib
Danish: XELJANZ 5 mg filmovertrukne tabletter tofacitinib
English: Lab Value (g/dL)
Danish: Laboratorieværdi (mmol/l)
English: BLISTER FOR 10 MG TABLETS
Danish: BLISTER KORT TIL 10 MG FILMOVERTRUKNE TABLETTER
English: Tofacitinib 10 mg twice daily Mean difference from MTXd (CI)
Danish: Tofacitinib 10 mg 2 gange dagligt Gennemsnitlig forskel fra MTX
English: In the clinical studies in UC, changes in liver enzyme tests observed with tofacitinib treatment were similar to the changes observed in clinical studies in RA.
Danish: I de kliniske studier med UC lignede de observerede ændringer i leverenzymtests under tofacitinibbehandlingen de ændringer, der blev observeret i kliniske studier med RA.
English: In the controlled portion of the RA phase 3 studies on background DMARDs (0-3 months) (studies II-V, see section 5.1), ALT elevations greater than 3x ULN were observed in 0.9%, 1.24% and 1.14% of patients receiving placebo, tofacitinib 5 mg and 10 mg twice daily, respectively.
Danish: 5.1), blev der observeret stigninger i ALAT > 3 x ULN hos 0,9 %, 1,24 % og 1,14 % af de patienter, der fik henholdsvis placebo, 5 mg og 10 mg tofacitinib 2 gange dagligt.
English: Severe (including patients undergoing haemodialysis)
Danish: patienter i hæmodialyse)
English: For recommended modifications based on lymphocyte counts, see section 4.2.
Danish: 4.2 for anbefalede dosisjusteringer iht.
English: Active substance: Ceftiofur
Danish: Aktivt stof: Ceftiofur
English: Milk: zero days.
Danish: Mælk: 0 dage
English: Date of first authorisation: 22nd May 2017
Danish: Dato for første markedsføringstilladelse: 22. maj 2017
English: 4.5 Interaction with other medicinal products and other forms of interaction Pharmacodynamic interactions
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion Farmakodynamiske interaktioner
English: Hypertensive patients requiring blood pressure treatment modifications.
Danish: Hypertensive patienter med behov for ændring af blodtryksbehandlingen
English: Treatment effect on the primary composite endpoint, its components and secondary endpoints
Danish: Det primære sammensatte endepunkt, dets komponenter og de sekundære endepunkter
English: If you forget to take a dose of Ivabradine Accord, take the next dose at the usual time.
Danish: Hvis De glemmer at tage en dosis Ivabradine Accord, skal De tage den næste dosis til normal tid.
English: Children Ivabradine Accord is not intended for use in children and adolescents younger than 18 years.
Danish: Børn Ivabradine Accord er ikke beregnet til børn og unge under 18 år.
English: Laboratori Fundacio Dau C/ C, 12-14 Pol. Ind. Zona Franca 08040 Barcelona
Danish: Laboratori Fundacio Dau C/ C, 12-14 Pol. Ind. Zona Franca 08040 Barcelona Spanien
English: If any of the above applies to you, talk straight away to your doctor before or while taking Ivabradine Accord.
Danish: Hvis noget af ovenstående gælder for Dem, skal De straks tale med Deres læge om det, før eller mens De tager Ivabradine Accord.
English: A large dose of Ivabradine Accord could make you feel breathless or tired because your heart slows down too much.
Danish: En stor dosis Ivabradine Accord kan få Dem til at føle Dem kortåndet eller træt, fordi Deres hjerte slår for langsomt.
English: Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol 4000
Danish: Polyvinylalkohol (E1203) Titandioxid (E171) Macrogol 4000
English: The calendar printed on the blister containing the tablets should help you remember when you last took a tablet of Ivabradine Accord.
Danish: Kalenderen på blisteren, som indeholder tabletterne, skal hjælpe Dem med at huske, hvornår De sidst tog en Ivabradine Accord tablet.
English: Special populations - Elderly: no pharmacokinetic differences (AUC and Cmax) have been observed between elderly (≥ 65 years) or very elderly patients (≥ 75 years) and the overall population (see section 4.2).
Danish: Særlige populationer - Ældre: Der er ikke observeret farmakokinetiske forskelle (AUC og Cmax) mellem ældre (≥ 65 år) eller gamle patienter (≥ 75 år) og den samlede population (se pkt.
English: Palpitations, supraventricular extrasystoles
Danish: Palpitationer, supraventrikulære ekstrasystoler
English: Ivabradine Accord mainly works by reducing the heart rate by a few beats per minute.
Danish: Ivabradine Accord virker hovedsageligt ved at nedsætte hjertefrekvensen med nogle få slag pr. minut.
English: Ivabradine is not recommended in patients with AV-block of 2nd degree.
Danish: Ivabradin kan ikke anbefales til patienter med 2. grads AV-blok.
English: Ivabradine Accord contains lactose
Danish: Ivabradine Accord indeholder lactose
English: The European Medicines Agency has waived the obligation to submit the results of studies with Ivabradine film-coated tablets in all subsets of the paediatric population in the treatment of angina pectoris.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Ivabradine filmovertrukne tabletter i alle undergrupper af den pædiatriske population med angina pectoris.
English: Marketing Authorisation Holder: Accord Healthcare S.L.U.
Danish: Indehaveren af markedsføringstilladelsen Accord Healthcare S.L.U.
English: In this way Ivabradine Accord helps to control and reduce the number of angina attacks.
Danish: På den måde hjælper Ivabradine Accord med at kontrollere og nedsætte antallet af anfald af hjertekrampe.
English: The following adverse reactions have been reported during clinical trials and are ranked using the following frequency: 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); very rare (<1/10,000); not known (cannot be estimated from the available data).
Danish: I de kliniske studier er der rapporteret om følgende bivirkninger, som er opstillet efter hyppighed i henhold til denne konvention: 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); meget sjælden (<1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Ivabradine Accord with food and drink Avoid grapefruit juice during treatment with Ivabradine Accord.
Danish: Brug af Ivabradine Accord sammen med mad og drikke Undgå grapefrugtjuice under behandling med Ivabradine Accord.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Ivabradine film-coated tabletsin children aged 0 to less than 6 months in the treatment of chronic heart failure.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Ivabradine filmovertrukne tabletter til børn i alderen 0 til under 6 måneder til behandling af kronisk hjerteinsufficiens.
English: Ivabradine Accord should be taken during meals.
Danish: Ivabradine Accord skal helst tages under et måltid.
English: The safety and efficacy of ivabradine in the treatment of chronic heart failure in children aged below 18 years have not yet been established.
Danish: Ivabradins sikkerhed og virkning ved behandling af kronisk hjerteinsufficiens hos børn i alderen under 18 år er endnu ikke klarlagt.
English: WESSLING Hungary Kft., Anonymus u. 6., Budapest, 1045, Hungary
Danish: WESSLING Hungary Kft., Anonymus u. 6., Budapest, 1045, Ungarn
English: Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF United Kingdom or
Danish: Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF Storbritannien eller
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere oplysninger om præparat findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: WESSLING Hungary Kft., Anonymus u. 6., Budapest, 1045, Hungary or
Danish: WESSLING Hungary Kft., Anonymus u. 6., Budapest, 1045, Ungarn eller
English: Use in patients with AV-block of 2
Danish: Anvendelse til patienter med 2. grads AV-blok
English: Hazard ratio [95% CI]
Danish: [95 % KI]
English: A randomised, double blind, placebo controlled study was performed in 116 paediatric patients (17 aged [6-12]months, 36 aged [1-3] years and 63 aged [3-18] years) with CHF and dilated cardiomyopathy (DCM) on top of optimal background treatment.
Danish: Et randomiseret, dobbeltblindet, placebokontrolleret studie blev udført med 116 pædiatriske patienter (17 i alderen [6-12] måneder, 36 i alderen [1-3] år og 63 i alderen [3-18] år) med kronisk hjerteinsufficiens og dilateret kardiomyopati (DCM) sammen med optimal igangværende behandling.
English: 14x1 film-coated tablets 28x1 film-coated tablets 56x1 film-coated tablets 84x1 film-coated tablets 98x1 film-coated tablets 100x1 film-coated tablets 112x1 film-coated tablets
Danish: 14x1 filmovertrukne tabletter 28x1 filmovertrukne tabletter 56x1 filmovertrukne tabletter 84x1 filmovertrukne tabletter 98x1 filmovertrukne tabletter 100x1 filmovertrukne tabletter 112x1 filmovertrukne tabletter
English: Bradycardia AV 1st degree block (ECG prolonged PQ
Danish: AV-blok af 1. grad (forlænget PQ-interval i ekg)
English: Talk to your doctor if you are breast-feeding or intending to breastfeed as breastfeeding should be discontinued if you take Ivabradine Accord.
Danish: Tal med lægen, hvis De ammer eller ønsker at amme, da amning skal ophøre, hvis De tager Ivabradine Accord.
English: This leaflet was last revised in MM/YYYY.
Danish: Denne indlægsseddel blev senest ændret: MM/ÅÅÅÅ
English: Ivabradine influences on retinal function.
Danish: Ivabradin påvirker funktionen af retina.
English: The starting dose was 0.02 mg/kg bid in age-subset [6-12]months, 0.05 mg/kg bid in [1-3] years and [3-18] years <40 kg, and 2.5 mg bid in [3-18] years and ≥ 40 kg.
Danish: Initialdosis var 0,02 mg/kg to gange dagligt i aldersgruppen [6-12] måneder, 0,05 mg/kg to gange dagligt ved [1-3] år og [3-18] år <40 kg, og 2,5 mg to gange dagligt i aldersgruppen [3-18] år og ≥ 40 kg.
English: Lactose anhydrous Magnesium stearate (E470b) Starch, pregelatinised (maize) Silica, colloidal hydrated (E551)
Danish: Lactose (vandfri) Magnesiumstearat (E470b) Stivelse, prægelatineret (majs) Silica, kolloid hydreret (E551)
English: A small statistically significant increase in the PCE was observed in a pre-specified subgroup of patients with angina patients in CCS class II or higher at baseline (n=12049) (annual rates 3.4% versus 2.9%, relative risk ivabradine/placebo 1.18, p=0.018), but not in the subgroup of the overall angina population in CCS class ≥ I (n=14286) (relative risk ivabradine/placebo 1.11, p=0.110).
Danish: En lille statistisk signifikant stigning i PCE blev observeret i en præ-specificeret subgruppe af patienter med angina pectoris i CCS-klasse II eller højere ved baseline (n=12.049) (årsrate 3,4 % versus 2,9 %, relativ risiko ivabradin/placebo 1,18, p=0,018), men ikke i subgruppen af den totale anginapopulation i CCS-klasse ≥ I (n=14.286) (relativ risiko ivabradin/placebo 1,11, p=0,110).
English: In a pooled analysis of all the Phase II/III double blind controlled clinical trials with a duration of at least 3 months including more than 40,000 patients, the incidence of atrial fibrillation was 4.86% in ivabradine treated patients compared to 4.08% in controls, corresponding to a hazard ratio of 1.26, 95% CI [1.15-1.39].
Danish: I en puljet analyse af alle fase II/III-dobbeltblindede kontrollerede kliniske studier med en varighed på mindst 3 måneder, der inkluderede flere end 40.000 patienter, var incidensen af atrieflimren 4,86 % hos ivabradinbehandlede patienter sammenlignet med 4,08 % i kontrolgruppen, svarende til en hazard ratio på 1,26, 95 % KI [1,15;1,39].
English: Ivabradine Accord may cause temporary luminous visual phenomena (a temporary brightness in the field of vision, see “Possible side effects”).
Danish: Ivabradine Accord kan forårsage forbigående lysfænomener (forbigående lysglimt i synsfeltet, se under ”Bivirkninger”).
English: The mean ivabradine doses allowing to achieve a 20% HRR were 0.13 ± 0.04 mg/kg bid, 0.10 ± 0.04 mg/kg bid and 4.1 ± 2.2 mg bid in the age subsets [1-3] years, [3-18] years and <40 kg and [3-18] years and ≥ 40 kg, respectively.
Danish: De gennemsnitlige ivabradindoser som muliggør opnåelse af 20 % reduktion i hjertefrekvens, var hhv. 0,13 ± 0,04 mg/kg to gange dagligt; 0,10 ± 0,04 mg/kg to gange dagligt og 4,1 ± 2,2 mg to gange dagligt i aldersgrupperne [1-3] år, [3-18] år og <40 kg og [3-18] år og ≥ 40 kg.
English: The SHIFT study was a large multicentre, international, randomised double-blind placebo controlled outcome trial conducted in 6505 adult patients with stable chronic CHF (for  4 weeks), NYHA class II to IV, with a reduced left ventricular ejection fraction (LVEF  35%) and a resting heart rate  70 bpm.
Danish: SHIFT-studiet var et stort multicenter, internationalt, randomiseret dobbeltblindt placebokontrolleret resultatstudie, der omfattede 6.505 voksne patienter med stabil kronisk hjerteinsufficiens (i ≥ 4 uger), NYHA-klasse II-IV, med nedsat venstre ventrikels uddrivningsfraktion (LVEF ≤ 35 %) og hvilepuls ≥ 70 slag i minuttet.
English: Talc (E553b) Yellow iron oxide (E172) Red iron oxide (E172)
Danish: Talkum (E553b) Gul jernoxid (E172) Rød jernoxid (E172)
English: In some cases (e.g. if you are elderly), your doctor may prescribe half the dose i.e., one half 5 mg tablet of Ivabradine Accord 5 mg (corresponding to 2.5 mg ivabradine) in the morning and one half 5 mg tablet in the evening.
Danish: I nogle tilfælde (fx hvis De er ældre) kan Deres læge halvere dosis, dvs. en halv Ivabradine Accord-tablet på 5 mg (svarende til 2,5 mg ivabradin) om morgenen og en halv tablet på 5 mg om aftenen.
English: In the SHIFT trial more patients experienced episodes of increased blood pressure while treated with ivabradine (7.1%) compared to patients treated with placebo (6.1%).
Danish: I SHIFT-studiet sås episoder med forhøjet blodtryk hos flere ivabradinbehandlede patienter (7,1 %) sammenlignet med placebobehandlede (6,1 %).
English: Ivabradine is indicated only for symptomatic treatment of chronic stable angina pectoris because ivabradine has no benefits on cardiovascular outcomes (e.g. myocardial infarction or cardiovascular death ) (see section 5.1).
Danish: Ivabradin er kun indiceret som symptomatisk behandling af kronisk stabil angina pectoris, idet ivabradin ikke har gavnlig virkning på kardiovaskulære udfald (fx myokardieinfarkt eller kardiovaskulær død) (se pkt.
English: INFORMATION IN BRAILLE Ivabradine Accord 5 mg
Danish: INFORMATION I BRAILLESKRIFT Ivabradine Accord 5 mg
English: In a 1277-patients randomised placebo-controlled study, ivabradine demonstrated a statistically significant additional efficacy on response to treatment (defined as a decrease of at least 3 angina attacks per week and/or an increase in the time to 1 mm ST segment depression of at least 60 s during a treadmill ETT) on top of amlodipine 5 mg o.d. or nifedipine GITS 30 mg o.d. at the trough of drug activity (12 hours after oral ivabradine intake) over a 6-week treatment period (OR = 1.3, 95% CI [1.0-1.7]; p=0.012).
Danish: I et randomiseret, placebokontrolleret studie, som omfattede 1.277 patienter, viste ivabradin en statistisk signifikant yderligere virkning på behandlingsrespons (defineret som fald i anfaldshyppighed på mindst 3 færre angina pectoris anfald per uge og/eller en stigning i tiden til 1 mm depression af STsegmentet på mindst 60 s i en arbejdstolerancetest) sammen med 5 mg amlodipin én gang dagligt eller nifedipin GITS (retarderet præparat) 30 mg én gang dagligt ved trough-niveauet for lægemidlets virkning (12 timer efter oral indtagelse af ivabradin) i en 6-ugers behandlingsperiode (OR = 1,3 95 % KI [1,0;1,7]; p=0,012).
English: Other secondary endpoints: - All cause death - Death from HF - Hospitalisation for any cause - Hospitalisation for CV reason
Danish: Sekundære endepunkter: - Død uanset årsag Død pga. hjerteinsufficiens Indlæggelse uanset årsag - Indlæggelse pga. kardiovaskulær sygdom
English: Do not take Ivabradine Accord if you are able to become pregnant unless you use reliable contraceptive measures (see “Do not take Ivabradine Accord”).
Danish: Tag ikke Ivabradine Accord, hvis De kan blive gravid, medmindre De anvender sikker prævention (se ”Tag ikke Ivabradine Accord”).
English: Ivabradine Accord is a heart medicine used to treat: - Symptomatic stable angina pectoris (which causes chest pain) in adult patients whose heart rate is over or equal to 70 beats per minute.
Danish: Ivabradine Accord er hjertemedicin, som anvendes til behandling af: Symptomerne ved stabil angina pectoris (en lidelse, som forårsager smerter i brystet) hos voksne patienter med en puls på mindst 70 slag i minuttet.
English: Urticaria, itching, skin reddening, feeling unwell.
Danish: Nældefeber, kløe, rødme af huden, utilpashed.
English: The tablets are available in Aluminium/ Aluminium perforated unit dose blister in pack-sizes of 14x1, 28x1, 56x1, 84x1, 98x1, 100x1 or 112x1 tablets.
Danish: Tabletterne fås i aluminium/aluminium perforeret enhedsdosisblister i pakningsstørrelser med 14x1, 28x1, 56x1, 84x1, 98x1, 100x1 eller 112x1 tabletter.
English: Pregnancy, lactation and women of child-bearing potential not using appropriate contraceptive measures (see section 4.6)
Danish: 4.5) - Graviditet, amning samt kvinder i den fertile alder, der ikke anvender sikker kontraception (se pkt.
English: - The other ingredients in the tablet core are: lactose anhydrous, magnesium stearate (E470b), pregelatinised starch (maize), colloidal hydrated silica (E551), and in the tablet coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000, talc (E553b), yellow iron oxide (E172), red iron oxide (E172).
Danish: Øvrige indholdsstoffer: vandfri lactose, magnesiumstearat (E 470b), prægelatineret stivelse (majs), kolloid hydreret silica (E 551) og i tabletovertrækket: polyvinylalkohol (E1203), titandioxid (E171), macrogol 4000, talkum (E553b), gul jernoxid (E 172) og rød jernoxid (E
English: Ivabradine Accord film-coated tablets are available in Aluminium/ Aluminium perforated unit dose blister in pack sizes of 14x1, 28x1, 56x1, 84x1, 98x1, 100x1 or 112x1 tablets.
Danish: Ivabradine Accord filmovertrukne tabletter fås i aluminium/aluminium perforeret enhedsdosisblister i pakningsstørrelser med 14x1, 28x1, 56x1, 84x1, 98x1, 100x1 eller 112x1 tabletter.
English: The frequency of possible side effects listed below is defined using the following convention: very common: may affect more than 1 in 10 people common: may affect up to 1 in 10 people uncommon: may affect up to 1 in 100 people rare: may affect up to 1 in 1,000 people very rare: may affect up to 1 in 10,000 people not known: frequency cannot be estimated from the available data
Danish: Bivirkningerne nedenfor er opdelt efter hyppighed som følger: Meget almindelig: kan påvirke flere end 1 ud af 10 mennesker Almindelig: kan påvirke op til 1 ud af 10 mennsker
English: Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.
Danish: Ivabradin er indiceret ved kronisk hjerteinsufficiens af NYHA-klasse II til IV med systolisk dysfunktion hos patienter med normal sinusrytme og hjertefrekvens på ≥ 75 slag i minuttet i kombination med standardbehandling inkluderende betablokker, eller når betablokker er kontraindiceret eller ikke tolereres (se pkt.