natgillin/translations-raw huggingface dataset:
I de kliniske studier med UC lignede de observerede ændringer i ANC under tofacitinib-behandlingen de ændringer, der blev observeret i kliniske studier med RA.
In the clinical studies in UC, changes in ANC observed with tofacitinib treatment were similar to the changes observed in clinical studies in RA.
Tofacitinib 5 mg 2 gange dagligt N= 344 Gennemsnit (SD)
Tofacitinib 5 mg twice daily N=344 Mean (SD)a
Dosis skal reduceres til 5 mg én gang dagligt, når den indicerede dosis ved tilstedeværelsen af normal leverfunktion er 5 mg to gange dagligt.
Dose should be reduced to 5 mg once daily when the indicated dose in the presence of normal renal function is 5 mg twice daily.
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).
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).
Det skal du vide, før du begynder at tage XELJANZ Sådan skal du tage XELJANZ Bivirkninger
What XELJANZ is and what it is used for What you need to know before you take XELJANZ How to take XELJANZ
XELJANZ 5 mg filmovertrukne tabletter
XELJANZ 5 mg film-coated tablets
Dosis skal reduceres til 5 mg to gange dagligt, når den indicerede dosis ved tilstedeværelsen af normal nyrefunktion er 10 mg to gange dagligt.
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.
XELJANZ 11 mg depottabletter tofacitinib
XELJANZ 11 mg prolonged-release tablets tofacitinib
Tofacitinib 10 mg 2 gange dagligt + MTX Gennemsnitlig forskel fra placebo (CI)
Tofacitinib 10 mg twice daily + MTX Mean difference from placebob
Måned 3: HAQ-DI
Month 3 NA
Tofacitinib som monoterapi 5 mg 2 gange dagligt N= 370
Tofacitinib 5 mg twice daily monotherapy N=370
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.
In the clinical studies in UC, changes in ALC observed with tofacitinib treatment were similar to the changes observed in clinical studies in RA.
Hver depottablet indeholder 11 mg tofacitinib (som tofacitinibcitrat).
Each prolonged-release tablet contains 11 mg of tofacitinib (as tofacitinib citrate).
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
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.
BLISTERKORT TIL 5 MG FILMOVERTRUKNE TABLETTER
BLISTER FOR 5 MG TABLETS
Blødende tyktarmsbetændelse
Musculoskeletal pain
• Tyktarmsbetændelse
• rheumatoid arthritis
Tofacitinib som monoterapi 10 mg 2 gange dagligt N= 394
Tofacitinib 10 mg twice daily monotherapy N=394
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.
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.
Tabel 6: Bivirkninger Systemorgankla sse
Table 6: Adverse drug reactions
PK: Farmakokinetik Tofacitinibs dosis skal reduceres til 5 mg to gange dagligt hos patienter, der får 10 mg to gange dagligt.
Tofacitinib dose should be reduced to 5 mg twice daily in patients receiving 10 mg twice daily.
XELJANZ 10 mg filmovertrukne tabletter tofacitinib
XELJANZ 10 mg film-coated tablets tofacitinib
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
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.
I de kliniske studier med UC lignede de observerede ændringer i lipider under tofacitinibbehandlingen de ændringer, der blev observeret i kliniske studier med RA.
In the clinical studies in UC, changes in lipids observed with tofacitinib treatment were similar to the changes observed in clinical studies in RA.
Studie I (ORAL Solo)
Study I (O RAL
Tofacitinib 5 mg 2 gange dagligt Gennemsnitlig forskel fra MTX
Tofacitinib 5 mg twice daily Mean difference from MTXd (CI)
XELJANZ 5 mg filmovertrukne tabletter tofacitinib
XELJANZ 5 mg film-coated tablets tofacitinib
Laboratorieværdi (mmol/l)
Lab Value (g/dL)
BLISTER KORT TIL 10 MG FILMOVERTRUKNE TABLETTER
BLISTER FOR 10 MG TABLETS
Tofacitinib 10 mg 2 gange dagligt Gennemsnitlig forskel fra MTX
Tofacitinib 10 mg twice daily Mean difference from MTXd (CI)
I de kliniske studier med UC lignede de observerede ændringer i leverenzymtests under tofacitinibbehandlingen de ændringer, der blev observeret i kliniske studier med RA.
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.
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.
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.
patienter i hæmodialyse)
Severe (including patients undergoing haemodialysis)
4.2 for anbefalede dosisjusteringer iht.
For recommended modifications based on lymphocyte counts, see section 4.2.
Aktivt stof: Ceftiofur
Active substance: Ceftiofur
Mælk: 0 dage
Milk: zero days.
Dato for første markedsføringstilladelse: 22. maj 2017
Date of first authorisation: 22nd May 2017
4.5 Interaktion med andre lægemidler og andre former for interaktion Farmakodynamiske interaktioner
4.5 Interaction with other medicinal products and other forms of interaction Pharmacodynamic interactions
Hypertensive patienter med behov for ændring af blodtryksbehandlingen
Hypertensive patients requiring blood pressure treatment modifications.
Det primære sammensatte endepunkt, dets komponenter og de sekundære endepunkter
Treatment effect on the primary composite endpoint, its components and secondary endpoints
Hvis De glemmer at tage en dosis Ivabradine Accord, skal De tage den næste dosis til normal tid.
If you forget to take a dose of Ivabradine Accord, take the next dose at the usual time.
Børn Ivabradine Accord er ikke beregnet til børn og unge under 18 år.
Children Ivabradine Accord is not intended for use in children and adolescents younger than 18 years.
Laboratori Fundacio Dau C/ C, 12-14 Pol. Ind. Zona Franca 08040 Barcelona Spanien
Laboratori Fundacio Dau C/ C, 12-14 Pol. Ind. Zona Franca 08040 Barcelona
Hvis noget af ovenstående gælder for Dem, skal De straks tale med Deres læge om det, før eller mens De tager Ivabradine Accord.
If any of the above applies to you, talk straight away to your doctor before or while taking Ivabradine Accord.
En stor dosis Ivabradine Accord kan få Dem til at føle Dem kortåndet eller træt, fordi Deres hjerte slår for langsomt.
A large dose of Ivabradine Accord could make you feel breathless or tired because your heart slows down too much.
Polyvinylalkohol (E1203) Titandioxid (E171) Macrogol 4000
Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol 4000
Kalenderen på blisteren, som indeholder tabletterne, skal hjælpe Dem med at huske, hvornår De sidst tog en Ivabradine Accord tablet.
The calendar printed on the blister containing the tablets should help you remember when you last took a tablet of Ivabradine Accord.
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.
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).
Palpitationer, supraventrikulære ekstrasystoler
Palpitations, supraventricular extrasystoles
Ivabradine Accord virker hovedsageligt ved at nedsætte hjertefrekvensen med nogle få slag pr. minut.
Ivabradine Accord mainly works by reducing the heart rate by a few beats per minute.
Ivabradin kan ikke anbefales til patienter med 2. grads AV-blok.
Ivabradine is not recommended in patients with AV-block of 2nd degree.
Ivabradine Accord indeholder lactose
Ivabradine Accord contains lactose
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.
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.
Indehaveren af markedsføringstilladelsen Accord Healthcare S.L.U.
Marketing Authorisation Holder: Accord Healthcare S.L.U.
På den måde hjælper Ivabradine Accord med at kontrollere og nedsætte antallet af anfald af hjertekrampe.
In this way Ivabradine Accord helps to control and reduce the number of angina attacks.
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).
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).
Brug af Ivabradine Accord sammen med mad og drikke Undgå grapefrugtjuice under behandling med Ivabradine Accord.
Ivabradine Accord with food and drink Avoid grapefruit juice during treatment with Ivabradine Accord.
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.
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.
Ivabradine Accord skal helst tages under et måltid.
Ivabradine Accord should be taken during meals.
Ivabradins sikkerhed og virkning ved behandling af kronisk hjerteinsufficiens hos børn i alderen under 18 år er endnu ikke klarlagt.
The safety and efficacy of ivabradine in the treatment of chronic heart failure in children aged below 18 years have not yet been established.
WESSLING Hungary Kft., Anonymus u. 6., Budapest, 1045, Ungarn
WESSLING Hungary Kft., Anonymus u. 6., Budapest, 1045, Hungary
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF Storbritannien eller
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF United Kingdom or
Yderligere oplysninger om præparat findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
WESSLING Hungary Kft., Anonymus u. 6., Budapest, 1045, Ungarn eller
WESSLING Hungary Kft., Anonymus u. 6., Budapest, 1045, Hungary or
Anvendelse til patienter med 2. grads AV-blok
Use in patients with AV-block of 2
[95 % KI]
Hazard ratio [95% CI]
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.
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.
14x1 filmovertrukne tabletter 28x1 filmovertrukne tabletter 56x1 filmovertrukne tabletter 84x1 filmovertrukne tabletter 98x1 filmovertrukne tabletter 100x1 filmovertrukne tabletter 112x1 filmovertrukne tabletter
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
AV-blok af 1. grad (forlænget PQ-interval i ekg)
Bradycardia AV 1st degree block (ECG prolonged PQ
Tal med lægen, hvis De ammer eller ønsker at amme, da amning skal ophøre, hvis De tager Ivabradine Accord.
Talk to your doctor if you are breast-feeding or intending to breastfeed as breastfeeding should be discontinued if you take Ivabradine Accord.
Denne indlægsseddel blev senest ændret: MM/ÅÅÅÅ
This leaflet was last revised in MM/YYYY.
Ivabradin påvirker funktionen af retina.
Ivabradine influences on retinal function.
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.
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.
Lactose (vandfri) Magnesiumstearat (E470b) Stivelse, prægelatineret (majs) Silica, kolloid hydreret (E551)
Lactose anhydrous Magnesium stearate (E470b) Starch, pregelatinised (maize) Silica, colloidal hydrated (E551)
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).
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).
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].
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].
Ivabradine Accord kan forårsage forbigående lysfænomener (forbigående lysglimt i synsfeltet, se under ”Bivirkninger”).
Ivabradine Accord may cause temporary luminous visual phenomena (a temporary brightness in the field of vision, see “Possible side effects”).
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.
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.
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.
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.
Talkum (E553b) Gul jernoxid (E172) Rød jernoxid (E172)
Talc (E553b) Yellow iron oxide (E172) Red iron oxide (E172)
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.
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.
I SHIFT-studiet sås episoder med forhøjet blodtryk hos flere ivabradinbehandlede patienter (7,1 %) sammenlignet med placebobehandlede (6,1 %).
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%).
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.
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).
INFORMATION I BRAILLESKRIFT Ivabradine Accord 5 mg
INFORMATION IN BRAILLE Ivabradine Accord 5 mg
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).
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).
Sekundære endepunkter: - Død uanset årsag Død pga. hjerteinsufficiens Indlæggelse uanset årsag - Indlæggelse pga. kardiovaskulær sygdom
Other secondary endpoints: - All cause death - Death from HF - Hospitalisation for any cause - Hospitalisation for CV reason
Tag ikke Ivabradine Accord, hvis De kan blive gravid, medmindre De anvender sikker prævention (se ”Tag ikke Ivabradine Accord”).
Do not take Ivabradine Accord if you are able to become pregnant unless you use reliable contraceptive measures (see “Do not take Ivabradine Accord”).
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.
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.
Nældefeber, kløe, rødme af huden, utilpashed.
Urticaria, itching, skin reddening, feeling unwell.
Tabletterne fås i aluminium/aluminium perforeret enhedsdosisblister i pakningsstørrelser med 14x1, 28x1, 56x1, 84x1, 98x1, 100x1 eller 112x1 tabletter.
The tablets are available in Aluminium/ Aluminium perforated unit dose blister in pack-sizes of 14x1, 28x1, 56x1, 84x1, 98x1, 100x1 or 112x1 tablets.
4.5) - Graviditet, amning samt kvinder i den fertile alder, der ikke anvender sikker kontraception (se pkt.
Pregnancy, lactation and women of child-bearing potential not using appropriate contraceptive measures (see section 4.6)
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
- 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).
Ivabradine Accord filmovertrukne tabletter fås i aluminium/aluminium perforeret enhedsdosisblister i pakningsstørrelser med 14x1, 28x1, 56x1, 84x1, 98x1, 100x1 eller 112x1 tabletter.
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.
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
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
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.
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.
Hvis De har glemt at tage Ivabradine Accord
If you forget to take Ivabradine Accord:
De må ikke tage Ivabradine Accord, hvis De er gravid eller planlægger at blive gravid (se under ”Tag ikke Ivabradine Accord”).
Do not take Ivabradine Accord if you are pregnant or are planning to have a baby (see “Do not take Ivabradine Accord”).