FrancophonIA/ELRC3.0 huggingface dataset:
English: Each 15 mg film-coated tablet contains 15 mg edoxaban (as tosilate).
Danish: Hver 15 mg filmovertrukket tablet indeholder 15 mg edoxaban (som tosilat).
English: 60 mg film-coated tablet: Yellow, round-shaped film-coated tablets (10.5 mm diameter) debossed with “DSC L60”.
Danish: 60 mg filmovertrukket tablet: Gule, runde filmovertrukne tabletter (10,5 mm diameter) præget med ”DSC L60”.
English: EU/1/16/1152/003 10 film-coated tablets EU/1/16/1152/004 14 film-coated tablets EU/1/16/1152/005 28 film-coated tablets EU/1/16/1152/006 30 film-coated tablets EU/1/16/1152/007 56 film-coated tablets EU/1/16/1152/008 60 film-coated tablets EU/1/16/1152/009 84 film-coated tablets EU/1/16/1152/010 90 film-coated tablets EU/1/16/1152/011 98 film-coated tablets EU/1/16/1152/012 100 film-coated tablets EU/1/16/1152/013 10 x 1 film-coated tablets EU/1/16/1152/014 50 x 1 film-coated tablets EU/1/16/1152/015 100 x1 film-coated tablets
Danish: EU/1/16/1152/012 100 filmovertrukne tabletter EU/1/16/1152/013 10 x 1 filmovertrukne tabletter EU/1/16/1152/014 50 x 1 filmovertrukne tabletter EU/1/16/1152/015 100 x 1 filmovertrukne tabletter
English: Roteas 60 mg film-coated tablets are yellow, round-shaped (10.5 mm diameter) and debossed with “DSC L60” on one side.
Danish: Roteas 60 mg filmovertrukne tabletter er gule, runde (10,5 mm i diameter) og præget med ”DSC L60 ” på den ene side.
English: Roteas 60 mg: Each tablet contains 60 mg edoxaban (as tosilate).
Danish: Roteas 60 mg: Hver tablet indeholder 60 mg edoxaban (som tosilat).
English: What Roteas is and what it is used for 2.
Danish: Virkning og anvendelse 2.
English: Table 9: Number of Intracranial Bleeding Events by creatinine clearance category in ENGAGE AF-TIMI 48, Safety Analysis On-Treatmenta CrCL subgroup (mL/min)
Danish: Tabel 9: Antal intrakraniale blødningshændelser pr. kreatininclearance-kategori i ENGAGE AF-TIMI 48, sikkerhedsanalyse under behandlinga CrClundergruppe (ml/min.)
English: 30 mg film-coated tablet: Pink, round-shaped film-coated tablets (8.5 mm diameter) debossed with “DSC L30”.
Danish: 30 mg filmovertrukket tablet: Lyserøde, runde filmovertrukne tabletter (8,5 mm diameter) præget med ”DSC L30”.
English: Each 30 mg film-coated tablet contains 30 mg edoxaban (as tosilate).
Danish: Hver 30 mg filmovertrukket tablet indeholder 30 mg edoxaban (som tosilat).
English: Injury, poisoning and procedural complications Surgical site haemorrhage
Danish: Traumer, forgiftninger og behandlingskomplikationer Blødning på indstiksstedet
English: Management of bleeding
Danish: Behandling af blødning
English: NAME OF THE MEDICINAL PRODUCT Roteas 30 mg film-coated tablets edoxaban
Danish: LÆGEMIDLETS NAVN Roteas 30 mg filmovertrukne tabletter edoxaban
English: NAME OF THE MEDICINAL PRODUCT Roteas 15 mg film-coated tablets edoxaban
Danish: LÆGEMIDLETS NAVN Roteas 15 mg filmovertrukne tabletter edoxaban
English: Each 60 mg film-coated tablet contains 60 mg edoxaban (as tosilate).
Danish: Hver 60 mg filmovertrukket tablet indeholder 60 mg edoxaban (som tosilat).
English: Roteas 30 mg film-coated tablets are pink, round-shaped (8.5 mm diameter) and debossed with “DSC L30” on one side.
Danish: Roteas 30 mg filmovertrukne tabletter er lyserøde, runde (8,5 mm i diameter) og præget med ”DSC L30 ”på den ene side.
English: Roteas 30 mg: hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc, carnauba wax, iron oxide red (E172).
Danish: Roteas 30 mg: hypromellose (E464), macrogol 8000, titandioxid (E171), talcum, carnaubavoks, jernoxid, rød (E172).
English: Table 5: Number of Ischaemic Strokes/SEE by creatinine clearance category in ENGAGE AFTIMI 48, mITT Analysis Set Overall Study CrCL subgroup (mL/min)
Danish: Tabel 5: Antal iskæmiske apopleksianfald/SEE pr. kreatininclearance-kategori i ENGAGE AFTIMI 48, mITT-analysesæt, samlet studie
English: Roteas 15 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
Danish: Roteas 15 mg: Tabletkerne: mannitol (E421), pregelatineret stivelse, crospovidon, hydroxypropylcellulose, magnesiumstearat (E470b).
English: • Bleeding inside the skull
Danish: • Blødning inde i kraniet
English: Subjects in both edoxaban treatment groups had their dose halved if one or more of the following clinical factors were present: moderate renal impairment (CrCL 30 - 50 mL/min), low body weight (≤ 60 kg) or concomitant use of specific P-gp inhibitors (verapamil, quinidine, dronedarone).
Danish: I begge behandlingsgrupper med edoxaban fik personerne deres dosis halveret, hvis en eller flere af følgende kliniske faktorer var til stede: moderat nedsat nyrefunktion (CrCl 30 - 50 ml/min.
English: Roteas 15 mg: hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc, carnauba wax, iron oxide red (E172), iron oxide yellow (E172).
Danish: Roteas 15 mg: hypromellose (E464), macrogol 8000, titandioxid (E171), talcum, carnaubavoks, jernoxid, rød (E172), jernoxid, gul (E172).
English: Roteas 60 mg: hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc, carnauba wax, iron oxide yellow (E172).
Danish: Roteas 60 mg: hypromellose (E464), macrogol 8000, titandioxid (E171), talcum, carnaubavoks, jernoxid, gul (E172).
English: • Bleeding in joints
Danish: • Blødning i leddene
English: In patients with end stage renal disease (ESRD) (CrCL < 15 mL/min) or on dialysis, the use of Roteas is not recommended (see sections 4.4 and 5.2).
Danish: Hos patienter med nyresygdom i slutstadiet (end stage renal disease, ESRD) (CrCl < 15 ml/min.)
English: Roteas 30 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
Danish: Roteas 30 mg: Tabletkerne: mannitol (E421), pregelatineret stivelse, crospovidon, hydroxypropylcellulose, magnesiumstearat (E470b).
English: Roteas 60 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
Danish: Roteas 60 mg: Tabletkerne: mannitol (E421), pregelatineret stivelse, crospovidon, hydroxypropylcellulose, magnesiumstearat (E470b).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS UNIT DOSE BLISTER (10 x 1 TABLETS) FOR 15 MG
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP ENHEDSDOSIS-BLISTER (10 x 1) TABLETTER MED 15 MG
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS UNIT DOSE BLISTER (10 x 1 TABLETS) FOR 60 MG
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER (10 x 1 TABLETTER) MED 60 MG
English: Vascular disorders Other haemorrhage
Danish: Vaskulære sygdomme Anden blødning
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS UNIT DOSE BLISTER (10 x 1 TABLETS) FOR 30 MG
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER (10 x 1 TABLETTER) MED 30 MG
English: For patients currently on a 30 mg dose (for one or more of the following clinical factors: moderate to severe renal impairment (CrCL 15 - 50 mL/min), low body weight, or use with certain P-gp inhibitors), administer a Roteas dose of 15 mg once daily together with an appropriate VKA dose.
Danish: Til patienter, der aktuelt får en 30 mg dosis (ved én eller flere af følgende kliniske faktorer: moderat til svært nedsat nyrefunktion (CrCl 15 - 50 ml/min.
English: What Roteas looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: ≥ 30 to ≤ 50 1,302 63 > 50 to ≤ 70 2,093 85 > 70 to ≤ 90 1,661 45 > 90 to ≤ 110 927 27 > 110 to ≤ 130 497 14
Danish: ≥ 30 til ≤ 50 1.302 63 > 50 til ≤ 70 2.093 85 > 70 til ≤ 90 1.661 45 > 90 til ≤ 110 927 27 > 110 til ≤ 130 497 14
English: In patients with mild renal impairment (CrCL > 50 - 80 mL/min), the recommended dose is 60 mg Roteas once daily.
Danish: Hos patienter med let nedsat nyrefunktion (CrCl > 50 - 80 ml/min.)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 14 FILM-COATED TABLETS FOR 60 MG
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER MED 14 FILMOVERTRUKNE TABLETTER MED 60 MG
English: ≥ 30 to ≤ 50 1,302 9 > 50 to ≤ 70 2,093 8 > 70 to ≤ 90 1,661 10 > 90 to ≤ 110 927 2 > 110 to ≤ 130 497 1
Danish: ≥ 30 til ≤ 50 1.302 9 > 50 til ≤ 70 2.093 8 > 70 til ≤ 90 1.661 10 > 90 til ≤ 110 927 2 > 110 til ≤ 130 497 1
English: Subdural haemorrhage
Danish: Subdural blødning
English: ≥ 30 to ≤ 50 1,302 16 > 50 to ≤ 70 2,093 19 > 70 to ≤ 90 1,661 17 > 90 to ≤ 110 927 5 > 110 to ≤ 130 497 2
Danish: ≥ 30 til ≤ 50 1.302 16 > 50 til ≤ 70 2.093 19 > 70 til ≤ 90 1.661 17 > 90 til ≤ 110 927 5 > 110 til ≤ 130 497 2
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 14 FILM-COATED TABLETS FOR 30 MG
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER MED 14 FILMOVERTRUKNE TABLETTER MED 30 MG
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 60 mg edoxaban (as tosilate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 60 mg edoxaban (som tosilat).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 15 mg edoxaban (as tosilate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 15 mg edoxaban (som tosilat).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 10 FILM-COATED TABLETS FOR 15 MG
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER MED 10 FILMOVERTRUKNE TABLETTER MED 15 MG
English: First Ischaemic Stroke n Event Rate (%/yr)b
Danish: p-værdi ICHb n Hændelsesrate (%/år)a
English: The concomitant use of edoxaban with other P-gp inducers (e.g. phenytoin, carbamazepine, phenobarbital or St. John's Wort) may lead to reduced edoxaban plasma concentrations.
Danish: Samtidig brug af edoxaban og andre P-gp-induktorer (f.eks. phenytoin, carbamazepin,
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 30 mg edoxaban (as tosilate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 30 mg edoxaban (som tosilat).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 10 FILM-COATED TABLETS FOR 60 MG
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER MED 10 FILMOVERTRUKNE TABLETTER MED 60 MG
English: Intra-articular haemorrhage
Danish: Intraartikulær blødning
English: 60 mg QD*
Danish: 60 mg en gang dagligt*
English: If you take more Roteas than you should
Danish: Hvis du har taget for meget Roteas
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 10 FILM-COATED TABLETS FOR 30 MG
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER MED 10 FILMOVERTRUKNE TABLETTER MED 30 MG
English: Roteas administration should be discontinued if severe haemorrhage occurs (see sections 4.8 and 4.9).
Danish: Hvis der forekommer svær blødning, skal administration af Roteas seponeres (se pkt.
English: Roteas 30 mg film-coated tablets
Danish: Roteas 15 mg filmovertrukne tabletter Roteas 30 mg filmovertrukne tabletter Roteas 60 mg filmovertrukne tabletter
English: In patients with severe hepatic impairment Roteas is not recommended (see sections 4.4 and 5.2).
Danish: Hos patienter med svært nedsat leverfunktion bør Roteas ikke anvendes (se pkt.
English: 60 mg once daily Dose recommendation for patients with one or more of the following clinical factors: Renal Impairment
Danish: 60 mg en gang dagligt Dosisanbefaling for patienter med en eller flere af følgende kliniske faktorer: Nedsat nyrefunktion Moderat eller svært (CrCl 15 - 50 ml/min.)
English: Renal and urinary disorders Macroscopic haematuria/urethral haemorrhage
Danish: Nyrer og urinveje Makroskopisk hæmaturi/uretral blødning
English: • Feeling sick
Danish: • Kvalme
English: Procedural haemorrhage
Danish: Nedsat nyrefunktion
English: Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTE) 30 mg QD ≥ 30 to ≤ 50
Danish: Behandling af DVT, behandling af LE og forebyggelse af tilbagevendende DVT og LE (VTE)
English: Hepatic impairment Roteas is not recommended in patients with severe hepatic impairment (see sections 4.2 and 5.2).
Danish: Nedsat leverfunktion Roteas bør ikke anvendes til patienter med svært nedsat leverfunktion (se pkt.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Berlin-Chemie (logo)
Danish: LÆGEMIDLETS NAVN Roteas 15 mg filmovertrukne tabletter edoxaban NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Berlin-Chemie (logo) UDLØBSDATO
English: The full EPAR for Ivabradine Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Ivabradine Accord findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Ivabradine Accord is available as tablets (5 and 7.5 mg) and can only be obtained with a prescription.
Danish: Ivabradine Accord fås som tabletter (5 og 7,5 mg) og udleveres kun efter recept.
English: In stable angina, these symptoms occur during physical effort.
Danish: Ved stabil angina pectoris viser disse symptomer sig under fysisk anstrengelse.
English: This is a summary of the European public assessment report (EPAR) for Ivabradine Accord.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ivabradine Accord.
English: As for every medicine, the company provided studies on the quality of Ivabradine Accord.
Danish: Som for alle lægemidler fremlagde virksomheden undersøgelser af kvaliteten af Ivabradine Accord.
English: Also, the doctor will consider stopping treatment if the medicine has only a limited effect on reducing symptoms or reducing the heart rate.
Danish: Lægen bør desuden overveje at stoppe behandlingen, hvis lægemidlet kun har en begrænset virkning på symptomerne eller kun i begrænset omfang sænker hjertefrekvensen.
English: When used for angina, treatment should be stopped if symptoms do not improve after 3 months.
Danish: Når lægemidlet anvendes til behandling af angina pectoris, bør behandlingen stoppes, hvis symptomerne ikke bedres i løbet af 3 måneder.
English: The Committee recommended that Ivabradine Accord be approved for use in the EU.
Danish: Udvalget anbefalede, at Ivabradine Accord godkendes til anvendelse i EU.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Procoralan, and do not need to be repeated for Ivabradine Accord.
Danish: Der er allerede gennemført undersøgelser af fordelene og risiciene ved det aktive stof i de godkendte anvendelser med referencelægemidlet, Procoralan, og det er ikke nødvendigt at gentage disse med Ivabradine Accord.
English: Treatment must be stopped if the heart rate is persistently below 50 beats per minute or if symptoms of bradycardia (slow heart rate) continue.
Danish: Behandlingen skal standses, hvis hjertefrekvensen vedholdende er lavere end 50 slag pr. minut, eller hvis den langsomme hjertefrekvens (bradykardi) fortsætter.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Ivabradine Accord has been shown to have comparable quality and to be bioequivalent to Procoralan.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Ivabradine Accord er af sammenlignelig kvalitet og er bioækvivalent med Procoralan.
English: Because Ivabradine Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Ivabradine Accord er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Ivabradine Accord therefore reduces or prevents the symptoms of angina.
Danish: Ivabradine Accord nedsætter eller forhindrer derved symptomerne på angina pectoris.
English: When this current is blocked, the heart rate is lowered, so that the heart has less work to do and needs less oxygenated blood.
Danish: Når denne strøm blokeres, nedsættes hjertefrekvensen, så hjertet skal arbejde mindre og ikke behøver så meget iltet blod.
English: Ivabradine Accord is a heart medicine used to treat the symptoms of long-term stable angina (pains to the chest, jaw and back, brought on by physical effort) in adults with coronary artery disease (heart disease caused by blockage of the blood vessels that supply the heart muscle).
Danish: Ivabradine Accord er et hjertelægemiddel, der anvendes til at behandle symptomer på kronisk stabil angina pectoris (smerter i brystet, kæben og ryggen, som opstår ved fysisk anstrengelse) hos voksne med koronararteriesygdom (hjertesygdom, hvor de blodkar, der forsyner hjertemuskulaturen med blod, er blokerede).
English: The medicine is used in patients with a normal heart rhythm whose heart rate is at least 70 beats per minute.
Danish: Lægemidlet anvendes hos patienter med normal hjerterytme og en hjertefrekvens på mindst 70 slag pr. minut.
English: Ivabradine Accord ivabradine
Danish: Ivabradine Accord ivabradin
English: By lowering the heart rate, Ivabradine Accord reduces the stress on the heart, thereby slowing the progression of heart failure and improving symptoms.
Danish: Ved at sænke hjertefrekvensen nedsætter Ivabradine Accord belastningen af hjertet og bremser dermed forløbet af hjertesvigt og giver bedring i symptomerne.
English: It is used in combination with standard therapy including beta-blockers, or in patients who cannot be treated with beta-blockers.
Danish: Det anvendes i kombination med standardbehandling, herunder betablokkere, eller når patienter ikke kan behandles med betablokkere.
English: For more information about treatment with Ivabradine Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ivabradine Accord, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This means that Ivabradine Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Procoralan.
Danish: Det betyder, at Ivabradine Accord er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Procoralan.
English: Ivabradine Accord contains the active substance ivabradine.
Danish: Ivabradine Accord indeholder det aktive stof ivabradin.
English: What measures are being taken to ensure the safe and effective use of Ivabradine Accord?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ivabradine Accord?
English: Other information about Ivabradine Accord
Danish: Andre oplysninger om Ivabradine Accord
English: Therefore, the CHMP's view was that, as for Procoralan, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Procoralan.
English: It is used either in patients who cannot take beta-blockers (another type of medicine to treat angina) or in combination with a beta-blocker in patients whose disease is not controlled by beta-blockers alone.
Danish: Det anvendes enten hos patienter, der ikke kan behandles med betablokkere (en anden type medicin mod angina pectoris), eller i kombination med en betablokker hos patienter, som ikke opnår kontrol med en betablokker alene.
English: It is not intended to provide practical advice on how to use Ivabradine Accord.
Danish: Det er ikke en praktisk vejledning i, hvordan Ivabradine Accord bør anvendes.
English: Ivabradine Accord is also used in patients with long-term heart failure (when the heart cannot pump enough blood to the rest of the body) and a normal heart rhythm whose heart rate is at least 75 beats per minute.
Danish: Ivabradine Accord anvendes desuden hos patienter med kronisk hjertesvigt (dvs. hjertet kan ikke pumpe tilstrækkeligt med blod rundt i kroppen) og normal hjerterytme med en hjertefrekvens på mindst 75 slag pr. minut.
English: What are the benefits and risks of Ivabradine Accord?
Danish: Hvilken fordel og risiko er der forbundet med Ivabradine Accord?
English: What is Ivabradine Accord and what is it used for?
Danish: Hvad er Ivabradine Accord, og hvad anvendes det til?
English: For practical information about using Ivabradine Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Ivabradine Accord, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The active substance in Ivabradine Accord, ivabradine, blocks the ‘If current' in the sinus node, the natural ‘pacemaker' that regulates the heart rate.
Danish: Det aktive stof i Ivabradine Accord, ivabradin, blokerer If-strømmen i sinusknuden, der er hjertets naturlige pacemaker, og som regulerer hjertefrekvensen.
English: The symptoms of angina are caused by the heart muscle not receiving enough oxygenated blood.
Danish: Anginasymptomerne skyldes, at hjertet ikke får tilstrækkeligt med iltet blod.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ivabradine Accord have been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der indført anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Ivabradine Accord.
English: Why is Ivabradine Accord approved?
Danish: Hvorfor blev Ivabradine Accord godkendt?
English: How has Ivabradine Accord been studied?
Danish: Hvordan blev Ivabradine Accord undersøgt?
English: How is Ivabradine Accord used?
Danish: Hvordan anvendes Ivabradine Accord?
English: How does Ivabradine Accord work?
Danish: Hvordan virker Ivabradine Accord?
English: This indicates that the system is activated (D).
Danish: Dette indikerer, at systemet er aktiveret (D).
English: • There were also deviations from the final protocol and statistical analysis plan.
Danish: • Der var desuden afvigelser fra den endelige protokol og statistiske analyseplan.
English: • where the bleed is and how serious it is
Danish: • hvor blødningen er, og hvor alvorlig den er
English: • Risk Management plan (RMP)
Danish: • Risikostyringsprogram (RMP)
English: Rare / not known
Danish: Meget sjælden / ikke kendt
English: Wash your hands thoroughly using soap and warm water.
Danish: Vask dine hænder grundigt med sæbe og varmt vand.
English: • your weight
Danish: • din vægt
English: The required dose is determined using the following formulae:
Danish: Den nødvendige dosis bestemmes ud fra følgende formel:
English: Minor including tooth extraction
Danish: Mindre inklusive tandudtrækning
English: • your bleeding is not being controlled with your usual dose of this medicine.
Danish: • din blødning ikke kan kontrolleres med din sædvanlige dosis af dette lægemiddel.
English: • Proceed with your next dose immediately and continue at regular intervals as advised by your doctor.
Danish: • Gå videre til din næste dosis med det samme, og fortsæt med regelmæssigt interval, som anvist af din læge.
English: These factors make control of such studies and interpretation of the results challenging.
Danish: Disse faktorer gør det udfordrende at kontrollere sådanne undersøgelser og fortolke resultaterne.
English: If bleeding is not controlled
Danish: Hvis blødningen ikke er under kontrol
English: The expert group was of the view that the relevant available data sources have been considered.
Danish: Ekspertgruppen var af den opfattelse, at de relevante foreliggende datakilder er taget i betragtning.
English: • Treatment regimens in EU are different from those in the SIPPET study.
Danish: • Behandlingsregimerne i EU er forskellige fra dem, der er anvendt i SIPPET-undersøgelsen.
English: A retrospective review has been done on 40 patients, and 39 patients were included in a prospective investigator-initiated clinical study.
Danish: Der blev udført en retrospektiv gennemgang af 40 patienter, og 39 patienter blev inkluderet i et prospektivt investigator-initieret klinisk studie.