FrancophonIA/ELRC3.0 huggingface dataset:
English: Similar effects on glycohemoglobin and the incidence of symptomatic hypoglycemia were observed in both treatment groups, however fasting plasma glucose decreased more from baseline in the insulin glargine group than in the NPH group.
Danish: Men blodsukkeret ved faste faldt mere fra basisline i insulin glargin gruppen end i NPH gruppen.
English: Lantus 100 units/ml solution for injection in a vial 5 ml vial
Danish: Lantus 100 enheder/ml injektionsvæske, opløsning, i et hætteglas 5 ml hætteglas
English: Alternative site 10 ml vials:
Danish: Alternativ fremstiller for 10 ml hætteglas
English: LABEL (5 ml vial)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET (5 ml hætteglas)
English: Lantus 100 units/ml solution for injection in a cartridge insulin glargine
Danish: Lantus 100 enheder/ml injektionsvæske, opløsning i cylinderampul insulin glargin
English: If you think you may have a problem with Lantus, have it checked by your doctor or pharmacist.
Danish: Få det undersøgt hos din læge eller på apoteket, hvis du mener der er et problem med Lantus.
English: Look at the vial before you use it. Only use it if the solution is clear, colourless and waterlike, and has no visible particles in it. Do not shake or mix it before use.
Danish: Opløsningen må kun bruges, hvis den er klar, farveløs og ligner vand og ikke indeholder synlige partikler.
English: Medicinal product subject to medical prescription
Danish: Oversigt over indlægssedlen
English: June 2018
Danish: Juni 2018
English: The absolute risk reduction was 4.2%.
Danish: Den absolutte risikoreduktion var 4,2 %.
English: The potential risk for humans is unknown.
Danish: Den potentielle risiko hos mennesker kendes ikke.
English: It usually appears between 40 and 50 years of age.
Danish: Den viser sig normalt mellem 40- og 50-års alderen.
English: Other side effects have also been reported:
Danish: Andre bivirkninger er også blevet rapporteret:
English: The median follow-up duration was 22.9 months.
Danish: Den mediane opfølgningstid var 22,9 måneder.
English: Therefore the intake of grapefruit juice should be avoided.
Danish: Indtagelse af grapefrugtjuice skal derfor undgås.
English: Hazard ratio [95% CI]
Danish: Hazard ratio [95 % KI]
English: Uncontrolled blood pressure
Danish: Ukontrolleret blodtryk
English: Abbreviations for days of the week
Danish: Forkortelser for ugedage
English: Temporary cardiac electrical pacing may be instituted if required.
Danish: Midlertidig kardial elektrisk pacing kan om nødvendigt igangsættes.
English: The higher than approved dose used in the study did not fully explain these findings.
Danish: Den højere ikke-godkendte dosis anvendt i dette studie forklarede ikke fuldstændigt disse fund.
English: If this happens, contact your doctor immediately.
Danish: Hvis det sker, skal De straks kontakte Deres læge.
English: Package leaflet: information for the patient
Danish: Indlægsseddel: Information til patienten
English: Do not take a double dose to make up for the forgotten dose.
Danish: De må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Treatment effect on the primary composite endpoint, its components and secondary endpoints
Danish: Behandlingens påvirkning af det primære sammensatte endepunkt, dets komponenter og de sekundære endepunkter
English: Arklow - Co. Wicklow - Ireland
Danish: Arklow - Co. Wicklow Irland
English: If you forget to take a dose of Corlentor, take the next dose at the usual time.
Danish: Hvis De glemmer at tage en dosis Corlentor, skal De tage den næste dosis til normal tid.
English: Fewer than 1% of patients changed their daily routine or discontinued the treatment in relation with phosphenes.
Danish: Færre end 1 % af patienterne måtte ændre deres daglige rutine eller stoppe behandlingen på grund af fosfener.
English: Children Corlentor is not intended for use in children and adolescents younger than 18 years.
Danish: Børn Corlentor er ikke beregnet til børn og unge under 18 år.
English: You can help by reporting any side effects you may get.
Danish: De kan hjælpe ved at indberette alle de bivirkninger, De får.
English: The usual dose is one tablet in the morning and one tablet in the evening.
Danish: Den sædvanlige dosis er en tablet om morgenen og en tablet om aftenen.
English: Headache, generally during the first month of treatment
Danish: Hovedpine, specielt i den første behandlingsmåned
English: It participates in the temporal resolution of the visual system, by curtailing the retinal response to bright light stimuli.
Danish: Den deltager i den temporale opløsningsevne af det visuelle system ved at forkorte det retinale respons på klare lysstimuli.
English: About 4% of an oral dose is excreted unchanged in urine.
Danish: Ca. 4 % af en oral dosis udskilles uomdannet med urinen.
English: All phosphenes resolved during or after treatment, of which a majority (77.5%) resolved during treatment.
Danish: Alle fosfener forsvandt under eller efter behandlingen, de fleste (77,5 %) under behandlingen.
English: The absolute bioavailability of the film-coated tablets is around 40%, due to first-pass effect in the gut and liver.
Danish: Den absolutte biotilgængelighed af de filmovertrukne tabletter er ca. 40 % på grund af en førstepassage-effekt i tarm og lever.
English: Other long-term repeat dose and carcinogenicity studies revealed no clinically relevant changes.
Danish: Andre langtidsstudier med gentagne doser og karcinogenicitetsstudier afslørede ingen klinisk relevante forandringer.
English: The calendar printed on the blister containing the tablets should help you remember when you last took a tablet of Corlentor.
Danish: Kalenderen på blisteren, som indeholder tabletterne, skal hjælpe Dem med at huske, hvornår De sidst tog en Corlentor tablet.
English: If any of the above applies to you, talk straight away to your doctor before or while taking Corlentor.
Danish: Hvis noget af ovenstående gælder for Dem, skal De straks tale med Deres læge om det, før eller mens De tager Corlentor.
English: Erythema Pruritus Urticaria
Danish: Erytem Pruritus Urticaria
English: There are no or limited amount of data from the use of ivabradine in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af ivabradin til gravide kvinder.
English: See the end of section 4 for how to report side effects.
Danish: Se sidst i punkt 4, hvordan De indberetter bivirkninger.
English: The total clearance is about 400 ml/min and the renal clearance is about 70 ml/min.
Danish: Total clearance er ca. 400 ml/min, og den renale clearance er ca. 70 ml/min.
English: The environmental risk assessment of ivabradine has been conducted in accordance to European guidelines on ERA.
Danish: Miljørisikovurderingen (ERA) af ivabradin blev udført i henhold til europæiske retningslinjer for ERA.
English: Women that need treatment with ivabradine should stop breast-feeding, and choose for another way of feeding their child.
Danish: Kvinder, der har behov for behandling med ivabradin, skal ophøre med at amme og vælge en anden form for ernæring til deres barn.
English: Ivabradine has been studied in clinical trials involving nearly 45,000 participants.
Danish: Ivabradin er blevet undersøgt i kliniske studier omfattende næsten 45.000 deltagere.
English: Bradycardia was reported by 3.3% of patients particularly within the first 2 to 3 months of treatment initiation.
Danish: Bradykardi rapporteredes af 3,3 % af patienterne, specielt inden for de første to til tre måneders behandling.
English: Ivabradine should therefore be used with precaution in this population.
Danish: Ivabradin skal derfor anvendes med forsigtighed hos denne population.
English: If there is no improvement in symptoms of angina within 3 months after start of treatment, treatment of ivabradine should be discontinued.
Danish: Hvis der ikke ses forbedringer i symptomerne på angina inden for 3 måneder efter behandlingsstart, skal ivabradinbehandlingen stoppes.
English: Food delayed absorption by approximately 1 hour, and increased plasma exposure by 20 to 30 %.
Danish: Føde forsinkede absorptionen med ca. 1 time og øgede plasmaeksponering med 20-30 %.
English: de los Madroños, 33 28043 Madrid Spain
Danish: de los Madroños, 33 28043 Madrid Spanien
English: The use of ivabradine is not recommended immediately after a stroke since no data is available in these situations.
Danish: Anvendelse af ivabradin anbefales ikke umiddelbart efter et slagtilfælde, da der ikke foreligger data for disse tilstande.
English: These episodes occurred most frequently shortly after blood pressure treatment was modified, were transient, and did not affect the treatment effect of ivabradine.
Danish: Disse episoder optrådte hyppigst umiddelbart efter ændringer i blodtryksbehandlingen, var forbigående og påvirkede ikke behandlingseffekten af ivabradin.
English: Corlentor should be taken during meals.
Danish: Corlentor skal helst tages under et måltid.
English: Marketing Authorisation Holder: Les Laboratoires Servier 50, rue Carnot
Danish: Indehaveren af markedsføringstilladelse Les Laboratoires Servier 50, rue Carnot
English: Ivabradine has no influence on the ability to use machines.
Danish: Ivabradin påvirker ikke evnen til at betjene maskiner.
English: Patients should be informed of signs and symptoms of atrial fibrillation and be advised to contact their physician if these occur.
Danish: Patienterne skal informeres om tegn og symptomer på atrieflimren og informeres om at kontakte deres læge, hvis disse tegn opstår.
English: A large dose of Corlentor could make you feel breathless or tired because your heart slows down too much.
Danish: En stor dosis Corlentor kan få Dem til at føle Dem kortåndet eller træt, fordi Deres hjerte slår for langsomt.
English: Annopol 6B - 03-236 Warszawa, Poland Laboratorios Servier, S.L, Avda.
Danish: Annopol 6B - PL-03-236 Warszawa, Polen Laboratorios Servier, S.L, Avda.
English: However, in post-marketing experience, cases of impaired driving ability due to visual symptoms have been reported.
Danish: Efter markedsføringen er der imidlertid indberettet tilfælde med nedsat køreevne på grund af synsforstyrrelser.
English: Aluminium/PVC blister packed in cardboard boxes.
Danish: Aluminium/PVC-blister pakket i papkartoner.
English: In addition, discontinuation of treatment should be considered if there is only limited symptomatic response and when there is no clinically relevant reduction in resting heart rate within three months.
Danish: Seponering skal også overvejes, hvis der kun er begrænset symptomatisk respons, og når der ikke er nogen klinisk relevant reduktion i hjertefrekvensen i hvile inden for 3 måneder.
English: Caution should be exercised in patients with retinitis pigmentosa.
Danish: Der skal iagttages forsigtighed hos patienter med retinitis pigmentosa.
English: Cessation of treatment should be considered if any unexpected deterioration in visual function occurs.
Danish: Det skal overvejes at stoppe behandlingen, hvis der indtræffer uventet forværring af synet.
English: Corlentor with food and drink Avoid grapefruit juice during treatment with Corlentor.
Danish: Brug af Corlentor sammen med mad og drikke Undgå grapefrugtjuice under behandling med Corlentor.
English: Corlentor contains lactose
Danish: Corlentor indeholder lactose
English: The safety and efficacy of ivabradine in children aged below 18 years have not yet been established.
Danish: Ivabradins sikkerhed og virkning hos børn i alderen under 18 år er endnu ikke klarlagt.
English: A drug utilisation study conducted in several EEA countries aimed at describing the characteristics of ivabradine users, as well as describing the patterns of use of ivabradine, and adherence to the risk minimisation measures.
Danish: Et studie af lægemiddelanvendelse udført i flere EEA-lande med det formål at beskrive karakteristika af ivabradinbrugere samt beskrive brugsmønstre for ivabradin samt overholdelse af risikominimeringsforanstaltningerne.
English: They generally occur within the first two months of treatment after which they may occur repeatedly and resolve during or after treatment
Danish: De forekommer almindeligvis inden for de første to måneder af behandlingen, hvorefter de kan forekomme gentagne gange og forsvinde under eller efter behandlingen.
English: 14 film-coated tablets [28 film-coated tablets] [56 film-coated tablets] [84 film-coated tablets] [98 film-coated tablets] [100 film-coated tablets] [112 film-coated tablets]
Danish: 14 filmovertrukne tabletter [28 filmovertrukne tabletter] [56 filmovertrukne tabletter] [84 filmovertrukne tabletter] [98 filmovertrukne tabletter] [100 filmovertrukne tabletter] [112 filmovertrukne tabletter]
English: 92284 Suresnes cedex - France
Danish: 92284 Suresnes cedex Frankrig
English: Very rare: Irregular heart beats.
Danish: Meget sjælden: Uregelmæssig puls.
English: AV 1st degree block (ECG prolonged PQ interval)
Danish: AV-blok af 1. grad (forlænget PQ-interval i ekg)
English: This leads to a reduction in cardiac workload and myocardial oxygen consumption.
Danish: Det medfører en reduktion i hjertets pumpearbejde og myokardiets iltforbrug.
English: Corlentor mainly works by reducing the heart rate by a few beats per minute.
Danish: Corlentor virker hovedsageligt ved at nedsætte hjertefrekvensen med nogle få slag pr. minut.
English: The Ndesmethylated derivative of ivabradine has been identified as the main active metabolite in humans.
Danish: Det N-demethylerede derivat af ivabradin er identificeret som den aktive hovedmetabolit hos mennesker.
English: Special populations - Older people: 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
Danish: Særlige populationer - Ældre personer: 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: Severe bradycardia should be treated symptomatically in a specialised environment.
Danish: Svær bradykardi skal behandles symptomatisk i en specialafdeling.
English: Ivabradine (N=3241) n (%)
Danish: Ivabradin (N=3.241) n (%)
English: In the ivabradine group, 67% of patients were treated with 7.5 mg twice a day.
Danish: I ivabradin-gruppen blev 67 % af patienterne behandlet med 7,5 mg to gange dagligt.
English: The treatment has to be initiated only in patient with stable heart failure.
Danish: Behandlingen må kun initieres hos patient med stabil hjerteinsufficiens.
English: If you are being treated for stable angina pectoris
Danish: Hvis De bliver behandlet for stabil angina pectoris
English: Your doctor will prescribe the right dose for you.
Danish: Deres læge vil ordinere den rette dosis til Dem.
English: The onset of phosphenes is generally within the first two months of treatment after which they may occur repeatedly.
Danish: Fosfener opstår generelt inden for de første to behandlingsmåneder, hvorefter de kan optræde gentagne gange.
English: There was no evidence of pharmacological tolerance (loss of efficacy) developing during treatment nor of rebound phenomena after abrupt treatment discontinuation.
Danish: Der var ikke tegn på udvikling af farmakologisk tolerans (tab af effekt) under behandlingen og heller ikke på rebound-fænomener efter abrupt afbrydelse af behandlingen.
English: These trials included a total of 4,111 patients with chronic stable angina pectoris, of whom 2,617 received ivabradine.
Danish: Studierne inkluderede 4.111 patienter med kronisk stabil angina pectoris, hvoraf 2.617 fik ivabradin.
English: AV 2nd degree block, AV 3rd degree block Sick sinus syndrome
Danish: AV-blok af 2. grad, AV-blok af 3. grad Syg sinus-syndrom
English: They are usually triggered by sudden variations in light intensity.
Danish: De udløses normalt af pludselige variationer i lysintensiteten.
English: The most common adverse reactions with this medicine are dose dependent and related to its mode of action:
Danish: De almindeligste bivirkninger med dette lægemiddel er dosisafhængige og relaterede til dets virkningsmåde:
English: Animal studies indicate that ivabradine is excreted in milk.
Danish: Dyrestudier indikerer, at ivabradin udskilles i mælk.
English: At higher doses, the decrease in heart rate is no longer proportional to ivabradine plasma concentrations and tends to reach a plateau.
Danish: Efter højere doser er faldet i hjertefrekvens ikke længere proportionalt med plasmakoncentrationen af ivabradin og tenderer til at nå et plateau.
English: Under physiological conditions, ivabradine is rapidly released from tablets and is highly water-soluble (>10 mg/ml).
Danish: Under fysiologiske betingelser frigøres ivabradin hurtigt fra tabletterne og er letopløseligt i vand (>10 mg/ml).
English: Linearity/non linearity The kinetics of ivabradine is linear over an oral dose range of 0.5 - 24 mg.
Danish: Linearitet/non-linearitet Ivabradins kinetik er lineær over en oral dosisspændvidde på 0,5 - 24 mg.
English: Chronic heart failure is a heart disease which happens when your heart cannot pump enough blood to the rest of your body.
Danish: Kronisk hjertesvigt er en hjertesygdom, der opstår, når hjertet ikke kan pumpe tilstrækkeligt blod rundt til resten af kroppen.
English: Patients with hypotension
Danish: Patienter med hypotension
English: Use in patients with AV-block of 2nd degree Ivabradine is not recommended in patients with AV-block of 2nd degree.
Danish: Anvendelse til patienter med 2. grads AV-blok Ivabradin kan ikke anbefales til patienter med 2. grads AV-blok.
English: Ivabradine 5 mg twice daily was shown to be effective on exercise test parameters within 3 to 4 weeks of treatment.
Danish: Ivabradin 5 mg to gange daglig viste sig at være effektivt på arbejdstestparametre i løbet af 3 til 4 ugers behandling.
English: To date, there is no evidence of a toxic effect of ivabradine on the retina, but the effects of long-term ivabradine treatment beyond one year on retinal function are currently not known.
Danish: Indtil dato er der ikke holdepunkter for en toksisk effekt af ivabradin på retina, men virkningen af langtidsbehandling længere end et år kendes ikke for øjeblikket.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet og karcinogenicitet.
English: If you still have angina symptoms and if you have tolerated the 5 mg twice daily dose well, the dose may be increased.
Danish: Hvis De stadig har symptomer på angina og hvis De har tålt dosis på 5 mg to gange dagligt godt, kan dosis øges.
English: Bradycardia was reported by 17.9 % of patients in the ivabradine group (2.1% in the placebo group).
Danish: Bradykardi blev rapporteret hos 17,9% af patienterne i ivabradingruppen (2,1% i placebogruppen).
English: They particularly occur within the first 2 to 3 months of treatment initiation.
Danish: De forekommer især inden for de føste 2 til 3 måneder efter indledning af behandlingen.
English: Papaellinas Ltd.
Danish: C.A. Papaellinas Ltd.
English: When pregnant animals were treated during organogenesis at exposures close to therapeutic doses, there was a higher incidence of foetuses with cardiac defects in the rat and a small number of foetuses with ectrodactylia in the rabbit.
Danish: Når gravide dyr blev behandlet under organogenesen ved eksponeringer tæt på de terapeutiske doser, var der en højere incidens af fostre med kardiale defekter hos rotte og et mindre antal fostre med ektrodaktyli hos kanin.
English: It is recommended that the treating physician should be experienced in the management of chronic heart failure.
Danish: Det anbefales, at den behandlende læge har erfaring med behandling af kronisk hjerteinsufficiens.
English: Hypromellose (E 464) Titanium dioxide (E171) Macrogol 6000
Danish: Hypromellose (E464) Titandioxid (E171) Macrogol 6000
English: This lowers the heart's need for oxygen especially in the situations when an angina attack is more likely to happen.
Danish: Det nedsætter hjertets behov for ilt, specielt i situationer, hvor der er større risiko for, at et anfald af hjertekrampe kan opstå.
English: The intake of the tablet during meals is recommended in order to decrease intra-individual variability in exposure (see section 4.2).
Danish: Det anbefales at indtage tabletterne under et måltid for at nedsætte forskelle i individuel eksponering (se pkt.
English: In this subgroup of patients, the safety profile of ivabradine is in line with the one of the overall population.
Danish: I denne patientundergruppe svarer ivabradins sikkerhedsprofil til profilen i hele populationen.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Corlentor 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 Corlentor i alle undergrupper af den pædiatriske population med angina pectoris.
English: The metabolism of this active metabolite also involves CYP3A4.
Danish: Metabolismen af den aktive metabolit involverer også CYP3A4.
English: Tablets must be taken orally twice daily, i.e. once in the morning and once in the evening during meals (see section 5.2).
Danish: Tabletterne skal tages per os to gange daglig, dvs. en tablet om morgenen og en om aftenen i forbindelse med et måltid (se pkt.
English: Calendar packs containing 14, 28, 56, 84, 98, 100 or 112 film-coated tablets.
Danish: Kalenderpakninger indeholdende 14, 28, 56, 84, 98, 100 eller 112 filmovertrukne tabletter.
English: No data are available in patients with creatinine clearance below 15 ml/min.
Danish: Der foreligger ikke data fra patienter med kreatininclearance under 15 ml/min.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Hvis Deres læge har fortalt Dem, at der er nogle sukkerarter, De ikke tåler, skal De kontakte lægen, før De tager denne medicin.
English: The tablets are available in calendar packs (Aluminium/PVC blisters) of 14, 28, 56, 84, 98, 100 or 112 tablets.
Danish: Tabletterne fås i kalenderpakninger (blisterkort af aluminium/PVC) med 14, 28, 56, 84, 98, 100 eller 112 tabletter.
English: Limited data are available in patients with mild to moderate hypotension, and ivabradine should therefore be used with caution in these patients.
Danish: Der foreligger kun begrænsede data fra patienter med let til moderat hypotension, og ivabradin bør anvendes med forsigtighed til disse patienter.
English: Your doctor will decide the right dose for you.
Danish: Deres læge fastsætter den rette dosis til Dem.
English: In this way Corlentor helps to control and reduce the number of angina attacks.
Danish: På den måde hjælper Corlentor med at kontrollere og nedsætte antallet af anfald af hjertekrampe.
English: Outcomes of these evaluations support the lack of environmental risk of ivabradine and ivabradine does not pose a threat to the environment.
Danish: Resultaterne af vurderingen bekræfter, at ivabradin ikke er forbundet med miljømæssige risici, og at ivabradin ikke udgør en trussel for miljøet.
English: Concomitant use not recommended
Danish: Samtidig anvendelse anbefales ikke
English: The possible occurrence of such luminous phenomena should be taken into account when driving or using machines in situations where sudden variations in light intensity may occur, especially when driving at night.
Danish: Den mulige optræden af sådanne lysfænomener skal tages i betragtning ved bilkørsel eller betjening af maskiner i situationer, hvor der kan indtræffe pludselige variationer i lysintensitet, især ved nattekørsel.
English: However, in the absence of extensive data, non urgent DC-cardioversion should be considered 24 hours after the last dose of ivabradine.
Danish: Da datamængden imidlertid ikke er omfattende, bør ikke-akut DC-kardiovertering overvejes inden for et døgn efter sidste dosis af ivabradin.