FrancophonIA/ELRC3.0 huggingface dataset:
English: The concomitant use of potent CYP3A4 inhibitors such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone is contra-indicated (see section 4.3).
Danish: Samtidig anvendelse af stærke CYP3A4-hæmmere som fx azol-antimykotika (ketoconazol, itraconazol), makrolidantibiotika (clarithromycin, erythromycin per os, josamycin, telithromycin), hiv-proteasehæmmere (nelfinavir, ritonavir) og nefazodon er kontraindiceret (se pkt.
English: - The other ingredients are in the tablet core: Mannitol, crospovidone, magnesium stearate, and in the film-coating: hypromellose, titanium dioxide, macrogol 400, glycerol.
Danish: - Øvrige indholdsstoffer: Mannitol, crospovidon, magnesiumstearat og i filmovertrækket:
English: It is used in combination with standard therapy, including beta-blocker therapy or when beta-blockers are contraindicated or not tolerated.
Danish: Zentiva bruges sammen med standardbehandling med betablokker, eller når patienten ikke må få eller ikke kan tåle betablokker.
English: If, during treatment, heart rate decreases below 50 beats per minute (bpm) at rest or the patient experiences symptoms related to bradycardia such as dizziness, fatigue or hypotension, the dose must be titrated downward including the lowest dose of 2.5 mg twice daily (one half 5 mg tablet twice daily).
Danish: Hvis hjertefrekvensen i hvile permanent falder til under 50 slag i minuttet (slag/min), eller hvis patienten får symptomer på bradykardi som fx svimmelhed, træthed, eller hypotension, skal dosis nedsættes, herunder den laveste dosis på 2,5 mg to gange dagligt (en halv 5 mg tablet to gange dagligt).
English: What you need to know before you take Ivabradine Zentiva 3.
Danish: Det skal du vide, før du begynder at tage Ivabradine Zentiva
English: EU/1/16/1144/003 EU/1/16/1144/004 EU/1/16/1144/005 EU/1/16/1144/006 EU/1/16/1144/007
Danish: EU/1/16/1144/004 EU/1/16/1144/005 EU/1/16/1144/006 EU/1/16/1144/007
English: nd and 3
Danish: 4.3 og 4.5).
English: - If you are breast-feeding.
Danish: - Hvis du ammer.
English: What Ivabradine Zentiva is and what it is used for
Danish: Virkning og anvendelse Ivabradine Zentiva (ivabradin) er hjertemedicin, som anvendes til behandling af:
English: Ventricular extrasystoles Atrial fibrillation Uncommon Palpitations Supraventricular extrasystoles
Danish: Ventrikulære ekstrasystoler Atrieflimren
English: SAT [sun]
Danish: SØN [sol]
English: Diplopia Visual impairment
Danish: Diplopi Nedsat syn
English: Posology For the different doses, film-coated tablets containing 5 mg and 7.5 mg ivabradine are available.
Danish: Dosering Til at danne de forskellige doser foreligger de filmovertrukne tabletter i styrker på 5 mg og 7,5 mg.
English: If you are pregnant and have taken Ivabradine Zentiva, talk to your doctor.
Danish: Tal med din læge, hvis du er gravid og har taget Ivabradine Zentiva.
English: Treatment must be discontinued if heart rate remains below 50 bpm or symptoms of bradycardia persist (see section 4.4).
Danish: Behandlingen skal seponeres, hvis hjertefrekvensen forbliver under 50 slag/min, eller hvis der er vedholdende symptomer på grund af bradykardi (se pkt.
English: Ivabradine Zentiva 5 mg film-coated tablets:
Danish: Ivabradine Zentiva 5 mg filmovertrukne tabletter:
English: Very rare
Danish: Ikke almindelig
English: How to take Ivabradine Zentiva
Danish: Sådan skal du tage Ivabradine Zentiva
English: - Combination with strong cytochrome P450 3A4 inhibitors such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone (see sections 4.5 and 5.2).
Danish: - Samtidig behandling med stærke CYP3A4-hæmmere som fx azol-antimykotika (ketoconazol, - itraconazol), makrolidantibiotika (clarithromycin, erythromycin per os, josamycin, - telithromycin), hiv-proteasehæmmere (nelfinavir, ritonavir) og nefazodon (se pkt.
English: Ivabradine Zentiva 7.5 mg
Danish: INFORMATION I BRAILLESKRIFT Ivabradine Zentiva 7,5 mg
English: Syncope, possibly related to bradycardia
Danish: Synkope, kan være forbundet med bradykardi
English: The mean ivabradine doses allowing to achieve a 20% HRR were 0.13±0.04 mg/kg b.i.d., 0.10±0.04 mg/kg b.i.d.
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: Package leaflet: Information for the patient Ivabradine Zentiva 5 mg film-coated tablets Ivabradine Zentiva 7.5 mg film-coated tablets
Danish: Indlægsseddel: Information til patienten Ivabradine Zentiva 5 mg filmovertrukne tabletter Ivabradine Zentiva 7,5 mg filmovertrukne tabletter Ivabradin
English: What you need to know before you take Ivabradine Zentiva Do not take Ivabradine Zentiva
Danish: Det skal du vide, før du begynder at tage Ivabradine Zentiva Sådan skal du tage Ivabradine Zentiva Bivirkninger
English: Ivabradine does not influence intracardiac conduction, contractility (no negative inotropic effect) or ventricular repolarisation: - In clinical electrophysiology studies, ivabradine had no effect on atrioventricular or intraventricular conduction times or corrected QT intervals.
Danish: Ivabradin påvirker ikke den intrakardiale overledning, kontraktiliteten (ingen negativ inotrop effekt) eller den ventrikulære repolarisering:
English: Asthenia, possibly related to bradycardia Fatigue, possibly related to bradycardia
Danish: Asteni, kan være forbundet med bradykardi Træthed, kan være forbundet med bradykardi
English: Uncommon Nausea Constipation Diarrhoea
Danish: Ikke almindelig Kvalme Obstipation
English: Stroke
Danish: Mavesmerter
English: Name and address of the manufacturer responsible for batch release S.C. Zentiva S.A
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse
English: Ivabradine Zentiva 5 mg film-coated tablets Ivabradine
Danish: Ivabradine Zentiva 5 mg filmovertrukne tabletter Ivabradin
English: Primary composite endpoint Components of the composite: - CV death - Hospitalisation for worsening HF Other secondary endpoints - All cause death - Death from HF - Hospitalisation for any cause - Hospitalisation for CV reason
Danish: - Død uanset årsag - Død pga. hjerteinsufficiens - Indlæggelse uanset årsag - Indlæggelse pga. kardiovaskulær sygdom
English: Renal impairment
Danish: Angioødem Udslæt
English: Ivabradine Zentiva 5 mg
Danish: INFORMATION I BRAILLESKRIFT Ivabradine Zentiva 5 mg
English: Romania
Danish: Tjekkiet
English: - If you suffer from severe renal problems.
Danish: - Hvis du lider af svære problemer med nyrerne.
English: Common (may affect up to 1 in 10 people) - Modification in the heart functioning (the symptoms are a slowing down of the heart rate).
Danish: - Ændret hjertefunktion (viser sig ved, at pulsen bliver langsommere).
English: Ivabradine Zentiva 7.5 mg film-coated tablets Ivabradine
Danish: Ivabradine Zentiva 7,5 mg filmovertrukne tabletter Ivabradin
English: One film-coated tablet contains 5 mg ivabradine (as hydrochloride).
Danish: ANGIVELSE AF AKTIVT STOF En filmovertrukket tablet indeholder 5 mg ivabradin (som hydrochlorid).
English: Ivabradine Zentiva 5 mg film-coated tablets are oblong, one side and both edges scored white tablets with dimensions 4.8×8.8 mm.
Danish: Ivabradine Zentiva 5 mg filmovertrukne tabletter er aflange, hvide tabletter med delekærv på den ene side og på begge sider med kanter.
English: Uncommon Dyspnoea
Danish: Ikke almindelig Eosinofili
English: Common (may affect up to 1 in 10 people) - Irregular rapid contraction of the heart, abnormal perception of heartbeat, uncontrolled blood pressure, headache, dizziness and blurred vision (cloudy vision).
Danish: ukontrolleret blodtryk, hovedpine, svimmelhed og uskarpt syn (uklart syn).
English: Glycerol
Danish: Bradykardi
English: In a post-hoc subgroup of patients with symptomatic angina at randomisation (n = 1,507), no safety signal was identified regarding cardiovascular death, hospitalization for acute MI or heart failure (ivabradine 12.0% versus placebo 15.5%, p = 0.05).
Danish: I en post-hoc undergruppe, der omfattede patienter med symptomatisk angina pectoris ved randomiseringen (n = 1.507), sås ingen faresignaler for så vidt angår kardiovaskulær død, indlæggelse pga.
English: One film-coated tablet contains 7.5 mg ivabradine (as hydrochloride).
Danish: ANGIVELSE AF AKTIVT STOF En filmovertrukket tablet indeholder 7,5 mg ivabradin (som hydrochlorid).
English: Ivabradine Zentiva (ivabradine) 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: - 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: or nefazodone (medicine to treat depression) or diltiazem, verapamil (used for high blood pressure or angina pectoris).
Danish: ritonavir) eller nefazodon (medicin til behandling af depressioner) eller diltiazem, verapamil
English: District 3,
Danish: U Kabelovny 130
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Ivabradine Zentiva Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Uncommon Muscle cramps
Danish: Ikke almindelig Muskelkramper
English: Ivabradine Zentiva 5 mg film-coated tablets Ivabradine Zentiva 7.5 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Ivabradine Zentiva 5 mg filmovertrukne tabletter Ivabradine Zentiva 7,5 mg filmovertrukne tabletter
English: Ivabradine Zentiva 7.5 mg film-coated tablets are white to off white, round tablet with diameter 7.1 mm. Ivabradine Zentiva is packed in OPA/Alu/PVC-Alu blisters and in paper carton.
Danish: Ivabradine Zentiva er pakket i Opa/Alu/PVC-Alu blister og i karton.
English: How does Ivabradine Zentiva work?
Danish: Sådan virker Ivabradine Zentiva
English: Mannitol
Danish: Amning
English: One film-coated tablet contains 7.5 mg ivabradine (hydrochloride).
Danish: Ivabradine Zentiva 7,5 mg filmovertrukne tabletter: En filmovertrukken tablet indeholder 7,5 mg ivabradin (som hydrochlorid).
English: Respiratory, thoracic and mediastinal disorders
Danish: Knogler, led, muskler og bindevæv
English: Each film-coated tablet contains 5 mg ivabradine (as hydrochloride) or 7.5 mg ivabradine (as hydrochloride).
Danish: (som hydrochlorid) eller 7,5 mg ivabradin (som hydrochlorid).
English: Blood and lymphatic system disorders Uncommon Eosinophilia Metabolism and nutrition disorders
Danish: Hypotension, kan være forbundet med bradykardi Luftveje, thorax og mediastinum Ikke almindelig Dyspnø Mave-tarm-kanalen
English: and 4.1±2.2 mg b.i.d.
Danish: 4.5 og 5.2).
English: If you think that the effect of Ivabradine Zentiva is too strong or too weak, talk to your doctor or pharmacist.
Danish: Tal med din læge eller apotekspersonalet, hvis du mener, at virkningen af Ivabradine Zentiva er for kraftig eller for svag.
English: • The Committee considered the notification of the referral triggered by the United Kingdom under article 29(4) of Directive 2001/83/EC.
Danish: • udvalget behandlede den indbringelse, der var indledt af Det Forenede Kongerige i medfør af artikel 29, stk. 4, i direktiv 2001/83/EF.
English: The relevant sections of the product information were updated accordingly.
Danish: De pågældende afsnit i produktinformationen blev ajourført i henhold hertil.
English: At the final CMDh discussion, there were two major issues where agreement could not be reached by Member States.
Danish: Ved den endelige drøftelse i CMDh var der to hovedpunkter, som medlemsstaterne ikke kunne nå til enighed om.
English: The number of patients was small and the statistical significance of the findings is uncertain.
Danish: Antallet af patienter var for lille, og den statistiske signifikans af resultaterne er usikker.
English: Risk for abuse and dependence
Danish: Risiko for misbrug og afhængighed
English: The CHMP was therefore asked to consider:
Danish: CHMP blev derfor anmodet om at tage stilling til:
English: Overall summary of the scientific evaluation of Dexamed (see Annex I)
Danish: Videnskabelige konklusionerSamlet resumé af den videnskabelige vurdering af Dexamed (se bilag I)
English: These data are further supported by the Arnold et al. (1978) study.
Danish: Disse data støttes yderligere af undersøgelsen foretaget af Arnold et al. (1978).
English: There are, however, methodological problems with this study.
Danish: Undersøgelsen er imidlertid behæftet med metodologiske problemer.
English: However, the number of responders increased to 33 (92%) after both stimulants were tried.
Danish: Antallet af respondere øgedes imidlertid til 33 (92 %), når begge centralt stimulerende midler blev anvendt.
English: The experts' panel recognises this risk but considers its frequency to be low.
Danish: Ekspertpanelet erkender denne risiko, man anser hyppigheden for at være lav.
English: The Netherlands considered that the granting of the marketing authorisation constitutes a potential serious risk to public health.
Danish: Nederlandene fandt, at udstedelsen af markedsføringstilladelsen er en potentiel alvorlig risiko for den offentlige sundhed,
English: In addition, this was an independent study published in 1991 which precludes the assessment of the original data.
Danish: Desuden er der tale om en uafhængig undersøgelse offentliggjort i 1991, hvorfor der ikke er mulighed for at vurdere de oprindelige data.
English: However it is noted that overall very few data is available in clinical practice to support this.
Danish: Det bemærkes dog, at der totalt kun foreligger meget få data fra klinisk praksis til støtte herfor.
English: In addition, the CHMP recommended that the risk management plan should be further updated (see annex IV).
Danish: Herudover anbefalede CHMP yderligere ajourføring af risikostyringsplanen (se bilag IV).
English: In addition to specific measures in the risk management plan, the committee recommended the monitoring of blood pressure and pulse rate in order to minimise these risks.
Danish: Foruden de specifikke foranstaltninger i risikostyringsplanen anbefalede udvalget overvågning af blodtryk og puls for at minimere disse risici.
English: During the referral procedure, the CHMP recommended safety related changes to the product information:
Danish: Under indbringelsesproceduren anbefalede CHMP sikkerhedsrelaterede ændringer af produktoplysningerne:
English: The author concludes that the individual patient response profiles are non-congruent, and that non-response or intolerable side effects with one stimulant do not preclude a good response to the other.
Danish: Forfatteren konkluderer, at responsprofilerne hos de enkelte patienter ikke er sammenfaldende, og at manglende respons eller utålelige bivirkninger med det ene stimulerende middel ikke udelukker god respons på det andet.
English: During the assessment of the application at Member State level, advice from the PRAC on the risk management plan was sought and the applicant agreed with the recommendation to:
Danish: Under ansøgningens vurdering på medlemsstatsniveau blev PRAC anmodet om rådgivning om risikostyringsplanen, og ansøgeren påtog sig at følge anbefalingen om:
English: In the Elia et al. study, approximately 30% of participants did not respond to one treatment but only 4% were non-responders to both.
Danish: I undersøgelsen af Elia et al. responderede ca. 30 % af deltagerne ikke på det ene middel, men kun 4 % var non-respondere på begge midler.
English: Therefore, the assessment of efficacy is based on an intensive literature search as well as on current European treatment guidelines.
Danish: Vurderingen af virkning er derfor baseret på en intensiv litteratursøgning samt gældende europæiske behandlingsretningslinjer.
English: • Introduction of a statement in section 4.8 on reporting of suspected adverse reactions.
Danish: • Indsættelse af en erklæring i punkt 4.8 om indberetning af formodede bivirkninger.
English: The two substances have similar efficacy in ADHD but different mechanisms of action.
Danish: De to stoffer har samme virkning ved ADHD, men forskellig virkningsmekanisme.
English: The study by Elia et al. (1991) concluded that there is a need to try both stimulants because there is individual variability in response.
Danish: I undersøgelsen foretaget af Elia et al. (1991) konkluderedes, at begge stimulerende midler bør forsøges, da responsen varierer individuelt.
English: There is also evidence that amfetamines increase release and turnover of serotonin.
Danish: Der er desuden evidens for, at amfetaminer øger frigivelsen og omsætningen af serotonin.
English: Experimentation with recreational drugs generally starts during adolescence, whereas treatment of ADHD can begin at an earlier age.
Danish: Eksperimenter med narkotika begynder sædvanligvis i ungdommen, hvorimod behandling af ADHD kan begynde i en tidligere alder.
English: The CHMP therefore considered that this publication can be regarded as supportive of efficacy but does not provide conclusive evidence.
Danish: CHMP fandt derfor, at denne publikation støtter virkningen, men ikke giver konklusiv evidens.
English: It is a Central Nervous System stimulant, more potent than the racemic mixture.
Danish: Det er et CNS-stimulerende middel, der er mere potent end den racemiske blanding.
English: The proposed risk minimisation measures are a combination of routine activities (inclusion of warnings in the product information) and the following educational materials and tools:
Danish: De foreslåede risikostyringsforanstaltninger er en kombination af rutinemæssige tiltag (indsættelse af advarsler i produktinformationen) og følgende oplysningsmateriale og redskaber:
English: Dexamfetamine, (2S)-1-phenylpropan-2-amine, is the dextrorotatory, stereoisomer of amfetamine.
Danish: Dexamfetamin, (2S)-1-phenylpropan-2-amin, er den højredrejende stereoisomer af amfetamin.
English: It is noted that all the guidelines mentioned in this article are from countries where dexamfetamine is already marketed for ADHD.
Danish: Det bemærkes, at alle de i artiklen omhandlede retningslinjer er fra lande, hvor dexamfetamin i forvejen markedsføres til ADHD.
English: This publication also includes a comprehensive review of the preclinical pharmacodynamics of the two compounds, which may help explain the observed variability in response.
Danish: Publikationen indeholder desuden en fuldstændig gennemgang af de to stoffers prækliniske farmakodynamik, som kan være en medvirkende forklaring på den iagttagne variabilitet i respons.
English: From the publication alone it is difficult to assess the meaningfulness of the suggested effect sizes based on which the level of response was assessed, but despite some lack of clarity regarding methodology it is noted that the conclusions are in line with those of the Elia et al. study.
Danish: Af denne publikation alene er det vanskeligt at vurdere meningsfuldheden af den formodede størrelse af effekten, som responsgraden blev vurderet på, men uanset nogen uklarhed om metodologien bemærkes det, at konklusionerne er på linje med konklusionerne af undersøgelsen foretaget af Elia et al.
English: It is noted that age can be a dominant factor in substance use disorder.
Danish: Det bemærkes, at alder kan være en dominerende faktor ved forkert omgang med stoffer.
English: Risks associated with long term use
Danish: Risici ved langtidsbrug
English: • Whether sufficient scientific and clinical evidence exists to support the use of the product as second line treatment of ADHD.
Danish: • om der er tilstrækkelig videnskabelig og klinisk evidens til at underbygge produktets anvendelse som andetvalgsbehandling af ADHD.
English: The identified risk of cardiomyopathy is mainly associated with chronic use, especially with high dose use.
Danish: Den konstaterede risiko for kardiomyopati er hovedsagelig knyttet til kronisk anvendelse, særligt ved høje doser.
English: • Checklists for pre-screening and on-going monitoring of patients' blood pressure, heart rate, growth (weight, height, appetite) and emergence of psychoses.
Danish: • tjeklister til præscreening og løbende overvågning af blodtryk, puls, vækst (vægt, højde, appetit) og opståen af psykoser
English: In other publications, authors seem to have further concluded that ADHD treatment with stimulants during childhood is associated with a reduction in the risk of substance use disorder later in life (Biederman et al. 1999; Wilens et al. 2003).
Danish: I andre populationer synes forfatterne yderligere at have konkluderet, at behandling af ADHD med stimulerende midler i barndommen er forbundet med nedsat risiko for stofmisbrug senere i livet (Biederman et al. 1999; Wilens et al. 2003).
English: Dexamfetamine is currently used for treatment of narcolepsy and attention deficit hyperactivity disorder (ADHD) in several EU countries including the reference Member State (RMS) in this procedure.
Danish: Dexamfetamin anvendes til behandling af narkolepsi og hyperaktiv opmærksomhedsforstyrrelse (ADHD) i flere EU-lande, herunder referencemedlemsstaten (RMS) i denne procedure.
English: This is acceptable as in well-established use applications it is not required that applicants provide results of pre-clinical tests and clinical trials, these are to be replaced by appropriate scientific literature.
Danish: Dette er acceptabelt, da ansøgninger vedrørende almindeligt anerkendte anvendelser ikke skal indeholde resultater af prækliniske og kliniske undersøgelser, og disse kan erstattes af passende videnskabelig litteratur.
English: It was noted that increased blood pressure may occur as well as tachycardia.
Danish: Det bemærkedes, at der kan optræde forhøjet blodtryk og takykardi.
English: The experts consulted expressed the fact that ADHD is less likely to produce euphoria in children when the products are used as intended.
Danish: De rådspurgte eksperter henviste til, at ADHD har mindre sandsynlighed for at medføre eufori hos børn, når produkterne anvendes som tilsigtet.
English: While the review has methodological limitations, the conclusions reached are based on relevant evidence.
Danish: Denne oversigt har metodologiske begrænsninger, men dens konklusioner bygger på relevant evidens.
English: Lastly, it is noted that lisdexamfetamine is an inactive prodrug which is absorbed to the bloodstream where it is gradually converted to dexamfetamine.
Danish: Endelig bemærkes det, at lisdexamfetamin er et inaktivt prodrug, der optages i blodbanen, hvor det gradvis omdannes til dexamfetamin.
English: Therefore, the CHMP was of the opinion that the benefit/risk ratio of Dexamed and associated names is considered to be favourable.
Danish: var CHMP af den opfattelse, at risk/benefit-forholdet for Dexamed og relaterede navne er positivt.
English: Grounds for positive opinion, amendments of the summary of product characteristics and package leaflet, and conditions to the Marketing Authorisations
Danish: Begrundelse for den positive udtalelse, ændringerne af produktresuméet og indlægssedlen og betingelserne for markedsføringstilladelserne
English: Its mechanism of action in ADHD is not fully understood, but its efficacy in treatment of ADHD has not been disputed during this procedure.
Danish: Dets virkningsmekanisme ved ADHD kendes ikke fuldt ud, men dets virkning til behandling af ADHD er ikke blevet bestridt ved denne procedure.
English: Treatment optimisation may be also easier to achieve with immediate-release forms when an initial titration phase is needed to determine the correct dosing levels.
Danish: Endvidere kan præparater med hurtig udløsning tænkes at gøre det lettere at optimere behandlingen, når der behøves en initial titreringsfase til at fastlægge det korrekte doseringsniveau.