FrancophonIA/ELRC3.0 huggingface dataset:
English: The study was considered acceptable for the estimation of PK parameters and properly designed in terms of wash-out, sampling periods and drug intake procedures.
Danish: Undersøgelsen blev anset for acceptabel til vurderingen af farmakokinetiske parametre og korrekt udformet med hensyn til udvaskning, prøveudtagningsperioder og procedurer for lægemiddelindtagelse.
English: The Applicant decided to perform a new BE study and submitted the full details of a single centre, randomised, single-dose, open-label, laboratory blinded 2-way crossover bioequivalence study comparing the rate and extent of absorption of Loratadine Sandoz 10 mg tablets versus the reference loratadine (Clarityne by ScheringPlough) under fasting conditions (Study SZ190/08).
Danish: Ansøgeren besluttede sig for at udføre en ny BEundersøgelse og indsendte alle de nærmere oplysninger fra en åben randomiseret, laboratorieblindet enkeltcenterundersøgelse af bioækvivalens med enkelt dosis og tovejs overkrydsning, der sammenlignede hastigheden og omfanget af absorptionen af Loratadin Sandoz 10 mg tabletter med referencelægemidlet loratadin (Clarityne fra Schering-Plough) i fastende tilstand (undersøgelse SZ190/08).
English: The CHMP concluded that the bioequivalence between Loratadine Sandoz 10 and the reference product was not sufficiently demonstrated and adopted a List of Outstanding Issues, requesting the Applicant to further substantiate bioequivalence.
Danish: CHMP konkluderede, at bioækvivalensen mellem Loratadin Sandoz 10 og referencelægemidlet ikke var tilstrækkeligt påvist og vedtog en liste over uafklarede spørgsmål, så ansøgeren kan dokumentere bioækvivalensen yderligere.
English: The sought indications for Loratadine Sandoz 10 were the relief of symptoms associated with seasonal and perennial allergic rhinitis and the treatment of the symptoms of chronic urticaria.
Danish: De indikationer, hvorom der ansøges for Loratadin Sandoz 10, var lindring af symptomer knyttet til sæsonbetinget og vedvarende allergisk rinit og behandling af symptomer på kronisk nældefeber.
English: the CHMP has recommended the refusal of the granting of the Marketing Authorisations in the Concerned Member States and the suspension of the Marketing Authorisation in the Member States where the product is currently authorised, for Loratadine Sandoz 10 and associated names (see Annex I).
Danish: Benefit/risk-forholdet for det generiske Loratadin Sandoz anses derfor for at være negativt anbefalede CHMP, at der gives afslag på markedsføringstilladelse i de berørte medlemsstater samt suspendering af markedsføringstilladelserne i de medlemsstater, hvor lægemidlet er godkendt på nuværende tidspunkt, for Loratadin Sandoz 10 og tilknyttede navne (se bilag I).
English: Loratadine and descarboethoxyloratadine concentrations in plasma were determined by s liquid chromatography assay with MS-MS detection.
Danish: Loratadin- og descarboethoxyloratadin-koncentrationerne i plasma blev fastsat ved hjælp af en væskekromatografianalyse.
English: While bioequivalence between Loratadine Sandoz 10 and the reference product was shown for the active metabolite, bioequivalence with regards to the parent compound was not demonstrated.
Danish: Mens bioækvivalensen mellem Loratadin Sandoz 10 og referencelægemidlet blev påvist for den aktive metabolit, var bioækvivalensen med hensyn til udgangsstoffet ikke påvist.
English: - bioequivalence between Loratadine Sandoz 10 and the reference product was not demonstrated for the parent compound,
Danish: Bioækvivalens mellem Loratadin Sandoz 10 og referencelægemidlet var ikke påvist for udgangsstoffet
English: United Kingdom Sandoz Limited Woolmer way
Danish: Sandoz Limited Woolmer way Bordon, Hants, GU35 9 QE
English: LORATADINA HEXAL AG 10 mg compresse
Danish: LORATADINA HEXAL AG 10 mg tablet
English: Estimates indicate that up to 7% of the Caucasian population may have this deficiency.
Danish: Estimater tyder på, at op til 7 % af den kaukasiske population kan have denne mangel.
English: Prevalence %
Danish: Forekomst i %
English: African/Ethiopian African American
Danish: Afrikaner/etiopier Amerikaner af afrikansk herkomst
English: “Paediatric population:
Danish: "Pædiatrisk population:
English: Annex III Amendments to relevant sections of the product information
Danish: Bilag III Ændringer til relevante afsnit af produktinformationen
English: Some people have a variation of this enzyme and this can affect people in different ways.
Danish: Nogle mennesker har en variant af dette enzym, og det kan påvirke mennesker på forskellige måder.
English: Estimates of prevalence of ultra-rapid metabolisers in different populations are summarized below:
Danish: Den estimerede forekomst af ultrahurtige metabolisers hos forskellige populationer er opsummeret nedenfor:
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: Produktinformationen kan efterfølgende opdateres efter behov af de relevante myndigheder i medlemsstaten i samarbejde med reference-medlemslandet i henhold til de procedurer, der er fastsat i afsnit III, kapitel 4, i Direktiv 2001/83/EF
English: These factors may worsen symptoms of morphine toxicity.”
Danish: Disse faktorer kan forværre symptomerne ved morphintoksicitet.”
English: Section 4.4 - Special warnings and precautions for use
Danish: 4.4 - Særlige advarsler og forsigtighedsregler vedrørende brugen
English: These amendments to the relevant sections of the Summary of Product Characteristics and Package Leaflet are the outcome of the referral procedure.
Danish: Disse ændringer til de relevante afsnit i produktresuméet og indlægssedlen er resultatet af referral-proceduren.
English: Other people are more likely to get serious side effects because a very high amount of morphine is produced.
Danish: Andre mennesker har en øget risiko for at få alvorlige bivirkninger, fordi der dannes en meget stor mængde morfin.
English: Section 4.6 - Fertility, pregnancy and lactation
Danish: 4.6 - Fertilitet, graviditet og amning
English: “CYP2D6 metabolism
Danish: "CYP2D6-metabolisering"
English: Caucasian
Danish: Kaukasier
English: If a patient has a deficiency or is completely lacking this enzyme an adequate therapeutic effect will not be obtained.
Danish: Hvis en patient helt eller delvist mangler dette enzym, vil der ikke opnås tilstrækkelig terapeutisk virkning.
English: Greek
Danish: Græker
English: In severe cases this may include symptoms of circulatory and respiratory depression, which may be life-threatening and very rarely fatal.
Danish: I svære tilfælde kan symptomerne omfatte kredsløbs- og respirationsdepression, hvilket kan være livstruende og i meget sjældne tilfælde dødeligt.
English: SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) [For all products in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below]
Danish: PRODUKTRESUMÉ [Det gælder alle præparater i Bilag I, at produktinformationen skal ændres (indsætning, udskiftning eller sletning af tekst afhængigt af, hvad der måtte være relevant), således at den afspejler den aftalte ordlyd som angivet nedenfor]
English: These patients convert codeine into morphine rapidly resulting in higher than expected serum morphine levels.
Danish: Disse patienter omdanner hurtigt codein til morphin, hvilket medfører højere morphinkoncentration i serum end forventet.
English: However, if the patient is an extensive or ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at commonly prescribed doses.
Danish: Hvis en patient derimod er en ekstensiv eller ultrahurtig metaboliser, er der en øget risiko for at få bivirkninger på grund af opioidtoksicitet, selv ved normalt ordinerede doser.
English: Section 2 - What you need to know before you <take> <use> <product name>
Danish: 2 - Det skal <du> vide, før <De> <du> begynder at <tage> <bruge> <særnavn>
English: Codeine and morphine passes into breast milk.”
Danish: Codein og morfin udskilles i modermælken."
English: PACKAGE LEAFLET (PL) [The following wording should be included in the package leaflet of the marketing authorisations:]
Danish: INDLÆGSSEDDEL [Nedenstående tekst skal inkluderes i indlægssedlen til markedsføringstilladelserne:]
English: Morphine is the substance that produces the effects of codeine.
Danish: Morfin er det stof, der giver virkningen af codein.
English: At normal therapeutic doses codeine and its active metabolite may be present in breast milk at very low doses and is unlikely to adversely affect the breast fed infant.
Danish: Ved normale terapeutiske doser kan codein og dets aktive metabolit være til stede i modermælk i meget lave koncentrationer, og det er usandsynligt, at dette påvirker det ammede barn.
English: If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite.
Danish: Hvis du oplever nogen af følgende bivirkninger, skal du ophøre med at tage denne medicin og straks søge lægehjælp: langsomt eller overfladisk åndedræt, forvirring, søvnighed, små pupiller, kvalme, opkastning, forstoppelse, appetitløshed. "
English: Codeine is not recommended for use in children in whom respiratory function might be compromised including neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures.
Danish: Det frarådes at anvende codein til børn, hvor lungefunktionen kan være påvirket, herunder ved neuromuskulære lidelser, svære hjerte- eller respirationslidelser, infektioner i øvre luftveje eller i lungerne, multiple traumer eller omfattende kirurgiske indgreb.
English: • “In children below the age of 12 years due to an increased risk of developing serious and lifethreatening adverse reactions.
Danish: • "Børn under 12 år, da risikoen for udvikling af alvorlige og livstruende bivirkninger er øget.
English: General symptoms of opioid toxicity include confusion, somnolence, shallow breathing, small pupils, nausea, vomiting, constipation and lack of appetite.
Danish: De generelle symptomer på opioidtoksicitet omfatter konfusion, søvnighed, overfladisk vejrtrækning, små pupiller, kvalme, opkastning, obstipation og appetitløshed.
English: However, if the patient is an ultrarapid metaboliser of CYP2D6, higher levels of the active metabolite, morphine, may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant, which may be fatal.”
Danish: Hvis patienten er en ultrahurtig CYP2D6-metaboliser, kan den aktive metabolit morphin imidlertid være til stede i højere koncentrationer i modermælken, og i meget sjældne tilfælde kan dette medføre symptomer på opioidtoksicitet hos barnet, som kan være dødelige."
English: Morphine is the substance that produces the effects of codeine and relieves pain and symptoms of cough.
Danish: Morfin er det stof, der giver virkningen af codein og lindrer smerter og hostesymptomer.
English: “Children with compromised respiratory function
Danish: Nordeuropæer "Børn med nedsat lungefunktion
English: “Do not take <codeine><Product name (if a combination product)> while you are breastfeeding.
Danish: "Tag ikke <codein><særnavn (hvis et kombinationspræparat)>, mens du ammer.
English: Codeine is metabolised by the liver enzyme CYP2D6 into morphine, its active metabolite.
Danish: Codein metaboliseres via CYP2D6 i leveren til morphin, codeins aktive metabolit.
English: Section 4 - Possible side effects
Danish: 4 - Bivirkninger
English: “Reporting of suspected adverse reactions
Danish: "Indberetning af formodede bivirkninger
English: Do not <take> <use> <product name>: “If you are under 12 years old” “If you know that you metabolise very rapidly codeine into morphine” “If you are breastfeeding”
Danish: <<Tag> <> ikke>> <særnavn> <:> "Hvis <De><du> er under 12 år" "Hvis du ved, at du omdanner codein til morfin meget hurtigt" "Hvis du ammer"
English: In some people, morphine is not produced or produced in very small quantities, and it will not provide enough pain relief or relieve their cough.
Danish: Hos nogle mennesker omdannes codein ikke til morfin, eller det omdannes i meget små mængder, og det vil ikke give tilstrækkelig smertelindring eller hjælpe på deres hoste.
English: In some people, morphine is not produced or produced in very small quantities, and it will not have an effect on their cough symptoms.
Danish: Hos nogle mennesker omdannes codein ikke til morfin, eller det omdannes i meget små mængder, og det vil ikke virke på deres hostesymptomer.
English: “<Codeine><Product name (if a combination product)> is contraindicated in women during breastfeeding (see section 4.3).
Danish: “<Codein><særnavn (hvis et kombinationspræparat)> er kontraindiceret hos kvinder, der ammer (se pkt.
English: • “In women during breastfeeding (see section 4.6)”
Danish: • "Kvinder, der ammer (se pkt.
English: • “In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers”
Danish: • "Patienter, som vides at have en betydeligt øget CYP2D6-aktivitet (ultra rapid metabolisers)"
English: “Codeine is transformed to morphine in the liver by an enzyme.
Danish: "Et enzym i leveren omdanner codein til morfin.
English: Children aged less than 12 years: <Codeine><product name (if a combination products)> is contraindicated in children below the age of 12 years (see sections 4.3).
Danish: Børn under 12 år: <Codein><særnavn (hvis et kombinationspræparat)> er kontraindiceret hos børn under 12 år (se pkt.
English: Warnings and precautions [Note: For products authorised in the cough and/or cold indication only:]
Danish: Advarsler og forsigtighedsregler [Bemærk: Gælder kun præparater godkendt til hoste og/eller forkølelse:]
English: “Reporting of side effects
Danish: Indberetning af bivirkninger
English: Section 4.3 - Contraindications [Note: For products authorised in the cough and/or cold indication only:]
Danish: 4.3 - Kontraindikationer [Bemærk: Gælder kun præparater godkendt til hoste og/eller forkølelse:]
English: Section 4.2 - Posology and method of administration [Note: For products authorised in the cough and/or cold indication only:]
Danish: 4.2 - Dosering og indgivelsesmåde [Bemærk: Gælder kun præparater godkendt til hoste og/eller forkølelse:]
English: Children aged less than 12 years: <Codeine><Product name (if a combination product)> is contraindicated in children below the age of 12 years for the symptomatic treatment of <cough><and/or><cold>1see sections 4.3).
Danish: Børn under 12 år: <Codein><særnavn (hvis et kombinationspræparat)> er kontraindiceret til børn under 12 år til symptomatisk behandling af <hoste><og/eller><forkølelse>1se pkt.
English: You can also report side effects directly via the national reporting system listed in Appendix V*.
Danish: Dette gælder også mulige bivirkninger, som ikke er medtaget i denne indlægsseddel <De> <Du> eller <Deres> <dine> pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V*.
English: Children aged 12 years to 18 years <Codeine><Product name (if a combination product)> is not recommended for use in children aged 12 years to 18 years with compromised respiratory function for the symptomatic treatment of <cough><and/or><cold>1 (see section 4.4).”
Danish: Børn fra 12 til 18 år <Codein><særnavn (hvis et kombinationspræparat)> bør ikke anvendes til børn i alderen 12 til 18 år med nedsat lungefunktion til symptomatisk behandling af <hoste><og/eller><forkølelse>1 (se pkt.
English: • “In women during breastfeeding (see section 4.6)” • “In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers”
Danish: 4.6)" • "Patienter, som vides at have en betydeligt øget CYP2D6-aktivitet (ultra rapid metabolisers)"
English: <cough><and/or><cold>1 due to an increased risk of developing serious and life-threatening adverse reactions.
Danish: • "Børn under 12 år til symptomatisk behandling af <hoste><og/eller><forkølelse>1, da risikoen for udvikling af alvorlige og livstruende bivirkninger er øget.
English: Adolescents older than 12 years of age <Codeine><Product name (if a combination product)> is not recommended in adolescents with compromised respiratory function for the treatment of <cough><and/or><cold>1.
Danish: Unge over 12 år <Codein><særnavn (hvis et kombinationspræparat)> frarådes til unge med vejrtrækningsproblemer til behandling af <hoste><og/eller><forkølelse>1.
English: Hungarian Northern European
Danish: Ungarer
English: Other reagents would provide different results.
Danish: Andre reagenser ville give andre resultater.
English: Frequencies are defined as:
Danish: Hyppighed defineres som:
English: The recommendation is also based on limited non-clinical data.
Danish: Anbefalingen er desuden baseret på begrænsede, ikke-kliniske data.
English: WEEK 1, WEEK 2, WEEK 3
Danish: UGE 1, UGE 2, UGE 3
English: - If you are taking
Danish: - Hvis du tager
English: sun as symbol moon as symbol
Danish: sol som symbol måne som symbol
English: The primary objective of PIONEER AF-PCI was to assess safety.
Danish: Det primære formål ved PIONEER AF-PCI var at vurdere sikkerheden.
English: Date of first authorisation: 30 September 2008 Date of latest renewal: 22 May 2018
Danish: Dato for første markedsføringstilladelse: 30. september 2008 Dato for seneste fornyelse: 22. maj 2018
English: Inter-ethnic differences
Danish: Interetniske forskelle
English: When should I seek advice from my health care provider?
Danish: Hvornår skal jeg søge råd hos lægen?
English: Different weight categories
Danish: Forskellige vægtkategorier
English: Your doctor will also tell you to take either:
Danish: Din læge vil også fortælle dig, at du enten skal tage:
English: Bleeding is the most common side effect.
Danish: Blødning er den almindeligste bivirkning.
English: Number of patients*
Danish: Antal patienter*
English: There is not enough information on its use in children and adolescents.
Danish: Der findes ikke tilstrækkelige oplysninger om anvendelse til børn og unge.
English: To be taken with food.
Danish: Tages sammen med mad.
English: WEEK 4
Danish: UGE 4
English: very common (≥ 1/10)
Danish: Meget almindelig (≥ 1/10)
English: In case of emergency, please notify:
Danish: I akutte situationer, kontakt venligst:
English: Macrogol 3350
Danish: Filmovertræk Macrogol 3350
English: Your doctor will also tell you to take acetylsalicylic acid.
Danish: Din læge vil også fortælle dig, at du skal tage acetylsalicylsyre.
English: The volume of distribution is moderate with Vss being approximately 50 litres.
Danish: Fordelingsvolumenet er moderat, idet Vss er cirka 50 liter.
English: • Interim analyses reports provided annually beginning Q4 2015 until completion of the study programme.
Danish: • Indsendelse af interime analyserapporter hvert år begyndende 4. kvartal 2015 indtil afslutningen af studieprogrammet.
English: DAY 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21
Danish: Dag 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21
English: • Recommendations for dose reduction in at risk populations
Danish: • Anbefalinger til dosisnedsættelse i risikopopulationer
English: Information for health care providers:
Danish: Information til sundhedspersonale:
English: Corresponding increases in pharmacodynamic effects were more pronounced.
Danish: Tilsvarende stigninger i de farmakodynamiske effekter var mere udtalte.
English: Day 1-21
Danish: Dag 1-21
English: Doctor's phone: Doctor's stamp:
Danish: Lægens telefonnummer: Lægens stempel:
English: Contact your doctor immediately if you have taken too many Xarelto tablets.
Danish: Kontakt lægen øjeblikkeligt, hvis du har taget for mange Xarelto-tabletter.
English: • The use of coagulation tests and their interpretation
Danish: • Brugen af koagulationstests og tolkning af samme
English: Thus, the results were consistent with the results of the pivotal randomised studies.
Danish: Resultaterne var således i overensstemmelse med resultaterne fra de pivotale randomiserede studier.
English: 20024 Garbagnate Milanese Italy
Danish: 20024 Garbagnate Milanese Italien
English: Xarelto is for oral use.
Danish: Xarelto er til oral anvendelse.
English: The treatment duration was up to 12 months depending on the individual randomisation date (median: 351 days).
Danish: Behandlingsvarigheden var op til 12 måneder afhængigt af den individuelle randomiseringsdato (median: 351 dage).
English: • Guidance regarding switching from or to rivaroxaban treatment
Danish: • Vejledning om skift fra eller til rivaroxaban-behandling
English: Patients were followed for a median of 23 months and maximum of 3.9 years.
Danish: Patienterne blev fulgt i en mediantid på 23 måneder og maksimalt i 3,9 år.
English: Transfusion of 2 or more units of packed red blood cells or whole blood*
Danish: Transfusion af 2 eller flere enheder pakkede røde blodceller eller helblod*
English: Excessive bleeding may lead to a sudden drop in blood pressure (shock).
Danish: Voldsom blødning kan medføre et pludseligt blodtryksfald (shock).
English: DAY 22 DAY 23 DAY 24 DAY 25 DAY 26 DAY 27 DAY 28
Danish: DAG 22 DAG 23 DAG 24 DAG 25 DAG 26 DAG 27 DAG 28
English: In some cases the bleeding may not be obvious.
Danish: I nogle tilfælde er disse blødninger ikke umiddelbart synlige.
English: 349 [189-362] days 353 [190-362] days 350 [186-362] days
Danish: 349 [189-362] dage 353 [190-362] dage 350 [186-362] dage
English: • Management of overdose situations
Danish: • Håndtering af tilfælde af overdosering
English: You should not drive or use machines if you are affected by these symptoms.
Danish: Du må ikke føre motorkøretøj eller betjene maskiner, hvis du oplever disse symptomer.
English: • Details of populations potentially at higher risk of bleeding
Danish: • Oplysning om populationer med potentielt højere risiko for blødninger
English: To ensure optimal protection from blood clots, never skip a dose.
Danish: For at få en optimal beskyttelse mod blodpropper må du aldrig springe en dosis over.
English: The results of the PK/PD analyses in Phase II and III were consistent with the data established in healthy subjects.
Danish: Resultaterne af PK/PD-analyserne i fase II og III var konsistente med de data, der blev fundet hos raske forsøgspersoner.
English: KM % Patients with events
Danish: KM % Patienter med hændelser
English: ♦ Keep this card with you at all times ♦ Present this card to every physician or dentist prior to treatment
Danish: ♦ Hav altid dette kort på dig ♦ Vis altid kortet til læge eller tandlæge før behandlingen
English: The risk may also be increased by traumatic or repeated epidural or spinal puncture.
Danish: Risikoen kan også stige ved traumatisk eller gentagen epidural- eller spinalpunktur.
English: The results of this patient population were also consistent with the overall efficacy and safety results.
Danish: Resultaterne i denne patientpopulation var også konsistente med de samlede resultater for virkning og sikkerhed.
English: • Patient Alert Cards [Text included in Annex III]
Danish: • Patientkort [Teksten til kortet fremgår af bilag III]
English: Table 1: Number of patients studied, total daily dose and maximum treatment duration in phase III studies
Danish: Tabel 1: Antal undersøgte patienter, total daglig dosis og maksimal behandlingsvarighed i fase III-studier
English: Treatment duration median [interquartile range]
Danish: Behandlingsvarighed median [interkvartilt interval]
English: TEE- guided (1 - 5 days of pretreatment) or conventional cardioversion (at least three weeks of pre-treatment) strategies were employed.
Danish: Der blev anvendt en TEE-guidet (1-5 dages førbehandling) eller konventionel (mindst tre ugers førbehandling) kardioverteringsstrategi.
English: The safety results in this subgroup of patients undergoing PCI were comparable to the overall safety results.
Danish: Sikkerhedsresultaterne i denne undergruppe af patienter, der gennemgik en PCI, var sammenlignelige med de samlede sikkerhedsresultater.
English: p-value b)
Danish: p-værdi b)