FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not take Nityr: - if you are allergic to nitisinone or any of the other ingredients of this medicine (listed in section - Do not breast-feed while taking this medicine, see section “Pregnancy and breast-feeding”.
Danish: Tag ikke Nityr - hvis De er allergisk over for nitisinon eller et af de øvrige indholdsstoffer i Nityr (angivet i punkt 6).
English: 4 years
Danish: 2 år
English: Probability of no HCC (95% confidence interval) at Start 2 years 4 years 6 years 2 years
Danish: Sandsynlighed for fravær af HCC (95 % konfidensinterval)
English: What you need to know before you take Nityr 3.
Danish: Virkning og anvendelse Det skal De vide, før De begynder at tage Nityr Sådan skal De tage Nityr Bivirkninger
English: Talk to your doctor or pharmacist before taking Nityr.
Danish: Kontakt lægen eller apotekspersonalet, før De tager Nityr, - hvis De får røde øjne eller andre tegn på påvirkninger på øjnene.
English: If you take more Nityr than you should
Danish: Hvis De har taget for meget Nityr
English: - This medicine has been prescribed for you.
Danish: - Lægen har ordineret Nityr til Dem personligt.
English: The new measures are:
Danish: De nye foranstaltninger er:
English: 17 July 2018 EMA/498908/2018
Danish: 17. juli 2018 EMA/498908/2018
English: An increased need for renal replacement therapy has been reported up to 90 days after HES administration.
Danish: Et øget behov for nyreerstatningsbehandling er blevet rapporteret op til 90 dage efter HES-administration.
English: They belong to the class of medicines known as colloids.
Danish: De tilhører en klasse af lægemidler, der kaldes kolloider.
English: • Patients who have questions or concerns should speak to their treating doctor.
Danish: • Patienter, der har spørgsmål eller betænkeligheder, bør tale med den læge, der behandler dem.
English: This programme will be implemented by the companies holding the marketing authorisations.
Danish: Programmet vil blive gennemført af de virksomheder, der er indehavere af markedsføringstilladelserne.
English: The review of HES solutions for infusion was initiated on 17 October 2017 at the request of the Swedish Medical Products Agency, under Article 107i of Directive 2001/83/EC.
Danish: Gennemgangen af HES-opløsninger til infusion blev indledt den 17. oktober 2017 på anmodning af den svenske lægemiddelstyrelse i henhold til artikel 107i i direktiv 2001/83/EF.
English: • Alternative therapeutic options are available for routine clinical practice and should be considered according to relevant clinical guidelines.
Danish: • Alternative behandlingsmuligheder er tilgængelige for rutinemæssig klinisk praksis og bør overvejes i overensstemmelse med relevante kliniske retningslinjer.
English: In the European Union, HES solutions for infusion have been approved via national procedures and are available in the Member States under various trade names.
Danish: I EU er HES-opløsninger til infusion godkendt via nationale procedurer og tilgængelige i medlemsstaterne under forskellige handelsnavne.
English: • The expected benefit of treatment should be carefully weighed against the uncertainties with regard to long-term safety.
Danish: • Den forventede fordel ved behandlingen bør afvejes nøje i forhold til den uvished, der er omkring sikkerheden på lang sigt.
English: After looking at these specific aspects, in May 2018 the PRAC confirmed its previous recommendation for suspension and sent a revised recommendation to the CMDh.
Danish: Efter at have set nærmere på disse specifikke aspekter bekræftede PRAC i maj 2018 sin tidligere anbefaling om suspension og fremsendte en revideret anbefaling til CMDh.
English: Blood coagulation parameters should be monitored carefully in case of prolonged use.
Danish: Blodkoagulationsparametre bør overvåges omhyggeligt ved længerevarende brug.
English: Besides blood products, there are two types of medicines used for plasma volume replacement: crystalloids and colloids.
Danish: Ud over blodprodukter findes der to typer lægemidler, som anvendes til at erstatte plasmavolumen: krystalloider og kolloider.
English: As the CMDh position was adopted by majority vote, it was sent to the European Commission.
Danish: Da CMDh's standpunkt blev vedtaget ved en flertalsafgørelse, blev det fremsendt til EuropaKommissionen.
English: Patients' kidney function should be monitored after HES administration.
Danish: Patienternes nyrefunktion bør overvåges efter HES-administration.
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Danish: CMDh er en instans, der repræsenterer EU's medlemsstater, og som har ansvaret for harmonisering af sikkerhedsstandarderne i EU for lægemidler, der godkendes via nationale procedurer.
English: Colloids contain large molecules such as starch, whereas crystalloids, such as saline or Ringer's solutions, are electrolyte solutions.
Danish: Kolloider indeholder store molekyler som f.eks. stivelse, mens krystalloider som f.eks. saltvand eller Ringer-opløsninger er elektrolytopløsninger.
English: Medicines to remain on the market provided that training, controlled access and warnings on the packaging are implemented
Danish: Lægemidlerne kan fortsat markedsføres, forudsat at oplæring, kontrolleret adgang og advarsler på pakningerne gennemføres
English: The CMDh agreed with the PRAC's assessment of the serious risks in critically ill patients and patients with sepsis.
Danish: CMDh var enig i PRAC's vurdering af de alvorlige risici for kritisk syge patienter og patienter med sepsis.
English: • the implementation of a controlled access programme by the companies holding the marketing authorisations to ensure that only accredited hospitals will be supplied with these medicines.
Danish: • gennemførelse af et program med kontrolleret adgang, som styres af de virksomheder, der er indehavere af en markedsføringstilladelse, for at sikre, at kun akkrediterede hospitaler får adgang til disse lægemidler.
English: • If you are given a HES infusion, your doctor will monitor your kidneys to check that they are working well enough.
Danish: • Hvis du får en HES-infusion, vil lægen overvåge din nyrefunktion for at sikre, at de fungerer godt nok.
English: The review was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC), EMA's Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations on 12 January 2018.
Danish: Gennemgangen blev først foretaget af Udvalget for Risikovurdering inden for Lægemiddelovervågning (PRAC), som har ansvar for vurdering af sikkerhedsspørgsmål vedrørende lægemidler til mennesker, og som fremsatte et sæt anbefalinger den 12. januar 2018.
English: • Additional studies are ongoing with HES solutions in patients with trauma and those undergoing elective surgery to further investigate the long-term safety of HES prescribed according to the recommendations for use (dose less than 30 ml/kg and duration less than 24 hours).
Danish: • Der gennemføres i øjeblikket en række studier af HES-opløsninger hos patienter med traumer og patienter, som skal gennemgå planlagt kirurgi, med henblik på at undersøge den langsigtede sikkerhed ved HES ordineret i overensstemmelse med den anbefalede brug (dosis på mindre end 30 ml/kg og varighed under 24 timer).
English: • Use of HES solutions for infusion should be restricted to the initial phase of volume resuscitation with a maximum time interval of 24 hours.
Danish: • Brug af HES-opløsninger til infusion bør begrænses til den indledende fase af genskabelse af væskebalancen med en maksimal varighed på 24 timer.
English: HES solutions should not be used for fluid maintenance.
Danish: HES-opløsninger bør ikke anvendes til opretholdelse af væskebalancen.
English: This followed further reflection, in consultation with EU Member States, on whether it would be feasible to introduce new measures that would effectively reduce the risks with these medicines.
Danish: Dette skridt kommer efter yderligere overvejelser og samråd med EU-medlemsstater om, hvorvidt det er muligt at gennemføre nye foranstaltninger, der effektivt kan reducere risiciene ved disse lægemidler.
English: The CMDh also requested marketing authorisation holders to conduct studies to check that only patients who should be treated with these medicines are receiving them.
Danish: CMDh krævede også, at indehaverne af markedsføringstilladelse skal gennemføre studier for at undersøge, om det kun er de patienter, der bør behandles med disse lægemidler, som rent faktisk får dem.
English: However, the CMDh gave further consideration to the place of HES in the clinical practice of some countries, noted that previous risk minimisation measures had some effect, and considered that a combination of new risk minimisation measures would effectively ensure that HES solutions are not used in patients at risk.
Danish: Imidlertid gjorde CMDh sig en række yderligere overvejelser vedrørende HES-opløsningernes rolle i den kliniske praksis i en række lande og bemærkede, at tidligere risikominimerende foranstaltninger havde haft en vis effekt, og vurderede i sidste ende, at en kombination af nye risikominimerende foranstaltninger effektivt kan sikre, at HES-opløsninger ikke anvendes hos patienter i risikogruppen.
English: The PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a position on 24 January 2018.
Danish: PRAC's anbefalinger blev overgivet til koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker (CMDh), som vedtog et standpunkt den 24. januar 2018.
English: Healthcare professionals will be informed in writing of the outcome of the review and the introduction of the new risk minimisation measures, which include the introduction of a controlled access programme requiring training of relevant healthcare professionals on the safe use of these medicines.
Danish: Sundhedspersoner vil blive informeret skriftligt om udfaldet af gennemgangen og indførelsen af de nye risikominimerende foranstaltninger, som omfatter indførelse af et program med kontrolleret adgang, der kræver oplæring af relevante sundhedspersoner i sikker brug af disse lægemidler.
English: In January 2018, EMA's safety committee PRAC recommended suspending the marketing authorisations of these medicines because they continued to be used in critically ill patients and patients with sepsis despite restrictions introduced in 2013 due to the risk of kidney injury and death in these patients.
Danish: I januar 2018 anbefalede EMA's sikkerhedskomité (PRAC) suspension af markedsføringstilladelserne for disse lægemidler, da de fortsat blev anvendt hos kritisk syge patienter og patienter med sepsis på trods af restriktioner indført i 2013 som følge af risikoen for nyreskade og dødsfald hos disse patienter.
English: • HES solutions for infusion are also contraindicated in dehydrated patients, hyperhydrated patients, patients with intracranial or cerebral haemorrhage, burn injuries, severe hyperkalaemia, hypernatraemia, hyperchloraemia, congestive heart failure, organ transplant patients and patients with impaired hepatic function.
Danish: • HES-opløsninger til infusion er også kontraindicerede hos dehydrerede patienter, hyperhydrerede patienter, patienter med intrakraniel blødning eller hjerneblødning, brandskader, svær hyperkaliæmi, hypernatriæmi, hyperkloræmi eller kongestivt hjertesvigt, organtransplanterede patienter og patienter med nedsat leverfunktion.
English: • writing directly to healthcare professionals to ensure that they are fully aware of the conditions of use of the medicines and the groups of patients that must not receive them due to an increased risk of kidney injury and death.
Danish: • skriftlig kommunikation direkte til sundhedspersonerne for at sikre, at de er fuldt ud klar over betingelserne for brug af lægemidlerne og de grupper, der ikke må behandles med dem på grund af en øget risiko for nyreskade og dødsfald.
English: The accreditation would require that relevant healthcare professionals receive training on the safe use of HES solutions for infusion.
Danish: Det er et krav for akkreditering, at relevante sundhedspersoner bliver oplært i sikker brug af HES-opløsninger til infusion.
English: They are given by infusion (drip) into a vein and are used as blood volume expanders to prevent a dangerous drop in blood pressure following acute bleeding.
Danish: De gives ved infusion (drop) i en blodåre og anvendes til at øge blodvolumen for at forebygge et farligt fald i blodtrykket efter akut blødning.
English: HES solutions should be discontinued at the first sign of coagulopathy.
Danish: HES-opløsninger bør seponeres ved første tegn på koagulopati.
English: • HES solutions for infusion are contraindicated in severe coagulopathy.
Danish: • HES-opløsninger til infusion er kontraindicerede ved svær koagulopati.
English: This is in addition to ongoing studies on the benefits and risks of HES solutions in patients with trauma and those undergoing elective surgery.
Danish: Dette skal ske i tillæg til de igangværende studier af fordelene og risiciene ved HES-opløsninger hos patienter, der har et traume, eller som skal gennemgå planlagt kirurgi.
English: Treatment should be guided by continuous haemodynamic monitoring so that the infusion is stopped as soon as haemodynamic goals have been achieved.
Danish: Behandlingen bør styres ved hjælp af kontinuerlig hæmodynamisk overvågning, og infusionen skal stoppes, så snart de hæmodynamiske mål er nået.
English: The CMDh position was adopted by majority vote and the matter was sent to the European Commission, which took an EU-wide legally binding decision on 17 July 2018.
Danish: CMDh's standpunkt blev vedtaget ved en flertalsafgørelse, og sagen blev fremsendt til EuropaKommissionen, som vedtog en retligt bindende afgørelse for hele EU den 17. juli 2018.
English: • HES solutions for infusion are used to replace fluids in the body after acute (sudden) blood loss.
Danish: • HES-opløsninger til infusion anvendes for at erstatte kropsvæske efter akut (pludseligt) blodtab.
English: The use of HES must be discontinued at the first sign of renal injury.
Danish: Brugen af HES skal seponeres ved første tegn på nyreskade.
English: On 27 June 2018, the CMDh1 decided that hydroxyethyl starch (HES) solutions for infusion should remain on the market provided that a combination of additional measures to protect patients is implemented.
Danish: Den 27. juni 2018 besluttede CMDh1, at hydroxyethylstivelsesopløsninger (HES-opløsninger) til infusion fortsat kan markedsføres, forudsat at en kombination af yderligere foranstaltninger til beskyttelse af patienterne gennemføres.
English: • warnings in the medicines' packaging and at the top of the summaries of product characteristics (SmPCs) reminding healthcare professionals that these medicines must not be used in patients with sepsis or kidney impairment or in critically ill patients;
Danish: • advarsler på lægemiddelpakningerne og øverst i produktresuméerne, som skal minde sundhedspersonerne om, at disse lægemidler ikke må anvendes hos patienter med sepsis eller nedsat nyrefunktion eller hos kritisk syge patienter
English: In April 2018, the European Commission requested that the PRAC and the CMDh further consider any possible unmet medical need that could result from a suspension, as well as the feasibility and likely effectiveness of additional risk minimisation measures.
Danish: I april 2018 bad Europa-Kommissionen PRAC og CMDh om yderligere at overveje, om en suspension kunne medføre ikke-opfyldte medicinske behov, og om det er muligt at gennemføre yderligere risikominimerende foranstaltninger samt deres sandsynlige virkning.
English: Further details about the training and the controlled access programme will be provided to hospitals and healthcare professionals in due time.
Danish: Yderligere detaljer om oplæringen og programmet med kontrolleret adgang vil blive sendt til hospitaler og sundhedspersoner i behørig tid.
English: As the CMDh position was adopted by majority vote, the CMDh position was sent back to the European Commission, which took an EU-wide legally binding decision on 17 July 2018.
Danish: Da CMDh's standpunkt var vedtaget ved en flertalsafgørelse, blev det sendt tilbage til EuropaKommissionen, som vedtog en retligt bindende afgørelse for hele EU den 17. juli 2018.
English: In June 2018, the CMDh concluded that HES solutions for infusion should remain on the market provided that a combination of additional measures to protect patients is implemented.
Danish: I juni 2018 konkluderede CMDh, at HES-opløsninger til infusion fortsat kan markedsføres, forudsat at en kombination af yderligere forholdsregler til beskyttelse af patienterne gennemføres.
English: Further details about the training and the controlled access programme will be provided to hospitals and healthcare professionals in due time;
Danish: Yderligere detaljer om oplæringen og programmet med kontrolleret adgang vil blive sendt til hospitaler og sundhedspersoner i behørig tid
English: HES solutions for infusion are used to replace plasma volume following acute (sudden) blood loss, where treatment with alternative products known as ‘crystalloids' alone is not considered sufficient.
Danish: HES-opløsninger til infusion anvendes til at erstatte plasmavolumen efter akut (pludseligt) blodtab, hvor behandling med alternative produkter (såkaldte krystalloider) alene ikke anses for tilstrækkeligt.
English: • Because of the risk of kidney injury and death, HES solutions for infusion must not be used in patients with blood infection or kidneys problems or in critically ill patients.
Danish: • På grund af risikoen for nyreskade og dødsfald må HES-opløsninger til infusion ikke anvendes hos patienter med blodforgiftning eller nyreproblemer og hos kritisk syge patienter.
English: • HES solutions for infusion should be used for managing hypovolaemia due to acute blood loss only when crystalloids alone are not considered sufficient.
Danish: • HES-opløsninger til infusion må kun bruges til behandling af hypovolæmi som følge af akut blodtab, når krystalloider alene skønnes at være utilstrækkeligt.
English: • Because of the risk of kidney injury and mortality, HES solutions for infusion are contraindicated in patients with sepsis or in critically ill patients.
Danish: • På grund af risikoen for nyreskade og dødsfald er HES-opløsninger til infusion kontraindiceret hos patienter med sepsis og hos kritisk syge patienter.
English: HES solutions for infusion are used for the management of hypovolaemia (low blood volume) caused by acute blood loss, where treatment with alternative infusion solutions known as ‘crystalloids' alone is not considered sufficient.
Danish: HES-opløsninger til infusion anvendes til behandling af hypovolæmi (lavt blodvolumen) forårsaget af akut blodtab, hvor behandling med alternative infusionsopløsninger (såkaldte krystalloider) alene ikke anses for tilstrækkeligt.
English: • HES solutions for infusion are contraindicated in patients with renal impairment or undergoing renal replacement therapy.
Danish: • HES-opløsninger til infusion er kontraindicerede hos patienter med nedsat nyrefunktion og hos patienter, som skal gennemgå nyreerstatningsbehandling.
English: EU/1/03/264/001 Zevalin
Danish: EU/1/03/264/001
English: 1 kit containing: 1 vial of ibritumomab tiuxetan, 1 vial of sodium acetate solution, 1 vial of formulation buffer and 1 empty reaction vial
Danish: 1 sæt indeholder: 1 hætteglas ibritumomab tiuxetan, 1 hætteglas natriumacetat, opløsning, 1 hætteglas bufferopløsning og 1 tomt reaktionshætteglas
English: 1.6 mg/ml Kit for radiopharmaceutica l preparation for infusion
Danish: 1,6 mg/ml Radiofarmaceutisk præparationssæt til en infusion
English: Route of administration
Danish: Hætteglas
English: Date of first authorisation: 12 November 2012 Date of latest renewal: 28 August 2017
Danish: Dato for første markedsføringstilladelse: 12. november 2012 Dato for seneste fornyelse: 28. august 2017
English: Diabetic ketoacidosis b,i,k
Danish: Diabetisk ketoacidose b,i,k
English: • Forxiga is used together with insulin.
Danish: • Forxiga anvendes sammen med insulin.
English: Forxiga is used in adult patients (aged 18 years and older).
Danish: Forxiga anvendes til voksne patienter (18 år og derover).
English: It is important to stay on any diet and exercise program recommended by your doctor while taking Forxiga.
Danish: Det er vigtigt at forblive på et diæt- og træningsprogram, som lægen anbefaler, mens du tager Forxiga.
English: • Talk with your doctor about the risk of diabetic ketoacidosis before you start to take Forxiga.
Danish: • Tal med din læge om risikoen for diabetisk ketoacidose, før du begynder at tage Forxiga.
English: • Your doctor may ask you to take Forxiga:
Danish: • Lægen kan bede dig om at tage Forxiga:
English: If you are taking Forxiga for type 1 diabetes: • The recommended dose is one 5 mg tablet each day.
Danish: Hvis du tager Forxiga mod type 1-diabetes: • Den anbefalede dosis er én 5 mg tablet hver dag.
English: Forxiga and other diabetes medicines
Danish: Forxiga og anden diabetesmedicin
English: More information is given below under ‘Other medicines and Forxiga'.
Danish: Der gives yderligere oplysninger under ”Brug af anden medicin sammen med Forxiga”.
English: Type 1 diabetes mellitus Treatment with Forxiga is to be initiated and supervised by specialists in type 1 diabetes.
Danish: Type 1-diabetes mellitus Behandling med Forxiga skal initieres og overvåges af specialister i type 1-diabetes.
English: If you are taking Forxiga for type 1 diabetes, it is important that you keep using insulin.
Danish: Hvis du tager Forxiga mod type 1-diabetes, er det vigtigt, at du fortsætter med at tage insulin.
English: If Fournier's gangrene is suspected, Forxiga should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Danish: Hvis der er mistanke om Fourniers gangræn, bør Forxiga seponeres, og øjeblikkelig behandling (herunder antibiotika og kirurgisk debridement) bør iværksættes.
English: • When you are treated with Forxiga, diabetic ketoacidosis can occur even if your blood sugar is normal.
Danish: • Når du behandles med Forxiga, kan diabetisk ketoacidose forekomme, selvom dit blodsukkerniveau er normalt.
English: Do not use this medicine after the expiry date, which is stated on the blister or carton after ‘EXP'.
Danish: Brug ikke Forxiga efter den udløbsdato ("EXP"), der står på blisterkort og pakning.
English: Forxiga is used for the types of diabetes called:
Danish: Forxiga anvendes til diabetestyperne kaldet:
English: Your doctor may ask you to take Forxiga: - on its own - if you cannot tolerate metformin.
Danish: Lægen kan bede dig om at tage Forxiga: - alene, hvis du ikke kan tåle metformin.
English: Dapagliflozin should not be initiated when patients are at a higher risk of DKA, such as:
Danish: Dapagliflozin bør ikke initieres hos patienter, der har en høj risiko for DKA, så som:
English: If you are taking Forxiga for type 2 diabetes:
Danish: Hvis du tager Forxiga mod type 2-diabetes:
English: Talk to your doctor, pharmacist or nurse before taking Forxiga:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet før du tager Forxiga:
English: Seek medical advice immediately and stop taking Forxiga if levels persist and symptoms present.
Danish: Søg straks lægehjælp, og stop med at tage Forxiga, hvis niveauerne fortsat er høje, og der er symptomer.
English: • Forxiga is used if your type 1 diabetes cannot be controlled with insulin alone.
Danish: • Forxiga anvendes, hvis din type 1-diabetes ikke kan kontrolleres med insulin alene.
English: Forxiga has not been studied in severe renal impairment (GFR < 30 mL/min) or end-stage renal disease (ESRD).
Danish: Forxiga er ikke undersøgt ved alvorlig nedsat nyrefunktion (GFR <30 ml/min) eller hos patienter i terminal nyresygdom (ESRD).
English: The metabolism of dapagliflozin is primarily via glucuronide conjugation mediated by UDP glucuronosyltransferase 1A9 (UGT1A9).
Danish: Dapagliflozins metabolisme foregår primært via glukuronidkonjugering medieret af UDP-glukuronyltransferase-1A9 (UGT1A9).