FrancophonIA/ELRC3.0 huggingface dataset:
English: What Imprida looks like and contents of the pack Imprida 5 mg/160 mg tablets are oval and dark yellow “NVR” on one side and “ECE” on the other side.
Danish: Imprida 5 mg/160 mg tabletter er ovale og mørkegule, præget med ”NVR” på den ene side og ”ECE” på den anden side.
English: Imprida 5 mg/80 mg film-coated tablets amlodipine/valsartan
Danish: Imprida 5 mg/80 mg filmovertrukne tabletter amlodipin/valsartan
English: Imprida 5 mg/160 mg film-coated tablets
Danish: Imprida 5 mg/160 mg filmovertrukne tabletter
English: EU/1/06/373/034 280 film-coated tablets (4x70) EU/1/06/373/037 280 film-coated tablets (20x14)
Danish: EU/1/06/373/034 280 filmovertrukne tabletter (4x70) EU/1/06/373/037 280 filmovertrukne tabletter (20x14)
English: EU/1/06/373/035 280 film-coated tablets (4x70) EU/1/06/373/038 280 film-coated tablets (20x14)
Danish: EU/1/06/373/035 280 filmovertrukne tabletter (4x70) EU/1/06/373/038 280 filmovertrukne tabletter (20x14)
English: EU/1/06/373/036 280 film-coated tablets (4x70) EU/1/06/373/039 280 film-coated tablets (20x14)
Danish: EU/1/06/373/036 280 filmovertrukne tabletter (4x70) EU/1/06/373/039 280 filmovertrukne tabletter (20x14)
English: Imprida 5 mg/160 mg film-coated tablets amlodipine/valsartan
Danish: Imprida 5 mg/160 mg filmovertrukne tabletter amlodipin/valsartan
English: Each tablet contains 10 mg amlodipine and 160 mg valsartan.
Danish: Hver tablet indeholder 10 mg amlodipin og 160 mg valsartan.
English: If you take more Imprida than you should
Danish: Hvis du har taget for meget Imprida
English: medicines used to treat fungal infections (e.g. ketoconazole, itraconazole); medicines used to treat bacterial infections (such as rifampicin, erythromycin, clarithromycin, talithromycin); verapamil, diltiazem (heart medicines); simvastatin (a medicine used to control high cholesterol levels); dantrolene (infusion for severe body temperature abnormalities); medicines used to protect against transplant rejection (ciclosporin).
Danish: ”vasodilatorer”; - medicin mod hiv/aids (f.eks. ritonavir, indinavir, nelfinavir); - medicin til behandling af svampeinfektioner (f.eks. ketoconazol, itraconazol); - medicin til behandling af bakterieinfektioner (f.eks. rifampicin, erythromycin, clarithromycin,
English: EU/1/06/373/001 7 film-coated tablets EU/1/06/373/002 14 film-coated tablets EU/1/06/373/003 28 film-coated tablets EU/1/06/373/004 30 film-coated tablets EU/1/06/373/005 56 film-coated tablets EU/1/06/373/006 90 film-coated tablets EU/1/06/373/007 98 film-coated tablets EU/1/06/373/008 280 film-coated tablets EU/1/06/373/025 56x1 film-coated tablet (unit dose) EU/1/06/373/026 98x1 film-coated tablet (unit dose) EU/1/06/373/027 280x1 film-coated tablet (unit dose)
Danish: EU/1/06/373/001 7 filmovertrukne tabletter EU/1/06/373/002 14 filmovertrukne tabletter EU/1/06/373/003 28 filmovertrukne tabletter EU/1/06/373/004 30 filmovertrukne tabletter EU/1/06/373/005 56 filmovertrukne tabletter EU/1/06/373/006 90 filmovertrukne tabletter EU/1/06/373/007 98 filmovertrukne tabletter EU/1/06/373/008 280 filmovertrukne tabletter EU/1/06/373/025 56x1 filmovertrukket tablet (enhedsdosis) EU/1/06/373/026 98x1 filmovertrukket tablet (enhedsdosis) EU/1/06/373/027 280x1 filmovertrukket tablet (enhedsdosis)
English: EU/1/06/373/017 7 film-coated tablets EU/1/06/373/018 14 film-coated tablets EU/1/06/373/019 28 film-coated tablets EU/1/06/373/020 30 film-coated tablets EU/1/06/373/021 56 film-coated tablets EU/1/06/373/022 90 film-coated tablets EU/1/06/373/023 98 film-coated tablets EU/1/06/373/024 280 film-coated tablets EU/1/06/373/031 56x1 film-coated tablet (unit dose) EU/1/06/373/032 98x1 film-coated tablet (unit dose) EU/1/06/373/033 280x1 film-coated tablet (unit dose)
Danish: EU/1/06/373/017 7 filmovertrukne tabletter EU/1/06/373/018 14 filmovertrukne tabletter EU/1/06/373/019 28 filmovertrukne tabletter EU/1/06/373/020 30 filmovertrukne tabletter EU/1/06/373/021 56 filmovertrukne tabletter EU/1/06/373/022 90 filmovertrukne tabletter EU/1/06/373/023 98 filmovertrukne tabletter EU/1/06/373/024 280 filmovertrukne tabletter EU/1/06/373/031 56x1 filmovertrukket tablet (enhedsdosis) EU/1/06/373/032 98x1 filmovertrukket tablet (enhedsdosis) EU/1/06/373/033 280x1 filmovertrukket tablet (enhedsdosis)
English: Purpura
Danish: Vaskulitis
English: EU/1/06/373/009 7 film-coated tablets EU/1/06/373/010 14 film-coated tablets EU/1/06/373/011 28 film-coated tablets EU/1/06/373/012 30 film-coated tablets EU/1/06/373/013 56 film-coated tablets EU/1/06/373/014 90 film-coated tablets EU/1/06/373/015 98 film-coated tablets EU/1/06/373/016 280 film-coated tablets EU/1/06/373/028 56x1 film-coated tablet (unit dose) EU/1/06/373/029 98x1 film-coated tablet (unit dose) EU/1/06/373/030 280x1 film-coated tablet (unit dose)
Danish: EU/1/06/373/009 7 filmovertrukne tabletter EU/1/06/373/010 14 filmovertrukne tabletter EU/1/06/373/011 28 filmovertrukne tabletter EU/1/06/373/012 30 filmovertrukne tabletter EU/1/06/373/013 56 filmovertrukne tabletter EU/1/06/373/014 90 filmovertrukne tabletter EU/1/06/373/015 98 filmovertrukne tabletter EU/1/06/373/016 280 filmovertrukne tabletter EU/1/06/373/028 56x1 filmovertrukket tablet (enhedsdosis) EU/1/06/373/029 98x1 filmovertrukket tablet (enhedsdosis) EU/1/06/373/030 280x1 filmovertrukket tablet (enhedsdosis)
English: Dysgeusia
Danish: Dyspnø
English: Vascular disorders
Danish: Erektil dysfunktion
English: Uncommon Very rare Uncommon Uncommon
Danish: Meget sjælden Ikke almindelig
English: Your doctor may also check your kidney function; anticonvulsant agents (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone); St. John's wort; nitroglycerin and other nitrates, or other substances called “vasodilators”; medicines used for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir);
Danish: Din læge vil måske også kontrollere din nyrefunktion; - krampehæmmende stoffer (f.eks. carbamazepin, phenobarbital, phenytoin, fosphenytoin,
English: Renal impairment
Danish: Faryngolaryngeale smerter
English: Common Common Uncommon Common
Danish: Ikke almindelig Almindelig Almindelig Almindelig
English: Pruritus
Danish: Paræstesi
English: Uncommon Uncommon Uncommon Uncommon Uncommon Uncommon Very rare Very rare
Danish: Ikke almindelig Ikke almindelig Meget sjælden Meget sjælden
English: Pitting oedema
Danish: Mave-tarmkanalen
English: Uncommon Uncommon Uncommon Uncommon Uncommon
Danish: Ikke almindelig Ikke almindelig Almindelig Ikke almindelig
English: Somnolence
Danish: Hypokaliæmi
English: 20 December 2013 EMA/14811/2014
Danish: Den 20. december 2013 EMA/14811/2014
English: The rate can then be increased but should not exceed 15 mg/h.
Danish: Hastigheden kan derefter øges, men bør ikke overstige 15 mg/h.
English: The MHRA therefore decided to request an EU-wide review of these medicines.
Danish: MHRA besluttede derfor at anmode om en EU-dækkende gennemgang af disse lægemidler.
English: These uses are no longer recommended because the available data are insufficient to support use in these conditions.
Danish: Disse anvendelser anbefales ikke længere, da de foreliggende data er utilstrækkelige til at støtte dem.
English: When the target blood pressure is reached, the dose should be reduced progressively.
Danish: Når målværdien af blodtrykket er nået, bør dosis nedsættes gradvis.
English: Medicines containing nicardipine given into a vein are authorised in the following EU Member States: Belgium, France, Luxemburg, the Netherlands and Spain.
Danish: Lægemidler indeholdende nicardipin til indgift i en vene er godkendt i følgende EU-medlemsstater: Belgien, Frankrig, Luxembourg, Nederlandene og Spanien.
English: The MHRA was concerned that the clinical data submitted were inadequate to determine the benefits and risks of the generic medicine in the proposed indications.
Danish: MHRA var betænkelig ved, at de indsendte kliniske data var utilstrækkelige til at fastslå fordele og risici ved det generiske lægemiddel til de ansøgte indikationer.
English: The review of intravenous nicardipine was initiated in July 2012 at the request of the United Kingdom, under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af lægemidler indeholdende nicardipin til intravenøs anvendelse blev indledt i juli 2012 på anmodning af Det Forenede Kongerige i medfør af artikel 31 i direktiv 2001/83/EF.
English: • treatment of acute life-threatening hypertension, particularly in the event of:
Danish: • behandling af akut livstruende hypertension, navnlig ved:
English: In adults, treatment should start with a continuous administration of nicardipine at a rate of 3-5 mg/h.
Danish: Hos voksne bør behandlingen begynde med kontinuerlig administration af nicardipin med en hastighed på 3-5 mg/h.
English: The CHMP recommendation was sent to the European Commission, which issued a final decision on 20 December 2013.
Danish: CHMP's udtalelse blev overgivet til Europa-Kommissionen, som vedtog en endelig afgørelse den 20. december 2013.
English: It works as a ‘calcium-channel blocker': this means that it blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter the cells.
Danish: Det virker som en calciumkanalblokker, dvs. det blokerer de særlige kanaler (calciumkanaler) på cellernes overflade, hvorigennem calciumioner normalt strømmer ind i cellerne.
English: • treatment of post-operative hypertension.
Danish: • behandling af postoperativ hypertension.
English: It should only be administered by specialists in well controlled environments, with continuous monitoring of blood pressure.
Danish: Det bør kun administreres af speciallæger under velkontrollerede forhold og med kontinuerlig blodtryksovervågning.
English: − malignant arterial hypertension/hypertensive encephalopathy;
Danish: − malign arteriel hypertension/hypertensiv encefalopati
English: The CHMP opinion was sent to the European Commission, which endorsed it and adopted a final legally binding decision valid throughout the EU on 20 December 2013.
Danish: CHMP's udtalelse blev overgivet til Europa-Kommissionen, som godkendte den og den 20. december 2013 vedtog en endelig og retligt bindende afgørelse med gyldighed i hele EU.
English: Regarding the posology, nicardipine should be administered by continuous intravenous infusion.
Danish: Hvad angår doseringen bør nicardipin administreres ved kontinuerlig intravenøs infusion.
English: The recommended therapeutic indications of intravenous nicardipine are now:
Danish: De anbefalede terapeutiske indikationer for intravenøst nicardipin er nu:
English: The UK medicines agency asked the CHMP to carry out an assessment of the benefit-risk balance of intravenous nicardipine and to issue an opinion on whether the marketing authorisations of these medicines should be maintained, varied, suspended or withdrawn across the European Union.
Danish: Det Forenede Kongeriges lægemiddelstyrelse bad CHMP om at foretage en fyldestgørende vurdering af benefit/riskforholdet for nicardipin til intravenøs anvendelse og om at fremsætte en udtalelse om, hvorvidt markedsføringstilladelserne for disse lægemidler bør opretholdes, ændres, suspenderes eller inddrages i hele EU.
English: Nicardipine was also used in some EU countries for controlled hypotension during anaesthesia, for controlling hypertension during surgery and for treating acute severe hypertension with left ventricular decompensation and pulmonary oedema.
Danish: Nicardipin blev i nogle EU-lande desuden anvendt til frembringelse af kontrolleret hypotension under anæstesi, til kontrol af hypertension under operationer og til behandling af akut svær hypertension med dekompensation af venstre ventrikel og lungeødem.
English: The Agency's Committee on Medicinal Products for Human Use (CHMP) concluded that these medicines should only be used to treat acute (sudden) lifethreatening high blood pressure and to control high blood pressure after an operation.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at disse lægemidler kun bør anvendes til behandling af pludseligt (akut) livstruende højt blodtryk og til kontrol af forhøjet blodtryk efter operationer.
English: The CHMP also recommended that these medicines should only be given by continuous infusion (drip) into a vein by a specialist in a hospital or intensive care unit.
Danish: CHMP anbefalede desuden, at disse lægemidler kun indgives kontinuerligt i drop (ved infusion i en vene) af en speciallæge på hospitaler eller intensivafdelinger.
English: • An EU-wide review of medicines containing nicardipine given into a vein has been carried out and recommendations have been given to ensure the safe and effective use of these medicines.
Danish: • Der er foretaget en EU-dækkende gennemgang af lægemidler indeholdende nicardipin til indgift i en vene, og der er givet anbefalinger for at sikre risikofri og effektiv anvendelse af disse lægemidler.
English: It also noted that medicines containing nicardipine given intravenously had been authorised in other EU countries but that the authorised uses differed between countries.
Danish: MHRA bemærkede desuden, at lægemidler indeholdende nicardipin til intravenøs anvendelse var godkendt i andre EU-lande, men at de godkendte anvendelser afveg mellem landene.
English: Having assessed the available evidence on the safety and effectiveness of intravenous nicardipine from published studies and post-marketing data, the CHMP concluded that an intravenous formulation of nicardipine is a useful treatment for high blood pressure in specific settings and with appropriate specialist intervention and monitoring.
Danish: Efter vurdering af den foreliggende dokumentation om sikkerheden og effektiviteten af nicardipin til intravenøs anvendelse i publicerede undersøgelser og data efter markedsføring konkluderede CHMP, at en intravenøs formulering af nicardipin er nyttig til behandling af forhøjet blodtryk under nærmere bestemte omstændigheder og med fornøden medvirken og overvågning af speciallæge.
English: Use of intravenous nicardipine medicines in other indications is no longer recommended.
Danish: Intravenøs anvendelse af lægemidler indeholdende nicardipin ved andre indikationer anbefales ikke længere.
English: • If you have any questions or concerns, speak to your doctor, pharmacist or nurse.
Danish: • Spørg lægen, apotekspersonalet eller sygeplejersken, hvis der er mere, du vil vide.
English: Nicardipine is an ‘antihypertensive' medicine that reduces blood pressure by allowing the blood vessels to relax.
Danish: Nicardipin er et blodtryksnedsættende lægemiddel (antihypertensivum), der reducerer blodtrykket ved at få blodkarrene til at afslappes.
English: − severe pre-eclampsia, when other intravenous antihypertensive agents are not recommended or are contra-indicated;
Danish: − svær præeklampsi, når andre antihypertensiva til intravenøs anvendelse frarådes eller er kontraindiceret
English: • These medicines will be given to you in hospital as a drip into a vein, and your blood pressure will be regularly monitored.
Danish: • På hospitalet vil sådanne lægemidler blive givet gennem et drop i en vene, og patientens blodtryk vil blive overvåget regelmæssigt.
English: • Medicines containing nicardipine given into a vein should be used to treat very severe high blood pressure, or to control high blood pressure after an operation.
Danish: • Lægemidler indeholdende nicardipin til indgift i en vene bør anvendes til behandling af meget svært forhøjet blodtryk eller til regulering af for højt blodtryk efter en operation.
English: The review of intravenous nicardipine was triggered by the UK medicines regulatory agency (MHRA), following submission in the UK of an application for a generic intravenous nicardipine medicine.
Danish: Gennemgangen af nicardipin til intravenøs anvendelse blev udløst af Det Forenede Kongeriges lægemiddelstyrelse (MHRA), efter at denne havde modtaget en ansøgning om et generisk nicardipinlægemiddel til intravenøs anvendelse.
English: − aortic dissection, when short acting beta-blocker therapy is not suitable, or in combination with a beta-blocker when beta-blockade alone is not effective;
Danish: − aortadissektion, når behandling med korttidsvirkende betablokkere ikke er hensigtsmæssig, eller kombineret med en betablokker, når betablokade alene ikke er effektiv
English: The EU-wide review of intravenous nicardipine has resulted in updated prescribing information for these medicines.
Danish: Den EU-dækkende gennemgang af intravenøst nicardipin resulterede i ajourførte produktoplysninger om lægemidlerne.
English: When calcium ions enter the cells in the muscles of blood vessel walls, this causes contraction.
Danish: Når calciumioner strømmer ind i muskelcellerne i blodkarrenes vægge, trækker karrene sig sammen.
English: On 24 October 2013, the European Medicines Agency completed a benefit-risk review of intravenous (given into a vein) nicardipine medicines.
Danish: Den 24. oktober 2013 afsluttede Det Europæiske Lægemiddelagentur en benefit/risk-vurdering af lægemidler indeholdende nicardipin til indgift i en vene (intravenøst).
English: Detailed information on the recommended uses of intravenous nicardipine, including instructions on how to use these medicines, can be found below.
Danish: Nedenfor er givet detaljerede oplysninger om de anbefalede anvendelser af intravenøst nicardipin samt anvisninger for brugen.
English: Nicardipine should be used with caution and at lower doses in specific patient populations, including patients with liver and kidney problems and children.
Danish: Hos særlige patientpopulationer, herunder patienter med lever- og nyresygdomme samt børn, bør der udvises forsigtighed, og dosis af nicardipin bør nedsættes.
English: By reducing the flow of calcium into the cells, nicardipine prevents the cells from contracting and this helps the blood vessels to relax.
Danish: Nicardipin mindsker indstrømningen af calcium i cellerne, så de ikke kan trække sig sammen.
English: 13 September 2013 EMA/579491/2013
Danish: Den 13. september 2013 EMA/579491/2013
English: The review of intravenous iron-containing medicines was initiated at the request of France, under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af jernholdige lægemidler til intravenøs indgivelse blev indledt på foranledning af Frankrig i medfør af artikel 31 i direktiv 2001/83/EF.
English: The French medicines agency asked the CHMP to carry out a full assessment of the benefit-risk balance and to issue an opinion on whether the marketing authorisations for these medicines should be maintained, varied, suspended or withdrawn across the European Union.
Danish: Den franske lægemiddelstyrelse bad CHMP om at foretage en komplet vurdering af benefit/risk-forholdet og fremsætte en udtalelse om, hvorvidt markedsføringstilladelserne for disse lægemidler bør opretholdes, ændres, suspenderes eller inddrages i hele EU.
English: The various iron preparations contain complexes of iron bound to other molecules such as sugar molecules.
Danish: De forskellige jernpræparater indeholder komplekser af jern bundet til andre molekyler såsom sukkermolekyler.
English: The CHMP concluded that the benefits of these medicines are greater than their risks, provided that adequate measures are taken to minimise the risk of allergic reactions.
Danish: CHMP konkluderede, at fordelene ved disse lægemidler er større end risiciene, forudsat at der træffes passende foranstaltninger til at reducere risikoen for allergiske reaktioner.
English: In addition, the CHMP considered that the current practice of first giving the patient a small test dose is not a reliable way to predict how the patient will respond when the full dose is given.
Danish: Desuden fandt CHMP, at den nuværende praksis med først at give patienten en lille testdosis ikke er pålidelig til at forudsige, hvordan patienten vil reagere på at få den fulde dosis.
English: • Data on the risk of hypersensitivity comes mainly from post-marketing spontaneous reports and the total number of life-threatening and fatal events reported is low.
Danish: • Data om risikoen for overfølsomhed hidrører hovedsagelig fra spontane indberetninger efter markedsføring, og det samlede antal indberettede livstruende hændelser og hændelser med dødelig udgang er lavt.
English: The CHMP also considered that, during pregnancy, allergic reactions are of particular concern as they can put both the mother and unborn child at risk.
Danish: CHMP tog desuden hensyn til, at allergiske reaktioner under graviditet er særligt betænkelige, da de kan udsætte både moderen og det ufødte barn for risiko.
English: In rare cases these injections can cause allergic reactions which can be serious.
Danish: I sjældne tilfælde kan disse injektioner medføre allergiske reaktioner, som kan være alvorlige.
English: On 27 June 2013 the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) completed its review of intravenous iron-containing medicines used to treat iron deficiency and anaemia (low red blood cell counts) associated with low iron levels.
Danish: Den 27. juni 2013 afsluttede Det Europæiske Lægemiddelagenturs Udvalg for Lægemidler til mennesker (CHMP) sin gennemgang af intravenøst indgivne jernholdige lægemidler, der anvendes til behandling af jernmangel og den deraf forårsagede anæmi (for lavt antal røde blodlegemer).
English: • If you have signs of an allergic reaction (such as feeling dizzy, swelling of your face and difficulty breathing), you should tell your doctor or nurse straight away.
Danish: • Hvis du får tegn på en allergisk reaktion (såsom svimmelhed, hævet ansigt og åndedrætsbesvær), bør du straks underrette lægen eller sygeplejersken.
English: The Committee therefore concluded that measures should be put in place to ensure the early detection and effective management of allergic reactions that may occur.
Danish: Udvalget konkluderede derfor, at der burde iværksættes foranstaltninger, der sikrer tidlig diagnose og effektiv behandling af eventuelle allergiske reaktioner.
English: • All prescribers should inform patients of the risk and seriousness of a hypersensitivity reaction and the importance of seeking medical attention if a reaction occurs.
Danish: • Alle ordinerende læger bør informere patienterne om risikoen og alvorligheden ved en overfølsomhedsreaktion samt vigtigheden af at søge lægehjælp ved en sådan reaktion.
English: The complexes involved in this procedure were ferric carboxymaltose, iron dextran, sodium ferric gluconate, iron isomaltoside and iron sucrose, which are authorised in all EU Member States via national procedures.
Danish: Denne gennemgang dækkede jernkomplekserne jerncarboxymaltose, jerndextran, natriumferrigluconat, jernisomaltosid og jernsukrose, som er godkendt i alle EU's medlemsstater via nationale procedurer.
English: The CHMP opinion was forwarded to the European Commission, which on 13 September 2013 endorsed it and adopted a final decision that is legally binding throughout the EU.
Danish: CHMP's udtalelse blev overgivet til Europa-Kommissionen, som den 13. september 2013 godkendte den og vedtog en endelig beslutning, der er retligt bindende i hele EU.
English: The CHMP recommendation was sent to the European Commission, which on 13 September 2013 endorsed it and adopted a final decision that is legally binding throughout the EU.
Danish: CHMP's anbefaling blev overgivet til Europa-Kommissionen, som den 13. september 2013 godkendte den og vedtog en endelig beslutning, der er retligt bindende i hele EU.
English: Patients should be closely observed for signs and symptoms of hypersensitivity reactions during and for at least 30 minutes following each injection of an intravenous iron medicine.
Danish: Patienterne skal overvåges tæt for tegn og symptomer på overfølsomhed under og mindst 30 minutter efter hver intravenøs injektion af et jernprodukt.
English: • As there are data indicating that allergic reactions may still occur in patients who have not reacted to a test dose, a test dose is no longer recommended.
Danish: • Da der er evidens for, at der godt kan forekomme allergiske reaktioner hos en patient, uden at denne har reageret på en testdosis, anbefales det ikke længere at give en sådan.