FrancophonIA/ELRC3.0 huggingface dataset:
English: This includes fractures (breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders needing radiotherapy (treatment with radiation) or surgery, and hypercalcaemia (high levels of calcium in the blood).
Danish: Dette omfatter frakturer (knoglebrud), rygmarvskompression (når rygmarven presses sammen af knoglen), knoglelidelser, der kræver stråleterapi eller operation, og hypercalcæmi (forhøjet calciumindhold i blodet).
English: Patients with tumours can have high levels of calcium in their blood, released from the bones.
Danish: Patienter med svulster kan have høje niveauer af calcium, afgivet fra knoglerne, i blodet.
English: The company that markets Zoledronic Acid Accord will provide a card to inform patients receiving Zoledronic Acid Accord about the risk of osteonecrosis of the jaw and to instruct them to contact their doctor if they get symptoms.
Danish: Virksomheden, der markedsfører Zoledronsyre Accord, vil udarbejde et kort med information til patienter, som modtager Zoledronsyre Accord, om risikoen for osteonekrose i kæben og med instrukser om at kontakte deres læge, hvis de oplever symptomer.
English: By preventing the breakdown of bones, Zoledronic Acid Accord also helps to reduce the amount of calcium released into the blood.
Danish: Ved at forebygge nedbrydningen af knoglerne medvirker Zoledronsyre Accord også til at reducere den mængde calcium, der afgives til blodet.
English: An overview of Zoledronic Acid Accord and why it is authorised in the EU
Danish: En oversigt over Zoledronsyre Accord, og hvorfor det er godkendt i EU
English: This is because Zoledronic Acid Accord is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Danish: Det skyldes, at Zoledronsyre Accord gives som infusion i en vene, så det aktive stof leveres direkte i blodbanen.
English: Zoledronic Acid Accord can also be used to treat hypercalcaemia caused by tumours.
Danish: Zoledronsyre Accord kan også anvendes til at behandle hypercalcæmi forårsaget af svulster.
English: Osteonecrosis of the jaw is a condition affecting the bones of the jaw, which could lead to pain, sores in the mouth or loose teeth.
Danish: Osteonekrose i kæben er en tilstand i kæbebenene, som kan føre til smerter, sår i munden eller løse tænder.
English: Zoledronic Acid Accord is a medicine used to prevent bone complications in adults with advanced cancer that is affecting the bone.
Danish: Zoledronsyre Accord er et lægemiddel til forebyggelse af knoglekomplikationer hos voksne med fremskreden kræft, der påvirker knoglerne.
English: Zoledronic Acid Accord contains the active substance zoledronic acid and is a ‘generic medicine'.
Danish: Zoledronsyre Accord indeholder det aktive stof zoledronsyre og er et "generisk lægemiddel".
English: The active substance in Zoledronic Acid Accord, zoledronic acid, is a bisphosphonate.
Danish: Det aktive stof i Zoledronsyre Accord, zoledronsyre, er et bisphosphonat.
English: What measures are being taken to ensure the safe and effective use of Zoledronic Acid Accord?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Zoledronsyre Accord?
English: Other information about Zoledronic Acid Accord
Danish: Andre oplysninger om Zoledronsyre Accord
English: What are the benefits and risks of Zoledronic Acid Accord?
Danish: Hvilke fordele og risici er der forbundet med Zoledronsyre Accord?
English: What is Zoledronic Acid Accord and what is it used for?
Danish: Hvad er Zoledronsyre Accord, og hvad anvendes det til?
English: Zoledronic Acid Accord (zoledronic acid)
Danish: Zoledronsyre Accord (zoledronsyre)
English: Why is Zoledronic Acid Accord authorised in the EU?
Danish: Hvorfor blev Zoledronsyre Accord godkendt i EU?
English: The reduction of bone loss helps to make bones less likely to break, which is useful in preventing fractures in cancer patients with bone metastases.
Danish: Nedsættelsen af knogletabet mindsker risikoen for knoglebrud, hvilket er til gavn for kræftpatienter med knoglemetastaser.
English: When used to prevent bone complications, the infusion can be repeated every three to four weeks, and patients should also take supplements of calcium and vitamin D. A lower dose is recommended for patients with bone metastases (when cancer has spread to the bone) if they have mild to moderately reduced kidney function.
Danish: Til forebyggelse af knoglekomplikationer kan infusionen gentages hver tredje til fjerde uge, og patienterne bør desuden tage calcium- og D-vitamintilskud.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zoledronic Acid Accord have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Zoledronsyre Accord.
English: How has Zoledronic Acid Accord been studied?
Danish: Hvordan blev Zoledronsyre Accord undersøgt?
English: How does Zoledronic Acid Accord work?
Danish: Hvordan virker Zoledronsyre Accord?
English: How is Zoledronic Acid Accord used?
Danish: Hvordan anvendes Zoledronsyre Accord?
English: This will help protect against the disease.
Danish: Dette er med til at beskytte mod sygdommen.
English: This summary was last updated in June 2017.
Danish: Dette sammendrag blev sidst ajourført i juni 2017.
English: The full EPAR for Vepured can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Vepured findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Protection starts 21 days after vaccination and lasts for 112 days.
Danish: Beskyttelsen indtræder 21 dage efter vaccinationen og varer i 112 dage.
English: What is Vepured and what is it used for?
Danish: Hvad er Vepured, og hvad anvendes det til?
English: This is a summary of the European public assessment report (EPAR) for Vepured.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Vepured.
English: The European Commission granted a marketing authorisation valid throughout the EU for Vepured on 17 August 2017.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Vepured den 17/08/2017.
English: The withdrawal period for meat from pigs treated with Vepured is ‘zero' days, which means there is no mandatory waiting time.
Danish: Tilbageholdelsestiden for kød fra svin, der behandles med Vepured, er "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid.
English: Vepured also reduced the weight loss of pigs in herds affected with the disease.
Danish: Vepured reducerede også vægttabet hos svin i besætninger, der var ramt af sygdommen.
English: It results in damage to blood vessels, causing fluid build up in the tissues of the stomach and bowel and affecting the blood supply of the brain, and can lead to death within 24 to 48 hours.
Danish: Det medfører skader på blodkarrene, forårsager væskeophobning i mave- og tarmvævet, påvirker blodforsyningen til hjernen og kan medføre død inden for 24-48 timer.
English: It is not intended to provide practical advice on how to use Vepured.
Danish: Det er ikke en praktisk vejledning i, hvordan Vepured bør anvendes.
English: Why is Vepured approved?
Danish: Hvorfor blev Vepured godkendt?
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Vepured's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Vepured opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: What are the risks associated with Vepured?
Danish: Hvilke risici er der forbundet med Vepured?
English: Other information about Vepured:
Danish: Andre oplysninger om Vepured
English: In the future, if the animals are exposed to the bacteria producing the unmodified toxin, their immune system will be able to make antibodies against the toxin more quickly.
Danish: Hvis dyrene efterfølgende udsættes for den bakterie, der danner det umodificerede toksin, vil deres immunsystem hurtigere kunne danne antistoffer mod toksinet.
English: Vepured contains adjuvants (aluminium hydroxide and DEAE-dextran) to enhance the immune response.
Danish: Vepured indeholder adjuvanser (aluminiumhydroxid og DEAE-dextran), der forstærker immunresponsen.
English: The most common side effects with Vepured (which may affect more than 1 in 10 animals) are mild inflammation at the injection site that resolves within 3 days of vaccination without treatment, mild depression on the day of vaccination and an increase in body temperature of maximum 1.1 °C which returns to normal within 1 day.
Danish: De hyppigste bivirkninger ved Vepured (som kan optræde hos mere end 1 ud af 10 dyr) er let inflammation på injektionsstedet, som forsvinder uden behandling i løbet af tre dage efter vaccinationen, let nedstemthed på vaccinationsdagen og en stigning i kropstemperaturen på højst 1,1 °C, som forsvinder i løbet af en dag.
English: Vepured contains verotoxin 2e that has been modified and inactivated so it can no longer cause disease.
Danish: Vepured indeholder verotoksin 2e, som er blevet modificeret og inaktiveret, så det ikke længere kan forårsage sygdom.
English: Oedema disease is found worldwide and usually occurs in the first few weeks of life of the piglets.
Danish: Ødemsyge findes i hele verden og forekommer som regel i smågrisenes første leveuger.
English: Vepured is a veterinary vaccine used to protect piglets against oedema disease (caused by verotoxin 2e produced by E. coli) and to reduce the loss of daily weight gain until slaughter.
Danish: Vepured er en veterinær vaccine, der anvendes til at beskytte smågrise mod ødemsyge (forårsaget af verotoksin 2e, der dannes af E. coli) og til at reducere det daglige vægttab indtil slagtningen.
English: When Vepured is given to pigs, the animal's immune system recognises the toxin contained in the vaccine as ‘foreign' and makes antibodies against it.
Danish: Når Vepured gives til svin, opfatter dyrets immunsystem toksinerne i vaccinen som "fremmede" og danner antistoffer mod dem.
English: Vepured is a vaccine containing modified, inactivated verotoxin 2e.
Danish: Vepured er en vaccine, der indeholder modificeret, inaktiveret verotoksin 2e.
English: Vepured is given to piglets from 2 days of age as a single injection into the muscle in the neck.
Danish: Vepured gives til smågrise, fra de er to dage gamle, som en enkelt injektion i nakkemuskulaturen.
English: What benefits of Vepured have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Vepured?
English: Vepured is available as a suspension for injection and can only be obtained with a prescription.
Danish: Vepured fås som injektionsvæske, suspension, og udleveres kun på recept.
English: Oedema disease is caused by a bacterial toxin (poison) known as verotoxin 2e that is produced by certain strains of Escherichia coli.
Danish: Ødemsyge skyldes et bakterietoksin (en gift) med navnet verotoksin 2e, som dannes af visse stammer af Escherichia coli.
English: How is Vepured used?
Danish: Hvordan anvendes Vepured?
English: A field study involving 2- to 3-day-old piglets, 1,173 of which were vaccinated with Vepured and 1,048 piglets given a dummy injection, showed that Vepured prevented death of virtually all the piglets from oedema disease over a 115 day period and there was a significant reduction in signs of the disease which included difficulty breathing, oedema (fluid retention) and signs related to the nervous system.
Danish: En feltundersøgelse hos to-tre dage gamle smågrise, hvoraf 1 173 blev vaccineret med Vepured, og 1 048 fik en uvirksom injektion, viste, at Vepured forebyggede død som følge af ødemsyge hos praktisk taget alle smågrise over en periode på 115 dage.
English: How does Vepured work?
Danish: Hvordan virker Vepured?
English: For more information about treatment with Vepured, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med Vepured, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: For practical information about using Vepured, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af Vepured, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: E. coli verotoxoid vaccine (inactivated recombinant)
Danish: Vepured vaccine (inaktiveret, rekombinant) mod E. coli-verotoksin
English: Hence, this has not been changed.
Danish: Denne er derfor ikke blevet ændret.
English: Drug Reactions and Interactions 2006.
Danish: Adverse Drug Reactions and Interactions 2006.
English: • contraindications were sometimes relative rather than absolute.
Danish: • Kontraindikationerne var nogle gange relative snarere end absolutte.
English: It presented in a succinct manner some important facts on these two molecules.
Danish: Den præsenterede kort nogle vigtige fakta om disse to molekyler.
English: In several countries there was no information in section 4.2 on this group of patients.
Danish: I flere lande var der ingen oplysninger i punkt 4.2 om denne patientgruppe.
English: • Aronson JK (editor).
Danish: • JK Aronson (redaktør).
English: A total of 214 patients (age range 64 - 81 years) were included in this trial.
Danish: I alt 214 patienter (i aldersgruppen 64-81 år) blev inkluderet i denne undersøgelse.
English: • Sweetman SC (editor), Martindale: The Complete Drug Reference 36.
Danish: • Sweetman SC (redaktør), Martindale: The Complete Drug Reference 36.
English: • lack of data concerning safety in specific patients groups was the only justification for listing certain contraindications;
Danish: • Manglende data vedrørende sikkerheden i bestemte patientgrupper var den eneste grund til at opliste visse kontraindikationer.
English: Press <http://www.medicinescomplete.com/> (Accessed Sep-Nov 2009)
Danish: Press <http://www.medicinescomplete.com/> (set sept.-nov. 2009)
English: Overall summary of the scientific evaluation of Vascace Plus and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Vascace Plus og relaterede navne (se bilag I)
English: Meyler's Side Effects of Drugs: The International Encyclopedia of Adverse
Danish: Meyler's Side Effects of Drugs: The International Encyclopedia of
English: The 76 non-responders were treated with combination therapy.
Danish: De 76 ikke-responderende patienter blev behandlet med kombinationsterapi.
English: Specific treatment advice was not included as treatment protocols may vary between countries.
Danish: Specifik behandlingsrådgivning blev ikke medtaget, da der kan være forskelle på behandlingsprotokollerne mellem medlemsstaterne.
English: Section 4.5 Interaction with Other Medicinal Products and Other Forms of Interaction
Danish: Punkt 4.5 Interaktion med andre lægemidler og andre former for interaktion
English: The paragraph ‘Clinical/Efficacy Studies' has been slightly rewording for more clarity.
Danish: Punktet "Kliniske undersøgelser/virkningsundersøgelser" er blevet lettere omformuleret for at skabe større klarhed.
English: Differences in level of detail existed between Member States for special warnings and precautions for use.
Danish: Der fandtes forskelle mellem medlemsstaterne i detaljeringsgraden af særlige advarsler og forsigtighedsregler vedrørende brugen.
English: The lowest dose which generated a significant effect was a dose of 2.5/6.25 mg.
Danish: Den laveste dosis, der gav en væsentlig effekt, var en dosis på 2,5/6,25 mg.
English: Furthermore, the addition of an ACE inhibitor may further attenuate this effect.
Danish: Desuden kan tilføjelse af en ACE-hæmmer yderligere svække denne virkning.
English: Treatment is difficult and rather infrequent, since patients with cirrhosis have a tendency towards low blood pressure.
Danish: Behandlingen er vanskelig og temmelig sjælden, da patienter med cirrose har tendens til lavt blodtryk.
English: The CHMP noted that the substitution of the free combination of the active substances given at the same dose is an acceptable indication based on the long experience of concomitant use.
Danish: CHMP bemærkede, at substitutionen af den frie kombination af de aktive stoffer givet i samme dosis er en acceptabel indikation baseret på langvarig erfaring med samtidig brug.
English: This wording of the therapeutic indications for Vascace Plus was identical in many EU countries.
Danish: Ordlyden af de terapeutiske indikationer for Vascace Plus var identisk i mange EU-lande.
English: Combination therapy with antihypertensive agents is rarely necessary.
Danish: Kombinationsterapi med antihypertensive stoffer er sjældent nødvendigt.
English: The proposed text included a general statement concerning emergency treatment of angioedema.
Danish: Den foreslåede formulering omfattede en generel erklæring om akut behandling af angioødem.
English: Section 4.7 Effects on Ability to Drive and Use Machines
Danish: Punkt 4.7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner
English: In some SPCs, relative contraindications were discussed in section 4.4 (Special Warnings and Precautions), rather than in section 4.3;
Danish: I nogle produktresuméer blev relative kontraindikationer drøftet i punkt 4.4 (Særlige advarsler og forsigtighedsregler) i stedet for i punkt 4.3.
English: Some SPCs recommend that fluid and electrolyte disturbances should be corrected before starting treatment.
Danish: I nogle produktresuméer anbefales det, at forstyrrelser af væske- og elektrolytbalancen korrigeres inden behandlingsstart.
English: Children The CHMP agreed that the use of Vascace Plus is not recommended in children.
Danish: Børn CHMP var enig i, at brugen af Vascace Plus ikke anbefales til børn.
English: A very cautious treatment is required due to the therapeutic properties of cilazapril and a cross reference to section 4.4 has been added.
Danish: Det er nødvendigt at være yderst forsigtig med behandlingen som følge af cilazaprils terapeutiske egenskaber, og der er blevet tilføjet en krydshenvisning til punkt 4.4.
English: Section 4.4 Special Warnings and Precautions for Use
Danish: Punkt 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen
English: The CHMP considered a number of areas of disharmony in the Product Information.
Danish: CHMP behandlede en række områder, hvor der var uoverensstemmelser i produktoplysningerne.
English: In addition, a long-term, randomized, blinded, parallel group, multicenter study was conducted specifically in elderly patients with mild to moderate hypertension.
Danish: Derudover blev der gennemført en langvarig randomiseret, blindet multicenterundersøgelse med en kontrolleret parallelgruppe specifikt bestående af ældre patienter med mild til moderat hypertension.
English: The proposed summary of the safety profile has been updated by the MAH taking into account the most recent guidelines and the definition of “frequency” used in the studies as supporting evidence.
Danish: Indehaveren af markedsføringstilladelsen har ajourført det foreslåede resumé af sikkerhedsprofilen under hensyntagen til de seneste retningslinjer og definitionen af "hyppighed", der anvendes i undersøgelser som understøttende dokumentation.
English: This was based on results of an epidemiological study which found that exposure to ACE inhibitors restricted to the first trimester of pregnancy was associated with increased risk of major congenital malformations including central nervous system and kidney malformations.
Danish: Dette var baseret på resultaterne af en epidemiologisk undersøgelse, der fandt, at eksponering for ACE-hæmmere begrænset til graviditetens første trimester var forbundet med øget risiko for store medfødte misdannelser, herunder misdannelser af centralnervesystemet og nyrerne.
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Danish: Videnskabelige konklusioner og begrundelser for ændring af produktresumé, etikettering og indlægsseddel fremlagt af Det Europæiske Lægemiddelagentur
English: Section 4.6 Pregnancy and Lactation
Danish: Punkt 4.6 Graviditet og amning
English: It is widely known that thiazides as a class can increase uric acid levels (Meyler; Martindale).
Danish: Det er velkendt, at thiazider som klasse kan øge urinsyreniveauet (Meyler, Martindale).
English: Over 600 of these patients received the cilazapril/hydrochlorothiazide combination for 6 months and more, and approximately 200 of these patients were treated with the combination for one year or longer.
Danish: Godt 600 af disse patienter fik kombinationen cilazapril/hydrochlorothiazid i seks måneder eller derover, og ca. 200 af disse patienter blev behandlet med kombinationen i et år eller derover.
English: In the SPC of several countries the same or slightly modified wording was used.
Danish: I adskillige lande blev den samme eller en lettere ændret ordlyd anvendt i produktresuméet.
English: Also the MAH presented the studies published which evaluated the combination of cilazapril and hydrochlorothiazide: Pordy et al (1995; 1994), Martina et al (1994), Yodfat et al. (1994), and Sanchez
Danish: Indehaveren af markedsføringstilladelsen fremlagde desuden resultaterne af de offentliggjorte undersøgelser, hvori kombinationen af cilazapril og hydrochlorothiazid blev evalueret: Pordy et al (1995; 1994), Martina et al (1994), Yodfat et al. (1994) og Sanchez (1989).
English: The pathophysiological association between liver impairment, cardiovascular function and arterial hypertension is complex.
Danish: Den patofysiologiske sammenhæng mellem nedsat leverfunktion, kardiovaskulær funktion og arteriel hypertension er kompleks.
English: In other countries a modified statement including also impaired liver function was given, or patients with liver impairment were contraindicated.
Danish: I andre lande blev der givet en ændret erklæring, som også omfattede nedsat leverfunktion, eller lægemidlet var kontraindiceret til patienter med nedsat leverfunktion.
English: • conditions for which Vascace Plus is not the recommended treatment (e.g. hyperaldosteronism), rather than causing specific harm, are listed as `contraindications'.
Danish: • De lidelser, for hvilke Vascace Plus ikke anbefales (f.eks. hyperaldosteronisme), er opstillet som "kontraindikationer", men de forårsager ikke specifik skade.
English: Many medicinal products were listed for Vascace Plus in one or several local SPCs.
Danish: Der var opført mange lægemidler for Vascace Plus i et eller flere lokale produktresuméer.
English: It reflected the relevant information on nonclinical safety data with cilazapril and hydrochlorothiazide.
Danish: Den afspejlede relevante oplysninger om ikke-kliniske sikkerhedsdata med cilazapril og hydrochlorothiazid.
English: The Core Data Sheet (CDS) wording for patients with impaired renal function has been used in this section of the SPCs in most of the countries.
Danish: Ordlyden i Core Data Sheet (CDS) for patienter med nedsat nyrefunktion er blevet anvendt i dette punkt af produktresuméet i de fleste lande.
English: The comment concerning the greater risk of hypotension in patients with cirrhosis, already included in some SPCs, was supported by Meyler's review.
Danish: Bemærkningen om den større risiko for hypotension hos patienter med cirrose, der allerede indgik i nogle produktresuméer, blev understøttet af Meylers gennemgang.
English: Serum electrolytes
Danish: Serumelektrolytter