natgillin/translations-raw huggingface dataset:
Bivirkninger rapporteret for Zoledronsyre Accord vurderes omhyggeligt, og der tages nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Zoledronic Acid Accord are carefully evaluated and any necessary action taken to protect patients.
Der er allerede foretaget studier over det aktive stofs fordele og risici ved godkendt brug med referencelægemidlet, Zometa, og de behøver ikke blive gentaget for Zoledronsyre Accord.
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Zometa, and do not need to be repeated for Zoledronic Acid Accord.
Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Zoledronsyre Accord er af sammenlignelig kvalitet og er bioækvivalent med Zometa.
The European Medicines Agency concluded that, in accordance with EU requirements, Zoledronic Acid Accord has been shown to have comparable quality and to be comparable to Zometa.
Det betyder, at Zoledronsyre Accord indeholder samme aktive stof og virker på samme måde som et "referencelægemiddel", som allerede er godkendt i EU, og som hedder Zometa.
This means that Zoledronic Acid Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Zometa.
Det var derfor agenturets opfattelse, at fordelene opvejer de identificerede risici som for Zometa, og at det kan godkendes til anvendelse i EU.
Therefore, the Agency's view was that, as for Zometa, the benefit outweighs the identified risk and it can be authorised for use in the EU.
Da Zoledronsyre Accord er et generisk lægemiddel, anses dets fordele og risici for at være de samme som for referencelægemidlet.
Because Zoledronic Acid Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicines'.
Der var ikke behov for "bioækvivalensstudier" for at undersøge, om Zoledronsyre Accord optages identisk med referencelægemidlet for at give det samme niveau af det aktive stof i blodet.
There was no need for ‘bioequivalence' studies to investigate whether Zoledronic Acid Accord is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Som for alle lægemidler har virksomheden leveret studier vedrørende kvaliteten af Zoledronsyre Accord.
As for every medicine, the company provided studies on the quality of Zoledronic Acid Accord.
Zoledronsyre Accord udleveres kun efter recept og må kun ordineres og gives af en sundhedsperson, der har erfaring med brugen af denne type lægemiddel, som gives i en vene.
Zoledronic Acid Accord can only be obtained with a prescription and must only be prescribed and given by a healthcare professional who has experience in the use of this type of medicine given into a vein.
Dette omfatter frakturer (knoglebrud), rygmarvskompression (når rygmarven presses sammen af knoglen), knoglelidelser, der kræver stråleterapi eller operation, og hypercalcæmi (forhøjet calciumindhold i blodet).
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).
Patienter med svulster kan have høje niveauer af calcium, afgivet fra knoglerne, i blodet.
Patients with tumours can have high levels of calcium in their blood, released from the bones.
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.
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.
Ved at forebygge nedbrydningen af knoglerne medvirker Zoledronsyre Accord også til at reducere den mængde calcium, der afgives til blodet.
By preventing the breakdown of bones, Zoledronic Acid Accord also helps to reduce the amount of calcium released into the blood.
En oversigt over Zoledronsyre Accord, og hvorfor det er godkendt i EU
An overview of Zoledronic Acid Accord and why it is authorised in the EU
Det skyldes, at Zoledronsyre Accord gives som infusion i en vene, så det aktive stof leveres direkte i blodbanen.
This is because Zoledronic Acid Accord is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Zoledronsyre Accord kan også anvendes til at behandle hypercalcæmi forårsaget af svulster.
Zoledronic Acid Accord can also be used to treat hypercalcaemia caused by tumours.
Osteonekrose i kæben er en tilstand i kæbebenene, som kan føre til smerter, sår i munden eller løse tænder.
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.
Zoledronsyre Accord er et lægemiddel til forebyggelse af knoglekomplikationer hos voksne med fremskreden kræft, der påvirker knoglerne.
Zoledronic Acid Accord is a medicine used to prevent bone complications in adults with advanced cancer that is affecting the bone.
Zoledronsyre Accord indeholder det aktive stof zoledronsyre og er et "generisk lægemiddel".
Zoledronic Acid Accord contains the active substance zoledronic acid and is a ‘generic medicine'.
Det aktive stof i Zoledronsyre Accord, zoledronsyre, er et bisphosphonat.
The active substance in Zoledronic Acid Accord, zoledronic acid, is a bisphosphonate.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Zoledronsyre Accord?
What measures are being taken to ensure the safe and effective use of Zoledronic Acid Accord?
Andre oplysninger om Zoledronsyre Accord
Other information about Zoledronic Acid Accord
Hvilke fordele og risici er der forbundet med Zoledronsyre Accord?
What are the benefits and risks of Zoledronic Acid Accord?
Hvad er Zoledronsyre Accord, og hvad anvendes det til?
What is Zoledronic Acid Accord and what is it used for?
Zoledronsyre Accord (zoledronsyre)
Zoledronic Acid Accord (zoledronic acid)
Hvorfor blev Zoledronsyre Accord godkendt i EU?
Why is Zoledronic Acid Accord authorised in the EU?
Nedsættelsen af knogletabet mindsker risikoen for knoglebrud, hvilket er til gavn for kræftpatienter med knoglemetastaser.
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.
Til forebyggelse af knoglekomplikationer kan infusionen gentages hver tredje til fjerde uge, og patienterne bør desuden tage calcium- og D-vitamintilskud.
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.
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.
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.
Hvordan blev Zoledronsyre Accord undersøgt?
How has Zoledronic Acid Accord been studied?
Hvordan virker Zoledronsyre Accord?
How does Zoledronic Acid Accord work?
Hvordan anvendes Zoledronsyre Accord?
How is Zoledronic Acid Accord used?
Dette er med til at beskytte mod sygdommen.
This will help protect against the disease.
Dette sammendrag blev sidst ajourført i juni 2017.
This summary was last updated in June 2017.
Den fuldstændige EPAR for Vepured findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
The full EPAR for Vepured can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Beskyttelsen indtræder 21 dage efter vaccinationen og varer i 112 dage.
Protection starts 21 days after vaccination and lasts for 112 days.
Hvad er Vepured, og hvad anvendes det til?
What is Vepured and what is it used for?
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Vepured.
This is a summary of the European public assessment report (EPAR) for Vepured.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Vepured den 17/08/2017.
The European Commission granted a marketing authorisation valid throughout the EU for Vepured on 17 August 2017.
Tilbageholdelsestiden for kød fra svin, der behandles med Vepured, er "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid.
The withdrawal period for meat from pigs treated with Vepured is ‘zero' days, which means there is no mandatory waiting time.
Vepured reducerede også vægttabet hos svin i besætninger, der var ramt af sygdommen.
Vepured also reduced the weight loss of pigs in herds affected with the disease.
Det medfører skader på blodkarrene, forårsager væskeophobning i mave- og tarmvævet, påvirker blodforsyningen til hjernen og kan medføre død inden for 24-48 timer.
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.
Det er ikke en praktisk vejledning i, hvordan Vepured bør anvendes.
It is not intended to provide practical advice on how to use Vepured.
Hvorfor blev Vepured godkendt?
Why is Vepured approved?
Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Vepured opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
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.
Hvilke risici er der forbundet med Vepured?
What are the risks associated with Vepured?
Andre oplysninger om Vepured
Other information about Vepured:
Hvis dyrene efterfølgende udsættes for den bakterie, der danner det umodificerede toksin, vil deres immunsystem hurtigere kunne danne antistoffer mod toksinet.
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.
Vepured indeholder adjuvanser (aluminiumhydroxid og DEAE-dextran), der forstærker immunresponsen.
Vepured contains adjuvants (aluminium hydroxide and DEAE-dextran) to enhance the immune response.
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.
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.
Vepured indeholder verotoksin 2e, som er blevet modificeret og inaktiveret, så det ikke længere kan forårsage sygdom.
Vepured contains verotoxin 2e that has been modified and inactivated so it can no longer cause disease.
Ødemsyge findes i hele verden og forekommer som regel i smågrisenes første leveuger.
Oedema disease is found worldwide and usually occurs in the first few weeks of life of the piglets.
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.
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.
Når Vepured gives til svin, opfatter dyrets immunsystem toksinerne i vaccinen som "fremmede" og danner antistoffer mod dem.
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.
Vepured er en vaccine, der indeholder modificeret, inaktiveret verotoksin 2e.
Vepured is a vaccine containing modified, inactivated verotoxin 2e.
Vepured gives til smågrise, fra de er to dage gamle, som en enkelt injektion i nakkemuskulaturen.
Vepured is given to piglets from 2 days of age as a single injection into the muscle in the neck.
Hvilke fordele viser undersøgelserne, at der er ved Vepured?
What benefits of Vepured have been shown in studies?
Vepured fås som injektionsvæske, suspension, og udleveres kun på recept.
Vepured is available as a suspension for injection and can only be obtained with a prescription.
Ødemsyge skyldes et bakterietoksin (en gift) med navnet verotoksin 2e, som dannes af visse stammer af Escherichia coli.
Oedema disease is caused by a bacterial toxin (poison) known as verotoxin 2e that is produced by certain strains of Escherichia coli.
Hvordan anvendes Vepured?
How is Vepured used?
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.
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.
Hvordan virker Vepured?
How does Vepured work?
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.
For more information about treatment with Vepured, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
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.
For practical information about using Vepured, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Vepured vaccine (inaktiveret, rekombinant) mod E. coli-verotoksin
E. coli verotoxoid vaccine (inactivated recombinant)
Denne er derfor ikke blevet ændret.
Hence, this has not been changed.
Adverse Drug Reactions and Interactions 2006.
Drug Reactions and Interactions 2006.
• Kontraindikationerne var nogle gange relative snarere end absolutte.
• contraindications were sometimes relative rather than absolute.
Den præsenterede kort nogle vigtige fakta om disse to molekyler.
It presented in a succinct manner some important facts on these two molecules.
I flere lande var der ingen oplysninger i punkt 4.2 om denne patientgruppe.
In several countries there was no information in section 4.2 on this group of patients.
• JK Aronson (redaktør).
• Aronson JK (editor).
I alt 214 patienter (i aldersgruppen 64-81 år) blev inkluderet i denne undersøgelse.
A total of 214 patients (age range 64 - 81 years) were included in this trial.
• Sweetman SC (redaktør), Martindale: The Complete Drug Reference 36.
• Sweetman SC (editor), Martindale: The Complete Drug Reference 36.
• Manglende data vedrørende sikkerheden i bestemte patientgrupper var den eneste grund til at opliste visse kontraindikationer.
• lack of data concerning safety in specific patients groups was the only justification for listing certain contraindications;
Press <http://www.medicinescomplete.com/> (set sept.-nov. 2009)
Press <http://www.medicinescomplete.com/> (Accessed Sep-Nov 2009)
Samlet resumé af den videnskabelige vurdering af Vascace Plus og relaterede navne (se bilag I)
Overall summary of the scientific evaluation of Vascace Plus and associated names (see Annex I)
Meyler's Side Effects of Drugs: The International Encyclopedia of
Meyler's Side Effects of Drugs: The International Encyclopedia of Adverse
De 76 ikke-responderende patienter blev behandlet med kombinationsterapi.
The 76 non-responders were treated with combination therapy.
Specifik behandlingsrådgivning blev ikke medtaget, da der kan være forskelle på behandlingsprotokollerne mellem medlemsstaterne.
Specific treatment advice was not included as treatment protocols may vary between countries.
Punkt 4.5 Interaktion med andre lægemidler og andre former for interaktion
Section 4.5 Interaction with Other Medicinal Products and Other Forms of Interaction
Punktet "Kliniske undersøgelser/virkningsundersøgelser" er blevet lettere omformuleret for at skabe større klarhed.
The paragraph ‘Clinical/Efficacy Studies' has been slightly rewording for more clarity.
Der fandtes forskelle mellem medlemsstaterne i detaljeringsgraden af særlige advarsler og forsigtighedsregler vedrørende brugen.
Differences in level of detail existed between Member States for special warnings and precautions for use.
Den laveste dosis, der gav en væsentlig effekt, var en dosis på 2,5/6,25 mg.
The lowest dose which generated a significant effect was a dose of 2.5/6.25 mg.
Desuden kan tilføjelse af en ACE-hæmmer yderligere svække denne virkning.
Furthermore, the addition of an ACE inhibitor may further attenuate this effect.
Behandlingen er vanskelig og temmelig sjælden, da patienter med cirrose har tendens til lavt blodtryk.
Treatment is difficult and rather infrequent, since patients with cirrhosis have a tendency towards low blood pressure.
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.
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.
Ordlyden af de terapeutiske indikationer for Vascace Plus var identisk i mange EU-lande.
This wording of the therapeutic indications for Vascace Plus was identical in many EU countries.
Kombinationsterapi med antihypertensive stoffer er sjældent nødvendigt.
Combination therapy with antihypertensive agents is rarely necessary.
Den foreslåede formulering omfattede en generel erklæring om akut behandling af angioødem.
The proposed text included a general statement concerning emergency treatment of angioedema.
Punkt 4.7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner
Section 4.7 Effects on Ability to Drive and Use Machines
I nogle produktresuméer blev relative kontraindikationer drøftet i punkt 4.4 (Særlige advarsler og forsigtighedsregler) i stedet for i punkt 4.3.
In some SPCs, relative contraindications were discussed in section 4.4 (Special Warnings and Precautions), rather than in section 4.3;
I nogle produktresuméer anbefales det, at forstyrrelser af væske- og elektrolytbalancen korrigeres inden behandlingsstart.
Some SPCs recommend that fluid and electrolyte disturbances should be corrected before starting treatment.
Børn CHMP var enig i, at brugen af Vascace Plus ikke anbefales til børn.
Children The CHMP agreed that the use of Vascace Plus is not recommended in children.
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.
A very cautious treatment is required due to the therapeutic properties of cilazapril and a cross reference to section 4.4 has been added.
Punkt 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen
Section 4.4 Special Warnings and Precautions for Use
CHMP behandlede en række områder, hvor der var uoverensstemmelser i produktoplysningerne.
The CHMP considered a number of areas of disharmony in the Product Information.
Derudover blev der gennemført en langvarig randomiseret, blindet multicenterundersøgelse med en kontrolleret parallelgruppe specifikt bestående af ældre patienter med mild til moderat hypertension.
In addition, a long-term, randomized, blinded, parallel group, multicenter study was conducted specifically in elderly patients with mild to moderate hypertension.
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.
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.
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.
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.
Videnskabelige konklusioner og begrundelser for ændring af produktresumé, etikettering og indlægsseddel fremlagt af Det Europæiske Lægemiddelagentur
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Punkt 4.6 Graviditet og amning
Section 4.6 Pregnancy and Lactation
Det er velkendt, at thiazider som klasse kan øge urinsyreniveauet (Meyler, Martindale).
It is widely known that thiazides as a class can increase uric acid levels (Meyler; Martindale).
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.
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.
I adskillige lande blev den samme eller en lettere ændret ordlyd anvendt i produktresuméet.
In the SPC of several countries the same or slightly modified wording was used.
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).
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
Den patofysiologiske sammenhæng mellem nedsat leverfunktion, kardiovaskulær funktion og arteriel hypertension er kompleks.
The pathophysiological association between liver impairment, cardiovascular function and arterial hypertension is complex.
I andre lande blev der givet en ændret erklæring, som også omfattede nedsat leverfunktion, eller lægemidlet var kontraindiceret til patienter med nedsat leverfunktion.
In other countries a modified statement including also impaired liver function was given, or patients with liver impairment were contraindicated.
• De lidelser, for hvilke Vascace Plus ikke anbefales (f.eks. hyperaldosteronisme), er opstillet som "kontraindikationer", men de forårsager ikke specifik skade.
• conditions for which Vascace Plus is not the recommended treatment (e.g. hyperaldosteronism), rather than causing specific harm, are listed as `contraindications'.