natgillin/translations-raw huggingface dataset:
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'.
Der var opført mange lægemidler for Vascace Plus i et eller flere lokale produktresuméer. 
Many medicinal products were listed for Vascace Plus in one or several local SPCs.
Den afspejlede relevante oplysninger om ikke-kliniske sikkerhedsdata med cilazapril og hydrochlorothiazid. 
It reflected the relevant information on nonclinical safety data with cilazapril and hydrochlorothiazide.
Ordlyden i Core Data Sheet (CDS) for patienter med nedsat nyrefunktion er blevet anvendt i dette punkt af produktresuméet i de fleste lande. 
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.
Bemærkningen om den større risiko for hypotension hos patienter med cirrose, der allerede indgik i nogle produktresuméer, blev understøttet af Meylers gennemgang. 
The comment concerning the greater risk of hypotension in patients with cirrhosis, already included in some SPCs, was supported by Meyler's review.
Serumelektrolytter 
Serum electrolytes
I nogle medlemsstater blev der medtaget supplerende oplysninger i advarsler om risikoen for hypotension, renovaskulær hypertension/nyrearteriestenose, nyretransplantation, brug ved samtidig hjerteinsufficiens, anæmi, hoste, etniske grupper, primær aldosteronisme og doping. 
Additional information was included in some Member States in warnings in respect of risk of hypotension, renovascular hypertension/renal artery stenosis, kidney transplantation, use in concomitant heart failure, anaemia, cough, ethnic groups, primary aldosteronism, and doping.
Urinsyregigt var opført som en kontraindikation i nogle produktresuméer for Vascace Plus og var medtaget under punkt 4.4 i de fleste andre og i CDS. 
Gout was listed as a contraindication in some SPCs for Vascace Plus, and was included under section 4.4 in most others and in the CDS.
Den foreslåede ordlyd for dette punkt i den harmoniserede etikettering var identisk med ordlyden i CDS. 
The text suggested for this section of the harmonized label was identical to the wording in the CDS.
Disse blev gennemført på patienter randomiseret til en af flere mulige behandlingsgrupper med cilazaprildoser på 0,5 mg, 1,0 mg eller 2,5 mg og hydrochlorothiaziddoser på 6,25 mg, 12,5 mg eller 25 mg alene eller i kombination. 
These were conducted with patients randomized to one of several possible treatment groups with cilazapril doses of 0.5 mg, 1.0 mg or 2.5 mg and hydrochlorothiazide doses of 6.25 mg, 12.5 mg or 25 mg alone or in combination.
Den aktuelle CDS og nogle produktresuméer omfattede en advarsel om brug af thiazider hos patienter med porfyri baseret på en advarsel i Martindales gennemgang. 
The current CDS and some SPCs included a warning concerning the use of thiazides in patients with porphyria based on a warning in Martindale's review.
Vascace Plus anvendes til behandling af hypertension hos patienter, der ikke reagerer tilfredsstillende på de enkelte komponenter alene. 
Vascace Plus is used in the treatment of hypertension in patients not responding satisfactorily to each component administered alone.
Antallet af lægemidler for Vascace Plus er betydeligt højere end for cilazapril alene, da der var blevet tilføjet adskillige molekyler, hvor der var mistanke om en potentiel interaktion med hydrochlorothiazid. 
The number of products for Vascace Plus is considerably higher than for cilazapril alone, since numerous molecules had been added where a potential interaction with hydrochlorothiazide was suspected.
CHMP godkendte det meste af forslaget fra indehaveren af markedsføringstilladelsen undtagen graviditet. 
The CHMP endorsed most of the MAH's proposal except for pregnancy.
CHMP var enig i en sådan fremgangsmåde. 
The CHMP agreed with such approach.
CHMP var enig med indehaveren af markedsføringstilladelsen i, at denne bivirkning ved thiazider skulle medtages under punkt 4.8, men ikke under punkt 4.4. 
The CHMP agreed with the MAH proposal to include this adverse effect of thiazides in section 4.8 but not under 4.4.
Advarslen er muligvis baseret på et problem med krydsreaktion med sulfonamidantibiotika, som man ved forværrer porfyri. 
The warning may be based on concerns about crossreactivity with sulfonamide antibiotics, which are know to aggravate porphyria.
Et diuretikum som hydrochlorothiazid øger virkningen af ACE-hæmmeren ved at stimulere reninangiotensin-systemet og ændre den hypertensive tilstand til en mere reninafhængig lidelse. 
A diuretic such as hydrochlorothiazide enhances efficacy of the ACE inhibitor by stimulating the renin-angiotensin system and shifting the hypertensive state to a more renin-dependent condition.
Listen over lægemidler, der kan interagere med enten cilazapril eller hydrochlorothiazid, blev opdateret. 
The list of drugs which may interact either with cilazapril or with hydrochlorothiazide was updated.
Forstyrrelser i elektrolytbalancen, herunder hypokalæmi, hyponatriæmi og dehydrering, er navnlig forbundet med thiazider, mens ACE-hæmmere kan forårsage hyperkalæmi. 
Electrolyte disturbances including hypokalaemia, hyponatraemia and dehydration are mainly associated with thiazides, whilst ACE inhibitors can cause hyperkalaemia.
I nogle produktresuméer indeholdt overskriften "hypotension" advarsler om brugen af anæstetika. 
Some SPCs included under the heading “hypotension” warnings about the use of anaesthetics.
Vascace Plus er en kombination af cilazapril (en angiotensinkonverterende enzymhæmmer) og hydrochlorothiazid (et thiaziddiuretikum). 
Vascace Plus is a combination of cilazapril (an angiotensin-converting enzyme inhibitor) and hydrochlorothiazide (a thiazide-diuretic agent).
I en undersøgelse (protokol nr. N2960C) blev det påvist, at patienter havde en generel nedsættelse af det diastoliske blodtryk i siddende stilling på 4,3 mm Hg før tilføjelsen af hydrochlorothiazid og 11,1 mm Hg efter tilføjelsen af hydrochlorothiazid. 
In one trial (protocol no. N2960C) it was shown that patients had an overall decrease in SDBP of 4.3 mm Hg before the addition of hydrochlorothiazide and 11.1 mm Hg after the addition of hydrochlorothiazide.
Doseringsanbefalingerne for patienter med cirrose/nedsat leverfunktion varierede betydeligt blandt medlemsstaterne. 
The dosing recommendations given for patients with cirrhosis/impaired liver function varied considerably among MSs.
Ud af disse patienter med mild til moderat hypertension (diastolisk blodtryk i siddende stilling 95 - 115 mm hg) blev 1 027 patienter behandlet med kombinationen cilazapril/hydrochlorothiazid, 453 patienter med cilazapril og 366 med hydrochlorothiazid alene, mens 238 patienter fik placebo. 
Of these patients with mild to moderate hypertension (sitting diastolic blood pressure 95 - 115 mm hg), 1.027 patients were treated with the cilazapril/hydrochlorothiazide combination, 453 patients with cilazapril and 366 with hydrochlorothiazide alone and 238 patients received placebo.
Den antihypertensive effekt i kombinationsgruppen blev opretholdt under hele denne langvarige undersøgelse og var af en størrelsesorden svarende til den, der blev observeret efter de første uger af cilazapril/hydrochlorothiazid-kombinationsterapien uden nogen udvikling i tolerancen over for behandlingen. 
The antihypertensive effect for the combination group was maintained for the duration of this long-term study and was of a similar magnitude to that observed after the first weeks of cilazapril/hydrochlorothiazide therapy combination with no development of tolerance for the therapy.
Skønnene over hyppigheden var baseret på den patientandel, der indberettede de enkelte bivirkninger under de kliniske undersøgelser af Vascace Plus. 
Estimates of frequency were based on the proportion of patients reporting each adverse reaction during Vascace Plus clinical trials.
CHMP konkluderede, at kontraindikationen i første trimester af graviditeten skal slettes fra produktoplysningerne for Vascace Plus, og produktoplysningerne skal ajourføres, så de indeholder den ordlyd, som arbejdsgruppen vedrørende lægemiddelovervågning anbefalede i forbindelse med såvel graviditet som amning. 
The CHMP concluded that the contraindication during the first trimester of pregnancy must be deleted from the product information of Vascace Plus and the PI should be updated to include the wording recommended by the PhVWP for both pregnancy and lactation.
Da det ikke er planen at indlede behandlingen med den faste kombination, godkendte CHMP følgende ordlyd: "I kliniske undersøgelser var effekten og tolerancen af cilazapril og hydrochlorothiazid givet samtidigt ens hos såvel ældre som yngre hypertensive patienter, selv om de farmakokinetiske data viser, at clearance af begge komponenter hos ældre patienter var nedsat (se pkt. 
As it is not foreseen to start treatment with the fixed combination, the CHMP endorsed the following: “In clinical studies, the efficacy and tolerability of cilazapril and hydrochlorothiazide administered concomitantly was similar in both elderly and younger hypertensive patients, although pharmacokinetic data show that clearance of both components in elderly patients was reduced (see section 5.2)”.
Oplysningerne om hydrochlorothiazids farmakokinetik i særlige populationer er blevet tilføjet punkt 
Information on pharmacokinetics of hydrochlorothiazide in special populations has been added to section 5.2.
CHMP godkendte følgende harmoniserede ordlyd for doseringen: "Dosis af Vascace Plus er én tablet (5,0 mg cilazapril og 12,5 mg hydrochlorothiazid), som tages én gang dagligt". 
The CHMP endorsed the following harmonised wording for the posology: “The dosage of Vascace Plus is one tablet (5.0 mg cilazapril and 12.5 mg hydrochlorothiazide) administered once daily”.
Desuden er angiotensinkonvertaseenzymhæmmere ifølge henstillingen fra arbejdsgruppen vedrørende lægemiddelovervågning kontraindiceret i andet og tredje trimester af graviditet, men ikke i første trimester af graviditet eller amning. 
Moreover, according to the PhVWP recommendation, angiotensin converting enzyme inhibitors are contraindicated in second and third trimesters of pregnancy but not during the first trimester of pregnancy or lactation.
CHMP har godkendt oplysningerne om de mulige interaktioner og resultaterne heraf. 
The information which is given about the possible interactions and their outcome are endorsed by the CHMP.
Efter en gennemgang og drøftelse af ACE-hæmmeres teratogene potentiale konkluderede arbejdsgruppen vedrørende lægemiddelovervågning, at kontraindikationen for ACE-hæmmere i første trimester af graviditeten ikke er begrundet som følge af den begrænsede dokumentation for en teratogen risiko. 
Following review and discussion regarding the teratogenic potential of ACE inhibitors, the Pharmacovigilance Working Party (PhVWP) concluded that the contraindication of ACE inhibitors during the first trimester of pregnancy is not justified given the limited evidence related to a teratogenic risk.
Til underbyggelse af den foreslåede indikation fremlagde indehaveren af markedsføringstilladelsen resultaterne af fire placebokontollerede kliniske undersøgelser sponsoreret af Roche, som omfattede 2 084 hypertensive patienter. 
To support the proposed indication the MAH presented 4 placebo controlled clinical trials sponsored by Roche and run in 2.084 hypertensive patients.
Desuden er navnene på og rækkefølgen af systemorganklasser blevet tilpasset for cilazapril og hydrochlorothiazid i henhold til MedDRA. 
Moreover, the names and order of System Organ Classes (SOCs) have been aligned for cilazapril and hydrochlorothiazide according to MedDRA.
Den største (dvs. 15 mm Hg) antihypertensive effekt af kombinationsterapien gav ikke anledning til en øget forekomst af hypotensive hændelser, som kunne give anledning til bekymring hos ældre patienter. 
The magnitude of the antihypertensive effect of the combination at peak (i. e. 15 mm Hg) did not render an increased incidence of hypotensive events, which could be of concern in elderly patients.