FrancophonIA/ELRC3.0 huggingface dataset:
English: The marketing authorisation is suspended on 12 June 2007
Danish: Fristen for fremsendelse af en skriftlig redegørelse fra indehaverne af markedsføringstilladelsen blev fastsat til den 14. januar 2008.
English: It will be replaced by Directive (2006/118/EC) which will come into force before 2013.
Danish: Artikel 35 i direktiv 2001/82/EF, med senere ændringer.
English: However, there are changes required to the SPCs of some of the authorised products to bring them in line with the indications and dosing regimens used in the environmental risk assessment.
Danish: Udvalget anbefalede desuden, at de relevante markedsføringstilladelser skulle ændres for at harmonisere indikationerne og dosisangivelserne, så de blev i overensstemmelse med dem, der blev anvendt i miljørisikovurderingen.
English: The CVMP having considered the data provided and the scientific discussion within the Committee concluded that after administration of products containing toltrazuril to the target animal the dose is excreted as a mixture of parent compound and a major metabolite toltrazuril sulfone.
Danish: På baggrund af de samlede fremlagte oplysninger og den faglige drøftelse i udvalget vedtog CVMP på mødet i juli 2008 ved konsensus en udtalelse, hvori det konkluderes, at vurderingen af den risiko, som toltrazuril og dets vigtigste metabolit, toltrazurilsulfon, frembyder for terrestriske planter og grundvandet, viste, at brugen af produkter indeholdende toltrazuril er acceptabel.
English: Litvinovska 609/3 190 21 Praha 9
Danish: London, den 26. september 2008 EMEA/402698/2008
English: However, in some Member States (Czech Republic, Hungary, Italy, The Netherlands, Portugal and the United Kingdom) administration can be repeated after five days in the face of severe challenge.
Danish: Der er tidligere blevet udstedt markedsføringstilladelser for veterinærlægemidler indeholdende toltrazuril beregnet til brug i fjerkræ til Bayer Healthcare og/eller Ceva Santé Animale i Østrig, Belgien, Bulgarien, Cypern, Den Tjekkiske Republik, Frankrig, Tyskland, Grækenland, Ungarn, Irland, Italien, Polen, Portugal, Rumænien, Slovakiet, Slovenien, Nederlandene og Det Forenede Kongerige i henhold til nationale procedurer for markedsføringstilladelser.
English: The data submitted by the Marketing Authorisation Holders was only for chickens and turkeys.
Danish: Udvalget anbefalede derfor opretholdelse af markedsføringstilladelserne for alle veterinærlægemidler indeholdende toltrazuril beregnet til behandling af høns og kalkuner.
English: Bayer Hungaria Kft.Co.
Danish: Den udpegede rapportør og medrapportør var henholdsvis R. Kearsley og G. J. Schefferlie.
English: LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: UDTALELSE SOM FØLGE AF EN INDBRINGELSE I HENHOLD TIL ARTIKEL 351 FOR ALLE GODKENDTE VETERINÆRLÆGEMIDLER INDEHOLDENDE TOLTRAZURIL TIL BEHANDLING AF FJERKRÆ Internationalt fællesnavn (INN): Toltrazuril
English: Pharmaceutical form Strength Indications
Danish: European Medicines Agency Veterinary Medicines and Inspections
English: It should be noted that a second course of treatment is not considered necessary as reported by Marketing Authorisation Holders.
Danish: Voldgiftsproceduren blev indledt den 11. oktober 2007 med vedtagelse af en liste med spørgsmål, der skulle forelægges indehaverne af markedsføringstilladelserne.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS
Danish: Listen over de berørte lægemiddelnavne fremgår af bilag I. De faglige konklusioner fremgår af bilag II, og ændringerne af de relevante afsnit i produktresuméet fremgår af bilag III.
English: For the exposure assessment the equations according to the CVMP guideline (Environmental Impact Assessment for Veterinary Medicinal Products in support of the VICH guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005)) were used with modified parameters to reflect the actual use of toltrazuril.
Danish: • En udvidet risikovurdering på grundlag af retningslinjer fra det internationale samarbejde om harmonisering af tekniske krav til registrering af veterinærlægemidler (VICH) viste fuldt og klart, at veterinærlægemidler, som indeholder toltrazuril og er beregnet til behandling af fjerkræ, må forventes at have en indvirkning på miljøet.
English: There is evidence of a non-acceptable risk for plants when manure obtained from Baycox 2.5 % treated poultry are applied to agricultural land.
Danish: Den 31. august 2007 indledte Tyskland i henhold til artikel 35 i direktiv 2001/82/EF, med senere ændringer, en sag for Fællesskabet vedrørende det nationalt godkendte produkt Baycox 2,5 (opløsning til fjerkræ).
English: Package size micrograms/0.5 ml
Danish: Pakningsstørrelse mikrogram/ 0,5 ml
English: 1 pre-filled pen + 1 needle
Danish: 1 fyldt pen + 1 kanyle
English: Solution for injection Subcutaneous use pre-filled syringe (glass)
Danish: Injektionsvæske, opløsning Subkutan anvendelse fyldt injekstionssprøjte (glas)
English: Cartridge in a prefilled pen (250 micrograms/ 0.5 ml)
Danish: Subkutan anvendelse cylinderampul i fyldt pen (250 mikrogram/ 0,5 ml )
English: 250 micrograms Solution for injection in pre-filled pen
Danish: Injektionsvæske, opløsning i fyldt pen
English: 1 pre-filled syringe
Danish: 1 fyldt injektionssprøjte mikrogram
English: In addition there was no evidence of unexpected safety concerns.
Danish: Desuden var der ingen tegn på uventede sikkerhedsproblemer.
English: Rezolsta contains two active substances.
Danish: Rezolsta indeholder to aktive stoffer.
English: Other information about Rezolsta
Danish: Andre oplysninger om Rezolsta
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rezolsta on 19/11/2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Rezolsta den 19. november 2014.
English: This is a summary of the European public assessment report (EPAR) for Rezolsta.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Rezolsta.
English: A risk management plan has been developed to ensure that Rezolsta is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Rezolsta anvendes så sikkert som muligt.
English: The full EPAR and risk management plan summary for Rezolsta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Rezolsta findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The recommended dose is one tablet a day, taken with food.
Danish: Den anbefalede dosis af Rezolsta er én tablet én gang dagligt, der tages sammen med et måltid.
English: What is Rezolsta and what is it used for?
Danish: Hvad er Rezolsta, og hvad anvendes det til?
English: Overall, 258 patients (82%) achieved this response after 24 weeks of treatment, and 253 patients (81%) at 48 weeks, which was comparable to results previously seen with darunavir plus ritonavir.
Danish: Samlet opnåede 258 patienter (82 %) denne virkning efter 24 ugers behandling, og 253 patienter (81 %) efter 48 uger.
English: Both active substances have already been shown to be effective, and combining them into a single tablet was considered to be more convenient than taking them separately, reducing the risk of errors.
Danish: Begge aktive stoffer er i forvejen påvist at være effektive, og at tage en enkelt tablet med begge stoffer blev anset for at være mere bekvemt end at tage dem hver for sig, så risikoen for fejl mindskes.
English: Why is Rezolsta approved?
Danish: Hvorfor blev Rezolsta godkendt?
English: What measures are being taken to ensure the safe and effective use of Rezolsta?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Rezolsta?
English: What are the risks associated with Rezolsta?
Danish: Hvilke risici er der forbundet med Rezolsta?
English: Rezolsta must not be taken by patients who have severely reduced liver function.
Danish: Rezolsta må ikke anvendes af patienter med svært nedsat leverfunktion.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Rezolsta's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Rezolsta opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: It is not intended to provide practical advice on how to use Rezolsta.
Danish: Det er ikke en praktisk vejledning i, hvordan Rezolsta bør anvendes.
English: Effectiveness was measured by a reduction in viral load (the amount of HIV-1 virus in the blood) to less than 50 copies/ml.
Danish: Effektiviteten blev målt på, om mængden af hiv-1-virus i blodet (den virale belastning) faldt til mindre end 50 kopier/ml.
English: Rezolsta is available as tablets that contain 800 mg of darunavir and 150 mg of cobicistat.
Danish: Rezolsta fås som tabletter med 800 mg darunavir og 150 mg cobicistat.
English: Rezolsta does not cure HIV infection or AIDS, but it can delay or reverse the damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Rezolsta helbreder ikke hiv-infektion eller aids, men kan sinke eller oprette den skade på immunsystemet og opståen af de infektioner og sygdomme, der er forbundet med aids.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Rezolsta, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Rezolsta, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Darunavir is a protease inhibitor.
Danish: Darunavir er en proteasehæmmer.
English: The most serious side effects were rash, diabetes, hypersensitivity (allergic) reactions, vomiting, and ‘immune reconstitution syndrome'.
Danish: De alvorligste bivirkninger var udslæt, sukkersyge, overfølsomhedsreaktioner (allergi), opkastning og “immunrekonstitutionssyndrom”.
English: It must also not be used together with certain other medicines as it may interact with them, thereby reducing the effectiveness of treatment or increasing the risk of side effects.
Danish: Rezolsta må heller ikke anvendes sammen med visse andre lægemidler, som det kan vekselvirke med, da dette forringer behandlingens virkning eller øger risikoen for bivirkninger.
English: Rezolsta can only be obtained with a prescription and treatment should only be started by a doctor who is experienced in managing HIV infection.
Danish: Rezolsta fås kun på recept, og behandlingen bør kun ordineres og påbegyndes af en læge med erfaring i behandling af hiv-infektion.
English: Rezolsta contains the active substances darunavir and cobicistat.
Danish: Rezolsta indeholder de aktive stoffer darunavir og cobicistat.
English: The most common side effects with Rezolsta (which may affect more than 1 in 10 people) are diarrhoea, nausea (feeling sick), and rash.
Danish: De hyppigste bivirkninger ved Rezolsta (som optræder hos mere end 1 ud af 10 patienter) er diarré, kvalme og udslæt.
English: Cobicistat acts as a ‘booster' to enhance the effects of darunavir, by prolonging the time in which it acts in the body.
Danish: Cobicistat forstærker virkningen af darunavir ved at forlænge det tidsrum, hvor det virker i kroppen.
English: For more information about treatment with Rezolsta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Rezolsta, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Rezolsta, taken in combination with other HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Danish: Når Rezolsta anvendes i kombination med andre hiv-lægemidler, mindsker det hiv-mængden i blodet og holder den nede.
English: For the full list of all side effects reported with Rezolsta, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med Rezolsta fremgår af indlægssedlen.
English: What benefits of Rezolsta have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Rezolsta?
English: Rezolsta is an antiviral medicine used, in combination with other medicines, to treat adults with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Rezolsta er et lægemiddel mod virus og anvendes sammen med andre lægemidler til behandling af voksne smittet med hiv-1 (humant immundefektvirus type 1).
English: Immune reconstitution syndrome happens when the patient's immune system starts working again and fights existing infections, causing inflammation at the site of the infection.
Danish: Immunrekonstitutionssyndrom opstår, når patientens immunsystem igen begynder at virke og modarbejde og bekæmper eksisterende infektioner.
English: Darunavir is currently authorised as Prezista and cobicistat as Tybost.
Danish: Darunavir er godkendt under navnet Prezista, og cobicistat under navnet Tybost.
English: For practical information about using Rezolsta, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Rezolsta, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Rezolsta used?
Danish: Hvordan anvendes Rezolsta?
English: Because darunavir and cobicistat have both previously been shown to be effective and are authorised for use in the treatment of HIV infection, studies were mainly carried out to show that Rezolsta produced similar effects and levels of darunavir in the blood to the two active substances given separately, and to darunavir given with a different booster medicine, ritonavir (an established combination).
Danish: Der blev derfor hovedsagelig udført undersøgelser til at påvise, at Rezolsta frembragte samme virkning og indhold af darunavir i blodet som når de to aktive stoffer indgives hvert for sig, og som darunavir, når dette gives sammen med et andet forstærkende lægemiddel, ritonavir (en anerkendt kombination).
English: The medicine is for use only in patients who have not received HIV treatment before or previously treated patients whose disease is not expected to be resistant to darunavir and who are healthy enough and have HIV virus levels below a certain threshold.
Danish: Desuden er det til brug hos tidligere behandlede patienter, hos hvem sygdommen ikke forventes at være resistent over for darunavir, som er tilstrækkeligt raske, og som har et indhold af hiv-virus under en bestemt værdi.
English: When the enzyme is blocked, the virus does not reproduce normally and its increase and spread slows down.
Danish: Det blokerer enzymet protease, som hiv-virusset behøver til at danne nye kopier af sig selv Når enzymet blokeres, kan virusset ikke formere sig på normal måde, og dets formering og spredning bliver derfor langsommere.
English: In addition, one main study was carried out to examine the safety and effectiveness of darunavir and cobicistat given with other HIV medicines, in 313 adult patients with HIV who had not been previously treated or who had been previously treated and whose infection was not expected to be resistant to darunavir.
Danish: Desuden blev der udført én hovedundersøgelse af sikkerheden og virkningen af darunavir og cobicistat sammen med andre hiv-lægemidler hos 313 voksne patienter med hiv.
English: How does Rezolsta work?
Danish: Hvordan virker Rezolsta ?
English: MA (EU) Number (Invented) Name
Danish: MF (EU)-nummer (Særnavn) Navn
English: This summary was last updated in 06-2018.
Danish: Dette sammendrag blev sidst ajourført i 06-2018.
English: Further information on Zebinix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Zebinix findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Zebinix received a marketing authorisation valid throughout the EU on 21 April 2009.
Danish: Zebinix modtog en markedsføringstilladelse med gyldighed i hele Den Europæiske Union den 21. april
English: It must not be used in people with second or third degree atrioventricular block (a problem with electrical transmission in the heart).
Danish: Det må ikke anvendes af personer med anden- eller tredjegrads atrioventrikulært blok (et problem med elektrisk transmission i hjertet).
English: Side effects were usually mild to moderate in intensity and occurred mostly in the first week of treatment.
Danish: Bivirkningerne var sædvanligvis milde til moderate og opstod hovedsageligt inden for den første uge af behandlingen.
English: Secondary generalisation occurs when the overactivity later reaches the whole brain.
Danish: Sekundær generalisering forekommer, når den stærke aktivitet senere breder sig til hele hjernen.
English: As for all medicines, data on the use of Zebinix are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Zebinix løbende overvåget.
English: It is available as tablets (200 mg, 400 mg, 600 mg and 800 mg) and as a suspension to be taken by mouth.
Danish: Det fås som tabletter (200 mg, 400 mg, 600 mg og 800 mg) og som en suspension til indtagelse gennem munden.
English: This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness or a sudden sense of fear.
Danish: Dette er en form for epilepsi, hvor for stærk elektrisk aktivitet i én side af hjernen giver symptomer som pludselige, sætvise bevægelser af en del af kroppen, forvrænget hørelse, lugtesans eller syn, følelsesløshed eller pludselig angst.
English: This compared with 25% of patients (10 out of 40) on placebo.
Danish: Dette skal sammenholdes med 25 % (10 af 40) af de patienter, der fik placebo.
English: Severe skin reactions, including Stevens-Johnson syndrome, have also been reported with Zebinix.
Danish: Alvorlige hudreaktioner, inklusive Stevens-Johnson Syndrome, er også blevet indberettet med Zebinix.
English: In these studies, all the children also received other epilepsy medicines.
Danish: I disse undersøgelser fik alle børnene også andre epilepsilægemidler.
English: All of the patients also received other epilepsy medicines.
Danish: Alle patienterne fik også andre epilepsilægemidler.
English: The European Medicines Agency decided that Zebinix's benefits are greater than its risks and that it be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Zebinix opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Other information about Zebinix
Danish: Andre oplysninger om Zebinix
English: An overview of Zebinix and why it is authorised in the EU
Danish: En oversigt over Zebinix og hvorfor det er godkendt i EU
English: A second study in children aged 2 to 18 years did not find a difference between Zebinix and placebo, this was explained by the fact that lower doses were used.
Danish: I en anden undersøgelse hos børn på mellem 2 og 18 år sås der ingen forskel på Zebinix og placebo, hvilket forklaredes med, at der blev anvendt lavere doser.
English: In clinical trials, around half of the patients treated with Zebinix experienced side effects.
Danish: I kliniske undersøgelser oplevede ca. halvdelen af de patienter, der blev behandlet med Zebinix, bivirkninger.
English: Side effects reported with Zebinix are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger indberettet for Zebinix vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: What measures are being taken to ensure the safe and effective use of Zebinix?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Zebinix?
English: The effects of Zebinix were also studied in children with partial-onset seizures.
Danish: Virkningen af Zebinix blev også undersøgt hos børn med partielle anfald.
English: Eslicarbazepine is thought to work by blocking ‘voltage-gated sodium channels', which stops sodium entering the nerve cells.
Danish: Eslicarbazepin menes at virke ved at blokere "spændings-gatede natriumkanaler", som forhindrer natrium i at trænge ind i nervecellerne.
English: The dose is then increased after one or two weeks to 20 mg/kg per day and then to 30 mg/kg per day, based on the patient's response.
Danish: Dosen øges derpå efter en eller to uger til 20 mg/kg om dagen og så til 30 mg/kg om dagen, afhængig af hvordan patienten reagerer på behandlingen.
English: In one study involving 123 children aged 6 to 16 years, Zebinix over 12 weeks halved the number of seizures in 51% of patients (42 out of 83).
Danish: I et studie med 123 børn på mellem 6 og 16 år halverede Zebinix over 12 uger antallet af anfald hos 51 % af patienterne (42 ud af 83).
English: For more information about using Zebinix, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af Zebinix, kan du læse indlægssedlen, eller kontakte lægen eller apoteket.
English: Zebinix must not be used in people who are hypersensitive (allergic) to eslicarbazepine acetate, any of the other ingredients or other carboxamide derivatives (medicines with a similar structure to eslicarbazepine acetate, such as carbamazepine or oxcarbazepine).
Danish: Zebinix må ikke anvendes hos personer, der er overfølsomme (allergiske) over for eslicarbazepinacetat, andre af indholdsstofferne eller andre carboxamidderivater (lægemidler med en struktur, der svarer til eslicarbazepinacetat, såsom carbamazepin eller oxcarbazepin).
English: Zebinix should not be used in patients with severe kidney problems and the dose should be adjusted in moderately impaired kidney function.
Danish: Zebinix bør ikke anvendes hos patienter med svære nyreproblemer, og dosen bør tilpasses ved moderat nedsat nyrefunktion.
English: Over the 12 weeks of treatment, this fell to 9.8 and 9.0 seizures per month in patients taking Zebinix 800 mg and Zebinix 1,200 mg respectively, compared with 11.7 per month in those taking placebo.
Danish: I løbet af de 12 ugers behandling faldt dette tal til 9,8 og 9,0 anfald pr. måned hos patienter, som fik henholdsvis Zebinix 800 mg og Zebinix 1.200 mg, sammenlignet med 11,7 pr. måned hos dem, der fik placebo.
English: In children weighing less than 60 kg, the starting dose is 10 mg per kg body weight once a day.
Danish: Hos børn, som vejer under 60 kg, er startdosen 10 mg pr. kg legemsvægt en gang dagligt.
English: For adults who take Zebinix on its own, a dose up to 1,600 mg may be used.
Danish: Hos voksne, som tager Zebinix alene, kan der anvendes en dosis på op til 1 600 mg.
English: Zebinix can be taken on its own, in newly diagnosed epilepsy, or can be added to existing antiepileptic medicines.
Danish: Zebinix kan tages alene, ved nydiagnosticeret epilepsi, eller kan tilføjes til behandling med eksisterende epilepsilægemidler.
English: For adults, the most common side effects with Zebinix (seen in more than 1 patient in 10) are dizziness, somnolence (sleepiness), headache and nausea.
Danish: Hos voksne er de hyppigste bivirkninger ved Zebinix (som optræder hos mere end 1 ud af 10 patienter) svimmelhed, søvntrang (søvnighed), hovedpine og kvalme.
English: For children and adults who use Zebinix in combination with other medicines the maximum dose is 1,200 mg once a day.
Danish: Hos børn og voksne, som anvender Zebinix i kombination med andre lægemidler, er den maksimale dosis 1 200 mg en gang dagligt.