FrancophonIA/ELRC3.0 huggingface dataset:
English: • Cough with sputum
Danish: • hoste med opspyt
English: Dose
Danish: Da
English: NAME OF THE MEDICINAL PRODUCT Orkambi 100 mg/125 mg granules in sachet lumacaftor/ivacaftor
Danish: LÆGEMIDLETS NAVN Orkambi 100 mg/125 mg granunat i brev lumacaftor/ivacaftor
English: What you need to know before your child takes Orkambi 3.
Danish: Det skal du vide, før dit barn begynder at tage Orkambi Sådan skal dit barn tage Orkambi Bivirkninger
English: 12 years and older Orkambi 200 mg/125 mg
Danish: Orkambi 200 mg/125 mg
English: ↓ repaglinide Due to induction of CYP3A/2C8 by LUM
Danish: Da CYP3A/2C8 induceres af LUM
English: NAME OF THE MEDICINAL PRODUCT Orkambi 100 mg/125 mg film-coated tablets lumacaftor/ivacaftor
Danish: LÆGEMIDLETS NAVN Orkambi 100 mg/125 mg filmovertrukne tabletter lumacaftor/ivacaftor
English: NAME OF THE MEDICINAL PRODUCT Orkambi 200 mg/125 mg film-coated tablets lumacaftor/ivacaftor
Danish: LÆGEMIDLETS NAVN Orkambi 200 mg/125 mg filmovertrukne tabletter lumacaftor/ivacaftor
English: Patients aged 2 to 5 years and weighing and less than 14 kg lumacaftor 100 mg/ivacaftor 125 mg sachet every 12 hours
Danish: For patienter i alderen 2 til 5 år og < 14 kg lumacaftor 100 mg + ivacaftor 125 mg
English: Long-term safety and efficacy rollover trial
Danish: Lever- og galdevejshændelser
English: ↔ LUM, IVA ↓ methylprednisolone,
Danish: ↔ LUM, IVA ↓ citalopram,
English: Concomitant use of CYP3A inhibitors
Danish: Samtidig anvendelse af CYP3A-hæmmere
English: ↔ LUM, IVA ↑ or ↓ fexofenadine
Danish: ↔ LUM, IVA ↓ bupropion
English: Your doctor may perform some eye examinations prior to and during treatment with Orkambi.Orkambi is not recommended in patients who have undergone an organ transplant.
Danish: Din læge kan udføre nogle øjenundersøgelser før og under behandlingen med Orkambi.
English: At Week-24, the treatment difference between lumacaftor 400 mg/ivacaftor 250 mg q12h and placebo for the mean absolute change (95% CI) in ppFEV1 from baseline in the pooled Trials 1 and 2 were 3.39 percentage points (P = 0.0382) for patients with ppFEV1 < 40 and 2.47 percentage points (P < 0.0001) for patients with ppFEV1 ≥ 40.
Danish: CI) i ppFEV1 fra baseline i de samlede studier 1 og 2 3,39 procentpoint (P = 0,0382) for patienter med ppFEV1 < 40 og 2,47 procentpoint (P < 0,0001) for patienter med ppFEV1 ≥ 40.
English: C.
Danish: Forl.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR SACHET
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ÆSKE TIL BREV
English: In Trial 7 (see Clinical efficacy and safety) in patients homozygous for the F508del-CFTR mutation aged 6 to 11 years, the treatment difference (LS mean) in sweat chloride for the absolute change at
Danish: I studie 7 (se Klinisk virkning og sikkerhed) hos patienter (homozygote med hensyn til F508del-CFTR-mutationen) i alderen 6 til 11 år var behandlingsforskellen (mindste kvadraters (least square, LS) gennemsnit) i chloridindholdet i sved for den absolutte ændring ved uge 24 sammenlignet med placebo -24,9 mmol/l (nominel P < 0,0001).
English: For patients aged 12 years and older 2 tablets of 200 mg/125 mg in the morning +
Danish: 2 tabletter med 200 mg/125 mg om morgenen +
English: Concomitant use of lumacaftor/ivacaftor with St. John's wort is not recommended.
Danish: Administration af lumacaftor/ivacaftor sammen med prikbladet perikon anbefales ikke.
English: prednisone Due to induction of CYP3A by LUM
Danish: triazolam Da CYP3A induceres af LUM
English: What you need to know before you take Orkambi 3.
Danish: Det skal du vide, før du begynder at tage Orkambi Sådan skal du tage Orkambi Bivirkninger
English: • Nasal congestion
Danish: • tilstoppet næse
English: If you stop giving your child Orkambi
Danish: Hvis dit barn har taget for meget Orkambi
English: Posology
Danish: Overtræk
English: Menstrual abnormalities
Danish: ↓ montelukast
English: Content Package size Withdrawal period
Danish: Indhold Pakningsstørrelse
English: Immediate packaging
Danish: Indgivelsesvej Indre Emballage
English: 1 pre-filled syringe Not applicable
Danish: 1 fyldt sprøjte
English: Member State EU/EEA
Danish: EU/EØS medlemsstat
English: For the mutual recognition procedure (MRP), Belgium acted as a reference Member State and Bulgaria, Croatia, France, Germany, Ireland, Italy, the Netherlands, Poland, Portugal, Romania, Slovenia, Spain and the United Kingdom were concerned Member States.
Danish: I forbindelse med den gensidige anerkendelsesprocedure handlede Belgien som referencemedlemsstat, og Bulgarien, Kroatien, Frankrig, Tyskland, Irland, Italien, Nederlandene, Polen, Portugal, Rumænien, Slovenien, Spanien og Det Forenede Kongerige var berørte medlemsstater.
English: This thorough investigations includes: 1.
Danish: Disse grundige undersøgelser omfatter:
English: − PSURs shall be provided every 6 months for the first 5 years of commercialisation.
Danish: − Indsende PSUR'er hver 6. måned i de første 5 år af markedsføringen.
English: The epidemiology of the disease is difficult to describe as a number of potential biases may have influenced the results.
Danish: Sygdommens epidemiologi er vanskelig at beskrive, da en række mulige bias kan have påvirket resultaterne.
English: Data have been provided to demonstrate the efficiency of the filtration step.
Danish: Der er fremlagt data til påvisning af filtreringens effektivitet.
English: No other concern was notified by the reference Member State.
Danish: Referencemedlemsstaten har ikke anmeldt andre anliggender.
English: Assessment of the data submitted
Danish: Vurdering af de indsendte data
English: List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant/marketing authorisation holder in the Member States
Danish: Liste med navne, lægemiddelform, styrke at det veterinære lægemiddel, dyreart, indgivelsesvej, ansøger/indehaver af markedsføringstilladelse i medlemsstaterne
English: With Commission Decisions 5694 of 10/08/2010 and 7077 of 07/10/2010 the marketing authorisations for PregSure BVD were suspended.
Danish: Ved Kommissionens afgørelse 5694 af 10.8.2010 og 7077 af 7.10.2010 blev markedsføringstilladelserne for PregSure BVD suspenderet.
English: Vaccines are important tools to combat Bovine Herpesvirus Type 1 Infection which is a notifiable disease in several Member States, e.g. Austria, Denmark, Germany.
Danish: Vacciner er et vigtigt redskab til bekæmpelse af bovin herpesvirus type 1-infektion, der er en anmeldelsespligtig sygdom i mange medlemsstater, f.eks. Østrig, Danmark og Tyskland.
English: Exclusion of infectious, toxic or any other cause in live animals, to be further detailed in the risk management plan.
Danish: Udelukkelse af infektiøse, toksiske og andre grunde hos levende dyr - skal beskrives nærmere i risikostyringsplanen.
English: Additionally, a surveillance and monitoring strategy has been proposed, which together with the suggested studies is deemed adequate and proportionate to the identified risk.
Danish: Desuden er der foreslået en overvågnings- og monitoreringsstrategi, der sammen med de omtalte studier skønnes at være tilstrækkelig og at stå i rimeligt forhold til den identificerede risiko.
English: Overall summary of the scientific evaluation of CattleMarker IBR Inactivated (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af CattleMarker IBR Inactivated (se bilag I)
English: The risk management plan should be submitted to the national competent authorities within 6 months of the Commission Decision and maintained until such time as the concerned national competent authorities consider that the risk profile of the product has been sufficiently characterised and all appropriate risk mitigation and surveillance measures have been implemented.
Danish: Risikostyringsplanen skal indsendes til de nationale kompetente myndigheder senest 6 måneder efter Kommissionens afgørelse og opretholdes, indtil de berørte nationale kompetente myndigheder vurderer, at produktets risikoprofil er tilstrækkeligt beskrevet, og alle relevante risikominimerings- og overvågningsforanstaltninger er gennemført.
English: However, a concern remains and the MAH committed to further investigate this result in two additional similar studies.
Danish: En vis betænkelighed findes dog stadig, og indehaveren af markedsføringstilladelsen har forpligtet sig til at undersøge dette resultat yderligere i to lignende suppleringsstudier.
English: − Clinically validate the upper limit for total protein content.
Danish: − Klinisk validere den øvre grænse for det samlede proteinindhold.
English: The marketing authorisation holder (MAH), Zoetis Belgium SA, submitted an application for mutual recognition of the marketing authorisation granted by Belgium in accordance with Article 32 of Directive 2001/82/EC.
Danish: Indehaveren af markedsføringstilladelsen, Zoetis Belgium SA, har indsendt en ansøgning om gensidig anerkendelse af den markedsføringstilladelse, som Belgien har udstedt i overensstemmelse med artikel 32 i direktiv 2001/82/EF.
English: Should proposals for alternative immunisation schemes, indications, or contraindications be necessary, these regulatory measures should also be handled consistently with the normal operating practices for adverse event reports and variations associated with veterinary medicinal products.
Danish: Hvis det skulle blive nødvendigt at indføre alternative immuniseringsplaner, indikationer eller kontraindikationer, skal disse regulatoriske foranstaltninger foretages i overensstemmelse med den normale praksis for bivirkningsrapportering og variationer, der benyttes for veterinærlægemidler.
English: − Show that there is no impact of the scaling-up (considering a worst-case scenario, i.e. the maximum commercial batch) on the efficiency of consistently decreasing the total protein content.
Danish: − Påvise, at opskaleringen (under hensyntagen til det værst tænkelige scenarie, dvs. den maksimale kommercielle batch) ikke har nogen indvirkning på effekten ved konsistent nedsættelse af det samlede proteinindhold.
English: To address the concerns on alloantibody response the marketing authorisation holder should ensure that the results of the study can be reliably interpreted.
Danish: For at tage højde for betænkelighederne med hensyn til alloantistofrespons skal indehaveren af markedsføringstilladelsen sikre, at studieresultaterne kan fortolkes pålideligt.
English: The limit should be equal to or below the quantity of total protein of the CattleMarker IBR vaccine used in hyperimmunisation study 9134R-08-11-457.
Danish: Denne grænse skal være lig med eller lavere end den samlede proteinmængde i den CattleMarker IBR-vaccine, der er anvendt i hyperimmuniseringsundersøgelse 9134R-08-11-457.
English: There have been great variations in pharmacovigilance reporting and it is difficult to conclude whether they are related to genuine variations of frequency of BNP occurrence or because of the differences of the information gathered on the condition.
Danish: Der har været store variationer i lægemiddelovervågningsrapporterne, og det er vanskeligt at konkludere, om disse skyldes egentlige variationer i forekomsten af BNP, eller om de skyldes forskelle i de oplysninger, der er indsamlet om sygdommen.
English: Risk management measures
Danish: Risikostyringsforanstaltninger
English: To set this specification the marketing authorisation holder shall:
Danish: I forbindelse med udarbejdelsen af denne specifikation skal indehaveren af markedsføringstilladelsen:
English: Since the issues raised by Germany remained unresolved, the Member States concerned failed to reach agreement regarding the marketing authorisation CattleMarker IBR Inactivated and consequently the matter was referred to the CVMP on 29 September 2015 under Article 33(4) of Directive 2001/82/EC.
Danish: Da de problemstillinger, som Tyskland har rejst, stadig ikke er løst, er det ikke lykkedes de berørte medlemsstater at nå til enighed med hensyn til markedsføringstilladelsen for CattleMarker IBR Inactivated, og derfor er sagen den 29. september 2015 blevet indbragt for CVMP i overensstemmelse med artikel 33, stk. 4, i direktiv 2001/82/EF.
English: • The marketing authorisation holder shall implement a single risk management plan addressing the following risk mitigation and surveillance measures:
Danish: • Indehaveren af markedsføringstilladelsen skal gennemføre en samlet risikostyringsplan med fokus på følgende risikominimerings- og overvågningsforanstaltninger:
English: As lack of alloantibody response would be anticipated leading to negative results they should be compared with the available data on Pregsure BVD and with an appropriate internal positive control.
Danish: Da manglende alloantistofrespons forventes at medføre negative resultater, skal disse sammenholdes med tilgængelige data om Pregsure BVD og med en passende intern positiv kontrol.
English: A large scale post-marketing prospective survey is deemed less effective to identify whether the level of BNP is acceptable when compared with the surveillance and monitoring strategy proposed, because the number of animals to be enrolled in such a study would exceed several thousands of animals (due to the estimated BNP frequency of around 0.01%) and the time span anticipated for BNP cases to occur consecutive to vaccination would not be shorter.
Danish: En omfattende prospektiv undersøgelse efter tilladelse til markedsføring skønnes at være mindre effektiv end den foreslåede overvågnings- og monitoreringsstrategi til at identificere, om BNP-niveauet er acceptabelt, da det antal dyr, der skal inkluderes i en sådan undersøgelse, vil være flere tusind (på grund af den skønnede BNPforekomst på ca. 0,01 %), og da det ikke forventes at tage kortere tid, før der opstår BNP-tilfælde efter vaccination.
English: The national competent authorities, coordinated by the reference Member State, shall ensure that the following conditions are fulfilled by the marketing authorisation holder:
Danish: De nationale kompetente myndigheder skal med referencemedlemsstaten som koordinator sikre, at indehaveren af markedsføringstilladelsen opfylder følgende betingelser:
English: − Send out a letter to all customers receiving the CattleMarker IBR Inactivated for the first time with additional information to raise awareness for possible BNP cases.
Danish: − Fremsende et brev til alle kunder, der modtager CattleMarker IBR Inactivated for første gang, med supplerende oplysninger, der øger bevidstheden om mulige BNPtilfælde.
English: BNP is a disease which can be fatal in neonatal calves and which has been experimentally reproduced by the intake of colostrum from dams which have alloantibodies.
Danish: BNP er en sygdom, der kan være fatal for nyfødte kalve, og som er blevet reproduceret eksperimentelt ved indtag af råmælk fra moderdyr, der har alloantistoffer.
English: Considering that the frequency of BNP is anticipated to be much lower than 0.01% (PregSure BVD BNP frequency) these measures, which will be included in a RMP, are considered the most efficient way to tackle this risk.
Danish: I betragtning af, at forekomsten af BNP forventes at ligge langt under 0,01 % (BNP-forekomsten ved brug af PregSure BVD), vurderes disse foranstaltninger, der indgår i risikostyringsplanen, at være den mest effektive måde at imødegå risikoen på.
English: Later the marketing authorisations for PregSure BVD were withdrawn by the MAH Pfizer (now Zoetis) from all EU and in 2011 even from non-EU countries after reports about BNP cases in PregSure BVD-vaccinated herds in New Zealand became public.
Danish: Senere trak markedsføringsindehaveren Pfizer (nu Zoetis) markedsføringstilladelserne for PregSure BVD tilbage i alle EU-lande og i 2011 også i tredjelande, efter at der var offentliggjort rapporter om BNP-tilfælde hos PregSure BVD-vaccinerede besætninger i New Zealand.
English: Due to the efficiency and safety of the gE deleted IBR vaccines currently on the market the eradication of IBR is making good progress and several European countries are on the way towards freedom from BoHV-1.
Danish: Takket være virkningen af og sikkerheden ved de gE-deleterede IBRvacciner, der aktuelt findes på markedet, gøres der store fremskridt i udryddelsen af IBR, og i mange europæiske lande er man også ved at slippe af med BoHV-1.
English: The CVMP was asked to consider the issues raised by Germany and conclude whether marketing authorisations for CattleMarker IBR Inactivated should be granted.
Danish: CVMP er blevet bedt om at forholde sig til de problemstillinger, som Tyskland har rejst, og afgøre, om der skal udstedes markedsføringstilladelser for CattleMarker IBR Inactivated.
English: These results show that the overall protein content per ml is higher in BVDV-1 antigen batches than in BoHV1 antigen batches.
Danish: Resultaterne viser, at det samlede proteinindhold pr. ml er højere i BVDV-1-antigen-batcher end i BoHV-1-antigen-batcher.
English: Several live and inactivated IBR marker vaccines are authorised and successfully used throughout the EU.
Danish: I hele EU har man godkendt mange levende og inaktiverede IBR-markørvacciner, der benyttes med god virkning.
English: Annex IV Conditions of the marketing authorisations
Danish: Bilag IV Betingelser for markedsføringstilladelserne
English: Animal species Route of administration
Danish: Lægemiddelform Dyreart Indgivelsesvej
English: CattleMarker IBR Inactivated fulfils the criteria for an effective IBR marker vaccine and provides the full therapeutic benefit.
Danish: CattleMarker IBR Inactivated opfylder kriterierne for en effektiv IBR-markørvaccine og giver fyldestgørende terapeutisk udbytte.
English: A filtration step using three filtration membranes has been integrated into the production process for clarification of the antigen preparations.
Danish: I fremstillingsprocessen er man begyndt at anvende filtrering ved brug af tre membraner for at gøre antigen-præparaterne klarere.
English: Prior to placing CattleMarker IBR Inactivated on the EU market the results should be submitted to the national competent authorities to be assessed by the authorities to their satisfaction.
Danish: Før CattleMarker IBR Inactivated markedsføres på det europæiske marked, skal resultaterne indsendes til og vurderes af de nationale kompetente myndigheder, der skal godkende dem.
English: Scientific conclusions and grounds for the granting of the marketing authorisations
Danish: Videnskabelige konklusioner og begrundelser for udstedelse af markedsføringstilladelserne
English: − Utilise the existing GMP product/batch recall procedures.
Danish: − Bruge de eksisterende produkt/batch-tilbagekaldelsesprocedurer i henhold til god fremstillingspraksis.
English: Any confirmed BNP calves will also be assessed for MHC-I alloantibodies.
Danish: Kalve, der har bekræftet BNP, skal også kontrolleres for MHC-I-alloantistoffer.
English: − The marketing authorisation holder should consider the development a method for assaying the protein content in the finished product.
Danish: − Indehaveren af markedsføringstilladelsen skal overveje udvikling af en metode til analyse af proteinindholdet i det endelige produkt.
English: Active immunisation of female cattle from 6 months of age is also indicated:
Danish: Produktet er også indiceret til aktiv immunisering af kviekalve i alderen 6 måneder og derover:
English: The abovementioned study results should be provided to the relevant national competent authorities for assessment prior to placing CattleMarker IBR Inactivated on the EU market and within 24 months of the Commission Decision.
Danish: Ovennævnte studieresultater skal indsendes til og vurderes af de nationale kompetente myndigheder, før CattleMarker IBR Inactivated lanceres på det europæiske marked, og senest 24 måneder efter Kommissionens afgørelse.
English: Onset of protection for female cattle is 2 weeks or 19 days prior to breeding or insemination and duration is 12 months post primary vaccination.
Danish: Hos kviekalve virker vaccinen efter 2 uger eller 19 dage inden bedækning eller insemination, og beskyttelsens varighed er 12 måneder efter den primære vaccine.
English: In 2010, due to these concerns, a procedure under Article 78 of Directive 2001/82/EC was initiated in which the CVMP concluded that although the aetiology of BNP had yet to be determined there was evidence to suggest that PregSure BVD may be associated with BNP and that the benefit-risk balance for the product was unfavourable.
Danish: I 2010 blev der på grund af disse bekymringer indbragt en sag for CVMP i henhold til artikel 78 i direktiv 2001/82/EF, hvor CVMP konkluderede, at der - selv om BNP's ætiologi stadig ikke var fastlagt - forelå evidens for, at PregSure BVD kunne være forbundet med BNP, og at produktets benefit/risk-forhold var ugunstigt.
English: • The marketing authorisation holder shall include a new specification in the finished product of a maximum total protein content.
Danish: • Indehaveren af markedsføringstilladelsen skal sørge for, at det endelige produkt omfatter en ny specifikation af det maksimale samlede proteinindhold.
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Danish: Det er de versioner af produktresumé, etikettering og indlægsseddel, som er foranstaltet i forbindelse med koordinationsgruppens sagsbehandling, der er gyldige.
English: • to reduce the incidence of abortions associated with BoHV-1 infections as demonstrated during the second trimester of gestation following challenge.
Danish: • med henblik på at reducere forekomsten af aborter i forbindelse med BoHV-1-infektion, typisk i drægtighedsperiodens andet trimester, efter eksponering.
English: − Prior to launch of the vaccine on the market and annually thereafter, provide specific training to the bovine sales and technical teams on the CattleMarker IBR Inactivated product safety profile, BNP and pharmacovigilance obligations.
Danish: − Før vaccinen lanceres på markedet og derefter én gang årligt: sørge for målrettede kurser til sælgere og teknikere, der beskæftiger sig med CattleMarker IBR Inactivated, vedrørende produktets sikkerhedsprofil, BNP og pligten til lægemiddelovervågning.
English: − Utilise the existing colostrum practices in case of BNP cases and develop further mitigation measure for colostrum.
Danish: − Benytte den eksisterende råmælk-praksis, der anvendes i BNP-tilfælde, og udarbejde yderligere risikominimeringsforanstaltninger for råmælk.
English: The potential risk deriving from the intended use of CattleMarker IBR Inactivated to trigger BNP is associated with the composition and manufacture of the vaccine and more specifically with the amount of Antigens Not related to the Active Substance (ANAS) and is also linked to the use of the vaccine in female cattle subject to repeated vaccinations.
Danish: Den potentielle risiko for udvikling af BNP ved den tilsigtede anvendelse af CattleMarker IBR Inactivated hænger sammen med sammensætningen og fremstillingen af vaccinen og mere specifikt med mængden af antigener, der ikke er relateret til det aktive stof (ANAS), ligesom det også er af betydning, at vaccinen anvendes til kviekalve, der skal vaccineres flere gange.
English: Nonetheless in the assessment in the frame of this procedure under Article 78 of Directive 2001/82/EC the frequency of the BNP caused by PregSure BVD was approximated to be around 0.01% by the CVMP.
Danish: I forbindelse med denne vurderingsprocedure, jf. artikel 78 i direktiv 2001/82/EF, skønner CVMP imidlertid, at forekomsten af PregSure BVD-forårsaget BNP ligger på omkring 0,01 %.
English: Applicant/marketing authorisation holder
Danish: Ansøger/markedsføringstilladelsens indehaver
English: − In addition to the usual pharmacovigilance system for the monitoring of animals vaccinated with CattleMarker IBR Inactivated, to conduct thorough investigations for any unexplained mortality in the offspring of vaccinated animals following documented use of CattleMarker IBR Inactivated.
Danish: − Ud over det sædvanlige lægemiddelovervågningssystem til monitorering af dyr, der er vaccineret med CattleMarker IBR Inactivated: gennemføre grundige undersøgelser, hvis der ses uventet mortalitet blandt afkommet fra vaccinerede dyr efter dokumenteret brug af CattleMarker IBR Inactivated.