FrancophonIA/ELRC3.0 huggingface dataset:
English: Written explanations were provided by the marketing authorisation holder on 17 August 2009.
Danish: Indehaveren af markedsføringstilladelsen fremsendte en skriftlig besvarelse af spørgsmålene den 17. august 2009.
English: The products are currently authorised for use in dogs for the treatment of congestive heart failure (NYHA classification grade II, III and IV) due to chronic degenerative valvular heart disease or cardiomyopathy, with or without adjunct diuretic (furosemide) or cardiac glycoside (digoxin/methyldigoxin) therapy.
Danish: Produkterne er i øjeblikket godkendt til brug til hunde til behandling af kongestiv hjerteinsufficiens (NYHA-klasse II, III og IV) som følge af kronisk degenerativ hjerteklapfejl eller kardiomyopati med eller uden supplerende behandling med diuretikum (furosemid) eller hjerteglykosid (digoxin/methyldigoxin).
English: On 2 July 2009 Belgium referred the matter to the Agency under Article 39 of Directive 2001/82/EC as amended by reference to Article 6(12) of Regulation (EC) No 1084/2003 due to concerns whether the marketing authorisation should be varied by adding cats as a new target species by considering if a placebo group is deemed necessary in a clinical field trial to assess the efficacy of ramipril in cats to reduce systolic blood pressure.
Danish: Den 2. juli 2009 indbragte Belgien sagen for agenturet i henhold til artikel 39 i direktiv 2001/82/EF, med senere ændringer, under henvisning til artikel 6, stk. 12, i forordning EF nr. 1084/2003, på grund af betænkeligheder ved, om markedsføringstilladelsen skulle ændres ved tilføjelsen af katte som ny dyreart, som lægemidlet er beregnet til, i form af overvejelser om, hvorvidt en placebogruppe skønnes nødvendig i en klinisk feltundersøgelse for at vurdere effekten af ramipril hos katte til sænkning af det systoliske blodtryk.
English: Vasotop P 0.625 mg, Vasotop P 1.25 mg and Vasotop P 2.5 mg tablets are veterinary medicinal products that contain the active ingredient ramipril at concentrations of 0.625 mg, 1.25 mg and 2.5 mg respectively.
Danish: Vasotop P 0,625 mg, Vasotop P 1,25 mg og Vasotop P 2,5 mg tabletter er veterinærlægemidler indeholdende det aktive stof ramipril i koncentrationer på henholdsvis 0,625 mg, 1,25 mg og 2,5 mg. Ramipril er en ACE-hæmmer (angiotensinkonverterende enzymhæmmer).
English: Further to rapporteurs' assessment of the currently available data, the CVMP adopted on 8 December 2009 an opinion recommending that the variation application for the veterinary medicinal products Vasotop P 0.625 mg tablet for dogs, Vasotop P 1.25 mg tablet for dogs and Vasotop P 2.5 mg tablet for dogs and associated names does not satisfy the criteria for approval in respect of efficacy.
Danish: I forlængelse af rapportørens vurdering af de forhåndenværende oplysninger vedtog CVMP den 8. december 2009 en udtalelse, hvori det fremgik, at ansøgningen om ændring indgivet for de veterinærmedicinske lægemidler Vasotop P 0,625 mg, tablet til hunde, Vasotop P 1,25 mg, tablet til hunde og Vasotop P 2,5 mg, tablet til hunde og tilknyttede navne ikke opfylder godkendelseskriterierne, hvad angår effekt.
English: The marketing authorisation holder (Intervet International B.V.) submitted applications for a type II variation subject to mutual recognition procedures for Vasotop P 0.625 mg, Vasotop P 1.25 mg and Vasotop P 2.5 mg tablets for dogs in order to include a new indication for cats as follows: For the reduction of elevated systolic blood pressure (between 160 and 230 mm Hg) and the control of associated clinical signs.
Danish: indsendte ansøgninger om en type II-ændring under proceduren for gensidig anerkendelse af markedsføringstilladelserne for Vasotop P 0,625 mg, Vasotop P 1,25 mg og Vasotop P 2,5 mg tabletter til hunde med henblik på at inkludere følgende nye indikation for katte: Til reduktion af forhøjet systolisk blodtryk (mellem 160 og 230 mm Hg) og regulering af tilknyttede kliniske tegn.
English: Opinion following an Article 6(12) referral for Vasotop P tablet for dogs EMA/183104/2010
Danish: Udtalelse som følge af en sag indbragt i henhold til artikel 6, stk. 12, for Vasotop P tablet til hunde
English: referral for Vasotop P
Danish: Indehaveren af markedsføringstilladelsen (Intervet International B.V.)
English: None of the events were fatal.
Danish: Ingen af hændelserne var fatale.
English: “+” denotes a censored observation.
Danish: “+” betegner en censureret observation.
English: Overall survival (OS) was also evaluated.
Danish: Samlet overlevelse (OS) blev også evalueret.
English: You will also have blood tests during treatment.
Danish: Du vil også få taget blodprøver i løbet af behandlingen.
English: Very limited data are available.
Danish: Der foreligger meget begrænsede data.
English: In Phase 2 studies, this increase was dose-dependent.
Danish: I fase 2-studier var denne stigning dosisafhængig.
English: The primary efficacy endpoint was 1-year survival rate.
Danish: Det primære effektendepunkt var 1-års overlevelsesrate.
English: Responses are summarised in Table 11.
Danish: Respons er sammenfattet i Tabel 11.
English: The effect of race was not examined as there was insufficient data in non-Caucasian ethnic groups.
Danish: Den racemæssige effekt blev ikke undersøgt, da der ikke var tilstrækkelige data i ikke-kaukasiske etniske grupper.
English: Other in-use storage time and conditions are the responsibility of the user.
Danish: Anden opbevaringstid og andre opbevaringsforhold er brugerens ansvar.
English: Duration of follow-up ranged up to 55 months.
Danish: Varigheden af opfølgning var op til 55 måneder.
English: Number of Patients (%)
Danish: Antal patienter (%)
English: YERVOY should not be frozen.
Danish: YERVOY må ikke nedfryses.
English: Table 9: Overall survival in observational studies
Danish: Tabel 9: Samlet overlevelse i observationsstudier
English: Including fatal outcome.
Danish: Inklusiv dødelig udgang.
English: The primary endpoints were safety and pharmacokinetics (PK).
Danish: De primære endepunkter var sikkerhed og farmakokinetik (PK).
English: In CA184178, deaths were reported at least 90 days of the last dose.
Danish: I CA184178 blev dødsfald rapporteret mindst 90 dage efter sidste dosis.
English: All patients were followed for at least 1 year.
Danish: Alle patienter blev fulgt i mindst 1 år.
English: No overall differences in safety or efficacy were reported between elderly (≥ 65 years) and younger patients (< 65 years).
Danish: Der blev ikke rapporteret om nogen generel forskel på sikkerhed eller virkning mellem ældre (≥ 65 år) og yngre patienter (< 65 år).
English: Date of first authorisation: 13 July 2011 Date of latest renewal: 21 April 2016
Danish: Dato for første markedsføringstilladelse: Dato for seneste fornyelse: 21 april 2016
English: Calculating the dose:
Danish: Beregning af dosis:
English: Very common decreased appetite decreased appetite
Danish: Meget almindelig nedsat appetit nedsat appetit
English: Tapering should occur over a period of at least 1 month.
Danish: Nedtrapningen bør foregå over en periode på mindst 1 måned.
English: Early diagnosis and appropriate management are essential to minimise life-threatening complications.
Danish: Tidlig diagnose og passende behandling er væsentlig for at minimere livstruende komplikationer.
English: The relationship of these malformations to treatment is unclear.
Danish: Forbindelsen mellem disse misdannelser og behandlingen er uklar.
English: No new or unexpected irARs were observed in this study.
Danish: Ingen nye eller uventede irAR'er blev observeret i dette studie.
English: a gp100 peptide vaccine is an experimental control.
Danish: a gp100 peptidvaccine er en forsøgskontrol.
English: The amount of YERVOY you will be given will be calculated based on your body weight.
Danish: Den mængde YERVOY du får, bliver beregnet ud fra din kropsvægt.
English: Fertility studies have not been performed.
Danish: Der er ikke udført fertilitetsstudier.
English: Other forms of interaction
Danish: Andre typer af interaktion
English: Rare myasthenia gravisd
Danish: Sjælden myasthenia gravisd
English: Human IgG1 crosses the placental barrier.
Danish: Human IgG1 passerer placentabarrieren.
English: The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe YERVOY are provided with the following:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle læger, som forventes at ordinere YERVOY, er forsynet med følgende:
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Danish: Det muliggør løbende overvågning af benefit/risk‑forholdet for lægemidlet.
English: The study enrolled 13 patients < 12 of age and 20 patients ≥ 12 years of age.
Danish: Studiet inkluderede 13 patienter <12 år og 20 patienter ≥12 år.
English: Deaths for pediatric patients are those with on-study events within 30 days of the last dose, except for “All Deaths,” which were >30 days after the last dose.
Danish: Dødsfald for pædiatriske patienter er dem, der har on-study hændelser indenfor 30 dage efter sidste dosis, undtagen for "Alle dødsfald", som var >30 dage efter den sidste dosis.
English: Changes in test results
Danish: Ændringer i testresultater
English: Age 12 to < 18 years
Danish: Alder 12 til < 18 år
English: Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events.
Danish: Toksicitetsgrader er i henhold til National Cancer Institute Common Terminology Criteria for Adverse Events.
English: Additional efficacy results are presented in Table 13.
Danish: Yderligere effektresultater er præsenteret i Tabel 13.
English: No treatment-related adverse effects on reproduction were detected during the first two trimesters of pregnancy.
Danish: Der blev ikke påvist nogen behandlingsrelaterede virkninger på reproduktionen i de to første trimestre i drægtighedsperioden.
English: Rare proteinuriad
Danish: Sjælden proteinurid
English: Advanced Melanoma and NonMelanoma Solid Tumors
Danish: Fremskredent melanom og nonmelanom solide tumorer
English: Do not drive, cycle or use machines after you have been given YERVOY unless you are sure you are feeling well.
Danish: Kør ikke bil eller cykel og anvend ikke maskiner, hvis du har fået YERVOY, medmindre du er sikker på, at du har det godt.
English: widespread/intense pruritus regardless of etiology
Danish: udbredt/intenst pruritus uanset ætiologi
English: Only very limited data are available in children younger than 12 years of age.
Danish: Kun meget begrænsede data er tilgængelige for børn under 12 år.
English: Tumor assessment was performed at Week 12.
Danish: Evaluering af tumorer blev foretaget ved uge 12.
English: Children younger than 12 years of age
Danish: Børn under 12 år
English: No other endocrine abnormalities were reported.
Danish: Ingen andre endokrine abnormaliteter blev rapporteret.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit‑forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: All Deaths, n (%)
Danish: Alle dødsfald, n (%)
English: Data presented in those sections primarily reflect experience from a Phase 3 study, MDX010-20.
Danish: De data, der præsenteres i disse afsnit, gengiver hovedsageligt erfaringer fra et fase 3studie, MDX010-20.
English: The YERVOY infusion is compatible with:
Danish: YERVOY-infusionen er kompatibel med:
English: if you have recently been prescribed Zelboraf (vemurafenib, another medicine for the treatment of skin cancer).
Danish: hvis du for nylig har fået ordineret Zelboraf (vemurafenib; et andet lægemiddel til behandling af hudkræft).
English: Based on a stratified proportional hazards model.
Danish: Udledt af en stratificeret proportional risikomodel.
English: Warnings and precautions Talk to your doctor before using YERVOY as it may cause:
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du bruger YERVOY, da det kan medføre:
English: Because of the limited number of patients in these analyses, no definitive conclusion regarding the efficacy of ipilimumab re-treatment can be drawn.
Danish: På grund af det begrænsede antal patienter i disse analyser kan der ikke drages nogen definitiv konklusion med hensyn til virkningen af genbehandling med ipilimumab.
English: Treatment must be initiated and supervised by specialist physicians experienced in the treatment of cancer.
Danish: Behandlingen skal initieres og superviseres af en læge med erfaring i cancerbehandling.
English: The majority had received all 4 doses during induction.
Danish: Størstedelen fik alle 4 doser under induktionsbehandlingen.
English: Treatment-Related Deaths, n
Danish: Behandlingsrelateret død, n
English: Vogt-Koyanagi-Harada syndromeh
Danish: Vogt-Koyanagi-Harada syndromh
English: How YERVOY is given YERVOY will be given to you in a hospital or clinic under the supervision of an experienced doctor.
Danish: Sådan får du YERVOY Du vil få YERVOY på et hospital eller en klinik under opsyn af en erfaren læge.
English: if you are taking any medicines that stop your blood from clotting (anticoagulants).
Danish: hvis du tager medicin, der forhindrer blodet i at størkne (antikoagulanter).
English: The final concentration should range from 1 to 4 mg/ml.
Danish: Den færdige koncentration bør være fra 1 til 4 mg/ml.
English: Please note that the reaction called DRESS may develop weeks or months after your last dose.
Danish: Du skal være opmærkosm på, at reaktionen DRESS kan opstå uger eller måneder efter din sidste dosis.
English: Do not stop treatment with YERVOY unless you have discussed this with your doctor.
Danish: Du må ikke stoppe behandlingen med YERVOY, medmindre du har aftalt det med lægen.
English: Appropriate hormone replacement should also be initiated.
Danish: Passende hormonsubstitutionsbehandling bør også initieres.
English: Not known pemphigoid
Danish: Ikke kendt pemphigoid
English: MedDRA v.17.0 for CA184070, v.19.0 for CA184178, and V.12.1 for Adult Safety Pool.
Danish: MedDRA v.17.0 for CA184070, v.19.0 for CA184178, og V.12.1 for poolede sikkerhedsdata fra voksne.
English: DRESS may be characterized by a long latency (two to eight weeks) between medicinal product exposure and disease onset.
Danish: DRESS kan være kendetegnet ved en lang latenstid (to til otte uger) mellem lægemiddeleksponering og sygdomsdebut.
English: ≥ Grade 2 for immune-related eye disorders NOT responding to topical immunosuppressive therapy a
Danish: ≥ Grad 2 for immunrelaterede øjensygdomme, der IKKE responderer på topikal immunosuppressiv behandling a
English: Tell your doctor immediately if you have any of these signs or symptoms or they get worse.
Danish: Fortæl det straks til lægen, hvis du får et eller flere af disse tegn eller symptomer eller hvis de bliver værre.
English: Age ≥ 12 to 21 years
Danish: Alder ≥ 12 til 21 år
English: Limited, but no long-term, safety data is available on the use of ipilimumab in adolescents 12 years of age and older.
Danish: Begrænsede, men ingen langsigtede, sikkerhedsdata er tilgængelige for brugen af ipilimumab hos unge på 12 år og derover.
English: YERVOY contains sodium
Danish: YERVOY indeholder natrium
English: Not reached
Danish: Ikke opnået
English: Withdraw the required volume of YERVOY concentrate using an appropriate sterile syringe.
Danish: Udtag den påkrævede mængde YERVOY koncentrat ved brug af en passende steril sprøjte.
English: Fatal cases have been reported in completed or ongoing clinical studies b
Danish: Der er rapporteret dødelige tilfælde i afsluttede eller igangværende kliniske studier b
English: Your doctor may give you other medicines in order to prevent more severe complications and reduce your symptoms, withhold the next dose of YERVOY, or stop your treatment with YERVOY altogether.
Danish: Din læge vil muligvis give dig anden medicin for at forebygge flere alvorlige komplikationer og mildne dine symptomer, udsætte den næste dosis af YERVOY eller helt stoppe din behandling med YERVOY.
English: Storage conditions and shelf life:
Danish: Opbevaringsbetingelser og holdbarhed:
English: • Brief introduction to ipilimumab and the purpose of this risk minimisation tool.
Danish: • Kort introduktion til ipilimumab og formålet med denne risikominimeringsforanstaltning.
English: Progressive signs of motor neuropathy must be considered immune-related and managed accordingly.
Danish: Progressive tegn på motorisk neuropati skal betragtes som immunrelaterede og behandles i overensstemmelse hermed.
English: Stopping your treatment may stop the effect of the medicine.
Danish: Hvis du stopper med behandlingen, kan virkningen af medicinen ophøre.
English: • Brief introduction to ipilimumab (and the purpose of this risk minimisation tool).
Danish: • Kort introduktion til ipilimumab (og formålet med denne risikominimeringsforanstaltning).
English: Patients with autoimmune disease
Danish: Patienter med autoimmun sygdom
English: This can affect your ability to drive, cycle or to use machines.
Danish: Dette kan påvirke din evne til at køre bil, cykle eller betjene maskiner.
English: YERVOY has minor influence on the ability to drive and use machines.
Danish: YERVOY påvirker i mindre grad evnen til at føre motorkøretøj eller betjene maskiner.
English: It also contains prompts to enter contact details of the physician and to alert other physicians that the patient is treated with ipilimumab.
Danish: Det indeholder også en opfordring om at påføre den ordinerende læges kontaktoplysninger og advare andre læger om, at patienten er i behandling med ipilimumab.
English: Long-term hormone replacement therapy may be necessary.
Danish: Langtidsbehandling med hormonsubstitution kan være nødvendigt.
English: All patients were HLA-A2*0201 type; this HLA type supports the immune presentation of gp100.
Danish: Alle patienter var type HLA-A2*0201; denne HLA‑type understøtter gp100's immunpræsentation.
English: Not reached (5.2, NE)
Danish: Ikke opnået (5,2; NE)
English: More than one vial of YERVOY concentrate may be needed to give the total dose for the patient.
Danish: Det kan være nødvendigt med mere end 1 hætteglas YERVOY koncentrat for at kunne give patienten den totale dosis.
English: It is very important for you to keep all your appointments to receive YERVOY.
Danish: Det er meget vigtigt, at du overholder alle dine aftaler om behandling med YERVOY.
English: The primary efficacy outcome measures were OS, ORR and PFS as determined by a Blinded Independent Central Review (BICR) in intermediate/poor risk patients.
Danish: De primære effektparametre var OS, ORR og PFS som bestemt af Blinded Independent Central Review (BICR) hos mellem- eller højrisikopatienter.
English: If there are signs of adrenal insufficiency but the patient is not in adrenal crisis, further investigations should be considered including laboratory and imaging assessment.
Danish: Hvis der er tegn på binyrebarkinsufficiens, men patienten ikke befinder sig i adrenal krise, bør yderligere undersøgelser overvejes, herunder laboratorieundersøgelser og billeddiagnostik.
English: Data from first-line RCC patients 75 years of age or older are too limited to draw conclusions on this population (see section 5.1).
Danish: Data fra førstelinje RCC-patienter ≥75 år er for begrænsede til at kunne drage konklusioner for denne population (se pkt.
English: No. at Risk mg/kg 965 429 127 73 41 29 28 12 8 4 0
Danish: Antal i risikogruppe mg/kg 965 429 127 73 41 29 28 12 8 4 0
English: However, for women above 50 years of age, the data supporting an OS benefit of ipilimumab treatment were limited.
Danish: For kvinder over 50 år var data til understøttelse af en OS-fordel dog begrænsede.
English: OS results at an additional analysis undertaken at a minimum follow-up of 36 months show outcomes consistent with the original analysis.
Danish: OS-resultaterne fra en yderligere analyse foretaget efter en opfølgningsperiode på minimum 36 måneder viste resultater i overensstemmelse med den oprindelige analyse.
English: thyroiditis, diabetes mellitusc
Danish: tyroiditis, diabetes mellitusc
English: Median age was 15 years.
Danish: Medianalder var 15 år.
English: These reactions are presented by system organ class and by frequency.
Danish: Bivirkningerne er opstillet i forhold til systemorganklasse og hyppighed.
English: To be taken into consideration when treating patients on a controlled sodium diet.
Danish: Dette skal der tages hensyn til ved behandling af patienter, der er på en kontrolleret saltfattig diæt.
English: After 28 months of follow-up, median OS was not reached in either of the nivolumab containing arms regardless of BRAF status.
Danish: Efter en opfølgningsperiode på 28 måneder blev median OS ikke nået i nogen af nivolumab-armene uanset BRAF-status.
English: Endocrine:
Danish: Endokrin:
English: Incidental cases of pemphigoid have been reported during post-marketing use.
Danish: Der er rapporteret enkelte tilfælde af pemphigoid under anvendelse efter markedsføring.
English: Permanent discontinuation of treatment or withholding of doses
Danish: Permanent seponering af behandling eller udsættelse af dosis
English: Additional information about these potentially inflammatory adverse reactions is provided in “Description of selected adverse reactions” and section 4.4.
Danish: Yderligere information om disse potentielt inflammatoriske bivirkninger gives i “Beskrivelse af udvalgte bivirkninger” og pkt.
English: Ask your doctor if you can breast-feed during or after treatment with YERVOY.
Danish: Spørg lægen, om du må amme under eller efter behandlingen med YERVOY.
English: No dose reduction of YERVOY is recommended.
Danish: Dosisreduktion af YERVOY frarådes.
English: Inflammation may cause serious damage to your body and some inflammatory conditions may be life-threatening.
Danish: Inflammation kan medføre alvorlige skader i din krop og nogle inflammationstilstande kan være livstruende.
English: The median age was 57 years.
Danish: Medianalderen var 57 år.
English: Moderate diarrhoea or colitis that either is not controlled with medical management or that persists (5-7 days) or recurs
Danish: Moderat diarre eller colitis, som enten ikke kontrolleres med medicinsk behandling eller vedvarer (5-7 dage) eller recidiverer
English: You may notice the appearance of new lesions or growth of existing lesions on your skin, which can be expected when you are being treated with YERVOY.
Danish: Du vil muligvis bemærke nye læsioner eller forværring af allerede eksisterende læsioner på huden, hvilket kan forventes, når du behandles med YERVOY.
English: Age (2-87 years) had no clinically important effect on the CL of ipilimumab.
Danish: Alder (2-87 år) havde ingen klinisk relevant effekt på CL af ipilimumab.
English: Your doctor will continue giving you YERVOY for a total of 4 doses, depending on your tolerance to the treatment.
Danish: Lægen vil fortsætte med at give dig YERVOY op til i alt 4 doser, afhængig af hvordan du tolererer behandlingen.
English: The most common clinical presentation includes headache and fatigue.
Danish: De mest almindelige kliniske tilstande omfatter hovedpine og træthed.
English: Secretion of IgGs in human milk is generally limited and IgGs have a low oral bioavailability.
Danish: Udskillelsen af IgG1 i human mælk er generelt begrænset, og IgG1 har lav oral biotilgængelighed.
English: In clinical trials, rapid tapering (over periods < 1 month) resulted in recurrence of diarrhoea or colitis in some patients.
Danish: I kliniske forsøg resulterede hurtig nedtrapning (over en periode på < 1 måned) i tilbagefald af diarre eller colitis hos nogle patienter.
English: Neutralising antibodies against ipilimumab ranged from 0 to 0.3%.
Danish: Neutraliserende antistoffer mod ipilimumab var mellem 0 og 0,3 %.