FrancophonIA/ELRC3.0 huggingface dataset:
English: Careful monitoring of therapeutic and adverse effects is recommended when ketoconazole is concomitantly administered with indinavir/ritonavir.
Danish: Omhyggelig monitorering af terapeutiske virkninger og bivirkninger anbefales, når ketoconazol administreres samtidigt med indinavir/ritonavir.
English: Careful monitoring of therapeutic and adverse effects is recommended when dexamethasone is concomitantly administered with indinavir/ritonavir.
Danish: Omhyggelig monitorering af terapeutisk virkning og bivirkninger anbefales, når dexamethason administreres samtidigt med indinavir/ritonavir.
English: Careful monitoring of therapeutic and adverse effects is recommended when tacrolimus is concomitantly administered with indinavir/ritonavir.
Danish: Omhyggelig monitorering af terapeutisk virkning og bivirkninger anbefales, når tacrolimus administreres samtidigt med indinavir/ritonavir.
English: headache, dizziness insomnia, hypoaesthesia; paraesthesia oral paraesthesia.
Danish: Insomnia, hypæstesi, paræstesi
English: ANTIHISTAMINES Fexofenadine
Danish: ANTIHISTAMINER Fexofenadin
English: Osteonecrosis:
Danish: Osteonekrose
English: Careful monitoring of therapeutic and adverse effects is recommended when atovaquone is concomitantly administered with indinavir/ritonavir.
Danish: Omhyggelig monitorering af terapeutiske virkninger og bivirkninger anbefales, når atovaquon administreres samtidigt med indinavir/ritonavir.
English: Careful monitoring of therapeutic and adverse effects is recommended when fentanyl is concomitantly administered with indinavir/ritonavir.
Danish: Omhyggelig monitorering af terapeutiske virkninger og bivirkninger anbefales, når fentanyl administreres samtidigt med indinavir/ritonavir.
English: Careful monitoring of therapeutic and adverse effects is recommended when carbamazepine is concomitantly administered with indinavir/ritonavir.
Danish: Omhyggelig monitorering af terapeutiske virkninger og bivirkninger anbefales, når carbamazepin administreres samtidigt med indinavir/ritonavir.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken, or might take any other medicines.
Danish: Brug af anden medicin sammen med CRIXIVAN Fortæl lægen, apotekspersonalet eller sundhedspersonalet, hvis De tager anden medicin, eller De har gjort det for nylig.
English: • acid reflux
Danish: • luft i maven
English: Recommendations concerning co-administration
Danish: samtidig administration
English: CRIXIVAN 400 mg hard capsules indinavir
Danish: CRIXIVAN 400 mg hårde kapsler indinavir
English: CRIXIVAN 400 mg hard capsules Indinavir
Danish: CRIXIVAN 400 mg hårde kapsler Indinavir
English: Careful monitoring of therapeutic and adverse effects is recommended when fexofenadine is concomitantly administered with indinavir/ritonavir.
Danish: Omhyggelig monitorering af terapeutiske virkninger og bivirkninger anbefales, når fexofenadin administreres samtidigt med indinavir/ritonavir.
English: Other medicines and CRIXIVAN
Danish: Bivirkninger CRIXIVAN
English: Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of carbamazepine.
Danish: Indinavir og ritonavir hæmmer CYP3A4 og som følge heraf forventes de at øge carbamazepins plasmakoncentration.
English: Careful monitoring of therapeutic and adverse effects is recommended when loratidine is concomitantly administered with indinavir/ritonavir.
Danish: Omhyggelig monitorering af terapeutiske virkninger og bivirkninger anbefales, når loratidin administreres samtidigt med indinavir/ritonavir.
English: Anti-Mycobacterial Isoniazid 300 mg QD (Indinavir 800 mg TID)
Danish: Isoniazid 300 mg QD (Indinavir 800 mg TID)
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.
Danish: Er De i tvivl så spørg lægen, apotekspersonalet eller sundhedspersonalet.
English: Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of ketoconazole.
Danish: Indinavir og ritonavir hæmmer CYP3A4 og som følge heraf forventes de at øge ketoconazols plasmakoncentration.
English: Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of fentanyl.
Danish: Indinavir og ritonavir hæmmer CYP3A4 og som følge heraf forventes de at øge fentanyls plasmakoncentration.
English: Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of tacrolimus.
Danish: Indinavir og ritonavir hæmmer CYP3A4 og som følge heraf forventes de at øge tacrolimus' plasmakoncentration.
English: Careful monitoring of therapeutic and adverse effects is recommended when buspirone is concomitantly administered with indinavir/ritonavir.
Danish: Omhyggelig monitorering af terapeutisk virkning og bivirkninger anbefales, når buspiron administreres samtidigt med indinavir/ritonavir.
English: Batch
Danish: TM
English: Sulphamethoxazole/ Trimethoprim 800 mg/160 mg BID (Indinavir 400 mg QID)
Danish: 800 mg/160 mg BID (Indinavir 400 mg QID)
English: Very common asthenia/fatigue, taste perversion, abdominal pain.
Danish: Asteni/træthed, smagsforstyrrelser, mavesmerter
English: Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of loratidine.
Danish: Indinavir og ritonavir hæmmer CYP3A4 og som følge heraf forventes de at øge loratidins plasmakoncentration.
English: Antifungals
Danish: Oral paræstesi
English: Interaction with indinavir/ritonavir not studied Indinavir and ritonavir inhibit CYP3A4 and as a result are expected to increase the plasma concentrations of buspirone.
Danish: Indinavir og ritonavir hæmmer CYP3A4 og som følge heraf forventes de at øge buspirons plasmakoncentration.
English: CRIXIVAN 200 mg hard capsules Indinavir
Danish: CRIXIVAN 200 hårde kapsler indinavir
English: Box 581, 2003 PC Haarlem, The Netherlands
Danish: Merck Sharp & Dohme B.V., Waarderweg 39, P.O. Box 581, 2003 PC Haarlem, Holland
English: European Medicines Agency
Danish: The European Medicines Agency
English: International Non-proprietary Name (INN): anecortave
Danish: Internationalt fællesnavn (INN): anecortave
English: The two main clinical studies were carried out in patients aged between 51 and 96 years of age, and lasted up to two years.
Danish: De to kliniske hovedundersøgelser er udført hos patienter i alderen 51 til 96 år og har strakt sig over indtil to år.
English: The application was at Day 180 when the Company withdrew.
Danish: Denne ansøgning var på dag 180, da firmaet trak den tilbage.
English: QUESTIONS AND ANSWERS ON WITHDRAWAL OF MARKETING APPLICATION for RETAANE
Danish: SPØRGSMÅL OG SVAR VEDRØRENDE TILBAGETRÆKNINGEN AF ANSØGNINGEN OM MARKEDSFØRINGSTILLADELSE for RETAANE
English: Compared to photodynamic therapy, Retaane was not as effective.
Danish: Sammenlignet med fotodynamisk behandling var Retaane ikke lige så effektivt.
English: What is Retaane?
Danish: Hvad er Retaane?
English: The effects of Retaane were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Retaane er først blevet testet i forsøgsmodeller, inden de er undersøgt hos mennesker.
English: The Company has informed the CHMP that there are clinical trials currently running in Europe.
Danish: Firmaet har oplyst til CHMP, at der er kliniske undersøgelser i gang i Europa.
English: It contains 30 mg/ml of the active substance anecortave acetate.
Danish: Det indeholder 30 mg/ml af det aktive stof anecortavacetat.
English: Therefore, at the time of the withdrawal, the CHMP's view was that the benefit had not been sufficiently demonstrated and did not outweigh the identified risks.
Danish: På tilbagetrækningstidspunktet var det derfor CHMP's opfattelse, at fordelene ikke var tilfredsstillende godtgjort og ikke opvejede de påviste risici.
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse eller i et program for anvendelse med særlig udleveringstilladelse og har behov for mere information om din behandling, bedes du kontakte den læge, der giver dig denne behandling.
English: It is able to stop or slow down the development of new blood vessels by interfering with the production of the proteins needed to build the vessels, and of the growth factors needed for the blood vessels to spread.
Danish: Det er i stand til at standse eller bremse dannelsen af nye blodkar ved at gribe ind i produktionen af de proteiner, der er nødvendige for opbygningen af karrene, og af de vækstfaktorer, der er nødvendige for, at karrene kan brede sig.
English: The studies measured visual acuity (the results of an eye test) to see how the patients had responded to treatment.
Danish: I undersøgelserne måltes synsstyrken (resultaterne af en synsprøve) for at finde ud af, hvordan patienterne havde reageret på behandlingen.
English: The letter from the Company notifying the EMEA of the withdrawal of Retaane is available here.
Danish: Firmaets brev til EMEA med meddelelsen om tilbagetrækningen for Retaane kan ses her.
English: Retaane was to be injected every 6 months directly into the space behind the eye, as a ‘depot' injection (a type of injection where the medicine is prepared in such a way that it is absorbed by the body very slowly).
Danish: Retaane skulle indsprøjtes hver 6. måned direkte i området bag øjet som en "depotindsprøjtning" (en form for indsprøjtning, hvor lægemidlet er præpareret på en sådan måde, at det optages meget langsomt i kroppen).
English: Retaane is a suspension for injection onto the outer part of the eye ball.
Danish: Retaane er en suspension til injektion i den ydre del af øjeæblet.
English: One compared Retaane at various strengths (3 mg, 15 mg or 30 mg) with a dummy treatment (placebo) in 128 patients.
Danish: I den ene sammenlignedes Retaane i forskellige styrker (3 mg, 15 mg og 30 mg) med virkningsløs behandling (placebo) hos 128 patienter.
English: Retaane was expected to be used to stop or slow down the development of these new blood vessels (neovascularisation) in the eye.
Danish: Retaane forventedes at standse eller bremse denne dannelse af nye blodkar (neovaskularisering) i øjet.
English: What was Retaane expected to be used for?
Danish: Hvad forventedes Retaane anvendt til?
English: A compassionate use programme is a programme through which doctors can request a medicine for a specific disease for one of their patients before the medicine is fully authorised.
Danish: Et program til anvendelse med særlig udleveringstilladelse er et program, hvor en læge kan anmode om udlevering af et lægemiddel til en bestemt sygdom, før lægemidlet er endeligt godkendt.
English: The CHMP had concerns that the effectiveness of Retaane was less than what they expected to see: Compared to placebo, Retaane has some effectiveness, but many patients were ‘lost' (exited the study) before the end of the study; and this affects the reliability of the results.
Danish: CHMP fandt grund til betænkelighed ved, at virkningen af Retaane var ringere end udvalget forventede: Retaane havde nogen virkning i forhold til placebo, men mange patienter "faldt ud" (udgik af undersøgelsen), før den var afsluttet, og dette anfægter resultaternes pålidelighed.
English: Anecortave, the active substance in Retaane, is similar in structure to cortisol, a natural hormone in the body.
Danish: Anecortav, det aktive stof i Retaane, minder i sin struktur om cortisol, der er et naturligt hormon i organismen.
English: After the CHMP had assessed the responses from the Company to a list of questions, there were still unresolved outstanding issues.
Danish: Efter at CHMP havde vurderet firmaets besvarelse af en række spørgsmål, tilbagestod der fortsat uafklarede punkter.
English: Based on the review of the initial documentation, the CHMP prepares a list of questions (at day 120), which is sent to the Company.
Danish: På grundlag af gennemgangen af den indledende dokumentation opstiller CHMP en række spørgsmål (på dag 120), der forelægges
English: The second compared the effect of Retaane 15 mg to photodynamic therapy (the standard treatment for the wet form of AMD, where laser treatment is used to destroy the newly formed blood vessels) in 530 patients.
Danish: I den anden sammenlignedes virkningen af Retaane 15 mg med fotodynamisk behandling (standardbehandlingen af den våde form af AMD, hvor man ved hjælp af laser ødelægger de nydannede blodkar) hos 530 patienter.
English: How is Retaane expected to work?
Danish: Hvordan forventes Retaane at virke?
English: The Company plans to continue the two clinical trials in wet AMD patients, as well as the clinical trial in dry AMD patients at risk of developing wet AMD.
Danish: Firmaet vil fortsætte de to kliniske undersøgelser hos patienter med våd AMD samt den kliniske undersøgelse af patienter, der har tør AMD og risiko for at vikle våd AMD.
English: The Company also plans to continue their compassionate use programme on a case-by-case basis.
Danish: Firmaet har desuden til hensigt at forsætte programmet for anvendelse med særlig udleveringstilladelse, baseret på engangsanvendelse.
English: Based on the review of the data submitted and the company's response to the CHMP list of questions at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that Retaane could not be approved for the treatment of subfoveal choroidal neovascularisation with classic component due to age-related macular degeneration.
Danish: Efter gennemgang af de foreliggende oplysninger og firmaets besvarelse af CHMP's spørgsmål var der i CHMP betænkelighed, og udvalgets foreløbige standpunkt var, at Retaane ikke kunne godkendes til behandling af subfoveal koroidal neovaskularisering med klassisk komponent som følge af aldersbetinget makuladegeneration.
English: Retaane was expected to be used to treat patients with the wet form of age-related macular degeneration.
Danish: Retaane forventedes anvendt til behandling af den våde form af aldersbetinget makuladegeneration.
English: This disease affects the central part of the retina (called the macula), at the back of the eye and causes loss of vision.
Danish: Sygdommen angriber den centrale del af nethinden (som kaldes den gule plet eller makula) bagest i øjet og medfører synstab.
English: have officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their application for a marketing authorisation for Retaane, for the treatment of subfoveal choroidal neovascularisation (CNV) with classic component due to age-related macular degeneration (AMD).
Danish: Den 28. februar 2006 underrettede Alcon Laboratories (U.K.) Limited officielt Udvalget for Humanmedicinske Lægemidler (CHMP) om, at firmaet ønskede at trække sin ansøgning om markedsføringstilladelse tilbage for Retaane til behandling af subfoveal koroidal neovaskularisering (CNV) med klassisk komponent som følge af aldersbetinget makuladegeneration (AMD).
English: The wet form of the disease is caused by abnormal blood vessels under the retina and the macula, which may bleed and leak fluid.
Danish: Den våde form af sygdommen skyldes dannelse af abnorme blodkar under nethinden og den gule plet.
English: may, before giving an opinion, ask any remaining question(s) (at day 180).
Danish: Når firmaet har besvaret spørgsmålene, gennemgår CHMP besvarelsen og kan, inden det afgiver en udtalelse, stille eventuelle supplerende spørgsmål (på dag 180).
English: London, 23 March 2006 Doc.Ref.
Danish: London, 23 March 2006 EMEA/H/C/635
English: What are the consequences of the withdrawal for patients undergoing clinical trials /
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Retaane eller i programmer for anvendelse med særlig udleveringstilladelse?
English: Seven sites in three countries have been investigated.
Danish: Syv undersøgelsescentre i tre lande er blevet undersøgt.
English: The study was well conducted and according to current scientific standards.
Danish: Undersøgelsen var veludført og i overensstemmelse med gældende videnskabelige standarder.
English: On 27 September 2012 a plenary meeting of the Standing Committee on Veterinary Medicinal Products took place.
Danish: Den 27. September 2012 afholdtes plenarmøde i Det Stående Udvalg for Veterinærlægemidler.
English: The application was submitted to Germany as reference Member State and Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and the United Kingdom as concerned Member States.
Danish: Ansøgningen blev indgivet med Tyskland som referencemedlemsstat og med Østrig, Belgien, Bulgarien, Cypern, Tjekkiet, Danmark, Estland, Frankrig, Grækenland, Ungarn, Irland, Italien, Letland, Litauen, Luxembourg, Malta, Nederlandene, Polen, Portugal, Rumænien, Slovakiet, Slovenien, Spanien og Det Forenede Kongerige som berørte medlemsstater.
English: Relevance of the choice of positive control product
Danish: Relevansen af det valgte positive kontrolprodukt
English: These higher doses and duration of treatment are authorised in a number of EU Member States, e.g. Denmark, the Netherlands and the United Kingdom.
Danish: Den højere dosering og behandlingsvarighed er godkendt i en række EU medlemsstater, f.eks. Danmark, Nederlandene og Det Forenede Kongerige.
English: Considering the data submitted, the Committee concluded as follows on issues raised in the notification received from Germany.
Danish: Efter gennemgang af de forelagte oplysninger konkluderede udvalget følgende vedrørende de rejste spørgsmål i anmeldelsen fra Tyskland.
English: List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant in the Member States
Danish: Liste over navne, lægemiddelform, styrke på det veterinærmedicinske produkt, dyrearter, administrationsmåde, ansøger i medlemslandene
English: According to the legal provisions set out in Annex I of Directive 2001/82/EC a positive control product should be an authorised product according to current European legislation.
Danish: I henhold til bestemmelserne i bilag I til direktiv 2001/82/EF skal et positivt kontrolprodukt være godkendt efter gældende europæisk lovgivning.
English: The design of the field study should follow the design of the field study V-0049-0059 in terms of the inclusion/exclusion criteria and clinical endpoints.
Danish: Undersøgelsens design skal følge designet af feltundersøgelse V-0049-0059 hvad angår inklusions- og eksklusionskriterier og kliniske endepunkter.
English: No robust information is available about the distribution of florfenicol to the site of infection.
Danish: Der foreligger ikke sikre oplysninger om fordelingen af florfenicol på infektionsstedet.
English: As the activity of florfenicol is time dependent, the active concentration has to be above MIC for a certain time.
Danish: Da aktiviteten af florfenicol er tidsafhængig, skal den aktive koncentration være over MIC-værdien i et vist tidsrum.
English: The persistence of A. pleuropneumoniae in alveolar macrophages might be one possible explanation for these results, but is not verified by clinical data.
Danish: Persistens of A. pleuropneumoniae i de alveolære makrofager kan være en mulig forklaring på disse resultater, men er ikke verificeret med kliniske data.
English: However, the role of post-antibiotic effect in terms of efficacy is disputable and no firm conclusions with regard to effect duration can be drawn.
Danish: Betydningen af den postantibiotiske effekt i form af virkning er imidlertid omdiskuteret, og der kan ikke drages endelige konklusioner om effektens varighed.
English: Scientific conclusions and grounds for refusal of the granting of the marketing authorisations
Danish: Videnskabelige konklusioner og begrundelse for afslag på ansøgningen om markedsføringstilladelser
English: This should include sufficiently large number of target animals to ensure the validity of the results in terms of both clinical relevance and statistical significance.
Danish: Undersøgelsen skal omfatte et tilstrækkeligt antal dyr til at sikre resultaternes validitet både i henseende til klinisk relevans og statistisk signifikans.
English: A positive control product should be used for comparison in a non-inferiority design.
Danish: Der skal anvendes et positivt kontrolprodukt, og undersøgelsens design skal være egnet til bestemmelse af non-inferioritet.
English: The active substance is included in veterinary medicinal products currently licensed in several countries in the European Union for use in cattle and pigs for the treatment of respiratory diseases.
Danish: Det aktive indholdsstof er indeholdt i veterinærmedicinske produkter, der er godkendt i flere lande i EU til behandling af luftvejssygdomme hos kvæg og svin.
English: On 31 August 2012, during the written phase of the Standing Committee procedure, the Netherlands submitted an objection to the opinion adopted by CVMP on 13 June 2012.
Danish: I den skriftlige fase af proceduren i det stående udvalg indgav Nederlandene den 31. august 2012 en indsigelse mod den udtalelse, som CVMP havde vedtaget den 13. juni 2012.
English: The reasons for these observations are not known and cannot be determined from this study, nor on basis of other data presented during this referral procedure.
Danish: Årsagerne til disse iagttagelser kendes ikke og kan ikke fastlægges ud fra undersøgelsen eller på grundlag af andre oplysninger, der er forelagt under indbringelsesproceduren.
English: Correlation between plasma concentrations and pulmonary concentrations or high failure rate
Danish: Korrelation mellem plasmakoncentrationer og lungekoncentrationer eller høj andel af behandlingssvigt
English: On 13 June 2012 the CVMP adopted an opinion regarding this referral.
Danish: Den 13. juni 2012 vedtog CVMP en udtalelse om denne indbringelse.
English: One explanation for the high failure rate of Nuflor Swine Once may be the short duration of active concentration at the infection sites.
Danish: En forklaring på den høje andel af behandlingssvigt med Nuflor Swine Once kan være den korte varighed af den aktive koncentration på infektionsstedet.
English: The official clinical break point for florfenicol sensitivity is ≤2 µg/ml.
Danish: Den officielle kliniske tærskelværdi for følsomheden over for florfenicol er ≤2 µg/ml.
English: However, the efficacy could not be clearly confirmed in the pivotal multicentre randomised controlled field study.
Danish: Virkningen kunne imidlertid ikke klart bekræftes i den randomiserede, kontrollerede felt-hovedundersøgelse.
English: Pharmacokinetic/pharmacodynamic models using the raw data provided by the applicant could give another explanation for the different treatment failure rates in the clinical field study.
Danish: Farmakokinetiske/farmakodynamiske modeller med anvendelse af de rådata, der er fremlagt af ansøgeren, kan muligvis give en anden forklaring på de forskellige andele af behandlingssvigt i den kliniske feltundersøgelse.
English: The Standing Committee noted that the CVMP recommended the granting of the marketing authorisation of the product subject to a condition requesting further clinical data on the efficacy of the veterinary medicinal product.
Danish: Det stående udvalg konstaterede, at CVMP anbefalede udstedelse af markedsføringstilladelse for produktet på betingelse af, at der blev fremlagt yderligere kliniske data om veterinærlægemidlets virkning.
English: The CVMP therefore considers that Nuflor Swine Once cannot fulfil the principles of responsible use of antimicrobials and concludes that the benefit-risk balance is negative.
Danish: CVMP finder derfor, at Nuflor Swine Once ikke kan opfylde principperne for hensigtsmæssig anvendelse af antimikrobielle stoffer, og konkluderer, at benefit/risk-forholdet er negativt.