FrancophonIA/ELRC3.0 huggingface dataset:
English: • The CHMP took into account that the linear intravenous agents, Multihance (gadobenic acid) and Primovist (gadoxetic acid), undergo hepatic uptake, and therefore have clinical utility for imaging poorly vascularised hepatic lesions, especially in the delayed phase imaging, that cannot be adequately studied with agents without hepatic uptake and thus allowing early diagnosis of potentially life threatening diseases.
Danish: • CHMP tog højde for, at de lineære intravenøse midler, Multihance (gadobensyre) og Primovist (gadoxinsyre) gennemgår hepatisk optagelse og derfor har klinisk anvendelighed til billeddannelse af dårligt vaskulariserede hepatiske læsioner, især i den forsinkede fasebilleddannelse, der ikke kan undersøges tilstrækkeligt med midler uden hepatisk optagelse, og dermed giver mulighed for tidlig diagnosticering af potentielt livstruende sygdomme.
English: • The PRAC took into account that the linear intravenous agents, Multihance (gadobenic acid) and Primovist (gadoxetic acid), undergo hepatic uptake, and therefore have clinical utility for imaging poorly vascularised hepatic lesions, especially in the delayed phase imaging, that cannot be adequately studied with agents without hepatic uptake and thus allowing early diagnosis of potentially life threatening diseases.
Danish: • PRAC tog højde for, at de lineære intravenøse midler, Multihance (gadobensyre) og Primovist (gadoxinsyre) gennemgår hepatisk optagelse og derfor har klinisk anvendelighed til billeddannelse af dårligt vaskulariserede hepatiske læsioner, især i den forsinkede fasebilleddannelse, der ikke kan undersøges tilstrækkeligt med midler uden hepatisk optagelse, og dermed giver mulighed for tidlig diagnosticering af potentielt livstruende sygdomme.
English: The benefit-risk balance of medicinal products containing intravenous gadobutrol, gadoteric acid, gadoteridol, gadoxetic acid, intravenous gadobenic acid in the indication of liver imaging, intra-articular gadoteric acid and intra-articular gadopentetic acid is favourable subject to agreed changes to the product information:
Danish: Risk/benefit-forholdet for lægemidler, der indeholder intravenøs gadobutrol, gadoterinsyre, gadoteridol, gadoxinsyre, intravenøs gadobensyre i indikationen af lever-billeddannelse, intra-artikulær gadoterinsyre og intra-artikulær gadopentetinsyre, er fordelagtig i forbindelse med vedtagne ændringer af produktinformationen:
English: The CHMP, as a consequence, considers that the benefit-risk balance of medicinal products containing intravenous gadobutrol, gadoteric acid, gadoteridol, gadoxetic acid, intravenous gadobenic acid in the indication of liver imaging, intra-articular gadoteric acid and intra-articular gadopentetic acid remains favourable subject to amendments to the product information.
Danish: Som følge heraf finder CHMP, at risk/benefit-forholdet for lægemidler, der indeholder intravenøs gadobutrol, gadoterinsyre, gadoteridol, gadoxinsyre, intravenøs gadobensyre i indikationen af leverbilleddannelse, intra-artikulær gadoterinsyre og intra-artikulær gadopentetinsyre fortsat er fordelagtig under forudsætning af ændringer af produktinformationen.
English: The PRAC also concluded that there are practical difficulties for an effective restriction of the number of doses administered during the lifetime of a patient.
Danish: PRAC konkluderede også, at der er praktiske vanskeligheder ved at gennemføre en effektiv begrænsning af antallet af doser, der indgives igennem en patients levetid.
English: Therefore, the CHMP considered that the benefits of gadobenic acid and gadoxetic acid outweigh the risks related to these products in the context of liver imaging.
Danish: Derfor overvejede CHMP, at fordelene ved gadobensyre og gadoxinsyre opvejer risiciene i forbindelse med disse lægemidler i kombination med billeddannelse af leveren.
English: • Although no adverse neurological effects, such as cognitive or movement disorders, have been demonstrated to be caused by gadolinium accumulation in the brain, long-term safety data are limited.
Danish: • Selvom der ikke er blevet påvist negative neurologiske virkninger, som f.eks. kognitive eller bevægelsesforstyrrelser, forårsaget af gadolinium-akkumulering i hjernen, er langsigtede sikkerhedsdata begrænset.
English: • Although no adverse neurological effects, such as cognitive or movement disorders, have yet been demonstrated to be caused by gadolinium accumulation in the brain, long-term safety data are limited.
Danish: • Selvom der endnu ikke er blevet påvist negative neurologiske virkninger, som f.eks. kognitive eller bevægelsesforstyrrelser, forårsaget af gadolinium-akkumulering i hjernen, er langsigtede sikkerhedsdata begrænset.
English: • The CHMP considered that the risk related to linear intravenous GdCAs gadobenic acid (in all indications besides liver imaging), gadodiamide, gadopentetic acid, and gadoversetamide, taking into account the whole safety profile, including the additional potential risk of harm from brain and other tissues accumulation outweighs the benefits.
Danish: • CHMP anså, at den risiko, der er forbundet med lineære intravenøse GdCA'er, gadobensyre (i alle indikationer ud over billeddannelse af leveren), gadodiamid, gadopentetinsyre og gadoversetamid under hensyntagen til hele sikkerhedsprofilen, inkl.
English: • The PRAC considered that the risk related to linear intravenous GdCAs gadobenic acid (in all indications besides liver imaging), gadodiamide, gadopentetic acid, and gadoversetamide, taking into account the whole safety profile, including the additional potential risk of harm from brain and other tissues accumulation outweighs the benefits.
Danish: • PRAC anså, at den risiko, der er forbundet med lineære intravenøse GdCA'er, gadobensyre (i alle indikationer ud over billeddannelse af leveren), gadodiamid, gadopentetinsyre og gadoversetamid under hensyntagen til hele sikkerhedsprofilen, inkl.
English: Therefore, the PRAC considered that the benefits of gadobenic acid and gadoxetic acid outweigh the risks related to these products in the context of liver imaging.
Danish: Derfor overvejede PRAC, at fordelene ved gadobensyre og gadoxinsyre opvejer risiciene i forbindelse med disse lægemidler i kombination med billeddannelse af leveren.
English: Therefore, PRAC considered that the benefits of gadobenic acid and gadoxetic acid outweigh their risks in the context of delayed phase liver imaging.
Danish: Derfor overvejede PRAC, at fordelene ved gadobensyre og gadoxinsyre opvejer risiciene i forbindelse med forsinket fasebilleddannelse af leveren.
English: Toxicity has been seen in other tissues where it accumulates (including NSF, skin plaques) and in non-clinical data.
Danish: NSF, hudplaques) og i ikkekliniske data.
English: Taking into account the evidence of accumulation of GdCAs in the brain, the fact that linear compounds have been detected in the brain to a much higher amount than the macrocyclic compounds and that they persist in the brain for a longer period, and considering the toxicity of Gd shown in non-clinical studies, the serious concerns about potential neurological harm, deposition in other tissues and its potential risks, and the identified risks associated with the use of linear GdCAs (including the risk of NSF and the gadolinium-associated plaques) and in view of the whole safety profile of these agents, PRAC maintained its conclusion that that the benefit in enhancement of MR images of intravenous linear agents does not outweigh the known and potential risks of these products.
Danish: Under hensyntagen til evidensen for akkumulering af GdCA'er i hjernen, den kendsgerning at lineære forbindelser er blevet påvist i årevis i hjernen i meget større mængde end de makrocykliske forbindelser, og at de persisterer i hjernen i en længere periode, og i betragtning af toksiciteten af Gd vist i prækliniske forsøg, de alvorlige bekymringer om potentiel neurologisk skade, aflejring i andre væv samt de potentielle risici og de identificerede risici forbundet med anvendelsen af lineære GdCA'er (inkl.
English: With regards to the condition for lifting the suspension the MAH shall submit evidence “that the product (potentially modified or not) does not undergo significant dechelation and does not lead to retention of gadolinium in tissues, including the brain in humans”, CHMP agreed in general with the proposal, however considered it necessary clarifying the meaning of this condition to avoid misunderstandings.
Danish: Med hensyn til betingelsen for ophævelse af suspenderingen skal indehaveren af markedsføringstilladelsen indsende beviser for, “at lægemidlet (potentielt modificeret eller ej) ikke gennemgår væsentlig dechelatering og ikke fører til retention af gadolinium i væv inkl.
English: Harmful effects and potential interaction with disease processes are possible in view of data supporting dechelation of linear agents in vivo and the known toxicity of unchelated gadolinium based on non-clinical data.
Danish: Skadelige virkninger og potentiel interaktion med sygdomsprocesser er mulige i betragtning af data, som understøtter dechelatering af lineære midler in vivo og den kendte toksicitet af uchelateret gadolinium på baggrund af ikkekliniske data.
English: Harmful effects and potential interaction with disease processes are plausible in view of stability data suggesting dechelation of linear agents in vivo and the known toxicity of unchelated gadolinium.
Danish: Skadelige virkninger og potentiel interaktion med sygdomsprocesser er plausible i betragtning af stabilitetsdata, som antyder dechelatering af lineære midler in vivo og den kendte toksicitet af uchelateret gadolinium.
English: Harmful effects and potential interaction with disease processes are plausible in view of data supporting dechelation of linear agents in vivo and the known toxicity of unchelated gadolinium.
Danish: Skadelige virkninger og potentiel interaktion med sygdomsprocesser er plausible i betragtning af data, som understøtter dechelatering af lineære midler in vivo og den kendte toksicitet af uchelateret gadolinium.
English: Although no adverse neurological effects have yet been demonstrated to be caused by gadolinium accumulation in the brain, long-term safety data are limited.
Danish: De langsigtede kliniske konsekvenser af en sådan gadolinium-retention er ikke kendt p.t. Selvom der endnu ikke er blevet påvist negative neurologiske virkninger forårsaget af gadolinium-akkumulering i hjernen, er langsigtede sikkerhedsdata begrænset.
English: This summary was last updated on 18/09/2015.
Danish: Dette sammendrag blev sidst ajourført i 18/09/2015.
English: In very rare cases they may be serious or fatal.
Danish: I meget sjældne tilfælde kan de være alvorlige eller dødelige.
English: A response is normally seen within three to four days.
Danish: Et respons ses normalt i løbet af 3-4 dage.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for RevitaCAM on 23/02/2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for RevitaCAM til den 23/02/2012.
English: Treatment should be discontinued after 10 days if no improvement is seen.
Danish: Behandlingen skal seponeres efter 10 dage, hvis der ikke ses forbedring.
English: Hands should always be washed after administrating the medicine.
Danish: Hænderne skal altid vaskes efter administration af lægemidlet.
English: The pump size and the number of sprays to be given are determined by the dog's weight.
Danish: Pumpens størrelse og antallet af sprays, der skal gives, bestemmes ud fra hundens vægt.
English: Treatment should be started at a single dose of 0.2 mg/kg body weight on the first day, and then continued at a maintenance dose of 0.1 mg/kg body weight once a day.
Danish: Behandlingen bør indledes med en enkeltdosis på 0,2 mg/kg kropsvægt på den første dag og derefter fortsættes med en vedligeholdelsesdosis på 0,1 mg/kg kropsvægt én gang dagligt.
English: For longer term treatment, the dose can be decreased to the lowest effective dose once a response has been seen.
Danish: Ved længerevarende behandling kan dosis nedjusteres til den laveste virkningsfulde dosis, når et respons er blevet observeret.
English: If accidental exposure occurs, hands should be washed immediately with soap and water.
Danish: I tilfælde af eksponering ved hændeligt uheld skal hænderne straks vaskes med vand og sæbe.
English: Other information about RevitaCAM:
Danish: Andre oplysninger om RevitaCAM:
English: It is available in pumps of different sizes (6 ml, 11 ml and 33 ml) delivering appropriate amounts of meloxicam for dogs of different weights.
Danish: Det er tilgængeligt i pumper af forskellig størrelse (6 ml, 11 ml og 33 ml), som leverer passende voluminer af meloxicam til hunde af forskellig vægt.
English: RevitaCAM must not be used in dogs less than six weeks of age and should not be used in cats.
Danish: RevitaCAM må ikke anvendes til hunde under 6 uger og bør ikke anvendes til katte.
English: People who are hypersensitive to NSAIDs should avoid contact with RevitaCAM.
Danish: Personer, som er overfølsomme (allergiske) over for NSAID'er, skal undgå kontakt med RevitaCAM.
English: It must not be used in dogs that are hypersensitive (allergic) to the active substance or to any of the other ingredients.
Danish: Det må ikke gives til hunde, der er overfølsomme (allergiske) over for det aktive stof eller andre af indholdsstofferne.
English: RevitaCAM is used in dogs to relieve inflammation and pain.
Danish: RevitaCAM anvendes til hunde til lindring af betændelse og smerter.
English: These generally occur within the first week of treatment and usually disappear once treatment has stopped.
Danish: Disse bivirkninger forekommer normalt i løbet af den første behandlingsuge og forsvinder i de fleste tilfælde efter seponering af behandlingen.
English: As prostaglandins trigger inflammation, pain, exudation and fever, meloxicam reduces these signs and symptoms.
Danish: Da prostaglandinerne er de stoffer, der udløser betændelse, smerter, eksudation og feber, mindsker meloxicam disse tegn og symptomer.
English: RevitaCAM is similar to Metacam oral solution containing the same active substance, but given in a different way, as an oromucosal spray.
Danish: RevitaCAM svarer til Metacam oral opløsning, der indeholder det samme aktive stof, men gives på en anden måde, som en mundhulespray.
English: RevitaCAM is a medicine that contains the active substance meloxicam.
Danish: RevitaCAM er et lægemiddel, der indeholder det aktive stof meloxicam.
English: Various studies looked at how RevitaCAM was absorbed and its effects in the body, in comparison with Metacam.
Danish: Forskellige undersøgelser så på, hvordan RevitaCAM blev optaget i kroppen, og på dets virkninger i kroppen i forhold til Metacam.
English: RevitaCAM contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Danish: RevitaCAM indeholder meloxicam, som tilhører gruppen af lægemidler kaldet non-steroide antiinflammatoriske lægemidler (NSAID'er).
English: Information on the prescription status of this product may be found on the label of the carton.
Danish: Oplysningerne om udleveringsbestemmelserne for dette lægemiddel findes på pakningens etiket.
English: In some dogs sneezing, coughing, gagging or drooling may be seen immediately after treatment administration.
Danish: Hos nogle hunde kan der observeres nysen, hosten, gylpning eller savlen straks efter administration af behandlingen.
English: It can be used for chronic (long term) musculo-skeletal disorders and for acute (sudden and short-lived) disorders, for instance, due to injury.
Danish: Det kan anvendes både ved kroniske (langvarige) lidelser i bevægeapparatet og akutte (pludselige og kortvarige) lidelser som for eksempel efter en skade.
English: Side effects sometimes seen with other NSAIDs, such as loss of appetite, vomiting, diarrhoea, blood appearing in the stools, renal (kidney) failure and apathy (lack of vitality) are occasionally seen with RevitaCAM.
Danish: De bivirkninger, der undertiden ses ved andre NSAID'er, såsom appetitløshed, opkastning, diarré, blod i afføringen, nyresvigt og apati (mangel på vitalitet), ses lejlighedsvis ved RevitaCAM.
English: What is the risk associated with RevitaCAM?
Danish: Hvilken risiko er der forbundet med RevitaCAM?
English: The CVMP considered that, in accordance with European Union requirements, RevitaCAM has been shown to be bioequivalent to Metacam.
Danish: CVMP vurderede, at det i overensstemmelse med EU-kravene er blevet påvist, at RevitaCAM er bioækvivalent med Metacam.
English: It is available as a 5 mg/ml oromucosal spray (a spray administered to the back of the mouth, towards the gums and /or inner cheek) for dogs.
Danish: Det fås som en 5 mg/ml mundhulespray, opløsning (en spray, der gives i den bageste del af munden mod gummerne og/eller indersiden af kinden), til hunde.
English: RevitaCAM should not be used in pregnant or lactating animals.
Danish: RevitaCAM bør ikke anvendes til drægtige eller diegivende dyr.
English: Why has RevitaCAM been approved?
Danish: Hvorfor blev RevitaCAM godkendt?
English: RevitaCAM must not be used in dogs with liver, heart or kidney problems, bleeding disorders, or dogs suffering from irritation or ulcers of the digestive tract.
Danish: RevitaCAM må ikke anvendes til hunde med lever-, hjerte- og nyreproblemer, blødningsforstyrrelser eller hunde som lider af irritation eller sår i fordøjelseskanalen.
English: The spray should be administered into the dog's mouth, with the mist being directed to the back and towards the gums and/or inner cheek.
Danish: Sprayen skal gives i hundens mund og rettes bagud og mod gummerne og/eller indersiden af kinden.
English: Therefore the CVMP's view was that, as for Metacam, RevitaCAM's benefits are greater than its risks when used for the approved indications and the
Danish: CVMP var derfor af den opfattelse, at fordelene ved RevitaCAM ligesom Metacam er større end risiciene, når det anvendes til de godkendte indikationer, og udvalget anbefalede udstedelse af markedsføringstilladelse for RevitaCAM.
English: What is RevitaCAM?
Danish: Hvad er RevitaCAM?
English: Studies provided for RevitaCAM were tests to determine that it is bioequivalent to the reference medicine, Metacam.
Danish: Undersøgelser, der er fremlagt om RevitaCAM, har været undersøgelser for at afgøre, at det er bioækvivalent med referencelægemidlet, Metacam.
English: What is RevitaCAM used for?
Danish: Hvad anvendes RevitaCAM til?
English: Based on the findings of the study, RevitaCAM was considered to be bioequivalent to the reference medicine.
Danish: På grundlag af undersøgelsesresultaterne blev RevitaCAM betragtet som bioækvivalent med referencelægemidlet.
English: How has RevitaCAM been studied?
Danish: Hvordan blev RevitaCAM undersøgt?
English: Consequently, RevitaCAM's benefit is taken as being the same as that of the reference medicine.
Danish: Derfor anses fordelene ved for at være de samme som referencelægemidlets.
English: What benefit has RevitaCAM shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved RevitaCAM?
English: How does RevitaCAM work?
Danish: Hvordan virker RevitaCAM?
English: The final opinion was converted into a decision by the European Commission on 9 September 2008.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 9. september 2008.
English: Healthcare professionals were to be reminded of these measures through a communication letter (Dear Healthcare Professional Letter).
Danish: Fagfolk inden for sundhedssektoren skulle gøres opmærksomme på disse foranstaltninger via et brev (Dear Healthcare Professional Letter).
English: The Member States' competent authorities will continue to keep the product under regular review.
Danish: Medlemsstaternes kompetente myndigheder skal fortsat føre regelmæssigt tilsyn med lægemidlet.
English: Written explanations were provided by the MAHs on 14 December 2008, 5 May 2008, 12 June 2008 and 20 June 2008.
Danish: Indehaverne af markedsføringstilladelsen fremsendte skriftlige redegørelser den 14. december 2007, den 5. maj 2008, den 12. juni 2008 og den 20. juni 2008.
English: ∗ Notes: the information given in this document and its annexes reflects only the CHMP opinion dated 26 June 2008.
Danish: ∗ Bemærkninger: Oplysningerne i dette dokument og bilagene afspejler udelukkende CHMP's udtalelse af 26. juni 2008.
English: During the February 2008 plenary meeting Dr. Rafe Survana was appointed Co-Rapporteur, replacing Dr. Matthew Thatcher.
Danish: På plenarmødet i februar 2008 blev dr. Rafe Survana udpeget som medrapportør i stedet for dr. Matthew Thatcher.
English: London, 23 October 2008 EMEA/438258/2008
Danish: London, den 23. oktober 2008 EMEA/CHMP/619551/2008
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, the amended product information in Annex III and the conditions of the marketing authorisation in Annex IV.
Danish: Listen over de pågældende lægemiddelnavne fremgår af bilag I. De faglige konklusioner findes i bilag II, det ændrede produktresumé findes i bilag III, og betingelserne for markedsføringstilladelsen findes i bilag IV.
English: France considered that a review of the benefit/risk profile of Arcoxia was needed.
Danish: Frankrig anså det for nødvendigt at foretage en fornyet undersøgelse af benefit/risk-forholdet for Arcoxia.
English: The arbitration procedure was discussed by the CHMP at its plenary meeting in September 2007 and a Rapporteur (Dr. Karl Broich) and Co-Rapporteur (Dr. Matthew Thatcher) were appointed.
Danish: Voldgiftsproceduren blev drøftet af CHMP på udvalgets plenarmøde i september 2007, og der blev udpeget en rapportør (dr. Karl Broich) og en medrapportør (dr. Matthew Thatcher).
English: As these concerns were not resolved during the course of the procedure, a notification of an official referral for arbitration under Article 6(12) of Commission Regulation EC No 1084/2003 to the CHMP was made by France on 19 September 2007.
Danish: Da disse spørgsmål ikke var blevet løst under proceduren, fremsendte Frankrig den 19. september 2007 en meddelelse om en officiel indbringelse af sagen for CHMP i henhold til artikel 6, stk. 12, i Kommissionens forordning nr. 1084/2003.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 6 (12) REFERRAL Arcoxia International non-proprietary name (INN): etoricoxib BACKGROUND INFORMATION *
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) - UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 6, STK. 12, Arcoxia Internationalt fællesnavn (INN): etoricoxib BAGGRUNDSOPLYSNINGER *
English: The CHMP therefore recommended that dose finding studies should be explored to conclude if treatment with 60mg once daily would also be adequate for some patients.
Danish: CHMP anbefalede derfor, at der blev gennemført dosistitreringsundersøgelser med sigte på at afgøre, om behandling med 60 mg en gang dagligt også kunne være tilstrækkeligt for visse patienter.
English: It was therefore difficult to determine risks for etoricoxib compared with ibuprofen, ketoprofen or other less-commonly used NSAIDs.
Danish: Det var derfor vanskeligt at bestemme risiciene ved etoricoxib sammenlignet med ibuprofen, ketoprofen eller mindre almindeligt anvendte NSAID.
English: Drug utilisation data showed that some patients with high blood pressure are being initiated on etoricoxib.
Danish: Dataene om anvendelsen af lægemidlet viste, at visse patienter med for højt blodtryk blev igangsat med etoricoxib.
English: The CHMP concluded that the data confirmed the known renovascular safety profile of etoricoxib (hypertension, oedema and congestive heart failure).
Danish: CHMP konkluderede, at dataene bekræftede den kendte renovaskulære sikkerhedsprofil for etoricoxib (hypertension, ødem og kongestiv hjerteinsufficiens).