FrancophonIA/ELRC3.0 huggingface dataset:
English: The first dose was given two hours before surgery, and treatment was continued for several days.
Danish: Den første dosis blev givet to timer før operationen, og behandlingen fortsatte i flere dage.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Cimalgex to Vétoquinol SA on 18/02/2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Cimalgex til Vétoquinol SA den 18/02/2011.
English: It works mainly by blocking an enzyme called cyclo-oxygenase-2 (COX2).
Danish: Det virker navnlig ved at blokere et enzym kaldet cyclooxygenase-2 (COX-2).
English: It is available as oblong chewable tablets, in three different strengths (8 mg, 30 mg and 80 mg).
Danish: Det fås som aflange tyggetabletter med tre forskellige styrker (8 mg, 30 mg og 80 mg).
English: A study in dogs (average age 8.8 years old) with chronic osteoarthritis lasted for up to 90 days.
Danish: En undersøgelse hos hunde (med en gennemsnitsalder på 8,8 år) med kronisk osteoartritis varede i op til 90 dage.
English: For longer-term treatment, regular monitoring should be undertaken by the veterinary surgeon.
Danish: Ved længere tids behandling bør dyrlægen foretage en regelmæssig kontrol.
English: Pain was assessed by the veterinarian (up to 24 hours after surgery and at the end of the follow-up treatment).
Danish: Smerterne blev vurderet af en dyrlæge (op til 24 timer efter operationen og ved afslutningen på den opfølgende behandling).
English: It must not be used together with corticosteroids or other NSAIDs.
Danish: Det må ikke anvendes sammen med kortikosteroider eller andre NSAID'er.
English: Cimalgex must not be used in dogs aged less than 10 weeks old, and if the dog is less than 6 months of age careful monitoring by the veterinarian is recommended.
Danish: Cimalgex må ikke anvendes til hunde, der er under 10 uger gamle, og hvis hunden er under 6 måneder gammel, anbefales det, at den overvåges nøje af en dyrlæge.
English: These field studies involved dogs of different age groups, genders and breeds.
Danish: Disse feltundersøgelser omfattede hunde i forskellige aldersgrupper, af forskelligt køn og af forskellige racer.
English: The active substance in Cimalgex, cimicoxib, belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Danish: Det aktive stof i Cimalgex, cimicoxib, tilhører en lægemiddelgruppe, der kaldes non-steroide antiinflammatoriske lægemidler (NSAID'er).
English: The benefit-risk balance may be found in the Scientific Discussion part of this EPAR.
Danish: Risk/benefit-forholdet fremgår af afsnittet om den videnskabelige drøftelse i denne EPAR.
English: Cimalgex is a veterinary medicine that contains cimicoxib.
Danish: Cimalgex er et veterinærlægemiddel, der indeholder cimicoxib.
English: The dogs received either Cimalgex or a comparator product (carprofen).
Danish: Hundene fik enten Cimalgex eller et sammenligningslægemiddel (carprofen).
English: This enzyme is involved in producing substances called prostaglandins, which are involved in pain and inflammation.
Danish: Dette enzym medvirker til at producere stoffer kaldet prostaglandiner, som er med til at udløse smerte og betændelse.
English: Cimalgex has been studied in laboratory animals, as well as in dogs that were treated in various veterinary practices and clinics across Europe (“field studies”) in which Cimalgex was compared with other licensed veterinary NSAID medicines.
Danish: Cimalgex blev undersøgt hos forsøgsdyr og hos hunde, der blev behandlet i forskellige dyrlægepraksisser og -klinikker i hele Europa ("feltundersøgelser"), hvor Cimalgex blev sammenlignet med andre godkendte NSAID-veterinærlægemidler.
English: People with a known hypersensitivity (allergy) to cimicoxib should avoid contact with Cimalgex tablets.
Danish: Personer med kendt overfølsomhed (allergi) over for cimicoxib skal undgå kontakt med Cimalgex tabletter.
English: Other information about Cimalgex:
Danish: Andre oplysninger om Cimalgex:
English: Once a day the dogs were given either Cimalgex or firocoxib, a medicine authorised for use for this condition.
Danish: En gang om dagen fik hundene enten Cimalgex or firocoxib, som er et lægemiddel, der er godkendt til behandling af denne tilstand.
English: Cimalgex was also shown to be as effective as the comparator NSAID, carprofen, in the management of peri-operative pain due to orthopaedic or soft tissue surgery during the first 24 hours after surgery.
Danish: Cimalgex viste sig også at være lige så effektivt som sammenlignings-NSAID'et carprofen til behandling af perioperative smerter som følge af ortopædisk kirurgi eller bløddelskirurgi i løbet af de første 24 timer efter operationen.
English: The effectiveness was determined based on both examinations by a veterinarian and assessments by the animal's owner of some signs of osteoarthritis (such as lameness, pain or difficulty moving).
Danish: Virkningen blev fastlagt ud fra både dyrlægeundersøgelser og hundeejernes vurderinger af visse tegn på osteoartritis (såsom halten, smerter eller bevægelsesvanskeligheder).
English: A second study involved dogs (various ages from four months upwards) undergoing either orthopaedic or soft tissue surgery.
Danish: En anden undersøgelse omfattede hunde (i forskellige aldre fra fire måneder og opefter), der fik enten ortopædisk kirurgi eller bløddelskirurgi.
English: Cimalgex is used in dogs to treat the pain and inflammation associated with osteoarthritis (a long term disease causing damage and pain in the joints).
Danish: Cimalgex anvendes til hunde for at behandle smerter og betændelse i forbindelse med osteoartritis (en langvarig sygdom, der medfører beskadigelse og smerter i leddene).
English: Cimicoxib may cause skin sensitisation and people should wash their hands after handling the tablets.
Danish: Cimicoxib kan medføre hudsensibilisering, og det anbefales at vaske hænder efter berøring af tabletterne.
English: The most common side effects with Cimalgex are mild and transient vomiting or diarrhoea.
Danish: De mest almindelige bivirkninger ved Cimalgex er let og forbigående opkastning eller diarré.
English: The CVMP decided that the benefits of Cimalgex are greater than its risks for the treatment of pain and inflammation associated with osteoarthritis, and the management of peri-operative pain due to orthopaedic or soft tissue surgery, and recommended that Cimalgex be given a marketing authorisation.
Danish: CVMP konkluderede, at fordelene ved Cimalgex er større end risiciene ved behandling af smerter og betændelse i forbindelse med osteoartritis og behandling af perioperative smerter som følge af ortopædisk kirurgi eller bløddelskirurgi, og CVMP anbefalede udstedelse af markedsføringstilladelse for Cimalgex.
English: It is also used for the management of pain and inflammation associated with surgery to the bones or soft tissues (such as muscles).
Danish: Det anvendes ligeledes til behandling af smerter og inflammation forbundet med knogle- eller bløddelskirurgi (f.eks. i musklerne).
English: Given daily, Cimalgex reduced pain and inflammation (and the signs of these, such as lameness) in dogs with chronic osteoarthritis, and was as effective as the comparator NSAID, firocoxib.
Danish: Hvis det blev givet dagligt, reducerede Cimalgex smerter og betændelse (og tegn på dette, f.eks. halten) hos hunde med kronisk osteoartritis, og det var lige så effektivt som sammenlignings-NSAID'et firocoxib.
English: When used for osteoarthritis, the tablets are given to the dog once a day, with or without food, at a dose of 2 mg/kg body weight, using the appropriate tablet(s) according to the dog's weight.
Danish: Når det anvendes mod osteoartritis, skal hunden have tabletterne en gang om dagen, med eller uden mad, i en dosis på 2 mg/kg kropsvægt, og der skal anvendes tabletter i en styrke, som passer til hundens vægt.
English: Cimalgex should not be used in dogs that are pregnant, breeding or lactating, or in dogs with problems affecting the stomach or gut, including ulcers or bleeding, or in dogs that have signs of bleeding problems.
Danish: Cimalgex må ikke anvendes til avlshunde, drægtige hunde eller diegivende hunde, til hunde med mave- eller tarmproblemer, herunder sår eller blødninger, eller til hunde, der har tegn på blødningsproblemer.
English: For a full list of all side-effects reported with Cimalgex, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Cimalgex fremgår af indlægssedlen.
English: By blocking the production of prostaglandins, cimicoxib reduces the pain and inflammation caused by osteoarthritis or surgery on the bones or soft tissues.
Danish: Ved at blokere dannelsen af prostaglandiner mindsker cimicoxib smerter og betændelse, som skyldes osteoartritis eller knogle- eller bløddelskirurgi.
English: Cimalgex must also not be used in dogs that are hypersensitive (allergic) to cimicoxib or any of the other ingredients in the tablets.
Danish: Cimalgex må heller ikke anvendes til hunde, der er overfølsomme (allergiske) over for cimicoxib eller et eller flere af hjælpestofferne i tabletterne.
English: Why has Cimalgex been approved?
Danish: Hvorfor blev Cimalgex godkendt?
English: What is the risk associated with Cimalgex?
Danish: Hvilken risiko er der forbundet med Cimalgex?
English: What is Cimalgex?
Danish: Hvad er Cimalgex?
English: When used with surgery, the tablets are given to the dog around two hours before the start of the operation at a dose of 2 mg/kg body weight, using the appropriate tablet(s) according to the dog's weight, and then once a day for the following three to seven days, based on the judgment of the veterinary surgeon.
Danish: Når tabletterne anvendes i forbindelse med kirurgi, skal hunden have dem ca. to timer inden operationens start i en dosis på 2 mg/kg kropsvægt, og der skal anvendes tabletter i en styrke, som passer til hundens vægt.
English: How has Cimalgex been studied?
Danish: Hvordan blev Cimalgex undersøgt?
English: What is Cimalgex used for?
Danish: Hvad anvendes Cimalgex til?
English: In case of accidental ingestion, medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
Danish: I tilfælde af utilsigtet indtagelse skal der straks søges lægehjælp.
English: What benefit has Cimalgex shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Cimalgex?
English: How does Cimalgex work?
Danish: Hvordan virker Cimalgex?
English: In the European Union, it was considered that this could potentially impact the marketing authorisations of a number of medicinal products.
Danish: I Den Europæiske Union blev det vurderet, at dette potentielt kunne have betydning for markedsføringstilladelserne for en række lægemidler.
English: In light thereof, the CHMP therefore confirmed its previous conclusions.
Danish: På den baggrund bekræftede CHMP således sine tidligere konklusioner.
English: According to Article 62(1) of Regulation (EC) 726/2004, such new data cannot be considered in the context of the re-examination.
Danish: I henhold til artikel 62, stk.1, i forordning (EF) 726/2004 kan nye oplysninger ikke tages i betragtning i forbindelse med en revurdering.
English: Overall conclusion and benefit-risk balance
Danish: Samlet konklusion og benefit/risk-forhold
English: It is used alone or in conjunction with statins in the treatment of hypercholesterolemia and hypertriglyceridemia.
Danish: Det anvendes alene eller sammen med statiner til behandling af hyperkolesterolæmi og hypertriglyceridæmi.
English: Other Cetero Research sites were not affected.
Danish: Cetero Researchs øvrige afdelinger var ikke berørt heraf.
English: On 01 August 2012, the United Kingdom triggered a referral under Article 31 of Directive 2001/83/EC for the identified nationally authorised products.
Danish: Den 1. august 2012 indledte Det Forenede Kongerige en indbringelsesprocedure i henhold til artikel 31 i direktiv 2001/83/EF for de identificerede nationalt godkendte lægemidler.
English: The conditions for the lifting of the suspension of the Marketing Authorisations are set out in Annex III of the CHMP opinion.
Danish: Betingelserne for ophævelse af suspenderingen af markedsføringstilladelserne fremgår af bilag III til CHMP's udtalelse.
English: It is used to reduce cholesterol levels in patients at risk of cardiovascular disease.
Danish: Det anvendes som kolesterolsænkende middel hos patienter med risiko for kardiovaskulær sygdom.
English: Grounds for suspension of the marketing authorisations
Danish: Begrundelse for suspendering af markedsføringstilladelserne
English: Annex II Scientific conclusions and grounds for suspension of the marketing authorisations
Danish: Bilag II Videnskabelige konklusioner og begrundelse for suspendering af markedsføringstilladelserne
English: The inspection identified significant instances of misconduct and violations of federal regulations, including falsification of documents and manipulation of samples.
Danish: Ved inspektionen konstateredes grove fejl og overtrædelser af USA's føderale lovgivning, herunder forfalskning af dokumenter og manipulation af prøver.
English: The EMA, CMD(h) and CHMP initiated a process to identify and assess all medicinal product dossiers that include studies conducted at the above mentioned facility during the identified time period.
Danish: EMA, CMD(h) og CHMP indledte en procedure for at identificere og vurdere alle lægemiddeldossierer, der omfatter undersøgelser udført på ovennævnte afdeling i den pågældende periode.
English: Overall summary of the scientific evaluation of Fenofibrato Pensa and Fenofibrato Ranbaxy (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Fenofibrato Pensa og Fenofibrato Ranbaxy (se bilag I)
English: The MAHs therefore stated their intention to repeat the study, with a study report expected to be available by 15th November 2012.
Danish: Indehaverne af markedsføringstilladelsen meddelte, at de derfor havde til hensigt at gentage undersøgelsen, og at undersøgelsesrapporten forventedes at foreligge den 15. november 2012.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for Fenofibrato Pensa and Fenofibrato Ranbaxy.
Danish: • udvalget behandlede proceduren i henhold til artikel 31 i direktiv 2001/83/EF for Fenofibrato Pensa og Fenofibrato Ranbaxy,
English: The CHMP therefore recommended the suspension of the marketing authorisations until adequate bioequivalence data is made available.
Danish: CHMP anbefalede derfor, at markedsføringstilladelserne suspenderes, indtil der foreligger fyldestgørende bioækvivalensdata.
English: Following the assessment of the grounds for the re-examination, the CHMP noted that the results from the new bioequivalence study became available after the CHMP adopted its opinion and were therefore not available to the CHMP during its initial assessment.
Danish: Efter vurderingen af begrundelserne for revurderingen bemærkede CHMP, at resultaterne af den nye bioækvivalensundersøgelse først var indkommet, efter at CHMP havde vedtaget sin udtalelse og derfor ikke var tilgængelige under den første vurdering.
English: The single pivotal bioequivalence study 10540314 using the 160 mg tablets was conducted by the Cetero Research facilities in Houston in 2005.
Danish: Der foreligger en enkelt bioækvivalenshovedundersøgelse 10540314 af 160-mg-tabletter, som blev udført af Cetero Research i Houston i 2005.
English: The US Food and Drug Administration informed the European Medicines Agency that following an inspection, concerns have been raised about the conduct of bio-analytical studies performed by the Cetero Research facilities in Houston (Texas, USA) during the period from April 2005 to June 2010.
Danish: USA's Food and Drug Administration (FDA) underrettede Det Europæiske Lægemiddelagentur om, at en inspektion har givet anledning til betænkeligheder vedrørende udførelsen af bioanalytiske undersøgelser på Cetero Researchs afdeling i Houston (Texas, USA) i perioden fra april 2005 til juni 2010.
English: Fenofibrato Pensa and Fenofibrato Ranbaxy are both available as 160mg tablets.
Danish: Fenofibrato Pensa og Fenofibrato Ranbaxy leveres begge som 160-mg-tabletter.
English: Following the adoption of the CHMP opinion during the September 2012 CHMP meeting, a request for re-examination was received from the MAH.
Danish: Efter vedtagelsen af CHMP's udtalelse på CHMP's møde i september 2012 modtog CHMP en anmodning om en revurdering fra indehaveren af markedsføringstilladelsen.
English: The CHMP noted the absence of samples from the critical pivotal bioequivalence study 10540314 and that there is therefore no possibility to reanalyse the data.
Danish: CHMP bemærkede, at der ikke findes prøver fra den afgørende bioækvivalenshovedundersøgelse 10540314, og at der derfor ikke kan foretages en ny analyse af oplysningerne.
English: Fenofibrato Pensa and Fenofibrato Ranbaxy contain fenofibrate, a drug of the fibrate class.
Danish: Fenofibrato Pensa og Fenofibrato Ranbaxy indeholder fenofibrat, der er et lægemiddel i klassen af fibrater.
English: In conclusion, the CHMP considered that the potential deficiencies in the conduct of bio-analytical studies by the Cetero Research facilities invalidate the pivotal bioequivalence study.
Danish: Som konklusion fandt CHMP, at de potentielle mangler i Cetero Researchs udførelse af de bioanalytiske undersøgelser afviser validiteten af bioækvivalenshovedundersøgelsen.
English: Therefore, given the serious doubts regarding the reliability and the correctness of the data from the critical pivotal bioequivalence study 10540314, submitted in support of the marketing authorisations, and in the absence of a reliable bioequivalence study specifically designed to establish the bioequivalence of Fenofibrato Pensa and Fenofibrato Ranbaxy to their reference product, the CHMP was unable to conclude on the bioequivalence of Fenofibrato Pensa and Fenofibrato Ranbaxy.
Danish: På baggrund af den alvorlige tvivl om pålideligheden og korrektheden af oplysningerne fra den afgørende bioækvivalenshovedundersøgelse 10540314-980, der var forelagt til støtte for markedsføringstilladelserne, og i mangel af en pålidelig bioækvivalensundersøgelse, der er udformet specifikt med henblik på at fastslå, hvorvidt Fenofibrato Pensa og Fenofibrato Ranbaxy er bioækvivalente med det tilsvarende EU-referencelægemiddel, var CHMP ude af stand til at drage konklusioner om bioækvivalensen for Fenofibrato Pensa og Fenofibrato Ranbaxy.
English: • The Committee considered that the available data gave rise to serious doubts as to the evidence of the bioequivalence of Fenofibrato Pensa and Fenofibrato Ranbaxy with the EU reference product in view of concerns on the reliability of the data, due to the findings of the inspection of the Cetero Research facilities.
Danish: • udvalget fandt, at de foreliggende oplysninger gav anledning til alvorlig tvivl om dokumentationen for bioækvivalensen af Fenofibrato Pensa og Fenofibrato Ranbaxy med EUreferencelægemidlet på baggrund af betænkeligheder med hensyn til pålideligheden af oplysningerne som følge af inspektionsresultaterne for Cetero Research,
English: The CHMP was of the opinion that the previous conclusions regarding bioequivalence will need to be confirmed by repeating the bioequivalence study.
Danish: CHMP var af den opfattelse, at bioækvivalensundersøgelsen skal gentages med henblik på at bekræfte de tidligere konklusioner vedrørende bioækvivalens.
English: Therefore, and in the absence of a reliable bioequivalence study specifically designed to establish the bioequivalence of Fenofibrato Pensa and Fenofibrato Ranbaxy to its EU reference product, the benefit-risk balance of Fenofibrato Pensa and Fenofibrato Ranbaxy cannot be considered to be favourable.
Danish: Som følge heraf og i mangel af en pålidelig bioækvivalensundersøgelse, der er udformet specifikt med henblik på at fastslå, hvorvidt Fenofibrato Pensa og Fenofibrato Ranbaxy er bioækvivalente med det tilsvarende EU-referencelægemiddel, kan benefit/risk-forholdet for Fenofibrato Pensa og Fenofibrato Ranbaxy ikke anses for tilfredsstillende.
English: In response to the CHMP list of questions, the MAHs stated that no samples were available to carry out a re-analysis.
Danish: Som svar på listen med spørgsmål fra CHMP oplyste indehaveren af markedsføringstilladelsen, at der ikke foreligger prøver, der kan analyseres igen.
English: Having assessed the available data, the CHMP retained serious doubts due to the findings of the inspection of the Cetero Research facilities in Houston (Texas, USA), regarding the reliability and the correctness of the data from the critical pivotal bioequivalence study submitted in support of the marketing authorisations.
Danish: Efter at have vurderet de foreliggende oplysningerog på baggrund af inspektionsresultaterne for Cetero Research-afdelingen i Houston (Texas, USA) var CHMP fortsat stærk i tvivl om pålideligheden og korrektheden af oplysningerne fra den afgørende bioækvivalenshovedundersøgelse, der var forelagt til støtte for markedsføringstilladelserne.
English: • The Committee considered that the responses of the MAH are not adequate to refute the serious doubts as to the evidence of the bioequivalence of Fenofibrato Pensa and Fenofibrato Ranbaxy with the EU reference product.
Danish: • udvalget fandt, at besvarelsen fra indehaveren af markedsføringstilladelsen ikke fyldestgørende afviser de alvorlige betænkeligheder vedrørende dokumentationen for, at Fenofibrato Pensa og Fenofibrato Ranbaxy er bioækvivalente med EU-referencelægemidlet,
English: • The Committee is of the opinion that considering the serious doubts in respect of the evidence of bioequivalence, the benefit-risk of Fenofibrato Pensa and Fenofibrato Ranbaxy cannot be confirmed.
Danish: • udvalget er af den opfattelse, at det på baggrund af de alvorlige tvivl med hensyn til dokumentationen af bioækvivalens ikke er muligt at fastlægge benefit/risk-forholdet for Fenofibrato Ranbaxy,
English: The Committee, as a consequence, recommended the suspension of the marketing authorisations for Fenofibrato Pensa and Fenofibrato Ranbaxy, pursuant to Article 116 of Directive 2001/83/EC; as a. the risk-benefit balance cannot be considered favourable and b. the particulars supporting the application as provided in Article 10 of Directive 2001/83/EC cannot be considered correct
Danish: a. benefit/risk-forholdet ikke kan anses for tilfredsstillende, og b. oplysningerne til støtte for ansøgningen som omhandlet i artikel 10 i direktiv 2001/83/EF ikke kan anses for at være korrekte.
English: The MAH submitted grounds for the re-examination, which consisted of a new bioequivalence study (study 2016_FENOF_11), carried out to replace the pivotal bioequivalence study (study 10540314), for which serious doubts were raised regarding the reliability and the correctness of the data.
Danish: Undersøgelsen skulle foretages i stedet for bioækvivalenshovedundersøgelsen (undersøgelse 10540314), som havde skabt alvorlig tvivl, om hvor vidt oplysningerne var pålidelige og korrekte.
English: The CHMP was requested to assess whether the deficiencies in conduct of bio-analytical studies performed by the Cetero Research facilities in Houston (Texas, USA) have impact on the benefit/risk of the concerned medicinal products and to give its opinion on whether the marketing authorisations for authorised medicinal products for which studies have been carried out or samples analysed by Cetero Research, during the identified time period, should be maintained, varied, suspended or withdrawn.
Danish: Udvalget blev desuden anmodet om at udtale sig om, hvorvidt markedsføringstilladelserne bør opretholdes, ændres, suspenderes eller inddrages for godkendte lægemidler, for hvilke Cetero Research i den pågældende periode har udført undersøgelser eller analyseret prøver.
English: List of the names, pharmaceutical form, strength of the medicinal products, route of administration, applicants in the Member States
Danish: Fortegnelse over lægemidlernes navne, lægemiddelform, styrke, indgivelsevej, ansøgere i medlemsstaterne
English: Delivrie 0,02 mg/3 mg Filmtabletten ethinylestradiol : 0.02 mg/ Drospirenone : 3 mg
Danish: Delivrie 0,02 mg/3 mg Filmtabletten