FrancophonIA/ELRC3.0 huggingface dataset:
English: Giotrif has been shown to significantly delay disease progression in patients with non-small cell lung cancer.
Danish: Det er påvist, at Giotrif væsentligt bremser sygdommens fremadskriden hos patienter med ikkesmåcellet lungekræft.
English: Giotrif is a medicine used to treat a type of lung cancer known as non-small cell lung cancer.
Danish: Giotrif er et lægemiddel til behandling af ikke-småcellet lungekræft.
English: This means that it blocks the action of a group of proteins known as ‘ErbB family' which are found on the surface of cancer cells and are involved in stimulating the cells to divide.
Danish: Det vil sige, at det hæmmer virkningen af proteiner, der tilhører ErbB-familien, og som findes på kræftcellernes overflade.
English: For practical information about using Giotrif, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Giotrif, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The recommended dose is 40 mg once daily but this may be increased to up to 50 mg per day in patients who tolerate the 40 mg dose, or interrupted and reduced in patients experiencing side effects.
Danish: Hvis patienten tåler en dosis på 40 mg, kan dosis øges indtil 50 mg dagligt.
English: How is Giotrif used?
Danish: Hvordan anvendes Giotrif?
English: What benefits of Giotrif have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Giotrif?
English: The CHMP considered that in patients treated with Giotrif the improvement in progression-free survival (how long they lived without the disease getting worse) was a meaningful benefit for patients.
Danish: CHMP fandt, at Giotrif gav patienterne en meningsfuld fordel i form af længere overlevelse uden forværring af sygdommen.
English: How does Giotrif work?
Danish: Hvordan virker Giotrif?
English: This summary was last updated in April 2012.
Danish: Dette sammendrag blev sidst ajourført i april 2012.
English: EMA/CVMP/19896/2007 EMEA/V/C/000082
Danish: EMA/67095/2007 EMEA/V/C/000082
English: Avoid contact with eyes and skin.
Danish: Undgå kontakt med øjne og hud.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Previcox on 13 September 2004.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Previcox den 13. september 2004.
English: Horse:
Danish: Hest:
English: Dog:
Danish: Hund:
English: If it occurs, rinse affected area immediately with water.
Danish: Skulle det ske bør det berørte område straks skylles med vand.
English: Other information about Previcox:
Danish: Andre oplysninger om Previcox:
English: Women of child-bearing age should avoid contact with, or wear disposable gloves, when administering the product.
Danish: Kvinder i den fødedygtige alder bør undgå kontakt med produktet eller have handsker på, når produktet administreres.
English: These reactions are generally of a transitory nature and are reversible when the treatment is stopped.
Danish: Disse reaktioner er sædvanligvis forbigående og svinder ved ophør af behandlingen.
English: The dose, duration of treatment and frequency will depend on the weight and type of animal and condition to be treated.
Danish: Dosis, hyppighed og varighed af behandlingen afhænger af den pågældende dyreart, dyrets vægt og den behandlede lidelse.
English: After the last day of treatment with Previcox, horses should not be slaughtered for 26 days (when treated with the oral paste).
Danish: Efter den sidste dag med behandling med Previcox skal der gå 26 dage før slagtning af heste (ved behandling med oral pasta).
English: Wash hands after use of the product.
Danish: Vask hænder efter at have administreret præparatet.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) decided that the benefits of Previcox are greater than any risks of treatment and they recommended that Previcox should be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Previcox var større end risiciene ved behandlingen, og anbefalede udstedelse af markedsføringstilladelse for Previcox.
English: Previcox is presented as chewable tablets for dogs (57 mg and 227 mg) and as an oral paste for horses (8.2 mg/g).
Danish: Previcox leveres som tyggetabletter (57 mg og 227 mg) til hunde og er desuden godkendt som oral pasta (8,2 mg/g) til heste.
English: The product was shown to be comparable to other reference products (carprofen and meloxicam, respectively).
Danish: Det blev påvist, at produktet svarer til andre, lignende produkter (carprofen og meloxicam).
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat or milk used for human consumption.
Danish: Tilbageholdelsestiden er den tid, der skal gå efter lægemidlets indgivelse, før dyret kan slagtes, og kødet kan anvendes til menneskeligt konsum, eller mælken fra dyret kan anvendes til menneskeligt konsum.
English: Previcox chewable tablets for dogs were studied in two large European field studies in dogs for a period of up to 90 days.
Danish: Previcox tyggetabletter til hunde er blevet undersøgt i to store europæiske feltundersøgelser hos hunde med en varighed på indtil 90 dage.
English: In case of accidental ingestion, it is necessary to seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: I tilfælde af indgift ved hændeligt uheld skal der straks søges lægehjælp, og indlægssedlen eller etiketten vises til lægen.
English: What is the risk associated with Previcox?
Danish: Hvilken risiko er der forbundet med Previcox?
English: Previcox tablets for dogs improved the scores for the relief of pain and inflammation.
Danish: Previcox tabletter til hunde forbedrede scoreværdierne for lindring af smerte og inflammation.
English: The use of Previcox is not permitted in mares producing milk for human consumption.
Danish: Previcox må ikke anvendes til hopper, der producerer mælk bestemt til menneskeligt forbrug.
English: Firocoxib blocks the enzyme (cyclo-oxygenase) that is involved in the production of prostaglandins.
Danish: Firocoxib blokerer det enzym (cyclooxygenase), der medvirker ved dannelse af prostaglandiner.
English: Previcox contains firocoxib, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs) belonging to the Coxib group, which acts by selective inhibition of cyclooxygenase-2 (COX-2).
Danish: Previcox indeholder firocoxib, der tilhører en klasse lægemidler, som kaldes nonsteroide antiinflammatoriske lægemidler (NSAID), herunder Coxib-gruppen, der virker ved selektiv hæmning af cyclooxygenase-2 (COX-2).
English: Administration of the product in accordance with the recommended dosing schedule for a period of up to 90 days resulted in an improvement in lameness score in dogs with established osteoarthritis.
Danish: Når produktet blev givet i henhold til den anbefalede doseringsplan i en periode på indtil 90 dage, resulterede dette i forbedret scoreværdi for halten hos hunde, der havde fået konstateret ledbetændelse.
English: Why has Previcox been approved?
Danish: Hvorfor blev Previcox godkendt?
English: Previcox must not be administered with corticosteroids or other NSAIDs.
Danish: Previcox må ikke gives sammen med kortikosteroider (binyrebarkhormoner) eller andre NSAID.
English: Previcox oral paste administered once daily for 14 days at a dose of 0.1 mg/kg improved clinical scores for lameness and soft tissue injuries in horses and also helped alleviate pain and inflammation associated with osteoarthritis in horses.
Danish: Previcox, oral pasta, indgivet i en dosis på 0,1 mg/kg én gang dagligt i 14 dage, forbedrede de kliniske scorer for halten og bløddelslæsioner hos heste og lindrede desuden smerte og inflammation ved ledbetændelse hos heste.
English: The CVMP concluded that Previcox oral paste was as effective as other authorised products (phenylbutazone and vedaprofen) in the alleviation of pain and inflammation associated with osteoarthritis and the reduction of associated lameness in horses.
Danish: CVMP konkluderede, at Previcox, oral pasta, var ligeså effektivt som andre godkendte produkter (fenylbutazon og vedaprofen) til at afhjælpe smerte, inflammation og halten ved ledbetændelse hos heste.
English: Return halved tablets to the blister and keep out of the reach of children.
Danish: Opbevar halverede tabletter i blisterpakningen og utilgængeligt for børn.
English: Previcox has been studied in laboratory animals, as well as in dogs and horses that were treated in various veterinary practices/clinics across Europe (“clinical studies”).
Danish: Previcox er dels undersøgt i laboratoriedyr, dels ved særlige kliniske undersøgelser hos hunde og heste, der er blevet behandlet i forskellige dyrlægepraksisser eller på klinikker i forskellige europæiske lande.
English: How has Previcox been studied?
Danish: Hvordan blev Previcox undersøgt?
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 etiketten/den ydre emballage.
English: What is Previcox used for?
Danish: Hvad anvendes Previcox til?
English: The results showed an improvement in lameness score in dogs with established osteoarthritis.
Danish: Resultaterne viste bedring i score-værdi for halten hos hunde, der havde fået konstateret ledbetændelse.
English: Previcox contains the active substance firocoxib, which belongs to a class of medicines having antiinflammatory action.
Danish: Previcox indeholder det aktive stof firocoxib, der tilhører en klasse lægemidler, som virker antiinflammatorisk (dæmpende på vævsirritation).
English: Two multi-centre studies were conducted (one in the US and one in Europe) to investigate the efficacy, safety and acceptability of firocoxib under field conditions when administered to horses orally once daily for 14 days at a dose of 0.1 mg/kg.
Danish: Der er udført to multicenterundersøgelser (den ene i USA, den anden i Europa) af virkningen, sikkerheden og tolerabiliteten af firocoxib under praktiske betingelser.
English: Care should also be taken when used with molecules displaying action on renal flow e.g. diuretics.
Danish: Forsigtighed skal udvises ved samtidig brug af midler med indvirkning på nyregennemstrømningen, f.eks. vanddrivende midler.
English: What is Previcox?
Danish: Hvad er Previcox?
English: How does Previcox work?
Danish: Hvordan virker Previcox?
English: What benefit has Previcox shown during the studies?
Danish: Hvilken fordel viser undersøgelserne ved Previcox?
English: Coxibs display pain relief, anti-inflammatory and antipyretic properties.
Danish: Lægemidler i Coxib-gruppen virker smertelindrende, antiinflammatorisk og feberstillende.
English: Previcox is used for a relief of pain and inflammation associated with osteoarthritis, soft-tissue, orthopaedic and dental surgery in dogs and for the alleviation of pain and inflammation associated with osteoarthritis and reduction of associated lameness in horses.
Danish: Previcox anvendes til smertelindring og mindskelse af inflammation ved ledbetændelse, med bløddels-, knogle- og tandkirurgi hos hunde.
English: As the prostaglandins are substances that trigger pain, inflammation and fever, Previcox, therefore, reduces those responses.
Danish: Prostaglandiner er stoffer, der udløser smerte, væskeudskillelse og inflammation.
English: The side effects of Previcox are typical for those seen with other medicines in this product class (NSAIDs) such as oral lesions (tissue damage) in the mouth of horses, soft faeces/diarrhoea or lethargy.
Danish: De består således i forandringer (vævsbeskadigelse) i hestenes mund, blød afføring/diarré og sløvhed.
English: This might potentially lead to problems of animal welfare.
Danish: Dette kan potentielt medføre dyrevelfærdsproblemer.
English: The animals were split into four groups.
Danish: Dyrene blev inddelt i fire grupper.
English: These data are supported by published literature.
Danish: Disse data støttes af publiceret litteratur.
English: Most of the animals recovered within 2-3 days.
Danish: Størstedelen af dyrene kom sig i løbet af 2-3 dage.
English: No data from other European countries/regions have been submitted, so it could not been evaluated if this situation is representative of the whole EU.
Danish: Der er ikke forelagt data fra andre europæiske lande eller regioner, hvorfor det ikke kan vurderes, om denne situation er repræsentativ for hele EU.
English: An extension of the treatment interval to 48 hours may be necessary in individual cases.
Danish: En forlængelse af doseringsintervallet til 48 timer kan være nødvendigt i det enkelte tilfælde.
English: No mortality was observed in the treatment groups.
Danish: Der var ingen dødelighed i behandlingsgrupperne.
English: An untreated group was included.
Danish: Der indgik en ubehandlet gruppe.
English: 1123 Budapest Hungary
Danish: 1123 Budapest Ungarn
English: Therefore, the recommendations made here can only be used as a starting point for individual dose setting.
Danish: Derfor kan nedenstående anbefaling kun bruges som udgangspunkt for en individuel dosering.
English: Regarding the ‘septicaemia' indication, this was present in the experimental study only.
Danish: Vedrørende indikationen “septikæmi” var denne kun til stede i den eksperimentelle undersøgelse.
English: The clinical response rate was 92%.
Danish: Den kliniske responsrate var 92 %.
English: In other cases, a combination of parenteral and oral administration or the parenteral route alone was used.
Danish: I andre tilfælde blev der anvendt en kombination af parenteral og oral administration eller parenteral administration alene.
English: The overall recovery rate was 46.7%.
Danish: Den samlede helbredelsesrate var 46,7 %.
English: Data were available from two studies.
Danish: Der forelå data fra to undersøgelser.
English: The bacteriological success was the first criteria of efficacy.
Danish: Bakteriologisk succes var det primære virkningskriterium.
English: These data come from different bibliographic publications as well as publicly available reports from European monitoring programs and cover the period between 1998 and 2009.
Danish: Disse data er hentet fra forskellige bibliografiske publikationer og offentliggjorte rapporter fra europæiske overvågningsprogrammer og omfatter perioden 1998-2009.
English: aureus, together with a bacteriological cure of 66.67%.
Danish: aureus, og bakteriologisk helbredelse hos 66,67 %.
English: The percentage of bacteriological cure (Staph.
Danish: Procentdelen af bakteriologisk helbredelse (Staph.
English: aureus in rabbits, no other veterinary medicinal products are authorised for this indication in this animal species in the EU.
Danish: aureus hos kaniner er intet andet veterinærlægemiddel godkendt til denne indikation hos denne dyreart i EU.
English: A positive control group treated with oxytetracyclin and an untreated group were included.
Danish: Der indgik en positiv kontrolgruppe behandlet med oxytetracyclin samt en ubehandlet gruppe.
English: Clinical and bacteriological cure were obtained.
Danish: Der opnåedes klinisk og bakteriologisk helbredelse.
English: It represents a practical approach in line with the aims of this procedure and is appropriate for the protection of consumer safety.
Danish: Den repræsenterer en praktisk tilgang i overensstemmelse med denne procedures formål og er tilstrækkelig til beskyttelse af forbrugersikkerheden.
English: The success rate was 76% on day 3 and 50% on day 10 in the test group versus 14.3% and 9.5%, respectively, for the same days, for the reference product.
Danish: Succesraten var 76 % på dag 3 og 50 % på dag 10 i testgruppen, mod henholdsvis 14,3 % og 9,5 % på de samme dage for referenceproduktet.
English: Types and mechanisms of resistance
Danish: Resistenstyper og resistensmekanismer
English: The clinical parameters improved.
Danish: Der var bedring i de kliniske parametre.
English: As regards to Mycoplasma bovis, this microorganism is difficult to be identified and assessed since it is often involved in mixed infections.
Danish: Hvad angår Mycoplasma bovis, er denne mikroorganisme vanskelig at identificere og vurdere, da den ofte er involveret i blandede infektioner.
English: Although the scientific justification for this indication is not as robust as desirable, a clinical cure (response to treatment) of 87.5% was obtained in infections involving Staph.
Danish: Skønt den videnskabelige begrundelse for denne indikation ikke er så velunderbygget, som det er ønskeligt, opnåedes der klinisk helbredelse (respons på behandling) hos 87,5 % ved infektioner med Staph.
English: Following intravenous injection:
Danish: Efter intravenøs injektion:
English: The study also unveiled very high resistance to quinolones (around 38% for ciprofloxacin).
Danish: Undersøgelsen viste også meget høj resistens over for quinoloner (cirka 38 % for ciprofloxacin).
English: The withdrawal period was derived from the first study, but also bearing in mind the results of the second (confirmatory) study.
Danish: Tilbageholdelsestiden blev beregnet af den første undersøgelse, men under hensyntagen til resultaterne af den anden (bekræftende) undersøgelse.
English: The overall benefit-risk balance of the products under this procedure was deemed positive subject to the recommended changes in the product information (see Annex III).
Danish: Det overordnede risk/benefit-forhold for produkterne i denne procedure blev anset for at være positivt under forudsætning af de anbefalede ændringer i produktinformationen (se bilag III).
English: The risk on individual level might be increased for rabbit as compared to other species.
Danish: Risikoen på det individuelle plan kan tænkes at være større for kaniner end for andre dyrearter.
English: Belgium Vandenbussche Farma Service Brusselsesteenweg 396
Danish: Belgien Vandenbussche Farma Service Brusselsesteenweg 396
English: These terms will apply to all age ranges and physiological status, as well as for both meat and/or milk production animals.
Danish: Disse betegnelser vil omfatte enhver alder og fysiologisk status og både kød- og mælkeproducerende dyr.
English: Filiala Filipesti SRL Str. Principala nr. 944 Filipestii de Padure Jud.
Danish: Rumænien PASTEUR Filiala Filipesti SRL Str. Principala nr. 944 Filipestii de Padure Jud.
English: The highest success rate was observed in calves ≤ 2 years old (71.4%), but it decreased in older animals.
Danish: Succesraten var størst hos kalve ≤ 2 år (71,4 %), men faldt med dyrenes alder.
English: Via Emilia, 285 Ozzano Emilia (BO) Italy
Danish: Via Emilia, 285 Ozzano Emilia (BO) Italien
English: Repeated injections should be made at different injection sites.
Danish: Gentagne injektioner bør gives på forskellige injektionssteder.
English: Better clinical results were observed in 3-4 weeks old animals compared to 1-2 weeks old animals.
Danish: De iagttagne kliniske resultater var bedre hos 3-4 uger gamle dyr end hos 1-2 uger gamle dyr.
English: 8501 Novo Mesto Slovenia
Danish: 8501 Novo Mesto Slovenien
English: Rabbits are raised in continuous systems where resistant bacteria might be persistent over time, however the overall risk would remain low due to the low consumption of rabbit meat.
Danish: Kaniner avles i kontinuerlige systemer, hvor resistente bakterier kan være persistente, men den samlede risiko vil være lav på grund af det lave forbrug af kaninkød.
English: It is not clear whether quinolone resistant Campylobacter infection is associated with adverse human health consequences.
Danish: Det er ikke klart, om infektion med quinolonresistente Campylobacter er forbundet med negative konsekvenser for menneskers sundhed.
English: 20037 Paderno Dugnano (MI) Italy
Danish: 20037 Paderno Dugnano (MI) Italien
English: Non-inferiority of the test product was demonstrated.
Danish: Der påvistes noninferioritet af det testede produkt.
English: Add, to all products and delete the existing text: 5.1.
Danish: For alle produkter indsættes følgende, idet den eksisterende tekst slettes: 5.1.
English: Several controlled experimental studies were conducted with induced infection (all of them together with M. haemolytica).
Danish: Der blev udført flere kontrollerede eksperimentelle undersøgelser med induceret infektion (alle sammen med M. haemolytica).
English: aureus in rabbits.
Danish: aureus hos kaniner.
English: Neither was appropriate for analysis using the statistical method.
Danish: Ingen af dem var egnet til analyse med den statistiske metode.
English: 5 days.
Danish: : 5 døgn
English: Further to the assessment of the available data several contraindications and warning sentences are recommended to ensure the safe use of the products.
Danish: Efter vurdering af de foreliggende data anbefales en række kontraindikationer og advarselssætninger af hensyn til produkternes sikre anvendelse.
English: The indications assessed are considered to be aligned with the principles of responsible use of fluoroquinolones in animals.
Danish: De vurderede indikationer anses for at være i overensstemmelse med principperne for forsvarlig brug af fluorquinoloner hos dyr.
English: However, the provided results do not allow assessing the efficacy of the products for each one of these agents individually because only data about M. haemolytica have been provided.
Danish: Resultaterne gør det imidlertid ikke muligt at vurdere produkternes virkning for hver af disse agenser, da der kun er forelagt data om M. haemolytica.
English: Friulchem via San Marco, 23 33099 Vivaro (PN) Italy
Danish: Friulchem via San Marco, 23 33099 Vivaro (PN) Italien
English: However, clinical efficacy of the recommended dose for respiratory infection has not been demonstrated.
Danish: Der er imidlertid ikke påvist klinisk virkning af den anbefalede dosis til luftvejsinfektion.
English: These extrapolations were considered acceptable as goats are considered as minor species.
Danish: Disse ekstrapolationer kunne godkendes, da geder anses for at være en mindre betydningsfuld art.
English: aureus strains, 17.2% of which were found to be methicillin-resistant4.
Danish: aureus, hvoraf 17,2 % fandtes at være meticillinresistente4.
English: In the case of dermatitis caused by Staph.
Danish: For dermatitis forårsaget af Staph.
English: from the period 2004-2006 until the period 2008-2009 in the isolates tested in Germany.
Danish: fra perioden 2004-2006 frem til perioden 2008-2009.
English: Germany Medistar Arzneimittel-Vertrieb GmbH
Danish: Tyskland Medistar Arzneimittel-Vertrieb GmbH
English: The withdrawal periods should be amended as proposed to provide assurance for consumer safety.
Danish: De fastsatte tilbageholdelsesperioder bør af hensyn til forbrugersikkerheden ændres som foreslået.
English: Burgos Spain
Danish: Burgos Spanien
English: A safety span of 30% was used to compensate for the deficiencies in the studies.
Danish: Der blev tillagt en sikkerhedsmargin på 30 % for at kompensere for manglerne i undersøgelserne.
English: 3641 RT Mijdrecht Netherlands
Danish: 3641 RT Mijdrecht Nederlandene
English: aureus) was 39.5% in the 2.5 mg/kg group and 82% in the 5 mg/kg group.
Danish: aureus) var 39,5 % i gruppen på 2,5 mg/kg og 82 % i gruppen på 5 mg /kg.
English: Add, to all products: CONTRAINDICATIONS
Danish: For alle produkter tilføjes: KONTRAINDIKATIONER
English: Using the alternative approach8 this represents an unusually high safety span in relation to the data generated with the recommended dose but a reasonable safety span (20%) in relation to the lower dose study.
Danish: Anvendes den alternative metode8, repræsenterer dette en usædvanlig høj sikkerhedsmargin i forhold til data genereret med den anbefalede dosis, men en rimelig sikkerhedsmargin (20 %) i forhold til undersøgelsen med den lave dosis.
English: aureus collected between 2006-2007 in Germany were resistant to enrofloxacin.
Danish: aureus, der i perioden 2006-2007 blev indsamlet i Tyskland, resistente over for enrofloxacin.
English: Add, to all products and delete the existing text: 5.1 Pharmacodynamic properties
Danish: For alle produkter indsættes følgende, idet den eksisterende tekst slettes: 5.1 Farmakodynamiske egenskaber