FrancophonIA/ELRC3.0 huggingface dataset:
English: For oral use as per table below.
Danish: Skal gives gennem munden som angivet i tabellen nedenunder.
English: In case of accidental ingestion, 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: Use this product under strict veterinary monitoring where there is a risk of gastro-intestinal bleeding, or if the animal previously displayed intolerance to NSAIDs.
Danish: Anvend dette præparat under nøje veterinær overvågning, hvor der er risiko for gastro-intestinale blødninger, eller hvis dyret tidligere har udvist intolerance over for NSAID-præparater.
English: EU/2/04/045/001 10 tablets EU/2/04/045/002 30 tablets EU/2/04/045/005 180 tablets EU/2/04/045/008 60 tablets
Danish: EU/2/04/045/001 10 tabletter EU/2/04/045/002 30 tabletter EU/2/04/045/005 180 tabletter EU/2/04/045/008 60 tabletter
English: In dogs seven months of age at the start of treatment at dose rates greater than or equal to 25 mg/kg/day (5 times the recommended dose) for six months, gastrointestinal adverse effects, i.e. vomiting were observed.
Danish: Hunde, der var 7 måneder gamle ved begyndelsen af behandlingen, blev behandlet med doser større end eller svarende til 25/mg/kg/dag (5 gange den anbefalede dosis) i 6 måneder, og gastrointestinale bivirkninger, eksempelvis opkast, blev iagttaget .
English: Gastrointestinal tract ulceration may be exacerbated by corticosteroids in animals given non-steroidal anti-inflammatory drugs.
Danish: Sårdannelse i mavetarmkanalen kan forværres af kortikosteroider hos dyr, der får non-steroide antiinflammatoriske præparater.
English: Laboratory studies in rabbits have shown evidence of maternotoxic and foetotoxic effects at dose rates approximating the recommended treatment dose for the dog.
Danish: Laboratorieundersøgelser af kaniner har påvist teratogene virkninger, føtal toksicitet og maternel toksicitet i doser svarende til den anbefalede behandlingsdosis til hund.
English: EU/2/04/045/003 10 tablets EU/2/04/045/004 30 tablets EU/2/04/045/006 180 tablets EU/2/04/045/009 60 tablets
Danish: EU/2/04/045/003 10 tabletter EU/2/04/045/004 30 tabletter EU/2/04/045/006 180 tabletter EU/2/04/045/009 60 tabletter
English: Administer 5 mg per kg bodyweight once daily as presented in the table below.
Danish: Anvend 5 mg pr. kg legemsvægt en gang dagligt som angivet i tabellen nedenunder.
English: In dogs ten weeks of age at the start of treatment at dose rates equal or greater to 25 mg/kg/day (5 times the recommended dose) for three months, the following signs of toxicity were observed: bodyweight loss, poor appetite, changes in the liver (accumulation of lipid), brain (vacuolisation), duodenum (ulcers) and death.
Danish: Hunde, der var 10 uger gamle ved begyndelsen af behandlingen, blev behandlet med doser svarende til eller større end 25/mg/kg/dag (5 gange den anbefalede dosis) i 3 måneder og følgende symptomer på toksicitet blev iagttaget: vægttab, nedsat ædelyst, ændringer i leveren (ophobning af fedtstof), hjerne (vakuolisering), duodenum (sår) og død.
English: Concomitant treatment with molecules displaying action on renal flow, e.g. diuretics or Angiotensin Converting Enzyme (ACE) inhibitors, should be subject to clinical monitoring.
Danish: Samtidig behandling med stoffer, der har indvirkning på den renale gennemstrømning, i.e. diuretika eller angiotensin konverterende enzym (ACE) hæmmere, bør være årsag til klinisk overvågning.
English: A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. INDEHAVER(E) AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: Previcox must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Danish: Previcox må ikke anvendes samtidig med andet NSAID eller glukokortikosteroider.
English: Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs).
Danish: Må ikke anvendes samtidig med kortikosteroider eller andre ikke-steroide anti-inflammatoriske præparater (NSAID-præparater).
English: Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) belonging to the Coxib group, which acts by selective inhibition of cyclooxygenase-2 (COX-2) - mediated prostaglandin synthesis.
Danish: Firocoxib er et non-steroidt anti-inflammatorisk præparat (NSAID), der tilhører gruppen Coxib, som virker ved selektiv inhibition af den cyclooxygenase-2 (COX-2) - medierede prostaglandin syntese.
English: It is possible that a proportion of such cases had sub-clinical renal or hepatic disease prior to the commencement of therapy.
Danish: En del af disse tilfælde skyldtes muligvis tilstedeværende subklinisk nyre- eller leverlidelse før behandlingens start.
English: COX-2 is the isoform of the enzyme that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever.
Danish: COX-2 er den isomer af enzymet, der er vist at blive induceret af proinflammatoriske stimuli og påstås at være primært ansvarlig for syntesen af prostanoide mediatorer for smerte, inflammation og feber.
English: COX-2 is the isoform of the enzyme that has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever.
Danish: COX-2 er den isomer af enzymet, som siges at være primært ansvarlig for syntese af prostanoide mediatorer for smerte, betændelse og feber.
English: Avoid use in any dehydrated, hypovolaemic or hypotensive animals, as there is a risk of increased renal toxicity.
Danish: Undgå anvendelse til dehydrerede, hypovolæmiske eller hypotensive dyr, da der er risiko for forøget nyretoksicitet.
English: Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) that acts by selective inhibition of cyclooxygenase-2 (COX-2) - mediated prostaglandin synthesis.
Danish: Firocoxib er et ikke-steroidt anti-inflammatorisk præparat (NSAID), der virker ved selektiv hæmning af cyclooxygenase-2 (COX-2) - medieret prostaglandinsyntese.
English: The peak concentration (Cmax) is 0.52 (± 0.22) µg/ml (equivalent to approximately 1.5 µM), area under the curve (AUC 0-24) is 4.63 (±1.91) µg x hr/ml, and oral bioavailability is 36.9 (± 20.4) percent.
Danish: (AUC 0-24) er 4,63 (± 1,91) μg x t/ml og oral biotilgængelighed er 36,9 (± 20,4) procent.
English: The treatment should be discontinued if any of these signs are observed: repeated diarrhoea, vomiting, faecal occult blood, sudden weight loss, anorexia, lethargy, degradation of renal or hepatic biochemistry parameters.
Danish: Behandlingen bør ophøre, hvis nogen af disse symptomer iagttages: gentagen diarre, opkastning, blod i afføringen, pludseligt vægttab, nedsat ædelyst, sløvhed, ændring af renale eller hepatiske biokemiske værdier.
English: Use this product under strict veterinary monitoring where there is a risk of gastrointestinal bleeding, or if the animal previously displayed intolerance to NSAIDs.
Danish: Anvend dette præparat under nøje veterinær overvågning, hvor der er risiko for mave-tarmblødning, eller hvis dyret tidligere ikke har kunnet tåle NSAID-præparater.
English: If adverse reactions like vomiting, repeated diarrhoea, faecal occult blood, sudden weight loss, anorexia, lethargy, degradation of renal or hepatic biochemistry parameters occur, use of the product should be stopped and the advice of a veterinarian should be sought.
Danish: Hvis bivirkninger, som opkastning, gentagen diarre, blod i fæces, pludseligt vægttab, nedsat ædelyst, sløvhed, ændring af renale eller hepatiske biokemiske værdier opstår, bør anvendelse af produktet ophøre og der bør søges råd hos en dyrlæge.
English: Administer 5 mg per kg bodyweight once daily.
Danish: Anvend 5 mg pr. kg legemsvægt én gang dagligt.
English: Administer 5 mg per kg bodyweight once daily as presented in the table below for up to 3 days as needed, starting approximately 2 hours prior to surgery.
Danish: Anvend 5 mg pr. kg legemsvægt en gang daglig som angivet i tabellen nedenunder i op til 3 dage efter behov.
English: The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.
Danish: De farmakokinetiske egenskaber af de præparater, der er brugt tidligere, bør tages med i overvejelserne for længden af den behandlingsfrie periode.
English: Avoid use in any dehydrated, hypovolaemic or hypotensive animals, as there is a potential risk of increased renal toxicity.
Danish: Undgå anvendelse til dehydrerede, hypovolæmiske eller hypotensive dyr, da der er en potentiel risiko for forøget nyretoksicitet.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle label
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Tabletbeholder
English: For the relief of post-operative pain and inflammation associated with soft-tissue, orthopaedic and dental surgery in dogs.
Danish: Til lindring af smerte og betændelse efter operation i forbindelse med bløddels-,knogle- og tandkirurgi hos hund.
English: In order to protect from moisture, store in the original package.
Danish: Opbevares i den originale yderpakning for at beskytte mod fugt.
English: For the relief of pain and inflammation associated with osteoarthritis in dogs.
Danish: Til lindring af smerte og betændelse i forbindelse med osteoarthritis hos hund.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {NATURE/TYPE}
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS Blisterfolie
English: Renal and/or hepatic disorders have been reported in very rare cases in dogs administered the recommended treatment dose.
Danish: I meget sjældne tilfælde er der rapporteret renale og/eller hepatiske lidelser hos hund efter behandling med den anbefalede dosis.
English: Body weight (kg) Number of chewable tablets by size mg/kg range
Danish: Antal tyggetabletter i forhold til legemsvægt mg/kg (interval)
English: In in-vitro canine whole blood assays, firocoxib exhibits approximately 380-fold selectivity for COX-2 over COX-1.
Danish: I in-vitro blodprøver fra hund har firocoxib vist sig at være ca. 380 gange mere selektiv over for COX-2 end over for COX-1.
English: Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such drugs should be observed for at least 24 hours before the commencement of treatment with Previcox.
Danish: Der skal derfor være en behandlingsfri periode med sådanne præparater på mindst 24 timer, før behandling med Previcox påbegyndes.
English: Concurrent administration of potentially nephrotoxic drugs should be avoided.
Danish: Samtidig anvendelse af potentielt nyretoksiske stoffer bør undgås.
English: Elimination is principally in the bile and gastrointestinal tract.
Danish: Elimination foregår fortrinsvis via galde og mave-tarmkanalen.
English: Following orthopaedic surgery and depending on the response observed, treatment using the same daily dosing schedule may be continued after the first 3 days, upon judgement of the attending veterinarian.
Danish: Behandlingen kan, efter dyrlægens vurdering, fortsætte ud over de 3 første dage efter knoglekirurgi, afhængig af det observerede respons.
English: Mode of action:
Danish: Virkningsmekanisme:
English: Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non-steroids.
Danish: Farmakoterapeutisk gruppe: anti-inflammatoriske og anti-rheumatiske præparater, non-steroider ATCvet-kode: QM01AH90.
English: Previcox 227 mg chewable tablets for dogs
Danish: Previcox 227 mg tyggetabletter til hund
English: Previcox 227 mg chewable tablets Firocoxib
Danish: Previcox 227 mg tyggetabletter Firocoxib
English: Previcox 57 mg chewable tablets Firocoxib
Danish: Previcox 57 mg tyggetabletter Firocoxib
English: Previcox 57 mg chewable tablets for dogs
Danish: Previcox 57 mg tyggetabletter til hund
English: PACKAGE LEAFLET Previcox 57 mg chewable tablets for dogs Previcox 227 mg chewable tablets for dogs
Danish: INDLÆGSSEDDEL Previcox 57 mg tyggetabletter til hund Previcox 227 mg tyggetabletter til hund
English: Previcox 57 mg chewable tablets for dogs Previcox 227 mg chewable tablets for dogs
Danish: Previcox 57 mg tyggetabletter til hund Previcox 227 mg tyggetabletter til hund
English: Do not use in pregnant or lactating bitches.
Danish: Må ikke anvendes til drægtige og diegivende tæver.
English: Chewable tablet
Danish: Tyggetabletter
English: Concurrent administration of potentially nephrotoxic drugs should be avoided as there might be an increased risk for renal toxicity.
Danish: Undgå samtidig anvendelse af potentielt nyretoksiske præparater, da der kan være forøget risiko for nyretokcicitet.
English: The final study results of these clinical trials should be considered before recommending the need of additional studies.
Danish: De endelige resultater af disse kliniske undersøgelser bør tages i betragtning, inden behovet for at udføre yderligere undersøgelser anbefales.
English: This document presents the conclusions on tranexamic acid.
Danish: Dette dokument fremlægger konklusionerne for tranexamsyre.
English: Tranexamic acid is a lysine analogue authorised for several indication since 1969.
Danish: Tranexamsyre er en analog til lysin og har været godkendt til adskillige indikationer siden 1969.
English: The Committee considered that the product information should be updated.
Danish: • Udvalget fandt, at produktoplysningerne bør opdateres.
English: The safety profile of TXA has evolved since its authorisation, and safety data has accumulated over the years.
Danish: Sikkerhedsprofilen for TXA har ændret sig siden lægemidlets godkendelse, og sikkerhedsdataene har akkumuleret sig over årene.
English: Haematuria and the risk for urethral obstruction should also be included as warnings.
Danish: Hæmaturi og risikoen for urethral obstruktion bør også inkluderes som advarsler.
English: The results of the BART trial did not have a negative impact on the benefit risk profile of TXA.
Danish: Resultaterne af BART-undersøgelsen havde ikke nogen negativ indvirkning på TXA's benefit/risk-profil.
English: Acute venous or arterial thrombosis should constitute a contraindication.
Danish: Akut vene- eller arterietrombose bør udgøre en kontraindikation.
English: The MAHs should present this information to national competent authorities when final results for the studies become available.
Danish: Indehaverne af markedsføringstilladelserne skal fremlægge sådanne oplysninger for de nationale kompetente myndigheder, når de endelige resultater af undersøgelserne foreligger.
English: Tranexamic acid had not previously been associated with an increased risk of mortality and this has remained unchanged post-publication of the BART study.
Danish: Tranexamsyre har ikke tidligere været associeret med en højere dødsrisiko, og dette forblev uændret i den senere publicering af BARTundersøgelsen.
English: Detailed grounds for re-examination submitted by the marketing authorisation holder
Danish: Detaljerede begrundelser for ny undersøgelse indsendt af indehaveren af markedsføringstilladelsen
English: The Committee considered the procedure under Article 31 of Directive 2001/83/EC, for aprotinin, aminocaproic acid and tranexamic acid (see Annex I).
Danish: • Udvalget overvejede proceduren under artikel 31 i direktiv 2001/83/EF for aprotinin, aminocapronsyre og tranexamsyre (se bilag I).
English: Therefore the CHMP concluded that the balance of risks and benefits for tranexamic acid is positive under normal conditions of use subject to the revision of the indications as follows:
Danish: Derfor konkluderede CHMP, at benefit/risk-forholdet for tranexamsyre er positivt under normale betingelser for anvendelse, under forudsætning af en revision af indikationerne som følger:
English: Tranexamic acid
Danish: Tranexamsyre
English: Therefore, the CHMP concluded that a PK study should not be requested as a condition at this point in time.
Danish: Derfor konkluderede CHMP, at udførelse af en farmakokinetisk undersøgelse ikke bør stilles som betingelse på nuværende tidspunkt.
English: The preliminary results of a randomised controlled clinical trial, the ‘Blood conservation using antifibrinolytics: a randomised trial in a cardiac surgery population' (BART) study, had shown that although the use of aprotinin was associated with less serious bleeding than either of the comparator drugs, an increase in 30 day all-cause mortality had been observed among patients receiving aprotinin compared to patients taking other medicines.
Danish: De foreløbige resultater af en randomiseret, kontrolleret klinisk undersøgelse ”Blood conservation using antifibrinolytics: a randomised trial in a cardiac surgery population” (BART) havde vist, at selvom brug af aprotinin var associeret med mindre alvorlig blødning end med nogen af sammenligningsstofferne, var der observeret højere dødelighed af alle årsager efter 30 dage hos patienter, der fik aprotinin, sammenlignet med patienter der fik andre lægemidler.
English: In addition, information on convulsions and visual disturbances including impaired colour vision are adverse events which can be serious and have been reported, but these risks had not been considered in the current authorised product information.
Danish: Derudover er der information om kramper og synsforstyrrelser, inklusive nedsat farvesyn, som kan være alvorlige og er blevet indberettet, men disse risici er ikke medtaget i de aktuelle godkendte produktoplysninger.
English: The same is applicable for fibrinolytic conditions following consumption coagulopathy except in those with predominant activation of the fibrinolytic system with acute severe bleeding.
Danish: Det samme gælder fibrinolytiske tilstande efter dissemineret intravaskulær koagulation, undtagen hos patienter med overvejende aktivering af det fibrinolytisk system med akut alvorlig blødning.
English: Having considered the detailed grounds for re-examination submitted by the MAH in writing, the CHMP considered that no additional conditions were necessary to ensure the safe and effective use of tranexamic acid.
Danish: Efter at have taget de detaljerede begrundelser for ny undersøgelse indsendt skriftligt af indehaveren af markedsføringstilladelsen i betragtning, fandt CHMP, at der ikke var behov for yderligere betingelser for at garantere en sikker og effektiv anvendelse af tranexamsyre.
English: Overall summary of the scientific evaluation of referral on antifibrinolytics Tranexamic acid containing medicinal products (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af indbringelse af antifibrinolytika Lægemidler, der indeholder tranexamsyre (se bilag I)
English: Thromboembolic events, including interaction with oestrogens have been reported.
Danish: Der er rapporteret om tromboemboliske hændelser, inklusive interaktion med østrogener.
English: Having considered the data presented, the CHMP noted that there are ongoing PK studies in children that could provide valuable information.
Danish: Efter at have taget de forelagte data i betragtning bemærkede CHMP, at der er igangværende farmakokinetiske undersøgelser af børn, der kan give værdifuld information.
English: One MAH for tranexamic acid containing medicinal products expressed its disagreement with the CHMP Opinion, focusing its grounds for re-examination on the following points:
Danish: Én indehaver af markedsføringstilladelsen til lægemidler, der indeholder tranexamsyre, var uenighed med CHMP's udtalelse og fokuserede sine begrundelser for ny undersøgelse på følgende punkter:
English: For some conditions modifications to the wording were proposed, in order to bring them in line with current scientific knowledge on the use of TXA.
Danish: Der blev foreslået ændringer til ordlyden til visse indikationer, så de blev opdateret i forhold til den aktuelle, videnskabelige viden om anvendelse af TXA.
English: The CHMP considered also the adverse reactions profile, including new adverse events (some of which serious) associated with the use of TXA.
Danish: CHMP tog også bivirkningsprofilen i betragtning, herunder nye bivirkninger (af hvilke nogle er alvorlige) associeret med anvendelse af TXA.
English: The ongoing studies could provide some relevant PK data in different age stratum and some pharmacodynamic data, which is considered of interest.
Danish: De igangværende undersøgelser kan muligvis give relevante farmakokinetiske data for forskellige alderstrin samt visse farmakodynamiske data, der anses som værende af interesse.
English: Taking into account all the available information on safety and efficacy, the Committee agreed on the variation of the marketing authorisation with the balance of the risks and benefits considered positive in the following revised indications for TXA:
Danish: Idet al foreliggende information om sikkerhed og virkning blev taget i betragtning, indvilgede udvalget i ændring af markedsføringstilladelsen med et benefit/risk-forhold, der blev anset som positivt, i følgende reviderede indikationer for TXA:
English: The MAH was not convinced that the fulfilment of a condition such as performing a pharmacokinetic study in children was an essential condition for the safe and effective use of tranexamic acid IV in adults.
Danish: • Indehaveren af markedsføringstilladelsen var ikke overbevist om, at opfyldelsen af et krav, såsom udførelse af en farmakokinetisk undersøgelse af børn, var et essentielt krav i forhold til sikker og effektiv brug af tranexamsyre IV hos voksne.
English: The MAHs are reminded that any new information on the use of TXA in children is considered valuable.
Danish: Indehaverne af markedsføringstilladelserne mindes om, at al ny information om anvendelse af TXA til børn anses som værdifuld.
English: On the basis of the above, the Committee recommended the variation to the terms of the marketing authorisation for the medicinal products containing tranexamic acid referred to in Annex I for which the amendments to the product information are set out in annex III of the opinion.
Danish: På ovenstående grundlag anbefalede udvalget ændring af betingelserne for markedsføringstilladelserne for de i bilag 1 anførte lægemidler indeholdende tranexamsyre, for hvilke ændringerne af produktoplysningerne fremgår af bilag III til udtalelsen.
English: This PK study had been requested by the CHMP in the article 31 referral on antifibrinolytics containing aprotinin, aminocaproic acid and tranexamic acid.
Danish: CHMP havde udbedt sig denne farmakokinetiske undersøgelse foretaget i artikel 31-indbringelsen om antifibrinolytika, der indeholder aprotinin, aminocapronsyre og tranexamsyre.
English: Several data sources informed the opinion of the Committee, including available data from clinical studies, published literature, spontaneous reports and other data submitted by marketing authorisation holders (MAHs) of medicinal products containing aprotinin, EACA or TXA.
Danish: Udvalgets udtalelse er baseret på en række datakilder, herunder foreliggende data fra kliniske undersøgelser, offentliggjort litteratur, spontane indberetninger og andre data, der er indsendt af indehaverne af markedsføringstilladelserne for lægemidler, der indeholder aprotinin, EACA og TXA.
English: In addition to cardiac surgery, the CHMP considered that sufficient evidence is available on the safety and efficacy of TXA in other indications, including in patients undergoing dental or surgical procedures or at risk of complications from bleeding.
Danish: Udover hjerteoperation fandt CHMP, at der er tilstrækkelig evidens om sikkerheden og virkningen af TXA til andre indikationer, herunder til patienter, der får foretaget dentale eller kirurgiske indgreb eller er i risiko for blødningskomplikationer.
English: The Committee considered the available scientific data, including evidence from new studies, on the efficacy of TXA.
Danish: • Udvalget tog foreliggende videnskabelige data, inklusive evidens fra nye undersøgelser, om virkningen af TXA i betragtning.
English: Tranexamic acid has also been associated with gastrointestinal adverse events, such as nausea, diarrhoea and vomiting.
Danish: Tranexamsyre har også været associeret med gastrointestinale bivirkninger såsom kvalme, diarré og opkastning.