FrancophonIA/ELRC3.0 huggingface dataset:
English: Some of the children were found to be CYP2D6 ultra-rapid metabolisers.
Danish: Nogle af børnene fandtes at være ultrahurtige CYP2D6-metabolisatorer.
English: In these patients, codeine is converted into morphine in the body at a faster rate than normal, resulting in high levels of morphine in the blood that can cause toxic effects such as breathing difficulties.
Danish: Hos disse patienter omdannes kodein hurtigere til morfin i kroppen end normalt, hvilket medfører høje koncentrationer af morfin i blodet, hvorved der opstår giftvirkninger såsom vejrtrækningsproblemer.
English: Some of the children who had suffered severe side effects had evidence of being ‘ultra-rapid metabolisers' of codeine.
Danish: Nogle af de børn, der havde fået svære bivirkninger, viste sig at være “ultrahurtige metabolisatorer” af kodein.
English: Most of the cases occurred after surgical removal of the tonsils or adenoids for obstructive sleep apnoea (frequent interruption of breathing during sleep).
Danish: Størstedelen af tilfældene optrådte efter operativ fjernelse af mandler eller polypper som behandling for obstruktiv søvnapnø (hyppige vejrtrækningsstop under søvn).
English: Codeine should therefore not be used in people of any age who are known to be ultra-rapid metabolisers nor in breastfeeding mothers (because codeine can pass to the baby through breast milk).
Danish: Kodein bør derfor ikke bruges hos personer, der uanset alder vides at være ultrahurtige metabolisatorer, eller hos ammende mødre (fordi ko
English: In these patients, codeine is converted into morphine in the body at a faster rate than normal, resulting in high levels of morphine in the blood that can cause toxic effects such as respiratory depression.
Danish: Hos disse patienter omdannes kodein hurtigere til morfin i kroppen end normalt, hvorved der opstår høje koncentrationer af morfin i blodet, som medfører giftvirkninger såsom nedsat vejrtrækning.
English: • Because of a risk of breathing problems, the use of codeine medicines for pain relief in children has been restricted: these medicines are now only to be used to treat acute (short lived) moderate pain in children above 12 years of age, and only if it cannot be relieved by other painkillers such as paracetamol or ibuprofen.
Danish: • På grund af risiko for vejrtrækningsproblemer er der indført begrænsninger i brugen af smertestillende lægemidler indeholdende kodein til børn: Disse lægemidler må nu kun anvendes til behandling af akutte (kortvarige) moderate smerter hos børn over 12 år, og kun hvis smerterne ikke kan lindres med andre smertestillende midler såsom paracetamol eller ibuprofen.
English: The children who had suffered severe side effects had evidence of being ‘CYP2D6 ultra-rapid metabolisers' of codeine.
Danish: De børn, der havde fået svære bivirkninger, viste tegn på at være “ultrahurtige CYP2D6-metabolisatorer” af kodein.
English: Codeine is a widely used opioid medicine for pain relief.
Danish: Kodein er et opioid, der har stor udbredelse som smertestillende middel.
English: • Codeine should not be used at all in children (aged below 18 years) who undergo surgery for the removal of the tonsils or adenoids to treat obstructive sleep apnoea, as these patients are more susceptible to respiratory problems.
Danish: • Kodein må slet ikke bruges hos børn (under 18 år) i forbindelse med operativ fjernelse af mandler eller polypper som behandling for obstruktiv søvnapnø, da disse patienter er mere udsat for at få vejrtrækningsproblemer.
English: • Codeine is now only indicated in patients older than 12 years of age for the treatment of acute moderate pain that cannot be relieved by other analgesics such as paracetamol or ibuprofen (alone).
Danish: • Kodein er nu kun indiceret til behandling af akutte moderate smerter hos patienter over 12 år, når smertelindring ikke kan opnås med andre analgetika såsom paracetamol eller ibuprofen (alene).
English: • All children (aged below 18 years) who undergo surgery for the removal of the tonsils or adenoids to treat obstructive sleep apnoea (frequent interruption of breathing during sleep) should not be given codeine as they are more at risk of breathing problems.
Danish: • Børn (under 18 år), der får fjernet mandler eller polypper på grund af søvnapnø (hyppigt vejrtrækningsstop under søvn) må ikke få kodein, da de er ekstra udsat for at få vejrtrækningsproblemer.
English: Restrictions on use of codeine for pain relief in childrenCMDh endorses PRAC recommendation
Danish: Begrænsninger for anvendelse af kodein mod smerter hos børn - CMDh vedtagerPRAC's anbefaling dein kan overføres til spædbarnet gennem modermælken).
English: • Codeine-containing medicines should only be used to treat acute (short lived) moderate pain in children above 12 years of age, and only if it cannot be relieved by other painkillers such as paracetamol or ibuprofen, because of the risk of respiratory depression associated with codeine use.
Danish: • Som følge af risikoen for nedsat vejrtrækning med kodein bør kodeinholdige lægemidler kun an vendes til behandling af akutte (kortvarige) moderate smerter hos børn over 12 år, og kun hvis smerterne ikke kan lindres med andre smertestillende midler såsom paracetamol eller ibuprofen.
English: The reason for this longer half-life is unknown.
Danish: Årsagen til denne forlængede halveringstid er ukendt.
English: No drug interaction studies have been performed.
Danish: Der er ikke udført lægemiddelinteraktionsstudier.
English: Do not eat, drink, or smoke when handling the product.
Danish: Der må ikke spises, drikkes eller ryges ved håndtering af produktet.
English: Wash hands after handling the product.
Danish: Vask hænder efter håndtering af produktet.
English: The key aim of intervention is to maintain renal perfusion.
Danish: Hovedformålet med intervention er at opretholde renal perfusion.
English: In rare cases these adverse reactions may be fatal.
Danish: I sjældne tilfælde kan disse bivirkninger være fatale.
English: Località Marino del Tronto 63100 Ascoli Piceno (AP) ITALY
Danish: Località Marino del Tronto 63100 Ascoli Piceno (AP) ITALIEN
English: Steady state pharmacokinetics was attained by the fourth treatment in most animals.
Danish: Steady state farmakokinetik blev opnået ved fjerde behandling hos de fleste dyr.
English: ATCvet code: QM01AH92.
Danish: ATCvet-kode: QM01AH92
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09/09/2008
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 09/09/2008.
English: Date of last renewal: 12/08/2013.
Danish: Dato for fornyelse af tilladelsen: 12/08/2013.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/084/001-005
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/08/084/001-005
English: Tablets also contain the following ingredients
Danish: Tabletterne indeholder også følgende hjælpestoffer:
English: Dogs aged 12 months or more.
Danish: Hunde på 12 måneder og derover.
English: It therefore possesses analgesic and anti-inflammatory properties.
Danish: Det har derfor analgetiske og antiinflammatoriske egenskaber.
English: At 25 mg/kg there was evidence of gastrointestinal ulceration.
Danish: Ved 25 mg/kg blev der påvist gastrointestinal ulceration.
English: There are two isoforms of COX, COX-1, and COX-2.
Danish: Der findes to COX isoformer, COX-1 og COX-2.
English: It is a diarylsubstituted pyrazole.
Danish: Det er et diarylsubstitueret pyrazol.
English: PACKAGE SIZE 2 tablets
Danish: PAKNINGSSTØRRELSE 2 tabletter
English: The treatment-free period should however, take into account the pharmacology of the medicinal products used previously.
Danish: Der skal dog ved fastsættelse af den behandlingsfri periodes varighed tages højde for det tidligere anvendte lægemiddels farmakologi.
English: Risks for interactions have to be accounted for throughout the effect period i.e. 1-2 months after administration of Trocoxil.
Danish: Der bør tages højde for risiko for interaktioner i hele virkningsperioden dvs. 1-2 måneder efter administration af Trocoxil.
English: THIS IS NOT A DAILY TREATMENT.
Danish: DETTE ER IKKE ET LÆGEMIDDEL TIL DAGLIG INDGIVELSE.
English: Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse effects.
Danish: Præmedicinering med andre antiinflammatoriske substanser kan medføre yderligere eller kraftigere bivirkninger.
English: In laboratory studies with young adult dogs, mean elimination half-life values ranged from 13.8 to 19.3 days.
Danish: I laboratorieundersøgelser med unge, voksne hunde var halveringstiden mellem 13,8 og 19,3 dage.
English: THIS IS NOT A DAILY NSAID.
Danish: DETTE ER IKKE ET NSAID TIL DAGLIG ADMINISTRATION.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and blister after Exp.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på ydre emballage og blisterpakningen efter EXP.
English: Adverse reactions could occur at any time point during this period.
Danish: Der kan forekomme bivirkningsreaktioner på et hvilket som helst tidspunkt i denne periode.
English: Therapeutic concentrations in fed dogs are reached rapidly and peak concentrations are obtained in less than 24 hours after administering a dose.
Danish: Terapeutiske koncentrationer nås hurtigt hos fodrede hunde og den maksimale koncentration nås mindre end 24 timer efter administration af en dosis.
English: Care should be taken to avoid treatment of animals that might not tolerate prolonged NSAID exposure.
Danish: Forsigtighed bør udvises med henblik på at undgå behandling af dyr, der eventuelt ikke tåler længerevarende NSAID-eksponering.
English: The products of COX-2 metabolism are also involved in ovulation, implantation and closure of the ductus arteriosus.
Danish: Produkterne af COX-2 metabolismen har også betydning for ovulation, implantation og lukning af ductus arteriosus.
English: Its activity culminates in the synthesis of local hormones and inflammatory mediators, termed eicosanoids, which include several prostaglandins.
Danish: Dets aktivitet kulminerer i syntesen af lokale hormoner og antiinflammatoriske mediatorer, kaldet eikosanoider, som omfatter adskillige prostaglandiner.
English: These IC concentrations may be compared with mean trough concentrations of mavacoxib in plasma in clinical subjects of 0.52 and 1.11 µg/mL, respectively, after the first and fifth doses.
Danish: Disse IC-koncentrationer kan sammenlignes med gennemsnitskoncentrationer af mavacoxib i plasma hos kliniske subjekter på henholdsvis 0,52 og 1,11 µg/ml efter den første og den femte dosis.
English: Do not use in dogs less than 12 months of age and/or less than 5 kg body weight.
Danish: Bør ikke anvendes til hunde under 12 måneder og/eller hunde, som vejer mindre end 5 kg.
English: Mavacoxib is 4-[5-(4-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]-benzenesulfonamide.
Danish: Mavacoxib er 4-[5-(4-fluorphenyl)-3-(trifluormethyl)-1H-pyrazol-1-yl]-benzensulfonamid.
English: Carton boxes containing one blister.
Danish: Æsker indeholdende én blisterpakning.
English: For this reason dogs with hepatic disorders should not be treated.
Danish: Derfor bør hunde med leversygdomme ikke behandles.
English: Manufacturer responsible for batch release: Pfizer Italia s.r.l.
Danish: Fremstiller ansvarlig for batchfrigivelse: Pfizer Italia s.r.l.
English: The dose is 2 mg mavacoxib per kg body weight given immediately before or with the dog's main meal.
Danish: Dosis er 2 mg mavacoxib pr. kg legemsvægt, som gives umiddelbart inden eller sammen med hundens hovedmåltid.
English: Dogs should be carefully monitored if Trocoxil is administered simultaneously with an anticoagulant.
Danish: Hunde bør overvåges omhyggeligt, hvis Trocoxil administreres samtidigt med antikoagulantia.
English: NSAIDs are highly bound to plasma proteins and may compete with other highly bound substances, such that concomitant administration may result in toxic effects.
Danish: NSAID'ere er stærkt bundet til plasmaproteiner og kan konkurrere med andre substanser, der har en høj bindingsgrad således, at samtidig administration kan resultere i toksiske virkninger.
English: The veterinary medicinal product does not require any special storage conditions.
Danish: Dette veterinærlægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: Use the dose prescribed by the veterinarian.
Danish: Anvend den dosis, der er ordineret af dyrlægen.
English: -Blister foil base: PVC film /aluminium foil/ nylon -Blister backing: vinyl heat seal coating /aluminium foil/polyester film/printable paper Not all pack sizes may be marketed.
Danish: Blisterfoliebund: PVC-film/aluminiumfolie/nylon Blisterbagside: vinyl varmeforsegling/aluminiumfolie/polyesterfilm/printvenligt papir Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: COX-2 exerts the major role in synthesising prostaglandins which have pivotal roles as mediators of pain, inflammation and fever.
Danish: COX-2 spiller den største rolle i prostaglandinsyntesen, der har afgørende betydning som mediator for smerte, inflammation og feber.
English: COX-1 is a widely distributed constitutive enzyme, primarily involved in maintaining organ and tissue function, whilst COX-2 is inducible at sites of tissue damage but in some organs it is also constitutive.
Danish: COX 1 er et bredt distribueret konstitutivt enzym, som primært står for opretholdelse af organ- og vævsfunktioner, mens COX-2 induceres, hvor der sker vævsskade, men i nogle organer er det også konstitutivt.
English: Advice for dog owner
Danish: Oplysninger til hundeejeren
English: A treatment cycle should not exceed 7 consecutive doses (6.5 months).
Danish: En behandlingsserie bør ikke overskride 7 på hinanden følgende doser (6,5 måneder).
English: Do not use in cases of heart insufficiency.
Danish: Bør ikke anvendes ved hjerteinsufficiens.
English: However, studies in laboratory animals administered other NSAIDs have shown increased pre- and post-implantation loss, embryo-foetal lethality, and malformations.
Danish: Laboratorieundersøgelser af dyr, der har fået andre NSAID'ere, har dog vist øget hyppighed af præ- og postimplantationstab, embryo/føtal letalitet og misdannelser.
English: For the treatment of pain and inflammation associated with degenerative joint disease in dogs in cases where continuous treatment exceeding one month is indicated.
Danish: Til behandling af smerter og inflammation i forbindelse med degenerative ledsygdomme hos hunde, hvor fortsat behandling ud over en måned er indiceret.
English: Animals with evidence of impaired renal or hepatic function, or with evidence of a protein or blood losing enteropathy are not suitable for treatment with Trocoxil.
Danish: Dyr med tegn på nedsat nyre- eller leverfunktion eller med tegn på enteropati, der medfører tab af protein eller blod, er ikke egnet til behandling med Trocoxil.
English: It is extensively distributed throughout the body and almost all the mavacoxib-related residues in plasma comprise parent drug.
Danish: Det fordeles bredt i kroppen og næsten alle mavacoxibrelaterede restkoncentrationer i plasma udgør oprindelig substans.
English: Mavacoxib is well absorbed after oral administration; bioavailability was 87% in fed dogs and 46 % in fasted conditions and the recommended dose is based on administration with food.
Danish: Biotilgængeligheden var 87 % hos fodrede hunde og 46 % ved faste og den anbefalede dosis er baseret på administration sammen med mad.
English: Veterinarians should be aware that clinical signs of adverse reactions may continue when supportive therapy (such as gastro protectants) is discontinued.
Danish: Dyrlægen bør være opmærksom på at kliniske tegn på bivirkninger fortsat vil kunne være til stede efter seponering af understøttende behandling (som f.eks. gastroprotektiva).
English: Mavacoxib is approximately 98% bound to plasma proteins.
Danish: Mavacoxib har en plasmaproteinbinding på ca. 98 %.
English: COX is a key enzyme in pathways of arachidonic acid metabolism.
Danish: COX er nøgleenzymet i arachidonsyremetabolismen.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Active substance:
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER
English: This corresponds to a duration of effect of 1-2 months after administration of the second dose (and following doses).
Danish: Dette svarer til en virkningsvarighed på 1-2 måneder efter administration af anden dosis (og efterfølgende doser).
English: Before prescribing Trocoxil and during treatment with Trocoxil, your veterinarian will check your dog for kidney and liver problems as well as for diseases of the intestines.
Danish: Før ordination af Trocoxil og under behandlingen med Trocoxil vil dyrlægen kontrollere din hund for nyre- og leverproblemer samt for tarmsygdomme.
English: If your dog needs surgery, inform the surgeon that the dog is using Trocoxil.
Danish: Hvis din hund skal opereres, så fortæl dyrlægen at hunden får Trocoxil.
English: The dose of Trocoxil chewable tablets is 2 mg/kg of body weight (see table below).
Danish: Dosis af Trocoxil tyggetabletter er 2 mg/kg legemsvægt (se nedenstående skema).
English: Therefore, clinical doses are predicted to produce low level inhibition of COX-1 and high level inhibition of COX-2.
Danish: Kliniske doser kan derfor forudsiges at udvise lavt hæmningsniveau af COX-1 og højt hæmningsniveau af COX-2.
English: In overdose safety studies, repeated doses of 5 mg/kg and 10 mg/kg were not associated with adverse clinical events, abnormal clinical chemistry or significant histological abnormalities.
Danish: I overdoseringsundersøgelser af sikkerheden blev gentagne doser på 5 mg/kg og 10 mg/kg ikke associeret med kliniske bivirkninger, unormal klinisk kemi eller signifikante histologiske abnormiteter.
English: Mavacoxib possessed a longer elimination half-life in clientowned animals.
Danish: Mavacoxib udviste en længere halveringstid hos privatejede dyr.
English: Both COX-1 and COX-2 are present constitutively in the kidney and are assumed to possess protective roles in adverse physiological circumstances.
Danish: Både COX-1 og COX-2 er konstitutivt til stede i nyrerne og formodes at have en beskyttende effekt ved uønskede fysiologiske tilstande.
English: Do not exceed the stated dose prescribed by your veterinarian.
Danish: Overskrid ikke den dosis, der er ordineret af dyrlægen.
English: Multiple-dose pharmacokinetic studies provided no evidence that mavacoxib produces autoinhibition or autoinductive changes in its clearance, and it exhibits linear pharmacokinetics with oral doses ranging from 2 to 50 mg/kg.
Danish: Farmakokinetiske studier med gentagne doser viser ikke tegn på, at mavacoxib medfører autohæmning eller autoinduktive ændringer i dets clearance og det udviser lineær farmakokinetik ved orale doser i området fra 2-50 mg/kg.
English: There is no specific antidote for mavacoxib overdose, but general supportive therapy, as applied to clinical overdosewith NSAIDs, should be given.
Danish: Der findes intet specifikt antidot mod mavacoxib-overdosis, men generel understøttende behandling, som gældende for overdosis af NSAID'ere, bør gives.
English: Triangular tablet with mottled brown appearance embossed with the tablet strength on one side, the reverse side is blank.
Danish: Trekantet, brun-marmoreret tablet med tabletstyrken præget på den ene side og glat på den anden side.
English: A treatment cycle with Trocoxil should not exceed 7 consecutive doses (6.5 months).
Danish: En behandlingscyklus med Trocoxil må ikke overskride 7 på hinanden følgende doser (6,5 måned).
English: Should another NSAID be administered after Trocoxil treatment, a treatment-free period of at least ONE MONTH should be ensured to avoid adverse effects.
Danish: Såfremt et andet NSAID skal administreres efter behandling med Trocoxil, skal det sikres, at der er en behandlingsfri periode på mindst EN MÅNED, for at undgå bivirkninger.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske
English: Particular attention should be paid to maintaining haemodynamic status.
Danish: Særlig opmærksomhed bør henledes på at opretholde hæmodynamisk status.
English: Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non-steroids, Coxibs.
Danish: Farmakoterapeutisk gruppe: Antiinflammatoriske og antireumatiske lægemidler, non-steroider, coxibs.
English: Trocoxil belongs to a group of medicines called Non-steroidal Anti-inflammatory drugs (NSAIDs) which are used to treat pain and inflammation.
Danish: Trocoxil tilhører en gruppe af lægemidler, der kaldes non-steroide anti-inflammatoriske lægemidler (NSAID'ere), som anvendes til behandling af smerter og betændelse.
English: To avoid such effects when Trocoxil is to be administered in replacement of another NSAID, ensure an appropriate treatment-free period of at least 24 hours before administering the first dose of Trocoxil.
Danish: For at undgå sådanne virkninger, hvis Trocoxil skal erstatte anden NSAID-behandling, skal der sikres en tilstrækkelig behandlingsfri periode på mindst 24 timer inden administration af den første dosis Trocoxil.
English: Ingestion of Trocoxil may be harmful for children, and prolonged pharmacological effects leading to e.g. gastrointestinal disorders may be observed.
Danish: Indtagelse af Trocoxil kan være skadeligt for børn, og forlængede farmakologiske virkninger, der kan medføre f.eks. gastrointestinale forstyrrelser kan ses.
English: ADVICE ON CORRECT ADMINISTRATION Trocoxil should be given immediately before or during the animal's main meal.
Danish: OPLYSNINGER OM KORREKT ANVENDELSE Trocoxil skal gives umiddelbart inden eller sammen med hundens hovedmåltid.
English: Silicified microcrystalline cellulose Artificial powdered beef flavour Croscarmellose sodium Sodium laurylsulfate Magnesium stearate
Danish: Silicificeret mikrokrystallinsk cellulose Pulver med kunstig kødsmag Croscarmellosenatrium Natriumlaurilsulfat
English: Tell your veterinarian if your dog is using a blood-thinning agent.
Danish: Fortæl det til dyrlægen, hvis din hund får blodfortyndende medicin.
English: Trocoxil should not be used in dehydrated dogs.
Danish: Trocoxil må ikke anvendes til hunde, der er i væskeunderskud.
English: Care should be taken to ensure that the tablet is ingested.
Danish: Det bør nøje sikres, at hunden indtager tabletten.
English: The safety of Trocoxil has not been established during pregnancy and lactation.
Danish: Trocoxils sikkerhed under drægtighed og laktation er ikke fastlagt.
English: Trocoxil chewable tablets are indicated for the treatment of pain and inflammation associated with degenerative joint disease in dogs where treatment for more than one month is needed.
Danish: Trocoxil tyggetabletter er beregnet til behandling af smerte og inflammation i forbindelse med degenerative ledsygdomme hos hunde, hvor behandling i mere end en måned er nødvendig.
English: Concurrent administration of potentially nephrotoxic veterinary medicinal products should be avoided.
Danish: Samtidig administration af potentielt nefrotoksiske veterinærlægemidler bør undgås.
English: A maximum treatment administration of 6.5 months continuous therapy is recommended so as to manage plasma levels of mavacoxib in animals which exhibit reduced elimination
Danish: En maksimal behandlingstid på 6,5 måneder med kontinuerlig administration anbefales, så plasmakoncentrationen af mavacoxib kan kontrolleres.
English: At 15 mg/kg there was evidence of vomiting, and softened/mucoid faeces and an increase in clinical chemistry parameters reflecting renal function.
Danish: Ved doser på 15 mg/kg blev der påvist opkastning og blød/slimet fæces samt en øgning i de klinisk-kemiske parametre, der afspejler nyrefunktionen.
English: Ensure appropriate hydration and haemodynamic status when animals receiving Trocoxil undergo anaesthesia and/or surgical procedures or develop conditions which may result in dehydration or compromised haemodynamic status.
Danish: Sørg for passende hyrdrering og hæmodynamisk status, hvis dyr i behandling med Trocoxil skal i narkose og/eller opereres eller udvikler en tilstand, der kan resultere i dehydrering eller kompromiteret hæmodynamisk status.