FrancophonIA/ELRC3.0 huggingface dataset:
English: They are available under the invented names Frexocel, Hirzia, Prexige and Stellige as film coated tablets for oral administration.
Danish: De fås under særnavnene Frexocel, Hirzia, Prexige og Stellige som filmovertrukne tabletter til oral indgivelse.
English: It is acknowledged that lumiracoxib 100 mg once daily offers a gastrointestinal safety advantage compared with naproxen 1000 mg and ibuprofen 2400 mg.
Danish: Det er dokumenteret, at lumiracoxib 100 mg en gang dagligt giver en gastrointestinal sikkerhedsfordel sammenlignet med naproxen 1000 mg og ibuprofen 2400 mg.
English: Several risk minimisation measures are presently in place, including a contraindication in patients with present or previous hepatic dysfunction or being treated with other hepatotoxic medicines; and recommendations for baseline and on treatment liver test monitoring.
Danish: Der bliver i øjeblikket truffet flere risikominimeringsforanstaltninger, herunder en kontraindikation for patienter, som har eller har haft leversygdomme, eller som behandles med andre hepatotoksiske lægemidler, og anbefalinger for baseline og for testovervågning af den behandlede lever.
English: However, there are alternatives with a comparable gastrointestinal safety profile including other COX-2 inhibitors or NSAID given together with gastroprotection.
Danish: Der findes dog alternativer med en tilsvarende gastrointestinal sikkerhedsprofil, herunder andre COX-2 hæmmere eller NSAID, der indgives sammen med gastroprotektion.
English: Importantly, the interval between treatment periods and the frequency of liver test monitoring which would be needed to sufficiently reassure the safe use is unknown.
Danish: Det er vigtigt at understrege, at man ikke ved, hvilket interval mellem behandlingsperioderne og hvilken levertestovervågningshyppighed der ville være nødvendig for at give en tilstrækkelig garanti for sikker brug.
English: However, such short treatment duration is not compatible with the effective management of a chronic disease (osteoarthritis of the knee and hip), and taking the characteristics of the disease into account, readministration of lumiracoxib would be necessary.
Danish: Et kort behandlingsforløb som dette muliggør dog ikke en effektiv håndtering af en kronisk sygdom (osteoartrose i knæ og hofter), og i betragtning af sygdommens karakteristika ville en fornyet indgivelse af lumiracoxib være nødvendig.
English: Following the provisions under Article 107 (2) of Directive 2001/83/EC, as amended, the Agency's Committee for Medicinal Products for Human Use (CHMP) prepared an Opinion on 13 December 2007 recommending the revocation of the Marketing Authorisations for all lumiracoxib containing medicinal products in Annex I. The CHMP also recommended that temporary measures are needed in order to protect public health and therefore recommends to the European Commission that the marketing and the use of lumiracoxib containing medicinal products be suspended forthwith in all concerned EU Member States awaiting the adoption of final measures.
Danish: I henhold til bestemmelserne i artikel 107, stk. 2, i direktiv 2001/83/EF, med senere ændringer, vedtog Udvalget for Humanmedicinske Lægemidler (CHMP) en udtalelse den 13. december 2007, hvor udvalget anbefaler en tilbagekaldelse af markedsføringstilladelserne for alle lægemidler indeholdende lumiracoxib i bilag I. CHMP anbefalede ligeledes, at der træffes midlertidige foranstaltninger for at beskytte folkesundheden, og derfor anbefalede CHMP Europa-Kommissionen, at markedsføring og anvendelse af lægemidler indeholdende lumiracoxib straks suspenderes i alle de berørte EUmedlemsstater i afventning af vedtagelsen af de endelige bestemmelser.
English: The Committee considered the procedure under Article 107 of Directive 2001/83/EC, as amended, for medicinal products containing lumiracoxib at the 100 mg dose.
Danish: Udvalget fulgte proceduren i artikel 107 i direktiv 2001/83/EF, med senere ændringer, for lægemidler indeholdende lumiracoxib i en dosis på 100 mg.
English: Taking all these elements into account, the CHMP concluded that the benefit/risk balance for lumiracoxib is not considered favourable and recommended the revocation of the Marketing Authorisations for the medicinal products referred to in Annex I.
Danish: På baggrund af alle disse elementer konkluderede CHMP, at benefit/risk-forholdet ved lumiracoxib ikke er positivt, og CHMP anbefalede en tilbagekaldelse af markedsføringstilladelserne for de lægemidler, der henvises til i bilag I.
English: The Committee considered that the proposed risk minimisation measures cannot assure adequate patient safety, and are not considered realistic given the approved clinical indication.
Danish: Udvalget var af den opfattelse, at de foreslåede risikominimeringsforanstaltninger ikke kan garantere en tilstrækkelig patientsikkerhed, og at de ikke er realistiske i betragtning af den godkendte kliniske indikation.
English: Lumiracoxib is indicated in the treatment of osteoarthritis of the knee and hip, which is a chronic, but not life-threatening disease, where long-term treatment is usually needed.
Danish: Lumiracoxib er indiceret til behandlingen af osteoartrose i knæ og hofter, som er en kronisk, men ikke livstruende sygdom, hvor det sædvanligvis er nødvendigt med en langvarig behandling.
English: Lumiracoxib is a non-steroidal anti-inflammatory drug (NSAID) belonging to the group of the selective cyclooxygenase-2 (COX-2) inhibitors indicated for symptomatic relief in the treatment of osteoarthritis of the knee and hip.
Danish: Lumiracoxib er et ikke-steroidt antiinflammatorisk lægemiddel (NSAID), der tilhører gruppen af selektive cyclo-oxygenase-2 (COX-2) hæmmere, som er indiceret til symptomlindring i behandlingen af osteoartrose i knæ og hofter.
English: The proposed risk minimisation measures are neither considered to assure adequate patient safety, nor to be realistic given the approved clinical indication.
Danish: De foreslåede risikominimeringsforanstaltninger anses hverken for at garantere en tilstrækkelig patientsikkerhed eller for at være realistiske i betragtning af den godkendte kliniske indikation.
English: On 9 November 2007, the United Kingdom Competent Authority (MHRA) issued a Rapid Alert informing the Member States, the EMEA and the European Commission in accordance with Article 107 of Directive 2001/83/EC, as amended, of the intention to suspend the Marketing Authorisations for lumiracoxib containing medicinal products in its Member State.
Danish: Den 9. november 2007 udsendte Det Forenede Kongeriges kompetente myndighed (MHRA) en hurtig varslingsmeddelelse, som i henhold til artikel 107 i direktiv 2001/83/EF, med senere ændringer, informerede medlemsstaterne, EMEA og Kommissionen om myndighedens intentioner om at suspendere markedsføringstilladelserne for lægemidler indeholdende lumiracoxib i medlemsstaten.
English: There is evidence from clinical trials that lumiracoxib is associated with a higher risk for hepatic adverse reactions compared with naproxen, ibuprofen and celecoxib.
Danish: De kliniske undersøgelser viser, at lumiracoxib giver en højere risiko for hepatiske bivirkninger sammenlignet med naproxen, ibuprofen og celecoxib.
English: The Committee considered that lumiracoxib is indicated for symptomatic relief in the treatment of osteoarthritis of the knee and hip and that this is a not a life-threatening condition.
Danish: Udvalget var af den opfattelse, at lumiracoxib er indiceret til symptomlindring i behandlingen af osteoartrose i knæ og hofter, og at dette ikke er en livstruende sygdom.
English: Lumiracoxib has demonstrated a gastrointestinal advantage compared with high doses of NSAIDs.
Danish: Lumiracoxib har vist sig at have en gastrointestinal fordel sammenlignet med høje doser af NSAID'er.
English: In its assessment the MHRA concluded that lumiracoxib at the 100 mg dose was associated with an increased risk of hepatotoxicity.
Danish: MHRA konkluderede i sin vurdering, at en dosis på 100 mg lumiracoxib gav en øget risiko for hepatotoksicitet.
English: An increased risk for serious hepatotoxic adverse drug reactions has been identified with lumiracoxib, for which an early onset cannot be excluded.
Danish: En øget risiko for alvorlige hepatotoksiske bivirkninger af lægemidlet er blevet konstateret med lumiracoxib, og det kan ikke udelukkes, at de starter på et tidligt tidspunkt.
English: No gastrointestinal advantage of lumiracoxib has been demonstrated against celecoxib, another COX-2 inhibitor.
Danish: Der er ikke påvist nogen gastrointestinal fordel ved lumiracoxib sammenlignet med celecoxib, som er en anden COX-2 hæmmer.
English: The Committee concluded that there is increasing evidence for lumiracoxib-associated risk of hepatotoxicity at the 100 mg dose, and in some cases a short time to onset cannot be excluded.
Danish: Udvalget konkluderede, at der er stadig større dokumentation for, at lumiracoxib giver risiko for hepatotoksicitet ved en dosis på 100 mg, og at det i nogle tilfælde ikke kan udelukkes, at bivirkningerne begynder efter kort tid.
English: The Committee, in light of the above findings, concluded that the benefit/risk balance of lumiracoxib containing medicinal products at the 100 mg dose is not favourable.
Danish: konkluderede udvalget, at benefit/risk-forholdet ved lægemidler indeholdende lumiracoxib i en dosis på 100 mg ikke er positivt.
English: Administer directly into the mouth.
Danish: Indgives direkte i munden.
English: The bacteria were isolated between 2001 and 2007 from clinical cases in Belgium, France, Germany, Hungary, Italy, Poland, Sweden and UK.
Danish: Bakterierne blev isoleret mellem 2001 og 2007 fra kliniske tilfælde i Belgien, Frankrig, Tyskland, Ungarn, Italien, Polen, Sverige og England.
English: Tell your veterinarian about all medicines that you intend to give the animal.
Danish: Fortæl din dyrlæge om al medicin, du har til hensigt at give dyret.
English: Veraflox oral suspension is supplied in two different presentations:
Danish: Veraflox oral suspension leveres i to forskellige pakninger:
English: Types and Mechanisms of Resistance
Danish: Resistenstyper og -mekanismer
English: ATCvet code: QJ01MA97
Danish: ATCvet-kode: QJ01MA97
English: For most infections the following treatment courses will be sufficient:
Danish: Ved de fleste infektioner vil følgende behandlingstider være tilstrækkelige:
English: The period of growth depends on the breed.
Danish: Vækstperioden afhænger af racen.
English: The rapidity and extent of bacterial killing are directly proportional to the drug concentration.
Danish: Hurtigheden og omfanget af bakteriel død er direkte proportional med koncentrationen af lægemidlet.
English: The bioavailability of the veterinary medicinal product is at least 60%.
Danish: Biotilgængeligheden for veterinærlægemidlet er mindst 60%.
English: In order to avoid cross-contamination, the same syringe should not be used for different animals.
Danish: For at undgå krydskontaminering bør den samme sprøjte ikke bruges til forskellige dyr.
English: (see section “Special Warnings”).
Danish: (se afsnit ”Særlige advarsler”).
English: The bioavailability of the tablet is at least 70%.
Danish: Tablettens biotilgængelighed er mindst 70%.
English: Duration of treatment (days)
Danish: Behandlingsvarighed (dage)
English: During treatment, animals should therefore not be exposed to excessive sunlight.
Danish: Dyr bør derfor ikke udsættes for overdrevent sollys under behandlingen.
English: ADVICE ON CORRECT ADMINISTRATION The oral suspension should be given by direct oral administration as shown below:
Danish: OPLYSNINGER OM KORREKT ANVENDELSE Den orale suspension skal gives ved direkte oral indgivelse, som vist nedenfor:
English: Yellowish to beige suspension.
Danish: Gullig til beige suspension.
English: Vomiting may be a symptom of overdose.
Danish: Opkastning kan være et symptom på overdosering.
English: Cross-resistance within the fluoroquinolone class of antimicrobials is common.
Danish: Kryds-resistens inden for flouroquinolonklassen af antimikrobelle lægemidler er almindelig.
English: Dose of Oral suspension to be given (ml)
Danish: Dosis Oral suspension som skal indgives (ml)
English: Approximately 40% of the administered product is excreted unchanged via the kidneys.
Danish: Omkring 40% af det indgivne lægemiddel udskilles uomdannet via nyrerne.
English: Antibacterial Spectrum
Danish: Antibakterielt spektrum
English: This veterinary medicinal product should only be used in severe cases of periodontal disease.
Danish: Dette veterinære lægemiddel bør kun bruges i svære tilfælde af periodontal sygdom.
English: The primary mode of action of the fluoroquinolones involves interaction with enzymes essential for major DNA functions such as replication, transcription and recombination.
Danish: Fluoroquinolonernes primære virkningsmekanisme omfatter interaktion med enzymer, som er essentielle for vigtige DNA-funktioner såsom replikation, transkription og rekombination.
English: In case of contact with the skin, rinse off with water.
Danish: I tilfælde af kontakt med huden, skylles med vand.
English: One blister contains 7 tablets.
Danish: Hvert blisterkort indeholder 7 tabletter.
English: Pyoderma occurs mostly secondary to an underlying disease, thus, it is advisable to determine the underlying cause and to treat the animal accordingly.
Danish: Pyodermi forekommer i de fleste tilfælde sekundært til en underliggende sygdom, det er således tilrådeligt at finde den underliggende årsag og behandle dyret derefter.
English: SPECIAL STORAGE CONDITIONS Store in the original container.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i den originale beholder.
English: When the dose requires a half tablet to be used the remaining portion should be given at the next administration.
Danish: Når doseringen kræver brug af en halv tablet, skal den anden halvdel af tabletten gives ved næste dosering.
English: Mechanical cleaning of teeth and removal of plaque and calculus or extraction of teeth are prerequisites for a persistent therapeutic effect.
Danish: Mekanisk rensning af tænder og fjernelse af plak og tandsten eller udtrækning af tænder en forudsætning for en vedvarende terapeutisk effekt.
English: Superficial pyoderma Deep pyoderma
Danish: Overfladisk pyodermi Dyb pyodermi
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12/04/2011
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 12/04/2011
English: Pharmacotherapeutic group: Antibacterials for systemic use, fluoroquinolones.
Danish: Farmakoterapeutisk gruppe: Antibakterielle lægemidler til systemisk brug, fluoroquinoloner.
English: People with known hypersensitivity to quinolones should avoid any contact with the veterinary medicinal product.
Danish: Personer med kendt overfølsomhed overfor quinoloner bør undgå kontakt med veterinærlægemidlet.
English: In vitro plasma protein binding is low (35%).
Danish: In vitro plasmaproteinbindingen er lav (35%).
English: Pradofloxacin may increase sensitivity of the skin to sunlight.
Danish: Pradofloxacin kan øge hudens følsomhed for sollys.
English: Interactions with other medicinal products and other forms of interaction: There are some medicines that you should not give to your animal during treatment because if given together they might cause serious adverse effects.
Danish: Interaktion med andre lægemidler og andre former for interaktion: Der er noget medicin, som du ikke bør give til dit dyr under behandlingen, fordi det kan forårsage alvorlige bivirkninger, hvis de gives sammen.
English: Although pradofloxacin has in-vitro activity against a wide range of Gram-positive and Gramnegative organisms, including anaerobic bacteria, this veterinary medicinal product should only be used for the approved indications (see section 4.2) and in accordance with the prudent use recommendations in section 4.5 of this SPC.
Danish: Selvom pradofloxacin har in-vitro effekt på et bredt spektrum af Gram-positive og Gram-negative bakterier, inklusiv anaerobe bakterier, bør det kun bruges mod de godkendte indikationer (se afsnit 4.2) og i overensstemmelse med forsigtighedsreglerne i afsnit 4.5 i dette SPC.
English: Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials.
Danish: Fluoroquinoloner bør reserveres til behandling af kliniske tilstande der har responderet dårligt, eller forventes at respondere dårligt, på andre typer antimikrobielle midler.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på etiketten og æsken efter EXP.
English: Number of 15 mg tablets
Danish: Antal 15 mg tabletter
English: Only those dogs for which periodontal treatment goals cannot be achieved by mechanical treatment alone should be treated with this veterinary medicinal product.
Danish: Kun de hunde hvor målet med periodontal behandling ikke kan opnås alene ved mekanisk behandling bør behandles med dette veterinærlægemiddel.
English: 400 South Oak Way Green Park
Danish: United Kingdom Bayer plc, 400 South Oak Way Green Park
English: Draw out the equivalent dosage into the syringe.
Danish: Træk den korrekte dosis op i sprøjten.
English: In vitro plasma protein binding is low (30%).
Danish: In vitro er plasmaproteinbindingen lav (30%).
English: • as adjunctive treatment to mechanical or surgical periodontal therapy in the treatment of severe infections of the gingiva and periodontal tissues caused by susceptible strains of anaerobic organisms, for example Porphyromonas spp.
Danish: • som tillægsbehandling til mekanisk eller kirurgisk periodontal behandling af svære infektioner i tandkød og periodontale væv forårsaget af følsomme stammer af anaerobe organismer, f.eks. Porphyromonas spp.
English: The duration of the treatment depends on the nature and severity of the infection and on the response to treatment.
Danish: Behandlingsvarigheden afhænger af infektionens type og sværhedsgrad samt af behandlingsrespons.
English: Do not use during lactation.
Danish: Må ikke anvendes under laktation.
English: However in the clinical studies feeding did not reveal any impact on the treatment effect.
Danish: De kliniske studier tyder dog ikke på at fødeindtag påvirker effekten af behandlingen.
English: The combination of fluoroquinolones with theophylline could increase the plasma levels of theophylline by altering its metabolism and thus should be avoided.
Danish: Kombinationen af flouroquinoloner og theophyllin kan øge plasmaniveauet af theophyllin ved at ændre dets metabolisme, og dette bør derfor undgås.
English: The combined use of fluoroquinolones with digoxin should also be avoided because of potentially increased oral bioavailability of digoxin.
Danish: Samtidig brug af flouroquinoloner og digoxin bør også undgås, på grund af en potentiel øgning af den orale biotilgængelighed af digoxin.
English: Do not eat, drink or smoke while handling the veterinary medicinal product.
Danish: Spis, drik og ryg ikke under håndtering af veterinærlægemidlet.
English: One syringe should therefore only be used for one animal.
Danish: Dvs. én sprøjte bør derfor kun bruges til et dyr.
English: (including S. pseudintermedius),
Danish: (inklusiv S. pseudintermedius),
English: Dogs, cats
Danish: Hund, Kat
English: - 7 tablets - 21 tablets - 70 tablets - 140 tablets
Danish: - 7 tabletter - 21 tabletter - 70 tabletter - 140 tabletter
English: The high volume of distribution (Vd) >4 l/kg body weight indicates good tissue penetration.
Danish: Det høje distributionsvolumen (Vd) >4 l/kg legemsvægt indikerer god vævspenetration.
English: All mechanisms lead to a reduced susceptibility of the bacteria to fluoroquinolones.
Danish: Alle mekanismerne fører til reduceret følsomhed af bakterien over for flouroquinoloner.
English: Tell your veterinarian if your animal has impaired kidney function.
Danish: Fortæl det til din dyrlæge, hvis dit dyr har nedsat nyrefunktion.
English: Shelf life of the veterinary medicinal product as packaged for sale: 3 years Shelf life after first opening the bottle: 3 months
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 3 år Opbevaringstid efter første åbning af flasken: 3 måneder
English: Avoid skin and eye contact with the veterinary medicinal product.
Danish: Undgå kontakt med hud og øjne med veterinærlægemidlet.
English: 10 Place de Belgique Paris La Défense FR-92250 La Garenne Colombes Tél: +33 1 49 06 56 00
Danish: 10 Place de Belgique Paris La Dèfense FR-92250 La Garenne Colombes Tél: +33 1 49 06 56 00
English: Vomiting and soft faeces may be symptoms of overdose.
Danish: Opkastning og tynd afføring kan være symptomer på overdosering.
English: Folding carton containing 30 ml white high density polyethylene (HDPE) bottle with a polyethylene adapter and a child-resistant closure.
Danish: Æske indeholdende en 30 ml hvid high density polyethylene (HDPE) flaske med en polyethylen adapter og en børnesikret lukkeanordning.
English: Official and local antimicrobial policies should be taken into account when the product is used.
Danish: Der bør tages hensyn til officielle og lokale antimikrobielle retningslinier ved brugen af produktet.
English: The major elimination pathway in cats is glucuronidation.
Danish: Den største udskillelsesvej i katte er glucuronidering.
English: The primary targets for pradofloxacin are the bacterial DNA gyrase and topoisomerase IV enzymes.
Danish: De primære targets for pradofloxacin er det bakterielle DNA-gyrase og topoisomerase IV-enzymer.
English: Pradofloxacin concentrations in skin homogenates of dogs exceed those in serum by up to seven times.
Danish: Pradofloxacin-koncentrationer i hudhomogenater fra hund overstiger koncentrationerne i plasma op til 7 gange.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Oral use.
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ(E)
English: After administration, the syringe should be cleaned with tap water and stored in the carton box together with the veterinary medicinal product.
Danish: Efter brug bør sprøjten rengøres med rindende vand og opbevares i æsken sammen med veterinærlægemidlet.
English: The combined use of Veraflox with theophylline (used with chronic respiratory conditions) or digoxin (used with congestive heart failure) should also be avoided because of potentially higher blood levels which could increase the effects of these drugs.
Danish: Kombination af Veraflox og theophyllin (anvendes mod kroniske luftvejssygdomme) eller digoxin (anvendes mod kongestivt hjertesvigt) bør også undgås, på grund af potentielt højere niveauer i blodet som kan øge virkningen af disse lægemidler.
English: The medication should be administered for as long as advised by your veterinarian.
Danish: Lægemidlet skal gives i så lang tid som dyrlægen har angivet.
English: Thus, one syringe should only be used for one animal.
Danish: Dvs. en sprøjte bør kun bruges til et dyr.
English: Severe infections of the gingiva and periodontal tissues
Danish: Alvorlige infektioner i tandkød og periodontale væv
English: PACKAGE SIZE 30 ml bottle
Danish: PAKNINGSSTØRRELSE 30 ml flaske
English: Doses
Danish: Dosis
English: Pradofloxacin has no effects on the developing cartilage of kittens of 6 weeks of age and older.
Danish: Pradofloxacin har ingen effekt på ledbrusk under udvikling hos katte på 6 ugers alderen og ældre.
English: The high volume of distribution (Vd) >2 l/kg bodyweight indicates good tissue penetration.
Danish: Det høje distributionsvolumen (Vd) >2 l/kg legemsvægt indikerer god vævspenetration.
English: Folding cartons containing aluminium blister packs.
Danish: Æsker indeholdende aluminium blisterkort.
English: Fluoroquinolones are known to cross the placenta and to be distributed into milk.
Danish: Det er kendt at flouroquinoloner krydser placenta samt fordeler sig i mælken.