FrancophonIA/ELRC3.0 huggingface dataset:
English: • chest pain or chest tightness
Danish: • smerter i eller strammende følelse omkring brystet
English: • fainting.
Danish: • besvimelse.
English: Dry ejaculation
Danish: Retrograd ejakulation
English: Method of administration
Danish: Administration
English: Musculoskeletal and connective tissue disorders
Danish: • muskelsvækkelse, muskelsmerter
English: • convulsions
Danish: • kvalme
English: • difficult or laboured breathing,
Danish: • pludselig hvæsende vejrtrækning
English: • delirium
Danish: • uklar bevidsthed (delirium)
English: • nasal congestion
Danish: • tilstoppet næse
English: • kidney failure
Danish: • nyresvigt
English: Bottle (HDPE) 90 (3 x 30) tablets
Danish: 90 (3 x 30) tabletter
English: Pharmaceutical form
Danish: Lægemiddelform Administration Emballage
English: Bottle (HDPE) 30 tablets
Danish: 30 tabletter
English: The stopper should not be punctured more than 20 times.
Danish: Proppen må ikke gennemstikkes mere end 20 gange.
English: The metabolism in horses has not been investigated.
Danish: Metabolismen hos heste er ikke undersøgt.
English: The active substance in Meloxidolor is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Danish: Det aktive stof i Meloxidolor er et tilladt stof, der er beskrevet i tabel 1 i bilaget til Kommissionens forordning (EU) nr. 37/2010:
English: Date of first authorisation: 22/04/2013 Date of last renewal: 20/04/2018
Danish: Dato for første tilladelse: 22/04/2013 Dato for seneste fornyelse af markedsføringstilladelse: 20/04/2018
English: Avoid introduction of contamination during use.
Danish: Undgå at indføre kontaminanter under brugen.
English: 21 % of the recovered dose is eliminated in urine (2 % as unchanged meloxicam, 19 % as metabolites) and 79 % in the faeces (49 % as unchanged meloxicam, 30 % as metabolites).
Danish: 21 % af den genfundne dosis elimineres i urin (2 % som uændret meloxicam, 19 % som metabolitter) og 79 % i fæces (49 % som uændret meloxicam, 30 % som metabolitter).
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: Hjælpestofferne anført under punkt 6.1 i SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommisionens forordning (EU) Nr. 37/2010 indikerer, at MRL-værdier ikke er påkrævet, eller som ikke anses for at være omfattet af Forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel.
English: Withdrawal period: Cattle:
Danish: Tilbageholdelsestid: Kvæg:
English: Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such veterinary medicinal products should be observed for at least 24 hours before commencement of treatment.
Danish: Forudgående behandling med antiinflammatoriske substanser kan resultere i yderligere eller forstærkede bivirkninger, og derfor bør der indlægges en periode uden behandling med sådanne veterinære lægemidler på mindst 24 timer, inden behandlingen påbegyndes.
English: Marketing authorisation holder: Le Vet Beheer B.V.
Danish: Indehaver af markedsføringstilladelsen: Le Vet Beheer B.V.
English: Meloxidolor alone will not provide adequate pain relief during the dehorning procedure.
Danish: Meloxidolor alene vil ikke give tilstrækkelig smertelindring under afhorning.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - Almindelig (flere end 1, men færre end 10 dyr af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr ud af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - Meget sjælden (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter).
English: Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects.
Danish: Andre NSAID-præparater, diuretika, antikoagulantia, aminoglykosid-antibiotika og substanser med høj proteinbinding kan konkurrere om bindingen og således føre til toksisk virkning.
English: 3421 TV Oudewater The Netherlands
Danish: 3421 TV Oudewater Nederlandene
English: Do not use in pigs less than 2 days old.
Danish: Må ikke anvendes til grise under 2 dage gamle.
English: Accidental self-injection may give rise to pain.
Danish: Tilfælde af selvinjektion kan medføre smerter.
English: ATCvet code: QM01AC06
Danish: ATCvet-kode: QM01AC06.
English: Sodium chloride Glycine
Danish: Natriumchlorid Glycin
English: In case of overdose symptomatic treatment should be initiated.
Danish: I tilfælde af overdosering bør symptomatisk behandling initieres.
English: In dogs and cats, Meloxicam is eliminated with a half-life of 24 hours.
Danish: Hos hunde og katte elimineres Meloxicam med en halveringstid på 24 timer.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Danish: Eventuelle ubrugte veterinærlægemidler eller affald fra sådanne veterinærlægemidler skal destrueres i overensstemmelse med de lokale krav.
English: There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range in dogs and cats.
Danish: Der er linearitet mellem den indgivne dosis og de observerede plasmakoncentrationer efter indgift af terapeutiske doser til hunde og katte.
English: THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Danish: TEKSTEN “KUN TIL DYR” SAMT BETINGELSER ELLER BEGRÆNSNINGER FOR UDLEVERING OG BRUG, om nødvendigt
English: In horses, in rare cases a transient swelling at the injection site can occur but resolves without intervention.
Danish: Hos heste kan i sjældne tilfælde forekomme en forbigående hævelse på injektionsstedet, som forsvinder uden indgriben.
English: Dogs and cats:
Danish: Hunde og katte:
English: Do not use in dogs and cats less than 6 weeks of age nor in cats of less than 2 kg.
Danish: Må ikke anvendes til hunde eller katte under 6 uger eller katte på mindre end 2 kg.
English: Particular care should be taken with regard to the accuracy of dosing including the use of an appropriate dosing device and careful estimation of body weight.
Danish: Der bør udvises særlig forsigtighed i forbindelse med doseringsnøjagtigheden, herunder anvendelse af en passende doseringsanordning og nøje bestemmelse af kropsvægt.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals: Accidental self-injection may give rise to pain.
Danish: Særlige forholdsregler der skal træffes af personer, der administrerer lægemidlet til dyr: Tilfælde af selvinjektion kan medføre smerter.
English: The veterinary medicinal product should not be administered by pregnant women or women of childbearing potential as Meloxicam may be harmful to the foetus and unborn child.
Danish: Dette veterinærlægemiddel må ikke administreres af gravide kvinder eller af kvinder i den fødedygtige alder, da Meloxicam kan være skadeligt for fosteret og det ufødte barn.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER FOR UDLEVERING OG BRUG
English: Pregnancy and lactation:
Danish: Frægtighed og laktation:
English: Five major metabolites were detected all having been shown to be pharmacologically inactive.
Danish: De fem hovedmetabolitter har vist sig at være farmakologisk inaktive.
English: The main pathway of meloxicam biotransformation is oxidation.
Danish: Den primære biotransformation af meloxicam sker via oxidation.
English: Dogs, cats, cattle (calves) and pigs
Danish: Hunde, katte, kvæg (kalve) og grise
English: Name and address of the manufacturer responsible for batch release Produlab Pharma B.V.
Danish: Navn og adresse på fremstiller ansvarlig for batchfrigivelse Produlab Pharma B.V.
English: More than 98 % of meloxicam is bound to plasma proteins.
Danish: Mere end 98 % af meloxicam er bundet til plasma proteiner.
English: Excipient: Ethanol
Danish: Hjælpestof: Ethanol
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Danish: Nærmere oplysninger om dette veterinærlægemiddel er tilgængelige på webstedet for Det Europæiske Lægemiddelagentur (http://www.ema.europa.eu/).
English: In cattle and pigs, the highest meloxicam concentrations are to be found in liver and kidney.
Danish: Hos kvæg og grise fandtes de højeste koncentrationer af meloxicam i lever og nyre.
English: Meloxicam is a Non-Steroidal Anti-Inflammatory Drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and antipyretic effects.
Danish: Meloxicam er et non-steroidt antiinflammatorisk stof (NSAID) i oxicam gruppen, som virker ved hæmning af prostaglandin syntesen, og derved udøver det en antiinflammatorisk, antiekssudativ, analgetisk og antipyretisk effekt.
English: 4941 SJ Raamsdonksveer The Netherlands
Danish: 4941 SJ Raamsdonksveer Nederlandene
English: Do not use after the expiry date stated on the label after EXP. Shelf-life after first opening the container:28 days.
Danish: Må ikke anvendes efter den udløbsdato, som er angivet på æsken og hætteglas efter EXP. Opbevaringstid efter første åbning af emballagen: 28 dage.
English: Approximately 75 % of the administered dose is eliminated via faeces and the remainder via urine in dogs.
Danish: Ca. 75 % af den indgivne dosis elimineres via fæces og den resterende del med urinen hos hunde.
English: Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams).
Danish: Farmakoterapeutisk gruppe: Antiinflammatoriske og antireumatiske lægemidler, non-steroider (oxicam).
English: Multi-packs of 5 x 20 ml and 10 x 20 ml.
Danish: Multi-pakker med 5 x 20 ml og 10 x 20 ml.
English: In cats, the detection of metabolites from the parent compound in urine and faeces, but not in plasma is indicative for their rapid excretion.
Danish: Hos katte indikerer påvisningen af metabolitter fra den uomdannede substans i urin og fæces, men ikke i plasma, hurtig udskillelse af metabolitterne.
English: Manufacturer responsible for the batch release: Produlab Pharma B.V.
Danish: Fremstiller ansvarlig for batchfrigivelse: Produlab Pharma B.V.
English: People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.
Danish: Personer med kendt overfølsomhed over for NSAIDpræparater bør undgå kontakt med veterinærlægemidlet.
English: If required, a second administration of meloxicam can be given after 24 hours.
Danish: Om nødvendigt kan injektionen af meloxicam gentages efter 24 timer.
English: Concurrent administration of potential nephrotoxic veterinary medicinal products should be avoided.
Danish: Samtidig administration af potentielt nefrotoksiske veterinærlægemidler bør undgås.
English: Meloxidolor must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Danish: Meloxidolor må ikke gives samtidig med andre NSAID-præparater eller glucocortikosteroider.
English: Treatment of calves with Meloxidolor 20 minutes before dehorning reduces post-operative pain.
Danish: Behandling af kalve med Meloxidolor 20 minutter før afhorning reducerer postoperativ smerte.
English: Do not use in horses less than 6 weeks of age.
Danish: Må ikke anvendes til heste under 6 uger.
English: Treatment of piglets with Meloxidolor before castration reduces post-operative pain.
Danish: Behandling af smågrise med Meloxidolor før kastration mindsker de postoperative smerter.
English: For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.
Danish: Til anvendelse ved akut luftvejsinfektion med passende antibiotisk behandling til mindskelse af kliniske tegn hos kvæg.
English: In cattle, meloxicam is also a major excretion product in milk.
Danish: Hos kvæg udskilles meloxicam ligeledes i høj grad i mælk.
English: Multi-pack of 12 x 100ml
Danish: Multipakning på 12 x 100 ml
English: {Label for 100 ml}
Danish: {Etiket til 100 ml}
English: Oral suspensions of meloxicam for dogs may be used for continuation of treatment at a dosage of 0.1 mg meloxicam/kg body weight, 24 hours after administration of the injection.
Danish: Orale suspensioner af meloxicam til hunde kan anvendes til fortsættelse af behandlingen med en dosis på 0,1 mg meloxicam/kg kropsvægt 24 timer efter administration af injektionen.
English: Cattle, pigs and horses
Danish: Kvæg, grise og heste
English: meat and offal: 15 days; milk: 5 days Pigs, horses: meat and offal: 5 days Not authorised for use in horses producing milk for human consumption.
Danish: kød og indmad: 15 dage; mælk: 5 dage Grise, heste: kød og indmad: 5 dage Må ikke anvendes til heste, hvis mælk er bestemt til menneskeføde.
English: Cattle: single subcutaneous or intravenous injection Pigs: single intramuscular injection Horses: single intravenous injection Read the package leaflet before use.
Danish: Kvæg: Enkelt subkutan injection eller intravenøs injektion Grise: Enkelt intramuskulær injektion Heste: Enkelt intramuskulær injektion Læs indlægssedlen inden brug.
English: Any oral follow-up therapy using meloxicam or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) should not be administered in cats, as appropriate dosage regimens for such follow-up treatments have not been established.
Danish: Oral opfølgningsbehandling med meloxicam eller andre non-steroide antiinflammatoriske lægemidler (NSAID-præparater) må ikke anvendes til katte, da passende dosering for en sådan behandling ikke er fastlagt.
English: Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin administration in calves, lactating cows and pigs.
Danish: Meloxicam har ligeledes antiendotoksisk effekt, da det har vist sig at hæmme produktion af thromboxan B2 forårsaget af E-coli endotoxin administration hos kalve, lakterende køer og grise.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY”
Danish: TEKSTEN “KUN TIL DYR“
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Danish: Dette gælder også bivirkninger, der ikke allerede er anført i denne indlægsseddel eller hvis De mener, at dette lægemiddel ikke har virket efter anbefalingerne.
English: Cattle and pigs: Can be used during pregnancy and lactation.
Danish: Kvæg og grise: Kan anvendes under drægtighed og laktation.
English: Do not use in pregnant or lactating dogs or cats.
Danish: Må ikke anvendes til drægtige eller lakterede hunde eller katte.
English: In cattle, meloxicam is also a major excretion product in milk and bile whereas urine contains only traces of the parent compound.
Danish: Hos kvæg udskilles meloxicam ligeledes i høj grad i mælk og galde, hvorimod urinen kun indeholder spor af modersubstansen.
English: Only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.
Danish: Efter subkutan injektion blev der kun iagttaget forbigående let hævelse på injektionsstedet hos mindre end 10 % af det kvæg, der blev behandlet i de kliniske undersøgelser.
English: Pregnancy and lactation: Dogs and cats: Do not use in pregnant or lactating dogs or cats.
Danish: Hunde og katte: Må ikke anvendes til drægtige eller lakterende hunde eller katte.
English: For cattle and pigs:
Danish: Kvæg og grise:
English: If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Danish: Hvis der optræder bivirkninger, bør behandlingen ophøre og dyrlægen kontaktes.
English: Shelf-life after first opening the immediate packaging: 28 days
Danish: Opbevaringstid efter første åbning af den indre emballage: 28 dage.
English: Following subcutaneous administration, meloxicam is completely bioavailable and maximal mean plasma concentrations of 0.73 g/ml in dogs and 1.1 µg/ml in cats were reached approximately 2.5 hours and 1.5 hours post administration, respectively.
Danish: Efter subkutan administration er meloxicam fuldstændigt biotilgængeligt, og maksimale gennemsnitlige plasmakoncentrationer på 0,73 g/ml hos hunde og 1,1 g/ml hos katte opnåedes henholdsvis ca. 2,5 og 1,5 time efter administration.
English: In cattle and pigs, subcutaneous, intramuscular as well as intravenous administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.
Danish: Subkutan, intramuskulær og intravenøs administration tolereres godt hos kvæg og grise; kun hos mindre end 10 % af behandlet kvæg i kliniske studier sås let og forbigående hævelse på injektionsstedet efter subkutan injektion.
English: In pigs, bile and urine contain only traces of the parent compound.
Danish: Hos grise indeholder galde og urin kun spor af modersubstansen.
English: Label for 100 ml
Danish: Etiket til 100 ml
English: To obtain pain relief for cattle and pigs during surgery co-medication with an appropriate anaesthetic/sedative/analgesic is needed.
Danish: Til smertelindring ved operationer på kvæg og grise kræves komedicinering med et passende anæstetikum/sedativ/analgetikum.
English: People with known hypersensitivity to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
Danish: Personer med kendt overfølsomhed over for non-steroide antiinflammatoriske lægemidler (NSAID-præparater) bør undgå kontakt med veterinærlægemidlet.
English: For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.
Danish: Ved anvendelse til behandling af diarré hos kvæg må dyret ikke være under en uge gammelt.
English: Meloxicam is eliminated with a half-life of 26 hours after subcutaneous injection in young cattle.
Danish: Meloxicam udskilles med en halveringstid på 26 timer efter subkutan injektion i ungkvæg.
English: Overdose (symptoms, emergency procedures, antidotes) In case of overdose, symptomatic treatment should be initiated.
Danish: Overdosis (symptomer, nødforanstaltninger, modgift) I tilfælde af overdosering bør symptomatisk behandling initieres.
English: Overdose (symptoms, emergency procedures, antidotes): In case of overdose symptomatic treatment should be initiated.
Danish: Overdosis (symptomer, nødforanstaltninger, modgift): I tilfælde af overdosering bør symptomatisk behandling initieres.
English: PACKAGE SIZE(S)
Danish: PAKNINGSSTØRRELSE(R)
English: For the relief of post-operative pain associated with minor soft tissue surgery such as castration.
Danish: Til lindring af postoperative smerter ved mindre bløddelsoperationer såsom kastration.
English: Bovine, caprine
Danish: Kvæg, geder
English: To obtain the best possible pain relieving effect post-surgery Meloxidolor should be administered 30 minutes before surgical intervention.
Danish: For at få størst mulig postoperativ smertelindring bør Meloxidolor administreres 30 minutter før det operative indgreb.
English: Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin administration in calves and pigs.
Danish: Meloxicam har desuden anti-endotoksiske egenskaber og hæmmer således den thromboxan B2produktion, der induceres ved administration af E. coli-endotoksin til kalve og grise.
English: Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Danish: Må ikke anvendes i tilfælde af overfølsomhed over for det aktive stof eller et eller flere af hjælpestofferne.
English: Pharmacologically active substance
Danish: Farmakologisk virksomt stof
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Danish: ANGIVELSE AF DE AKTIVE STOFFER OG ANDRE INDHOLDSSTOFFER
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE AND THE IMMEDIATE PACKAGE
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG DEN INDRE EMBALLAGE
English: Solution for injection
Danish: Vand til injektionsvæsker
English: To obtain the best possible pain relieving effect for pigs post-surgery Meloxidolor should be administered 30 minutes before surgical intervention.
Danish: For at få størst mulig postoperativ smertelindring hos grise bør Meloxidolor administreres 30 minutter før det operative indgreb.
English: For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age
Danish: Ved behandling af diarré hos kvæg bør præparatet ikke gives til dyr, som er mindre end en uge gamle.
English: Typical adverse reactions of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have rarely been reported.
Danish: Typiske non-steroide anti-inflammatoriske (NSAID-præparater) bivirkninger såsom appetitløshed, opkastning, diarré, fækal okkult blødning, apati og nyresvigt er set sjældent.
English: Meloxicam Meloxicam Bovine, caprine, porcine, rabbit,
Danish: Meloxicam Meloxicam Kvæg, geder, grise, kaniner, dyr af hestefamil ien
English: Disposal: read package leaflet.
Danish: Bortskaffelse; Læs indlægssedlen
English: For dogs, cats and cattle it is also a major biliary excretion product whereas urine contains only traces of the parent compound.
Danish: Hos hunde, katte og kvæg udskillesstoffet i høj grad via galden, hvorimod urinen kun indeholder spor af uomdannet substans.
English: PACKAGE SIZES
Danish: PAKNINGSSTØRRELSE
English: Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral rehydration, as there may be a potential risk of renal toxicity.
Danish: Undgå anvendelse til alvorligt dehydrerede, hypovolæmiske eller hypotensive dyr, som kræver parenteral rehydrering, da der foreligger potentiel risiko for skade.
English: Česká republika Sevaron ltd Palackeho trida 163 a 61200 Brno Tel. +420 541 426 370
Danish: Palackeho trida 163 a 61200 Brno Tel. +420 541 426 370
English: Antiinflammatory agents/Non steroidal antiinflammatory agents
Danish: Antiinflammat oriske lægemidler/ikkesteroide antiinflammatoriske lægemidler
English: Label for 10 ml and 20 ml
Danish: Etiket til 10 ml og 20 ml
English: Do not use in dogs and cats suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Danish: Må ikke anvendes til hunde eller katte med gastro-intestinale lidelser som f.eks. irritation og tegn på blødning, svækket lever-, hjerte- eller nyrefunktion og hæmoragiske lidelser.
English: In very rare cases anaphylactic reactions, which may be serious (including fatal), may occur and should be treated symptomatically.
Danish: I meget sjældne tilfælde kan anafylaktiske reaktioner som kan være alvorlige (herunder dødelige) forekomme.
English: In pigs, after intramuscular administration, the mean plasma elimination half-life is approximately 2.5 hours.
Danish: Hos grise, efter intramuskulær administration, er den gennemsnitlige halveringstid ca. 2,5 time.