FrancophonIA/ELRC3.0 huggingface dataset:
English: Chronic musculoskeletal disorders: Response to long-term therapy should be monitored at regular intervals by a veterinary surgeon.
Danish: Kroniske muskulo-skeletale lidelser: Reaktion ved langtidsbehandling bør overvåges regelmæssigt af dyrlægen.
English: The suspension can be given using either of the two measuring syringes provided in the package (depending on weight of dog).
Danish: Opløsningen kan gives ved brug af en af de to målesprøjter der findes i pakken (afhængig af hundens vægt).
English: Administer 0.6 mg/kg body weight, once daily for up to 14 days.
Danish: Indgiv 0,6 mg/kg kropsvægt en gang daglig i op til 14 dage.
English: To ensure correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing or overdosing.
Danish: For at sikre korrekt dosering, bør legemsvægten bestemmes så præcist som muligt for at undgå undereller overdosering.
English: For post-operative pain relief in cats, safety has only been documented after thiopental/halothane anaesthesia.
Danish: Til post-operativ smertelindring hos katte er sikkerheden kun dokumenteret efter thiopental/halothananæstesi.
English: A clinical response is normally seen within 3-4 days.
Danish: En klinisk reaktion ses normalt inden for 3 - 4 dage.
English: One gram contains:
Danish: Et gram indeholder:
English: The tablets can be administered with or without food, are flavoured and are taken by most dogs voluntarily.
Danish: Tabletterne kan administreres sammen med eller uden foder, er tilsat smag og ædes villigt af de fleste hunde.
English: A pale yellow homogenous paste.
Danish: En lysegul, homogen pasta.
English: Therefore the use in this species is not recommended during pregnancy and lactation.
Danish: Derfor frarådes anvendelse til denne dyreart under drægtighed og laktation.
English: Laboratory studies in cattle have not provided any evidence for teratogenic, foetotoxic, or maternotoxic effects.
Danish: Laboratorieundersøgelser af kvæg har ikke afsløret teratogene virkninger, føtal toksicitet eller maternel toksicitet.
English: Advice on correct administration To be administered with food or directly into the mouth.
Danish: Råd om korrekt administration Skal gives sammen med foder eller direkte i munden.
English: Hydroxypropyl cellulose Glycerol
Danish: Hydroxypropylcellulose Glycerol
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Danish: Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, må dette veterinære lægemiddel ikke blandes med andre veterinære medicinske produkter.
English: The active substance in Loxicom 20 mg/ml solution for injection for cattle, pigs and horses is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Danish: Det aktive stof i Loxicom 20 mg / ml injektionsvæske, opløsning til kvæg, grise og heste er et tilladt stof beskrevet i Tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010:
English: BN {number}
Danish: Lot {nummer}
English: The volume of distribution is 0.3 l/kg in dogs and 0.09 l/kg in cats.
Danish: Fordelingsvoluminet er 0,3 l/kg i hunde og 0,09 l/kg i katte.
English: In the case of overdose, adverse reactions (as listed in Section 4.6) are expected to be more severe and more frequent.
Danish: I tilfælde af overdosering kan bivirkninger (som angivet i afsnit 4.6) forventes at optræde alvorligere og hyppigere.
English: For longer term treatment, once clinical response has been observed (after ≥ 4 days), the dose can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic musculo-skeletal disorders may vary over time.
Danish: Ved længerevarende behandling kan dosis, når der er observeret klinisk respons (efter ≥ 4 dage), justeres til den laveste, effektive individuelle dosis, idet der tages hensyn til, at graden af smerte og inflammation forbundet med kroniske muskulo-skeletale lidelser kan variere over tid.
English: The oral follow-up dose may be administered once daily (at 24-hour intervals) for up to four days.
Danish: Den orale opfølgningsdosis kan administreres 1 gang dagligt (i 24 timers intervaller), i op til 4 dage.
English: The metabolism in horses was not investigated.
Danish: Metabolismen hos heste er ikke undersøgt.
English: Cats: subcutaneous use.
Danish: Katte: subcutan anvendelse.
English: Oral paste.
Danish: Oral pasta.
English: Post-operative pain and inflammation following surgical procedures: In case additional pain relief is required, multimodal pain therapy should be considered.
Danish: Post-operativ smerte og inflammation efter kirurgiske indgreb: I tilfælde hvor supplerende smertelindring er nødvendig, bør multimodal smertebehandling overvejes
English: Oral paste
Danish: Oral pasta
English: Meloxicam is eliminated with a half-life of 24 hours in dogs and 15 hours in cats.
Danish: Meloxicam elimineres med en halveringstid på 24 i hunde og 15 timer i katte.
English: Maximal plasma concentrations are obtained after approximately 2 - 3 hours.
Danish: Der opnås maksimale plasmakoncentrationer efter cirka 2-3 timer.
English: Meloxicam Meloxicam Bovine, caprine, porcine, rabbit,
Danish: Meloxicam Meloxicam Bovin, kaprin, porcin, kanin,
English: Samohýl group a.s.
Danish: S Samohýl group a.s.
English: Due to the loading dose, steady state PK is reached after 2 days (48h).
Danish: Med den foreskrevne initialdosis opnås steady state PK efter 2 dage (48 timer).
English: Each ml contains:
Danish: Hver ml indeholder:
English: CONTENT BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
Danish: PAKNINGSSTØRRELSE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: The oral follow-up dose may be administered for up to a total of four doses at 24 hour intervals.
Danish: Den orale opfølgningsdosis kan administreres i op til 4 dage i 24 timers intervaller.
English: Particular care should be taken with regard to the accuracy of dosing.
Danish: Der skal udvises særlig omhyggelighed hvad angår doseringspræcision.
English: Dogs: intravenous or subcutaneous use.
Danish: Hunde: intravenøs eller subcutan anvendelse.
English: To be administered with food or directly into the mouth.
Danish: Skal gives sammen med foder eller direkte i munden.
English: In horses, a transient swelling at the injection site can occur but resolved without intervention.
Danish: Hos heste kan forekomme en forbigående hævelse på injektionsstedet, som forsvinder uden indgriben.
English: Once broached, use by……………………….
Danish: Efter anbrud, abvendes senest……………………….
English: АСКЛЕП - ФАРМА ООД гр.
Danish: Република България АСКЛЕП - ФАРМА ООД гр.
English: Accidental self injection may cause pain.
Danish: Utilsigtet selv-injektion kan give smerter.
English: Colourless glass injection vial of 10, 20 or 100 ml, closed with a bromobutyl stopper and sealed with an aluminium cap.
Danish: Farveøs glas-injektionshætteglas på 10, 20 or 100 ml, lukket med en bromobutyl-stopper og forseglet med en aluminiumshætte.
English: Do not use in animals less than 6 weeks of age nor in cats of less than 2 kg.
Danish: Må ikke anvendes til dyr der er yngre end 6 uger eller til katte der vejer mindre end 2 kg.
English: Low-density polyethylene pre-filled syringes containing 8.4 g of product in cartons of 1, 7, or 14 syringes.
Danish: Fyldte sprøjter af lavdensitets polyethylen med 8,4 g lægemiddel i æsker med 1, 7 eller 14 sprøjter.
English: The tablets can be broken into equal halves.
Danish: Tabletterne kan deles i to lige store dele.
English: See also section 4.3.
Danish: Se også afsnit 4.3.
English: Isolated cases of adverse reactions typically associated with NSAIDs were observed in clinical trials (slight urticaria, diarrhoea).
Danish: Der er observeret isoleret tilfælde af bivirkninger, typiskforbundet med NSAID'er ved kliniske forsøg (let urticaria, diarré).
English: Method and route of administration:
Danish: Administrationsmetode og -vej:
English: A clinical response is normally seen within 7 days.
Danish: Et klinisk respons ses typisk indenfor 7 dage.
English: Pregnancy and lactation: See section "Contraindications".
Danish: Drægtighed og laktation: Se afsnittet 'Kontraindikationer'.
English: One syringe division of paste should be administered per 50 kg bodyweight.
Danish: Der bør indgives en sprøjtedel pasta per 50 kg kropsvægt.
English: In case of overdose, adverse reactions, as listed in section "Adverse reactions", are expected to be more severe and more frequent.
Danish: I tilfælde af overdosering forventes bivirkninger, som angivet i afsnittet 'Bivirkninger', at optræde alvorligere og hyppigere.
English: Administration of the veterinary medicinal product by the subcutaneous route in cattle and the intramuscular route in pigs is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of cattle treated in clinical studies.
Danish: dministration af veterinærlægemidlet ved subkutan injektion hos kvæg og intramuskulært injektion hos svin er veltolereret, og kun en lille forbigående hævelse på injektionsstedet efter subkutan administration var observeret hos mindre end 10% af kvæg behandlet i kliniske studier.
English: Elimination Meloxicam is eliminated with a terminal half-life of 7.7 hours.
Danish: Elimination Meloxicam udskilles med en terminal halveringstid på 7,7 timer.
English: Each syringe delivers 420 mg meloxicam, sufficient to treat 700 kg of bodyweight.
Danish: Hver sprøjte giver 420 mg meloxicam, som er tilstrækkeligt til behandling af 700 kg kropsvægt.
English: For dogs weighing less than 4 kg the use of meloxicam containing oral suspension for dogs is recommended.
Danish: Til hunde der vejer mindre end 4 kg anbefales en oral suspension til hunde indeholdende meloxicam.
English: The volume of distribution is 0.12 l/kg.
Danish: Distributionsvoluminet er 0,12 l/kg.
English: Shelf-life of the halved tablet: 24-hours
Danish: Opbevaringstid for halverede tabletter i blister: 24 timer
English: A yellow solution.
Danish: En gul opløsning.
English: In animals at anaesthetic risk (e.g. aged animals) intravenous or subcutaneous fluid therapy during anaesthesia should be taken into consideration.
Danish: Hos dyr, hvor der er anæstesirisici (f.eks. ældre dyr) skal det overvejes at anvende intravenøs eller subcutan væsketerapi under bedøvelsen.
English: The oral paste is available in the following pack sizes: - 1 carton box containing 1 syringe - 1 carton box containing 7 syringes
Danish: Oral pasta fås i følgende pakningsstørrelser: 1 kartonæske med 1 sprøjte 1 kartonæske med 7 sprøjter 1 kartonæske med 14 sprøjter
English: Reduction of post-operative pain (over a period of 24 hours): single intravenous or subcutaneous injection before surgery, for example at the time of induction of anaesthesia.
Danish: Reduktion af post-operative smerter (over en periode på 24 timer): enkelt intravenøs eller subcutan injektion inden kirurgi, f.eks. på tidspunktet for iværksættelse af anæstesi.
English: The recommended maximum volume to be administered at a single injection site is 2 ml.
Danish: Den anbefalede maksimale mængde, som skal administreres på en enkelt injektionssted er 2 ml.
English: The syringe fits onto the bottle and has a kg-body weight scale which corresponds to the maintenance dose.
Danish: Sprøjten passer på flasken og har en kg-kropsvægt angivelse der svarer til vedligeholdelsesdosis.
English: The recommended maximum volume to be administered at a single injection site is 10 ml.
Danish: Den anbefalede maksimale mængde, som skal administreres på en enkelt injektionssted er 10 ml.
English: To a minor extent it also inhibits collagen-induced thrombocyte aggregation.
Danish: I mindre omfang hæmmer det også collagen-induceret trombocytaggregation.
English: Diarrhoea in calves of over one week of age and young, non-lactating cattle.
Danish: Diarré hos kalve, der er mere end en uge gamle og hos ikke-lakterende ungkvæg.
English: The following clinical signs (some of which may be serious) have been reported in clinical studies following administration of the product at 5x overdose: dull behaviour, diarrhoea, oedema, buccal mucosal ulceration and/or dark coloured urine.
Danish: Følgende kliniske tegn (hvoraf hvilke kan være alvorlige) er blevet indberettet ved kliniske studier efter indgivelse af overdosis af produktet: sløv adfærd, diarré, ødem, bukkal mucosal ulceration og/eller mørkfarvet urin.
English: When the product is used according to the recommended dosage regime, steady state concentrations of meloxicam in plasma are reached on the second day of treatment.
Danish: Når produktet anvendes i henhold til den anbefalede dosering, opnås en steady-state-koncentration af meloxicam i plasma på behandlingens 2. dag.
English: The tablet can be divided into equal halves.
Danish: Tabletten kan deles i to ens halvdele.
English: Following subcutaneous administration, meloxicam is completely bioavailable and maximal mean plasma concentrations of 0.73 µg/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 subcutan administration er meloxicam fuldstændig bioavailable og maksimal gennemsnitsplasmakoncentrationer på 0,73 µg/ml i hunde og 1,1 µg/ml i katte blev nået henholdsvis ca. 2,5 timer og 1,5 timer efter administration.
English: Cattle, pigs and horses.
Danish: Kvæg, grise og heste.
English: Meloxicam is completely absorbed following oral administration and maximal plasma concentrations are obtained after approximately 4.5 hours.
Danish: Meloxicam absorberes fuldstændigt efter oral administration og maksimale plasmakoncentrationer opnås efter ca. 4,5 timer.
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.
English: Administration of the product by the subcutaneous route in cattle and the intramuscular route in pigs is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in cattle treated in clinical studies.
Danish: Administration af veterinærlægemidlet ved subkutan injektion hos kvæg og intramuskulært injektion hos svin er veltolereret, og kun en lille forbigående hævelse på injektionsstedet efter subkutan administration var observeret hos kvæg behandlet i kliniske studier.
English: Each vial is closed with a bromobutyl bung and sealed with an aluminium cap.
Danish: Hvert hætteglas er lukket med en bromobutyl prop og forseglet med en aluminiums hætte.
English: Dosage:
Danish: Dosering:
English: 50 mg/g Benzyl alcohol 10 mg/g
Danish: 50 mg/g Benzylalkohol 10 mg/g
English: NO ENTRY
Danish: Ingen indførsel
English: Store below 30 ºC.
Danish: Opbevares under 30 ºC.
English: Benzyl alcohol Saccharin sodium powder Purified water
Danish: Benzylalkohol Saccharinnatriumpulver Vand, renset
English: Each syringe has an integrated adapter with a “kg/body weight” graduation, in divisions of paste per 50 kg bodyweight.
Danish: Hver sprøjte har en integreret adapter med en graduering efter "kg/kropsvægt" opdelt i pasta pr. 50 kg kropsvægt.
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 product.
Danish: Hjælpestofferne anført under punkt 6.1 i SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens 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: In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should be treated symptomatically.
Danish: I meget sjældne tilfælde kan anafylaktoide reaktioner som kan være alvorlige (herunder dødelige) forekomme og bør behandles symptomatisk.
English: Light brown oval biconvex tablet with a score line on one face and plain on the other.
Danish: Lysebrun oval, bikonveks tablet med delekærv på den ene side.
English: Alternatively therapy may be initiated with Loxicom 5 mg/ml solution for injection.
Danish: Alternativ behandling kan igangsættes med Loxicom 5 mg/ml opløsning til injektion.
English: Not authorised for use in animals producing milk for human consumption.
Danish: Må ikke anvendes til dyr, hvis mælk er bestemt til menneskeføde.
English: The use of a meloxicam containing oral suspension for dogs may be considered for an even more precise dosing.
Danish: En oral suspension til hunde indeholdende meloxicam, kan anvendes til mere nøjagtig dosering.
English: In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.
Danish: I meget sjældne tilfælde kan anafylaktiske reaktioner opstå, og disse skal behandles symptomatisk.
English: For use in the alleviation of inflammation and the relief of pain in both acute and chronic musculoskeletal disorders, a suitable oral therapy containing meloxicam, administered in accordance with label recommendations, may be used for continuation of treatment.
Danish: Ved lindring af betændelse og smerter ved såvel akutte som kroniske lidelser i bevægeapparatet, kan en passende oral behandling med meloxicam, indgivet i overensstemmelse med den anbefalede dosering, anvendes til fortsættelse af behandlingen.
English: Each ml contains: Meloxicam
Danish: Hver ml indeholder: Meloxicam
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 anti endotoksisk 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: Blisters
Danish: Blister
English: Equidae
Danish: Equida e
English: The syringe has an integrated adapter and has a kg/body weight graduation.
Danish: Sprøjten har en integreret adapter og en graduering efter kg/kropsvægt.
English: Solution for injection.
Danish: Opløsning til injection.
English: Five major metabolites were detected all having been shown to be pharmacologically inactive.
Danish: Der blev påvist fem hovedmetabolitter, som alle har vist sig at være farmakologisk inaktive.
English: Musculo-skeletal disorders: single subcutaneous injection.
Danish: Muskel-skelet-forstyrrelser: enkelt subcutan injektion.
English: Alternatively, therapy may be initiated with a solution for injection containing 5 mg meloxicam/ml.
Danish: Alternativt kan behandling indledes med injektionsvæske indeholdende 5 mg/ml meloxicam .
English: Puerperal septicaemia and toxaemia (MMA syndrome) with antibiotic therapy.
Danish: Puerperal sepsis og toksikæmi (MMA-syndrom) med antibiotika-behandling.
English: Loxicom 0.5 mg/ml Oral Suspension for Cats is available in bottle of 5 ml, 15 ml and 30 ml volumes.
Danish: akningsstørrelse Loxicom 0,5 mg/ml oral suspension til katte forhandles i flasker à 5 ml, 15 ml og 30 ml.
English: The active substance in Loxicom is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010.
Danish: Meloxicam er en aktiv substans som beskrevet i tabel 1 i bilag til Kommissionens Forordning (EU) Nr. 37/2010:
English: Loxicom must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Danish: Loxicom må ikke administreres sammen med andre NSAID-præparater eller glucokortikosteroider.
English: Cattle: Single subcutaneous or intravenous injection.
Danish: Kvæg: En enkelt Subkutan eller intravenøs injektion.
English: Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by intravenous E. coli endotoxin administration in calves and pigs.
Danish: Meloxicam har også antiendotoksiske egenskaber, idet det har vist sig at hæmme produktionen af thromboxan B2 induceret ved intravenøs E. coli endotoxin-indgivelse hos kalve og grise.
English: Benzyl Alcohol 10 mg
Danish: Benzylalkohol 10 mg
English: Blister packs of 10 tablets per strip composed of PVC/PVDC base foil and aluminium lidding foil in cartons containing 10, 20, 100 or 500 tablets.
Danish: Blisterpakninger med 10 tabletter pr. PVC/PVDC blister med aluminium dække folie i æsker indeholdende 10,20,100 eller 500 tabletter
English: EXP: Once opened, use within 6 months.
Danish: UDL: Efter åbning anvendes inden 6 måneder.
English: After two intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.9 μg/ml was reached after 1 hour in pigs.
Danish: Efter to intramuskulære doser på 0,4 mg meloxicam/kg opnåedes efter 1 time en Cmax værdi på 1,9 µg/ml hos grise.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the blister after EXP.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på kartonen og blisterkortet efter EXP.
English: Post-operative pain and inflammation following surgical procedures:
Danish: Post-operative smerter og inflammation, efter kirurgiske indgreb:
English: Thus for the first day, twice the maintenance volume will be required.
Danish: Der skal således den første dag anvendes dobbelt vedligeholdelsesdosis.
English: Store below 30ºC
Danish: Opbevares under 30 ºC
English: All major metabolites have been shown to be pharmacologically inactive.
Danish: Alle væsentlige metaboliter har vist sig at være farmakologisk inaktive.
English: To ensure administration of a correct dose, body weight should be determined as accurately as possible.
Danish: For at sikre korrekt dosering bør katten vejes så nøjagtigt som muligt.
English: Overdose (symptoms, emergency procedures, antidotes): In the case of overdose, symptomatic treatment should be initiated.
Danish: Overdosis (symptomer, nødforanstaltninger, modgift): I tilfælde af overdosering bør symptomatisk behandling initieres.
English: Polyethylene terephthalate bottle containing 10, 32, 100, 2 x 100 or 200 ml with two polyethylene/polypropylene measuring syringes.
Danish: Polyethylenterephthalat-flakse indeholdende 10, 32, 100, 2 x 100 eller 200 ml med to polyethylen/polypropylen-målesprøjter.
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injection
Danish: Natriumhydroxid (til pH-justering) Saltsyre (til pH-justering) Vand til injektionsvæsker
English: There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range in dogs.
Danish: Der er en lineær relation mellem den indgivne dosis og den plasmakoncentration der observeres i det terapeutiske doseringsområde hos hunde.
English: In very rare cases loss of appetite, lethargy, abdominal pain and colitis have been reported.
Danish: I meget sjældne tilfælde er der indberettet tab af appetit, letargi, mavesmerter og colitis.
English: The suspension can be given using either of the two measuring syringes provided in the package.
Danish: Opløsningen kan gives ved brug af en af de to målesprøjter der findes i pakken.
English: The 1 ml measuring polyethylene/polypropylene syringe has a kg-body weight scale for cats (0.5 to 10 kg).
Danish: 1 ml polyethylen/polypropylen doseringssprøjten ser forsynet med en kg - legemsvægt skala for katte (0,5-10 kg).
English: After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmaxvalues of 2.1 μg/ml and 2.7 μg/ml were reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively.
Danish: Efter en enkelt subkutan dosis på 0,5 mg meloxicam/kg opnåedes Cmax værdier på 2,1 µg/ml efter 7,7 timer og 2,7 µg/ml efter 4 timer hos henholdsvis ungkvæg og lakterende køer.
English: Active substance: Meloxicam
Danish: Aktivt stof: Meloxicam
English: Bovine, caprine
Danish: Bovin, kaprin
English: Acute musculo-skeletal disorders:
Danish: Akutte muskulo-skeletale lidelser:
English: Horses: Single intravenous injection.
Danish: Heste: En enkelt intravenøs injektion.