FrancophonIA/ELRC3.0 huggingface dataset:
English: The efficacy of Cerenia in reduction of nausea was demonstrated in studies using a model (xylazineinduced nausea).
Danish: Cerenias reducerende virkning på kvalme blev vist i studier, hvor der blev anvendt en model (kvalme forårsaget af xylazin).
English: Cerenia is not a sedative and some motion sick dogs may show nausea-like signs during travel such as salivation and lethargy.
Danish: Cerenia er ikke et beroligende middel og nogle hunde, som lider af transportsyge, kan vise tegn på kvalme under rejsen i form af savlen og døsighed.
English: Shelf life after first opening the immediate packaging: 28 days.
Danish: Opbevaringstid efter åbning af den indre emballage: 28 dage.
English: The anti-emetic effect persists for at least 12 hours, which for convenience may allow administration the night before early morning travel.
Danish: Den antiemetiske effekt varer i mindst 12 timer, hvilket muliggør administration aftenen før en tidlig afrejse.
English: • Firstly, fold or cut along the perforation between each tablet as shown by the scissor symbol 
Danish: • Fold eller skær først langs den stiplede linie mellem hver tablet angivet ved saksesymbolet 
English: As maropitant is accumulated in the body during a 14-day treatment period due to metabolic saturation, careful monitoring of liver function should be implemented during long term treatment.
Danish: Da maropitant akkumuleres i kroppen under en 14-dages behandlingsperiode på grund af en metabolisk mætning, bør der ved langtidsbehandling iværksættes omhyggelig overvågning af leverfunktionen og bivirkninger.
English: Apart from transient reactions at the injection site following subcutaneous administration, Cerenia solution for injection was well tolerated in dogs and young cats injected daily with up to 5 mg/kg (5 times the recommended dose) for 15 consecutive days (3-times the recommended duration of administration).
Danish: Bortset fra forbigående reaktioner ved injektionsstedet under subkutan injektion, var Cerenia veltålt af hunde og unge katte, der fik daglige injektioner med Cerenia injektionsvæske, opløsning op til 5 mg/kg (5 gange den anbefalede dosis) i 15 på hinanden følgende dage (3 gange den anbefalede doseringsvarighed).
English: Signs of nausea in dogs including excessive salivation and lethargy might remain after treatment.
Danish: Symptomer på kvalme hos hunde inklusive kraftig savlen og sløvhed kan fortsætte efter behandling.
English: CYP1A and CYP3A-related enzymes were identified as the feline isoforms involved in the hepatic biotransformation of maropitant.
Danish: CYP1A og CYP3A-relaterede enzymer blev identificeret som kattens isoformer, der indgår i leverens omdannelse af maropitant.
English: The tablets have a score line allowing the tablet to be halved, with the letters “MPT” and figures denoting the quantity of maropitant on one side, the reverse side is blank.
Danish: Hver tablet er mærket med bogstaverne ”MPT” og tal, der angiver mængden af maropitant på den ene side og glat på den anden side.
English: EXP {month/year} Once broached, use by:………..
Danish: EXP {måneder/år} Efter anbrud anvendes inden
English: Amber molded glass type 1 vial, 20 ml, chlorobutyl rubber stopper and aluminium overseal with flip-off button.
Danish: Ravfarvet glashætteglas type 1, 20 ml, chlorobutyl gummiprop og aluminiumhætte med afrivningsflap.
English: In dogs, Cerenia solution for injection can be used to treat or prevent vomiting once daily for up to 5 days.
Danish: Hos hunde kan Cerenia bruges til at behandle eller forebygge opkastning en gang daglig i op til 5 dage.
English: PACKAGE LEAFLET: Cerenia tablets for dogs
Danish: INDLÆGSSEDDEL Cerenia tabletter til hunde
English: Following a single intravenous dose at 1 mg/kg the initial plasma concentration was 363 ng/ml.
Danish: Efter en enkelt intravenøs dosis på 1 mg/kg, den oprindelige plasmakoncentration var 363 ng/ml.
English: Increases of approximately 10% in the QT interval of the ECG were observed in a study on healthy beagle dogs administered 8 mg/kg orally; however, such an increase is unlikely to be of clinical significance.
Danish: En stigning på omkring 10 % i QT-intervallet ved EKG blev observeret i et studie med sunde beagler efter oral administration af 8 mg/kg.
English: The bioavailability of maropitant after subcutaneous administration in dogs was 90.7%.
Danish: Den subkutane biotilgængelighed af maropitant til hunde var 90,7 %.
English: The use of Cerenia solution for injection against vomiting due to motion sickness is not recommended.
Danish: Brug af Cerenia-injektionsvæske, opløsning mod opkastning forårsaget af køresyge anbefales ikke.
English: DATE ON WHICH PACKAGE LEAFLET WAS LAST APPROVED
Danish: DATO FOR SENESTE GODKENDELSE AF INDLÆGSSEDLEN
English: 5.2 Pharmacokinetic particulars Dogs
Danish: 5.2 Farmakokinetiske oplysninger Hunde:
English: Shelf life after first opening the vial: 28 days.
Danish: Opbevaringstid efter åbning af hætteglasset: 28 dage.
English: • For the prevention and treatment of vomiting, in conjunction with Cerenia solution for injection and in combination with other supportive measures.
Danish: • Til forebyggelse og behandling af opkastning i forbindelse med behandling med Cerenia injektionsvæske, opløsning og i kombination med anden støttebehandling.
English: Following a single intravenous dose at 1 mg/kg the initial plasma concentration was 1040 ng/ml.
Danish: Efter en enkelt intravenøs dosis på 1 mg/kg, den oprindelige plasmakoncentration var 1040 ng/ml.
English: Cerenia should be used with caution in animals suffering from or with predisposition for cardiac diseases as maropitant has affinity to Ca- and K-ion channels.
Danish: Cerenia bør bruges med forsigtighed til dyr, der lider af, eller er prædisponerede for hjertelidelser, da maropitant har affinitet til Ca- og K-ion-kanalerne.
English: In the case of accidental eye exposure, flush the eyes with plenty of water and seek medical attention.
Danish: I tilfælde af at stoffet ved et uheld kommer i øjet, skyl øjet med masser af vand og der søges læge.
English: Cerenia tablets were well tolerated when administered for 15 days at dosages up to 10 mg/kg bodyweight per day.
Danish: Cerenia tabletter givet daglig i 15 dage i doser op til 10 mg/kg legemsvægt per dag tåltes godt.
English: The tablets also contain Sunset Yellow (E110) as a colorant.
Danish: Tabletterne indeholder også Sunset Yellow (E110) som farvestof.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Danish: ANGIVELSE AF DET AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER
English: FAREVA AMBOISE Zone Industrielle, 29 route des Industries 37530 Pocé-sur-Cisse FRANCE
Danish: FAREVA AMBOISE Zone Industrielle, 29 route des Industries 37530 Pocé-sur-Cisse FRANKRIG
English: The volume of distribution at steady-state (Vss) was 9.3 l/kg and systemic clearance was 1.5 l/h/kg.
Danish: Steady-state fordelingsvolumen (Vss) var 9,3 l/kg og systemisk clearance var 1,5 l/time/kg.
English: Following repeated oral administration for two consecutive days at a daily dose of 8 mg/kg, accumulation was 218%.
Danish: Efter oral administration gentaget i to på hinanden følgende dage med en daglig dosis på 8 mg/kg var akkumulationen 218 %.
English: It also contains metacresol (as preservative).
Danish: Den indeholder også metakresol som konserveringsmiddel.
English: Good veterinary practice indicates that antiemetics should be used in conjunction with other veterinary and supportive measures, such as dietary control and fluid replacement therapy while addressing the underlying causes of the vomiting.
Danish: God veterinær praksis foreskriver, at antiemetika bør bruges sammen med andre veterinære og støttende forholdsregler, som kontrolleret fodring og væsketerapi rettet mod den specifikke årsag til opkastningerne.
English: Cerenia Solution for Injection: FAREVA AMBOISE Zone Industrielle, 29 route des Industries 37530 Pocé-sur-Cisse FRANCE
Danish: Cerenia injektionsvæske: FAREVA AMBOISE Zone Industrielle, 29 route des Industries 37530 Pocé-sur-Cisse FRANKRIG
English: Cerenia tablets should not be administered wrapped or encapsulated in food as this may delay dissolution of the tablet and consequently the onset of the effect.
Danish: Cerenia-tabletter bør ikke gives ”indpakket” i foder, da dette kan forsinke opløsningen af tabletten og dermed tablettens virkning.
English: Cerenia should not be used concomitantly with Ca-channel antagonists as maropitant has affinity to Ca-channels.
Danish: Cerenia bør ikke bruges samtidigt med potente Ca-antagonister, da maropitant har affinitet til Ca-ion-kanalerne.
English: The responsible veterinarian should make a benefit-risk assessment before using Cerenia in dogs under 8 or 16 weeks of age, respectively, or in pregnant or lactating bitches.
Danish: Den ansvarlige dyrlæge bør foretage en risikovurdering før brug af Cerenia til hunde under 8 respektive 16 uger eller til drægtige eller diegivende tæver.
English: • For the treatment and prevention of nausea induced by chemotherapy.
Danish: • Til behandling og forebyggelse af kvalme forårsaget af kemoterapi.
English: − rare (more than 1 but less than 10 animals in 10,000 animals treated)
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) - Almindelige (flere end 1, men færre end 10 dyr af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr 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: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box / Tablets
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske af karton/Tabletter
English: Peak concentrations were followed by a decline in systemic exposure with an apparent elimination half-life (t0.5) of 4.03 hours.
Danish: Peak-koncentrationerne blev fulgt af et fald i systemisk eksponering med en omtrentlig eliminationshalveringstid (t ½,) på 4,03 timer.
English: The duration of the effect is approximately 24 hours and, therefore, tablets can be given the night before administration of an agent that may cause emesis (e.g. chemotherapy).
Danish: Virkningen varer ca. 24 timer, og derfor kan tabletterne gives aftenen før administrationen af et stof, der kan forårsage opkastning (f.eks. kemoterapi).
English: Injecting the product at refrigerated temperature may reduce pain at injection.
Danish: Smerte ved injektion kan reduceres ved at produktet injiceres i kold tilstand.
English: Signs of nausea including excessive salivation and lethargy might remain during treatment.
Danish: Tegn på kvalme i forbindelse med transportsyge inklusive forøget spytsekretion og sløvhed kan vedblive under behandlingen.
English: Tablets are breakable along the score line on the tablet.
Danish: Tabletter kan deles via delekærven på tabletten.
English: Cerenia solution for injection should be injected subcutaneously or intravenously, once daily, at a dose of 1 mg/kg bodyweight (1 ml/10 kg bodyweight).
Danish: Cerenia injektionsvæske, opløsning skal injiceres subkutant eller intravenøst, en gang daglig med en dosis på 1 mg pr. kg legemsvægt (1 ml pr.10 kg legemsvægt).
English: It is recommended to initiate treatment of emesis with Cerenia solution for injection.
Danish: Det anbefales at starte behandling af opkastning med Cerenia injektionsvæske, opløsning.
English: • For the prevention of vomiting and the reduction of nausea, except that induced by motion sickness.
Danish: • Til forebyggelse af opkastning og reduktion af kvalme, undtagen opkastning forårsaget af transportsyge.
English: Maropitant displays linear kinetics when administered subcutaneously within the 0.25-3 mg/kg dose range.
Danish: Maropitant viser lineær farmakokinetik efter subkutan administration inden for 0,25-3 mg/kg.
English: The solution for injection contains 10 mg maropitant per ml as maropitant citrate monohydrate as a clear, colourless to light yellow solution.
Danish: Injektionsvæsken indeholder 10 mg maropitant pr. ml som maropitant citrat monohydrat, som en klar, farveløs til svagt gul opløsning.
English: Renal clearance is a minor route of elimination, with less than 1% of a 1 mg/kg subcutaneous dose appearing in the urine as either maropitant or its major metabolite.
Danish: Renal clearance er en ubetydelig eliminationsvej med mindre end 1 % af en subkutan dosis på 1 mg/kg genfundet i urinen enten som maropitant eller dens største metabolit.
English: Each tablet contains 16 mg, 24 mg, 60 mg or 160 mg maropitant as maropitant citrate monohydrate.
Danish: Hver tablet indeholder 16 mg, 24 mg, 60 mg eller 160 mg maropitant som maropitant citrat monohydrat.
English: Cerenia solution for injection should be injected subcutaneously or intravenously, once daily, at a dose of 1 mg/kg bodyweight (1 ml/10 kg bodyweight) for up to 5 consecutive days.
Danish: Cerenia injektionsvæske, opløsning skal injiceres subkutant, en gang dagligt med en dosis på 1 mg/kg legemsvægt (1 ml/10 kg legemsvægt) i op til 5 på hinanden følgende dage.
English: • For the treatment of vomiting, in combination with other supportive measures.
Danish: • Til behandling af opkastning i kombination med anden støtteterapi.
English: Renal and faecal clearances are minor routes of elimination for maropitant, with less than 1% of a 1 mg/kg subcutaneous dose appearing in the urine or faeces as maropitant.
Danish: Renal og fækal clearance er en ubetydelig eliminationsvej for maropitant med mindre end 1 % af en subkutan dosis på 1 mg/kg genfundet i urinen eller fæces som maropitant.
English: In case of accidental self-injection seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: I tilfælde af selvindgivelse ved hændeligt uheld skal der straks søges læge, og indlægssedlen eller etiketten bør vises til lægen.
English: Cerenia 16 mg tablets for dogs Cerenia 24 mg tablets for dogs Cerenia 60 mg tablets for dogs Cerenia 160 mg tablets for dogs maropitant
Danish: Cerenia 16 mg tabletter til hunde Cerenia 24 mg tabletter til hunde Cerenia 60 mg tabletter til hunde Cerenia 160 mg tabletter til hunde maropitant
English: Cerenia 10 mg/ml solution for injection for dogs and cats is available in 20 ml amber glass vials.
Danish: Cerenia 10 mg/ml injektionsvæske, opløsning til hunde og katte findes i 20 ml ravfarvet hætteglas.
English: To prevent vomiting, Cerenia solution for injection should be administered more than 1 hour in advance.
Danish: For at forebygge opkastning bør Cerenia injektionsvæske, opløsning gives mere end 1 time på forhånd.
English: The elimination t1/2 following intravenous dosing was approximately 4.9 h. There appears to be an age-related effect on the pharmacokinetics of maropitant in cats with kittens having higher clearance than adults.
Danish: Det synes at være en alders-relateret virkning på farmakokinetikken af maropitant hos katte med killinger, der har en højere clearance end voksne.
English: Maropitant is metabolised in the liver and therefore should be used with caution in patients with hepatic disease.
Danish: Maropitant nedbrydes i leveren og skal derfor bruges med forsigtighed til patienter med leverlidelse.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Glass vial / Solution for injection
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Hætteglas/Injektionsvæske, opløsning
English: The volume of distribution at steady-state (Vss) was 2.3 l/kg and systemic clearance was 0.51 l/h/kg.
Danish: Steady-state fordelingsvolumen (Vss) var 2,3 l/kg og systemisk clearance var 0,5 l/time/kg.
English: Good veterinary practice indicates that antiemetics should be used in conjunction with other veterinary and supportive measures such as dietary control and fluid replacement therapy while addressing the underlying causes of the vomiting.
Danish: God veterinær praksis foreskriver, at antiemetika bør bruges sammen med anden veterinær og teknisk håndtering af dyr som kontrolleret fodring og væsketerapi rettet mod den specifikke årsag til opkastningerne.
English: Maropitant is a neurokinin 1 (NK1) receptor antagonist, which acts by inhibiting the binding of substance P, a neuropeptide of the tachykinin family.
Danish: Maropitant er en neurokinin 1 (NK1) receptor antagonist, som virker ved at hæmme bindingen af substans P, et neuropeptid af tachykinin familien.
English: Maropitant is metabolised in the liver and therefore should be used with caution in dogs with liver disease.
Danish: Maropitant metaboliseres i leveren og skal derfor bruges med forsigtighed til dyr med leverlidelse.
English: Peak concentrations were followed by a decline in systemic exposure with an apparent elimination half-life (t1/2) of 16.8 hours.
Danish: Peak-koncentrationerne blev fulgt af et fald i systemisk eksponering med en omtrentlig eliminationshalveringstid (t ½,) på 16,8 timer.
English: The effect duration is approximately 24 h and therefore treatment can be given the night before administration of an agent that may cause emesis e.g. chemotherapy.
Danish: Varigheden af effekten er omkring 24 timer og derfor kan behandlingen gives aftenen før behandling med et middel, der kan give opkastning, f.eks. kemoterapi.
English: • For the prevention of nausea induced by chemotherapy.
Danish: • Til forebyggelse af kvalme forårsaget af kemoterapi.
English: Maropitant displays linear kinetics when administered subcutaneously within the 0.5-2 mg/kg dose range.
Danish: Maropitant viser lineær farmakokinetik efter subkutan indgivelse af 0,5-2 mg/kg.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box / Solution for injection
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske af karton/Injektionsvæske, opløsning
English: Peak concentrations were followed by a decline in systemic exposure with an apparent elimination half-life (t1/2) of 8.84 hours.
Danish: Peak-koncentrationerne blev fulgt af et fald i systemisk eksponering med en omtrentlig eliminationshalveringstid (t ½,) på 8,84 timer.
English: Cerenia can be used to treat or prevent vomiting either as tablets or as solution for injection administered once daily.
Danish: Cerenia kan bruges til at behandle eller forebygge opkastning, enten som tabletter eller som injektionsvæske, opløsning givet én gang dagligt.
English: For motion sickness, a light meal or snack before dosing is recommended; prolonged fasting before administration should be avoided.
Danish: Mod transportsyge anbefales at give et let måltid eller en godbid før dosering.
English: Following repeated subcutaneous administration of once-daily doses of 1 mg/kg bodyweight for five consecutive days, accumulation was 146%.
Danish: Efter gentagen subkutan administration i daglige doser på 1 mg/kg legemsvægt i fem på hinanden følgende dage var akkumulationen 146 %.
English: 1 ml of solution contains 10 mg maropitant (as maropitant citrate monohydrate).
Danish: 1 ml af injektionsvæske indeholder 10 mg maropitant (som maropitantcitratmonohydrat).
English: The safety of Cerenia has not been established in dogs less than 8 weeks of age, or in cats less than 16 weeks of age, and in pregnant or lactating dogs and cats.
Danish: Sikkerheden af Cerenia er ikke undersøgt i hunde yngre end 8 uger eller hos katte yngre end 16 uger og hos drægtige eller diegivende hunde og katte.
English: For prevention of vomiting induced by motion sickness, (only for dogs 16 weeks of age or older)
Danish: Til forebyggelse af opkastning forårsaget af transportsyge (kun til hunde, der er 16 uger eller ældre).
English: Following repeated oral administration for five consecutive days at a daily dose of 2 mg/kg, accumulation was 151%.
Danish: Efter gentagen daglig oral administration i fem på hinanden følgende dage af 2 mg/kg var akkumulationen 151 %.
English: The safety of the veterinary medicinal product has not been established in dogs less than 16 weeks of age for the 8 mg/kg dose (motion sickness), and in dogs less than 8 weeks of age for the 2 mg/kg dose (vomiting) as well as in pregnant or lactating bitches.
Danish: Sikkerheden af det veterinærmedicinske lægemiddel er ikke undersøgt i hunde yngre end 16 uger for dosen 8 mg/kg (transportsyge), hos hunde yngre end 8 uger for dosen 2 mg/kg (opkastning) eller hos drægtige eller diegivende tæver.
English: In dogs, Cerenia can be used to treat or prevent vomiting either as tablets or as solution for injection administered once daily.
Danish: Hos hunde kan Cerenia bruges til at behandle eller forebygge opkastning, enten som tabletter eller som injektionsvæske, opløsning givet én gang dagligt.
English: Cerenia 16 mg tablets for dogs Cerenia 24 mg tablets for dogs Cerenia 60 mg tablets for dogs Cerenia 160 mg tablets for dogs
Danish: Cerenia 16 mg tabletter, til hunde Cerenia 24 mg tabletter, til hunde Cerenia 60 mg tabletter, til hunde Cerenia 160 mg tabletter, til hunde
English: For the prevention of nausea induced by chemotherapy and treatment and prevention of vomiting (except motion sickness), (only for dogs 8 weeks of age or older).
Danish: Til forebyggelse af kvalme forårsaget af kemoterapi og til behandling og forebyggelse af opkastning (undtagen transportsyge) (kun til hunde, der er 8 uger eller ældre).
English: Renal clearance is a minor route of elimination, with less than 1% of an 8 mg/kg oral dose appearing in the urine as either maropitant or its major metabolite.
Danish: Renal clearance er en ubetydelig eliminationsvej med mindre end 1 % genfundet i urinen enten som maropitant eller dens største metabolit efter en oral dosis på 8 mg/kg.
English: NAME OF MARKETING AUTHORISATION HOLDER
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
English: The responsible veterinarian should make a benefit-risk assessment before using Cerenia in dogs less than 8 weeks of age, or in cats less than 16 weeks of age, or in pregnant or lactating bitches and cats.
Danish: Den ansvarlige dyrlæge bør foretage en risikovurdering før brug af Cerenia til hunde under 8 uger, hos katte mindre end 16 uger eller til drægtige eller diegivende katte og hunde.
English: For prevention of nausea induced by chemotherapy and treatment and prevention of vomiting (except motion sickness), only for dogs 8 weeks of age or older
Danish: Til forebyggelse af kvalme forårsaget af kemoterapi og til behandling og forebyggelse af opkastning (undtagen transportsyge), kun til hunde, der er 8 uger eller ældre.
English: Following repeated subcutaneous administration of once-daily doses of 1 mg/kg bodyweight for five consecutive days, accumulation was 250%.
Danish: Efter gentagen subkutan administration i daglige doser på 1 mg/kg legemsvægt i fem på hinanden følgende dage var akkumulationen 250 %.
English: To prevent vomiting induced by motion sickness, Cerenia tablets should be administered once daily, at a dose of 8 mg maropitant per kg bodyweight, using the numbers of tablets given in the table below.
Danish: For at forebygge opkastning forårsaget af transportsyge gives Cerenia-tabletter en gang dagligt med en dosis på 8 mg maropitant pr. kg. legemsvægt med det antal tabletter, som er angivet i nedenstående tabel.
English: To remove a tablet from the blister the following sequence should be carried out;
Danish: Tabletterne udtages fra blisterpakningen på følgende måde:
English: The safety of the veterinary medicinal product has not been established in dogs less than 8 weeks of age, or in cats less than 16 weeks of age, and in pregnant or lactating dogs and cats.
Danish: Det veterinærmedicinske lægemiddels sikkerhed er ikke undersøgt hos hunde yngre end 8 uger, eller hos katte yngre end 16 uger, og hos drægtige og diegivende hunde og katte.
English: Maropitant is a potent and selective neurokinin (NK-1) receptor antagonist, which acts by inhibiting the binding of substance P, a neuropeptide of the tachykinin family, in the CNS.
Danish: Maropitant er en potent og selektiv neurokinin (NK-1) receptor-antagonist, som virker ved at hæmme bindingen af substans P, et neuropeptid af tachykinin gruppen, i centralnervesystemet.
English: • Find the pull-back notch (or cut) as shown by the arrow symbol .
Danish: • Find afrivningsslippen eller skær som vist ved pilesymbolet