FrancophonIA/ELRC3.0 huggingface dataset:
English: Infections caused by fungi of the Fusarium family that have not improved during treatment with amphotericin B or when amphotericin B has had to be stopped; Infections caused by fungi that cause the conditions known as chromoblastomycosis and mycetoma that have not improved during treatment with itraconazole or when itraconazole has had to be stopped;
Danish: Infektioner fremkaldt af svampe som medfører en tilstand der kaldes chromoblastomykose og/eller mycetoma, hvis infektionen ikke er behandlet tilstrækkelig med itraconazol eller hvis De har måtte stoppe behandlingen med dette middel;
English: You should use effective contraception while you are taking Posaconazole SP if you are a woman who could become pregnant.
Danish: Hvis De er kvinde, som kunne blive gravid, bør De anvende sikker prævention, mens De tager Posaconazole SP.
English: Inflammation or failure of the liver, rarely leading to death Enlargement of both the liver and spleen, liver tenderness Blistering rash, large purple discolourations on the skin caused by bleeding underneath the skin Inflammation of the kidneys
Danish: Blæredannende udslæt, store blålige misfarvninger af huden forårsaget af blødning under huden Betændelse af nyrerne
English: rash mouth ulceration, alopecia Stevens Johnson syndrome, vesicular rash
Danish: Stevens Johnson syndrom, vesikulært udslæt
English: Multiple, time-matched ECGs collected over a 12 hour period were obtained before and during administration of posaconazole (400 mg twice daily with high fat meals) from 173 healthy male and female volunteers aged 18 to 85 years.
Danish: Fra 173 raske forsøgspersoner, mænd og kvinder mellem 18 og 85 år, blev der før og efter indgift af posaconazol (400 mg to gange dagligt med et fedtrigt måltid) indsamlet flere tidsmæssigt sammenlignelige EKG'er over en 12 timers periode.
English: Coccidioidomycosis: 11 of 16 patients were successfully treated (at the end of treatment complete or partial resolution of signs and symptoms present at baseline) with posaconazole 800 mg/day in divided doses for a median of 296 days and up to 460 days.
Danish: Coccidioidomykose: 11 ud af 16 patienter var tilfredsstillende behandlet (efter endt behandling fuldstændig eller delvis bedring af alle tegn og symptomer på infektion, der var til stede ved
English: The use of combination antifungal therapies should not decrease the efficacy of either posaconazole or the other therapies; however, there is currently no clinical evidence that combination therapy will provide an added benefit.
Danish: Kombinationsbehandling med antimykotika skulle ikke nedsætte effekten af hverken posaconazol eller de andre lægemidler.
English: Concomitant use of posaconazole and rifabutin and similar inducers (e.g. rifampicin) should be avoided unless the benefit to the patient outweighs the risk.
Danish: Samtidig administration af posaconazol og rifabutin og lignende induktorer (f.eks. rifampicin) bør undgås,
English: Before you take Posaconazole SP 3.
Danish: Det skal De vide, før De begynder at tage Posaconazole SP Sådan skal De tage Posaconazole SP 4.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE (Bottle label)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE
English: Calcium channel blockers metabolised through CYP3A4 (e.g. diltiazem, verapamil, nifedipine, nisoldipine): Frequent monitoring for adverse events and toxicity related to calcium channel blockers is recommended during co-administration with posaconazole.
Danish: Calciumantagonister metaboliseret via CYP3A4 (f.eks. diltiazem, verapamil, nifedipin, nisoldipin):
English: hepatosplenomegaly, liver tenderness, asterixis
Danish: carbamazepin, fenobarbital, primidon.
English: Metabolism and nutrition disorders
Danish: Stofskiftesygdomme og ernæringsbetingede sygdomme Almindelig:
English: Cardiac disorders Uncommon:
Danish: Karsygdomme Usædvanlig:
English: BEFORE YOU TAKE POSACONAZOLE SP
Danish: DET SKAL DE VIDE, FØR DE BEGYNDER AT TAGE POSACONAZOLE SP
English: The active substance in Posaconazole SP oral suspension is posaconazole.
Danish: Aktivt stof: posaconazol.
English: (See Annex I: Summary of Product Characteristics, 4.2)
Danish: Oversigt over indlægssedlen: Virkning og anvendelse 2.
English: Eye disorders Uncommon: Rare:
Danish: Øjensygdomme Usædvanlig:
English: Wash hands after use.
Danish: Vask hænderne efter håndtering.
English: The inter-individual variation in kinetics may be large, up to 70 CV% for AUC.
Danish: Den individuelle variation i kinetikken kan være stor, op til 70 CV % for AUC.
English: ATCvet code: QA04AD90.
Danish: ATCvet-kode: QA04AD90
English: Dog body weight (kg)
Danish: Hundens vægt (kg)
English: No data have been presented on overdoses in adult cats.
Danish: Der er ikke blevet præsenteret data for overdoseringer hos voksne katte.
English: * Correct dose for dogs of less than 3 kg cannot be accurately achieved.
Danish: * Til hunde under 3 kg kan præcis dosering ikke opnås.
English: Prolonged fasting before administration should be avoided.
Danish: Lang faste inden administrationen bør undgås.
English: Vall de Bianya 17813 (Girona) SPAIN
Danish: Vall de Bianya 17813 (Girona) SPANIEN
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products in the same syringe.
Danish: Da der ikke er foretaget forligelighedsstudier, må dette veterinære lægemiddel ikke blandes med andre veterinære lægemidler i samme sprøjte.
English: Manufacturer responsible for batch release: FAREVA AMBOISE Zone Industrielle,
Danish: Fremstiller ansvarlig for batchfrigivelse: FAREVA AMBOISE Zone Industrielle,
English: In cats, moderate to severe response to injection is very commonly observed (in approximately one third of cats).
Danish: Det er meget almindeligt at der hos katte observeres moderat til alvorligt respons over for injektion (hos cirka en tredjedel af kattene).
English: Pharmacotherapeutic group: Antiemetics.
Danish: Farmakoterapeutisk gruppe: Antiemetica.
English: A clear, colourless to light yellow solution.
Danish: En klar, farveløs til svagt gul opløsning.
English: These signs are temporary and should resolve when the journey ends.
Danish: Disse symptomer er forbigående og ophører, når transporten er slut.
English: For the major metabolite 10.4% of the maropitant dose was recovered in urine and 9.3% in faeces.
Danish: For den største metabolit blev 10,4 % af maropitant genfundet i urinen og 9,3 % i fæces.
English: Cerenia Tablets:
Danish: Cerenia tabletter:
English: Date of first authorisation: 29/09/2006.
Danish: Dato for første markedsføringstilladelse: 29/09/2006 Dato for seneste fornyelse af markedsføringstilladelse: 29/09/2011
English: The elimination halflife at 8 mg/kg was 5.47 hours.
Danish: Eliminationshalveringstiden efter 8 mg/kg var 5,47 timer.
English: With the extended use of Cerenia tablets in dogs from 5 to 14 consecutive days, the periodic safety update report (PSUR) cycle for Cerenia has been reset and the data lock point for the next PSUR is 30 June 2014 for submission of 6 monthly reports (covering all authorised presentations of the product) for the next two years, followed by yearly reports for the subsequent two years and thereafter at 3 yearly intervals.
Danish: Efter udvidet anvendelse af Cerenia-tabletter til hunde fra 5 til 14 sammenhængende dage er den periodiske opdaterede sikkerhedsindberetninger (PSUR) cyklus blevet nulstillet og ”data lock point” (DLP) for den næste PSUR vil være 30. juni 2014 for indsendelse af 6 månedlige rapporter (der dækker alle godkendte pakningsstørrelser af produktet) for de næste to år, efterfulgt af årlige rapporter for de næste 2 år og derefter på 3 års mellemrum.
English: Use only according to the benefit-risk assessment by the responsible veterinarian.
Danish: Bruges kun efter risikovurdering af den ansvarlige dyrlæge.
English: EXP {month/year} Once broached, use within 28 days.
Danish: EXP {måneder/år} Efter anbrud anvendes inden 28 dage.
English: Pale orange tablet
Danish: Lys orange tablet.
English: People with known hypersensitivity to maropitant should administer the veterinary medicinal product with caution.
Danish: Personer med kendt overfølsomhed over for maropitant bør administrere veterinærlægemidlet med forsigtighed.
English: Sulphobutyl ether β-cyclodextrin (SBECD) Metacresol
Danish: Sulfobutylether β-cyklodekstrin (SBECD) Metakresol
English: In case treatment for a longer period than 5 days is regarded as necessary, careful monitoring of potential adverse events should be implemented.
Danish: Hvis det vurderes, at det er nødvendigt at behandle i mere en 5 dage, bør der iværksættes omhyggelig monitorering af potentielle bivirkninger.
English: In very rare cases, anaphylactic type reactions (allergic oedema, urticaria, erythema, collapse, dyspnoea, pale mucous membranes) may occur.
Danish: I meget sjældne tilfælde kan anafylaktiske reaktioner (allergisk ødem, urticaria, erytem, kollaps, dyspnø, blege slimhinder) forekomme.
English: Estimates for the oral bioavailability of maropitant were 23.7% at 2 mg/kg and 37.0% at 8 mg/kg.
Danish: Beregninger af den orale biotilgængelighed af maropitant var 23,7 % efter 2 mg/kg og 37,0 % efter 8 mg/kg.
English: Shelf life of half tablets: 2 days.
Danish: Opbevaringstid efter halvering af tabletter: 2 dage.
English: Intravenous administration of Cerenia should be given as a single bolus without mixing the product with any other fluids.
Danish: Ved intravenøs anvendelse Cerenia bør gives som en enkelt bolus uden at blande produktet med andre væsker.
English: • Holding one side of the cut firmly, pull the other side towards the centre of the blister until the tablet is visible.
Danish: • Mens der holdes fast på den ene side ved snittet, trækkes den anden side mod midten af blisterpakningen til tabletten kan ses.
English: Vomiting is a complex process coordinated centrally by the emetic centre.
Danish: Opkastning er en kompleks proces centralt styret af brækningscentret.
English: Although Cerenia has been demonstrated to be effective in both the treatment and prevention of emesis induced by chemotherapy, it was found more efficacious if used preventively.
Danish: Selvom det er påvist at Cerenia er effektiv både til behandling og forebyggelse mod opkastning fremkaldt af kemoterapi, blev det fundet mest effektivt, når det blev brugt forebyggende.
English: Due to the frequent occurrence of transient pain during subcutaneous injection, appropriate animal restraining measures may have to be applied.
Danish: På grund af den hyppige forekomst af forbigående smerte under subkutan injektion, skal dyret eventuelt fastholdes på en passende måde.
English: Dogs should be carefully observed following administration to ensure that each tablet is swallowed.
Danish: Hunden bør observeres omhyggeligt efter indgivelsen for at sikre, at hver tablet er slugt.
English: Substance P is found in significant concentrations in the nuclei comprising the emetic centre and is considered the key neurotransmitter involved in vomiting.
Danish: Substans P findes i signifikante koncentrationer i nuclei der indbefatter brækningscentret og betragtes som den væsentligste neurotransmitter i brækningsprocessen.
English: Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Sunset Yellow (E110) as a colorant
Danish: Croskarmellose natrium Lactose monohydrat Magnesiumstearat Mikrokrystallinsk cellulose Sunset Yellow (E110) som farve
English: • For the prevention of perioperative nausea and vomiting and improvement in recovery from general anaesthesia after use of the μ-opiate receptor agonist morphine.
Danish: • Til forebyggelse af perioperativ kvalme og opkastning samt forbedring af rekonvalescens efter universel anæstesi efter anvendelse af µ-opiatreceptoragonisten morphin.
English: EU/2/06/062/001 (16 mg tablets) EU/2/06/062/002 (24 mg tablets) EU/2/06/062/003 (60 mg tablets) EU/2/06/062/004 (160 mg tablets)
Danish: EU/2/06/062/001 (16 mg tabletter) EU/2/06/062/002 (24 mg tabletter) EU/2/06/062/003 (60 mg tabletter) EU/2/06/062/004 (160 mg tabletter)
English: Vomiting can be associated with serious, severely debilitating conditions and the cause should be investigated.
Danish: Opkastninger kan skyldes alvorlige, stærkt svækkende lidelser og årsagen skal undersøges.
English: In laboratory studies, maropitant has been shown to be a potential eye irritant.
Danish: I laboratorieundersøgelser har maropitant vist sig at være et muligt øjenirriterende stof.
English: During clinical studies maropitant plasma levels conferred efficacy from 1 hour after administration.
Danish: I kliniske studier viste maropitant plasmaniveauerne effekt fra 1 time efter administrationen.
English: Maropitant (as maropitant citrate monohydrate)
Danish: Maropitant (som maropitant citrat monohydrat)
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label of the vial after EXP.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på hætteglassets etiket efter EXP.
English: The elimination t1/2 following intravenous dosing was approximately 5.8 h.
Danish: Elimination t1/2 efter intravenøs dosis var på omkring 5,8 timer.
English: Administering Cerenia on a completely empty stomach may cause your dog to vomit.
Danish: Hvis hunden får Cerenia på en fuldstændig tom mave, kan det fremkalde opkastning hos hunden.
English: Maropitant displays non-linear pharmacokinetics (AUC increases more than proportionally with increasing dose) when administered orally within the 1-16 mg/kg dose range.
Danish: Maropitant viser non-lineær farmakokinetik (AUC forøges mere end proportionalt med stigende dosis) efter oral indgift i intervallet 1-16 mg/kg.
English: The safety of maropitant during treatment beyond 5 days has not been explored in the target population (i.e. young dogs suffering from viral enteritis).
Danish: Maropitants sikkerhed ved behandling af målpopulationen (dvs. unge hunde der lider af viral enterititis) i mere end 5 dage er ikke undersøgt.
English: At a dose of 8 mg/kg, Cmax of 776 ng/ml was reached at 1.7 hours post-dosing.
Danish: Ved en dosis på 8 mg/kg, blev Cmax på 776 ng/ml nået 1,7 timer efter dosering.
English: Note: No attempt should be made to remove the tablet by pushing it through the blister backing as this will damage both the tablet and blister.
Danish: OBS: Man bør ikke forsøge at trykke tabletten gennem bagsiden af blister pakningen, da dette både vil beskadige tabletten og blisterpakningen.
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Danish: BILAG II A. FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG C. ANGIVELSE AF MRL-VÆRDIER D. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: An unused half tablet should be returned to the opened blister and kept within the cardboard outer.
Danish: Ubrugte halve tabletter lægges tilbage i den åbnede blister og opbevares i æsken.
English: The anti-emetic efficacy of maropitant against central and peripheral emetics was demonstrated in experimental studies including apomorphine, cisplatin and syrup of ipecac (dogs) and xylazine (cats).
Danish: Den antiemetiske effekt af maropitant mod centrale og perifere emetika blev vist i eksperimentelle studier inklusive apomorfin, cisplatin og syrupus ipecacuana (hunde) og xylazin (katte).
English: Maropitant undergoes cytochrome P450 (CYP) metabolism in the liver.
Danish: Maropitant metaboliseres via cytokrom P450 (CYP) i leveren.
English: Each tablet contains 0.075% w/w Sunset Yellow (E110) as a colorant.
Danish: Hver tablet indeholder 0,075 % w/w Sunset Yellow (E110) farvestof.
English: Cerenia tablets have been shown to be effective in the treatment of emesis, however where the frequency of vomiting is high, orally administered Cerenia may not be absorbed before the next vomiting event occurs.
Danish: Cerenia-tabletter er vist effektive til behandling af opkastning, men når frekvensen af opkastningerne er høj, bliver oralt administreret Cerenia muligvis ikke optaget inden næste opkastning.
English: Therefore, it is recommended to administer the antiemetic prior to administration of the chemotherapeutic agent.
Danish: Derfor anbefales det at dosere det antiemetiske præparat inden doseringen af det kemoterapeutiske stof.
English: Maropitant is non-sedative and should not be used as a sedative in motion sickness.
Danish: Maropitant er ikke sederende og bør ikke bruges som sedativum mod transportsyge.
English: This centre consists of several brainstem nuclei (area postrema, nucleus tractus solitarius, dorsal motor nucleus of the vagus) that receive and integrate sensory stimuli from central and peripheral sources and chemical stimuli from the circulation and the cerebro-spinal fluid.
Danish: Dette center består af flere hjernestammer (area postrema, nucleus tractus solitarius, N. vagus dorsale motoriske kerne), som modtager og integrerer sensoriske stimuli fra centrale og perifere veje og kemiske stimuli fra kredsløbet og cerebrospinalvæsken.
English: Use only according to the benefit-risk assessment by the responsible veterinarian, because conclusive reproductive toxicity studies have not been conducted in any animal species.
Danish: Må kun bruges efter risikovurdering af den ansvarlige dyrlæge, da der for ingen dyrearters vedkommende er gennemført konklusive reproduktionstoksikologiske undersøgelser.
English: Each cardboard box contains 1 vial.
Danish: Hver æske indeholder 1 hætteglas.
English: Half-tablets should be stored for a maximum of two days after removal from the blister.
Danish: Halve tabletter bør højst opbevares i 2 dage efter de er trykket ud af blisterpakken.
English: Tablets should be administered at least one hour before starting the journey.
Danish: Tabletterne bør gives mindst én time før rejsens påbegyndelse.
English: Cerenia solution for injection may be administered for up to five days and Cerenia tablets for up to fourteen days.
Danish: Cerenia injektionsvæske, opløsning kan gives i op til 5 dage og Cerenia tabletter i op til 14 dage.
English: One ml of solution contains:
Danish: 1 ml af injektionsvæske indeholder:
English: Interaction with other medicinal products and other forms of interaction: Cerenia should not be used concomitantly with Ca-channel antagonists as maropitant has affinity to Ca-channels.
Danish: Interaktion med andre lægemidler og andre former for interaktion: Cerenia bør ikke bruges samtidig med Ca-kanal antagonister, da maropitant har affinitet til Cakanaler.
English: Treatment may be repeated for a maximum of two consecutive days.
Danish: Behandling kan gentages i højst 2 på hinanden følgende dage.
English: Plasma protein binding of maropitant in cats was estimated to be 99.1%.
Danish: Plasma proteinbindingen af maropitant hos katte skønnes til at være 99,1 %.
English: A variety of in vitro assays have demonstrated that maropitant binds selectively at the NK1 receptor with dose-dependent functional antagonism of substance P activity.
Danish: En række forskellige in vitro tests har vist, at maropitant binder sig selektivt til NK1-receptoren med dosisafhængig funktionel antagonisme af aktiviteten af substans P.
English: Cerenia tablets are supplied in blister packs with four tablets per pack.
Danish: Cerenia tabletter findes i blisterpakninger med 4 tabletter i hver pakke.
English: Metacresol (as preservative)
Danish: Metakresol (som konserveringsmiddel)
English: By inhibiting the binding of substance P within the emetic centre, maropitant is effective against neural and humoral (central and peripheral) causes of vomiting.
Danish: Ved at hæmme substans P i brækningscentret er maropitant effektivt mod neurogene og humorale (centrale og perifere) årsager til brækning.
English: The bioavailability of maropitant after subcutaneous administration in cats was 91.3%.
Danish: Biotilgængelighed af maropitant efter subkutan administration til katte var 91,3 %.
English: Maropitant is highly bound to plasma proteins and may compete with other highly bound drugs.
Danish: Maropitant er stærkt bundet til plasmaproteiner og kan konkurrere med andre stærkt bundne stoffer.
English: Pain at injection site may occur when injected subcutaneously.
Danish: Smerte på injektionsstedet kan forekomme under subkutan injektion.
English: As the pharmacokinetic variation is large and maropitant accumulates in the body after once daily repeated administration, lower doses than recommended might be sufficient in some individuals and when repeating the dose.
Danish: Da den farmakokinetiske variation er stor og maropitant akkumuleres i kroppen efter en gentagelse af en daglig dosis, kan lavere dosis end den anbefalede være tilstrækkelig hos nogle hunde, når dosis skal gentages.
English: CYP2D15 and CYP3A12 were identified as the canine isoforms involved in the hepatic biotransformation of maropitant.
Danish: CYP2D15 og CYP3A12 blev identificeret som hundens isoformer, der indgår i leverens omdannelse af maropitant.
English: Products such as Cerenia should be used in conjunction with other supportive measures such as dietary control and fluid replacement therapy, as recommended by your veterinary surgeon.
Danish: Lægemidler som Cerenia bør bruges sammen med andre forholdsregler som kontrol med foderet og væsketerapi, som anbefalet af din dyrlæge.
English: In some individual dogs and when repeating the treatment, lower doses than recommended might be sufficient.
Danish: Ved gentagen behandling kan lavere dosis end den anbefalede være tilstrækkeligt hos nogle hunde.
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Danish: Kontakt din dyrlæge eller apotekspersonalet vedrørende bortskaffelse af lægemidler, der ikke længere findes anvendelse for.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER / Tablets
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister/tabletter
English: Cerenia should be used with caution in animals suffering from or with predisposition for heart diseases.
Danish: Cerenia bør bruges med forsigtighed til dyr, der lider af, eller er prædisponerede for hjertelidelser
English: The volume of distribution at steady-state (Vss) determined after intravenous administration at 1-2 mg/kg ranged from approximately 4.4 to 7.0 l/kg.
Danish: Steady-state fordelingsvolumen (Vss) bestemt efter intravenøs administration af 1-2 mg/kg lå fra omkring 4,4 til 7,0 l/kg.
English: For subcutaneous or intravenous use in dogs and cats.
Danish: Til subkutan eller intravenøs injektion hos hunde og katte.
English: Cerenia tablets are available in 16 mg, 24 mg, 60 mg and 160 mg strength.
Danish: Cerenia tabletter findes i 16 mg, 24 mg, 60 mg og 160 mg.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: TEKSTEN “KUN TIL DYR”SAMT BETINGELSER ELLER BEGRÆNSNINGER FOR UDLEVERING OG BRUG, OM NØDVENDIGT
English: 29 route des Industries 37530 Pocé-sur-Cisse FRANCE
Danish: 29 route des Industries 37530 Pocé-sur-Cisse FRANKRIG
English: Plasma protein binding of maropitant in dogs is more than 99%.
Danish: Plasma proteinbindingen af maropitant hos hunde er højere end 99 %.
English: Cardboard box containing one aluminium-aluminium blister pack, each containing four tablets per pack.
Danish: Papæske indeholdende en aluminium-aluminium blister pakning med fire tabletter i hver pakke.
English: To prevent vomiting, tablets should be given more than 1 hour in advance.
Danish: For at forebygge opkastning bør tabletterne gives mere end 1 time på forhånd.
English: Vomiting can be associated with serious, severely debilitating conditions including gastrointestinal obstructions; therefore, appropriate diagnostic evaluations should be employed.
Danish: Opkastninger kan skyldes alvorlige, stærkt svækkende lidelser inklusive blokeringer i mavetarmkanalen, hvorfor en passende diagnostisk undersøgelse skal foretages.
English: Prevention of motion sickness
Danish: Forebyggelse af transportsyge
English: Giving your dog a light meal or snack before administering the tablet could help preventing this effect.
Danish: Hvis hunden får et let måltid eller en godbid inden dosering har det vist sig at hjælpe til at begrænse denne virkning.