FrancophonIA/ELRC3.0 huggingface dataset:
English: By 31 December 2014 MAHs were also required to improve quality of information on authorised medicines submitted to the EMA, bring their medicinal product entries up-to-date and submit additional information in line with the guidance and processes described in Chapter 3.II: Extended EudraVigilance product report message (XEVPRM) user guidance document.
Danish: Inden den 31. december 2014 skulle indehaverne af markedsføringstilladelserne desuden forbedre kvaliteten af de oplysninger om godkendte lægemidler, de havde indsendt til EMA, opdatere data om deres produkter og indsende supplerende oplysninger i overensstemmelse med den vejledning og de processer, der er beskrevet I Chapter 3.II: Extended EudraVigilance product report message (XEVPRM) user guidance.
English: For documents related to submission of authorised medicines data visit the Guidance document webpage.
Danish: For dokumenter vedrørende indsendelse af oplysninger om godkendte lægemidler henvises til websiden Guidance documents.
English: • calculating the Pharmacovigilance Fees payable by MAHs;
Danish: • beregning af de gebyrer for lægemiddelovervågning, der skal betales af indehaverne af markedsføringstilladelser;
English: For information related to submission of authorised medicines data visit the Data submission webpage.
Danish: For information om indsendelse af oplysninger om godkendte lægemidler henvises til websiden Data submission for authorised medicines.
English: MAHs are also obliged to maintain the submitted medicinal product information and notify the EMA of any newly authorised medicines or variations to the terms of the marketing authorisation using the XEVPRM format.
Danish: Indehaverne af markedsføringstilladelserne har desuden pligt til at opdatere de indsendte oplysninger om lægemidlerne og underrette EMA om alle lægemidler godkendt for nyligt eller ændringer i betingelserne for markedsføringstilladelsen i XEVPRM-format.
English: To ensure the quality of data submitted to the EudraVigilance database, at least one user from each organisation should receive training.
Danish: For at sikre kvaliteten af de oplysninger, der indsendes til EudraVigilance-databasen, skal mindst én bruger fra hver organisation gennemgå et kursus i eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD), der tilbydes som personligt kursus eller som e-læring.
English: You may need to read it again
Danish: De får muligvis behov for at læse den igen
English: % of treated dogs*
Danish: % af behandlede hunde*
English: Do not administer Yarvitan:
Danish: Giv ikke Yarvitan:
English: * : in line with the recommended treatment schedule
Danish: * : på linje med det anbefalede behandlingsskema
English: Mitratapide has no central effect.
Danish: Mitratapid har ingen central virkning.
English: • significant loss of appetite.
Danish: • væsentlig appetitløshed.
English: • This medicine has been prescribed for your dog only and you should not pass it on to others.
Danish: • Dette lægemiddel er kun ordineret til Deres hund, og De bør ikke give det videre til andre.
English: treatment no treatment treatment normal feeding nutrition programme nutrition programme
Danish: behandling ingen behandling behandling normal fodring ernæringsprogram ernæringsprogram
English: ADVICE ON CORRECT ADMINISTRATION
Danish: OPLYSNINGER OM KORREKT ADMINISTRATION
English: Thereafter, your dog should follow a nutrition programme.
Danish: Derefter bør Deres hund følge et ernæringsprogram.
English: In addition, hyperkalaemia was occasionally observed.
Danish: Derudover blev der af og til observeret hyperkaliæmi.
English: The most important metabolic transformation is sulphoxidation, which produces three active metabolites.
Danish: Den vigtigste metaboliske transformation er sulfoxidation, der frembringer tre aktive metaboliter.
English: Do not use after the expiry date stated on the label and carton (EXP.).
Danish: Må ikke anvendes efter udløbsdatoen angivet på etiketten og æsken (EXP.).
English: Your veterinary surgeon will advise you on the type of food your dog will need.
Danish: Deres dyrlæge vil rådgive Dem om, hvilken type foder, Deres hund vil have behov for.
English: Once the dog has eaten the complete portion, give the remaining amount of food to the dog.
Danish: Når først hunden har spist hele portionen, gives den resterende mængde af fodret til hunden.
English: (this is due to a malfunction of the adrenal gland).
Danish: (dette skyldes en fejlfunktion i binyrerne).
English: Interactions with other drug types were not specifically investigated.
Danish: Interaktioner med andre lægemiddeltyper blev ikke specifikt undersøgt.
English: Read all of this leaflet carefully before you start administering the medicine to your dog:
Danish: Læs hele denne indlægsseddel omhyggeligt, inden de begynder at give dette lægemiddel til Deres hund:
English: After each dose, the syringe should be removed from the bottle.
Danish: Efter hver dosis bør sprøjten fjernes fra flasken.
English: Day 36-56
Danish: Dag 36-56
English: Day 22-35
Danish: Dag 22-35
English: If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Danish: Hvis De bemærker nogen alvorlige virkninger eller andre virkninger, der ikke er nævnt i denne indlægsseddel, så giv Deres dyrlæge besked.
English: Laboratory animals and dogs rapidly absorb orally administered mitratapide.
Danish: Laboratoriedyr og hunde absorberer hurtigt peroralt administreret mitratapid.
English: Mitratapide and its metabolites bind very extensively (> 99 %) to plasma proteins and distribute to the tissues.
Danish: Mitratapid og dets metaboliter bindes meget omfattende (> 99 %) til plasmaproteiner og fordeles til vævene.
English: Generally, the severity of these effects increased with increasing dose.
Danish: Virkningernes sværhedsgrad øgedes generelt med dosis.
English: Thereafter, feeding should be in accordance with energy requirements for maintenance (to be calculated by the veterinarian).
Danish: Fodringen bør derefter være i overensstemmelse med enegikravene for vedligeholdelse (udregnes af dyrlægen).
English: The treatment is part of an overall weight management programme which also includes a nutrition programme.
Danish: Behandlingen er en del af et totalt vægtbehandlingsprogram, der også omfatter et ernæringsprogram.
English: Introducing appropriate lifestyle changes (e.g. increased exercise), in conjunction with this weight management programme, may provide additional benefits.
Danish: Indførelse af passende ændringer i livsstil (f.eks. øget motion) i forbindelse med dette vægtbehandlingsprogram, kan give yderligere fordele.
English: The pharmacokinetic parameters display variable dependency on dose and vary slightly between the first and the second three week treatment periods of a complete treatment schedule.
Danish: De farmakokinetiske parametre udviser variabel afhængighed af dosis og varierer en anelse mellem den første og den anden tre ugers behandlingsperiode i en fuldstandig behandlingsplan.
English: The following adverse reactions were observed during the clinical trials (pooled data*):
Danish: Følgende bivirkninger blev observeret under de kliniske afprøvninger (poolede data*):
English: Mitratapide also has a slight appetite decreasing effect, which is linked to its mode of action.
Danish: Mitratapid har også en let appetitnedsættende virkning, hvilket er forbundet med dets virkningsmåde.
English: It is assumed that these effects are mediated by MTP inhibition at the level of the enterocyte.
Danish: Det antages, at disse virkninger er mediaret af MTPhæmning på enterocytniveauet.
English: In most cases, these effects are mild and transient.
Danish: I de fleste tilfælde er disse virkninger lette og forbigående.
English: • if your dog is hypersensitive (allergic) to mitratapide or to any of the other ingredients.
Danish: • hvis Deres hund er overfølsom (allergisk) over for mitratapid eller nogen af de andre indholdsstoffer.
English: This is related to the mode of action of the product and should not be considered as a side effect, unless it becomes very significant (this is when your dog stops eating for two consecutive days).
Danish: Dette har forbindelse med produktets virkningsmåde og bør ikke betragtes som en bivirkning, medmindre den bliver meget væsentlig (hvilket er, når hunden holder op med at spise i to på hinanden følgende dage).
English: In clinical trials, the following weight loss percentages were obtained:
Danish: I kliniske afprøvninger blev der opnået følgende procenter vægttab:
English: Mitratapide is a potent inhibitor of the microsomal triglyceride transfer protein (MTP).
Danish: Mitratapid er en potent hæmmer af det mikrosomale triglycerid transfer protein (MTP).
English: During the first 21 days of treatment, the quantity of food the animal receives may remain unchanged.
Danish: Under de første 21 dages behandling kan mængden af foder, som dyret får, forblive uændret.
English: Tell your veterinary surgeon if you notice any of the following:
Danish: Fortæl det til Deres dyrlæge, hvis De lægger mærke til noget af følgende:
English: This results in blockage of the uptake of dietary lipids.
Danish: Dette resulterer i blokering af ernæringsmæssige lipider.
English: The absorption of lipid soluble drugs used concomitantly with mitratapide has not been investigated.
Danish: Absorptionen af lipidopløselige lægemidler anvendt samtidig med mitratapid er ikke blevet undersøgt.
English: You should check with your veterinary surgeon if you are unsure.
Danish: De bør kontrollere det med Deres dyrlæge, hvis der er noget, De er usikker på.
English: To be used as part of an overall weight management programme which also includes appropriate dietary changes.
Danish: Anvendes som en del af et totalt vægtbehandlingsprogram, der også omfatter passende kostændringer.
English: The use in dogs for breeding purposes has not been evaluated.
Danish: Anvendelsen til hunde til opdræt er ikke blevet evalueret.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Janssen Pharmaceutica N.V.
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Janssen Pharmaceutica N.V.
English: Butylated hydroxyanisole (E 320)
Danish: Butyleret hydroxyanisol (E 320)
English: Fill the syringe by pulling the plunger until it reaches the mark on the dosing pipette corresponding to the correct body weight of the dog.
Danish: Fyld sprøjten ved at trække i stemplet, indtil det når markeringen på doseringspipetten, der svarer til hundens korrekte legemsvægt.
English: Please inform your veterinary surgeon if your dog is taking or has recently taken any other medicines, even those not prescribed.
Danish: Underret Deres dyrlæge, hvis Deres hund får eller for nylig har fået nogen anden medicin, også hvis det ikke er ordineret.
English: This can be achieved either with a regular pet food or with a low calorie (diet) pet food.
Danish: Dette kan opnås enten med a almindeligt dyrefoder eller med lavkaloriedyrefoder (diætfoder).
English: No specific antidote is available.
Danish: Der findes ingen specifik modgift.
English: Mitratapide therapy should be restricted to one treatment course for an individual dog.
Danish: Mitratapidbehandling bør begrænses til ét behandlingsforløb for en individuel hund.
English: Therefore, for dogs receiving treatments in addition to the product, drug interactions should be monitored closely.
Danish: Hunde, der får behandlinger i forbindelse med produktet, bør derfor overvåges nøje for lægemiddelinteraktioner.
English: If accidental eye contact occurs, flush immediately with copious amounts of water.
Danish: Hvis der forekommer kontakt til øjnene, skal der straks skylles med rigelige mængder vand.
English: Following oral administration, the bioavailability of mitratapide (parent compound and metabolites) is in the range from 55 to 69%, the volume of distribution is approximately 5 l/kg.
Danish: Efter peroral administration er biotilgængeligheden af mitratapid (moderforbindelsen og metaboliter) i området fra 55 til 69%, fordelingsvolumen er cirka 5 l/kg.
English: Pharmacotherapeutic group: Peripherally acting antiobesity products, ATCvet Code: QA08AB90
Danish: Farmakoterapeutisk gruppe: Perifert virkende antifedme produkter, ATC vet kode: QA08AB90.
English: Administer the product orally during 2 periods of 21 days with an interval of 14 days without treatment in between.
Danish: Giv produktet peroralt over 2 perioder på 21 dage med et mellemrum på 14 dage uden behandling imellem.
English: Always administer Yarvitan exactly as your veterinary surgeon has instructed you.
Danish: Giv altid Yarvitan nøjagtig som Deres dyrlæge har fortalt Dem.
English: In clinical trials, treated animals rapidly regained weight following cessation of treatment when diet was not restricted.
Danish: I kliniske afprøvninger genvandt dyrene hurtigt vægten efter ophør med behandlingen, når ernæringen ikke blev begrænset.
English: US field trial pooled data weight loss category placebo mitratapide placebo mitratapide placebo mitratapide
Danish: US feltafprøvning poolede data vægttabskategori placebo mitratapid placebo mitratapid placebo mitratapid
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/
Danish: Nærmere oplysninger om dette veterinærlægemiddel er tilgængelige på webstedet for Det europæiske Lægemiddelagenturs (EMEA) http://www.emea.europa.eu/
English: Treatment should be given with food.
Danish: Behandlingen bør gives med fodret.
English: Mitratapide
Danish: Mitratapid
English: The dosing pipette has a gradation in body weight:
Danish: Doseringspipetten har en gradinddeling i legemsvægt:
English: Clinical observation
Danish: Klinisk observation
English: Percentages of dogs per weight loss category for mitratapide versus placebo:
Danish: Procenter af hunde pr.vægttabskategori for mitratapid versus placebo:
English: Do not use in dogs less than 18 months of age.
Danish: Bør ikke anvendes til hunde under 18 måneder.
English: Your veterinary surgeon should monitor closely the intake of any other medicines in addition to the product.
Danish: Deres dyrlæge bør nøje overvåge indtagelsen af andre lægemidler samtidig med brug af dette produkt.
English: Administration of mitratapide to dogs results in reduced uptake of dietary lipids, dose dependent decreases in serum cholesterol and triglyceride and an increased presence of triglyceride containing droplets in enterocytes.
Danish: Administration af mitratapid til hunde resulterer i reduceret optagelse af ernæringsmæssige lipider, dosisafhængigt fald i serumkolesterol og triglyceride og en øget tilstedeværelse af triglyceridindeholdende smådråber i enterocyter.
English: Vomiting, diarrhoea or softened stools may occur during treatment.
Danish: Opkastning, diaré eller blød afføring kan forekomme under behandlingen.
English: The following clinical signs were observed after 3 or 5 times overdosing in dogs: softened or liquid faeces, vomiting, salivation, anorexia, severe weight loss, emaciated appearance, dehydration and pale mucosae.
Danish: De følgende kliniske tegn blev observeret efter 3 eller 5 gange overdosering hos hunde: Blød eller flydende fæces, opkastning, savlen, anoreksi, kraftigt vægttab, udtæret udseende, dehydrering og blege slimhinder.
English: • in dogs less than 18 months of age.
Danish: • hvis Deres hund er under 18 måneder gammel
English: In order to allow proper dosing, the dog should be weighed on day 1 and day 35 (this is at the start of each treatment period).
Danish: For at kunne give en korrekt dosering bør hunden vejes dag 1 og dag 35 (dette er ved begyndelsen af hver behandlingsperiode).
English: The dosing pipettes provided with the product show graduations corresponding to the correct body weight of the dog.
Danish: Doseringspipetten, der kommer sammen med produktet, viser gradueringer, der svarer til hundens korrekte legemsvægt.
English: Placebo vomiting : occasional ( 3x) vomiting : repeated (> 3 x) diarrhoea / soft stools anorexia / decreased appetite lethargy / weakness * data from 360 dogs over the whole treatment period.
Danish: Placebo opkastning : nu og da (≤ 3x) opkastning : gentagent (> 3 x) diaré / blød afføring anoreksi / nedsat appetit letargi / svaghed * data fra 360 hunde over hele behandlingsperioden.
English: Do not refrigerate.This veterinary medicinal product does not require any special storage conditions.
Danish: Må ikke opbevares i køleskab.Dette veterinærlægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: In addition, treatment should be interrupted and the advice of a veterinarian should be sought where the observed body weight loss is severe and rapid.
Danish: Derudover bør behandlingen afbrydes, og der bør søges dyrlæge, når det observerede vægttab er omfattende og hurtigt.
English: Shelf-life after first opening the container: 3 months.
Danish: Opbevaringstid efter første åbning af beholderen: 3 måneder.
English: In order to allow proper dosing, the dog should be weighed on day 1 and on day 35 (i.e. at the start of each treatment period).
Danish: For at give mulighed for korrekt dosering bør hunden vejes dag 1 og dag 35 (dvs. Ved begyndelsen af hver behandlingsperiode).
English: Therefore, administer the product with the syringe onto a portion of the food.
Danish: Giv derfor produktet med sprøjten på en portion af fodret.
English: In laboratory studies, decreases in serum albumin, globulin, total protein, calcium and alkaline phosphatase and increases in ALT and AST were detected following administration of the product at the recommended treatment dose.
Danish: I laboratorieundersøgelser blev der detekteret fald i serumalbumin, globulin, total protein, kalcium og alkalisk fosfatase og stigning i ALT og AST efter administration af produktet ved den anbefalede behandlingsdosis.
English: This veterinary medicinal product does not require any special storage conditions.
Danish: Dette veterinærlægemiddel kræver ingen særlige forholdsregler vedrørende opbevaring.
English: The terminal plasma half-life is 6.3 hours for mitratapide, 9.8 hours and 11.7 hours for the sulphoxides, respectively, and 44.7 hours for the sulphone metabolite.
Danish: Den terminale plasmahalveringstid er henholdsvis 6,3 timer for mitratapid, 9,8 timer og 11,7 timer sulfoxiderne, og 44,7 timer for sulfonmetaboliten.
English: Butylated hydroxyanisole (E 320) 2 mg/ml For a full list of excipients, see section 6.1
Danish: Butyleret hydroxyanisol (E 320) 2 mg/ml Se afsnit 6.1 for en fuldstændig fortegnelse over hjælpestoffer
English: • if overweight or obesity in your dog is caused by a concomitant systemic disease such as hypothyroidism (this is due to a malfunction of the thyroid gland) or hyperadrenocorticism.
Danish: • hvis Deres hunds overvægt eller fedme skyldes en samtidig systemisk lidelse såsom hypothyroidisme (dette skyldes en fejlfunktion i thyroidea kirtlen) eller hyperadrenocorticisme.
English: A colourless to slightly yellow solution.
Danish: En farveløs til let gullig opløsning.
English: • if your dog is pregnant or during lactation.
Danish: • hvis Deres hund er drægtig eller under laktation.
English: Mitratapide 5 mg/ml
Danish: Mitratapid 5 mg/ml
English: • if your dog has impaired liver function.
Danish: • hvis Deres hund har nedsat leverfunktion.
English: Do not use in dogs in which overweight or obesity is caused by a concomitant systemic disease such as hypothyroidism or hyperadrenocorticism.
Danish: Bør ikke anvendes til hunde i de tilfælde, hvor overvægten eller fedmen skyldes en samtidig systemisk sygdom såsom hypothyroidisme eller hyperadrenocorticisme.
English: No drug interactions were observed in studies where Yarvitan was administered concomitantly with NSAIDs (carprofen, meloxicam) or ACE inhibitors (enalapril, benazepril).
Danish: Der blev ikke observeret nogen lægemiddelinteraktioner i undersøgelser, hvor Yarvitan blev givet samtidig med NSAID'er (carprofen, meloxicam) eller ACE-hæmmere (enalapril, benazepril).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE LABEL AMBER GLASS BOTTLE 120 and 210 ml
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ETIKET PÅ RAVFRAVET GLASFLASKE 120 OG 210 ML
English: The pipette should be washed and dried and the cap should be screwed back on tightly.
Danish: Pipetten bør vaskes og tørre, og låget skrues tæt fast igen.
English: After multiple dosing, the highest concentrations are present in the adrenal glands, liver, jejunum and kidney, but there is no exposure in the brain, excluding any central effect of the product.
Danish: Efter flere doseringer er de højeste koncentrationer til stede i binyrerne, leveren, jejunum og nyrerne, men der er ingen eksponering i hjernen.
English: Shelf-life of the veterinary medicinal product as packaged for sale: 3 years Shelf-life after first opening the immediate packaging: 3 months 6.4 Special precautions for storage
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 3 år Opbevaringstid efter første åbning af beholderen: 3 måneder
English: A decreased appetite may occur during treatment.
Danish: Der kan forekomme nedsat appetit under behandlingen .
English: Loss of appetite may occur during treatment.
Danish: Appetitløshed kan forekomme under behandlingen.
English: Accumulation of triglycerides inside the enterocytes may be followed by decreased appetite.
Danish: Akkumulation af triglycerider inde i enterocyterne kan inducere en følelse af mæthed, hvilket giver en negativ feedback på appetit.
English: In case of accidental overdosing, symptomatic therapy should be administered.
Danish: I tilfælde af overdosering ved et uheld, bør der gives symptomatisk behandling.
English: If vomiting, significantly reduced appetite or diarrhoea repeatedly occurs, treatment should be interrupted and the advice of a veterinarian should be sought.
Danish: Hvis der forekommer opkastning, væsentlig nedsat appetit eller gentagne diaréer, bør behandlingen afbrydes, og der bør søges dyrlæge.
English: SPECIAL STORAGE CONDITIONS Do not refrigerate.
Danish: SÆRLIGE OPPBEVARINGSBETINGELSER Må ikke opbevares i køleskab.
English: In fed dogs, a single dose of 0.63 mg mitratapide/kg bodyweight results in maximum concentrations of the parent substance in plasma of on average 0.012 g/ml attained 3.5 hours after dosing; the sulphoxide metabolites reach maximum concentration of on average 0.0136 g/ml and 0.0168 g/ml, respectively after 6.5 hours and 8.5 hours; the sulphone metabolite reaches 0.0092 g/ml after 17.5 hours.
Danish: Hos fodrede hunde resulterer en enkelt dosis 0,63 mg mitratapid/kg legemsvægt af Yarvitan i maksimumkoncentrationer af modersubstansen i plasma på gennemsnitlig 0,012 µg/ml opnået 3,5 timer efter dosering; sulfoxidmetaboliterne når maksimumkoncentration på gennemsnitlig henholdsvis 0,0136 µg/ml og 0,0168 µg/ml efter 6,5 timer og 8,5 timer; sulfonmetaboliten når 0,0092 µg/ml efter 17,5 timer.
English: • softened stools
Danish: • blød afføring
English: After each dose, the pipette should be washed and dried and the bottle cap screwed back on tightly.
Danish: Efter hver dosering bør pipetten vaskes og tørre, og flaskelåget skrues tæt til igen.
English: PACKAGE SIZE 120 ml
Danish: PAKNINGSSTØRRELSE 120 ml
English: In order to avoid this rebound weight gain, it is necessary to continue the feeding for maintenance regimen after the end of treatment with the product.
Danish: For at undgå denne genvundne vægtøgning, er det nødvendigt at fortsætte fodringen for vedligeholdelsesregimen efter afslutningen af behandling med produktet.
English: Use the dosing pipette as provided with the product.
Danish: Anvend doseringspipetten, der kommer sammen med produktet.
English: This is related to the mode of action of the product and should not be considered as an adverse reaction unless it becomes very significant.
Danish: Det mulige appetittab skyldes produktets virkningsmåde, og det. bør ikke betragtes som en bivirkning, med mindre det bliver meget udtalt.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/063/001-3
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/06/063/001-3
English: EXP: Once opened, use within 3 months.
Danish: EXP: Efter åbning anvendes inden 3 måneder.