FrancophonIA/ELRC3.0 huggingface dataset:
English: 2 Guideline for the testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestations in dogs and cats (EMA/CVMP/EWP/005/2000-Rev.2) - link skin tissue being collected on study days 0, 90, 180, 210, and 300 (i.e. in the post-treatment phase), and samples of bone marrow collected on study days 0 and D300.
Danish: 2 Guideline for the testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestations in dogs and cats (EMA/CVMP/EWP/005/2000-Rev.2) - link
English: 4.2 Indications for use, specifying the target species
Danish: 4.2 Terapeutiske indikationer
English: Bayer Vital GmbH, Geschäftsbereich Tiergesundheit 51368 Leverkusen Germany
Danish: 51368 Leverkusen
English: Foresto 4.50 g + 2.03 g, g zgardă antiparazitară pentru câini >8 kg
Danish: Foresto 4,50 g + 2,03 g, zgardă antiparazitară pentru câini >8 kg
English: Pharmaceutical form
Danish: INDLÆGSSEDDEL
English: This summary was last updated in February 2015.
Danish: Dette sammendrag blev sidst ajourført i februar 2015.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Zuprevo on 6 May 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zuprevo den 6. maj 2011.
English: The dose to use is calculated according to the animal's weight.
Danish: Den dosis, som skal anvendes, beregnes ud fra dyrets vægt.
English: Cattle may also experience pain at the time of injection.
Danish: Kvæg kan også få smerter på injektionstidspunktet.
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Danish: Hvis du ønsker yderligere oplysninger om baggrunden for CVMP's anbefalinger, kan du læse den videnskabelige drøftelse (også en del af denne EPAR).
English: The medicine should not be given into a blood vessel.
Danish: Lægemidlet må ikke gives i et blodkar.
English: The withdrawal period for meat is nine days for pigs and 47 days for cattle.
Danish: Tilbageholdelsestiden for kød er ni dage for svin og 47 dage for kvæg.
English: 229 pigs were treated with Zuprevo and 227 pigs were untreated controls that received saline.
Danish: 229 svin blev behandlet med Zuprevo, og 227 svin var ubehandlede kontroldyr, som fik saltvand.
English: Other information about Zuprevo:
Danish: Andre oplysninger om Zuprevo:
English: The animal should be monitored and if signs of respiratory problems are still present after two days (pigs) or two to three days (cattle), the treatment should be switched to another antibiotic.
Danish: Dyret bør overvåges, og hvis der stadig er tegn på luftvejsproblemer efter to dage (svin) eller to-tre dage (kvæg), skal der skiftes behandling til et andet antibiotikum.
English: In case of accidental contact, the skin should be washed immediately with soap and water, and the eyes flushed with clean water.
Danish: I tilfælde af uforvarende kontakt skal huden straks vaskes med vand og sæbe, og øjnene skal skylles med rent vand.
English: This medicine is not allowed to be used in animals producing milk for human consumption.
Danish: Det er ikke tilladt at anvende lægemidlet hos dyr, som producerer mælk til menneskeligt konsum.
English: It works by blocking the bacterias' ribosomes, the parts of the cell where proteins are produced, and blocking the growth of bacteria.
Danish: Det virker ved at blokere bakteriernes ribosomer, som er de dele af cellen, hvor der dannes proteiner, hvorved bakteriernes vækst blokeres.
English: The benefit/risk balance may be found in the scientific discussion module of this EPAR.
Danish: Benefit/risk-forholdet fremgår af afsnittet om den videnskabelige drøftelse i denne EPAR.
English: The CVMP concluded that the benefits of Zuprevo outweigh the risks for the approved indications and recommended that Zuprevo be given a marketing authorisation.
Danish: CVMP konkluderede, at fordelene ved Zuprevo opvejer risiciene ved de godkendte indikationer, og anbefalede udstedelse af markedsføringstilladelse for Zuprevo.
English: The treatment studies looked at the improvement of the signs of respiratory disease and the prevention studies looked at the absence of signs of infection (fever, respiratory or behaviour abnormalities) in animals exposed to infection.
Danish: I behandlingsundersøgelserne undersøgte man forbedringen af symptomerne på luftvejssygdom, og i forebyggelsesundersøgelserne så man på fraværet af tegn på infektion (feber, respiratoriske eller adfærdsmæssige abnormiteter) hos dyr udsat for infektion.
English: Special caution should be taken to avoid accidental self-injection, as laboratory studies in dogs showed cardiovascular effects after intramuscular injection of high doses of tildipirosin.
Danish: Der bør udvises særlig opmærksomhed ved utilsigtet selvinjektion, idet laboratorieundersøgelser hos hunde viste kardiovaskulær effekt efter intramuskulær injektion af høje doser tildipirosin.
English: In the field studies, the medicine was compared with other antibiotics used in these diseases (tulathromycin or florfenicol).
Danish: I feltstudierne blev lægemidlet sammenlignet med andre antibiotika, som anvendes til disse sygdomme (tulathromycin eller florfenicol).
English: Zuprevo is an antibiotic that belongs to the group ‘macrolides'.
Danish: Zuprevo er et antibiotikum, som tilhører gruppen af »macrolider«.
English: The studies in SRD included pigs between three and 21 weeks of age, and those in BRD included cattle between one and 24 months of age.
Danish: Undersøgelserne af SRD omfattede svin, der var mellem tre og 21 uger gamle, og undersøgelserne af BRD omfattede kvæg, der var mellem én og 24 måneder gamle.
English: When using the antibiotic Zuprevo, it is essential to closely follow the instructions in the package leaflet to minimise the development of antibiotic resistance.
Danish: Når antibiotikummet Zuprevo tages, er det vigtigt at følge anvisningerne i indlægssedlen nøje for at mindske risikoen for at udvikle antibiotikaresistens.
English: Tildipirosin may cause sensitisation by skin contact.
Danish: Tildipirosin kan medføre overfølsomhed ved kontakt med huden.
English: Zuprevo should only be used when the bacteria are sensitive to tildipirosin.
Danish: Zuprevo bør kun anvendes, når bakterierne er modtagelige for tildipirosin.
English: The withdrawal period is the time allowed after administration of the medicine before the animal can be slaughtered and the meat or milk used for human consumption.
Danish: Tilbageholdelsestiden er den tid, der skal gå efter injektion af lægemidlet, før dyret kan slagtes, og kødet kan anvendes til menneskeligt konsum, eller før mælken kan anvendes til menneskeligt konsum.
English: Zuprevo is available as a solution for injection containing tildipirosin 40 mg/ml (for pigs) or 180 mg/ml (for cattle).
Danish: Zuprevo fås som en injektionsvæske, opløsning, der indeholder tildipirosin 40 mg/ml (til svin) eller 180 mg/ml (til kvæg).
English: Zuprevo is given as a single injection, into muscle for pigs, and under the skin for cattle.
Danish: Zuprevo gives som en enkelt injektion til svin i en muskel og til kvæg under skindet.
English: Zuprevo should not be used in animals that are hypersensitive (allergic) to macrolide antibiotics or to any of the excipients.
Danish: Zuprevo må ikke anvendes til dyr, som er overfølsomme (allergiske) over for antibiotika indeholdende macrolider eller et eller flere af hjælpestofferne.
English: Zuprevo is a veterinary medicine that contains tildipirosin.
Danish: Zuprevo er et lægemiddel til dyr, der indeholder tildipirosin.
English: What is the risk associated with Zuprevo?
Danish: Hvilken risiko er der forbundet med Zuprevo?
English: medical advice should be sought immediately and the package leaflet or the label should be shown to the doctor.
Danish: I tilfælde af utilsigtet selvinjektion skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: The effectiveness of Zuprevo used for treatment and metaphylaxis of SRD in diseased pigs as well as in clinically healthy in-contact pigs was investigated in a field study in which an outbreak of SRD was confirmed with at least 30% of the pens showing clinical signs of SRD, including at least 10% of animals per pen within 1 day or 20% within 2 days or 30% within 3 days.
Danish: Effektiviteten af Zuprevo til behandling og metafylakse af SRD hos syge svin samt hos de klinisk sunde svin, der var i kontakt med de syge svin, blev undersøgt i en feltundersøgelse, med et bekræftet udbrud af SRD, hvor mindst 30 % af stierne viste kliniske symptomer på SRD, herunder mindst 10 % af dyrene i hver sti inden for 1 dag, eller 20 % inden for to dage, eller 30 % inden for 3 dage.
English: Zuprevo is an antibiotic used in pigs to treat swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica and Haemophilus parasuis.
Danish: Zuprevo er et antibiotikum, som anvendes til behandling af luftvejsinfektioner (SRD) hos svin i forbindelse med Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica og Haemophilus parasuis.
English: The effectiveness of Zuprevo was shown to be comparable to that of tulathromycin or florfenicol in the treatment of SRD, and in the treatment and prevention of BRD.
Danish: Det blev påvist, at effektiviteten af Zuprevo var sammenlignelig med effektiviteten af tulathromycin eller florfenicol til behandling af SRD og til behandling og forebyggelse af BRD.
English: Laboratory as well as field studies were conducted to look at the use of Zuprevo in both the treatment and metaphylaxis of SRD and the treatment and prevention of BRD.
Danish: Der blev gennemført både laboratorieundersøgelser og feltundersøgelser af anvendelsen af Zuprevo til både behandling og metafylakse af SRD og til behandling og forebyggelse af BRD.
English: During severe outbreaks of SRD Zuprevo can also be used metaphylactically which means to treat at the same time both diseased pigs and those clincially healthy pigs in close contact with them, to prevent them from developing clinical signs and to prevent further spread of the disease.
Danish: Under svære udbrud af SRD kan Zuprevo også anvendes metafylaktisk, hvilket vil sige, at syge svin og de klinisk sunde svin, som er i kontakt med de syge svin, behandles samtidig med henblik på at undgå, at de sunde svin udvikler kliniske symptomer, og forhindre sygdommen i at spredes yderligere.
English: When Zuprevo was used for treatment and metaphylaxis of SRD in diseased and clinically healthy incontact pigs approximately 86% of the healthy pigs remained free of clinical signs of disease compared with approximately 65% of pigs in the untreated control group.
Danish: Ved anvendelse af Zuprevo til behandling og metafylakse af SRD hos syge svin og de klinisk sunde svin, som var i kontakt med de syge svin, forblev ca. 86 % af de sunde svin frie for kliniske sygdomssymptomer, sammenlignet med ca. 65 % af svinene i den ubehandlede kontrolgruppe.
English: What is Zuprevo?
Danish: Hvad er Zuprevo?
English: Animals treated with Zuprevo may develop a swelling at the site of the injection, especially when larger volumes are used, therefore each injection is limited to a maximum volume (5 ml in pigs and 10 ml in cattle).
Danish: Dyr, som behandles med Zuprevo, kan udvikle hævelse på injektionsstedet, især når der anvendes store mængder, hvorfor hver injektion er begrænset til et maksimalt volumen (5 ml hos svin og 10 ml hos kvæg) Hævelsen kan vare i op til tre dage hos svin og en til to uger hos kvæg.
English: Zuprevo is used in cattle to treat and prevent bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Danish: Zuprevo anvendes til behandling og forebyggelse af luftvejsinfektioner (BRD) hos kvæg i forbindelse med Mannheimia haemolytica, Pasteurella multocida og Histophilus somni.
English: Why has Zuprevo been approved?
Danish: Hvorfor blev Zuprevo godkendt?
English: When used to prevent BRD, the presence of the disease in the herd should be confirmed before use.
Danish: Når Zuprevo anvendes til forebyggelse af BRD, skal det inden brug bekræftes, at sygdommen er til stede i bestanden.
English: What is Zuprevo used for?
Danish: Hvad anvendes Zuprevo til?
English: How has Zuprevo been studied?
Danish: Hvordan blev Zuprevo undersøgt?
English: What benefit has Zuprevo shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Zuprevo?
English: How does Zuprevo work?
Danish: Hvordan virker Zuprevo?
English: Patients were treated for up to 3 years.
Danish: Patienterne blev behandlet i op til 3 år.
English: Your doctor will be able to decide what is suitable for you.
Danish: Din læge vil kunne afgøre, hvad der er egnet til dig.
English: The second daily dose can be taken with or without food.
Danish: Den anden daglige dosis kan tages sammen med eller uden mad.
English: 1 Quarter 2026
Danish: Første kvartal 2026
English: Due to the increased urine production it is also important that you always have access to a toilet.
Danish: På grund af den øgede urinproduktion er det også vigtigt, at du altid har adgang til et toilet.
English: • allergic reactions (see above)
Danish: • allergiske reaktioner (se ovenfor)
English: Date of first authorisation: 27 May 2015
Danish: Dato for første markedsføringstilladelse: 27. maj 2015
English: • Advice if such symptoms occur
Danish: • Råd i tilfælde af at sådanne symptomer forekommer
English: Smoking and alcohol
Danish: Rygning og alkohol
English: Access to water
Danish: Adgang til vand
English: Not known: frequency cannot be estimated from the available data
Danish: Ikke kendt: hyppighed kan ikke estimeres ud fra forhåndenværende data
English: The lower dose is taken 8 hours later.
Danish: Den laveste dosis tages 8 timer senere.
English: Liver transplantation was necessary.
Danish: Levertransplantation var påkrævet.
English: Drinking enough water
Danish: Drik tilstrækkeligt med vand
English: In particular this applies to patients with inadequately controlled type II diabetes.
Danish: Dette gælder især for patienter med utilstrækkeligt kontrolleret type 2 diabetes.
English: Your medicine is supplied in the following pack sizes:
Danish: Din medicin leveres i følgende pakningsstørrelser:
English: A non-interventional post-authorisation safety study (PASS) to investigate the risks of:
Danish: Ikke-interventionssikkerhedsundersøgelser efter tilladelse til markedsføring (PASS) for at undersøge risikoen for:
English: 1101 CT, Amsterdam Netherlands
Danish: 1101 CT, Amsterdam Holland
English: Pre-specified secondary endpoints were tested sequentially.
Danish: De præ-definerede sekundære endepunkter blev testet sekventielt.
English: In particular let your doctor know if you are taking:
Danish: Du skal især fortælle lægen, om du tager:
English: Recommended guidelines for permanent discontinuation include:
Danish: Anbefalede retningslinjer for permanent seponering omfatter:
English: If you take the higher dose very late in the day you may have to go to the toilet at night more frequently.
Danish: Hvis du tager den højeste dosis meget sent på dagen, kan det være, at du skal på toilettet hyppigere om natten.
English: Less than 1 % of intact active substance is excreted unchanged in the urine.
Danish: Mindre end 1 % uomdannet aktivt stof udskilles uændret med urinen.
English: The absolute bioavailability of tolvaptan is about 56 %.
Danish: Tolvaptans absolutte biotilgængelighed er ca. 56 %.
English: • Patterns of medicinal product utilisation, especially with regards to off label use and use in patients over 50 years old
Danish: • Mønstre af lægemiddelforbrug, især ved off-label anvendelse og brug hos patienter over 50 år
English: The daily amount of Jinarc is split into two doses, one bigger than the other.
Danish: Den daglige mængde Jinarc skal deles i to doser, den ene større end den anden.
English: To find the best dose your doctor will regularly check how well you are tolerating a prescribed dose.
Danish: For at finde den bedste dosis vil din læge jævnligt kontrollere, hvor godt du kan tåle en ordineret dosis.
English: The advice of a hepatologist is recommended.
Danish: Det anbefales at søge råd hos en hepatolog.
English: The inclusion criteria identified patients who at baseline had evidence of early disease progression.
Danish: Inklusionskriterierne identificerede patienter, som ved baseline havde evidens på tidlig sygdomsprogression.
English: • if you cannot drink enough water (see “drinking enough water” below) or if you have to restrict your fluid intake.
Danish: • hvis du ikke kan drikke nok vand (se “Drik tilstrækkeligt med vand” nedenfor), eller hvis dit væskeindtag skal begrænses.
English: Consequently, the frequency of these adverse events is qualified as "not known".
Danish: Hyppigheden af sådanne bivirkninger er derfor angivet som "ikke kendt".
English: Stop taking Jinarc and immediately contact a doctor or go to the nearest hospital if you:
Danish: Hold op med at tage Jinarc og kontakt straks en læge eller nærmeste hospital, hvis du:
English: Remember to take the medicine pack with you so that it is clear what you have taken.
Danish: Husk at tage medicinens emballage med, så de ved, hvad du har taget.
English: 30 mg (further reduction to 15 mg if 30 mg are not well tolerated)
Danish: 30 mg (yderligere reduktion til 15 mg, hvis 30 mg ikke tolereres godt)
English: • thirst (requiring excessive drinking of water)
Danish: • tørst (der gør det nødvendigt at drikke store mængder vand)
English: Jinarc has not been studied in children and adolescents (under age 18) and its use is therefore not recommended in these age groups.
Danish: Jinarc er ikke blevet undersøgt hos børn og unge (under 18 år), og dets brug kan derfor ikke anbefales til børn.
English: Tolvaptan is only a minor component in plasma (3 %).
Danish: Tolvaptan er kun en mindre komponent i plasma (3 %).
English: During treatment with Jinarc, your doctor will arrange monthly blood tests to check for changes in your liver function.
Danish: Under behandling med Jinarc vil din læge arrangere månedlige blodprøver for at kontrollere for ændringer i din leverfunktion.
English: During long-term treatment electrolytes have to be monitored at least every three months.
Danish: Under vedvarende behandling skal elektrolytter kontrolleres mindst hver 3. måned.
English: Very common: may affect more than 1 in 10 people
Danish: Meget almindelig: kan forekomme hos flere end 1 ud af 10 personer
English: If you forget to take your medicine you should take the dose as soon as you remember on the same day.
Danish: Hvis du har glemt at tage din medicin, skal du tage dosis, så snart du husker det samme dag.
English: Some people may feel dizzy, weak or tired after being given Jinarc.
Danish: Nogle mennesker kan føle sig svimle, svage eller trætte, efter at de har taget Jinarc.
English: • if your kidneys do not work (no urine production)
Danish: • hvis dine nyrer ikke fungerer (ingen produktion af urin)
English: There are no adequate data from the use of tolvaptan in pregnant women.
Danish: Der er ingen tilstrækkelige data fra anvendelse af tolvaptan til gravide kvinder.
English: If you notice any of the following side effects, you may need urgent medical attention.
Danish: Hvis du bemærker en eller flere af følgende bivirkninger, kan du få brug for akut lægehjælp.
English: Similar changes with other medicinal products have been associated with the potential to cause irreversible and potentially life-threatening liver injury.
Danish: Lignende ændringer set hos andre lægemidler er blevet forbundet med risiko for at forårsage irreversibel og potentielt livstruende leverskade.
English: Appropriate replacement of water and/or electrolytes must continue until aquaresis abates.
Danish: Passende erstatning af vand og/eller elektrolytter skal fortsættes, indtil aquaresis ophører.
English: This condition must be excluded prior and during treatment with tolvaptan.
Danish: Denne tilstand skal udelukkes inden og under behandling med tolvaptan.
English: DO NOT take a double dose to make up for forgotten individual doses.
Danish: Du må IKKE tage en dobbeltdosis som erstatning for den glemte dosis.
English: Before bedtime you must drink 1 or 2 glasses of water even if you do not feel thirsty and you must also drink water after you urinating at night.
Danish: Før sengetid skal du drikke 1 eller 2 glas vand, selvom du ikke er tørstig, og du skal også drikke vand, efter at du har ladet vandet om natten.
English: Therefore, please inform your doctor immediately if you have signs that could indicate potential liver problems such as:
Danish: Derfor skal du straks kontakte din læge, hvis du har symptomer, som kunne indikere mulige leverproblemer som f.eks.:
English: Other potential causes of renal dysfunction or dehydration must be evaluated and addressed.
Danish: Andre potentielle årsager til nyredysfunktion eller dehydrering skal evalueres og korrigeres.
English: The most frequent adverse reactions are related to water loss.
Danish: De hyppigste bivirkninger vedrører vandtab.
English: If you have taken more tablets than your prescribed dose, drink plenty of water and contact your doctor or your local hospital immediately.
Danish: Hvis du har taget flere tabletter end den ordinerede dosis, skal du straks drikke rigeligt med vand og kontakte din læge eller nærmeste hospital.
English: The design was used to minimize the impact of early discontinuation and missing data on trial endpoints.
Danish: Designet blev anvendt for at minimere indvirkningen af seponering før tid og manglende data på forsøgets endepunkter.
English: • ALT or AST > 5-times ULN for more than 2 weeks
Danish: • ALT eller AST > 5 gange ULN i mere end 2 uger
English: Uncommon Not known*
Danish: Ikke kendt*
English: If you do not take your tablets on one day, take your normal dose on the next day.
Danish: Hvis du glemmer at tage dine tabletter den ene dag, skal du tage den normale dosis den næste dag.
English: The frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived from spontaneous reports.
Danish: Hyppigheden af bivirkninger, der er rapporteret efter markedsføringen, kan ikke fastsættes, da der er tale om spontane indberetninger.
English: All ADRs are listed by system organ class and frequency; very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Danish: Bivirkningerne er angivet efter systemorganklasse og hyppighed: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: It is therefore important that you have access to water and that you are able to drink sufficient amounts when you feel thirsty.
Danish: Det er derfor vigtigt, at du har adgang til vand, og at du er i stand til at drikke tilstrækkelige mængder, når du er tørstig.
English: Tolvaptan affinity for the human V2 receptor is 1.8 times that of native AVP.
Danish: Tolvaptans affinitet for den humane V2-receptor er 1,8 gange større end for det native AVP.
English: • diuretics or other medicines for the treatment of high blood pressure.
Danish: • diuretika og andre lægemidler til behandling af forhøjet blodtryk.
English: Uncommon: may affect up to 1 in 100 people • increase of bilirubin (a substance that can cause yellowing of skin or eyes) in the blood
Danish: Ikke almindelig: kan forekomme hos op til 1 ud af 100 personer • forhøjet bilirubin (et stof, der kan forårsage gulfarvning af hud eller øjne) i blodet
English: Fatigue, Thirst
Danish: Træthed, Tørst
English: Do not use this medicine after the expiry date which is stated on the carton, wallet card and the blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen, etuiet eller blisteren efter “EXP”.