FrancophonIA/ELRC3.0 huggingface dataset:
English: MiPet Easecto was as effective as moxidectin/imidacloprid and the percentage of MiPet Easecto-treated dogs with no live mites was 15%, 69%, 93%, 94%, 100% and 100% on days 30, 60, 90, 120, 150 and 180, respectively.
Danish: MiPet Easecto var lige så effektivt som moxidectin/imidacloprid, og andelen af MiPet Easecto-behandlede hunde uden levende mider var på 15%, 69 %, 93 %, 94 %, 100 % og 100 % på henholdsvis dag 30, 60, 90, 120, 150 og 180.
English: MiPet Easecto is available as chewable tablets (5, 10, 20, 40, 80 and 120 mg) and can only be obtained with a prescription.
Danish: MiPet Easecto fås som tyggetabletter (5, 10, 20, 40, 80 og 120 mg) og udleveres kun efter recept.
English: This is a summary of the European public assessment report (EPAR) for MiPet Easecto.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for MiPet Easecto.
English: It is not intended to provide practical advice on how to use MiPet Easecto.
Danish: Det er ikke en praktisk vejledning i, hvordan MiPet Easecto bør anvendes.
English: What is MiPet Easecto and what is it used for?
Danish: Hvad er MiPet Easecto, og hvad anvendes det til?
English: However, the following side effects are seen in less than 1 dog in 10,000: mild and short-lived vomiting and diarrhoea as well as tremor (shaking), ataxia (inability to coordinate body movements) or convulsions.
Danish: Følgende bivirkninger er dog set hos færre end 1 ud af 10 000 hunde: let og kortvarig opkastning og diarré samt rystelser, manglende evne til at koordinere kropsbevægelser og kramper.
English: The company that makes Simparica has agreed that its scientific data can be used for MiPet Easecto (‘informed consent').
Danish: Den virksomhed, som fremstiller Simparica, har indvilget i, at dens videnskabelige oplysninger må anvendes for MiPet Easecto (informeret samtykke).
English: Other information about MiPet Easecto
Danish: Andre oplysninger om MiPet Easecto
English: The active substance in MiPet Easecto, sarolaner acts as an ‘ectoparasiticide'.
Danish: Det aktive stof i MiPet Easecto, sarolaner, virker som et "ektoparasiticid".
English: For treatment of tick and flea infestations MiPet Easecto should be given once every month throughout the flea and/or tick season for optimal control.
Danish: Til behandling af flåt- og loppeangreb gives MiPet Easecto én gang om måneden i hele loppe- og/eller flåtsæsonen for at opnå bedst kontrol.
English: For MiPet Easecto the percentage of dogs with no live ear mites present was 91% at day 30 increasing to 99% on day 60, following two treatments.
Danish: Ved MiPet Easecto var andelen af hunde uden levende øremider på 91 % på dag 30, hvilket steg til 99 % på dag 60 efter to behandlinger.
English: MiPet Easecto was as effective as moxidectin/imidacloprid.
Danish: MiPet Easecto var lige så effektivt som moxidectin/imidacloprid.
English: A field study was conducted in dogs infested with at least three live attached ticks.
Danish: Der blev gennemført en feltundersøgelse hos hunde med angreb af mindst tre levende, fasthægtede flåter.
English: The effectiveness of MiPet Easecto against fleas was investigated in a field study in dogs infested with at least five live fleas.
Danish: Virkningen af MiPet Easecto mod lopper blev undersøgt i en feltundersøgelse hos hunde med angreb af mindst fem levende lopper.
English: Side effects with MiPet Easecto are not common.
Danish: Bivirkninger ved MiPet Easecto ses ikke hyppigt.
English: MiPet Easecto is a veterinary medicine used to treat infestations with ticks and fleas, demodectic and sarcoptic mange (skin infestations caused by two different types of mites) and ear mite infestations in dogs.
Danish: MiPet Easecto er et lægemiddel til dyr, der anvendes til behandling af flåt- og loppeangreb samt demodicose- og Sarcoptes-skab (skadedyrsangreb i huden forårsaget af to forskellige typer mider) og øremideangreb hos hunde.
English: Why is MiPet Easecto approved?
Danish: Hvorfor blev MiPet Easecto godkendt?
English: What are the risks associated with MiPet Easecto?
Danish: Hvilke risici er der forbundet med MiPet Easecto?
English: Safety information has been included in the summary of product characteristics and the package leaflet for MiPet Easecto, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Danish: Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for MiPet Easecto, herunder passende forholdsregler, som skal følges af sundhedspersoner og den, der er ejer af eller ansvarlig for dyret.
English: For treatment of demodectic mange MiPet Easecto should be given once a month for at least three months.
Danish: Til behandling af demodicose-skab gives MiPet Easecto en gang om måneden i mindst tre måneder.
English: MiPet Easecto was as effective as moxidectin and imidacloprid in eliminating live mites in skin scrapings.
Danish: MiPet Easecto var lige så effektivt som moxidectin og imidacloprid til at udrydde levende mider i afskrab fra huden.
English: For treatment of sarcoptic mange, MiPet Easecto is given monthly for two consecutive months.
Danish: Til behandling af Sarcoptes-skab gives MiPet Easecto en gang om måneden i to måneder i træk.
English: In a study involving dogs with ear mite infestation, 283 dogs were treated with MiPet Easecto and 131 dogs received moxidectin/imidacloprid (a spot-on mite treatment).
Danish: I en undersøgelse, der omfattede hunde med øremideangreb, blev 283 hunde behandlet med MiPet Easecto, og 131 hunde fik moxidectin/imidacloprid (en spot-on midebehandling).
English: In a study with 98 dogs with demodectic mange, 63 dogs were treated with MiPet Easecto monthly for up to six months and 35 dogs received moxidectin/imidacloprid.
Danish: I en undersøgelse med 98 hunde med demodicose-skab blev 63 hunde behandlet med MiPet Easecto månedligt i op til seks måneder, og 35 hunde fik moxidectin/imidacloprid.
English: 189 dogs were treated with MiPet Easecto for three months whilst 96 dogs were given another medicine, spinosad.
Danish: 189 hunde blev behandlet med MiPet Easecto i tre måneder, mens 96 hunde fik et andet lægemiddel, spinosad.
English: 53 dogs were treated with MiPet Easecto for two months whilst 26 dogs were given a medicine containing moxidectin and imidacloprid.
Danish: 53 hunde blev behandlet med MiPet Easecto i to måneder, mens 26 hunde fik et lægemiddel indeholdende moxidectin og imidacloprid.
English: After MiPet Easecto is given its activity against ticks and fleas lasts for at least 5 weeks.
Danish: Efter indgivelse virker MiPet Easecto mod flåter og lopper i mindst fem uger.
English: MiPet Easecto was as effective as spinosad in reducing flea counts for up to 90 days after treatment.
Danish: MiPet Easecto var lige så effektivt som spinosad til at nedsætte antallet af lopper i op til 90 dage efter behandlingen.
English: MiPet Easecto was as effective as fipronil in reducing tick counts for up to 90 days after treatment.
Danish: MiPet Easecto var lige så effektivt som fipronil til at nedsætte antallet af flåter i op til 90 dage efter behandlingen.
English: 122 dogs were treated with MiPet Easecto for three months whilst 59 dogs were treated with another medicine, fipronil, against ticks.
Danish: 122 hunde blev behandlet med MiPet Easecto i tre måneder, mens 59 hunde blev behandlet med et andet lægemiddel, fipronil, mod flåter.
English: MiPet Easecto can be used as part of the management of flea allergy dermatitis (an allergic reaction to flea bites).
Danish: MiPet Easecto kan anvendes som led i behandlingen af hudbetændelse ved overfølsomhed for loppebid (loppebetinget allergisk dermatitis).
English: How is MiPet Easecto used?
Danish: Hvordan anvendes MiPet Easecto?
English: For more information about treatment with MiPet Easecto, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med MiPet Easecto, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: For practical information about using MiPet Easecto, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af MiPet Easecto, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: What benefits of MiPet Easecto have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved MiPet Easecto?
English: How does MiPet Easecto work?
Danish: Hvordan virker MiPet Easecto?
English: He/she may decide if your dose should be adjusted.
Danish: Han/hun kan afgøre, om Deres dosis skal justeres.
English: • Risk management plan (RMP) Not applicable.
Danish: Risikostyringsplan (RMP) Ikke relevant.
English: In the elderly, the half-life is increased by about 40 % (10 to 11 hours).
Danish: Hos ældre øges halveringstiden med ca. 40 % (10 til 11 timer).
English: You should not stop your treatment without discussing this with your doctor.
Danish: De bør ikke standse med behandlingen uden aftale med Deres læge..
English: Read all of this leaflet carefully before you or your child start using this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden De eller Deres barn begynder at bruge dette lægemiddel, da den indeholder vigtige oplysninger.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/741/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/741/001
English: There was no effect on embryomortality and no increased incidence of malformations.
Danish: Der var ingen effekt på embryo-mortaliteten og ingen øget forekomst af malformationer.
English: Date of latest renewal: 14 November 2016
Danish: Dato for første markedsføringstilladelse: 14. december 2011 Dato for seneste fornyelse: 14. november 2016
English: Levetiracetam SUN must be administered twice a day, once in the morning and once in the evening, at about the same time each day.
Danish: Levetiracetam SUN skal indgives to gange dagligt, én gang om morgenen og én gang om aftenen, på omtrent samme tidspunkt hver dag.
English: The pharmacokinetic and safety profiles did not identify any safety concerns.
Danish: Farmakokinetik og sikkerhedsprofiler identificerede ingen sikkerhedsproblemer.
English: The major metabolic pathway (24 % of the dose) is an enzymatic hydrolysis of the acetamide group.
Danish: Den vigtigste metaboliseringsvej (24 % af dosis) er enzymatisk hydrolyse af acetamid-gruppen.
English: You can be switched from one to the other without changing dose.
Danish: De kan blive skiftet fra den ene til den anden uden dosisjustering.
English: Hydrolysis of the acetamide group was measurable in a large number of tissues including blood cells.
Danish: Hydrolyse af acetamidgruppen var målelig i en lang række væv, inklusive blodceller.
English: Cases of encephalopathy generally occurred at the beginning of the treatment (few days to a few months) and were reversible after treatment discontinuation.
Danish: Tilfælde af encefalopati forekom generel i begyndelsen af behandlingen (fra få dage til flere måneder) og var reversibel efter seponering af behandlingen.
English: Polska Ranbaxy (Poland) Sp. Z o. o.
Danish: Ranbaxy (Poland) Sp. Z o. o. ul.
English: If not used immediately, in-use storage time and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke anvendes umiddelbart, er opbevaringstid og opbevaringsbetingelser før anvendelse brugerens eget ansvar og vil normalt ikke være mere end 24 timer ved 2-8 °C, medmindre fortyndingen er foretaget under kontrollerede og validerede aseptiske forhold.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and carcinogenic potential.
Danish: Non-kliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, genotoksicitet og carcinogent potentiale.
English: Blood methotrexate and levetiracetam levels should be carefully monitored in patients treated concomitantly with the two drugs
Danish: Niveauet af methotrexat og levetiracetam i blodet bør omhyggeligt monitoreres hos patienter, som behandles samtidigt med de to lægemidler.
English: Currently available data are described in sections 4.8, 5.1, and 5.2 but no recommendation on a posology can be made.
Danish: 4.8, 5.1, og 5.2, men der kan ikke gives nogen anbefaling vedrørende dosering.
English: In addition, it partially reverses the reductions in GABA- and glycine-gated currents induced by zinc and β-carbolines.
Danish: Desuden ophæver det delvist reduktionen i GABA- og glycin-medierede strømme, induceret af zink og βcarboliner.
English: This leaflet was last revised in {month/YYYY} Other sources of information
Danish: Denne indlægsseddel blev senest ændret {måned ÅÅÅÅ} Andre informationskilder
English: Neither levetiracetam nor its primary metabolite are significantly bound to plasma proteins (< 10 %).
Danish: Hverken levetiracetam eller den primære metabolit bindes i signifikant grad til plasmaproteiner (<10 %).
English: Your total daily dose and frequency of administration remain the same.
Danish: Deres totale daglige dosis og antal indgivelser forbliver den samme.
English: Adverse reactions are presented in the order of decreasing seriousness and their frequency is defined as follows: 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) and very rare (<1/10,000).
Danish: Bivirkningerne er præsenteret i rækkefølge efter faldende alvorlighed, og deres hyppighed er defineret på følgende måde: 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).
English: Alcohol No data on the interaction of levetiracetam with alcohol are available.
Danish: Alkohol Der foreligger ingen data vedrørende interaktion mellem levetiracetam og alkohol.
English: Conversion to or from oral to intravenous administration can be done directly without titration.
Danish: Overgang til eller fra oral til intravenøs anvendelse kan foretages direkte uden titrering.
English: Therefore a 50 % reduction of the daily maintenance dose is recommended when the creatinine clearance is < 60 ml/min/1.73 m2.
Danish: Derfor anbefales en reduktion på 50 % af den daglige vedligeholdelsesdosis, når kreatininclearance er <60 ml/min/1,73 m2.
English: Patients are advised not to drive or use machines until it is established that their ability to perform such activities is not affected.
Danish: Patienter rådes til ikke at føre motorkøretøj og betjene maskiner, før det er fastslået, at deres evne til at udføre sådanne aktiviteter ikke er påvirket.
English: Levetiracetam SUN concentrate is an alternative for patients when oral administration is temporarily not feasible.
Danish: Levetiracetam SUN-koncentrat er et alternativ til patienter, når oral administration midlertidigt ikke er mulig.
English: Six-month seizure freedom was achieved in 73.0% of levetiracetam-treated patients and 72.8% of carbamazepine-CR treated patients; the adjusted absolute difference between treatments was 0.2% (95% CI: -7.8 8.2).
Danish: 6 måneders anfaldsfrihed blev opnået hos 73,0 % af de patienter, som blev behandlet med levetiracetam og hos 72,8 % af de patienter, som blev behandlet med carbamazepin CR; den tilpassede absolutte forskel mellem behandlingerne var 0,2 % (95 % CI: -7,8 8,2).
English: The dialyser extraction efficiency is 60 % for levetiracetam and 74 % for the primary metabolite.
Danish: Effektiviteten ved dialyseekstraktion er 60 % for levetiracetam og 74 % for den primære metabolit.
English: Levetiracetam therapy can be initiated with either intravenous or oral administration.
Danish: Behandling med Levetiracetam kan indledes med enten intravenøs eller oral administration.
English: The major route of excretion was via urine, accounting for a mean 95 % of the dose (approximately 93 % of the dose was excreted within 48 hours).
Danish: Hovedparten blev udskilt via urinen, gennemsnitligt 95 % af dosis (ca. 93 % af dosis blev udskilt inden for 48 timer).
English: Adverse reactions reported in clinical studies (adults, adolescents, children and infants > 1 month) and from post-marketing experience are listed in the following table per System Organ Class and per frequency.
Danish: Bivirkninger rapporteret fra kliniske studier (voksne, unge, børn og spædbørn >1 måned)) og efter markedsføring er angivet i nedenstående tabel i henhold til systemorganklasse og hyppighed.
English: UB3 4AZ HAYES United Kingdom tel. +44 (0) 208 848 8688
Danish: UB3 4AZ HAYES United Kingdom Phone: +44 (0) 208 848 8688
English: A doctor or a nurse will administer you Levetiracetam SUN as an intravenous infusion.
Danish: En læge eller en sygeplejerske vil give Dem Levetiracetam SUN som intravenøs infusion.
English: • Periodic safety update reports (PSURs) The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu..
English: Results related to behavioural and emotional functioning indicated a worsening in levetiracetam treated patients on aggressive behaviour as measured in a standardized and systematic way using a validated instrument (CBCL - Achenbach Child Behavior Checklist).
Danish: Resultater relateret til adfærds- og følelsesmæssig funktion indikerede en forværring af aggressiv adfærd hos patienter behandlet med levetiracetam, vurderet på en standardiseret og systematisk måde ved brug af et valideret værktøj (CBLC - Achenbach Child Behavior Checklist).
English: In a study reflecting clinical practice, the concomitant antiepileptic medication could be withdrawn in a limited number of patients who responded to levetiracetam adjunctive therapy (36 adult patients out of 69).
Danish: I et studie, som afspejlede klinisk praksis, kunne samtidig antiepileptisk medicin seponeres hos et begrænset antal patienter, som responderede på levetiracetam som tillægsbehandling (36 voksne patienter ud af 69).
English: Due to possible different individual sensitivity, some patients might experience somnolence or other central nervous system related symptoms, especially at the beginning of treatment or following a dose increase.
Danish: Da den individuelle følsomhed er forskellig, kan nogle patienter opleve døsighed eller andre CNS- relaterede symptomer især i begyndelsen af behandlingen eller ved dosisøgning.
English: It was concluded that levetiracetam was not different (non inferior) from placebo with regard to the change from baseline of the Leiter-R Attention and Memory, Memory Screen Composite score in the per-protocol population.
Danish: Det blev konkluderet, at levetiracetam ikke adskilte sig (non-inferiort) fra placebo, hvad angår ændring i forhold til baseline i score opnået i ”Leiter-R Attention and Memory, Memory Screen Composite"- testen i per protokol-populationen.
English: At the beginning of the treatment or at dose increase of the side effects like sleepiness, tiredness and dizziness may be more common.
Danish: I begyndelsen af behandlingen eller i forbindelse med dosisøgning kan bivirkninger såsom søvnighed, træthed og svimmelhed være mere almindelige.
English: - A small number of people being treated with anti-epileptics such as Levetiracetam SUN have had thoughts of harming or killing themselves.
Danish: - En lille andel af de personer, der bliver behandlet med epilepsimedicin, som for eksempel Levetiracetam SUN, har haft selvmordstanker eller tanker om at gøre skade på sig selv.
English: The cumulative urinary excretion of levetiracetam and its primary metabolite accounted for 66 % and 24 % of the dose, respectively during the first 48 hours.
Danish: Den akkumulerede urinudskillelse af levetiracetam og dets primære metabolit var inden for de første 48 timer henholdsvis 66 % og 24 % af dosis.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Der er anført en 2D-stregkode, som indeholder en entydig identifikator
English: However subjects, who took levetiracetam in the long-term open label follow-up study, did not experience a worsening, on average, in their behavioural and emotional functioning; in particular measures of aggressive behavior were not worse than baseline.
Danish: Deltagere, som fik levetiracetam i det langvarige, åbne opfølgningsstudie, oplevede imidlertid generelt ikke nogen forværring af deres adfærds- og følelsesmæssige funktion; navnlig var graden af aggressiv adfærd ikke forværret i forhold til baseline.
English: Do not use Levetiracetam SUN - if you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Levetiracetam SUN - Hvis De er allergisk over for levetiracetam, pyrrolidonderivater eller et af de øvrige indholdsstoffer i Levetiracetam SUN (angivet i punkt 6).
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på de fremstillerne, der er ansvarlige for batchfrigivelse
English: From a microbiological point of view, the product should be used immediately after dilution.
Danish: Ud fra et mikrobiologisk synspunkt, bør præparatet anvendes umiddelbart efter fortynding.
English: For doctors and nurses, more detailed direction for the proper use of Levetiracetam SUN is provided in section 6.
Danish: For læger og sygeplejersker er der angivet mere detaljerede retningslinjer for korrekt anvendelse af Levetiracetam SUN i punkt 6.
English: The intravenous formulation is an alternative to the oral formulation.
Danish: Den intravenøse formulering er et alternativ til indtagelse gennem munden.
English: Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Danish: Levetiracetam er et lægemiddel mod epilepsi (et lægemiddel som anvendes til behandling af epileptiske anfald).
English: NL-2132 JH Hoofddorp The Netherlands
Danish: NL-2132 JH Hoofddorp Holland
English: This recommendation is based on a study in adult renally impaired patients.
Danish: Nedenstående anbefaling er baseret på et studie med voksne patienter med nedsat nyrefunktion.
English: Pancytopenia neutropenia, agranulocytosis
Danish: Pancytopeni, neutropeni, agranulocytose
English: 1500 mg twice daily (1) Children 25 kg or less should preferably start the treatment with an oral solution.
Danish: 1500 mg to gange dagligt (1) Børn på 25 kg og derunder bør starte behandlingen med en oral opløsning.
English: The following information is intended for healthcare professionals only: Directions for the proper use of Levetiracetam SUN is provided in section 3.
Danish: Nedenstående oplysninger er til læger og sundhedspersonale: Retningslinjer for korrekt anvendelse af Levetiracetam SUN er beskrevet i punkt 3.
English: In addition, levetiracetam does not affect the in vitro glucuronidation of valproic acid.
Danish: Desuden påvirker levetiracetam ikke in vitro-glukuronidering af valproatsyre.
English: The active substance, levetiracetam, is a pyrrolidone derivative (S-enantiomer of α-ethyl-2-oxo-1-pyrrolidine acetamide), chemically unrelated to existing antiepileptic active substances.
Danish: Det aktive stof, levetiracetam er et pyrrolidonderivat (S-enantiomer af α-ethyl-2-oxo-1pyrrolidinacetamid), og er kemisk set ikke beslægtet med kendte antiepileptisk aktive stoffer.