FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the evaluation of the currently-available data, the CVMP concluded that the overall benefitrisk balance for veterinary medicinal products containing zinc oxide to be administered orally to pigs is negative, as the benefits of zinc oxide for the prevention of diarrhoea in pigs do not outweigh the risks for the environment.
Danish: På baggrund af evalueringen af de oplysninger, der er tilgængelige på nuværende tidspunkt, konkluderede CVMP, at det overordnede benefit/risk-forhold for veterinære lægemidler, der indeholder zinkoxid og skal gives oralt til svin, er negativt, da fordelene ved zinkoxid til forebyggelse af diarré hos svin ikke opvejer risikoen for miljøet.
English: EMA/394961/2017
Danish: juni 2017
English: Oral use bottle (HDPE)
Danish: Filmovertrukket tablet Oral anvendelse Flaske (HDPE)
English: It is given once a day for five days.
Danish: Det gives en gang dagligt i fem dage.
English: The medicine was well tolerated.
Danish: Lægemidlet tolereredes godt.
English: This summary was last updated in November 2008.
Danish: Dette sammendrag blev sidst ajourført i 11-2008.
English: It is available in a 10 ml bottle.
Danish: Det fås i en 10 ml flaske.
English: This is usually temporary and happens primarily in older dogs.
Danish: Dette er sædvanligvis midlertidigt og forekommer hovedsageligt hos ældre hunde.
English: One large field trial was conducted in different centres throughout Europe.
Danish: Der blev gennemført en stor feltundersøgelse i forskellige centre rundt om i Europa.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Easotic to Virbac S.A. on 20/11/2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Easotic til Virbac S.A. den 20.11.2008.
English: Other information about Easotic:
Danish: Andre oplysninger om Easotic:
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) EASOTIC EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) EASOTIC EPAR - sammendrag for offentligheden
English: The inside of the ear should be cleaned and dried before treatment and any excess hair cut away.
Danish: Indersiden af øret skal renses og tørres inden behandlingen, og overskydende hår klippes af.
English: Mild reddening of the ear has been seen in around 2% of dogs.
Danish: Der er iagttaget mild rødme i øret i ca. 2 % af hundene.
English: The dose is 1 ml, which is given directly into the ear by one activation of the pump supplied with the bottle.
Danish: Dosis er 1 ml, der gives direkte i øret ved at aktivere pumpen, som leveres med flasken.
English: Equal numbers of dogs were assigned to each group, of different breeds, ages, sex and weight.
Danish: Grupperne bestod af det samme antal hunde, men med forskellig race, alder, køn og vægt.
English: Easotic has been studied in dogs in both laboratory and field trials.
Danish: Easotic blev undersøgt hos hunde i både laboratorie- og feltundersøgelser.
English: This stops the bacteria growing, resulting in their death.
Danish: Det standser bakteriernes vækst, hvilket resulterer i, at de dør.
English: It acts by preventing bacteria making proteins.
Danish: Det virker ved at forhindre bakterier i at producere proteiner.
English: Gentamicin sulphate is an antibiotic that belongs to the group aminoglycosides.
Danish: Gentamicinsulfat er et antibiotikum, som tilhører gruppen af aminoglycosider.
English: If a person accidentally takes the medicine or eye irritation occurs, seek medical advice immediately and show the package leaflet or the label to a doctor.
Danish: Hvis en person ved en fejl indtager lægemidlet, eller hvis der opstår øjenirritation, skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: Ear infections in dogs can be caused by bacteria or fungi.
Danish: Øreinfektioner hos hunde kan forårsages af bakterier eller svampe.
English: What is the risk associated with Easotic?
Danish: Hvilken risiko er der forbundet med Easotic?
English: Easotic contains three active substances: hydrocortisone aceponate, miconazole nitrate and gentamicin sulphate.
Danish: Easotic indeholder tre aktive stoffer: hydrocortisonaceponat, miconazolnitrat og gentamicinsulfat.
English: If accidental skin or eye contact occurs, wash immediately with lots of water.
Danish: Ved utilsigtet kontakt med hud eller øjne skal det pågældende område straks vaskes med rigeligt vand.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Easotic exceed the risks for the treatment of acute otitis externa, and acute exacerbation of recurrent otitis externa associated with bacteria susceptible to gentamicin and fungi susceptible to miconazole in particular Malassezia pachydermatis, and recommended that Easotic be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Easotic var større end risiciene ved behandling af akut ekstern otitis og akut forværring af recidiverende ekstern otitis forårsaget af bakterier, der er modtagelige for gentamicin, og svampe, der er modtagelige for miconazol, især Malassezia pachydermatis, og anbefalede udstedelse af markedsføringstilladelse for Easotic.
English: They often lead to the ear(s) being inflamed (red, swollen and itchy).
Danish: De medfører ofte inflammation i øret/ørerne (rødme, hævelse og kløe).
English: Easotic must not be used in dogs that may be allergic to the active substances or any of the other ingredients, if the eardrum is perforated, at the same time as other medicines that can harm the ear, or in dogs with a parasite infection called generalised demodecosis (mange).
Danish: Easotic må ikke anvendes til hunde, som kan være allergiske over for de aktive stoffer eller et af de andre stoffer, hvis trommehinden er perforeret, samtidigt med andre lægemidler, som kan beskadige øret, eller til hunde med en parasitinfektion kaldet generaliseret demodecose (skab).
English: Hydrocortisone aceponate is a glucocorticosteroid, which is a type of substance that helps to reduce inflammation and itching.
Danish: Hydrocortisonaceponat er et glucocorticosteroid, hvilket er en form for stof, som medvirker til at reducere inflammation og kløe.
English: What is Easotic?
Danish: Hvad er Easotic?
English: It is an ear drop suspension for dogs, that is white in colour.
Danish: Det er øredråber, hvid suspension, til hunde.
English: Two of the active substances in Easotic, miconazole nitrate and gentamicin sulphate, work against the cause of the infection, while the third one, hydrocortisone aceponate, works on the inflammation.
Danish: To af de aktive stoffer i Easotic, miconazolnitrat og gentamicinsulfat, modarbejder årsagen til infektionen, mens det tredje, hydrocortisonaceponat, indvirker på inflammationen.
English: Why has Easotic been approved?
Danish: Hvorfor blev Easotic godkendt?
English: Easotic is used to treat dogs that suffer from acute or recurrent episodes of ear infections (otitis externa).
Danish: Easotic anvendes til behandling af hunde, som lider af akutte eller recidiverende øreinfektioner (ekstern otitis).
English: The use of ear preparations may be associated with damage to hearing.
Danish: Anvendelse af ørepræparater kan medføre høreskader.
English: In the study, the effectiveness of Easotic was compared with that of ear drops containing three similar active substances in dogs with acute or recurrent bacterial or fungal ear infections.
Danish: I undersøgelsen blev Easotics effekt sammenlignet med effekten af øredråber indeholdende tre lignende stoffer hos hunde med akut eller recidiverende bakterie- eller svampeinfektioner i øret.
English: For a full list of all side-effects reported with Easotic, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Easotic fremgår af indlægssedlen.
English: Miconazole nitrate is an antifungal that works by preventing the formation of ergosterol, which is an important part of fungal cell walls.
Danish: Miconazolnitrat er et middel mod svampe, som virker ved at forebygge dannelse af ergosterol, der er en vigtig komponent i svampecellernes væg.
English: What is Easotic used for?
Danish: Hvad anvendes Easotic til?
English: How has Easotic been studied?
Danish: Hvordan blev Easotic undersøgt?
English: When used at the recommended dose for five days, Easotic was as effective as the comparator medicine in improving the symptoms of ear infection (redness, swelling, ear discharge and discomfort).
Danish: Easotic var lige så effektivt som komparatorlægemidlet til at forbedre symptomerne på øreinfektion (rødme, hævelse, øreflåd og ubehag), når det blev anvendt i den anbefalede dosis i fem dage.
English: What benefit has Easotic shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Easotic?
English: How does Easotic work?
Danish: Hvordan virker Easotic?
English: List of the name, pharmaceutical form, strength of the medicinal product, route of administration, marketing authorisation holder in the Member States
Danish: Liste over navne, lægemiddelformer, lægemiddelstyrke, indgivelsesvej, indehaver af markedsføringstilladelsen i medlemslandene
English: Austria implant, pre-filled syringe subcutaneous use
Danish: Østrig implantat, fyldt injektionssprøjte
English: NexGard received a marketing authorisation valid throughout the EU on 11 February 2014.
Danish: NexGard fik en markedsføringstilladelse med gyldighed i hele EU den 11. februar 2014.
English: NexGard kills fleas within 8 hours and ticks within 48 hours.
Danish: NexGard dræber lopper i løbet af 8 timer og flåter i løbet af 48 timer.
English: Further information on NexGard can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/NexGard.
Danish: Yderligere oplysninger om NexGard findes på agenturets websted under: ema.europa.eu/medicines/veterinary/EPAR/NexGard.
English: The European Medicines Agency decided that NexGard's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur besluttede, at fordelene ved NexGard opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Only one chewable tablet at a time should be removed from the blister to prevent children from accessing the product.
Danish: Der bør kun fjernes én tyggetablet ad gangen fra blisterkortet for at forhindre børn i at få adgang til produktet.
English: The effectiveness of NexGard was investigated in both laboratory and field studies.
Danish: NexGards effektivitet er undersøgt i både laboratorieundersøgelser og feltstudier.
English: Afoxolaner kills parasites by causing an over-stimulation of their nervous system.
Danish: Afoxolaner dræber parasitter ved at fremkalde en overstimulering af deres nervesystem.
English: Other information about NexGard
Danish: Andre oplysninger om NexGard
English: It blocks the normal movement of charged chloride particles (ions) in and out of nerve cells, especially those associated with gamma-aminobutyric acid (GABA), a substance which conveys messages between nerves (neurotransmitter).
Danish: Det blokerer den normale transport af ladede kloridpartikler (ioner) ind og ud af nervecellerne, navnlig dem, der er forbundet med gammaaminosmørsyre (GABA), et stof, der overfører signaler mellem nerverne
English: After being given, its actions last for at least 5 weeks against fleas and up to one month against ticks.
Danish: Efter indgivelse holder virkningen sig i mindst 5 uger mod lopper og op til én måned mod flåter.
English: Because parasites must start feeding on the dog in order to be killed by the medicine, there may be a risk of transmission of diseases with which they may be infected.
Danish: Da parasitter skal begynde at suge næring fra hunden for at blive dræbt af lægemidlet, kan det ikke udelukkes, at de kan overføre sygdomme, de kan være inficeret med.
English: In order for the active substance to have an effect, fleas and ticks must attach to the skin and commence feeding on the dog's blood.
Danish: For at det aktive stof kan blive virksomt, skal lopper og flåter først hægte sig fast i huden og begynde at tage næring fra hundens blod.
English: For more information about using NexGard, see the package leaflet or contact your veterinarian or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af NexGard, kan du læse indlægssedlen eller kontakte din dyrlæge eller apoteket.
English: NexGard reduced the number of fleas and ticks by at least 98% and was at least as effective as a spoton medicine containing pyriprole (another medicine against fleas and ticks).
Danish: NexGard reducerede antallet af lopper og flåter med mindst 98 % og var mindst lige så effektivt som et spot-on-lægemiddel, der indeholder pyriprol (et andet lægemiddel mod lopper og flåter).
English: NexGard is given as a tablet of the appropriate strength for the dog's bodyweight.
Danish: NexGard gives som en tablet af passende styrke til hundens kropsvægt.
English: An overview of NexGard and why it is authorised in the EU
Danish: En oversigt over NexGard, og hvorfor det er godkendt i EU
English: Treatment should be repeated at monthly intervals during the flea or tick seasons, monthly for demodectic mange until the mange is successfully treated (as confirmed by two negative skin scrapings one month apart) and monthly for two months for sarcoptic mange, or longer if treatment is unsuccessful as indicated by clinical signs and skin scrapings.
Danish: Behandlingen bør gentages med månedlige intervaller i løbet af loppe- eller flåtsæsonen, månedligt ved demodicoseskab, indtil skabet er behandlet med vellykket resultat (som bekræftet ved to negative hudskrabninger med én måneds mellemrum) og månedligt i to måneder ved sarcoptesskab eller længere, hvis kliniske tegn og hudskrabninger viser, at behandlingen ikke har virket.
English: Why is NexGard authorised in the EU?
Danish: Hvorfor blev NexGard godkendt i EU?
English: NexGard contains the active substance afoxolaner.
Danish: NexGard indeholder det aktive stof afoxolaner.
English: What is NexGard and what is it used for?
Danish: Hvad er NexGard, og hvad anvendes det til?
English: NexGard reduced the number of live mites by 97% 56 days after starting treatment and by 98% 84 days after starting treatment.
Danish: NexGard reducerede antallet af levende mider med 97 % 56 dage efter påbegyndelse af behandlingen og med 98 % 84 dage efter påbegyndelse af behandlingen.
English: In an EU field study involving 146 dogs with flea and/or tick infestations, a single treatment with NexGard was effective in treating flea and tick infestations in dogs for up to 30 days after treatment.
Danish: I en EU-feltundersøgelse med 146 hunde med angreb af lopper og/eller flåter var en enkelt behandling med NexGard effektiv ved angreb af lopper og flåter hos hunde i op til 30 dage efter behandlingen.
English: What are the risks associated with NexGard?
Danish: Hvilke risici er der forbundet med NexGard?
English: Afoxolaner kills fleas before they can lay eggs and so helps to reduce contamination of the dogs' environment.
Danish: Afoxolaner dræber lopperne, før de kan lægge æg, og nedsætter derved spredning af smitte til hundens omgivelser.
English: NexGard is a medicine used to treat infestations with fleas and ticks, as well as demodectic and sarcoptic mange (skin infestations caused by two different types of mites) in dogs.
Danish: NexGard er et lægemiddel, der anvendes til behandling af angreb med lopper og flåter såvel som demodicose- og sarcoptesskab (skadedyrsangreb i huden forårsaget af to forskellige typer af mider) hos hunde.
English: NexGard reduced the number of live mites by 96% 28 days after starting treatment and by 100% 56 days after starting treatment.
Danish: NexGard reducerede antallet af levende mider med 96 % 28 dage efter påbegyndelse af behandlingen og med 100 % 56 dage efter påbegyndelse af behandlingen.
English: A third EU field study involved 38 dogs with sarcoptic mange which were treated monthly for two months with NexGard.
Danish: En tredje EU-feltundersøgelse omfattede 38 hunde med sarcoptesskab, som blev behandlet månedligt i to måneder med NexGard.
English: It may be used as part of the management of flea allergy dermatitis (an allergic reaction to flea bites).
Danish: Det kan anvendes som led i behandlingen af hudbetændelse forårsaget af loppebid (en allergisk reaktion mod loppebid).
English: The active substance in NexGard, afoxolaner, acts as an ‘ectoparasiticide'.
Danish: Det aktive stof i NexGard, afoxolaner, er et ektoparasitdræbende middel.
English: NexGard is available as chewable tablets in four different strengths for use in dogs of different weights.
Danish: NexGard fås som tyggetabletter i fire forskellige styrker, så de kan anvendes til hunde med forskellig vægt.
English: A second EU field study involved 31 dogs with demodectic mange which were treated monthly on 3 occasions with NexGard.
Danish: En anden EU-feltundersøgelse omfattede 31 hunde med demodicoseskab, som blev behandlet tre gange med en måneds mellemrum med NexGard.
English: This results in uncontrolled activity of the nervous system and the paralysis and
Danish: Dette medfører ukontrolleret aktivitet i nervesystemet, så lopperne, flåterne og miderne lammes og dør.
English: How is NexGard used?
Danish: Hvordan anvendes NexGard?
English: How does NexGard work?
Danish: Hvordan virker NexGard?
English: What benefits of NexGard have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved NexGard?
English: These patients should be monitored closely.
Danish: Disse patienter bør monitoreres tæt.
English: > 3 hours to ≤ 7 days
Danish: > 3 timer til ≤ 7 dage
English: YES NO
Danish: JA NEJ
English: The company will start to include the pre-infusion check list in packs packed at the packaging site as soon as possible but at the latest on 15 November 2012.
Danish: Virksomheden vil begynde at inkludere tjeklisten i pakningerne på pakkestedet snarest muligt, men senest den 15. november 2012.
English: Date of first authorisation: 01 September 2010 Date of latest renewal: 06 September 2015
Danish: Dato for første markedsføringstilladelse: 01. september 2010 Dato for seneste fornyelse: 01. september 2015
English: Read all steps before administration.
Danish: Læs alle punkter før administration.
English: When giving BRINAVESS, follow these instructions:
Danish: Ved indgivelse af BRINAVESS skal disse instruktioner følges:
English: Overall, BRINAVESS was effective in 70.2% (1,359/1,936) of these patients.
Danish: Overordnet var BRINAVESS effektivt hos 70,2% (1.359/1.936) af disse patienter.
English: 15 rue du Bicentenaire 92800 Puteaux France
Danish: 15 rue du Bicentenaire 92800 Puteaux Frankrig
English: In the remaining patients, electrical cardioversion can be recommended.
Danish: Hos de resterende patienter kan elektrisk konvertering anbefales.
English: Efficacy versus amiodarone (AVRO)
Danish: Effekt versus amiodaron (AVRO)
English: Tell your doctor if you have a pacemaker.
Danish: Fortæl det til lægen, hvis De har pacemaker.
English: Variations of colour within this range do not affect potency.
Danish: Farvevariationer inden for dette område påvirker ikke virkningsgraden.
English: ACT III BRINAVESS Placebo P-Value† BRINAVESS Placebo P-Value†
Danish: ACT III BRINAVESS Placebo P-værdi† BRINAVESS Placebo P-værdi†
English: Patients who did not respond to treatment were managed by the physician using standard care.
Danish: Patienter, som ikke responderede på behandlingen, blev håndteret af lægen ved anvendelse af standardbehandling.
English: †Cochran-Mantel-Haenszel test
Danish: †Cochran-Mantel-Haenszel (CMH) test
English: By 90 minutes after the start of infusion, this difference was reduced to 8.1 msec.
Danish: 90 minutter efter infusionsstart var denne difference reduceret til 8,1 ms.
English: Your doctor may decide to stop the infusion if he observes any of the following abnormal changes of:
Danish: Deres læge kan beslutte at stoppe infusionen, hvis han/hun iagttager nogen af følgende ikke ser unormale forandringer af:
English: However, a syringe pump is acceptable provided that the calculated volume can be accurately given within the specified infusion time.
Danish: Dog er en sprøjtepumpe acceptabel, forudsat at den beregnede volumen kan gives præcist inden for den specificerede infusionstid.
English: The osmolality of the medicinal product is controlled between the following range: 270-320 mOsmol/kg
Danish: Lægemidlets osmolalitet er kontrolleret inden for følgende område: 270-320 mOsmol/kg
English: These reactions occurred around the time of infusion, were transient and were rarely treatment limiting.
Danish: Disse reaktioner forekom omkring infusionstidspunktet, var forbigående og var sjældent begrænsende for behandlingen.
English: You must not use BRINAVESS if any of the above apply to you.
Danish: De må ikke bruge BRINAVESS, hvis noget af ovenstående passer på Dem.
English: BRINAVESS must NOT be given to any patients with a “YES” response below:
Danish: BRINAVESS må IKKE gives til patienter, hvis der kan svares "JA" til et af nedenstående spørgsmål:
English: The diluted sterile concentrate is chemically and physically stable for 12 hours at or below 25 °C.
Danish: Det fortyndede sterile koncentrat er kemisk og fysisk stabilt i 12 timer ved eller under 25 °C.
English: It will be given to you into your vein over 10 minutes.
Danish: De vil få det i en blodåre over 10 minutter.
English: If you think that you may have been given too much BRINAVESS, tell your doctor straight away.
Danish: Hvis De tror, De kan have fået for meget BRINAVESS, skal De straks sige det til lægen.
English: In general, bradycardia responded well to discontinuation of treatment and/or administration of atropine.
Danish: Generelt reagerede bradykardi godt på seponering af behandlingen og/eller administration af atropin.
English: From a microbiological point of view, the medicinal product should be used immediately.
Danish: Fra et mikrobiologisk synspunkt bør lægemidlet anvendes straks.
English: Does the patient have a systolic blood pressure < 100 mm Hg?
Danish: Har patienten et systolisk blodtryk < 100 mm Hg?
English: If you get dizzy, you should avoid driving or operating machinery after receiving BRINAVESS.
Danish: Hvis De bliver svimmel, bør De undgå at køre bil eller betjene maskiner, efter De har fået BRINAVESS.
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon
Danish: Hyppighederne defineres som: Meget almindelig (≥ 1/10); Almindelig (≥ 1/100 til < 1/10); Ikke almindelig (≥ 1/1.000 til ≤ 1/100).
English: Before giving you this medicine, your doctor will decide whether to test your blood to see how well it clots and also to see your potassium level.
Danish: Før De får denne medicin, vil lægen beslutte, om Deres blod skal undersøges for at se, hvor godt det størkner og også for at se indholdet af kalium.
English: With continuation of the medicine infusion as recommended above, the majority of these patients continue to convert to sinus rhythm.
Danish: Ved fortsættelse af medicininfusion som anbefalet ovenfor fortsætter flertallet af patienter med at konvertere til sinusrytme.
English: • you are taking other rhythm control medicines
Danish: • De tager anden medicin til rytmekontrol
English: • if you have had new or worsening chest pain (angina) diagnosed by your doctor as an acute coronary syndrome in the last 30 days or you have had a heart attack in the last 30 days
Danish: • hvis De har haft nye eller forværrede smerter i brystet (angina), som af Deres læge er blevet diagnosticeret som akut koronar syndrom inden for de seneste 30 dage, eller hvis De har haft et hjerteanfald inden for de seneste 30 dage
English: Information on how to prepare the solution is available at the end of this leaflet.
Danish: Oplysninger om tilberedningen af opløsningen er givet i slutningen af denne indlægsseddel.
English: If you have very low blood pressure or slow heart rate or certain changes in your ECG while using this medicine, your doctor will stop your treatment.
Danish: Hvis De har meget lavt blodtryk eller langsom hjerterytme eller visse forandringer i Deres EKG, mens De får denne medicin, vil lægen stoppe behandlingen.