FrancophonIA/ELRC3.0 huggingface dataset:
English: The percentage of subjects who had a level of antibodies in their blood that was high enough to neutralise the H1N1 virus (seroprotection rate) was 100% in children and close to 100% in adults.
Danish: Andelen af forsøgspersoner, som havde en tilstrækkelig høj mængde antistoffer i blodet til at neutralisere H1N1-virusset (serobeskyttelsesprocent), var 100 % i børnenes tilfælde og tæt på 100 % i de voksnes tilfælde.
English: This will include information on its side effects and its safety in children, the elderly, pregnant women, patients with severe conditions and people who have problems with their immune systems.
Danish: Dette omfatter oplysninger om vaccinens bivirkninger og sikkerhed, når den gives til børn, ældre, gravide, meget syge patienter og personer med nedsat immunforsvar.
English: The company also presented information from studies in 641 adults carried out using an earlier version of Humenza, containing a ‘bird flu' strain H5N1.
Danish: Virksomheden har desuden fremlagt oplysninger fra undersøgelser af 641 voksne, som blev udført under anvendelse af en tidligere version af Humenza indeholdende en ”fugleinfluenza”-stamme af typen H5N1.
English: Humenza contains a flu strain called A/California/7/2009 (H1N1)-like strain (NYMC X-179A).
Danish: Humenza indeholder en influenzastamme kaldet A/California/7/2009 (H1N1)lignende stamme (NYMC X-179A).
English: Humenza should not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at trace levels in the vaccine, such as ovalbumin (a protein in egg white), egg or chicken proteins, neomycin, octoxinol-9 and formaldehyde.
Danish: Humenza må ikke gives til patienter, der har haft en anafylaktisk reaktion (en alvorlig allergisk reaktion) over for nogen af vaccinens komponenter eller over for nogen af de sporstoffer, den indeholder, f.eks. ovalbumin (et protein i æggehvide), æg, kyllingeprotein, neomycin, octonixol-9 eller formaldehyd.
English: Humenza is a vaccine to protect against ‘pandemic' flu.
Danish: Humenza er en vaccine til beskyttelse mod ”pandemisk” influenza.
English: Humenza contains small amounts of haemagglutinins (proteins from the surface) of a virus called A(H1N1)v that is causing the current pandemic.
Danish: Humenza indeholder små mængder hæmagglutininer (overfladeproteiner) fra et virus kaldet A(H1N1)v, som er årsag til den aktuelle pandemi.
English: The company that makes Humenza will supply further data on the medicine, in particular on its safety from a study in 3,000 subjects.
Danish: Virksomheden, der fremstiller Humenza, vil fremlægge yderligere oplysninger om lægemidlet, navnlig dets sikkerhed, fra en undersøgelse af 3 000 forsøgspersoner.
English: The solvent contains an ‘adjuvant' (a compound containing oil) to enhance the immune response.
Danish: Solvensen indeholder et ”adjuvans” (en olieholdig forbindelse), som giver en bedre immunrespons.
English: Humenza is a vaccine.
Danish: Humenza er en vaccine.
English: Which measures are being taken to ensure the safe use of Humenza?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Humenza?
English: The Committee decided that Humenza's benefits are greater than its risks for the prophylaxis of influenza in the officially declared H1N1 pandemic situation and recommended that it be given marketing authorisation.
Danish: Udvalget besluttede, at fordelene ved Humenza opvejer risiciene, når det anvendes til forebyggende behandling mod influenza under den officielt erklærede H1N1-pandemi, og anbefalede udstedelse af markedsføringstilladelse for Humenza.
English: What is the risk associated with Humenza?
Danish: Hvilken risiko er der forbundet med Humenza?
English: The most common side effects with Humenza (seen with more than 1 in 10 doses of the vaccine) are headache, myalgia (muscle pain) and pain at the site of injection.
Danish: De hyppigste bivirkninger ved Humenza (set ved flere end 1 ud af 10 doser vaccine) er hovedpine, muskelsmerter og smerter på injektionsstedet.
English: What information is still awaited for Humenza?
Danish: Hvilke oplysninger afventes der stadig for Humenza?
English: These studies are looking at the ability of Humenza to trigger the production of antibodies (‘immunogenicity') against the H1N1 flu strain.
Danish: Undersøgelserne ser på Humenzas evne til at aktivere produktionen af antistoffer (”immunogenicitet”) mod H1N1-influenzastammen.
English: Humenza is a vaccine that is given by injection.
Danish: Humenza er en vaccine, der gives som injektion.
English: For the full list of all side effects reported with Humenza, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Humenza fremgår af indlægssedlen.
English: Why has Humenza been approved?
Danish: Hvorfor blev Humenza godkendt?
English: Humenza is given as one dose, injected into the upper arm or thigh muscle.
Danish: Humenza gives som én dosis via injektion i overarmen eller lårmusklen.
English: What is Humenza?
Danish: Hvad er Humenza?
English: How has Humenza been studied?
Danish: Hvordan blev Humenza undersøgt?
English: What is Humenza used for?
Danish: Hvad anvendes Humenza til?
English: Humenza has been given ‘Conditional Approval'.
Danish: Humenza er blevet godkendt under særlige omstændigheder.
English: How is Humenza used?
Danish: Hvordan anvendes Humenza?
English: What benefit has Humenza shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Humenza?
English: How does Humenza work?
Danish: Hvordan virker Humenza?
English: Fipronil: Absolute bioavailability: 9.5 %.
Danish: Fipronil: Absolut biotilgængelighed: 9,5 %.
English: ATCvet code: QP53AX65.
Danish: ATCvet-kode: QP53AX65.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06/05/2011.
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 06/05/2011.
English: The use of protective gloves is recommended.
Danish: Anvendelse af beskyttelseshandsker anbefales.
English: Used pipettes should be disposed of immediately.
Danish: Anvendte pipetter skal bortskaffes straks.
English: Part the coat until the skin is visible.
Danish: Del pelsen indtil huden er synlig.
English: 29, avenue Tony Garnier FR-69007 Lyon France.
Danish: 29, avenue Tony Garnier 69007 Lyon
English: Do not smoke, drink or eat whilst handling.
Danish: Undgå at ryge, drikke eller spise under påføringen.
English: Remove the pipette and hold it upright.
Danish: Fjern pipetten og hold den lodret.
English: Do not use after the expiry date stated on the outer package after EXP.
Danish: Må ikke anvendes efter den udløbsdato, som er angivet på yderpakningen efter EXP.
English: Avoid direct contact with the application site.
Danish: Undgå direkte kontakt med behandlingsstedet.
English: The three active substances are well distributed over the haircoat of the dog during the first week after application.
Danish: De tre aktive stoffer fordeles godt i hundens hårlag i løbet af den første uge efter påføringen.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Nærmere oplysninger om dette veterinærlægemiddel er tilgængelige på webstedet for Det Europæiske Lægemiddelagentur http://www.ema.europa.eu/.
English: The CVMP at their meeting on 18 February 2016 decided that one additional five-year renewal was required in view of the outstanding pharmacovigilance data that were undergoing evaluation at the time of the renewal procedure and to ensure that the MAH's pharmacovigilance system is adequate to enable collection and evaluation of adverse events in line with the requirements.
Danish: CVMP besluttede på deres møde den 18. februar 2016 at en yderligere fornyelse af markedsføringstilladelsen om 5 år er nødvendig set i lyset af de pharmacovigilance data, som var under evaluering på tidpunktet for fornyelsesproceduren og for at sikre at indehaveren af markedsføringstilladelsens pharmacovigilance system er tilstrækkelig i stand til at indsamle og evaluere bivirkninger i overensstemmelse med kravene.
English: Systemic absorption of CERTIFECT is low for all three active substances following topical administration.
Danish: Systemisk absorption af CERTIFECT er lav for alle tre aktive stoffer efter udvortes behandling.
English: Children should not be allowed to play with treated dogs until the application site is dry.
Danish: Giv ikke børn lov til at lege med behandlede hunde, før påføringsstedet er tørt.
English: It is therefore recommended that dogs are not treated during the day, but during the early evening, and that recently treated animals are not allowed to sleep with owners, especially children.
Danish: Det anbefales derfor, at hunde ikke behandles i løbet af dagen men tidligt på aftenen, og at nyligt behandlede dyr ikke får lov til at sove sammen med deres ejere, især børn.
English: Distribution, metabolism, and excretion
Danish: Fordeling, metabolisme og udskillelse
English: Elimination of fleas and ticks within 24 hours.
Danish: Fjernelse af lopper og flåter inden for 24 timer.
English: Major metabolites are distributed over the entire haircoat of the dog.
Danish: Større metabolitter fordeles over hele hundens hårlag.
English: (S)-Methoprene is extensively degraded into carbon dioxide and acetate that are subsequently incorporated into endogenous materials.
Danish: (S)-methopren nedbrydes i udstrakt grad til kuldioxid og acetat, som efterfølgende indgår i endogent materiale.
English: For this reason the transmission of infectious diseases cannot be completely excluded if conditions are unfavourable.
Danish: Derfor kan overførsel af infektiøse lidelser ikke helt udelukkes, såfremt betingelserne er ugunstige.
English: Place the tip of the pipette on the skin.
Danish: Anbring toppen af pipetten på huden.
English: Select the appropriate pipette size for the weight of the dog.
Danish: Vælg den korrekte pipettestørrelse i henhold til hundens vægt.
English: The treated area may appear wet or oily after treatment.
Danish: Det behandlede område kan forekomme vådt eller fedtet efter behandling.
English: Other forms of dermatitis including pemphigus-like conditions may occur in even rarer instances.
Danish: Andre former for dermatitis inklusive pemphigus-lignende tilstande kan forekomme i yderst sjældne tilfælde.
English: For dogs over 60 kg, use the appropriate combination of two pipettes that most closely matches the bodyweight.
Danish: Til hunde over 60 kg anvendes en kombination af de to pipettestørrelser, der kommer tættest på hundens vægt.
English: A pharmacokinetic study in dogs, of the active substances alone and in combination, showed that no drug interactions occur between the active substances that affect their pharmacokinetic parameters.
Danish: En farmakokinetisk undersøgelse hos hund af de aktive stoffer alene samt i kombination viste, at der ikke er nogen interaktion mellem de aktive stoffer, der påvirker de farmakokinetiske parametre.
English: BATCH NUMBER {number}
Danish: BATCHNUMMER nummer
English: In very rare instances, certain sensitive dogs may develop skin irritation at the application site.
Danish: I meget sjældne tilfælde kan visse sensitive hunde udvikle hudirritation på applikationsstedet.
English: This veterinary medicinal product may cause skin sensitisation, allergic reactions and mild eye irritation in humans.
Danish: Dette veterinærlægemiddel kan forårsage hudoverfølsomhed, allergiske reaktioner og mild øjenirritation hos mennesker.
English: Dogs 2-10 kg
Danish: Hund 2-10 kg
English: Studies have demonstrated that there is no pharmacodynamic and pharmacokinetic interaction in mammals between fipronil, (S)-methoprene and amitraz.
Danish: Studier har vist, at der ikke er nogen farmakodynamisk og farmakokinetisk interaktion hos pattedyr mellem fipronil, (S)-methopren og amitraz.
English: Moreover, at sublethal concentrations these compounds have the ability to cause anorexia in acari and suppress their reproduction.
Danish: Endvidere har disse stoffer, i subletale koncentrationer, evne til at forårsage anorexi hos mider og undertrykke deres reproduktion.
English: A low dose of amitraz together with fipronil has shown synergistic efficacy against ticks resulting in an increased speed of kill (starting at 2 hours and greater than 90 % at 24 hours) and a longer duration of activity when compared to the active substances administered alone.
Danish: En lav dosis amitraz sammen med fipronil har vist synergistisk effekt over for flåter, der resulterer i en forøget drabshastighed (starter ved 2 timer og større end 90% efter 24 timer) og længere effektvarighed sammenlignet med de to aktive stoffer administreret alene.
English: Detailed information on this product is available on the website of the European Medicines Agency
Danish: Nærmere oplysninger om dette veterinærlægemiddel er tilgængelige på webstedet for Det Europæiske
English: If the dog requires shampooing, it is better to do so before applying the
Danish: Hvis det er nødvendigt at bade hunden med shampoo, er det bedre at gøre det inden
English: For the 1.07 ml pipette: Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Danish: For 1,07 ml pipette: Opbevaringstid for veterinærlægemidlet i salgspakning: 2 år.
English: Animals or persons with a known hypersensitivity to any of the active ingredients or excipients should avoid contact which, on very rare occasions, can cause respiratory irritation and dermal reactions in certain individuals.
Danish: Dyr eller mennesker med kendt overfølsomhed over for de aktive stoffer eller hjælpestoffer skal undgå kontakt med præparatet, der i meget sjældne tilfælde kan forårsage irritation af luftveje og give hudreaktioner hos visse individer.
English: CERTIFECT spot-on solution
Danish: CERTIFECT spot-on, opløsning
English: Amitraz degrades on the haircoat of the dog into N-methyl-N'-(2,4-xylyl) formamidine (< 5 % of amitraz concentrations).
Danish: Amitraz nedbrydes i hundens pels til N-methyl-N'-(2,4-xylyl)formamidin (< 5 % af amitraz koncentrationer).
English: The concentrations of fipronil, fipronil sulfone, amitraz and S-methoprene in the haircoat then decrease with time and are detectable for at least 58 days after dosing.
Danish: Koncentrationerne af fipronil, fipronilsulfon, amitraz og (S)-methopren i hårlaget aftager med tiden, men kan måles i mindst 58 dage efter behandlingen.
English: Small concentrations of dimethylaniline, a minor degradation product of amitraz, were also observed on the haircoat of the dog post-application but in negligible quantities.
Danish: Små koncentrationer af dimethylanilin, et mindre nedbrydningsprodukt af amitraz, blev også vist i hundens pels efter behandling, men i ubetydelige koncentrationer.
English: Fipronil sulfone is produced on the haircoat (mean concentrations < 16 % of fipronil during the first month after treatment).
Danish: Fipronilsulfon produceres i pelsen (gennemsnitlige koncentrationer på < 16 % af fipronil i den første måned efter behandling).
English: These measures should help
Danish: Disse foranstaltninger skal bidrage til at beskytte miljøet.
English: Apply onto dry skin where the animal cannot lick it off and make sure that animals do not lick
Danish: Påfør præparatet på tør hud, hvor dyret ikke kan slikke det af og sørg for, at dyr ikke slikker hinanden
English: However the attachment of single ticks after treatment cannot be excluded.
Danish: Imidlertid kan tilhæftning af enkelte flåter efter behandling ikke undgås.
English: Each strength of the veterinary medicinal product is available in cards with 1 pipette and in carton
Danish: Hver styrke af veterinærlægemidlet findes som blisterkort med 1 pipette og i æsker med 3 pipetter.
English: (S)-Methoprene is an insect growth regulator (IGR) of the class of compounds known as juvenile hormone analogues that inhibit the development of immature stages of insects.
Danish: (S)-methopren er en insekt vækst regulator (IGR) der tilhører stofgruppen ”juvenile hormonanaloger”, som hæmmer udviklingen af immature insektstadier.
English: In these cases do not treat more frequently than once a fortnight.
Danish: I disse tilfælde skal der ikke behandles hyppigere end med 14 dages interval.
English: Stored pipettes must be kept in the intact foil package.
Danish: Pipetter skal opbevares i den ubrudte foliepakning.
English: Pregnancy and lactation: Can be used during pregnancy and lactation.
Danish: Drægtighed og diegivning: Kan anvendes under drægtighed og diegivning.
English: The mean maximum concentration (Cmax): 19 ng/ml in plasma found after 5 days (Tmax).
Danish: Den gennemsnitlige maksimale koncentration (Cmax): 19 ng/ml i plasma efter 5 dage (Tmax).
English: Do not administer orally or via any other route.
Danish: Må ikke gives gennem munden eller via nogen anden administrationsvej.
English: The secondary packaging consists of a plastic/ aluminium blister with a plastic/ aluminium backing.
Danish: Den ydre pakning er et plastik/aluminium blister med en plastik/aluminium bagside.
English: Fipronil's major metabolite on the haircoat of the dog and in the blood stream is the sulfone derivative.
Danish: Fipronils væsentlige metabolit i hundens pels og i blodet er sulfonderivatet.
English: The on-animal ovicidal activity of (S)-methoprene results from either direct penetration of the eggshell of newly laid eggs or from absorption through the cuticle of the adult fleas.
Danish: Den ovicide effekt af (S)-methopren på hunden skyldes enten direkte penetration gennem skallen af det nylagte æg eller absorption gennem den voksne loppes cuticula.
English: Excipients essential for proper administration: butylhydroxyanisole (0.02 %) and butylhydroxytoluene
Danish: Hjælpestoffer som er nødvendige for korrekt administration: butylhydroxyanisol (0,02 %) og butylhydroxytoluen (0,01 %).
English: For a pack of 3, first separate one blister from the others by tearing along the perforation.
Danish: En pakke med 3 pipetter: først adskilles et blister fra de andre ved at rive langs perforeringen.
English: (S)-Methoprene and Amitraz: Dermal absorption is very low and all plasma concentrations were below the limit of quantification (10 ng/ml) for (S)-methoprene and were undetectable for amitraz (< 0.75 ng/ml) in most samples.
Danish: (S)-methopren og amitraz: Absorptionen gennem hud er meget lav, og alle plasmaværdier var under den målbare grænseværdi (10 ng/ml) for (S)-methopren og ikke sporbar for amitraz (< 0,75 ng/ml) i de fleste prøver.
English: Plasma concentrations were below 1 ng/ml (limit of quantification) by approximately 33 days following topical administration.
Danish: Plasmakoncentrationer var under 1 ng/ml (målbar grænseværdi) ca. 33 dage efter topikal behandling.
English: PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: Other ectoparasiticides for topical use.
Danish: Farmakoterapeutisk gruppe: Andre ektoparasitære midler til brug på huden.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
Danish: PAKNINGSSTØRRELSE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL
English: One treatment prevents further infestations for 5 weeks by ticks and for up to 5 weeks by fleas.
Danish: En behandling forebygger mod yderligere angreb i 5 uger mod flåter og op til 5 uger mod lopper.
English: For the 2.14 ml, 4.28 ml or 6.42 ml pipette: Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Danish: For 2,14 ml, 4,28 ml eller 6,42 ml pipette: Opbevaringstid for veterinærlægemidlet i salgspakning: 3 år.
English: CERTIFECT should not enter water courses as this may be dangerous for fish and aquatic organisms.
Danish: CERTIFECT må ikke udledes i vandløb, da dette kan være farligt for fisk og andre organismer i
English: Should this occur, contact your veterinarian promptly for treatment advice and discontinue use of the product.
Danish: Hvis dette sker, skal du omgående kontakte dyrlægen for vejledning om behandling og ophøre med brugen af produktet.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release
Danish: A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE Navn og adresse på fremstilleren ansvarlig for batchfrigivelse
English: Squeeze the pipette, apply about half of the contents half way down the neck between the base of the skull and the shoulder blades.
Danish: Klem pipetten, anbring ca. halvdelen af indholdet halvvejs nede på nakken mellem basis af hovedet og skulderbladene.
English: The combination of amitraz and fipronil acts on multiple sites of the nervous systems of ticks.
Danish: Kombinationen af amitraz og fipronil virker på fleres steder i flåternes nervesystem.
English: Monthly intervals throughout the tick and/or flea seasons, based on local epidemiological situations.
Danish: Anvendes med månedlige intervaller i flåt- og/eller loppesæsonen i henhold til lokale epidemiologiske
English: In case of massive flea infestation and at the beginning of the control measures these areas should be treated with a suitable environmental product and then vacuumed regularly.
Danish: I tilfælde af massivt loppeangreb samt ved starten af behandlingen, anbefales det at behandle disse områder med et egnet bekæmpelsesmiddel og at støvsuge dem regelmæssigt.
English: The risk of experiencing adverse reactions (see section 4.6) may however increase with overdosing, so animals should always be treated with the correct pipette size according to bodyweight.
Danish: 4.6 ”Bivirkninger”) kan imidlertid stige ved overdosering, så dyr skal altid behandles med den korrekte pipettestørrelse i henhold til deres
English: - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Danish: - Meget almindelig (mere end 1 ud af 10 dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (mere end 1, men færre end 10 dyr ud af 100 dyr) - Ualmindelige (mere end 1, men færre end 10 dyr ud af 1.000 dyr) - Sjældne (mere end 1, men færre end 10 dyr ud af 10.000 dyr) - Meget sjælden (færre end 1 dyr ud af 10.000 dyr, herunder isolerede rapporter).
English: All stages of fleas can infest the dog's basket, bedding and regular resting areas such as carpets and soft furnishings.
Danish: Alle loppestadier kan angribe hundens kurv, leje og sædvanlige hvilesteder såsom tæpper og bløde møbler.
English: Fipronil and its metabolite fipronil sulfone act at ligand-gated chloride channels, in particular those gated by the neurotransmitter gamma-aminobutyric acid (GABA) as well as desensitising (D) and nondesensitising (N) channels gated by glutamate (Glu, unique invertebrate ligand-gated chloride channels), thereby blocking pre- and post-synaptic transfer of chloride ions across cell membranes.
Danish: Fipronil og dets metabolit fipronilsulfon virker ved at påvirke de ligand-styrede kloridkanaler, især de, der styres af neurotransmitteren GABA (gamma-aminosmørsyre), såvel de desensibiliserende (D) som de ikke-desensibiliserende (N) kanaler styret af glutamat (Glu, unikke invertebrat ligand-styrede kloridkanaler), hvorved de blokerer den præ- og postsynaptiske overførsel af klorioner over cellemembraner.
English: For spot-on application only.
Danish: Kun spot-on anvendelse.
English: However, shampooing or immersion of the animal in water directly after treatment or frequent shampooing may reduce the duration of activity.
Danish: Imidlertid kan badning med vand eller shampoo umiddelbart efter behandling eller hyppig badning med shampoo reducere effektens varighed.
English: Known side-effects of amitraz and its metabolites are due to alpha-2-adreno-receptor agonist effects.
Danish: Kendte bivirkninger af amitraz og dets metabolitter skyldes virkning af alpha-2-adreno-receptor agonist.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER