FrancophonIA/ELRC3.0 huggingface dataset:
English: On 18 October 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Balaxur, intended for the treatment of moderate to moderately severe Alzheimer's disease in patients who are already taking memantine and donepezil.
Danish: Den 18. oktober 2012 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgningen om markedsføringstilladelse for lægemidlet Balaxur, der er bestemt til behandling af moderat til moderat svær Alzheimers sygdom hos patienter, som i forvejen får memantin og donepezil.
English: Balaxur was expected to be used to treat moderate to moderately severe Alzheimer's disease, in patients who are already taking a daily dose of 20 mg memantine and 10 mg donepezil.
Danish: Balaxur forventedes anvendt til behandling af moderat til moderat svær Alzheimers sygdom hos patienter, der i forvejen får en daglig dosis på 20 mg memantin og 10 mg donepezil.
English: Strength Pharmaceutical Form
Danish: Lægemiddelform Administration Emballage Paknings-størrelse
English: The product tastes bitter.
Danish: Produktet smager bittert.
English: Especially severe cases may require more prolonged and more frequent treatment.
Danish: Særligt svære tilfælde kan kræve en længere og hyppigere behandling.
English: Therefore they can be treated without special considerations.
Danish: Derfor kan de blive behandlet uden nogen specielle hensyn.
English: Wash hands thoroughly after use.
Danish: Vask grundigt hænder efter brug.
English: Do not allow recently treated animals to groom each other.
Danish: Tillad ikke nyligt behandlede dyr at soignere hinanden.
English: The expiry date refers to the last day of that month.
Danish: Udløbsdatoen refererer til den sidste dag i den pågældende måned
English: Remove one pipette from the package.
Danish: Tag en pipette ud af pakningen.
English: In the study these reactions were common (seen in 2 of 106 treated dogs).
Danish: I studiet var disse reaktioner almindelige (set hos 2 af 106 behandlede hunde).
English: Do not use this veterinary medicinal product after the expiry date stated on the label and carton.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på etiketten og æsken.
English: Do not eat, drink or smoke during application.
Danish: Spis, drik og ryg ikke under påføringen.
English: This is not a sign of intoxication and disappears within some minutes without treatment.
Danish: Dette er ikke et tegn på forgiftning og det forsvinder efter nogle minutter uden nogen form for behandling.
English: Imidacloprid is toxic for birds, especially canaries.
Danish: Imidacloprid er toksisk for fugle, specielt kanariefugle.
English: Do not use on canaries.
Danish: Må ikke bruges til kanariefugle.
English: These signs disappear without further treatment.
Danish: Disse symptomer forsvinder uden yderligere behandling.
English: It is also active against gastrointestinal nematodes.
Danish: Det er også aktivt overfor gastrointestinale nematoder.
English: Dogs should not be allowed to swim in surface waters for 4 days after treatment.
Danish: Hunde bør derfor ikke svømme i vandløb i 4 dage efter behandling.
English: Each unit dose (pipette) contains:
Danish: Hver dosisenhed (pipette) indeholder:
English: Incompatibilities: None known.
Danish: Uforligeligheder: Ingen kendte
English: The T ½ in dogs is about 28.4 days.
Danish: T½ i hunde er omkring 28,4 dage.
English: The use of activated charcoal may be beneficial.
Danish: Brugen af aktivt kul kan være gavnlig.
English: Wherever possible apply to undamaged skin.
Danish: Hvor det er muligt anvendes produktet på uskadet hud.
English: The mean T ½ in cats ranges between 18.7 and 25.7 days.
Danish: Den gennemsnitlige T½ hos katte ligger mellem 18,7 og 25,7 dage.
English: The result is flaccid paralysis of affected parasites, followed by their death and/or expulsion.
Danish: Resultatet er lammelse af angrebne parasitter efterfulgt af deres død og/eller udstødning.
English: Allow the application site to dry before permitting contact with such materials.
Danish: Lad derfor påføringsstedet tørre før kontakt med disse materialer tillades.
English: No interactions between Advocate and routinely used veterinary medicinal products or medical or surgical procedures have been observed.
Danish: Der er ikke set interaktioner mellem Advocate og rutinemæssigt anvendte veterinære lægemidler eller operative procedurer.
English: Bayer Hungária Kft. HU-1123 Budapest Alkotás u. 50
Danish: Bayer Hungária Kft. 1123 Budapest HU-Alkotás u. 50
English: The ensuing inhibition of cholinergic transmission in insects results in paralysis and death.
Danish: Den efterfølgende hæmning af den cholinerge transmission hos insekter resulterer i lammelse og død.
English: See sections 4.5 and 6.6.
Danish: Se sektion 4.5 og 6.6
English: Advocate should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Danish: Advocate må ikke udledes i vandløb, da dette kan være farligt for fisk og andre organismer i vandet.
English: Chemically, it is more accurately described as a chloronicotinyl nitroguanidine.
Danish: Kemisk nærmere beskrevet som et chloronicotinyl nitroguanidin.
English: There is no known specific antidote.
Danish: Der findes ikke nogen specifik antidot.
English: It can be found on the body surface throughout the treatment interval.
Danish: Det kan findes på hudoverfladen igennem hele behandlingsperioden.
English: A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.
Danish: Der anbefales en yderligere dyrlægeundersøgelse 30 dage efter behandling, da nogle dyr kræver en 2. behandling.
English: Benzyl alcohol Butylhydroxytoluene Propylene carbonate
Danish: Benzylalkohol Butylhydroxytoluen Propylencarbonat
English: Alternative treatment should be administered.
Danish: En alternativ behandling bør da påbegyndes.
English: 0.4 minimum of 10 minimum of 1
Danish: 0,4 minimum 10 minimum 1
English: In these severe cases concomitant supportive treatment is necessary as treatment with the product alone may not be sufficient to prevent death of the animal.
Danish: I disse alvorlige tilfælde kan det være nødvendigt med anden samtidig støttende behandling da behandling med produktet alene kan være utilstrækkeligt for at forebygge dyrets død.
English: Seek the advice of your veterinarian.
Danish: Spørg dyrlægen til råds.
English: The product's efficacy has not been tested in ferrets weighing over 2 kg and therefore the duration of effect might be shorter in these animals.
Danish: Produktets effekt er ikke testet hos fritter der vejer mere end 2 kg. Varigheden af effekten kan derfor være kortere hos disse dyr.
English: See section 6.6.
Danish: Se sektion 6.6
English: To achieve the best possible response in these severe cases, at the discretion of the veterinarian, Advocate can be applied once a week and for a prolonged time.
Danish: For at opnå det bedste resultat i disse særligt svære tilfælde, kan Advocate, efter dyrlægens vurdering, gives 1 gang i ugen over en længere periode.
English: for cats
Danish: Til katte
English: The treatment schedule should be based on the local epidemiological situation.
Danish: Behandlingsplanen bør baseres på den lokale epidemiologiske situation.
English: Imidacloprid has minimal pharmacological activity in mammals.
Danish: Imidacloprid har en minimal farmakologisk aktivitet hos pattedyr.
English: Moxidectin, 23-(O-methyloxime)-F28249 alpha is a second-generation macrocyclic lactone of the milbemycin family.
Danish: Moxidectin, 23-(O-methyloxime)-F28249 alpha, er en 2. generations macrocyklisk lacton tilhørende milbemycin familien.
English: Do not use in kittens under 9 weeks of age.
Danish: Må ikke anvendes til killinger under 9 uger.
English: Moxidectin interacts with GABA and glutamate-gated chloride channels.
Danish: Moxidectin interfererer med GABA og glutamat regulerede kloridkanaler.
English: This leads to opening of the chloride channels on the postsynaptic junction, the inflow of chloride ions and induction of an irreversible resting state.
Danish: Dette fører til en postsynaptisk åbning af kloridkanalerne, indløb af kloridioner og induktion af en irreversibel hviletilstand.
English: The administration of a single dose every 4 weeks for 2 to 4 months is efficacious against Demodex canis and leads to a marked improvement of clinical signs particularly in mild to moderate cases.
Danish: Påføring af en enkelt dosis hver 4. uge i 2 til 4 måneder er effektiv mod Demodex canis og fører til udpræget forbedring af de kliniske tegn, især i milde til moderate tilfælde.
English: Apply only to undamaged skin.
Danish: Anvend kun produktet på uskadet hud.
English: 0.4 minimum of 10 minimum of 2.5
Danish: 0,4 minimum 10 Minimum 2,5
English: Apply topically to the skin between the shoulder blades.
Danish: Påføres huden mellem skulderbladene.
English: The safety of the product has only been evaluated in dogs classified as either Class 1 or 2 for heartworm disease in laboratory studies and in a few Class 3 dogs in a field study.
Danish: Produktets sikkerhed er kun vurderet hos hunde med tropisk hjerteorm (Dirofilaria immitis) klassificeret til klasse 1 eller 2 ved laboratorie-forsøg og enkelte klasse 3 i et fieldstudie.
English: ATCvet code: QP54AB52.
Danish: ATC vet-kode: QP54AB52
English: 1 pipette 2 pipettes 3 pipettes 4 pipettes 6 pipettes 9 pipettes 12 pipettes 21 pipettes 42 pipettes
Danish: 1 pipette 2 pipetter 3 pipetter 4 pipetter 6 pipetter 9 pipetter 12 pipetter 21 pipetter 42 pipetter
English: Do not use in dogs classified as Class 4 for heartworm disease as the safety of the product has not been evaluated in this animal group.
Danish: Bør ikke anvendes til hunde med tropisk hjerteorm (dirofilaria immitis) klassificeret til Klasse 4 da sikkerheden ved produktet ikke er vurderet hos denne gruppe dyr.
English: Dosage schedule for cats:
Danish: Doseringsskema til katte:
English: When 40 % of the unit dose was given orally, severe neurological signs were observed.
Danish: Ved indgivelse af 40% af dosen oralt, observeredes alvorlige neurologiske symptomer.
English: Date of first authorisation: 02/04/2003.
Danish: Dato for første markedsføringstilladelse: 02/04/2003 Dato for seneste fornyelse af markedsføringstilladelse: 14/01/2013
English: Following absorption from the skin, moxidectin is distributed systemically throughout the body tissues but due to its lipophilicity it is concentrated mainly in the fat.
Danish: Efter absorption fra huden fordeles moxidectin systemisk i alle kroppens væv, men på grund af dets lipofilicitet koncentreres det primært i fedtet.
English: Do not use in puppies under 7 weeks of age.
Danish: Må ikke anvendes til hvalpe under 7 uger.
English: Imidacloprid has a high affinity for the nicotinergic acetylcholine receptors in the post-synaptic region of the central nervous system (CNS) of the flea.
Danish: Imidacloprid binder sig med høj affinitet til de nikotinerge acetylcholin receptorer i den postsynaptiske del af loppens centralnervesystem (CNS).
English: Capillaria) boehmi (adults),
Danish: Capillaria) boehmi (voksne stadier),
English: The product may, in rare cases, cause local hypersensitivity reactions.
Danish: Produktet kan i sjældne tilfælde forårsage lokale overfølsomhedsreaktioner.
English: Oral administration of 10% of the recommended dose produced no adverse effects.
Danish: Oral indgivelse af 10% af den anbefalede dosis, gav ikke nogen bivirkninger.
English: Interaction with other medicinal products and other forms of interaction: During treatment with Advocate no other antiparasitic macrocyclic lactone should be administered.
Danish: Interaktion med andre lægemidler og andre former for interaktion: Under behandling med Advocate må der ikke bruges andre antiparasitære midler af arten makrocykliske laktoner.
English: The solvent in Advocate may stain or damage certain materials including leather, fabrics, plastics and finished surfaces.
Danish: Opløsningsmidlet i Advocate kan plette eller beskadige visse materialer såsom læder, tekstiler, plast og behandlede overflader.
English: To establish a treatment routine, it is recommended that the same day or date be used each month.
Danish: For at opnå en rutinemæssig behandling anbefales det, at produktet påføres samme dag eller dato hver måned.
English: Due to the weak nature of the interaction with mammalian nicotinergic receptors and the postulated poor penetration through the blood-brain barrier in mammals, it has virtually no effect on the mammalian CNS.
Danish: Pga. den svage affinitet til pattedyrs nikotinerge receptorer og den forventede svage penetration gennem blod/hjerne barrieren hos pattedyr, har stoffet praktisk taget ingen effekt på pattedyrs CNS.
English: Advocate should not enter water courses as it has harmful effects on aquatic organisms: moxidectin is highly toxic to aquatic organisms.
Danish: Advocate bør ikke kommes i vandløb, da produktet har en skadelig effekt på organismer som lever i vandet: Moxidectin er meget giftigt for organismer der lever i vand.
English: In all cases it is essential that the treatment should be continued until skin scrapings are negative on at least 2 consecutive monthly occasions.
Danish: I alle tilfælde er det yderst vigtigt at behandlingen forsættes, indtil hudskrabning er negativ i mindst 2 på hinanden følgende måneder.
English: Studies have shown that monthly treatment of dogs will prevent infections caused by Uncinaria stenocephala.
Danish: Undersøgelser har vist at månedlig behandling af hunde vil forebygge infektioner forårsaget af Uncinaria stenocephala.
English: However, frequent shampooing or immersion of the animal in water after treatment may reduce the efficacy of the product.
Danish: Hyppig indsæbning eller badning af dyret i vand efter at det er behandlet kan imidlertid reducere produktets effekt.
English: Salivation may occasionally occur if the animal licks the application site immediately after treatment.
Danish: Savlen kan forekomme, hvis dyret slikker påføringsstedet umiddelbart efter behandling.
English: It is slowly eliminated from the plasma as manifested by detectable moxidectin concentrations in plasma throughout the treatment interval of one month.
Danish: Det elimineres langsomt fra plasma, som vist ved målbare moxidectin-plasmakoncentrationer gennem behandlingsperioden på en måned.
English: Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakningen: 3 år
English: Capillaria) boehmi (adults) The product should be administered monthly for two consecutive months.
Danish: Capillaria) boehmi (voksne stadier) Produktet bør appliceres en gang om måneden i 2 på hinanden følgende måneder.
English: If the animal licks the application site after treatment, neurological signs (most of which are transient) may be observed in very rare cases (see section 4.10).
Danish: Hvis dyret slikket på applikationsstedet efter behandlingen, kan der i meget sjældne tilfælde ses neurologiske symptomer (de fleste er af kort varighed) (se sektion 4.10).
English: Treatment and prevention of Angiostrongylus vasorum
Danish: Behandling og forebyggelse af Angiostrongylus vasorum
English: The product should be administered monthly.
Danish: Produktet bør påføres månedligt.
English: • the treatment of Angiostrongylus vasorum and Crenosoma vulpis,
Danish: • behandling af Angiostrongylus vasorum og Crenosoma vulpis,
English: As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying disease appropriately.
Danish: Da infektioner med Demodex er en multi-faktoriel sygdom anbefales det også at behandle eventuelle underliggende sygdomme på passende måde, hvis muligt.
English: It is advisable to prevent auto-coprophagia between the two treatments in order to prevent possible reinfection.
Danish: Undgå at hunden spiser sin egen afføring mellem de to behandlinger for at undgå mulig reinfektion.
English: A single dose should be administered twice 4 weeks apart.
Danish: En enkelt dosis påføres 2 gange med 4 ugers mellemrum.
English: Weight of dog [kg]
Danish: Hundens vægt (kg)
English: Therefore, it may be necessary to combine Advocate treatment with treatments aimed at breaking the flea life cycle in the surroundings.
Danish: Derfor kan det være nødvendigt at kombinere Advocate behandling med omgivelsesbehandling for at bryde loppens livscyklus.
English: Imidacloprid, 1-(6-Chloro-3-pyridylmethyl)-N-nitro-imidazolidin-2-ylideneamine is an ectoparasiticide belonging to the chloronicotinyl group of compounds.
Danish: Imidacloprid, 1-(6-klor-3-pyridylmethyl)-N-nitro-imidazolidin-2-ylideneamine, er et middel mod ektoparasitter tilhørende gruppen af chloronicotinyl forbindelser.
English: Treatment of microfilariae (D. immitis)
Danish: Behandling af microfilariae (D. immitis)
English: Transient mydriasis, salivation, vomiting and transient rapid respiration were observed.
Danish: Forbigående pupiludvidelse, spytflåd, opkastning og forbigående hurtig vejrtrækning blev observeret.
English: With the dog in a standing position, part the coat between the shoulder blades until the skin is visible.
Danish: Med hunden i stående stilling deles pelsen mellem skulderbladene indtil huden er synlig.
English: When the product is applied in 3 to 4 separate spots (see section 4.9), specific care should be taken to prevent the animal licking the application sites.
Danish: Når produktet er påført 3-4 forskellige steder (se sektion 4.9), bør der holdes særligt øje med at dyret ikke slikker på påføringsstedet.
English: When replacing another heartworm preventative product in a heartworm prevention programme, the first treatment with Advocate must be given within 1 month of the last dose of the former medication.
Danish: Hvis behandling med Advocate erstatter en anden forebyggende behandling mod hjerteorm, skal den første behandling med Advocate gives senest en måned efter den sidste behandling af det tidligere præparat.
English: It is therefore recommended that all dogs 6 months of age or more, living in areas endemic for heartworm, should be tested for existing adult heartworm infection before being treated with the product.
Danish: Det anbefales derfor at alle hunde på 6 måneder eller derover, der lever i områder hvor der er hjerteorm, bør testes for eksisterende voksne hjerteorm infektioner før behandling med produktet påbegyndes.
English: The entire contents of the pipette should be applied evenly as 3 or 4 spots along the top of the back, from between the shoulders to the base of the tail.
Danish: Pipettens indhold påføres 3 eller 4 steder på ryggen fra skulderbladene til halerod.
English: Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the skin.
Danish: Placér spidsen af pipetten på huden og tryk fast adskillige gange for at tømme indholdet ud direkte på huden.
English: Treatment should be stopped in dogs that show no improvement or do not respond in mite count after 2 months treatment.
Danish: Behandlingen bør stoppes, hvis hunden ikke viser tegn på forbedring, eller der ikke er en forbedring i antallet af mider, efter to måneders behandling.
English: Weight of cat [kg]
Danish: Kattens vægt (kg)
English: Only “Advocate for small cats and ferrets” (0.4 ml) must be used.
Danish: Kun ”Advocate til små katte og fritter” (0,4 ml) må anvendes.
English: At the discretion of the veterinarian, infected dogs should be treated with an adulticide to remove adult heartworms.
Danish: Inficerede hunde bør, efter dyrlægens skøn, behandles med et adulticid for at fjerne voksne hjerteorm.
English: Pharmacotherapeutic group: Antiparasitic products, insecticides and repellents, macrocyclic lactones, milbemycins.
Danish: Farmakoterapeutisk gruppe: Parasitter, insekticider og afskrækningsmidler, makrocykliske laktoner, milbemyciner.
English: In very rare case the product may cause respiratory irritation in sensitive individuals.
Danish: I meget sjældne tilfælde kan der opstå respiratorisk irritation hos følsomme individer.
English: Treatment and prevention of Angiostrongylus vasorum A single dose should be administered.
Danish: Behandling og forebyggelse af Angiostrongylus vasorum En enkelt dosis påføres.
English: If adult heartworm infection is diagnosed, the infection should be treated in accordance with current scientific knowledge.
Danish: Hvis voksen hjerteorm infektion er diagnostiseret, bør infektionen behandles i henhold til teknisk viden.
English: It is recommended that cats and ferrets living in, or travelling to, areas endemic for heartworm are treated monthly with the product to protect them from heartworm disease.
Danish: Det anbefales, at katte og fritter, der bor i eller rejser til områder med hjerteorm, behandles månedligt med produktet for at beskytte dem mod hjerteorm sygdomme.
English: Application at the base of the skull will minimise the opportunity for the animal to lick the product.
Danish: Påføring ved kraniets start vil minimere dyrets mulighed for at slikke produktet i sig.
English: Ivermectin-sensitive Collie dogs tolerated up to 5 times the recommended dose repeated at monthly intervals without any adverse effects, but the safety of application at weekly intervals has not been investigated in ivermectin-sensitive Collie dogs.
Danish: Ivermectin-følsomme collier tålte op til 5 gange anbefalet dosis efter gentagen månedlig påføring uden nogen bivirkninger, men sikkerheden efter ugentlig påføring er ikke undersøgt i ivermectin-følsomme collier.
English: The treatment schedule should be based on individual veterinary diagnosis and on the local epidemiological situation.
Danish: Behandlingsplanen bør baseres på individuel veterinær diagnose samt den lokale epidemiologiske situation.
English: Treatment of demodicosis (caused by Demodex canis)
Danish: Behandling af infektioner med Demodex (forårsaget af Demodex canis)
English: People with a known hypersensitivity to benzyl alcohol, imidacloprid or moxidectin should administer the product with caution.
Danish: Ved kendt overfølsomhed over for benzylalkohol, imidacloprid eller moxidectin bør produktet anvendes med forsigtighed.
English: The safety of Advocate has not been evaluated when administered on the same day as an adulticide.
Danish: Sikkerheden af Advocate er ikke undersøgt ved applicering samme dag som et adulticid.
English: Do not apply directly to the ear canal.
Danish: Applicér ikke direkte i øregangen.
English: 0.4 ml and 0.8 ml per pipette.
Danish: 0,4 ml og 0,8 ml per pipette
English: Prevention of spirocercosis (Spirocerca lupi)
Danish: Forebyggelse af spirocercose (Spirocerca lupi)
English: In certain individual cats Notoedres cati infestation may be severe.
Danish: Hos enkelte katte kan infestation med Notoedres cati være alvorlig.
English: Gastrointestinal signs (vomiting, diarrhoea, inappetence) and lethargy are also common adverse reactions following treatment in such dogs.
Danish: Gastrointestinale symptomer (opkastning, diarre, appetitløshed) og sløvhed er også almindelige reaktioner efter behandling hos sådanne hunde.
English: During treatment with Advocate no other antiparasitic macrocyclic lactone should be administered.
Danish: Under behandling med Advocate må der ikke bruges andre antiparasitære midler af arten makrocykliske laktoner.
English: Oral uptake by Collie or Old English Sheep dogs and related breeds or crossbreeds should be prevented.
Danish: Oral indtagelse bør undgås af Collier og Old English Sheepdogs og beslægtede racer eller krydsninger.
English: Unit Dose Imidacloprid Moxidectin
Danish: Enhed Imidacloprid Moxidectin
English: Brief contact of the animal with water on one or two occasions between monthly treatments is unlikely to significantly reduce the efficacy of the product.
Danish: Hvis dyret har kortvarig kontakt med vand ved en eller to lejligheder mellem de månedlige behandlinger, er det usandsynligt at produktets effekt reduceres mærkbart.
English: Flea larvae in the pet's surroundings are killed after contact with a pet treated with the product.
Danish: Loppelarver i dyrets omgivelser bliver dræbt efter kontakt med et dyr, der er behandlet med dette produkt.