FrancophonIA/ELRC3.0 huggingface dataset:
English: This veterinary medicinal product contains amitraz, which can lead to neurological side-effects in humans.
Danish: Dette veterinærlægemiddel indeholder amitraz, der kan føre til neurologiske bivirkninger hos enkelte mennesker.
English: Fipronil sulfone decreased to concentrations of < 0.6 μg/g by 58 days after topical application.
Danish: Fripronilsulfon faldt til koncentrationer på < 0,6 ug/g 58 dage efter behandlingen.
English: To minimise the potential for inhalation, apply in the open air or in a well ventilated area.
Danish: For at minimere risikoen for indånding anbefales det, at præparatet påføres i fri luft eller i et velventileret rum.
English: Repeat the application at the base of the neck in front of the shoulder blades to empty the pipette.
Danish: Gentag behandlingen nederst i nakkeregionen lige foran skulderbladene for at tømme pipetten.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - 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: Hyppigheden af bivirkninger er defineret som: - 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: Signs are transitory and generally resolve without treatment within 24 hours.
Danish: Symptomerne er forbigående og vil sædvanligvis forsvinde uden behandling inden for 24 timer.
English: Each unit dose (dual cavity pipette) delivers:
Danish: Hver enhed (dobbelkamret pipette) indeholder:
English: Treatment of infestations by chewing lice (Trichodectes canis).
Danish: Behandling af angreb af bidende lus (Trichodectes canis).
English: CERTIFECT 67 mg/ 60.3 mg/ 80 mg spot-on solution for dogs 2-10 kg
Danish: CERTIFECT 67 mg/ 60,3 mg/ 80 mg spot-on, opløsning til hund 2-10 kg
English: Dogs
Danish: Hund.
English: CERTIFECT 134 mg/ 120.6 mg/ 160 mg spot-on solution for dogs 10-20 kg CERTIFECT 268 mg/ 241.2 mg/ 320 mg spot-on solution for dogs 20-40 kg CERTIFECT 402 mg/ 361.8 mg/ 480 mg spot-on solution for dogs 40-60 kg
Danish: CERTIFECT 134 mg/ 120,6 mg/ 160 mg spot-on, opløsning til hund 10-20 kg CERTIFECT 268 mg/ 241,2 mg/ 320 mg spot-on, opløsning til hund 20-40 kg CERTIFECT 402 mg/ 361,8 mg/ 480 mg spot-on, opløsning til hund 40-60 kg
English: Do not use on sick (e.g. systemic diseases, diabetes, fever) or convalescent animals.
Danish: Må ikke anvendes til afkræftede eller syge dyr (f.eks. systemiske lidelser, diabetes, feber).
English: Amitraz is a formamidine acaricide that acts as an agonist on octopamine receptors causing an overstimulation of octopaminergic synapses in acari, resulting in tremors and convulsions.
Danish: Amitraz er et formamidin acaricid, der virker agonistisk på octopamin receptorer, hvorved det forårsager en overstimulering af octopaminerge synapser i mider.
English: The treatment indirectly reduces the risk of transmission of tick-borne diseases (canine babesiosis, monocytic ehrlichiosis, granulocytic anaplasmosis and borreliosis) from infected ticks for 4 weeks.
Danish: Behandlingen nedsætter indirekte risikoen for overførsel af flåtbårne sygdomme (babesiose, monocytær ehrlichiose, granulocytær anaplasmose og borreliose) fra inficerede flåter i 4 uger.
English: After treatment with CERTIFECT ticks will generally be killed and fall off the dog within 24 hours after infestation without having a blood meal.
Danish: Efter behandling med CERTIFECT vil flåter sædvanligvis dræbes og falde af hunden inden for 24 timer efter infestationen uden at have haft et blodmåltid.
English: Low levels of N-methyl-N'-(2,4-xylyl) formamidine were detectable for 30 days after dosing.
Danish: Lave værdier af N-methyl-N'-(2,4-xylyl)formamidin kunne måles i op til 30 dage efter behandling.
English: If symptoms are severe or persist, alternatively the antidote alpha-2-adreno-receptor antagonist atipamezole hydrochloride may be used.
Danish: Hvis symptomerne er alvorlige eller vedvarer, kan antidoten alpha-2-adreno-receptor antagonist
English: The veterinary medicinal product is an insecticidal and acaricidal solution for topical use, containing adulticidal active ingredients, fipronil and amitraz, in combination with an ovicidal and larvicidal
Danish: Veterinærlægemidlet er en insekticid og acaricid opløsning til udvortes brug, der indeholder adulticide aktive stoffer, fipronil og amitraz, sammen med et ovicidt og larvicidt aktiv stof, (S)-methopren.
English: Separate one blister from the others by tearing along perforation.
Danish: Et blister adskilles fra de andre ved at rive langs perforeringen.
English: WITHDRAWAL PERIOD Not applicable
Danish: 10. TILBAGEHOLDELSESTID Ikke relevant.
English: They may consist of hypersalivation, vomiting, lethargy, hyperglycaemia, bradycardia or bradypnea.
Danish: Disse kan være hypersalivation, opkast, letargi, hyperglykæmi, bradykardi eller bradypnø.
English: The product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD).
Danish: Præparatet kan indgå som led i behandlingen af loppebetinget allergisk dermatitis (FAD).
English: The recommended minimum dose is 6.7 mg/kg bodyweight for fipronil, 6 mg/kg for (S)-methoprene and 8 mg/kg for amitraz.
Danish: Den anbefalede minimumsdosering er 6,7 mg/kg legemsvægt for fipronil, 6 mg/kg for (S)-methopren og 8 mg/kg for amitraz.
English: carton box 3 pipettes
Danish: 3 pipetter 3 pipetter 3 pipetter 3 pipetter
English: Any unused veterinary medicinal product or waste materials derived from it should be disposed of in accordance with local requirements and should not enter water courses as this may be dangerous for fish
Danish: Eventuelle ubrugte lægemidler eller affald fra sådanne produkter skal destrueres i overensstemmelse med de lokale krav og må ikke udledes i vandløb, da dette kan være farligt for fisk og andre
English: (S)-Methoprene (mg)
Danish: (S)-methopren (mg)
English: Treated animals should not be bathed until 48 hours after treatment.
Danish: Behandlede dyr skal ikke vaskes/bades før 48 timer efter behandlingen.
English: Transient skin reactions at the application site (skin discolouration, local hair loss, itching, redness) and general itching or hair loss may occur on rare occasions.
Danish: Forbigående hudreaktioner på applikationsstedet (hudmisfarvning, lokalt hårtab, kløe, rødmen) samt generel kløe og hårtab kan forekomme i sjældne tilfælde.
English: Lethargy, ataxia, emesis, anorexia, diarrhoea, excessive salivation, hyperglycaemia, increased sensitivity to stimulation, bradycardia or bradypnea may be observed.
Danish: Letargi, ataksi, emesis, anoreksi, diaré, voldsom savlen, hyperglykæmi, forstærket berøringssans, bradykardi eller bradypnø kan iagttages.
English: The veterinary medicinal product remains effective after exposure to sunlight or if the animal becomes wet after rain, bathing, or water immersion.
Danish: Veterinærlægemidlet forbliver effektivt selv om dyret bliver udsat for sollys eller bliver vådt af regn eller badning med vand.
English: If it accidentally gets into the eyes, they should be thoroughly flushed with water.
Danish: Hvis det ved et uheld kommer i øjnene, skal der skylles omhyggeligt med vand.
English: Use a pair of scissors to cut the blister along the dotted line (or fold on the corner as shown and pull
Danish: Anvend en saks til at klippe blisteret langs den stiplede linje (eller fold ned til hjørnet som angivet, og træk
English: Cut off the pipette tip with a pair of scissors.
Danish: Klip pipettens top af med en saks.
English: Treatment and prevention of infestations in dogs by ticks (Ixodes ricinus, Dermacentor reticulatus, Rhipicephalus sanguineus, Ixodes scapularis, Dermacentor variabilis, Haemaphysalis elliptica, Haemaphysalis longicornis, Amblyomma americanum and Amblyomma maculatum) and fleas (Ctenocephalides felis and Ctenocephalides canis).
Danish: Behandling og forebyggelse af flåtangreb (Ixodes ricinus, Dermacentor reticulatus, Rhipicephalus sanguineus, Ixodes scapularis, Dermacentor variabilis, Haemaphysalis elliptica, Haemaphysalis longicornis, Amblyomma americanum og Amblyomma maculatum) og loppeangreb (Ctenocephalides felis og Ctenocephalides canis) hos hund.
English: Prevention of environmental flea contamination by inhibiting the development of all flea immature
Danish: Forebyggelse af smittespredning til omgivelserne ved at forhindre udvikling af alle umodne
English: dogs 2-10 kg dogs 10-20 kg dogs 20-40 kg dogs 40-60 kg
Danish: hunde 2-10 kg hunde 10-20 kg hunde 20-40 kg hunde 40-60 kg
English: Dogs should be prevented from accessing streams and rivers for 48-hours following treatment.
Danish: Hunde bør ikke have adgang til vandløb i 48 timer efter behandlingen.
English: Prevention of environmental flea contamination by inhibiting the development of all flea immature stages.
Danish: Forebyggelse af smittespredning til omgivelserne ved at forhindre udvikling af alle umodne loppestadier.
English: METHOD AND ROUTE OF ADMINISTRATION Spot-on use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Spot-on brug.
English: Remains effective after exposure to sunlight or if the animal becomes wet after rain, bathing, or water immersion.
Danish: Forbliver effektivt selv om dyret bliver udsat for sollys eller bliver vådt af regn, badning eller anden kontakt med vand.
English: Use a pair of scissors to cut the blister along the dotted line (or fold the blister on the corner as
Danish: Anvend en saks til at klippe blisteret langs den stiplede linje (eller fold ned til hjørnet som
English: Dogs 10-20 kg Dogs 20-40 kg Dogs 40-60 kg
Danish: Hund 10-20 kg Hund 20-40 kg Hund 40-60 kg
English: NAME OF THE MARKETING AUTHORISATION HOLDER MERIAL
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN MERIAL
English: Repeat the application at the base of the neck in front of the shoulder blades to
Danish: Gentag behandlingen nederst i nakkeregionen lige foran skulderbladene
English: The risk of developing canine babesiosis, monocytic ehrlichiosis, granulocytic anaplasmosis and borreliosis for 4 weeks is thereby
Danish: Risikoen for at udvikle babesiose, monocytær ehrlichiose, granulocytær anaplasmose og borreliose
English: This results in uncontrolled activity of the central nervous system and death of insects or acari.
Danish: Dette resulterer i en ukontrolleret CNS-aktivitet med deraf følgende drab af insekter
English: EXPIRY DATE {month/year}
Danish: UDLØBSDATO måned/år
English: Specific tick detachment properties described as an expellant action causing ticks to withdraw their mouthparts rapidly and fall off the host animal have been reported for amitraz.
Danish: Dette beskrives som en expellerende virkning, der får flåten til hurtigt at trække sine munddele til sig og falde af værtsdyret.
English: In case of incorrect use, seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: I tilfælde af forkert brug søg omgående lægehjælp og vis indlægssedlen eller etiketten til lægen.
English: Safety has been demonstrated with up to 5 times the recommended dose in healthy adult dogs (treated up to 6 times at two-week intervals) and in puppies (aged 8 weeks treated once).
Danish: Sikkerheden er demonstreret med op til 5 gange den anbefalede dosis hos raske voksne hunde (behandlet op til 6 gange med 2 ugers interval) og hos hvalpe (8 uger gamle behandlet en gang).
English: The product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis
Danish: Præparatet kan indgå som led i behandlingen af loppebetinget allergisk eksem.
English: Amitraz is a monoamine oxidase inhibitor (MAOI); therefore, people taking MAOI-containing medication should take particular care and avoid direct contact with the product.
Danish: Amitraz er en monoaminoxidaseinhibitor (MAO-hæmmere); derfor skal mennesker, der indtager medicin indeholdende MAO-hæmmere, være særlig forsigtige og undgå direkte kontakt med produktet.
English: Spot-on application only.
Danish: Spot-on brug.
English: Safety has been also demonstrated with up to 5 times the recommended dose in healthy adult dogs (treated up to 6 times at two-week intervals) and in puppies (aged 8 weeks treated once).
Danish: Sikkerheden er også demonstreret med op til 5 gange den anbefalede dosis til raske voksne hunde (behandlet op til 6 gange med 2-ugers intervaller) og til hvalpe (8 uger gamle behandlet en gang).
English: CERTIFECT treatment causes detachment of ticks when applied to a dog with a pre-existing infestation, disrupts attachment and rapidly kills ticks within 24 hours thus inhibiting the blood meal and the concomitant risk of transmission of tick-borne pathogens.
Danish: Det stopper flåtens tilhæftning og dræber den hurtigt inden for 24 timer; således forhindres blodoptagelsen og den samtidige risiko for overførsel af flåtbårne patogener.
English: 6.5 Nature and composition of immediate packaging Purple dual chamber pipette: The primary packaging is composed of two heat-formed polyolefin chambers with a central polyolefin-coated aluminium partition.
Danish: Den indre pakning er fremstillet af to varmeforseglede polyolefin hylstre adskilt i midten med en polyolefinbelagt aluminium skillevæg.
English: (S)-methoprene is also effective in preventing flea larvae and pupae from developing, which prevents contamination of the environment of the treated animals with the immature stages of fleas.
Danish: (S)-methopren er også virksomt ved at forhindre loppelarver og -pupper i at udvikle sig.
English: The recommended minimum dose is 6.7 mg/kg bodyweight (b.w.)
Danish: Den anbefalede minimumsdosering er 6,7 mg/kg legemsvægt for fipronil, 6 mg/kg for (S)-methopren
English: Clear amber to yellowish solution.
Danish: Klar ravgul til gullig opløsning.
English: If side effects are noted, seek immediate medical assistance and show the package leaflet or label to the physician.
Danish: Hvis der observeres tegn på bivirkninger, skal der øjeblikkeligt søges lægehjælp, og pakningen vises til lægen.
English: In the absence of additional safety studies, do not repeat the treatment at intervals of less than 2weeks, do not treat puppies less than 8 weeks of age and dogs less than 2 kg bodyweight.
Danish: Da der ikke foreligger sikkerhedsstudier, skal behandlingen ikke gentages med hyppigere intervaller end 2 uger.
English: If side effects are noted, seek immediate medical assistance and show the package leaflet or label to
Danish: Hvis der observeres tegn på bivirkninger, skal der øjeblikkeligt søges lægehjælp, og pakningen eller
English: Safety was also demonstrated in breeding, pregnant and lactating animals treated at 28-day intervals with multiple consecutive doses of up to 3 times the maximum recommended dose.
Danish: Sikkerheden blev også demonstreret i avlsdyr, drægtige og diegivende dyr, der blev behandlet fortløbende med 28 dages intervaller med flere doser på op til 3 gange den maksimale anbefalede
English: Safety was demonstrated in breeding, pregnant and lactating animals treated at 28-day intervals with multiple consecutive doses of up to 3 times the maximum recommended dose.
Danish: Sikkerheden er demonstreret i avlsdyr, drægtige og diegivende dyr, der blev behandlet fortløbende med flere doser med 28 dages intervaller op til 3 gange den maksimale anbefalede dosis.
English: In case of accidental spillage onto skin, wash off immediately with soap and water.
Danish: Vask øjeblikkelig med sæbe og vand hvis lægemidlet ved et uheld kommer i kontakt med huden.
English: If symptoms are severe or persist alternatively use antidote (atipamezole hydrochloride).
Danish: Anvend eventuelt modgiften atipamezolhydrochlorid, hvis symptomerne er alvorlige eller vedvarer.
English: Volume of unit dose (ml)
Danish: Indhold pr. pipette (ml)
English: THE WORDS “KEEP OUT OF THE SIGHTAND REACH OF CHILDREN” Keep out of the sight and reach of children.
Danish: Special forholdsregler til brug hos dyr: Undgå kontakt med hundens øjne.
English: Each 1.07 ml of solution contains: Fipronil 67 mg, (S)-Methoprene 60.3 mg, Amitraz 80 mg
Danish: 67,0 mg, (S)-methopren.
English: This veterinary medicinal product contains amitraz, which is a monoamine oxidase inhibitor (MAOI); therefore, in the absence of studies, this veterinary medicinal product should not be used on dogs treated with MAOI.
Danish: Dette veterinærlægemiddel indeholder amitraz, som er en monoaminoxidaseinhibitor (MAOhæmmere).
English: In the absence of additional safety studies, do not repeat the treatment at intervals of less than 2 weeks, do not treat puppies less than 8 weeks of age, and dogs less than 2 kg bodyweight (b.w.
Danish: Hvalpe yngre end 8 uger og hunde mindre end 2 kg legemsvægt må ikke behandles.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Danish: KLINISKE OPLYSNINGER
English: These people may not appear to be depressed.
Danish: Disse personer ser måske ikke ud til at være deprimerede.
English: • Unusual behaviour.
Danish: • Usædvanlig adfærd.
English: Section 2.
Danish: Punkt 2.
English: These are the rules:
Danish: Dette er reglerne:
English: • Existing depression getting worse
Danish: • Eksisterende depression bliver værre.
English: This form confirms that you have been told about the risks and that you will follow the rules above.
Danish: Denne formular bekræfter, at du er blevet fortalt om risiciene, og at du vil følge ovenstående regler.
English: • She understands the teratogenic risk.
Danish: - Hun forstår den teratogene risiko.
English: • The patient has acknowledged the aforementioned conditions.
Danish: - Patienten har bekræftet ovennævnte betingelser.
English: Your doctor can give you more information.
Danish: Din læge kan give dig flere oplysninger.
English: • Signs of psychosis: a loss of contact with reality, such as hearing voices or seeing things that are not there.
Danish: • Tegn på psykose: tab af kontakt med virkeligheden, såsom at høre stemmer eller se ting, der ikke er der.
English: Contact your doctor straight away if you get signs of any of these mental problems.
Danish: Kontakt straks din læge, hvis du får tegn på nogen af disse psykiske problemer.
English: The medicine is likely to pass into your milk and may harm your baby.
Danish: Lægemidlet vil sandsynligvis passere over i din brystmælk og kan skade din baby.
English: It also includes thoughts about hurting yourself or ending your life.
Danish: Det omfatter også tanker om at skade dig selv eller tage dit eget liv.
English: Discuss with your doctor which methods would be suitable for you.
Danish: Tal med din læge om hvilke metoder, der passer til dig.
English: Your doctor will discuss all these points with you, using a checklist and will ask you (or a parent/guardian) to sign it.
Danish: - Din læge vil tale om alle disse punkter med dig ved hjælp af en tjekliste og vil bede dig (eller en forælder/værge) om at underskrive den.
English: These amendments to the relevant sections of the product information are the outcome of the referral procedure.
Danish: Disse ændringer til de relevanter punkter i produktinformationen er resultatet af referralproceduren.
English: However, discontinuation of <INN> may be insufficient to alleviate symptoms and therefore further psychiatric or psychological evaluation may be necessary.
Danish: Seponering af <INN> kan dog være utilstrækkelig til at lindre symptomer, og derfor kan yderligere psykiatrisk eller psykologisk vurdering være nødvendig.
English: However, there could be individual factors (e.g. damaged skin barrier, excessive use) that contribute to an increased systemic exposure.
Danish: Der kan dog være individuelle faktorer (f.eks. beskadiget hudbarriere, overdreven brug), som bidrager til en øget systemisk eksponering.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: Produktresuméet kan efterfølgende opdateres af medlemsstaternes kompetente myndigheder, i samarbejde med referencemedlemsstaten, hvor det er relevant, i overensstemmelse med bestemmelserne i kapitel 4, afsnit III i direktiv 2001/83/EC.
English: That may not be enough to stop the effects: you may need more help, and your doctor can arrange this.
Danish: Dette er muligvis ikke nok til at stoppe virkningerne: Du kan få brug for mere hjælp, og din læge kan sørge for dette.
English: The dates and results of pregnancy tests should be documented.
Danish: Dato og resultater af graviditetstest skal dokumenteres.
English: As these products will now be subject to additional monitoring the black symbol and relevant statement should be included preceding section 1.
Danish: Da disse produkter nu vil være omfattet af supplerende overvågning, bør det sorte symbol og relevante udsagn indgå forud for punkt 1.
English: Male patients should be reminded that they must not share their medication with anyone, particularly not females.
Danish: Mandlige patienter skal mindes om, at de ikke må dele deres medicin med nogen, slet ikke kvinder.
English: Awareness by family or friends may be useful to detect mental health deterioration.
Danish: Opmærksomhed udvist af familie eller venner kan være nyttig i opdagelsen af forringelse af den psykiske tilstand.
English: • The potential for pregnancy must be assessed for all female patients.
Danish: - Muligheden for graviditet skal vurderes for alle kvindelige patienter.
English: • Depression or related disorders.
Danish: • Depression eller relaterede lidelser.
English: − If you are pregnant
Danish: − Hvis du er gravid.
English: • She has acknowledged that she has understood the hazards and necessary precautions associated with the use of [INN].
Danish: - Hun har bekræftet, at hun har forstået de risici og de nødvendige forholdsregler, der er i forbindelse med brugen af [INN].
English: • Even if she has amenorrhea she must follow all the advice on effective contraception.
Danish: - Selv om hun har amenoré, skal hun følge alle råd om effektiv prævention.
English: • Some people have had thoughts or feelings about hurting themselves or ending their own lives (suicidal thoughts), have tried to end their own lives (attempted suicide), or have ended their lives (suicide).
Danish: • Nogle personer har haft tanker eller følelser om at skade sig selv eller tage deres eget liv (selvmordstanker), har forsøgt at tage deres eget liv (selvmordsforsøg) eller har taget deres eget liv (selvmord).
English: Follow-up visits
Danish: Opfølgende besøg
English: However, you must never share your medication with anyone.
Danish: Du må dog aldrig dele din medicin med nogen.
English: This is because of the risk of serious harm to the unborn baby
Danish: Dette skyldes risikoen for alvorlig skade på det ufødte barn.
English: These conditions also concern women who are not currently sexually active unless the prescriber considers that there are compelling reasons to indicate that there is no risk of pregnancy.
Danish: Disse betingelser vedrører også kvinder, der ikke aktuelt er seksuelt aktive, medmindre ordinerende læge mener, at der er overbevisende grunde til at indikere, at der ikke er nogen risiko for graviditet.
English: The levels of oral retinoid in the semen of men taking <TRADENAME> are too low to harm their partners' unborn baby.
Danish: Niveauet af oral retinoid i sæden hos mænd, der tager <HANDELSNAVN> er for lavt til at skade partnerens ufødte baby.
English: You should never give this medicinal product to another person.
Danish: Du må aldrig give dette lægemiddel til en anden person.
English: The same information is also available on the following URL: [URL to be included] <and the <NCA> website >>.
Danish: Samme oplysninger er også tilgængelige på følgende hjemmeside: [URL medtages] <og Lægemiddelstyrelsens hjemmeside>>.